UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
or
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-53772
WARNER CHILCOTT PUBLIC LIMITED COMPANY
(Exact name of Registrant as specified in its charter)
| Ireland | 98-0626948 | |
|
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
Unit 19 Ardee Business Park, Hale Street
Ardee, Co. Louth, Ireland
(Address of principal executive offices)
+353.41.685.6983
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ¨ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | x | Accelerated filer | ¨ | |||
| Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | ¨ | |||
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.) Yes ¨ No x
As of April 30, 2010, the registrant had 252,168,751 ordinary shares outstanding.
Items other than those listed above have been omitted because they are not applicable.
2
PART I. Financial Information
| Item 1. | Condensed Consolidated Financial Statements |
WARNER CHILCOTT PUBLIC LIMITED COMPANY
CONDENSED CONSOLIDATED BALANCE SHEETS
(All amounts in thousands except share amounts)
(Unaudited)
See accompanying notes to the unaudited condensed consolidated financial statements.
3
WARNER CHILCOTT PUBLIC LIMITED COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(All amounts in thousands except per share amounts)
(Unaudited)
|
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
|||||||
|
REVENUE |
||||||||
|
Net sales |
$ | 709,456 | $ | 239,024 | ||||
|
Other revenue |
51,846 | 6,965 | ||||||
|
Total revenue |
761,302 | 245,989 | ||||||
|
COSTS, EXPENSES AND OTHER |
||||||||
|
Cost of sales (excludes amortization of intangible assets) |
217,436 | 48,750 | ||||||
|
Selling, general and administrative |
320,057 | 46,766 | ||||||
|
Research and development |
31,148 | 23,872 | ||||||
|
Amortization of intangible assets |
160,912 | 56,993 | ||||||
|
Interest (income) |
(43 | ) | (65 | ) | ||||
|
Interest expense |
72,441 | 18,082 | ||||||
|
(LOSS) / INCOME BEFORE TAXES |
(40,649 | ) | 51,591 | |||||
|
(Benefit) / provision for income taxes |
(23,406 | ) | 8,255 | |||||
|
NET (LOSS) / INCOME |
$ | (17,243 | ) | $ | 43,336 | |||
|
(Loss) / Earnings per share: |
||||||||
|
Basic |
$ | (0.07 | ) | $ | 0.17 | |||
|
Diluted |
$ | (0.07 | ) | $ | 0.17 | |||
See accompanying notes to the unaudited condensed consolidated financial statements.
4
WARNER CHILCOTT PUBLIC LIMITED COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
See accompanying notes to the unaudited condensed consolidated financial statements.
5
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
1. General
The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States (U.S. GAAP) for complete consolidated financial statements have been condensed or are not included herein. The interim statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31, 2009 (the Annual Report).
The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim condensed consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. The Company has made certain reclassifications to prior period information to conform to the current period presentation. The Company is responsible for the unaudited interim condensed consolidated financial statements included in this document. All intercompany transactions and balances have been eliminated in consolidation.
In periods prior to the quarter ended September 30, 2009, the Companys consolidated financial statements presented the accounts of Warner Chilcott Limited, a Bermuda company, and all of its wholly-owned subsidiaries. In August 2009, the Company completed its redomestication from Bermuda to Ireland. As a result of the transaction, Warner Chilcott Public Limited Company, a public limited company organized in, and a tax resident of, Ireland, became the ultimate public holding company of the Warner Chilcott group. References throughout to we, our or the Company refer to Warner Chilcott Limited and its subsidiaries prior to the redomestication and to Warner Chilcott Public Limited Company and its subsidiaries since the redomestication. In addition, references throughout to ordinary shares refer to Warner Chilcott Limiteds Class A common shares, par value $0.01 per share, prior to the redomestication and to the Companys ordinary shares, par value $0.01 per share, since the redomestication.
2. Summary of Significant Accounting Policies
The following policies had significant changes from Note 2 of the Companys 2009 audited consolidated financial statements included in the Annual Report and below are required interim updates.
Revenue Recognition
Revenue from product sales is recognized when title and risk of loss to the product transfers to the customer, which is based on the transaction shipping terms. Recognition of revenue also requires reasonable assurance of the collection of a fixed amount of sales proceeds and the completion of all performance obligations. The Company warrants products against defects and for specific quality standards, permitting the return of products under certain circumstances. Product sales are recorded net of all sales-related deductions including, but not limited to: sales returns, rebates, customer loyalty programs and fee for service arrangements with certain distributors. The Company establishes accruals for its sales-related deductions in the same period that it recognizes the related sales based on select criteria for estimating such contra revenues including, but not limited to: estimated utilization or redemption rates, costs related to the programs and other historical data. These reserves reduce revenues and are included as either a reduction of accounts receivable or as a component of accrued expenses. Included in net sales are amounts earned under contract manufacturing agreements with third parties.
On October 30, 2009, pursuant to the purchase agreement dated August 24, 2009 (as amended, the Purchase Agreement), between the Company and The Procter & Gamble Company (P&G), the Company acquired the global branded prescription pharmaceutical business (PGP) of P&G for $2,919,261 in cash and the assumption of certain liabilities (the PGP Acquisition). As a result of the PGP Acquisition, the Company began to offer Medicare rebates and assumed significant managed care contracts. The costs incurred by the Company in connection with these rebates are considered sales-related deductions which reduce reported net sales. The Company estimates the accruals for these programs, based on estimated utilization rates, costs related to the programs and other historical data.
On March 30, 2010 the Patient Protection and Affordable Care Act of 2010 was signed into law. This law impacts the Companys net sales by increasing certain rebates it pays per prescription, most notably Medicaid rebates. The new law is not expected to have a material impact on the Companys revenues.
As of March 31, 2010 and December 31, 2009, the amounts related to all sales-related deductions included as a reduction of accounts receivable were $37,168 and $41,828, respectively. The amounts included in accrued liabilities were $352,698 and $333,292 as of March 31, 2010 and December 31, 2009, respectively. The provisions recorded to reduce gross sales to net sales were $218,417 and $49,318 in the quarters ended March 31, 2010 and 2009, respectively.
The Company recognizes revenue related to licensing rights to sell products using the Companys patents, based on third-party sales, as earned in accordance with contractual terms when the third-party sales can be reasonably estimated and collection is reasonably assured. These amounts are included as a component of other revenue. The Company also has agreements with other pharmaceutical companies to co-promote certain products. Revenues and related product costs are recognized on a gross basis in transactions where the Company
6
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
is deemed to be the principal in the transaction. Revenues earned based on a percentage of the co-promotion partners net sales are recognized, on a net basis, when the co-promotion partners ship the related products and title passes to their customers. Contractual payments due to co-promotion partners are included within selling, general & administrative (SG&A) expense and contractual payments due from co-promotion partners are included within other revenue. Total other revenue for the quarters ended March 31, 2010 and 2009 was $51,846 and $6,965, respectively.
3. PGP Acquisition
As discussed above, on October 30, 2009, the Company acquired PGP for $2,919,261 in cash and the assumption of certain liabilities. Under the terms of the Purchase Agreement, the Company acquired P&Gs portfolio of branded pharmaceutical products, prescription drug pipeline, manufacturing facilities in Puerto Rico and Germany and a net receivable owed from P&G of approximately $60,000. The total purchase price of $2,919,261 was allocated to the estimated fair value of the assets acquired and liabilities assumed as of the acquisition date.
The acquisition of PGP was accounted for as a business combination using the acquisition method of accounting. The results of operations of PGP since October 30, 2009 have been included in the Companys condensed consolidated statement of operations. The purchase price allocation as of December 31, 2009 previously presented in the Annual Report, as well as the purchase price allocation as of March 31, 2010 is considered preliminary pending completion of the final valuation.
The goodwill associated with this acquisition is reported within the Companys North American segment. The goodwill results from expected synergies from the transaction, including complementary products that will enhance the Companys overall product portfolio, which the Company believes will result in incremental revenue and profitability. During the quarter ended March 31, 2010, the increase in goodwill shown below was the result of fair value adjustments to the identifiable net assets acquired. Final determination of the fair values may result in further adjustments to these values.
|
As of
December 31, 2009 |
Quarter Ended
March 31, 2010 Adjustments |
As
of
March 31, 2010 |
|||||||
|
Purchase Price: |
|||||||||
|
Cash consideration |
$ | 2,919,261 | | $ | 2,919,261 | ||||
|
Identifiable net assets: |
|||||||||
|
Total identifiable net assets |
$ | 2,857,325 | (32,688 | ) | $ | 2,824,637 | |||
|
Goodwill |
61,936 | 32,688 | 94,624 | ||||||
|
Total |
$ | 2,919,261 | | $ | 2,919,261 | ||||
4. LEO Transaction
On September 23, 2009, the Company entered into a definitive asset purchase agreement (the LEO Transaction Agreement) with LEO Pharma A/S (LEO) pursuant to which LEO paid the Company $1,000,000 in cash in order to terminate the Companys exclusive license to distribute LEOs DOVONEX and TACLONEX products (including all dermatology products in LEOs development pipeline) in the United States and to acquire certain assets related to the Companys distribution of DOVONEX and TACLONEX products in the United States. The transaction (the LEO Transaction) closed simultaneously with the execution of the LEO Transaction Agreement. In connection with the LEO Transaction, the Company entered into a distribution agreement with LEO pursuant to which the Company agreed to, among other things, (1) continue to distribute DOVONEX and TACLONEX on behalf of LEO, for a distribution fee, through September 23, 2010 and (2) purchase inventories of DOVONEX and TACLONEX from LEO. In addition, the Company agreed to provide certain transition services for LEO for a period of up to one year after the closing.
The LEO Transaction resulted in a gain of $393,095 (or $380,088, net of tax). In addition, during the third quarter of 2009, the Company recorded a deferred gain of $68,919 relating to the sale of certain inventories to LEO in connection with the LEO Transaction. In the fourth quarter of 2009, the Company recognized $34,184 of the deferred gain as a reduction to cost of sales ($33,500 net of tax). In the quarter ended March 31, 2010, the Company recognized $25,111 of the deferred gain as a reduction to cost of sales ($24,609 net of tax). The remaining $9,624 of the deferred gain is expected to be recognized during the remainder of 2010 as the Company continues to distribute products for LEO under the distribution agreement. The aggregate gain from the LEO Transaction is expected to be $462,014 (or $447,629 net of tax).
5. Earnings Per Share (EPS)
The Company accounts for EPS in accordance with Financial Accounting Standards Board Accounting Standards Codification (ASC) Topic 260, Earnings Per Share and related guidance, which requires two calculations of EPS to be disclosed: basic and diluted. The numerator in calculating basic and diluted EPS is an amount equal to consolidated net (loss) / income for the periods presented. The denominator in calculating basic EPS is the weighted average shares outstanding for the respective periods. The
7
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
denominator in calculating diluted EPS is the weighted average shares outstanding plus the dilutive effect of stock option grants and restricted share grants or their equivalent, when applicable. The following is the calculation of EPS for the quarters ended March 31, 2010 and 2009, respectively:
|
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
||||||
|
Net (loss) / income available to ordinary shareholders |
$ | (17,243 | ) | $ | 43,336 | ||
|
Weighted average number of ordinary and potential ordinary shares outstanding: |
|||||||
|
Basic number of ordinary shares outstanding |
251,003,407 | 250,390,945 | |||||
|
Dilutive effect of stock option grants and unvested restricted stock grants or their equivalent |
| 212,584 | |||||
|
Diluted number of ordinary and potential ordinary shares outstanding |
251,003,407 | 250,603,529 | |||||
|
(Loss)/earnings per ordinary share: |
|||||||
|
Basic |
$ | (0.07 | ) | $ | 0.17 | ||
|
Diluted |
$ | (0.07 | ) | $ | 0.17 | ||
|
Amounts not included in calculation of diluted EPS as their impact was anti-dilutive under the treasury stock method: |
|||||||
|
Stock options to purchase ordinary shares |
8,035,816 | 6,569,527 | |||||
|
Unvested restricted stock grants or their equivalent |
1,118,539 | 707,176 | |||||
6. Collaboration Arrangements
As a result of the PGP Acquisition, the Company became party to new collaborative arrangements to develop and commercialize drug candidates. Collaborative activities include research and development, marketing and selling (including promotional activities and physician detailing), and manufacturing and distribution. These collaborative arrangements often require milestone and royalty or profit share payments, as well as expense reimbursements or payments to the third party. Each collaborative arrangement is unique in nature and the Companys more significant arrangements are discussed below.
Sanofi
The Company and Sanofi-Aventis U.S. LLC (Sanofi) are parties to an agreement to co-promote ACTONEL on a global basis, excluding Japan (as amended, the Actonel Collaboration Agreement). Pursuant to the Actonel Collaboration Agreement, a joint oversight committee comprised of equal representation from the Company and Sanofi is responsible for overseeing the development and promotion of ACTONEL. The Companys and Sanofis rights and obligations are specified by geographic market. In certain geographic markets, the Company and Sanofi share selling and advertising and promotion (A&P) costs as well as product profits based on contractual percentages. In the geographic markets where the Company is deemed to be the principal in transactions with customers, the Company recognizes all revenues from sales of the product along with the related product costs. The Companys share of selling, A&P and contractual profit sharing expenses are recognized in SG&A expenses. In geographic markets where the Company is not the principal in transactions with customers, revenue is recognized on a net basis, in other revenue for amounts earned based on Sanofis sale transactions with its customers. The Actonel Collaboration Agreement expires on January 1, 2015. For the quarter ended March 31, 2010, the Company recognized net sales and other revenue related to ACTONEL of $235,722 and $26,586, respectively, and co-promotion expenses of $107,094 were recognized in SG&A expense.
In April 2010, the Company and Sanofi entered into an amendment to the Actonel Collaboration Agreement. Under the terms of the amendment, the Company took full operational control over the promotion, marketing and research & development (R&D) decisions for ACTONEL in the United States and Puerto Rico, and assumed responsibility for all associated costs relating to those activities. Prior to the amendment, the Company shared such costs with Sanofi in these territories. The Company remained the principal in transactions with customers in the United States and Puerto Rico and continues to invoice all sales in these territories. In return, it was agreed that Sanofi would receive, as part of the global collaboration payments between the parties, collaboration payments from the Company based on an agreed upon percentage of U.S. and Puerto Rico net sales for the remainder of the term of the Actonel Collaboration Agreement, which expires on January 1, 2015.
Novartis
The Company and Novartis Pharmaceuticals Corporation (Novartis) are parties to an agreement to co-promote ENABLEX, developed by Novartis, in the U.S. The Company shares expenses with Novartis pursuant to the agreement and these costs are included within SG&A. The Company receives a contractual percentage of Novartis sales of ENABLEX, which is recorded, on a net basis, in other revenue. Under the agreement which expires in August 2016, the Company may be required to make payments to Novartis upon the achievement of various sales milestones that could aggregate up to $15,000. For the quarter ended March 31, 2010, the Company recognized other revenue related to ENABLEX of $18,180.
8
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
7. Inventories
Inventories consist of the following:
|
As of
March 31, 2010 |
As of
December 31, 2009 |
|||||
|
Finished goods |
$ | 108,172 | $ | 179,347 | ||
|
Work-in-progress/Bulk |
26,465 | 34,084 | ||||
|
Raw materials |
23,285 | 22,772 | ||||
|
Total |
$ | 157,922 | $ | 236,203 | ||
Amounts above are net of $7,568 and $7,495 related to inventory obsolescence reserves as of March 31, 2010 and December 31, 2009, respectively. As of December 31, 2009, finished goods inventories included a fair market value step-up adjustment related to the PGP Acquisition of $105,504. This increase in the cost of inventory resulting from purchase accounting was recognized in the statement of operations in the quarter ended March 31, 2010. Product samples are stated at cost ($6,482 and $5,017 as of March 31, 2010 and December 31, 2009, respectively) and are included in prepaid expenses and other current assets.
8. Goodwill and Intangible Assets
The Companys goodwill and a trademark have been deemed to have indefinite lives and are not amortized. The following table represents the Companys changes in goodwill:
|
Balance, December 31, 2009 |
$ | 1,060,644 | |
|
Increase as a result of fair value adjustments to identifiable net assets acquired in the PGP Acquisition |
32,688 | ||
|
Balance, March 31, 2010 |
$ | 1,093,332 | |
In-process research and development (IPR&D) acquired through the acquisition of a business is capitalized as non-amortizable intangible assets. These costs will begin to be amortized if the associated regulatory approval is received. If regulatory approval is not received, and the R&D study is considered to be no longer viable, the IPR&D would be considered impaired. Until such time that both events occur, IPR&D is treated as an indefinite-lived intangible asset. The Companys licensing agreements and certain trademarks that do not have indefinite lives are being amortized on either a straight-line or accelerated basis over their useful lives not to exceed 15 years.
The Companys intangible assets as of March 31, 2010 consist of the following components:
|
Gross Carrying
Value |
Accumulated
Amortization |
Net Carrying
Value |
|||||||
|
Definite-lived intangible assets |
|||||||||
|
ASACOL |
$ | 1,850,206 | $ | 100,516 | $ | 1,749,690 | |||
|
ACTONEL |
525,938 | 79,989 | 445,949 | ||||||
|
ESTRACE Cream |
411,000 | 221,189 | 189,811 | ||||||
|
OVCON / FEMCON FE product family |
401,000 | 352,395 | 48,605 | ||||||
|
DORYX |
331,300 | 167,305 | 163,995 | ||||||
|
FEMHRT product family |
318,500 | 287,506 | 30,994 | ||||||
|
ESTROSTEP FE |
199,100 | 189,368 | 9,732 | ||||||
|
ENABLEX |
90,731 | 9,267 | 81,464 | ||||||
|
Other products intellectual property |
237,362 | 133,110 | 104,252 | ||||||
|
Total Definite-lived intangible assets |
4,365,137 | 1,540,645 | 2,824,492 | ||||||
|
Indefinite-lived intangible assets |
|||||||||
|
Trademark |
30,000 | | 30,000 | ||||||
|
IPR&D |
247,588 | | 247,588 | ||||||
|
Total intangible assets, net |
$ | 4,642,725 | $ | 1,540,645 | $ | 3,102,080 | |||
9
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
Aggregate amortization expense related to intangible assets was $160,912 (including $120,845 for the newly acquired PGP products) and $56,993 for the quarters ended March 31, 2010 and 2009, respectively. The Company continuously reviews its products remaining useful lives based on each products estimated future cash flows. As of March 31, 2010, estimated amortization expense based on current forecasts (excluding indefinite-lived intangible assets) for the remainder of 2010 and for each of the next five years was as follows:
| Amortization | |||
|
2010 |
$ | 472,948 | |
|
2011 |
498,537 | ||
|
2012 |
409,172 | ||
|
2013 |
362,433 | ||
|
2014 |
291,712 | ||
|
2015 |
215,168 | ||
|
Thereafter |
574,522 | ||
| $ | 2,824,492 | ||
9. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following:
|
As of
March 31, 2010 |
As of
December 31, 2009 |
|||||
|
Product rebate accruals (commercial and government) |
$ | 190,870 | $ | 182,017 | ||
|
ACTONEL co-promotion liability |
154,702 | 169,114 | ||||
|
Sales return reserves |
103,027 | 106,378 | ||||
|
Customer loyalty and coupon programs |
58,801 | 44,897 | ||||
|
Payroll, commissions, and employee costs |
43,469 | 33,677 | ||||
|
Severance accruals |
28,688 | 33,133 | ||||
|
Contractual obligations |
22,786 | 21,787 | ||||
|
Professional fees |
16,753 | 18,002 | ||||
|
Research and development expense accruals |
10,181 | 7,101 | ||||
|
Value-added tax liabilities |
8,664 | 7,465 | ||||
|
Obligations under product licensing and distribution agreements |
6,661 | 6,361 | ||||
|
Advertising and promotion |
4,680 | 8,829 | ||||
|
Deferred income |
4,137 | 5,741 | ||||
|
Uncertain tax positions(1) |
1,943 | 1,943 | ||||
|
Interest payable |
470 | 3,729 | ||||
|
Other |
16,044 | 18,629 | ||||
|
Total |
$ | 671,876 | $ | 668,803 | ||
| (1) | As of March 31, 2010 and December 31, 2009, all income tax liabilities were related to reserves recorded under ASC Topic 740, Accounting for Income Taxes, (ASC 740). In addition, income tax reserves included as a component of other non-current liabilities as of March 31, 2010 and December 31, 2009 totaled $9,694, respectively. |
10. Indebtedness
New Senior Secured Credit Facilities
On October 30, 2009, Warner Chilcott Holdings Company III, Limited (Holdings III), WC Luxco S.à r.l. (the Luxco Borrower), Warner Chilcott Corporation (WCC) (the US Borrower) and Warner Chilcott Company, LLC (WCCL) (the PR Borrower, and together with the Luxco Borrower and the US Borrower, the Borrowers) entered into a credit agreement (the Credit Agreement) with a syndicate of lenders (the Lenders), Credit Suisse, Cayman Islands Branch as administrative agent, Bank of America Securities LLC as syndication agent and JPMorgan Chase Bank, N.A. as documentation agent, pursuant to which the Lenders provided senior secured credit facilities (the New Senior Secured Credit Facilities) in an aggregate amount of $3,200,000 comprised of (i) $2,950,000 in aggregate term loan facilities and (ii) a $250,000 revolving credit facility that is available to all Borrowers. The term loan facilities were comprised of (i) a $1,000,000 Term A facility that matures on October 31, 2014 and (ii) a $1,600,000 Term B
10
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
facility and a $350,000 delayed-draw term loan facility that mature on April 30, 2015. On December 16, 2009, the Borrowers entered into an amendment (Amendment No. 1) to the Credit Agreement, pursuant to which the Credit Agreement was amended to create a new tranche of term loans (the Additional Term Loans) which was borrowed on December 30, 2009 by the US Borrower in an aggregate principal amount of $350,000 in order to finance, together with cash on hand, the repurchase or redemption (as described below) of any and all of the issued and outstanding Notes. On December 16, 2009, the outstanding delayed-draw term loan facility was terminated. The revolving credit facility provides for a $20,000 sublimit for swing line loans and a $50,000 sublimit for the issuance of standby letters of credit. Any swing line loans and letters of credit would reduce the available commitment under the revolving credit facility on a dollar-for-dollar basis. The interest rates on the borrowings under the New Senior Secured Credit Facilities, other than swing line loans, are (i) for the Term A facility, LIBOR (with a floor of 2.25%) plus 3.25%, or ABR, as defined, plus 2.25% and (ii) for the Term B facility, the revolving credit facility and the Additional Term Loans, LIBOR (with a floor of 2.25%) plus 3.50% or ABR, as defined, plus 2.50%. The carrying amounts reported in the consolidated balance sheets as of March 31, 2010 and December 31, 2009 for the Companys debt outstanding under its New Senior Secured Credit Facilities approximates fair value since interest is at variable rates and it re-prices frequently.
The loans and other obligations under the New Senior Secured Credit Facilities (including in respect of hedging agreements and cash management obligations) are (i) guaranteed by Holdings III and substantially all of its subsidiaries (subject to certain exceptions and limitations) and (ii) secured by substantially all of the assets of the Borrowers and each guarantor (subject to certain exceptions and limitations). As a result of making optional prepayments of $400,000 in the quarter ended March 31, 2010 the current portion of the long-term debt was reduced to $140,490. As of March 31, 2010 there were letters of credit totaling $1,500 outstanding. As a result, the Company had $248,500 available under the revolving credit facility as of March 31, 2010.
Prior Senior Secured Credit Facilities
On January 18, 2005, Holdings III and its subsidiaries, WCC and WCCL, entered into the $1,790,000 prior senior secured credit facilities (the Prior Senior Secured Credit Facilities) with Credit Suisse as administrative agent and lender, and the other lenders and parties thereto. The Prior Senior Secured Credit Facilities consisted of $1,640,000 of term loans (including $240,000 of delayed-draw term loans) and a $150,000 revolving credit facility, of which $30,000 and $15,000 were available for letters of credit and swing line loans, respectively, to WCC and WCCL. All of the remaining outstanding debt under the Prior Senior Secured Credit Facilities was repaid with a portion of the proceeds of the LEO Transaction in September 2009.
8.75% Notes
On January 18, 2005, WCC, a wholly-owned U.S. subsidiary, issued $600,000 aggregate principal amount of Notes. The Notes were initially guaranteed on a senior subordinated basis by the Company, Holdings III, WC Luxco S.à.r.l., Warner Chilcott Intermediate (Luxembourg) S.à.r.l., WC Pharmaceuticals I Limited, the U.S. operating subsidiary (Warner Chilcott (US), LLC) and WCCL. Interest payments on the Notes were due semi-annually in arrears on each February 1 and August 1. The issuance costs related to the Notes were being amortized to interest expense over the ten-year term of the Notes using the effective interest method.
On December 15, 2009, WCC commenced a cash tender offer pursuant to an Offer to Purchase and Consent Solicitation (the Offer to Purchase) for any and all of its then remaining $380,000 aggregate principal amount of outstanding Notes. In connection with the Offer to Purchase, WCC purchased $290,540 aggregate principal amount of the Notes in December of 2009 for a total price of $304,341 (104.75% of the principal amount), plus accrued interest. Following the Companys acceptance for purchase of $290,540 aggregate principal amount of the Notes on December 30, 2009, $89,460 aggregate principal amount of the Notes remained outstanding. In January of 2010, pursuant to the Offer to Purchase, WCC received and accepted for purchase approximately $2,000 aggregate principal amount of additional Notes. Finally, on February 1, 2010, WCC redeemed all of the remaining outstanding Notes in accordance with the Indenture. The redemption price for the redeemed Notes was $1,043.75 per $1,000.00 principal amount plus accrued and unpaid interest. The interest premium recognized in the condensed consolidated statement of operations as a result of the tender offer was $3,914 in the quarter ended March 31, 2010.
Components of Indebtedness
As of March 31, 2010, the Companys outstanding funded debt was solely comprised of the New Senior Secured Credit Facilities. As of March 31, 2010, mandatory principal repayments of long-term debt in the remainder of 2010 and each of the five years ending December 31, 2011 through 2015 were as follows:
|
Year Ending December 31, |
Aggregate
Maturities |
||
|
2010 |
$ | 86,617 | |
|
2011 |
215,490 | ||
|
2012 |
215,490 | ||
|
2013 |
215,490 | ||
|
2014 |
315,490 | ||
|
2015 |
1,471,548 | ||
|
Total long-term debt |
$ | 2,520,125 | |
11
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
11. Stock-Based Compensation Plans
The Companys stock-based compensation, including grants of non-qualified options to purchase ordinary shares and grants of restricted ordinary shares or their equivalent, is measured at fair value on the date of grant and is recognized in the statement of operations as compensation expense over the applicable vesting periods. Total stock-based compensation expense recognized for the quarters ended March 31, 2010 and 2009 was $4,683 and $2,632, respectively. Unrecognized future compensation expense was $32,288 as of March 31, 2010, which will be recognized as an expense over a remaining weighted average period of 1.24 years.
In establishing the value of the options on the grant dates, the Company uses its actual historical volatility for its ordinary shares to estimate its expected future volatility at each grant date. The fair value of options is determined on the grant dates using the Black-Scholes method of valuation and that amount is recognized as an expense over the four year vesting period. The options have a term of ten years. The Company assumed that the options would be exercised, on average, in six years. Using the Black-Scholes valuation model, the fair value of the options was determined using the following assumptions:
| 2010 Grants | 2009 Grants | |||
|
Dividend yield |
None | None | ||
|
Expected volatility |
35.00% | 35.00% | ||
|
Risk-free interest rate |
3.61 3.83% | 2.35 3.84% | ||
|
Expected term (years) |
6.00 | 6.00 |
The weighted average remaining contractual term of all outstanding options to purchase ordinary shares granted is 7.87 years.
The following is a summary of the equity award activity for unvested restricted ordinary shares, or their equivalent, in the period from December 31, 2009 through March 31, 2010:
| Restricted Share Grants | ||||||
|
(in thousands except per share amounts) |
Number of
Ordinary Shares |
Weighted
Average Fair Value on Grant Date |
||||
|
Unvested restricted ordinary shares at December 31, 2009 |
775 | $ | 14.52 | |||
|
Granted shares |
420 | 27.18 | ||||
|
Vested shares |
(180 | ) | 14.18 | |||
|
Forfeited shares |
(15 | ) | 16.24 | |||
|
Unvested restricted ordinary shares at March 31, 2010 |
1,000 | $ | 19.87 | |||
The following is a summary of the equity award activity for non-qualified options to purchase ordinary shares in the period from December 31, 2009 through March 31, 2010:
| Options to Purchase Ordinary Shares | |||||||||
|
(in thousands except per share amounts) |
Number of
Options |
Weighted
Average Fair Value on Grant Date |
Weighted
Average Exercise Price |
||||||
|
Balance at December 31, 2009 |
6,321 | $ | 4.14 | $ | 16.93 | ||||
|
Granted options |
1,898 | 10.96 | 27.02 | ||||||
|
Exercised options |
(121 | ) | 6.73 | 15.20 | |||||
|
Forfeited options |
(62 | ) | 6.16 | 15.28 | |||||
|
Balance at March 31, 2010 |
8,036 | $ | 5.70 | $ | 19.35 | ||||
|
Vested and exercisable at March 31, 2010 |
3,363 | $ | 2.76 | $ | 19.39 | ||||
The intrinsic value of non-qualified options to purchase ordinary shares is calculated as the difference between the closing price of the Companys ordinary shares and the exercise price of the non-qualified options that had a strike price below the closing price. The intrinsic value for the non-qualified options to purchase ordinary shares, that are in the money as of March 31, 2010, is as follows:
| (in thousands except per share amounts) |
Number of
options |
Weighted
Average Exercise Price |
Closing
Stock Price |
Intrinsic
Value |
|||||||
|
Balance outstanding at March 31, 2010 |
6,130 | $ | 16.96 | $ | 25.52 | $ | 52,473 | ||||
|
Vested and exercisable at March 31, 2010 |
3,363 | $ | 19.39 | $ | 25.52 | $ | 20,615 | ||||
12
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
12. Commitments and Contingencies
Product Development Agreements
In July 2007, the Company entered into an agreement with Paratek Pharmaceuticals, Inc. (Paratek) under which the Company acquired certain rights to novel tetracyclines under development for the treatment of acne and rosacea. The Company paid an upfront fee of $4,000 and agreed to reimburse Paratek for R&D expenses incurred during the term of the agreement. The Company may make additional payments to Paratek upon the achievement of various developmental milestones that could aggregate up to $24,500. In addition, the Company agreed to pay royalties to Paratek based on the net sales, if any, of the products covered under the agreement.
In December 2008, the Company signed an agreement with Dong-A PharmTech Co. Ltd. (Dong-A), to develop and if approved market its orally-administered udenafil product, a PDE5 inhibitor, for the treatment of erectile dysfunction (ED) in the United States. The Company paid $2,000 in connection with signing the agreement. In March 2009, the Company paid $9,000 to Dong-A, which was included in R&D expense in the quarter ended March 31, 2009, upon the achievement of a developmental milestone under the agreement. The Company agreed to pay for all development costs incurred during the term of the agreement and may make additional payments to Dong-A of $13,000 upon the achievement of contractually-defined milestones in relation to the ED product. In addition, the Company agreed to pay a profit-split to Dong-A based on operating profit (as defined in the agreement), if any, on the product.
In April 2010, the Company amended its agreement with Dong-A to add the right to develop, and if approved, market in the U.S. and Canada, Dong-As udenafil product for the treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH). The Company currently is preparing to commence Phase II clinical trials for the BPH indication. This amendment resulted in the Company making an up-front payment to Dong-A of $20,000 in April 2010. This amount will be included as R&D expense during the quarter ended June 30, 2010. Under the amendment, the Company may make additional payments to Dong-A in an aggregate amount of $25,000 upon the achievement of contractually-defined milestones in relation to the BPH product. These payments would be in addition to the potential milestone payments in relation to the ED product described above. The Company also agreed to pay Dong-A a percentage of net sales of the BPH product in the U.S. and Canada, if any.
In February 2009, the Company acquired the U.S. rights to NexMed Inc.s (NexMed) topically applied alprostadil cream for the treatment of ED and the previous license agreement between the Company and NexMed relating to the product was terminated. Under the terms of the acquisition agreements, the Company paid NexMed an up-front payment of $2,500, which was included in R&D expense in the quarter ended March 31, 2009, and agreed to pay a milestone payment of $2,500 to NexMed upon the Food and Drug Administrations (FDA) approval of the product New Drug Application. The Company is currently working to prepare its complete response to the non-approvable letter that the FDA delivered to NexMed in July 2008 with respect to the product.
Product Development Agreements PGP Acquisition
As part of the PGP Acquisition, the Company became party to certain agreements including the following:
In July 2005, PGP entered into a co-development and co-promotion agreement with Novartis under which Novartis agreed to co-develop and co-promote ENABLEX. Under the agreement, the Company may be required to make payments to Novartis upon the achievement of various sales and developmental milestones that could aggregate up to $15,000.
In June 2006, PGP entered into an agreement with Watson Pharmaceuticals, Inc. (Watson) under which PGP acquired the rights to certain products under development relating to transdermal delivery systems for testosterone for use in females. Under the product development agreement, the Company may be required to make additional payments to Watson upon the achievement of various developmental milestones that could aggregate up to $25,000. Further, the Company agreed to pay a supply fee and royalties to Watson on the net sales of those products.
In June 2007, PGP entered into an agreement with Dong Wha Pharm. Ind. Co. Ltd. (Dong-Wha). Under the agreement, PGP acquired an exclusive license to develop, manufacture and commercialize compounds world wide, excluding Asia, for the treatment of osteoporosis. The agreement permits termination by the Company upon 90 days notice. In April 2010, the Company notified Dong-Wha of its intent to terminate the agreement. The termination will be effective in July 2010. The Company has no further payment obligations to Dong-Wha.
Other
The Company and Sanofi are parties to the Actonel Collaboration Agreement. Pursuant to the Actonel Collaboration Agreement, a joint oversight committee comprised of equal representation from the Company and Sanofi is responsible for overseeing the development and
13
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
promotion of ACTONEL. The rights and obligations of the Company and Sanofi are specified by geographic market. In certain geographic markets, the Company and Sanofi share development and promotion costs as well as product profits based on contractual percentages. Pursuant to this agreement, the Company is obligated to incur an agreed upon amount for A&P and selling each fiscal year in certain countries. See Note 19 for a discussion of the recent amendment of the Actonel Collaboration Agreement with respect to the U.S. and Puerto Rico.
As mentioned above, the Company and Novartis are parties to an agreement to co-promote ENABLEX, developed by Novartis, in the United States. The Company and Novartis share development and promotion costs pursuant to the agreement. Such costs incurred by the Company are included within SG&A. The Company receives a contractual percentage of Novartis sales of ENABLEX, which is recorded on a net basis in other revenue. Pursuant to this agreement, the Company is obligated to incur an agreed upon amount for A&P and selling each fiscal year.
13. Legal Proceedings
General Matters
The Company is involved in various legal proceedings in the normal course of its business, including product liability and other litigation. The Company records reserves related to legal matters when losses related to such litigation or contingencies are both probable and reasonably estimable. The Company maintains insurance with respect to potential litigation in the normal course of its business based on its consultation with its insurance consultants and outside legal counsel, and in light of current market conditions, including cost and availability. In addition, the Company self-insures for certain liabilities not covered under its litigation insurance based on estimates of potential claims developed in consultation with its insurance consultants and outside legal counsel.
The following discussion is limited to the Companys material on-going legal proceedings, including the Companys legal proceedings as a result of the PGP Acquisition:
Hormone Therapy Product Liability Litigation
Approximately 716 product liability suits, including some with multiple plaintiffs, have been filed against, or tendered to, the Company related to its hormone therapy (HT) products, FEMHRT, ESTRACE, ESTRACE Cream and medroxyprogesterone acetate. Under the purchase and sale agreement pursuant to which the Company acquired FEMHRT from Pfizer Inc. (Pfizer) in 2003, the Company agreed to assume certain product liability exposure with respect to claims made against Pfizer after March 5, 2003 and tendered to the Company relating to FEMHRT products. The cases are in the early stages of litigation and the Company is in the process of analyzing and investigating the individual complaints.
The lawsuits were likely triggered by the July 2002 and March 2004 announcements by the National Institute of Health (NIH) of the terminations of two large-scale randomized controlled clinical trials, which were part of the Womens Health Initiative (WHI), examining the long-term effect of HT on the prevention of coronary heart disease and osteoporotic fractures, and any associated risk for breast cancer in postmenopausal women. In the case of the trial terminated in 2002, which examined combined estrogen and progestogen therapy (the E&P Arm of the WHI Study), the safety monitoring board determined that the risks of long-term estrogen and progestogen therapy exceeded the benefits, when compared to a placebo. WHI investigators found that combined estrogen and progestogen therapy did not prevent heart disease in the study subjects and, despite a decrease in the incidence of hip fracture and colorectal cancer, there was an increased risk of invasive breast cancer, coronary heart disease, stroke, blood clots and dementia. In the trial terminated in 2004, which examined estrogen therapy, the trial was ended one year early because the NIH did not believe that the results were likely to change in the time remaining in the trial and that the increased risk of stroke could not be justified for the additional data that could be collected in the remaining time. As in the E&P Arm of the WHI study, WHI investigators again found that estrogen only therapy did not prevent heart disease and, although study subjects experienced fewer hip fractures and no increase in the incidence of breast cancer compared to subjects randomized to placebo, there was an increased incidence of stroke and blood clots in the legs. The estrogen used in the WHI Study was conjugated equine estrogen and the progestin was medroxyprogesterone acetate, the compounds found in Premarin ® and Prempro, products marketed by Wyeth (now a part of Pfizer). Numerous lawsuits were filed against Wyeth, as well as against other manufacturers of HT products, after the publication of the summary of the principal results of the E&P Arm of the WHI Study.
Approximately 80% of the complaints filed against, or tendered to, the Company did not specify the HT drug alleged to have caused the plaintiffs injuries. These complaints broadly allege that the plaintiff suffered injury as a result of an HT product. The Company has sought the dismissal of lawsuits that, after further investigation, do not involve any of our products. The Company has successfully reduced the number of HT suits it will have to defend. Of the approximately 716 suits that were filed against, or tendered to, the Company, 477 have been dismissed and 94 involving ESTRACE have been successfully tendered to Bristol-Myers pursuant to an indemnification provision in the asset purchase agreement pursuant to which we acquired ESTRACE. The purchase agreement included an indemnification agreement whereby Bristol-Myers indemnified the Company for product liability exposure associated with ESTRACE products that were shipped prior to July 2001. The Company has forwarded agreed upon dismissal notices in another 20 cases to plantiffs counsel.
14
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
ONJ Product Liability Litigation
The Company is a defendant in approximately 83 cases involving 91 plaintiffs who allege, among other things, that the Companys bisphosphonate drug ACTONEL caused them to suffer osteonecrosis of the jaw (ONJ), a rare but serious condition that involves severe loss, or destruction, of the jawbone. These cases have been filed in either federal or state courts in the United States, except for one lawsuit in provincial court in Canada. Sanofi, which co-promotes ACTONEL with the Company, is a defendant in most of the cases. In some of the cases, manufacturers of other bisphosphonate products are also named as defendants. Plaintiffs have typically asked for unspecified monetary and injunctive relief, as well as attorneys fees. In addition, the Company is aware of three other potential claimants who are under a tolling agreement suspending the statutes of limitation related to their claims. The Company is in the initial stages of discovery in the litigation, and cannot at this time predict the outcome of these lawsuits and claims or their financial impact. Under the Actonel Collaboration Agreement Sanofi has agreed to indemnify the Company, subject to certain limitations, for 50% of the losses from any product liability claims in the U.S. and Canada relating to ACTONEL brought prior to April 1, 2010, which would include ONJ-related claims that were pending as of March 31, 2010. Pursuant to the April 2010 amendment to the Actonel Collaboration Agreement, the Company will be fully responsible for any product liability claims in the U.S. and Puerto Rico relating to ACTONEL brought on or after April 1, 2010.
The Company may be liable for product liability, warranty or similar claims in relation to PGP products, including ONJ-related claims that were pending as of the closing of the PGP Acquisition. The Companys agreement with P&G provides that P&G will indemnify the Company for 50% of the losses from any such claims pending as of October 30, 2009, subject to certain limits.
The Company currently maintains product liability insurance coverage for claims between $25 million and $170 million, above which the Company is self-insured. The Companys insurance may not apply to damages or defense costs related to the above mentioned HT claims or the above mentioned ONJ claims, including any claim arising out of HT or ACTONEL products with labeling that does not conform completely to FDA approved labeling. Labeling changes for ESTRACE Tablets that conform to such communications are currently pending before the FDA. Although it is impossible to predict with certainty the outcome of any litigation, an unfavorable outcome in these proceedings is not anticipated. An estimate of the range of potential loss, if any, to us relating to these proceedings is not possible at this time.
ASACOL 400 mg Patent Matters
In September 2007, PGP and Medeva Pharma Suisse AG (Medeva) received a Paragraph IV certification notice letter from Roxane Laboratories, Inc. (Roxane), a subsidiary of Boehringher Ingelheim Corporation, indicating that Roxane had submitted to the FDA an Abbreviated New Drug Application (ANDA) seeking approval to manufacture and sell a generic version of PGPs ASACOL 400 mg product (ASACOL 400). The notice letter contended that Medevas U.S. Patent No. 5,541,170 (the 170 Patent) and U.S. Patent No. 5,541,171 (the 171 Patent), formulation and method patents which PGP exclusively licenses from Medeva covering the ASACOL 400 mg product (ASACOL 400), were invalid and not infringed. The 170 Patent and 171 Patent expire in July 2013. In October 2007, Medeva and PGP filed a patent lawsuit against Roxane in the U.S. District Court for the District of New Jersey alleging infringement of the 170 Patent. The lawsuit resulted in a stay of FDA approval of Roxanes ANDA until March 2010. The trial has not yet been scheduled. However, unless the District Court decides earlier in its favor, Roxane has agreed not to launch a generic version of ASACOL 400 before November 1, 2010. In addition, Roxane has agreed that if the case is fully submitted to the District Court by November 1, 2010, it will not launch until the District Court decides the case. While the Company and Medeva intend to vigorously defend the 170 Patent and pursue their legal rights, the Company can offer no assurance as to when the lawsuit will be decided, whether the lawsuit will be successful or that a generic equivalent of the ASACOL 400 mg product will not be approved and enter the market prior to the expiration of the 170 Patent in 2013.
ACTONEL Patent Matters
In July 2004, PGP received a Paragraph IV certification notice letter from a subsidiary of Teva Pharmaceutical Industries, Ltd. (together with its subsidiaries Teva) indicating that Teva had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of PGPs ACTONEL product. The notice letter contended that PGPs U.S. Patent No. 5,583,122 (the 122 Patent), a new chemical entity patent expiring in June 2014 (including a 6-month pediatric extension of regulatory exclusivity), was invalid, unenforceable or not infringed. In August 2004, PGP filed a patent lawsuit against Teva in the U.S. District Court for the District of Delaware charging Teva with infringement of the 122 Patent. In January 2006, Teva admitted patent infringement but alleged that the 122 Patent was invalid and, in February 2008, the District Court decided in favor of PGP and upheld the 122 Patent as valid and enforceable. In May 2009, the U.S. Court of Appeals for the Federal Circuit unanimously upheld the decision of the District Court.
In August 2008, December 2008 and January 2009, PGP and Hoffman-La Roche Inc. (Roche) received Paragraph IV certification notice letters from Teva, Sun Pharma Global, Inc. (Sun) and Apotex Inc. and Apotex Corp. (together Apotex) indicating that each such company had submitted to the FDA an ANDA seeking approval to manufacture and sell generic versions of the once-a-month ACTONEL product (ACTONEL OaM). The notice letters contended that Roches U.S. Patent No. 7,192,938 (the 938 Patent), a method patent expiring in November 2023 (including a 6-month pediatric extension of regulatory exclusivity) which Roche licensed to PGP with respect to ACTONEL OaM, was invalid, unenforceable or not infringed. PGP and Roche filed patent infringement suits against Teva in September 2008, Sun in January 2009 and Apotex in March 2009 in the U.S. District Court for the
15
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
District of Delaware charging each with infringement of the 938 Patent. The lawsuits result in a stay of FDA approval of each defendants ANDA for 30 months from the date of PGPs and Roches receipt of notice, subject to the prior resolution of the matters before the court. Teva delivered the first Paragraph IV certification notice letter to PGP and Roche. The stay of approval of Tevas ANDA will expire on the earlier of February 2011 or the resolution of the suit. Additionally, ACTONEL OaM has FDA exclusivity through April 2011 and the underlying 122 Patent expires in June 2014 (including a 6-month extension of regulatory exclusivity). The suits against Teva and Apotex have been consolidated for pretrial purposes. While a pretrial schedule has been set, and a pretrial conference scheduled, no trial date has been set. While the Company and Roche intend to vigorously defend the 938 Patent and protect their legal rights, the Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful or that a generic equivalent of ACTONEL OaM will not be approved and enter the market prior to the expiration of the 938 Patent in 2023.
On December 1, 2009, the Company received a Paragraph IV certification notice letter from Aurobindo Pharma Limited (Aurobindo) regarding the Companys ACTONEL 5, 30 and 35 mg dosage strengths tablets (ACTONEL Tablets), which are covered by the Companys U.S. Patent No. 6,165,513 (the 513 Patent), as well as U.S. Patent Nos. 5,994,329, 6,015,801, 6,432,932 and 6,465,443, owned by Merck & Co., Inc. (Merck) and licensed by the Company (the Merck Patents). The Paragraph IV certification notice letter advised the Company of the filing of an ANDA with the FDA requesting approval to manufacture and sell a generic version of ACTONEL Tablets prior to the expiration of the 513 patent in 2018 and the Merck Patents in 2019. Merck did not assert the Merck Patents in any of the prior ACTONEL patent litigation. The Company has elected not to bring an infringement action with respect to this ANDA. In addition, Aurobindo did not certify against the 122 Patent, which expires in June 2014 (including a 6-month extension of regulatory exclusivity) and covers all of the Companys ACTONEL products (including the ACTONEL Tablets). As a result, the Company does not believe that Aurobindo will be permitted to market its proposed ANDA product prior to the expiration of Tevas 180-day period of marketing exclusivity following the June 2014 expiration (including a 6-month extension of regulatory exclusivity) of the 122 Patent.
On February 12, 2010, the Company received a Paragraph IV certification notice letter from Mylan Pharmaceuticals Inc. (Mylan) regarding the Companys ACTONEL With Calcium Tablets (Copackaged) (ACTONEL/Calcium), which are covered by the Companys 513 Patent, as well as the Merck Patents owned by Merck and licensed by the Company. The Paragraph IV certification letter advised the Company of the filing of an ANDA with the FDA requesting approval to manufacture and sell a generic version of ACTONEL/Calcium prior to the expiration of the 513 patent in 2018 and the Merck Patents in 2019. The certification notice letter sets forth allegations of non-infringement and/or the invalidity of the 513 and Merck patents. Merck did not assert the Merck Patents in any of the prior ACTONEL patent litigation. The Company previously discontinued sales of ACTONEL/Calcium and has elected not to bring an infringement action with respect to this ANDA. In addition, Mylan did not certify against the 122 Patent which expires in June 2014 (including a 6-month extension of regulatory exclusivity) and covers all of the Companys ACTONEL products (including ACTONEL/Calcium). As a result, the Company does not believe that Mylan will be permitted to market its proposed ANDA product prior to the expiration of Tevas 180-day period of marketing exclusivity following the June 2014 expiration (including a 6-month extension of regulatory exclusivity) of the 122 Patent.
On February 24, 2010, the Company received a Paragraph IV certification notice letter from Mylan indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell generic versions of the Companys 5, 30, 35 and 75 mg dosage strength ACTONEL tablets, as well as ACTONEL OaM tablets. The notice letter contends that the 513 Patent, the Merck Patents and the 938 Patent which cover the products are invalid and/or will not be infringed. The Company and Roche filed a patent suit against Mylan in April 2010 in the United States District Court for the District of Delaware charging Mylan with infringement of the 938 Patent. The lawsuit results in a stay of FDA approval of Mylans ANDA for 30 months from the date of the Companys and Roches receipt of notice, subject to prior resolution of the matter before the court. Additionally, ACTONEL OaM has FDA exclusivity through April 2011, and Mylan did not certify against the underlying 122 Patent which expires in June 2014 (including a 6-month extension of regulatory exclusivity) and covers all of the Companys ACTONEL products. As a result, the Company does not believe that Mylan will be permitted to market its proposed ANDA products prior to the expiration of Tevas 180-day period of marketing exclusivity following the June 2014 expiration of the 122 Patent (including a 6-month extension of regulatory exclusivity). No trial date has been set. While the Company and Roche intend to vigorously defend the 938 Patent and protect their legal rights, the Company can offer no assurance as to when the lawsuit will be decided, whether the lawsuit will be successful or that Mylans generic versions of ACTONEL tablets will not be approved and enter the market prior to the expiration of the 938 Patent in 2023.
DORYX Patent Matters
As a result of the enactment of the QI Program Supplemental Funding Act of 2008 (the QI Act) on October 8, 2008, Mayne Pharma International Pty. Ltd.s (Mayne) U.S. Patent No. 6,958,161 (the 161 Patent) covering the Companys DORYX product was submitted to the FDA for listing in the FDAs Orange Book and potential generic competitors that had filed an ANDA prior to the listing of the 161 Patent were permitted to certify to the listed patent within 120 days of the enactment of the QI Act. In November and December 2008, and January 2009, the Company and Mayne received Paragraph IV certification notice letters from Actavis Elizabeth LLC (Actavis), Mutual Pharmaceutical Company, Inc. (Mutual), Mylan, Impax Laboratories, Inc. (Impax) and Sandoz Inc. (Sandoz) indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell generic
16
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
versions of DORYX 100 and 75 mg delayed-release tablets (DORYX 100 and 75). Those notice letters contend that the 161 Patent is invalid, unenforceable or not infringed. In December 2008 and January 2009, the Company and Mayne filed lawsuits against each of the potential generic competitors in the United States District Court for the District of New Jersey, charging them with infringement of the 161 Patent. In March 2009, the Company received the FDAs response to a citizen petition that it had submitted requesting that the FDA impose a 30-month stay of approval on ANDAs referencing DORYX 100 and 75 that were filed prior to the listing of the 161 Patent under the transition rules of the QI Act. In its joint response to the citizen petitions of the Company and several other petitioners, the FDA took the position that a 30-month stay would not apply to approvals for such ANDAs. On November 9, 2009, pursuant to an agreement among the Company, Mayne and Mutual, the District Court dismissed the lawsuit against Mutual concerning generic versions of DORYX 100 and 75 following Mutuals agreement to withdraw its ANDA with respect to such products.
In March 2009, the Company and Mayne received Paragraph IV certification notice letters from Impax and Mylan indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of DORYX 150 mg delayed-release tablets (DORYX 150). The notice letters contend that the 161 Patent is not infringed. In March 2009, the Company and Mayne filed a lawsuit against Impax in the United States District Court for the District of New Jersey, charging Impax with infringement of the 161 Patent. In May 2009, the Company and Mayne filed a lawsuit against Mylan in the United States District Court for the District of New Jersey charging Mylan with infringement of the 161 Patent. In February 2010, the Company and Mayne received a Paragraph IV certification notice letter from Heritage Pharmaceuticals Inc. (Heritage) indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of DORYX 100 and 75 and DORYX 150 (together DORYX 150, 100 and 75). The notice letter contends that the 161 Patent is not infringed. In March 2010, the Company and Mayne filed a lawsuit against Heritage in the United States District Court for the District of New Jersey charging Heritage with infringement of the 161 Patent. Based on the FDAs March 2009 guidance, the Company believes that because each of Impaxs and Mylans ANDAs with respect to generic versions of DORYX 150, and Heritages ANDA with respect to generic versions of DORYX 150, 100 and 75, were submitted after the listing of the 161 Patent in the FDAs Orange Book, that the FDA will stay approval of these generic versions of the products for up to 30 months, subject to the prior resolution of the matter before the District Court.
In January 2010, the Company and Mayne received a Paragraph IV certification notice letter from Sandoz indicating that it had amended its ANDA previously submitted to the FDA requesting approval to manufacture and sell generic versions of DORYX 100 and 75 to include a generic version of DORYX 150. The notice letter contends that the 161 Patent is invalid, unenforceable or not infringed. In January 2010, the Company and Mayne filed a lawsuit against Sandoz in the United States District Court for the District of New Jersey charging Sandoz with infringement of the 161 Patent with respect to DORYX 150. While the Company can give no assurance, it believes that under current law, the FDA may not approve Sandozs amended ANDA with respect to DORYX 150 until 180 days following the date on which the first filer of an ANDA with respect to DORYX 150 enters the market, unless the first filer transfers or forfeits its first filer rights, for example by failing to begin marketing its product in a timely manner.
All of the actions against Actavis, Mylan, Impax and Sandoz relating to DORYX 100 and 75, as well as our lawsuits against Impax and Mylan relating to DORYX 150 have been consolidated for discovery purposes. The same is expected for the Sandoz DORYX 150 lawsuit. As the lawsuit against Heritage is only recently filed, it is uncertain whether the Heritage lawsuit will be consolidated with the others or proceed on a separate track. No trial dates been set by the District Court. While the Company and Mayne intend to vigorously defend the 161 Patent and pursue their legal rights, the Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful or that a generic equivalent of DORYX 150, 100 or 75 will not be approved and enter the market prior to the expiration of the 161 Patent in 2022.
LOESTRIN 24 FE Patent Matters
On July 31, 2009 the Company received a Paragraph IV certification notice letter from Lupin Ltd. indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Companys oral contraceptive, LOESTRIN 24 FE. The notice letter contends that the Companys U.S. Patent No. 5,552,394 (the 394 Patent) which covers LOESTRIN 24 FE and expires in 2014 is invalid, unenforceable or not infringed. In September 2009, the Company filed a lawsuit against Lupin Ltd. and its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (collectively Lupin), in the District of Delaware charging Lupin with infringement of the 394 Patent. The lawsuit results in a stay of FDA approval of Lupins ANDA for 30 months from the date of the Companys receipt of such notice, subject to the prior resolution of the matter before the court. On October 21, 2009 Lupin answered alleging invalidity and non-infringement of the 394 Patent. No trial date has yet been set. In January 2009, the Company entered into a settlement and license agreement with Watson Pharmaceuticals, Inc. (together with its subsidiaries, Watson) to resolve patent litigation related to the 394 Patent. Under the agreement, Watson was permitted to commence marketing its generic equivalent product on the earlier of January 22, 2014 or the date on which another generic version of LOESTRIN 24 FE enters the U.S. market. Under current law, unless Watson forfeits its first filer status, the FDA may not approve Lupins ANDA until 180 days following the date on which Watson enters the market. The Company believes Watson may have forfeited its first filer status as a result of its failure to obtain approval by the FDA of its ANDA within the requisite period. As a result, while the Company has filed an infringement suit against Lupin and intends to vigorously defend the 394 Patent and pursue its legal rights, it can offer no assurance as to when the lawsuit will be decided, whether the lawsuit will be successful or that a generic equivalent of LOESTRIN 24 FE will not be approved and enter the market prior to the expiration of the 394 Patent in 2014.
17
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
FEMCON FE Patent Matters
On July 31, 2009 the Company received a Paragraph IV certification notice letter from Lupin Ltd. indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Companys oral contraceptive, FEMCON FE. The notice letter contends that the Companys U.S. Patent No. 6,667,050 (the 050 Patent) which covers FEMCON FE and expires in 2019 is invalid or not infringed. In September 2009, the Company filed a lawsuit against Lupin in the District of Delaware charging Lupin with infringement of the 050 Patent. The lawsuit results in a stay of FDA approval of Lupins ANDA for 30 months from the date of the Companys receipt of such notice, subject to the prior resolution of the matter before the court. On October 21, 2009, Lupin answered alleging invalidity and non-infringement of the 050 patent. No trial date has yet been set. In December 2008, the Company entered into a settlement and license agreement with a subsidiary of Barr Pharmaceuticals, Inc. (together with its subsidiaries, Barr), which was subsequently acquired by Teva, to resolve the Companys patent litigation related to FEMCON FE. Under the terms of the agreement, Teva was not permitted to launch a generic version of FEMCON FE until the earlier of July 1, 2012 or, among other circumstances, the date that is two years following the date of the filing of a new ANDA with a Paragraph IV certification by a third-party. In January 2009, the Company entered into a settlement and license agreement with Watson to resolve patent litigation related to FEMCON FE. Under the agreement, Watson was permitted to commence marketing its generic equivalent product on the earlier of 180 days after Teva enters the market with a generic equivalent product, or January 1, 2013. If Lupin filed its ANDA with respect to FEMCON FE during 2009 and Tevas ANDA with respect to a generic version of FEMCON FE is approved, Teva may be able to enter the market with a generic version of FEMCON as early as 2011. While the Company has filed an infringement suit against Lupin and intends to vigorously defend the 050 Patent and pursue its legal rights, it can offer no assurance as to when the lawsuit will be decided, whether the lawsuit will be successful or that a generic equivalent of FEMCON FE will not be approved and enter the market prior to the expiration of the 050 Patent in 2019.
False Claims Act Litigation
In December 2009, the Company was served with a civil complaint brought by an individual plaintiff, purportedly on behalf of the United States, alleging that the Company and over 20 other pharmaceutical manufacturers violated the False Claims Act (FCA), 31 U.S.C. § 3729(a)(1)(A), (B), by submitting false records or statements to the federal government, thereby causing Medicaid to pay for unapproved or ineffective drugs. The plaintiffs original complaint was filed under seal in 2002, but was not served on the Company until 2009. The complaint alleges that the Company submitted to the Centers for Medicare and Medicaid Services (CMS) false information regarding the safety and effectiveness of certain nitroglycerin transdermal products. The plaintiff alleges that CMS included these products in its list of reimbursable prescription drugs and that, as a consequence federal Medicaid allegedly reimbursed state Medicaid programs for a portion of the cost of such products. The plaintiff asserts that from 1996 until 2003 the federal Medicaid program paid approximately $9.8 million to reimburse the states for the Companys nitroglycerin transdermal products. The complaint seeks treble damages; a civil penalty of up to ten thousand dollars for each alleged false claim; and costs, expenses and attorneys fees.
The Company expects to file its response to the complaint during the second or third quarter of 2010. The Company intends to defend this action vigorously and currently believes that the complaint lacks merit. The Company has a number of defenses to the allegations in the complaint and anticipates filing a motion to dismiss the action. Although it is impossible to predict with certainty the outcome of any litigation, an unfavorable outcome in these proceedings is not anticipated. The estimate of the range of potential loss, if any, to the Company relating to these proceedings is not possible at this time.
14. Income Taxes
The Company operates in many tax jurisdictions including: the Republic of Ireland, the United States, the United Kingdom, Puerto Rico, Germany, Switzerland, Canada and other Western European countries. The Companys effective tax rate for the quarter ended March 31, 2010 was 57.6%, which reflected a tax benefit on the quarterly loss as a result of the mix of income in the various jurisdictions the company operates in and a tax ruling granting the Company a reduced Swiss tax rate for 2009. The effective tax rate for the quarter ended March 31, 2009 was 16.0%. The effective income tax rate for interim reporting periods is volatile due to changes in income mix among the various tax jurisdictions in which the Company operates, the impact of discrete items, impacts from the purchase accounting related to the PGP Acquisition, as well as the overall level of consolidated income before income taxes. The Companys estimated annual effective tax rate for all periods includes the impact of changes in income tax liabilities related to reserves recorded under ASC Topic 740.
15. Segment Information
After the PGP Acquisition, the Company organized its business into two reportable segments, North America (which includes the U.S., Canada and Puerto Rico) and the Rest of the World (ROW) consistent with how it manages its business and views the markets it serves. The Company manages its businesses separately in North America and the ROW as components of an enterprise for which separate information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate
18
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
resources and assess performance. Prior to the PGP Acquisition, all of the Companys revenues were derived domestically through one reportable segment. Following the PGP Acquisition, the Company expanded into Western Europe, Canada, the United Kingdom and Australia. In addition to managing the Companys results of operations in the two reportable segments, the Company manages revenues at a brand level.
An operating segments performance is primarily evaluated based on segment operating income, which excludes interest, and is used by the chief operating decision maker to evaluate the success of a specific region. The Company believes that segment operating income is an appropriate measure for evaluating the operating performance of its segments. However, this measure should be considered in addition to, not a substitute for, or superior to, income from operations or other measures of financial performance prepared in accordance with generally accepted accounting principles.
The following represents the Companys segment operating profit and a reconciliation to its condensed consolidated income before taxes for the quarters ended March 31, 2010 and 2009:
|
North
America |
ROW | Eliminations(1) |
Total
Company |
|||||||||||
|
Quarter Ended March 31, 2010 |
||||||||||||||
|
Total revenue |
$ | 794,768 | $ | 209,825 | $ | (243,291 | ) | $ | 761,302 | |||||
|
Segment operating profit |
$ | 64,292 | $ | 35,345 | $ | (62,043 | ) | $ | 37,594 | |||||
|
Corporate (costs) |
(5,845 | ) | ||||||||||||
|
Interest (expense), net |
(72,398 | ) | ||||||||||||
|
(Loss) before taxes |
$ | (40,649 | ) | |||||||||||
|
Quarter Ended March 31, 2009 |
||||||||||||||
|
Total revenue |
$ | 245,989 | $ | | $ | | $ | 245,989 | ||||||
|
Segment operating profit |
$ | 69,608 | $ | | $ | | $ | 69,608 | ||||||
|
Corporate (costs) |
| |||||||||||||
|
Interest (expense), net |
(18,017 | ) | ||||||||||||
|
Income before taxes |
$ | 51,591 | ||||||||||||
| (1) | Eliminations represent inter-segment revenues and related cost of sales. |
The following table presents total net revenues by product for the quarters ended March 31, 2010 and 2009:
|
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
|||||
|
Revenue breakdown by product |
||||||
|
ACTONEL(1) |
$ | 262,308 | $ | | ||
|
ASACOL |
165,020 | | ||||
|
LOESTRIN 24 FE |
78,751 | 52,365 | ||||
|
DORYX |
50,900 | 50,383 | ||||
|
DOVONEX |
37,804 | 28,004 | ||||
|
TACLONEX |
34,906 | 36,583 | ||||
|
ESTRACE Cream |
29,758 | 23,223 | ||||
|
ENABLEX royalty |
18,180 | | ||||
|
FEMCON FE |
10,636 | 12,939 | ||||
|
FEMHRT |
9,293 | 12,692 | ||||
|
Other Womens Healthcare |
10,692 | 4,084 | ||||
|
Other Oral Contraceptives |
7,432 | 7,869 | ||||
|
Other Hormone Therapy |
7,398 | 6,280 | ||||
|
Other products |
26,015 | 927 | ||||
|
Contract manufacturing product sales |
5,129 | 3,675 | ||||
|
Other revenue |
7,080 | 6,965 | ||||
|
Total revenue |
$ | 761,302 | $ | 245,989 | ||
| (1) | Other revenue related to ACTONEL is combined with its product net sales for the purposes of segment reporting. |
19
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
The following tables present capital expenditures, amortization of intangible assets and depreciation expense for the quarters ended March 31, 2010 and 2009:
| North America | ROW | Total Company | |||||||
|
Quarter ended March 31, 2010 |
|||||||||
|
Capital expenditures |
$ | 10,115 | $ | 5,347 | $ | 15,462 | |||
|
Amortization of intangible assets |
137,212 | 23,700 | 160,912 | ||||||
|
Depreciation expense |
6,044 | 1,447 | 7,491 | ||||||
|
Quarter ended March 31, 2009 |
|||||||||
|
Capital expenditures |
$ | 6,548 | $ | | $ | 6,548 | |||
|
Amortization of intangible assets |
56,993 | | 56,993 | ||||||
|
Depreciation expense |
3,026 | | 3,026 | ||||||
The following table presents total revenue by significant country of domicile for the quarters ended March 31, 2010 and 2009:
|
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
|||||
|
U.S. |
$ | 562,386 | $ | 239,043 | ||
|
Canada |
40,557 | | ||||
|
UK / Republic of Ireland |
24,993 | | ||||
|
Puerto Rico |
7,817 | 6,946 | ||||
|
Other |
125,549 | | ||||
|
Total |
$ | 761,302 | $ | 245,989 | ||
16. Reliance on Significant Suppliers
The following table shows revenue generated from products provided by significant suppliers as a percentage of total revenues. In the event that a supplier suffers an event that causes it to be unable to manufacture the Companys product requirements for a sustained period and we are unable to obtain the product requirements from an alternative supplier, the resulting shortages of inventory could have a material adverse effect on the business of the Company.
|
Quarter Ended
March 31, |
||||||
| 2010 | 2009 | |||||
|
LEO |
10 | % | 26 | % | ||
|
Mayne Pharma International Pty. Ltd. |
7 | % | 20 | % | ||
|
Lonza Inc. |
34 | % | | |||
|
Cambrex Corporation |
19 | % | | |||
17. Comprehensive Income
ASC Topic 220, Comprehensive Income, requires foreign currency translation adjustments and certain other items, which were reported in shareholders equity to be separately disclosed as other comprehensive income / (loss). Other comprehensive income / (loss) is comprised of net income plus the period activity within accumulated other comprehensive income / (loss). Other comprehensive income was $(28,925) and $45,108 for the quarters ended March 31, 2010 and 2009, respectively. In the quarter ended March 31, 2009, other comprehensive income included unrealized gains/(losses) on the Companys interest rate swap contract.
The components of accumulated other comprehensive income / (loss) consist of:
|
As of
March 31, 2010 |
As of
December 31, 2009 |
|||||||
|
Cumulative translation adjustment |
$ | (19,358 | ) | $ | (7,676 | ) | ||
|
Actuarial gains related to defined benefit plans (net of tax) |
3,769 | 3,769 | ||||||
|
Total |
$ | (15,589 | ) | $ | (3,907 | ) | ||
20
WARNER CHILCOTT PUBLIC LIMITED COMPANY
Notes to the Condensed Consolidated Financial Statements
(All amounts in thousands except share amounts, per share amounts or unless otherwise noted)
18. Retirement Plans
As a result of the PGP Acquisition, the Company assumed defined benefit retirement pension plans covering certain employees in Western Europe. Retirement benefits are generally based on an employees years of service and compensation. Funding requirements are determined on an individual country and plan basis and subject to local country practices and market circumstances. Prior to the PGP Acquisition, the Company did not offer any defined benefit pension plans and, therefore, there is no net periodic benefit cost for the quarter ended March 31, 2009.
The net periodic benefit cost of the Companys defined benefit plans for the quarter ended March 31, 2010 included the following components:
|
Non-U.S. Plans
Defined Benefit |
||||
|
Service cost |
$ | 529 | ||
|
Interest cost |
1,049 | |||
|
Expected return on plan assets |
(864 | ) | ||
|
Amortization of: |
| |||
|
Actuarial losses |
| |||
|
Prior service costs |
| |||
|
Net periodic benefit cost |
$ | 714 | ||
Company Contributions
For the three months ended March 31, 2010, the Company contributed $55,976 to non-U.S. retirement plans.
19. Subsequent Events
Sanofi
In April 2010, the Company and Sanofi entered into an amendment to the Actonel Collaboration Agreement. Under the terms of the amendment, the Company took full operational control over the promotion, marketing and R&D decisions for ACTONEL in the United States and Puerto Rico, and assumed responsibility for all associated costs relating to those activities. Prior to the amendment, the Company shared such costs with Sanofi in these territories. The Company remained the principal in transactions with customers in the United States and Puerto Rico and continues to invoice all sales in these territories. In return, it was agreed that Sanofi would receive as part of the global collaboration payments between the parties, collaboration payments from the Company based on an agreed upon percentage of U.S. and Puerto Rico net sales for the remainder of the term of the Actonel Collaboration Agreement, which expires on January 1, 2015. Prior to the amendment, net profits from the sale of ACTONEL in these territories were allocated between the Company and Sanofi based on contractual percentages.
Dong-A
In April 2010, the Company amended its agreement with Dong-A to add the right to develop, and if approved, market, in the U.S. and Canada, Dong-As udenafil product, a PDE5 inhibitor, for the treatment of lower urinary tract symptoms associated with BPH. The Company currently is preparing to commence Phase II clinical trials for the BPH indication. This amendment resulted in the Company making an up-front payment to Dong-A of $20,000 in April 2010, which will be included in R&D expense in the second quarter of 2010. Under the amendment, the Company may make additional payments to Dong-A in the aggregate amount of $25,000 upon the achievement of contractually-defined milestones in relation to the BPH product. The Company also agreed to pay Dong-A a percentage of net sales of the BPH product in the U.S. and Canada, if any.
PGP France
On April 30, 2010, after receiving all needed approvals, the Company completed the acquisition of P&Gs pharmaceutical business in France (PGP France). During the period from the closing of the PGP Acquisition on October 30, 2009 until April 30, 2010, P&G operated PGP France for the benefit of the Company. During that period the results of operations for PGP France were for the Companys account and were reflected in the Companys financial statements. Upon closing of the acquisition of PGP France, the Company acquired the assets, including the profits generated after October 30, 2009, and assumed the liabilities of PGP France. No additional consideration was paid to P&G in connection with the PGP France closing.
21
| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
You should read the following discussion together with our condensed consolidated financial statements and the related notes included elsewhere in this Form 10-Q and our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2009 (Annual Report). This discussion contains forward-looking statements, which involve risks and uncertainties. Our actual results may differ materially from those we currently anticipate as a result of many factors, including the factors we describe under Risk Factors in our Annual Report and elsewhere in this Form 10-Q.
Summary
The following are certain significant events that occurred during the quarter ended March 31, 2010:
| |
In March 2010, we made optional prepayments aggregating $400.0 million of our term loan indebtedness under our new senior secured credit facilities (the New Senior Secured Credit Facilities); |
| |
Our revenue for the quarter ended March 31, 2010 was $761.3 million and our net (loss) was ($17.2) million. |
Strategic Transactions
During 2009, we completed two strategic transactions that impacted our results of operations during the quarter ended March 31, 2010 and will continue to have a significant impact on our future operations.
PGP Acquisition
On October 30, 2009, pursuant to the purchase agreement dated August 24, 2009 (as amended, the Purchase Agreement), between the Company and The Procter & Gamble Company (P&G), we acquired the global branded prescription pharmaceutical business (PGP) for $2,919.3 million in cash and the assumption of certain liabilities (the PGP Acquisition). The purchase price is subject to certain post-closing adjustments. Under the terms of the Purchase Agreement, we acquired P&Gs portfolio of branded pharmaceutical products, prescription drug pipeline, manufacturing facilities in Puerto Rico and Germany and a net receivable owed from P&G of approximately $60.0 million. The total purchase price of $2,919.3 million was allocated to the estimated fair value of the assets acquired and liabilities assumed as of the date of the PGP Acquisition. The purchase price allocation as of March 31, 2010 is considered preliminary pending completion of the final valuation. In order to fund the consideration for the PGP Acquisition, certain of our subsidiaries entered into the New Senior Secured Credit Facilities, comprised of $2,950.0 million in aggregate term loan facilities and a $250.0 million revolving credit facility. On October 30, 2009, the Company borrowed $2,600.0 million of the aggregate $2,950.0 million of term loan facilities to finance the PGP Acquisition. The PGP Acquisition was accounted for as a business combination using the acquisition method of accounting. The results of operations of PGP since October 30, 2009 have been included in the Companys condensed consolidated statement of operations.
In connection with the closing of the PGP Acquisition and in order to facilitate the transition of the PGP business, we and P&G entered into a Transition Services Agreement, effective as of October 30, 2009 (the Transition Services Agreement). Pursuant to the terms of the Transition Services Agreement, P&G agreed to provide us with specified services for a limited time following the closing of the PGP Acquisition, including with respect to the following: order acquisition and management, distribution, customer service, purchasing and procurement systems, integrated supply network systems, manufacturing execution systems, IT support, sales and marketing, research and development and regulatory and certain accounting and finance related services. We agreed to pay P&G a fee for these services through the term of the Transition Services Agreement.
LEO Transaction
On September 23, 2009, we entered into a definitive asset purchase agreement (the LEO Transaction Agreement) with LEO Pharma A/S (LEO) pursuant to which LEO paid us $1,000.0 million in cash in order to terminate the Companys exclusive license to distribute LEOs DOVONEX and TACLONEX products (including all products in LEOs development pipeline) in the United States and to acquire certain assets related to the Companys distribution of DOVONEX and TACLONEX products in the United States (the LEO Transaction). The transaction closed simultaneously with the execution of the LEO Transaction Agreement. In connection with the LEO Transaction, we entered into a distribution agreement with LEO pursuant to which we agreed to, among other things, (1) continue to distribute DOVONEX and TACLONEX on behalf of LEO, for a distribution fee, through September 23, 2010 and (2) purchase inventories of DOVONEX and TACLONEX from LEO. As a result of the distribution agreement with LEO, our gross margin percentage during the term of the distribution agreement will be negatively impacted in 2010 as we continue to record net sales and costs of sales at nominal distributor margins. In addition, we agreed to provide certain transition services for LEO for a period of up to one year after the closing.
The LEO Transaction resulted in a gain of $393.1 million (or $380.1 million, net of tax). During the third quarter of 2009, we recorded a deferred gain of $68.9 million relating to the sale of certain inventories to LEO in connection with the LEO Transaction. In the fourth quarter of 2009, we recognized $34.2 million of the deferred gain as a reduction to cost of sales ($33.5 million, net of tax). In the quarter ended March 31, 2010, we recognized $25.1 million of the deferred gain as a reduction to cost of sales ($24.6 million, net of tax). The
22
remaining $9.6 million of the deferred gain is expected to be recognized during the remainder of 2010 as we continue to distribute products for LEO under the distribution agreement. The aggregate gain from the LEO Transaction is expected to be $462.0 million ($447.6 million, net of tax).
Operating Results for the quarters ended March 31, 2010 and 2009
Revenue
The following table sets forth our unaudited revenue for the quarters ended March 31, 2010 and 2009, as well as the corresponding dollar and percentage changes:
| Quarter Ended March 31, |
Increase
(decrease) |
||||||||||||
| (dollars in millions) | 2010 | 2009 | Dollars | Percent | |||||||||
|
Womens Healthcare: |
|||||||||||||
|
Oral Contraceptives |
|||||||||||||
|
LOESTRIN 24 FE |
$ | 78.8 | $ | 52.4 | $ | 26.4 | 50.4 | % | |||||
|
FEMCON FE |
10.6 | 12.9 | (2.3 | ) | (17.8 | )% | |||||||
|
Other Oral Contraceptives |
7.4 | 7.8 | (0.4 | ) | (5.6 | )% | |||||||
|
Total oral contraceptives |
$ | 96.8 | $ | 73.1 | $ | 23.7 | 32.3 | % | |||||
|
Hormone Therapy |
|||||||||||||
|
ESTRACE Cream |
$ | 29.8 | $ | 23.2 | $ | 6.6 | 28.1 | % | |||||
|
FEMHRT |
9.3 | 12.7 | (3.4 | ) | (26.8 | )% | |||||||
|
Other Hormone Therapy |
7.4 | 6.3 | 1.1 | 17.8 | % | ||||||||
|
Total hormone therapy |
$ | 46.5 | $ | 42.2 | $ | 4.3 | 10.1 | % | |||||
|
ACTONEL (1) |
$ | 262.3 | $ | | $ | 262.3 | 100.0 | % | |||||
|
Other womens healthcare products |
10.7 | 4.1 | 6.6 | 161.8 | % | ||||||||
|
Total Womens Healthcare |
$ | 416.3 | $ | 119.4 | $ | 296.9 | 248.5 | % | |||||
|
Dermatology: |
|||||||||||||
|
DORYX |
$ | 50.9 | $ | 50.4 | $ | 0.5 | 1.0 | % | |||||
|
TACLONEX (2) |
34.9 | 36.6 | (1.7 | ) | (4.6 | )% | |||||||
|
DOVONEX (2) |
37.8 | 28.0 | 9.8 | 35.0 | % | ||||||||
|
Total Dermatology |
$ | 123.6 | $ | 115.0 | $ | 8.6 | 7.5 | % | |||||
|
Gastroenterology: |
|||||||||||||
|
ASACOL |
$ | 165.0 | $ | | $ | 165.0 | 100.0 | % | |||||
|
Urology: |
|||||||||||||
|
ENABLEX (1) |
$ | 18.2 | $ | | $ | 18.2 | 100.0 | % | |||||
|
Other: |
|||||||||||||
|
Other products net sales |
$ | 26.0 | $ | 0.9 | $ | 25.1 | n.m. | ||||||
|
Contract manufacturing product sales |
5.1 | 3.7 | 1.4 | 39.6 | % | ||||||||
|
Other revenue |
7.1 | 7.0 | 0.1 | 1.7 | % | ||||||||
|
Total Revenue |
$ | 761.3 | $ | 246.0 | $ | 515.3 | 209.5 | % | |||||
| (1) | Includes other revenue as classified in our condensed consolidated statement of operations. |
| (2) | Includes sales recorded pursuant to our distribution agreement with LEO during the quarter ended March 31, 2010. |
Revenue in the quarter ended March 31, 2010 was $761.3 million, an increase of $515.3 million, or 209.5%, compared to the same quarter in the prior year. The primary drivers of the increase in revenue were the products acquired from the PGP Acquisition, primarily ACTONEL, ASACOL and ENABLEX, which together contributed $445.5 million of revenue growth in the quarter ended March 31, 2010, compared to the prior year quarter. Also contributing to the increase in revenue was growth in the net sales of LOESTRIN 24 FE, which contributed $26.4 million of revenue growth in the quarter ended March 31, 2010, compared to the prior year quarter. The growth delivered by these products was partially offset by net sales declines in certain other products. In addition to transactions such as the PGP Acquisition, period over period changes in the net sales of our products are a function of a number of factors including changes in: market demand, gross selling prices, sales-related deductions from gross sales to arrive at net sales and the levels of pipeline inventories of our products held by our direct and indirect customers. We use IMS Health, Inc. (IMS) estimates of filled prescriptions for our products as a proxy for market demand in the U.S.
23
Net sales of our oral contraceptive products increased $23.7 million, or 32.3%, in the quarter ended March 31, 2010, compared with the prior year quarter. LOESTRIN 24 FE generated revenues of $78.8 million in the quarter ended March 31, 2010, an increase of 50.4%, compared with $52.4 million in the prior year quarter. The increase in LOESTRIN 24 FE net sales was primarily due to increases in filled prescriptions of 70.8% and higher average selling prices, offset in part by the impact of higher sales-related deductions primarily due to increased utilization of customer loyalty cards and a contraction of pipeline inventories relative to the prior year quarter.
Revenues of ACTONEL were $262.3 million in the quarter ended March 31, 2010. Revenues in North America totaled $153.8 million, including $120.3 million in the United States. Filled prescriptions of ACTONEL in the U.S. decreased 21.7% in the quarter ended March 31, 2010 compared to the same quarter in the prior year. On a sequential basis, filled prescriptions in the U.S. decreased 9.9% in the quarter ended March 31, 2010 compared to the fourth quarter of 2009. Generic competition in Canada began to negatively impact our net sales of ACTONEL in the first quarter of 2010 and we expect generic competition in Western Europe to negatively impact our net sales of ACTONEL beginning in the fourth quarter of 2010. In addition, in the United States, ACTONEL continues to face market share declines due to the impact of managed care initiatives encouraging the use of generic versions of other products.
Net sales of our dermatology products increased $8.6 million, or 7.5%, in the quarter ended March 31, 2010, compared with the prior year quarter. Net sales of DORYX were essentially flat as compared to the prior year quarter as increases in filled prescriptions of 32.1% and higher average selling prices were offset by increases in sales related deductions and a contraction of pipeline inventories relative to the prior year quarter. The increase in sales related deductions compared with the prior year quarter was primarily due to the increased usage of our customer loyalty card for DORYX 150 mg. DOVONEX and TACLONEX revenues recorded during the quarter ended March 31, 2010 totaled $72.7 million, a net increase of $8.1 million as compared to the prior year quarter. As a result of the LEO Transaction and related distribution agreement with LEO, we record revenue and cost of sales at distributor margins for all TACLONEX and DOVONEX products. We will continue to record revenue and cost of sales from the distribution of the products for LEO during 2010 until the termination of the distribution agreement. This will continue to negatively impact our gross margin percentage during the distribution period.
Net sales of ASACOL in the quarter ended March 31, 2010 were $165.0 million. Revenues in North America totaled $152.2 million, including $147.4 million in the United States. Filled prescriptions of ASACOL in the U.S. decreased 7.0% in the quarter ended March 31, 2010 compared to the same quarter in the prior year. On a sequential basis, filled prescriptions in the U.S. decreased 5.5% in the quarter ended March 31, 2010 compared to the fourth quarter of 2009. In October 2007, PGP and Medeva Pharma Suisse AG (Medeva), the owner of the formulation and method patent for PGPs ASACOL 400 mg product, filed a patent infringement suit against Roxane Laboratories, Inc. (Roxane), a subsidiary of Boehringher Ingelheim Corporation, which triggered a 30-month stay of FDA approval with respect to Roxanes ANDA for a generic version of the ASACOL 400 mg product. See Note 13 to our Notes to the Condensed Consolidated Financial Statements for the quarter ended March 31, 2010 included in this Form 10-Q. Our ASACOL 800 mg product (known as ASACOL HD in the U.S.) was launched in the United States in June 2009 and has protection under a separate formulation patent until 2021, which is not currently subject to litigation. This patent does not protect the ASACOL 400 mg product. In 2009 and the first quarter of 2010, the ASACOL 400 mg product accounted for the substantial majority of our total ASACOL net sales.
Cost of Sales (excluding amortization of intangible assets)
The tables below show the calculation of cost of sales and cost of sales percentage for the quarters ended March 31, 2010 and 2009:
| (dollars in millions) |
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
$
Change |
Percent
Change |
||||||||||
|
Product net sales |
$ | 709.5 | $ | 239.0 | $ | 470.5 | 196.8 | % | ||||||
|
Cost of sales (excluding amortization) |
$ | 217.4 | $ | 48.8 | $ | 168.6 | 346.0 | % | ||||||
|
Cost of sales percentage |
30.6 | % | 20.4 | % | ||||||||||
Cost of sales (excluding amortization) increased $168.6 million, or 346.0%, in the quarter ended March 31, 2010 compared with the prior year quarter, due to the 196.8% increase in product net sales, the $105.5 million impact of the purchase accounting inventory step-up as a result of the PGP Acquisition that was recognized in cost of sales in the quarter and approximately $73.0 million of costs for DOVONEX and TACLONEX products distributed at nominal distributor margins under the LEO distribution agreement. This increase was offset in part by a $25.1 million gain relating to the sale of certain inventories in connection with the LEO Transaction and the favorable change in product mix as a result of the PGP Acquisition. Our cost of sales, as a percentage of product net sales, increased from 20.4% in the quarter ended March 31, 2009 to 30.6% in the quarter ended March 31, 2010. Excluding the impact of the purchase accounting inventory step-up recognized in the quarter ended March 31, 2010, the PGP Acquisition is expected to have a favorable impact on our cost of sales percentage in 2010 compared with 2009 periods.
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Selling, General & Administrative (SG&A) expenses
SG&A expenses were comprised of the following expenses for the quarters ended March 31, 2010 and 2009:
| (dollars in millions) |
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
$
Change |
Percent
Change |
||||||||
|
Advertising and Promotion (A&P) |
$ | 31.0 | $ | 7.7 | $ | 23.3 | 303.8 | % | ||||
|
Selling and Distribution |
167.8 | 22.9 | 144.9 | 633.6 | % | |||||||
|
General, Administrative and Other (G&A) |
121.3 | 16.2 | 105.1 | 647.6 | % | |||||||
|
Total |
$ | 320.1 | $ | 46.8 | $ | 273.3 | 584.4 | % | ||||
SG&A expenses for the quarter ended March 31, 2010 were $320.1 million, an increase of $273.3 million, or 584.4%, from $46.8 million in the prior year quarter. A&P expenses in the quarter ended March 31, 2010 increased $23.3 million, or 303.8%, compared with the prior year quarter, primarily due to advertising and other promotional spending attributable to the acquired PGP products. Selling and distribution expenses for the quarter ended March 31, 2010 increased by $144.9 million, or 633.6%, compared to the prior year quarter. The increase is primarily due to the Sanofi-Aventis U.S. LLC (Sanofi) co-promotion expense of $107.1 million under the Actonel Collaboration Agreement between us and Sanofi, increased headcount resulting from the acquisition of the PGP sales forces as well as new expenses related to the acquired PGP products. G&A expenses in the quarter ended March 31, 2010 increased $105.1 million, or 647.6%, compared with the prior year quarter, due in large part to increases in infrastructure costs, compensation expenses and professional and legal fees primarily relating to the PGP Acquisition. Included in G&A expenses in the quarter ended March 31, 2010 were $11.5 million of legal, consulting and other professional fees relating to the PGP Acquisition, expenses payable to P&G under the Transition Services Agreement of $22.8 million and severance costs of $12.5 million.
R&D
Our investment in R&D for the quarter ended March 31, 2010 was $31.1 million, an increase of $7.2 million, or 30.5%, compared with $23.9 million in the prior year quarter. The quarter ended March 31, 2009 included $11.5 million of milestone payments including $9.0 million to Dong-A PharmTech Co. Ltd. (Dong-A), upon the achievement of a developmental milestone under our agreement for the development of an orally-administered udenafil product for the treatment of erectile dysfunction and $2.5 million to NexMed, Inc. (NexMed) in connection with our acquisition of NexMeds U.S. rights to its topically applied alprostadil cream. Excluding these milestone payments in 2009, R&D expenses increased $18.7 million. The increase in R&D expenses in the quarter ended March 31, 2010 relative to the prior year quarter was primarily due to costs incurred relating to ongoing clinical studies, the addition of R&D projects from PGP and higher costs associated with an increase in personnel and facilities.
Amortization of intangible assets
Amortization of intangible assets in the quarters ended March 31, 2010 and 2009 was $160.9 million and $57.0 million, respectively. The increase in amortization expense in the quarter ended March 31, 2010 compared to the prior year quarter was due primarily to the amortization of intellectual property assets acquired in the PGP Acquisition which accounted for $120.8 million of the amortization expense in the quarter ended March 31, 2010. We expect amortization expense to significantly increase in 2010 as a result of the PGP Acquisition. We continuously review our products remaining useful lives based on each product familys estimated future cash flows. Our amortization methodology is calculated on either an accelerated or a straight-line basis to match the expected useful life of the asset, with identifiable assets assessed individually or by product family.
Interest income and interest expense (Net interest expense)
Net interest expense for the quarter ended March 31, 2010 was $72.4 million, an increase of $54.4 million, or 301.8%, from $18.0 million in the prior year quarter. Included in net interest expense in the quarter ended March 31, 2010 was $19.6 million relating to the write-off of debt finance costs associated with the purchase and redemption of the remaining portion of our 8.75% senior subordinated notes due 2015 (the Notes) and with the optional prepayment of $400.0 million of indebtedness under our New Senior Secured Credit Facilities. Included in net interest expense in the quarter ended March 31, 2009 was $1.3 million relating to the write-off of debt finance costs associated with the optional prepayment of $100.0 million of indebtedness under our prior senior secured credit facilities (the Prior Senior Secured Credit Facilities). Excluding the write-off of debt finance costs, net interest expense increased $36.1 million. The increase in net interest expense in the quarter ended March 31, 2010 was primarily due to an increase in the amount of our outstanding indebtedness under our New Senior Secured Credit Facilities used to fund the PGP Acquisition relative to our total outstanding indebtedness in the prior year quarter.
Income taxes
We operate in many tax jurisdictions including: the Republic of Ireland, the United States, the United Kingdom, Puerto Rico, Germany, Switzerland, Canada and other Western European countries. Our effective tax rate for the quarter ended March 31, 2010 was 57.6%, which reflected a tax benefit on the quarterly loss as a result of the mix of income in the various jurisdictions we operate in and a tax ruling granting us a reduced tax rate in Switzerland for 2009. The effective tax rate for the quarter ended March 31, 2009 was 16.0%. The effective income tax rate for interim reporting periods is volatile due to changes in income mix among the various tax jurisdictions in which we operate, the impact of discrete items, impacts from the purchase accounting related to the PGP Acquisition, as well as the overall level of consolidated income before income taxes. The Companys estimated annual effective tax rate for all periods includes the impact of changes in income tax liabilities related to reserves recorded under ASC Topic 740.
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Net (loss) / income
Due to the factors described above, we reported a net (loss) of ($17.2) million and net income of $43.3 million in the quarters ended March 31, 2010 and 2009, respectively.
Operating Results by Segment
After the PGP Acquisition, we organized our business into two reportable segments, North America (which includes the U.S., Canada and Puerto Rico) and the Rest of the World (ROW) consistent with how we manage our business and view the markets we serve. We manage our business separately in North America and the ROW as components of an enterprise for which separate information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and assess performance. Prior to the PGP Acquisition, all of our revenues were derived domestically through one reportable segment. Following the PGP Acquisition, we expanded into Western Europe, Canada, the United Kingdom and Australia. In addition to managing our results of operations in the two reportable segments, we manage revenues at a brand level. The discussion set forth above presents a discussion of revenues at the brand level. We measure an operating segments performance primarily based on segment operating income, which excludes interest, and is used by the chief operating decision maker to evaluate the success of a specific region.
In the quarter ended March 31, 2010, revenues in North America were $794.8 million, compared to $246.0 million in the quarter ended March 31, 2009. Revenues in the ROW in the quarter ended March 31, 2010 were $209.8 million, compared to zero in the quarter ended March 31, 2009 prior to the PGP Acquisition. Revenues in North America increased as a result of the PGP Acquisition and growth in net sales of promoted products as described above. Revenues in ROW increased due to the PGP Acquisition, as we did not generate revenues in ROW prior to the PGP Acquisition.
Segment operating profit in North America was $64.3 million in the quarter ended March 31, 2010, compared to $69.6 million in the quarter ended March 31, 2009. ROW segment operating profit in the quarter ended March 31, 2010 was $35.3 million compared to zero in the quarter ended March 31, 2009. Segment operating profit in North America grew as a result of the factors described above. In the quarter ended March 31, 2010, we recognized $71.0 million and $34.5 million in North America and the ROW, respectively, as a charge in the cost of sales relating to the inventory step-up from the PGP Acquisition.
Financial Condition, Liquidity and Capital Resources
Cash
At March 31, 2010, our cash on hand was $246.0 million, as compared to $539.0 million at December 31, 2009. As of March 31, 2010, our total debt consisted of $2,520.1 million of borrowings under our New Senior Secured Credit Facilities.
The following table summarizes our net (decrease) in cash and cash equivalents:
| (Dollars in millions) |
Quarter Ended
March 31, 2010 |
Quarter Ended
March 31, 2009 |
||||||
|
Net cash provided by operating activities |
$ | 245.2 | $ | 105.3 | ||||
|
Net cash (used in) investing activities |
(18.4 | ) | (9.4 | ) | ||||
|
Net cash (used in) financing activities |
(517.5 | ) | (101.5 | ) | ||||
|
Effect of exchange rates on cash and cash equivalents |
(2.3 | ) | | |||||
|
Net (decrease) in cash and cash equivalents |
$ | (293.0 | ) | $ | (5.6 | ) | ||
Our net cash provided by operating activities for the quarter ended March 31, 2010 increased $139.9 million over the prior year period. We reported a net (loss) of ($17.2) million for the quarter ended March 31, 2010 compared with net income of $43.3 million in the prior year quarter. Included in net (loss) for the quarter ended March 31, 2010 was a non-cash charge of $105.5 million relating to the write-off of the fair value step-up on inventories acquired in the PGP Acquisition as such inventories were sold. Also impacting net (loss) in the quarter ended March 31, 2010 is non-cash amortization expense, which increased $103.9 million as compared to the prior year quarter, primarily as a result of the amortization of intangible assets acquired in the PGP Acquisition. Our liability for unrecognized tax benefits (including interest) under Financial Accounting Standards Board Accounting Standards Codification (ASC) Topic 740, Accounting for Income Taxes, (ASC 740) which is expected to settle within the next twelve months is $1.9 million. Our liability for unrecognized tax benefits (including interest) under ASC 740 which is expected to settle after twelve months is $9.7 million. While we currently have negative working capital of $108.3 million, we believe that cash flows generated from operations will be adequate to cover any such shortfall.
Our net cash used in investing activities during the quarter ended March 31, 2010 totaled $18.4 million, consisting of $2.9 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisition of FEMHRT and $15.5 million relating to capital expenditures. The cash flows used in investing activities in the quarter ended March 31, 2009 totaled $9.4 million, consisting of $2.9 million of contingent purchase consideration paid to Pfizer in connection with the 2003 acquisition of FEMHRT,
26
and $6.5 million relating to capital expenditures. Our capital expenditures in 2010 are expected to be significantly higher than 2009 levels due to investments in our infrastructure in support of our growing global business, including investment in manufacturing, supply chain, IT, R&D and other corporate initiatives.
Our net cash used in financing activities in the quarter ended March 31, 2010 was $517.5 million and principally consisted of repayments of $429.9 million of principal indebtedness under the New Senior Secured Credit Facilities, including scheduled repayments of $29.9 million and optional prepayments of $400.0 million, and the repurchase and redemption of the remaining $89.5 million aggregate principal amount of our Notes. Our net cash used in financing activities in the quarter ended March 31, 2009 was primarily the result of our repayment of $101.5 million of debt under the Prior Senior Secured Credit Facilities.
Other
In April 2010, the Company amended its agreement with Dong-A to add the right to develop, and if approved, market, in the U.S. and Canada, Dong-As udenafil product for the treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH). This amendment resulted in the Company making an up-front payment to Dong-A of $20.0 million in April 2010. This amount will be included as R&D expense during the quarter ending June 30, 2010.
New Senior Secured Credit Facilities
On October 30, 2009, Warner Chilcott Holdings Company III, Limited (Holdings III), WC Luxco S.à r.l. (the Luxco Borrower), Warner Chilcott Corporation (WCC) (the US Borrower) and Warner Chilcott Company, LLC (WCCL) (the PR Borrower, and together with the Luxco Borrower and the US Borrower, the Borrowers) entered into a credit agreement (the Credit Agreement) with a syndicate of lenders (the Lenders), Credit Suisse, Cayman Islands Branch as administrative agent, Bank of America Securities LLC as syndication agent and JPMorgan Chase Bank, N.A. as documentation agent, pursuant to which the Lenders provided the New Senior Secured Credit Facilities in an aggregate amount of $3,200.0 million comprised of (i) $2,950.0 million in aggregate term loan facilities and (ii) a $250.0 million revolving credit facility that is available to all Borrowers. The term loan facilities were comprised of (i) a $1,000.0 million Term A facility that matures on October 31, 2014 and (ii) a $1,600.0 million Term B facility and a $350.0 million delayed-draw term loan facility that mature on April 30, 2015. On December 16, 2009, the Borrowers entered into an amendment (Amendment No. 1) to the Credit Agreement, pursuant to which the Credit Agreement was amended to create a new tranche of term loans (the Additional Term Loans) which was borrowed on December 30, 2009 by the US Borrower in an aggregate principal amount of $350.0 million in order to finance, together with cash on hand, the repurchase or redemption (as described below) of any and all of the issued and outstanding Notes. On December 16, 2009, the outstanding delayed-draw term loan facility was terminated. The revolving credit facility provides for a $20.0 million sublimit for swing line loans and a $50.0 million sublimit for the issuance of standby letters of credit. Any swing line loans and letters of credit would reduce the available commitment under the revolving credit facility on a dollar-for-dollar basis. The interest rates on the borrowings under the New Senior Secured Credit Facilities, other than swing line loans, are (1) for the Term A facility, LIBOR (with a floor of 2.25%) plus 3.25%, or ABR, as defined, plus 2.25% and (2) for the Term B facility, the revolving credit facility and the Additional Term Loans, LIBOR (with a floor of 2.25%) plus 3.50% or ABR, as defined, plus 2.50%.
The loans and other obligations under the New Senior Secured Credit Facilities (including in respect of hedging agreements and cash management obligations) are (i) guaranteed by Holdings III and substantially all of its subsidiaries (subject to certain exceptions and limitations) and (ii) secured by substantially all of the assets of the Borrowers and each guarantor (subject to certain exceptions and limitations). As a result of making optional prepayments of $400.0 million in the quarter ended March 31, 2010 the current portion of the long-term debt was reduced to $140.5 million. As of March 31, 2010 there were letters of credit totaling $1.5 million outstanding. As a result, we had $248.5 million available under the revolving credit facility as of March 31, 2010.
Prior Senior Secured Credit Facilities
On January 18, 2005, Holdings III and its subsidiaries, WCC and WCCL, entered into the $1,790.0 million Prior Senior Secured Credit Facilities with Credit Suisse as administrative agent and lender, and the other lenders and parties thereto. The Prior Senior Secured Credit Facilities consisted of $1,640.0 million of term loans (including $240.0 million of delayed-draw term loans) and a $150.0 million revolving credit facility, of which $30.0 million and $15.0 million were available for letters of credit and swing line loans, respectively, to WCC and WCCL. All of the remaining outstanding debt under the Prior Senior Secured Credit Facilities was repaid with a portion of the proceeds of the LEO Transaction in September 2009.
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Components of Indebtedness
As of March 31, 2010, the Companys outstanding funded debt was solely comprised of the New Senior Secured Credit Facilities. As of March 31, 2010, mandatory principal repayments of long-term debt in the remainder of 2010 and each of the five years ending December 31, 2011 through 2015 were as follows:
|
Year Ending December 31, |
Aggregate
Maturities (in millions) |
||
|
2010 |
$ | 86.6 | |
|
2011 |
215.5 | ||
|
2012 |
215.5 | ||
|
2013 |
215.5 | ||
|
2014 |
315.5 | ||
|
2015 |
1,471.5 | ||
|
Total long-term debt |
$ | 2,520.1 | |
Our ability to make scheduled payments of principal, or to pay the interest or additional interest, on, or to refinance our indebtedness, or to fund planned capital expenditures will depend on our future performance, which, to a certain extent, is subject to general economic, financial, competitive, legislative, regulatory and other factors that are beyond our control. Based on the current level of operations, we believe that cash flow from operations for each of our significant subsidiaries, available cash and short-term investments, together with borrowings available under the New Senior Secured Credit Facilities, will be adequate to meet our future liquidity needs throughout 2010. We note that future cash flows from operating activities may be adversely impacted by the settlement of contingent liabilities and could fluctuate significantly from quarter-to-quarter based on the timing of certain working capital components and capital expenditures. To the extent we generate excess cash flow from operations, net of cash flows from investing activities, in the absence of other compelling opportunities such as in-licensing transactions, business or product acquisitions, internal product development activities or other investment opportunities, we intend to make optional prepayments of our long-term debt or purchases of such debt in privately negotiated open market transactions. As a result of the above mentioned prepayments of long-term debt, we may recognize non-cash expenses for the write-off of applicable debt finance costs which is a component of interest expense. Our assumptions with respect to future costs may not be correct, and funds available to us from the sources discussed above may not be sufficient to enable us to service our indebtedness under the New Senior Secured Credit Facilities or to cover any shortfall in funding for any unanticipated expenses. In addition, to the extent we make future acquisitions, we may require new sources of funding including additional debt, or equity financing or some combination thereof. We may not be able to secure additional sources of funding on favorable terms or at all.
Acquisitions
As a part of our business strategy, from time to time we consider acquisitions, in-licensing and partnership opportunities involving complimentary products. We cannot guarantee that any such transactions will be consummated.
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
The principal market risks (i.e., the risk of loss arising from adverse changes in market rates and prices) to which we are exposed are interest rates on debt and movements in exchange rates among foreign currencies. We had neither foreign currency option contracts nor any interest rate hedges at March 31, 2010.
The following risk management discussion and the estimated amounts generated from analytical techniques are forward-looking statements of market risk assuming certain market conditions occur. Actual results in the future may differ materially from these projected results due to actual developments in the global financial markets.
Interest Rate Risk
We manage debt and overall financing strategies centrally using a combination of short- and long-term loans with either fixed or variable rates. Based on variable rate debt levels of $2,520.1 million as of March 31, 2010, a 1.0% change in interest rates would impact net interest expense by approximately $6.3 million per quarter. In addition, indebtedness outstanding under our New Senior Secured Credit Facility is subject to a LIBOR floor of 2.25%. Currently, the LIBOR rates are below the floor of 2.25% and therefore an increase in interest rates would only impact our net interest expense to the extent it exceeds the floor of 2.25%.
Foreign Currency Risk
As a result of the PGP Acquisition, a significant portion of our earnings and assets are in foreign jurisdictions where transactions are denominated in currencies other then the U.S. dollar (primarily the Euro and British pound). Depending on the direction of change relative to the U.S. dollar, foreign currency values can increase or decrease the reported dollar value of our net assets and results of operations. Our international-based revenues, as well as our international net assets, expose our revenues and earnings to foreign currency exchange rate changes.
We may enter into hedging and other foreign exchange management arrangements to reduce the risk of foreign currency exchange rate fluctuations to the extent that cost-effective derivative financial instruments or other non-derivative financial instrument approaches are available. As of March 31, 2010, we have not entered into any derivative financial instruments. Derivative financial instruments are not expected to be used for speculative purposes. The intent of gains and losses on hedging transactions is to offset the
28
respective gains and losses on the underlying exposures being hedged. Although we may decide to mitigate some of this risk with hedging and other activities, our business will remain subject to foreign exchange risk from foreign currency translation exposures that we will not be able to manage through effective hedging or the use of other financial instruments.
Inflation
Inflation did not have a material impact on our operations during the quarters ended March 31, 2010 and 2009.
| Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
(a) Disclosure controls and procedures
The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed by the Company is accumulated and communicated to the Companys management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer at a reasonable level, evaluated the effectiveness of the Companys disclosure controls and procedures. Based on their evaluation, as of March 31, 2010, the Companys Chief Executive Officer and Chief Financial Officer have concluded that the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) are effective.
(b) Changes in internal controls over financial reporting
During the quarter ended March 31, 2010 there have been no changes in our internal control over financial reporting that have
PART II. OTHER INFORMATION
| Item 1. | Legal Proceedings |
We are involved in various legal proceedings of a nature considered normal to our business, including product liability and other litigation and contingencies. We record reserves related to legal matters when losses related to such litigation or contingencies are both probable and reasonably estimable. We maintain insurance with respect to potential litigation in the normal course of our business based on our consultation with our insurance consultants and outside legal counsel, and in light of current market conditions, including cost and availability. In addition, we self-insure for certain liabilities not covered under our litigation insurance based on estimates of potential claims developed in consultation with our insurance consultants and outside legal counsel.
See Note 13 to our Notes to the Condensed Consolidated Financial Statements for the quarter ended March 31, 2010 included in this Form 10-Q for a description of our significant legal proceedings.
| Item 1A. | Risk Factors |
In addition to the other information in this report, the factors discussed in Risk Factors in our periodic filings, including our Annual Report on Form 10-K for the year ended December 31, 2009 (Annual Report), should be carefully considered in evaluating the Company and its businesses. The risks and uncertainties described in our periodic reports are not the only ones facing the Company and its subsidiaries. Additional risks and uncertainties, not presently known to us or otherwise, may also impair our business operations. If any of the risks described in our periodic filings or such other risks actually occur, our business, financial condition or results of operations could be materially and adversely affected.
| Item 6. | Exhibits |
| 10.1 | U.S. Amendment Agreement, effective April 1, 2010, by and between Warner Chilcott Company, LLC and Sanofi-Aventis U.S. LLC, to the Amended and Restated Collaboration Agreement, dated October 8, 2004, by and between Warner Chilcott Company, LLC (as assignee of the Proctor & Gamble Company and Proctor & Gamble Pharmaceuticals, Inc.) and Sanofi-Aventis U.S. LLC (as successor in interest to Aventis Pharmaceuticals, Inc.) | |
| 31.1 | Certification of the Chief Executive Officer under Rule 13a-14(a) of the Securities Exchange Act, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 31.2 | Certification of the Chief Financial Officer under Rule 13a-14(a) of the Securities Exchange Act, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32 | Certification of the Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| | Portions of this Exhibit have been omitted pursuant to a request for confidential treatment. Those portions have been filed separately with the Securities and Exchange Commission. |
29
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| WARNER CHILCOTT PUBLIC LIMITED COMPANY | ||||||
| Date: May 7, 2010 | By: | / S / R OGER M. B OISSONNEAULT | ||||
| Name: | Roger M. Boissonneault | |||||
| Title: | President and Chief Executive Officer | |||||
| Date: May 7, 2010 | By: | / S / P AUL H ERENDEEN | ||||
| Name: | Paul Herendeen | |||||
| Title: | Executive Vice President and Chief Financial Officer | |||||
30
Exhibit 10.1
CONFIDENTIAL TREATMENT REQUESTED UNDER
17 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 240.24b-2.
[*****] INDICATES OMITTED MATERIAL THAT IS THE
SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.
EXECUTION COPY
U.S. AMENDMENT AGREEMENT
This U.S. AMENDMENT AGREEMENT (together with all Exhibits referenced herein and attached hereto, this Amendment ) effective as of April 1, 2010 is entered into between Warner Chilcott Company, LLC, a limited liability company organized and existing under the laws of Puerto Rico with a place of business at Union Street, Road 195 Km 1.1, Fajardo, PR 00738 ( WC ), and Sanofi-Aventis U.S. LLC, a corporation organized under the laws of the State of Delaware with a place of business at 300 Somerset Corporate Blvd., Bridgewater, New Jersey 08807 ( S-A ) (WC and S-A are individually referred to herein as a Party and collectively as the Parties ).
W I T N E S S E T H :
WHEREAS, WC (as assignee of The Procter & Gamble Company and Procter & Gamble Pharmaceuticals, Inc.) and S-A (as successor-in-interest to Aventis Pharmaceuticals Inc.) are parties to an Amended and Restated Collaboration Agreement, dated as of October 8, 2004 (as amended, the Collaboration Agreement ); and
WHEREAS, WC and S-A desire to amend the Collaboration Agreement to restructure the commercialization efforts for the Product in the USA.
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the Parties hereby agree to amend the terms and conditions of the Collaboration Agreement as follows:
1. Definitions . All capitalized terms used herein, unless otherwise defined herein, shall have the meanings given them in the Collaboration Agreement.
(a) For purposes of this Amendment, Local R&D Efforts shall mean all R&D Efforts undertaken in the WC Exclusive Territory from and after the U.S. Restructuring Effective Date other than any R&D Efforts mutually agreed by the Parties pursuant to Section III(G) of the Collaboration Agreement.
(b) For the sake of clarification and for purposes of this Amendment, the Parties acknowledge and agree that to the extent applicable, (A) all references to P&G in the Collaboration Agreement shall be deemed to include WC, and (B) all references to API in the Collaboration Agreement shall be deemed to include S-A.
2. U.S. Restructuring . Notwithstanding anything in the Collaboration Agreement to the contrary, the Parties agree that their respective rights and obligations with respect to the Product (and, to the extent applicable, Product Improvements and OTC Products) in the USA shall be revised as set forth in this Amendment. For purposes of this Amendment, and consistent with the Collaboration Agreement, the Parties acknowledge and agree that any reference to the USA in this Amendment shall be deemed to include the Commonwealth of Puerto Rico.
(a) Establishment of WC Exclusive Territory . Effective on April 1, 2010 (the U.S. Restructuring Effective Date ), a new area consisting of the USA and referred to as the WC Exclusive Territory shall be established within the Territory, and the USA shall cease to be considered part of the Co-Promotion Territory.
(b) Management Structure . From and after the U.S. Restructuring Effective Date:
(i) subject to the terms and conditions of this Amendment, including Sections 2(b)(ii), 2(b)(iii), 2(d) and 12 hereof, WC, either directly and/or through one or with one or more of its Affiliates, shall have the sole right (x) to market, promote, detail, distribute, and sell the Product within the WC Exclusive Territory and (y) to make all decisions with respect thereto consistent with its obligations under the Collaboration Agreement, as amended hereby, and the terms of this Amendment, and such decisions (including all plans relating to the foregoing) need not be submitted to, nor approved by, nor require any prior consultation with, S-A or any committee, task force or similar body established under the Collaboration Agreement. Accordingly, subject to the terms and conditions of this Amendment, and without limiting the foregoing:
(A) all Promotion Efforts, Marketing Efforts and Local R&D Efforts, if any, to be undertaken in the WC Exclusive Territory shall be determined in the sole and absolute discretion, and shall be the sole and exclusive responsibility, of WC;
(B) there shall be no restrictions on WCs ability to engage Contract Representatives to perform Detailing Efforts in the WC Exclusive Territory; and
(C) WC shall not be obligated to perform a specified level of Promotion Efforts, Marketing Efforts or Local R&D Efforts in the WC Exclusive Territory (and, accordingly, no penalty payment shall be applicable to Detailing Efforts in the WC Exclusive Territory);
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(ii) WC and each of its applicable Affiliates shall use commercially reasonable efforts to register, market, promote, detail, distribute, and sell the Product in the WC Exclusive Territory in a manner consistent with good business practice and comparable with efforts customarily used in the pharmaceutical industry by pharmaceutical companies relating to products in a similar stage of development and approval and with equivalent economic value, and considering the relevant regulatory, legal, business, scientific, commercial and other facts and circumstances; and
(iii) notwithstanding anything in this Amendment to the contrary, WC covenants to S-A that during the Term:
(A) neither it nor any of its Affiliates shall take any action, nor fail to take any action, with the specific intent of reducing the amount of Net Outside Sales in the WC Exclusive Territory in any Contract Year below the Lower Threshold listed in the table in Section 3(b) of this Amendment for such Contract Year;
(B) neither it nor any of its Affiliates shall take any action, nor fail to take any action, that would reasonably be expected to reduce the amount of Net Outside Sales in the WC Exclusive Territory in any Contract Year below the Lower Threshold listed in the table in Section 3(b) of this Amendment for such Contract Year; and
(C) the recognition by WC and its Affiliates of revenues and deductions for purposes of calculating Net Outside Sales shall be consistent with United States generally accepted accounting principles and financial accounting and reporting standards applicable to WC and its Affiliates, consistently applied across WC and its Affiliates and in accordance with past practice; provided that nothing in this clause (C) shall limit or otherwise prevent WC or any of its Affiliates from making any change in its methods of accounting to the extent (1) required by United States generally accepted accounting principles or such other financial accounting and reporting standards, (2) required by law or regulation or (3) such change would not reasonably be expected to reduce the amount of Net Outside Sales in the WC Exclusive Territory in any Contract Year below the Lower Threshold listed in the table in Section 3(b) of this Amendment for such Contract Year.
(c) First Quarter 2010 . WC hereby represents and warrants that WC and its Affiliates have booked sales of, and shipped, the Product in the USA during the quarterly period commencing on January 1, 2010 in the ordinary course of business consistent with (i) the past practices of WC and its Affiliates and (ii) United States generally accepted accounting principles and financial accounting and reporting standards applicable to WC and its Affiliates, consistently applied across WC and its Affiliates.
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(d) Reports and Forecasts . WC shall, from and after the U.S. Restructuring Effective Date, provide S-A with the following information:
(i) no more than ninety (90) and no less than sixty (60) days prior to the beginning of each Contract Year, an initial forecast (the Initial Forecast ) of anticipated Net Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for each Quarter of such Contract Year using such methodology as WC uses in the forecasting of such Net Outside Sales for its own internal purposes; provided that for purposes of Contract Year 2010, WC shall provide the Initial Forecast for each Quarter remaining in Contract Year 2010 on or prior to April 15, 2010;
(ii) within five (5) Business Days of each of April 15 (other than Contract Year 2010), July 15 and October 15 of each Contract Year, an update (each, an Updated Forecast ) of the most recently delivered Initial Forecast or Updated Forecast, as the case may be, setting forth the anticipated Net Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for each Quarter (or portion thereof) remaining in such Contract Year using such methodology as WC uses in the forecasting of such Net Outside Sales for its own internal purposes;
(iii) within ten (10) Business Days after each month end, a report setting forth the actual Net Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for such month, together with the calculation thereof, including the amount of all discounts, returns, deductions and other adjustments having the effect of reducing Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for such month as contemplated by Schedule I-C of the Collaboration Agreement and Section 3(e) of this Amendment; and
(iv) within thirty (30) days after each Quarter end, a report in the form set forth in Exhibit B attached hereto, setting forth the actual Net Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for such Quarter, together with the calculation thereof, including the amount of all discounts, returns, deductions and other adjustments having the effect of reducing Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for such Quarter as contemplated by Schedule I-C of the Collaboration Agreement and Section 3(e) of this Amendment, which items shall, for purposes of this Amendment, be the only items having the effect of reducing Outside Sales of the Product (or any OTC Product, if applicable) in the WC Exclusive Territory for such Quarter.
(e) Recording of Sales .
(i) WC and/or one or more of its Affiliates shall solicit and accept orders for, and ship and invoice sales of, the Product from and to non-Affiliate third parties in the WC Exclusive Territory at prices to be established solely by WC and/or one or more of its Affiliates.
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(ii) For purposes of clarification, from and after the U.S. Restructuring Effective Date, if the Product is sold or otherwise transferred as part of a package with other products, the Net Outside Sales for such Product shall be the Net Outside Sales applicable to such Product as if sold separately, less the pro-rata amount of any discount associated with the package. The operation of the calculations in this Section 2(e)(ii) is demonstrated by the examples set forth in Schedule IV(E)(2) of the Collaboration Agreement.
(f) Expenses . From and after the U.S. Restructuring Effective Date:
(i) WC and/or one or more of its Affiliates shall bear all costs and expenses undertaken by WC and/or any of its Affiliates related to Promotion Efforts, Marketing Efforts and Local R&D Efforts within the WC Exclusive Territory undertaken from and after the U.S. Restructuring Effective Date; and
(ii) notwithstanding anything in the Collaboration Agreement to the contrary (including Section XII(F)(8) of the Collaboration Agreement), WC shall be responsible fully for all royalty payments required by the License Agreement among WC (as assignee of The Procter & Gamble Company and its affiliates), Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd in respect of any sales of the Product in the WC Exclusive Territory made from and after the U.S. Restructuring Effective Date.
(g) Third-Party Rights .
(i) Notwithstanding anything in the Collaboration Agreement to the contrary, from and after the U.S. Restructuring Effective Date, WC may grant one or more non-Affiliate third parties (each, a Third-Party Licensee ) the right to market, promote, detail, distribute and/or sell the Product in the WC Exclusive Territory; provided that S-As prior written consent (not to be unreasonably withheld, conditioned or delayed) shall be required prior to WC granting any Third-Party Licensee the right to distribute and/or sell the Product in the WC Exclusive Territory for its own account. Each such Third-Party Licensee shall be bound by the terms and conditions of this Amendment (including Sections 2(b)(ii) and 2(b)(iii) hereof) in the same manner and to the same extent as though such Third-Party Licensee were WC; provided that WC shall be responsible for any breach by any Third-Party Licensee of any obligations imposed on WC hereunder.
(ii) From and after the U.S. Restructuring Effective Date, subject to the immediately succeeding sentence, the sales of Product by any Third-Party Licensee in the WC Exclusive Territory shall be included in the calculation of Net Outside Sales of the Product in the WC Exclusive Territory for the applicable period. When the Third-Party Licensee resells a Product in the WC
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Exclusive Territory purchased from WC or any of WCs Affiliates, (A) the sale of such Product by WC or any of WCs Affiliates to the Third-Party Licensee shall be included in the calculation of Net Outside Sales for the applicable period in which such sale is made and (B) the corresponding resale of such Product by the Third-Party Licensee, reduced by the amount previously included in the calculation of Net Outside Sales with respect to the sale of such Product to the Third-Party Licensee pursuant to clause (A), shall be included in the calculation of Net Outside Sales for the applicable period in which such resale is made.
(iii) WC shall have the right to disclose from and after the U.S. Restructuring Effective Date and during the Term Confidential Information to any Third-Party Licensee (or potential Third-Party Licensee) that WC reasonably believes is necessary in order for such Third-Party Licensee to market, promote, detail, distribute or sell the Product in the WC Exclusive Territory from and after the U.S. Restructuring Effective Date and during the Term; provided, however , WC shall not disclose any Confidential Information of S-A or any of its Affiliates, relating to S-A or any of its Affiliates, or disclosed to WC or any of its Affiliates by S-A or any of its Affiliates, in each case without the prior written consent of S-A; provided, further , that (A) WC shall ensure that any such Third-Party Licensee is bound by obligations of confidentiality substantially similar to, and no less protective than, those imposed on WC pursuant to the Collaboration Agreement and (B) WC shall be responsible for any breach by such Third-Party Licensee of the confidentiality obligations imposed on WC pursuant to the Collaboration Agreement or on the Third-Party Licensee pursuant to this Section 2(g)(iii).
(h) Health Registrations . From and after the U.S. Restructuring Effective Date:
(i) WC and/or one or more of its Affiliates shall continue to hold and shall use commercially reasonable efforts to maintain in good order all Health Registrations related to the Product in the WC Exclusive Territory; and
(ii) WC and/or one or more of its Affiliates shall be solely and fully responsible for all costs and expenses of maintaining Health Registrations with respect to the Product in the WC Exclusive Territory, including all administrative costs and expenses and all country specific registration fees (including user fees); provided that all such costs and expenses in the USA relating to the time period prior to the U.S. Restructuring Effective Date shall be allocated among the Parties in accordance with the Collaboration Agreement (without giving effect to this Amendment).
(i) Product Recalls .
(i) From and after the U.S. Restructuring Effective Date, WC and/or one or more of its Affiliates shall have the sole discretion within the WC Exclusive Territory to determine whether and upon what terms and conditions the Product shall be recalled or otherwise withdrawn from sale to non-Affiliate
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third parties (for purposes of this Section 2(i), a WC Recall ). Prior to the making of any WC Recall decision, however, WC shall provide notice to S-As Alliance General Manager in accordance with Section XXV(M) of the Collaboration Agreement and shall use reasonable efforts to consult with S-A. WC and/or one or more of its Affiliates shall assume sole responsibility for all discussions with regulatory officials within the WC Exclusive Territory regarding all aspects of the WC Recall decision and the execution thereof.
(ii) From and after the U.S. Restructuring Effective Date, WC and/or one or more of its Affiliates shall bear all costs and expenses of any WC Recall to the extent relating to Products shipped to a non-Affiliate third party for sale on or after the U.S. Restructuring Effective Date in the WC Exclusive Territory; provided that the costs and expenses of any Recall to the extent relating to any Product shipped to a non-Affiliate third party for sale prior to the U.S. Restructuring Effective Date in the USA shall continue to be shared ***** in accordance with the Collaboration Agreement (without giving effect to this Amendment); provided, further, that S-A shall bear any reasonable and customary costs and expenses for the WC Recall to the extent such WC Recall is due to the gross negligence or intentional misconduct of S-A. Determination of such gross negligence or intentional misconduct shall be made by arbitration pursuant to Section XVI(B)(1) of the Collaboration Agreement. For the avoidance of doubt, where Product is shipped to a non-Affiliate third party for sale, but title to such Product does not pass concurrent therewith (such as in a consignment sale), such shipment shall not constitute shipment to a non-Affiliate third party for sale for purposes of this Section 2(i)(ii) unless and until such Product is actually sold to a non-Affiliate third party.
(iii) Each Party agrees to, and shall cause its Affiliates to, coordinate in good faith with the other Party and its Affiliates in connection with any WC Recall or any other Recall if requested by the other Party in order to comply with applicable law in any country.
(iv) For the sake of clarification, each Party, on behalf of itself and its Affiliates, acknowledges and agrees that:
(A) the phrase any Product Liability Action arising from Active Ingredient as used in the second (2nd) paragraph of Article 13 of the Tablet Supply Agreement, effective as of June 18, 2008 (the Tablet Supply Agreement ), by and between Sanofi Winthrop Industrie ( SWI ) and Procter & Gamble Pharmaceuticals, Inc. or Procter & Gamble Pharmaceuticals SARL, shall be construed to mean any Product Liability Action to the extent arising from Active Ingredient (including Product Liability Actions arising from the composition of the Active Ingredient or failure to warn);
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(B) the phrase any Product Liability Action arising from Risedronate Tablets as used in the third (3rd) paragraph of Article 13 of the Tablet Supply Agreement shall be construed to mean any Product Liability Action to the extent arising from Risedronate Tablets Manufactured by SWI (including Product Liability Actions arising from defects in such Risedronate Tablets), but excluding in any event any actions to the extent arising from Active Ingredient;
(C) for purposes of the Collaboration Agreement (as amended by this Amendment), the last paragraph of Article 13 of the Tablet Supply Agreement shall be construed with respect to the WC Exclusive Territory to include the words , except as set forth in this Article 13, before the word shall in such paragraph; and
(D) subject to clarifications set forth in this clause (iv), the provisions of this Section 2(i) and Article 5 hereof shall not in any way affect or limit either Partys, or any of their Affiliates, obligations under the Tablet Supply Agreement (including Article 13 thereof).
(j) Trademarks . In the WC Exclusive Territory, the Product shall be sold under a trademark selected and owned by WC or any of its Affiliates. WC and/or one or more of its Affiliates shall be responsible fully for applying for, maintaining, enforcing and defending all trademarks owned by WC or any of its Affiliates related to the Product in the WC Exclusive Territory. From and after the U.S. Restructuring Effective Date, WC and/or one or more of its Affiliates shall be fully responsible for all Trademark Expenses in the WC Exclusive Territory; provided that, for the sake of clarification, all Trademark Expenses in the USA incurred prior to the U.S. Restructuring Effective Date shall be allocated among the Parties in accordance with Section IV(I) of the Collaboration Agreement (without giving effect to this Amendment).
(k) Applicability of First Quarter 2010 Obligations . The Parties acknowledge and agree that notwithstanding anything in Article IV of the Collaboration Agreement to the contrary, the following shall apply with respect to the USA within the Co-Promotion Territory for the period commencing on January 1, 2010 and through March 31, 2010 (the First Quarter 2010 ):
(i) Promotion and Marketing Efforts . Neither Party shall have any liability to the other for failing to perform any Detailing Efforts, Non-Detailing Promotion Efforts or Marketing Efforts within the USA during the First Quarter 2010. Without limiting the preceding sentence, the provisions of Section IV(B)(8) of the Collaboration Agreement (Under Performance of Detailing Efforts) shall be inapplicable to the USA for the semi-annual period commencing on January 1, 2010 and ending on June 30, 2010.
(ii) Purchase and Sale of Detailing Efforts, Non-Detailing Promotion Efforts and Marketing Efforts . The Parties agree that for purposes of Article IV of the Collaboration Agreement, all Detailing Efforts, Non-Detailing Promotion
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Efforts and Marketing Efforts performed by S-A or any S-A Affiliate in the USA during the First Quarter 2010 that are required to be purchased by WC or any WC Affiliate shall be reported, and all costs and expenses incurred in connection therewith shall be invoiced and paid, at the times contemplated with respect to all other countries in the Co-Promotion Territory.
3. Economic Terms; Global Reimbursement Payment; Prepayments .
(a) Global Reimbursement Payment Formula . Notwithstanding anything in the Collaboration Agreement to the contrary, the Parties agree that the global reimbursement payment formula set forth in Schedule II(B) of the Collaboration Agreement shall be amended, effective on the U.S. Restructuring Effective Date, to (i) add a new variable, referred to as WCET, to signify the economic arrangements between the Parties with respect to the WC Exclusive Territory and (ii) remove the ***** variable, as follows:
*****
(b) WCET Variable Calculation . For purposes of Schedule II(B) of the Collaboration Agreement, for each Quarter commencing on or after the U.S. Restructuring Effective Date, the WCET variable shall be equal to:
(i) the product of (A) ***** times (B) the lesser of (1) the total Net Outside Sales of the Product in the WC Exclusive Territory for such Quarter and all prior Quarters (if any) occurring in the same Contract Year as such Quarter and (2) the amount set forth opposite the heading Lower Threshold in the table below for the applicable Contract Year in which such Quarter occurs; plus
(ii) the product of (A) ***** times (B) the greater of (1) zero and (2) an amount equal to (x) the total Net Outside Sales of the Product in the WC Exclusive Territory for such Quarter and all prior Quarters (if any) occurring in the same Contract Year as such Quarter minus (y) the amount set forth opposite the heading Higher Threshold in the table below for the applicable Contract Year in which such Quarter occurs; minus
(iii) any amounts previously paid in accordance with clauses (i) and (ii) above for all prior Quarters (if any) occurring in the same Contract Year as such Quarter .
| Contract Year | ||||||||||
| 2010 1 | 2011 | 2012 | 2013 | 2014 | ||||||
|
Lower Threshold ($MM) |
***** | ***** | ***** | ***** | ***** | |||||
|
Upper Threshold ($MM) |
***** | ***** | ***** | ***** | ***** | |||||
|
1 From the U.S. Restructuring Effective Date to December 31, 2010. |
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Examples of the calculation of the WCET variable described in this Section 3(b) for Contract Years 2010 and 2011 are attached as Exhibit A to this Amendment. If the Parties agree to amend, alter, or otherwise modify the payment allocations pursuant to the Collaboration Agreement, the Parties agree that such amendment, alternation or modification shall include as a component the continued payment of the amount represented by the WCET variable through the end of the Term.
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(c) Prepayments .
(i) WC or one of its Affiliates shall, (i) no later than the end of each of April, May, June, July, August and September of Contract Year 2010 and (ii) no later than the end of each of January, February, March, April, May and June of Contract Years 2011 through 2014, pay S-A an amount equal to (A) the amount set forth opposite the heading Lower Threshold in the table in Section 3(b) above for the applicable Contract Year in which such month occurs multiplied by (B) ***** and then divided by (C) ***** (each such payment, a Monthly Global Reimbursement Prepayment ).
(ii) Notwithstanding anything in the Collaboration Agreement to the contrary:
(A) for (x) the Quarter ending June 30, 2010 and (y) the first Quarter of each of Contract Year 2011 through 2014 (each such Quarter, a First Payment Quarter ), the Parties shall calculate the global reimbursement payment for such First Payment Quarter in accordance with Section II(B) of the Collaboration Agreement (after giving effect to Sections 3(a) and (b) of this Amendment), but no payment of the global reimbursement payment for such First Payment Quarter shall be made within sixty (60) days of the end of such First Payment Quarter pursuant to Section II(B) of the Collaboration Agreement;
(B) for (x) the Quarter ending September 30, 2010 and (y) the second Quarter of each of Contract Year 2011 through 2014 (each such Quarter, a Second Payment Quarter ), the global reimbursement payment for such Second Payment Quarter shall be equal to (1) the global reimbursement payment for such Second Payment Quarter calculated in accordance with Section II(B) of the Collaboration Agreement (after giving effect to Sections 3(a) and (b) of this Amendment, but without giving effect to this Section 3(c)) plus (2) the global reimbursement payment calculated, but not paid, pursuant to clause (A) above for the First Payment Quarter occurring in the same Contract Year as such Second Payment Quarter minus (3) (but only to the extent that the sum of clause (1) and clause (2) is positive) the aggregate amount of the Monthly Global Reimbursement Prepayments paid by WC and its Affiliates in such Contract Year pursuant to Section 3(c)(i) of this Amendment (or such portion thereof that reduces that sum of clause (1) and clause (2) to zero). Any portion of the aggregate amount of the Monthly Global Reimbursement Prepayments paid by WC and its Affiliates in such Contract Year pursuant to Section 3(c)(i) of this Amendment that is not applied pursuant to clause (3) (such amount, the
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Excess Prepayment Amount ) shall be applied to offset the global reimbursement payments for subsequent Quarters occurring in such Contract Year and/or paid by S-A pursuant to clause (C) below; and
(C) for each remaining Quarter in Contract Years 2010 through 2014, the global reimbursement payment for such Quarter shall, if a positive number, be reduced on a dollar-for-dollar basis up to, but not below, zero by the amount, if any, of the Excess Prepayment Amount for such Contact Year not previously applied to reduce the global reimbursement payment for any prior Quarter in such Contract Year; provided that if after calculating the global reimbursement payment for the last Quarter in Contract Years 2010 through 2014 pursuant to this clause (C), the Excess Prepayment Amount for such Contact Year has not been applied in full to reduce the global reimbursement payments for such Contract Year, S-A shall pay the balance thereof to WC (or one or more of WCs Affiliates designated by WC) at the same time the global reimbursement payment for such Quarter is required to be paid pursuant to Section II(B) of the Collaboration Agreement.
(iii) The Parties shall as soon as reasonably practicable after the date of this Amendment cooperate in good faith to agree in writing to examples illustrating the application of the Monthly Global Reimbursement Prepayments for Contract Year 2011, which, following such agreement, shall be appended as Exhibit C to this Amendment.
(d) Contract Year 2010 . The Parties agree that for purposes of calculating the WCET variable for Contract Year 2010 in accordance with clause (b) above, Contract Year 2010 shall be deemed to commence on the U.S. Restructuring Effective Date and, accordingly, any Net Outside Sales in the USA occurring between January 1, 2010 through March 31, 2010 shall be excluded from the calculations pursuant to clause (b) above and shall instead be taken into consideration in the calculation of the ***** variable for such period in accordance with the Collaboration Agreement (without giving effect to this Amendment).
(e) Discounts, Returns, Deductions and Other Adjustments . For purposes of calculating Net Outside Sales for any period in the WC Exclusive Territory, all discounts, returns, deductions and other adjustments to Outside Sales contemplated by Schedule I-C of the Collaboration Agreement shall offset Outside Sales in accordance with United States generally accepted accounting principles, consistently applied.
(f) Certain Understandings . For purposes of calculating the global reimbursement payment pursuant to Schedule II(B) of the Collaboration Agreement, and notwithstanding anything in Schedule II(B) of the Collaboration Agreement to the contrary:
(i) from and after the U.S. Restructuring Effective Date, all Net Outside Sales, costs and associated expenses with respect to the WC Exclusive Territory shall be excluded from the calculation of the ***** variable of the global reimbursement payment formula; and
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(ii) from and after the U.S. Restructuring Effective Date, the ***** variable shall no longer be applicable and shall not be calculated pursuant to, or be included in, the global reimbursement payment.
(iii) from and after the U.S. Restructuring Effective Date, any sales by WC or any of its Affiliates or Third Party Licensees of any Competing Product(s) (as defined below) in the WC Exclusive Territory shall be included in Outside Sales of the Product for purposes of calculating the WCET variable described in Section 3(b) of this Amendment; provided that such sales shall not be included in the calculation described in Section 3(b)(ii) of this Amendment. For purposes of this clause (iii), Competing Product(s) means any product(s) owned or licensed by WC or any of its Affiliates for the following indications: (A) any indication of Risedronate that was approved by the USFDA prior to the US Restructuring Effective Date, (B) any indication for the treatment of osteoporosis, Pagets disease or osteogenesis imperfecta and/or (C) any Product Improvement.
4. Intellectual Property Rights and Enforcement .
(a) Enforcement of Patents .
(i) Notwithstanding anything in Sections XII(F)(2) through (7) of the Collaboration Agreement to the contrary, from and after the U.S. Restructuring Effective Date, WC and/or one or more of its Affiliates shall have the sole and exclusive right to respond to, defend and prosecute any actions or proceedings of the type set forth in Section XII(F)(1) of the Collaboration Agreement brought with respect to the P&G Patent set forth on Exhibit D.1 in connection with the filing of an Abbreviated New Drug Application and to the extent relating to the WC Exclusive Territory (including, (x) the right to sue for past damages and (y) in the case of Section XII(F)(1)(b) of the Collaboration Agreement, the right to control and appoint lead counsel for the defense of any such action or proceeding) (collectively, WCET ANDA Actions ), at WCs or such Affiliates sole cost and expense.
(ii) For the avoidance of doubt, from and after the U.S. Restructuring Effective Date, and except as set forth in Section 4(a)(i) of this Amendment with respect the WCET ANDA Actions, Sections XII(F)(2) through (7) of the Collaboration Agreement shall govern any actions or proceedings of the type set forth in Section XII(F)(1) of the Collaboration Agreement with respect to the API Patent set forth on Exhibit D.2 and the P&G Patents to the extent relating to the WC Exclusive Territory (including, (A) the right to sue for past damages and (B) in the case of Section XII(F)(1)(b) of the Collaboration Agreement, the right to control and appoint lead counsel for the defense of any such action or proceeding) (collectively Other Patent Actions , and, together with WCET ANDA Actions, collectively Patent Actions ). The Parties acknowledge and
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agree that Section XII(F)(5) of the Collaboration Agreement shall be inapplicable within the WC Exclusive Territory with respect to any API Patents not set forth on Exhibit D.2 .
(iii) With respect to any Other Patent Action of the type set forth in Section XII(F)(1)(b) of the Collaboration Agreement, notwithstanding anything in this Amendment or the Collaboration Agreement to the contrary, the Parties acknowledge and agree that if either Party (and/or its Affiliate) shall be individually named as a defendant in such action, then such Party shall give prompt written notice to the other Party of such action. WC shall assume the defense of each such Other Patent Action of the type set forth in Section XII(F)(1)(b), and shall have the sole and exclusive right to control and appoint counsel for such action. The Parties further acknowledge and agree that the provisions described in the second, third and fourth sentences of Section XII(F)(2) of the Collaboration Agreement and the provisions of Sections XII(F)(6) and XII(F)(7) of the Collaboration Agreement shall apply to each Other Patent Action of the type set forth in Section XII(F)(1)(b).
(iv) For the avoidance of doubt, should the Party (and/or its Affiliate) controlling any Patent Action under this Section 4 or Section XII(F) of the Collaboration Agreement receive any payment or other consideration from a third party in such Patent Action involving the grant, abandonment, agreed invalidity of or relinquishment of patent rights covering the Product in the WC Exclusive Territory, it shall first recoup its reasonable out-of-pocket expenses associated with the matter and shall thereafter share such payment equally with the non-controlling Party.
(b) Enforcement of Trademarks . Notwithstanding anything in Section XII(G) of the Collaboration Agreement to the contrary, from and after the U.S. Restructuring Effective Date:
(i) notwithstanding Section XII(G)(2) of the Collaboration Agreement, S-A shall have no right to either (A) request that WC or any of its Affiliates take action to terminate any infringement by a third party of a trademark owned by WC or any of its Affiliates under which a Product is sold in the WC Exclusive Territory (a WCET Infringement ) or (B) institute any action in the WC Exclusive Territory to terminate such WCET Infringement if WC or any of its Affiliates fails to do so; accordingly, for the sake of clarification, from and after the U.S. Restructuring Effective Date, S-A shall have no obligations (if any) with respect to any WCET Infringement pursuant to the Collaboration Agreement (including Section XII(G) of the Collaboration Agreement);
(ii) notwithstanding Section XII(G)(3) of the Collaboration Agreement, WC and/or one or more of its Affiliates shall be entitled to and responsible for all costs or damages obtained or awarded to WC and/or one or more of its Affiliates in connection with any action instituted pursuant to under Section XII(G)(1) of the Collaboration Agreement with respect to the WC Exclusive Territory; and
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(iii) WC and/or one or more of its Affiliates shall have the right to consent to the entry of any judgment in connection with any WCET Infringement in the WC Exclusive Territory and settle any such WCET Infringement in its sole and absolute discretion.
For the sake of clarification, the Parties acknowledge and agree that this Section 4(b) does not, and shall not be construed to, grant to WC any rights to enforce or take any action with respect to any trademarks owned by S-A or any of its Affiliates, including the S-A Names and Trademarks, and that all such rights are expressly reserved to S-A
(c) Maintenance . Notwithstanding anything in Section XII(E) of the Collaboration Agreement to the contrary, from and after the U.S. Restructuring Effective Date, (i) WC and/or one or more of its Affiliates shall be responsible for paying, and shall pay, all fees and expenses and take all other actions necessary to maintain the P&G Patents and trademarks owned by WC or any of its Affiliates under which a Product is sold in the WC Exclusive Territory for the full term thereof under the Collaboration Agreement; and (ii) S-A and/or one or more of its Affiliates shall be responsible for paying, and shall pay, all fees and expenses and take all other actions necessary to maintain the API Patents in the WC Exclusive Territory for the full term thereof under the Collaboration Agreement. The Parties acknowledge and agree that this provision shall not apply to the Warner Chilcott name and trademark and any name or trademark derived from, confusingly similar to or including any of the foregoing (collectively, WC Corporate Marks ).
(d) Certain Understandings . Each of the Parties agrees that, notwithstanding the foregoing provisions of this Article 4, the provisions of the Collaboration Agreement (without giving effect to this Amendment) shall continue to apply in accordance with their terms to (i) any action or proceeding of the type set forth in Section XII(F)(1) of the Collaboration Agreement relating to the USA that was commenced prior to the U.S. Restructuring Effective Date, (ii) any Infringement in the USA of trademarks under which a Product is sold for which notice thereof was provided by one Party to the other in accordance with Section XII(G)(1) of the Collaboration Agreement prior to the U.S. Restructuring Effective Date, and (iii) the allocation of the fees and expenses of maintaining the P&G Patents and API Patents in the USA that were incurred prior to U.S. Restructuring Effective Date.
(e) Ownership . With respect to the P&G Patents and the trademarks under which the Product is sold, in each case, owned by WC and its Affiliates, WC represents and warrants to S-A that as between WC and its Affiliates WC owns all right, title and interest in, to and under such P&G Patents and trademarks. WC and/or its Affiliates shall not sell, assign, or otherwise transfer (except for pledges, grants of security interests or the like securing indebtedness of WC and/or any of its Affiliates) any of the trademarks owned by WC or any of its Affiliates related to the Product (other than any WC Corporate Marks) and/or any of the P&G Patents during the Term to a third party without the prior written
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consent of S-A (not to be unreasonably withheld, conditioned or delayed). For the avoidance of doubt, the preceding sentence shall not in any way affect or limit WCs rights under Section XVII(J) of the Collaboration Agreement (Change in Control Put/Call Rights) or Section 2(g) of this Amendment.
5. Product Liability .
(a) Indemnity .
(i) Subject to Section 13 of the Tablet Supply Agreement as modified by Sections 2(i)(iv) and Section 5(a)(ii) of this Amendment, and notwithstanding anything in Section XV(A)(1) of the Collaboration Agreement to the contrary, WC shall bear full responsibility for, and shall defend, indemnify and hold S-A and its Affiliates and their respective directors, officers and employees harmless from and against, all Losses (including, reasonable fees and expenses of attorneys) arising out of or related to any third-party Product Liability Action brought on or after the U.S. Restructuring Effective Date within the WC Exclusive Territory against either Party or any of its Affiliates (such Losses, U.S. Post Restructuring Product Liability Losses ). Notwithstanding anything in Section XV(B) of the Collaboration Agreement (Procedures for Indemnification) to the contrary, WC, as the Indemnitor in any Assertion for which indemnity may be sought pursuant to Section 5(a)(i) of this Amendment, shall be entitled to assume the defense of any such Assertion and appoint counsel for the defense of any such Assertion.
(ii) Notwithstanding Section 5(a)(i) of this Amendment, S-A shall bear full responsibility for, and shall defend, indemnify and hold harmless WC and its Affiliates and their respective directors, officers and employees from, any U.S. Post Restructuring Product Liability Losses to the extent caused by the gross negligence or intentional misconduct of S-A or any of its Affiliates or any of their respective directors, officers or employees. The determination of gross negligence or intentional misconduct shall be determined by a court of competent jurisdiction adjudicating such matter in a final and non-appealable decision or in a binding settlement between the Parties.
(b) Insurance . WC shall cause S-A to be named as an additional insured under the existing product liability insurance policy(ies) of WC and its Affiliates as promptly as reasonably practicable after the date hereof, and shall thereafter use its commercially reasonable efforts to ensure that S-A remains an additional insured under such policy(ies) for the remainder of the Term; provided that WC shall not be required to pay any increased premiums or incur or pay any costs in connection with the foregoing (other than reasonable and customary fees and expenses).
6. S-A Names and Trademarks.
(a) Certain Definitions . For the purposes of this Amendment:
(i) Packaging Materials collectively means and includes any prescription information (including labeling, bottle inserts, indications and safety instructions), packaging (including the box and bottle, as applicable) and similar materials relating to the packaging of the Product, in each case that have been previously approved by S-A pursuant to the Collaboration Agreement prior to the U.S. Restructuring Effective Date.
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(ii) Promotional Materials collectively means and includes any materials other than Products or Packing Materials, including any sales, promotional and marketing materials, Product literature, signage, stationary, training materials and similar materials relating to the marketing and promotion of the Product, in each case that have been previously approved by S-A pursuant to the Collaboration Agreement prior to the U.S. Restructuring Effective Date.
(iii) S-A Names and Trademarks means the names and trademarks sanofi-aventis or sanofi (in any style or design), and any name or mark derived from, confusingly similar to or including any of the foregoing.
(b) Transitional Trademark License . S-A hereby grants WC and its Affiliates a limited, non-assignable, non-transferable, transitional license, with no right to sublicense, solely to continue to use the S-A Names and Trademarks in connection with Products, Packaging Materials and Marketing Materials in the WC Exclusive Territory in accordance with, and for the applicable time periods set forth in, this Section 6. In no event shall WC or any of its Affiliates use any S-A Names and Trademarks after the U.S. Restructuring Effective Date in any form, in any manner and/or for any purpose different from WCs use of such S-A Names and Trademarks in the USA pursuant to the Collaboration Agreement during the ***** period preceding the U.S. Restructuring Effective Date. WC, on behalf of itself and its Affiliates, admits the validity, and S-As ownership, of all right, title and interest in and to the S-A Names and Trademarks and agrees that any and all goodwill, rights or interests that might be acquired by the use of the S-A Names and Trademarks by WC or its Affiliates shall inure to the sole benefit of S-A. WC, on behalf of itself and its Affiliates, admits and agrees that WC and its Affiliates have been extended only a mere permissive right to use the S-A Names and Trademarks as provided in this Section 6 which is not coupled with any ownership interest.
(c) Alliance for Better Bone Health . As provided in this Section 6, WC and its Affiliates shall discontinue use of the trade name Alliance for Better Bone Health (the Specified Trade Name ) within the same time periods as set forth in this Section 6 with respect to the discontinuation of their use of the S-A Names and Trademarks.
(d) Electronic Communications . As soon as practicable following the U.S. Restructuring Effective Date, and in any event within ***** after the U.S. Restructuring Effective Date, WC shall, and shall cause its Affiliates to, remove all S-A Names and Trademarks and the Specified Trade Name from any internet or other electronic communications of WC and/or any of its Affiliates to the extent relating to, or describing, activities in the WC Exclusive Territory, including use in any applicable internet domain names.
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(e) Packaging Materials and Sale of Products .
(i) Packaging Materials . As soon as practicable following the U.S. Restructuring Effective Date, and in any event within ***** after the U.S. Restructuring Effective Date, WC shall, and shall cause its Affiliates to, cease (A) manufacturing and producing any Packaging Materials or other components of finished packaged Product bearing any of the S-A Names and Trademarks and/or the Specified Trade Name for use in the WC Exclusive Territory, and (B) using Packaging Materials held in inventory bearing any of the S-A Names and Trademarks and/or the Specified Trade Name to package manufactured Products for use in the WC Exclusive Territory; provided that, in the event that WC or any of its Affiliates may be faced with a Packaging Materials shortfall ( i.e. , where there may be more Product ready for packaging than Packaging Materials available that do not bear the S-A Names and Trademarks and/or the Specified Trade Name) following such ***** period and such shortfall may result in delayed shipping of Product, then the Parties shall discuss in good faith an extension of the right to use Packaging Materials held in inventory bearing any of the S-A Names and Trademarks and/or Specified Trade Name to package manufactured Products for use in the WC Exclusive Territory beyond such ***** period in order to avoid and/or mitigate any such delay. Notwithstanding the foregoing, for the purposes of clarification, Packaging Materials or other components of finished packaged Product bearing any of the S-A Names and Trademarks and/or the Specified Trade Name manufactured or produced after the U.S. Restructuring Effective Date for use in the WC Exclusive Territory may only be manufactured and produced in the ordinary course of business and in such volumes as are consistent with WCs past practices.
(ii) Sale of Products . Notwithstanding anything herein to the contrary, within ***** after the U.S. Restructuring Effective Date, WC shall, and cause its Affiliates to, cease selling Products with Packaging Materials bearing any of the S-A Names and Trademarks and/or the Specified Trade Name in the WC Exclusive Territory.
(f) Promotional Materials .
(i) As soon as practicable following the U.S. Restructuring Effective Date, and in any event within ***** after the U.S. Restructuring Effective Date, WC shall, and shall cause its Affiliates to, cease manufacturing or producing any Promotional Materials bearing any of the S-A Names and Trademarks and/or the Specified Trade Name for use in the WC Exclusive Territory.
(ii) As soon as practicable following the U.S. Restructuring Effective Date, and in any event within ***** after the U.S. Restructuring Effective Date, WC shall, and shall cause its Affiliates to, cease using all Promotional Materials bearing any of the S-A Names and Trademarks and/or the Specified Trade Name in the WC Exclusive Territory.
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(g) Quality Control .
(i) S-A shall have the right to exercise reasonable quality control over the use of the S-A Names and Trademarks by WC and its Affiliates pursuant to this Section 6, for the purpose of protecting and maintaining the goodwill associated with the S-A Names and Trademarks and the reputation of S-A and its Affiliates.
(ii) The Parties acknowledge and agree that all Products, Packaging Materials and Promotional Materials bearing the S-A Names and Trademarks shall (A) be of at least the same high standards of quality, appearance and other standards that are observed immediately prior to the U.S. Restructuring Effective Date by WC, S-A and their Affiliates with respect to such Products, Packaging Materials and Promotional Materials, and (B) comply in all material respects with all applicable laws and industry standards, specifications, protocols and quality control standards.
(h) Termination of Transitional Trademark License .
(i) Except as otherwise expressly provided in this Section 6, from and after the U.S. Restructuring Effective Date, WC and each of its Affiliates shall stop using the S-A Names and Trademarks and the Specified Trade Name in the WC Exclusive Territory (except for such uses as are otherwise permitted under applicable law or under a separate agreement between the Parties).
(ii) Upon expiration of the transitional trademark license granted pursuant to this Section 6, (i) all rights and licenses granted to WC and its Affiliates pursuant this Section 6 shall cease, (ii) WC and each of its Affiliates shall destroy any and all Packaging Materials (including Packaging Materials that are components of finished Product) and Promotional Materials bearing any of the S-A Names and Trademarks and/or the Specified Trade Name, in each case under their possession, custody or control in the WC Exclusive Territory in whatever format, and (iii) upon the request of S-A, WC shall certify such destruction to S-A.
(iii) Notwithstanding anything in this Amendment to the contrary, S-A and its Affiliates acknowledge and agree that if WC and/or any of its Affiliates publishes, disseminates or otherwise uses any of the S-A Names and Trademarks and/or the Specified Trade Name by means of the internet (or similar or successor technology) pursuant to the terms and conditions of any separate agreement (including any Collaboration Agreement Document) between the Parties otherwise permitting use of such names and/or trademarks outside of the WC Exclusive Territory, such conduct may have the effect of causing such names and/or trademarks to be published inside the WC Exclusive Territory. In such cases only, and subject to such use not being targeted specifically at Persons located inside the WC Exclusive Territory, S-A and its Affiliates hereby waive their right to make any claim against WC and/or any of its Affiliates in respect of a breach of this Section 6 based upon such use.
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7. Transfer of S-A Employees . As set forth below in this Section 7, S-A shall cooperate with WC and/or one or more of its Affiliates with respect to the hiring of certain sales representatives and/or district sales managers who are currently employed by S-A or one or more of its Affiliates and who currently are, or were within the ***** preceding the date hereof, involved in the marketing, promotion and/or sale of the Product within the USA.
(a) Information . Set forth in Exhibit F hereto is a list of current S-A sales representatives and district sales managers available to WC (collectively, the S-A Sales Employees ), including *****.
(b) Communication Strategy . S-A shall (i) as promptly as reasonably practicable following *****, notify each S-A Sales Employee that he or she has been identified as a potential candidate for the WC sales force and (ii) promptly (and no less frequently than daily) report to WC which S-A Sales Employees have received such notification since the last report to WC. With respect to each S-A Sales Employee, upon the earlier of (x) the time that S-A has notified WC that such S-A Sales Employee has received the notification described in the preceding sentence, and (y) 11:59 p.m. (EDT) on *****, WC shall as promptly as reasonably practicable thereafter deliver to such S-A Sales Employee the employee communication in substantially the form approved by both Parties prior to the date hereof. Until the expiration of the Transition Period (as defined below) and except as provided above, written communications applicable to the S-A Sales Employees collectively shall be approved in advance by both Parties. Without limiting the foregoing, as part of the communications strategy, S-A shall inform all S-A Sales Employees that *****. Until the expiration of the Transition Period, S-A and each of its Affiliates shall not, and shall take all reasonable measures to ensure that their respective employees and agents of S-A shall not, *****.
(c) Process .
(i) During the ***** period commencing on the date hereof (the Transition Period ), S-A will provide reasonable assistance to WC and its Affiliates to communicate with and schedule interviews for any S-A Sales Employee for potential employment with WC and/or any of its Affiliates, including granting WC reasonable access to S-A facilities, if necessary, to conduct employment interviews. WC shall be responsible for all travel expenses related to employee interviews to the extent such expenses are paid directly by WC. WC shall reimburse S-A for expenses incurred in connection with any S-A Sales Employees attendance of such interviews (A) if WC has elected not to directly pay such travel expenses and (B) to the extent
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reimbursement for such travel expenses is consistent with S-As policies currently in effect for S-A Sales Employees with respect to travel and other business expenses (subject to WCs requirements with respect to reporting and documentation of such expenses).
(ii) Prior to the end of the Transition Period, WC and/or one or more of its Affiliates may make offers of employment to any S-A Sales Employees selected by WC and/or one or more of its Affiliates. Each S-A Sales Employee receiving such an offer will be required to accept or decline such offer no later than ***** after such offer is extended or on such other date as may be specified by WC or such Affiliate (each S-A Sales Employee who receives an offer during the Transition Period and subsequently commences employment with WC, a Transferring Employee ) and WC shall notify S-A of the projected employment commencement date for each Transferring Employee. For the avoidance of doubt, all S-A Sales Employees must accept or decline any offer from WC before the end of the Transition Period and only those S-A Sales Employees that accept such offer during such period shall be included as a Transferring Employee for purposes of the calculation in Section 7(d)(i).
(iii) WC will promptly notify S-A after WC has determined that a S-A Sales Employee will not become an employee of WC or any of its Affiliates for any reason, including as a result of not being interviewed, not receiving an offer of employment or declining an offer of employment (each notice, a Selection Notice ). S-A shall continue the employment of each S-A Sales Employee on the same terms and conditions as in effect as of the date hereof until the earlier of (A) the date that a S-A Sales Employee commences employment with WC or any of its Affiliates, (B) S-As receipt of a Selection Notice in respect of such S-A Sales Employee, (C) the date on which there are ***** or more Transferring Employees, or (D) the last day of the Transition Period, unless such S-A Sales Employees employment terminates due to death, disability, voluntary resignation or termination for cause, in each case prior to such date. S-A shall not (A) be obligated hereunder to continue the employment of any S-A Sales Employee beyond the date set forth in the previous sentence or (B) *****.
(iv) To the extent that WC offers employment to any S-A Sales Employee during the period commencing ***** and ending ***** and such S-A Sales Employee accepts employment with WC on or prior to *****, WC shall provide notice of such employment to S-A within ten (10) Business Days following such acceptance.
(d) Employment-Related Payments .
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(i) No more than ***** days after the U.S. Restructuring Effective Date, WC and/or one or more of its Affiliates shall pay to S-A an amount equal to the product (which if negative shall be deemed to be zero) of (A) ***** and (B) a number equal to the Employee Gap. For purposes hereof, the Employee Gap equals the difference between (x) ***** minus (y) the sum of the number of Transferring Employees plus the number of S-A Sales Employees who continue employment with S-A or any of its Affiliates following the Transition Period or are offered employment or rehired by S-A or any of its Affiliates prior to the payment date set forth in the first sentence of this Section 7(d)(i).
(ii) WC and/or one or more of its Affiliates shall pay to S-A ***** for each S-A Sales Employee for the period (the Reimbursable Period ) from the U.S. Restructuring Effective Date to the earlier of (A) the date on which there are ***** or more Transferring Employees and (B) the last day of the Transition Period; provided, however , that in the event that any S-A Sales Employees employment with S-A and its Affiliates terminates prior to the end of the Reimbursable Period (for any reason), the amount payable under this Section 7(d)(ii) shall be reduced by an amount equal to ***** multiplied by the number of days prior to the end of the Reimbursable Period when each such S-A Sales Employees employment with S-A and its Affiliates terminates (a per capita, per day reduction in the reimbursement amount). Following the end of the Reimbursable Period, S-A shall provide to WC all information reasonably necessary for WC to compute the reimbursement amount under this Section 7(d)(ii) and, upon receipt of all necessary information, WC and/or one or more of its Affiliates shall promptly pay to S-A the reimbursement amount due under this Section 7(d)(ii).
(e) Indemnification .
(i) Subject to the provisions of this Section 7(e), WC shall assume liability for, indemnify and hold S-A harmless from and against any civil or criminal recoveries, settlement payments or penalties paid by S-A and/or its Affiliates, and any reasonable attorneys fees incurred by S-A and/or its Affiliates, as a result of any Covered Claims. For these purposes, the term Covered Claims means (i) claims or charges made against S-A and/or its Affiliates relating to conduct of WC and/or its Affiliates in effectuating the processes described in this Section 7, (including the selection by WC and/or its Affiliates of the S-A Sales Employees to whom WC and/or its Affiliates make invitations to interview and offers of employment and the hiring of the same) and (ii) claims or charges made against S-A and/or its Affiliates as a result of the termination of the employment of S-A Sales Employees other than the Transferring Employees (the Non-Transferring S-A Sales Employees ) by S-A and/or its Affiliates during the period from the date hereof through the date ***** after the date hereof; provided that, in selecting the Non-Transferring S-A Sales Employees whose employment will be terminated during this period and managing the process of terminating, retaining and redeploying Non-Transferring S-A Sales Employees, S-A and its Affiliates have not engaged in practices that
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are discriminatory or have an adverse effect on any protected class when compared to the entire group of S-A Sales Employees. If S-A and/or any of its Affiliates becomes aware of any potentially Covered Claim, S-A shall promptly give notice to WC and WC and/or one or more of its Affiliates shall have the right to participate in all matters relating to the management and response of any such potential or actual Covered Claim and shall have the right to approve all significant expenditures relating to the management and response to such potential or actual Covered Claim, including selection of counsel and any settlement offers. This indemnity shall survive the termination of the Collaboration Agreement.
(ii) Subject to this Section 7(e), for the avoidance of doubt, nothing contained herein is intended to transfer any employment-related liabilities with respect to any S-A Sales Employee arising as a consequence of the employment or termination of employment of any S-A Sales Employee by S-A.
(f) Prior Service Credit . WC and/or its Affiliates shall treat, and cause the applicable benefit plans to treat, the service of the Transferring Employees with S-A attributable to any period before commencement of employment with WC and/or its Affiliates as service rendered to WC and/or its Affiliates for purposes of eligibility to participate, vesting and for other appropriate benefits (excluding *****), including applicability of any minimum waiting periods, under applicable benefit plans.
8. Transition Assistance .
(a) S-A agrees that it shall use commercially reasonable efforts to cooperate with WC from and after the U.S. Restructuring Effective Date to provide WC with, or assist WC in the procurement of, the following information:
(i) a reasonably detailed description of (A) all activities planned or committed from S-As and its Affiliates respective local opportunity funds in the WC Exclusive Territory with respect to the Product, including speaker meetings, lunch and learns, grand rounds, symposia (including regional symposia and satellite symposia) and any regional initiatives, (B) all contracts and agreements and contact points relating to S-As and its Affiliates respective professional digital initiatives in the WC Exclusive Territory with respect to the Product (including Medscape and Epocrates), and (C) all contracts and agreements between Corbett Accel Healthcare Group or any of its Affiliates and S-A or any of its Affiliates relating to the WC Exclusive Territory with respect to the Product; and
(ii)(A) a reasonably detailed description of all grants relating to the Product in the WC Exclusive Territory committed for studies that have commenced and are in process as of the date of this Amendment, including details of any study grant requests received in the twelve (12) months preceding the date of this Amendment and that are subject to review, (B) copies of any manuscripts and abstracts led by medical employees or representatives of S-A or
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any of its Affiliates relating to the Product for forthcoming publications, posters and oral submissions and (C) a description of any ongoing activities or commitments with patient or physician associations in the WC Exclusive Territory led by medical employees or representatives of S-A or any of its Affiliates relating to the Product.
To the knowledge of S-A (without an opportunity to make appropriate inquiries to the S-A Sales Employees), programs meeting the criteria set forth in Section 8(a) of this Amendment for the month of April, May and June 2010 are described in Exhibit E.1 hereto. S-A shall use commercially reasonable efforts to provide WC with the information required by Section 8(a) of this Amendment as soon as reasonably practicable, with priority given to those programs taking place earlier than later and with the intent of providing WC with at least two weeks notice of any such programs wherever possible.
(b) WC or one or more of its Affiliates shall reimburse (to the extent not previously reimbursed) S-A for all reasonable out-of-pocket costs and expenses incurred by S-A or any of its Affiliates (whether incurred prior to or after the U.S. Restructuring Effective Date) with respect to any activities, grants, or other commitments initiated or planned by S-A or any of its Affiliates that are scheduled to occur following the U.S. Restructuring Effective Date within the WC Exclusive Territory; provided that neither WC or any of its Affiliates shall be under any obligation to reimburse S-A or any of its Affiliates for the amount of any costs and expenses relating to any such activity, grant, or other commitment that would, when aggregated with all other costs and expenses previously reimbursed for activities falling within the same category as such activity on Exhibit E.2 to this Amendment, exceed the aggregate amount set forth opposite such category of activity on Exhibit E.2 to this Amendment. The Parties acknowledge and agree that for any activities, grants or other commitments that are not included on Exhibit E.2 (including activities, grants or other commitments that are not the subject of binding commitments), S-A shall have the right to terminate any such activities, grants or other commitments; provided that (A) S-A shall use commercially reasonable efforts to provide in writing as much notice as reasonably practicable to WC prior to any such termination and (B) WC shall not have provided notice to S-A that WC shall bear all costs and expenses relating to such activity, grant or commitment prior to its termination. With respect to the costs and expenses required to be reimbursed in accordance with the first sentence of this Section 8(b) that are payable by S-A or any of its Affiliates after the U.S. Restructuring Effective Date, to the extent reasonably feasible (based on S-As existing policies, practices, and systems), S-A shall not, and S-A shall cause its Affiliates not to, pay directly such costs and expenses and to instead promptly forward, or cause to be forwarded, any invoices received by S-A or any of its Affiliates in respect of such costs and expenses to WC for payment by WC or any of its Affiliates. S-A hereby represents and warrants to WC that neither S-A nor any of its Affiliates has rescheduled any activity initially scheduled to occur prior to the U.S. Restructuring Effective Date to occur after the U.S. Restructuring Effective Date with the specific intent of avoiding being responsible, in whole or in part, for the costs and expenses associated with such activity as a result of the transactions contemplated by this Amendment.
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(c) From and after the U.S. Restructuring Effective Date, to the extent either WC or S-A identifies additional materials or information reasonably related to Sections 8(a)(i) and 8(a)(ii) above that have not been previously provided prior to the applicable time period specified in Section 8(a) of this Amendment and that WC reasonably requests, S-A will use commercially reasonable efforts to provide promptly such information to WC. The Parties further agree that from and after the U.S. Restructuring Effective Date, to the extent either WC or S-A identifies any other materials or information not contemplated by the preceding sentence reasonably related to the performance of a Partys obligations under this Amendment that have not been previously provided, the Parties will promptly discuss whether, and to what extent, such information shall be disclosed by the Party with such materials or information.
(d) The Parties will reasonably cooperate to arrange the return and/or destruction (at WCs direction) of samples of the Product and, if determined necessary by WC, promotional materials held by S-A or any of its Affiliates for use in or related to the WC Exclusive Territory; provided that WC or one or more of its Affiliates shall reimburse S-A for the reasonable and customary expenses incurred by S-A and its Affiliates in connection with any such return and/or destruction.
9. Commercialization of Secondary Products . Notwithstanding anything in Article XXII of the Collaboration Agreement to the contrary, each Party shall have the right in the WC Exclusive Territory from and after the U.S. Restructuring Effective Date to commercialize Secondary Products for any indication other than (x) any indication of Risedronate that was approved by the USFDA prior to the US Restructuring Effective Date and (y) any indication for the treatment of osteoporosis, Pagets disease or osteogenesis imperfecta (collectively, Competitive Indications ) but in any event only with dosage levels that would not reasonably be susceptible to off-label use for any Competitive Indication. Notwithstanding the foregoing, if S-A or any of its Affiliates acquires a patent or files a patent application on and after the U.S. Restructuring Effective Date which is an API Patent by virtue of its claiming a class of compounds (or methods of making or using thereof) that includes Risedronate (or methods of making or using Risedronate) but which patent is associated with a Secondary Product then marketed or under development for indications other than Competitive Indications, then the parties acknowledge and agree that the license grant in Section XII(C) of the Collaboration Agreement shall not extend to use of Risedronate and products containing Risedronate for such indications other than Competitive Indications.
10. Additional Agreements and Understandings .
(a) Guarantees . Notwithstanding any other provision of this Amendment to the contrary, as a condition precedent to the effectiveness of this Amendment, no later than the U.S. Restructuring Effective Date, WC shall deliver to S-A, at WCs sole cost and expense, an executed guarantee executed by each of Warner Chilcott plc and Warner Chilcott Pharmaceuticals Inc. in the form attached as Exhibit G hereto.
(b) Setoff Rights . In addition to the provisions of Section XXV(B) of the Collaboration Agreement, each Party and its Affiliates shall have the right, to the maximum extent permitted by applicable law, to setoff any amounts owed by such Party or any of its
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Affiliates to the other Party or any of its Affiliates under any Collaboration Agreement Document (including this Amendment) against amounts due to such Party or any of its Affiliates by such other Party or any of its Affiliates under any Collaboration Agreement Document (including this Amendment), and vice versa.
(c) S-A License Grant .
(i) For the avoidance of doubt, WC and its Affiliates acknowledge and agree that (A) the rights granted to S-A in the first sentence of each of Sections IV(A)(1), IVa(A)(1), V(A)(1) and VI(A)(1) of the Collaboration Agreement include a license (which may be sublicensed to Affiliates of S-A) of such applicable rights under the P&G Patents and P&G Know How, and (B) S-A is (x) the sole licensee of such rights in the Secondary Co-Promotion Territory and the Co-Marketing Territory, (y) the exclusive licensee of such rights (even as to WC and its Affiliates) in the Potential Co-Promotion Territory and (z) as a non-exclusive licensee in Spain.
(ii) Subject to Section 10(c)(iv) of this Amendment, WC and its Affiliates hereby grant to S-A a non-exclusive, non-assignable, non-transferable license, with no right to sublicense (except to S-As Affiliates or to the extent necessary to exercise the limited have made rights granted to S-A herein), under the P&G Patents and P&G Know How to make, have made and import Products solely for the limited purpose of selling such Products in the Secondary Co-Promotion Territory, Co-Marketing Territory, Potential Co-Promotion Territory and/or Spain (in each case as applicable); provided that the foregoing license shall only be effective to the extent that, and for so long as, S-A and its Affiliates have the right to sell such Products in such territories, as applicable.
(iii) WC and its Affiliates hereby grant to S-A a non-exclusive, non-assignable, non-transferable license, with no right to sublicense (except to S-As Affiliates), to use the Actonel trademark during the Term in connection with the exercise of the rights granted to S-A under Sections IV(A)(1), IVa(A)(1) and VI(A)(1) of the Collaboration Agreement to market, promote, detail, distribute and sell Product, as applicable, in the Secondary Co-Promotion Territory, Potential Co-Promotion Territory and Spain, as applicable; provided, however , that in no event shall S-A or any of its Affiliates use the Actonel trademark after the U.S. Restructuring Effective Date in any form, in any manner and/or for any purpose different from S-As and its Affiliates use of the Actonel trademark pursuant to the Collaboration Agreement during the ninety (90) day period preceding the U.S. Restructuring Effective Date. S-A, on behalf of itself and its Affiliates, admits the validity, and WCs ownership, of all right, title and interest in and to the Actonel trademark and agrees that any and all goodwill, rights or interests that might be acquired by the use of the Actonel trademark by S-A or any of its Affiliates shall inure to the sole benefit of WC. S-A, on behalf of itself and its Affiliates, admits and agrees that S-A and its Affiliates have been extended only a mere permissive right to use the Actonel trademark as provided in this Section 10(c)(iii) which is not coupled with any ownership
25
interest. WC shall have the right to exercise reasonable quality control over the use of the Actonel trademark by S-A or any of its Affiliates pursuant to this Section 10(c)(iii), for the purpose of protecting and maintaining the goodwill associated with the Actonel trademark and the reputation of WC and its Affiliates. S-A, on behalf of itself and its Affiliates, acknowledges and agrees that all materials used or created by S-A or any of its Affiliates bearing the Actonel trademark (including those of the type or nature described in the definition of Packaging Materials and Promotional Materials) shall (A) be of at least the same high standards of quality, appearance and other standards that are observed immediately prior to the U.S. Restructuring Effective Date by WC, S-A and their Affiliates with respect to similar materials and (B) comply in all material respects with all applicable laws and industry standards, specifications, protocols and quality control standards. Upon expiration of the Term, the trademark license granted pursuant to this Section 10(c)(iii) shall terminate automatically and (i) all rights and licenses granted to S-A and its Affiliates pursuant this Section 10(c)(iii) shall cease, (ii) S-A and each of its Affiliates shall destroy any and all materials bearing the Actonel trademark, in each case under their possession, custody or control in whatever format, and (iii) upon the request of WC, S-A shall certify such destruction to WC.
(iv) Notwithstanding anything in this Amendment, the Collaboration Agreement or the Supply Agreement to the contrary:
(A) With respect to the exercise of S-As have made rights hereunder in connection with the manufacture of (x) the Active Ingredient (as defined in the Supply Agreement), S-A (including through any of its Affiliates) shall not exercise such have made rights through any third party Person other than (1) an Affiliate of S-A, (2) ***** or (3) another supplier approved in writing by WC in WCs sole discretion, and (y) Risedronate Tablets (as defined in the Supply Agreement), S-A shall not exercise such have made rights through any third party Person other than (1) an Affiliate of S-A, (2) ***** or (3) another supplier approved in writing by WC in WCs sole discretion. To the extent WC or any of its Affiliates shall have negotiated an exclusive arrangement with any permitted or approved source of supply relating to the Product or any applicable component thereof that would prohibit or materially impede S-A or any of its Affiliates from contracting with such permitted or approved source of supply for the manufacture of the Product or component thereof to the extent S-A exercises the have made rights granted under Section 10(c)(ii) of this Amendment, WC shall, and shall cause its Affiliates to, waive such exclusivity (provided that neither WC nor any of its Affiliates shall have any liability to S-A or any of its Affiliates should such source of supply refuse to enter into any supply arrangement with S-A or any of its Affiliates following the waiver of such exclusivity).
26
(B) S-A (including through any of its Affiliates) shall not exercise the rights granted to it under Section 10(c)(ii) of this Amendment at any time, except to the extent that S-A elects to do so by delivering written notice thereof to WC at any time in which a Supply Interruption Trigger shall have occurred and be continuing (it being understood that following such time that S-A elects to exercise such right, S-A shall continue to be free to exercise the rights granted to it under Section 10(c)(ii) of this Amendment regardless of whether such Supply Interruption Trigger is later remedied). For purposes of this Amendment, Supply Interruption Trigger means any time at which each of the following is satisfied:
(1) WC shall have failed to pay, or caused to be paid, all or any portion of the global reimbursement payment for any Quarter pursuant to Section II(B) of the Collaboration Agreement when due (other than any payment being disputed in good faith by WC or any of its Affiliates or setoff pursuant to Section 10(b) of this Amendment) and such failure is continuing for more than 30 days after written notice of such failure to pay;
(2) S-A is not then in breach of any obligation to make a payment of money when due under any Collaboration Agreement Document (other than any payment being disputed in good faith by S-A or any of its Affiliates or setoff pursuant to Section 10(b) of this Amendment); and
(3) WC or its applicable Affiliate shall have failed to fulfill a firm order for Product pursuant to the Supply Agreement by more than thirty (30) days after the required delivery date (other than under circumstances primarily caused by (a) any event of the type described in Section XXV(H) of the Collaboration Agreement (which shall include delays of third-party suppliers or contractors to furnish components, materials or supplies resulting from events beyond WCs and its Affiliates control), (b) a failure of S-A or any of its Affiliates to comply with its obligations set forth in any Collaboration Agreement Document or (c) a failure of the Product to meet Specifications (as defined in the Supply Agreement), to the extent the Products failing to meet such Specifications are being replaced in accordance with the terms of the Supply Agreement or the failure to meet such Specifications is being disputed in good faith).
(v) Notwithstanding anything herein to the contrary, for purposes of this Section 10(c):
(A) S-A shall only be entitled to sublicense its rights in accordance with the terms and conditions of this Section 10(c) to an
27
Affiliate for so long as such entity remains an Affiliate of S-A (it being understood that all such sublicenses granted to any such Affiliate of S-A shall terminate automatically upon such Person ceasing to be an Affiliate of S-A);
(B) in no event shall any sublicense granted in accordance with the terms and conditions of this Section 10(c) be broader in scope than the rights granted to S-A pursuant to this Section 10(c) and/or include the right for the applicable sublicensee to grant further sublicenses; and
(C)(1) S-A shall cause each sublicensee to be bound by the terms and conditions of the Collaboration Agreement (as amended by this Amendment), (2) S-A shall be responsible for any breach of the Collaboration Agreement (as amended by this Amendment) by each such sublicensee and (3) any act or omission of a sublicensee that would be a breach of the Collaboration Agreement (as amended by this Amendment) if performed by S-A shall be deemed to be a breach by S-A of the Collaboration Agreement (as amended by this Amendment).
(d) Supply Agreement . The Supply Agreement, dated as of June 15, 1998 (the Supply Agreement ), by and between Warner Chilcott Pharmaceuticals, Inc. (formerly known as Procter & Gamble Pharmaceuticals, Inc.) and Hoechst Marion Roussel Aktiengesellschaft ( Hoechst ), is hereby amended to provide that the Parties acknowledge and agree that the rejection of the Collaboration Agreement by any Party in any bankruptcy proceeding (including any proceeding described in Section XVII(C)(1) of the Collaboration Agreement) shall be deemed to constitute a breach of the Supply Agreement by such Party entitling the other Party to terminate the Supply Agreement in its entirety, and, in the case of S-A, regardless of whether S-A elects to retain its rights under the licenses granted under the Collaboration Agreement pursuant to Section 365(n) of the U.S. Bankruptcy Code.
(e) Exclusive Supply Provisions . If S-A elects to exercise its rights granted to it under Section 10(c)(ii) of this Amendment in connection with the occurrence of a Supply Interruption Trigger pursuant to Section 10(c)(iv)(B) of this Amendment, the Parties acknowledge and agree that S-A and its Affiliates, including Hoechst, shall be relieved of their exclusivity obligations set forth in Section 2.2(b) of the Supply Agreement and, from and after the date S-A makes such election pursuant to Section 10(c)(iv)(B) of this Amendment, such exclusivity obligations shall be of no further force and effect.
11. Local U.S. Marketing Services Agreement . Each of WC and S-A agrees to cause each of its Affiliates that is party to the Marketing Services Agreement currently in effect with respect to the USA to enter into an agreement terminating such Marketing Services Agreement as promptly as reasonably practicable after the U.S. Restructuring Effective Date.
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12. Product Improvements .
(a) Notwithstanding anything in Sections III(D) and XVIII of the Collaboration Agreement to the contrary, from and after the U.S. Restructuring Effective Date, S-A shall have no right to participate in the development or commercialization of any potential Product Improvement to extent relating to the WC Exclusive Territory
(b) For the avoidance of doubt, the Parties agree that (i) ***** shall continue to be considered a Joint Product Improvement and (ii) the 150 mg Risedronate product referred to as Libertas 150 (in the formulation previously presented to S-A) shall continue to be considered a P&G Product Improvement.
13. Public Announcements .
(a) External Communications . For purposes of clarification, Article XIII(E) of the Collaboration Agreement shall apply to this Amendment.
(b) Internal Communications . Each Party shall consult with one another in good faith with respect to any employee announcements, communications to employees and other similar internal communications with respect to the initial announcement of the transactions contemplated hereby. Any employee announcements, communications to employees and other similar internal communications with respect to the initial announcement of this Amendment or the transactions contemplated hereby shall be approved by both Parties in advance, provided that such approval shall not be unreasonably withheld, conditioned or delayed.
(c) Timing of Initial Announcement . In no event will either party make any press releases or similar publicity, employee announcements, communications to employees or other similar internal communications with respect to the transactions contemplated by this Amendment prior to April 5, 2010.
14. Miscellaneous .
(a) Good Faith and Fair Dealing . Notwithstanding any other provision of this Amendment to the contrary, (i) in carrying out the terms of this Amendment, each Party agrees to deal with the other Party in good faith and in a manner of fair dealing and (ii) each Party acknowledges and agrees that nothing in this Amendment, nor any exercise of its rights (whether or not discretionary) nor performance of its obligations hereunder, shall be deemed to constitute a waiver, or other derogation, of the implied covenant of good faith and fair dealing, which shall remain in full force and effect.
(b) Interpretative Provisions . The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. Any singular term in this Amendment shall be deemed to include the plural, and any plural term the singular. Whenever the words include, includes or including are used in this Amendment, they shall be deemed to be followed by the words without limitation, whether or not they are in fact followed by those words or words of like import. References to any agreement or contract are to that agreement or contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof.
29
(c) Counterparts . This Amendment may be executed in one or more counterparts, each of which shall be deemed to be an original.
(d) Governing Law . The construction, validity and performance of this Amendment shall be governed in all respects by the laws of the State of Ohio without reference to the choice of law provisions thereof, whether common law or statutory. Any dispute arising under this Amendment shall be resolved in accordance with the terms set forth in Article XVI of the Collaboration Agreement.
(e) Effectiveness and Ratification . Except as specifically provided for in this Amendment, the terms of the Collaboration Agreement are hereby ratified and confirmed and remain in full force and effect.
[ Remainder of Page Intentionally Left Blank ]
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IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed by their duly authorized representatives as of the date first above written.
| SANOFI-AVENTIS U.S. LLC | ||||
| By: |
/s/ Gregory Irace |
|||
| Name: | Gregory Irace | |||
| Title: | President & CEO | |||
| WARNER CHILCOTT COMPANY, LLC | ||||
| By: |
/s/ Max A. Torres |
|||
| Name: | Max A. Torres | |||
|
Title: |
VP and General Manager Business Operations | |||
Exhibit A
*****
A-1
Exhibit B
Actonel Exhibit - GTN
| Actual | Forecast | Variance | ||||||||||||||||||||||||||||
| Current Month | YTD | Current Month | YTD | Current Month | YTD | |||||||||||||||||||||||||
| $ | % | $ | % | $ | % | $ | % | $ | % | $ | % | |||||||||||||||||||
|
Outside Sales |
| 100 | % | 100 | % | | 100 | % | 100 | % | | | ||||||||||||||||||
|
Cash Discounts |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Returns and Adjustments |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Returns |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Distribution Discounts |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Other Adjustments |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Decline in PRICE |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Special Allowances |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Rebates and Discounts |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Commercial |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Medicare/Medicaid |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
GovernmentVA/DOD |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Other Rebates / Discounts |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Temporary PRICE Reductions |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Loyalty Cards |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Other Temporary Price Reductions |
| 0 | % | 0 | % | | 0 | % | 0 | % | | 0 | % | | 0 | % | ||||||||||||||
|
Net Outside Sales |
| 100 | % | | 100 | % | | 100 | % | | 100 | % | | 0 | % | | 0 | % | ||||||||||||
B-1
Exhibit C
*****
C-1
EXHIBIT D.1
Specified P&G Patents
*****
EXHIBIT D.2
API Patents
*****
D-1
EXHIBIT E.1
*****
E.1-1
EXHIBIT E.2
*****
E.2-1
EXHIBIT F
S-A Sales Employees
*****
F-1
EXHIBIT G
FORM OF GUARANTEE
GUARANTEE dated as of , 2010 by Warner Chilcott plc ( WC ), a public limited company incorporated under the laws of Ireland, and Warner Chilcott Pharmaceuticals Inc. (the Subsidiary Guarantor ), an Ohio corporation (jointly and severally, the Guarantors and each, with its successors, a Guarantor ) for the benefit of Sanofi-Aventis U.S. LLC (with its successors and assigns, the Beneficiary ).
WHEREAS, WC is the parent company of Warner Chilcott Company, LLC, a limited liability company organized and existing under the laws of Puerto Rico (with its successors, the Obligor ), and the Subsidiary Guarantor is an operating subsidiary of the Obligor; and
WHEREAS, the Obligor (as assignee of The Procter & Gamble Company and Procter & Gamble Pharmaceuticals, Inc.) is party to the Amended and Restated Collaboration Agreement dated as of October 8, 2004 with the Beneficiary (as successor in interest to Aventis Pharmaceuticals Inc.) (the Collaboration Agreement ), as amended from time to time, and has entered into the U.S. Amendment Agreement dated as of , 2010 with the Beneficiary (the Amendment and the Collaboration Agreement, as previously amended and as amended by the Amendment , the Amended Collaboration Agreement ), whereby pursuant to the Amendment, the Obligor and the Beneficiary have agreed, among other things, to restructure the commercialization efforts for the Product (as defined in the Amended Collaboration Agreement); and
WHEREAS, in consideration of the financial and other support that the Obligor has provided, and such financial and other support as the Obligor may in the future provide, to the Guarantors, the Guarantors are willing to enter into this Guarantee;
NOW, THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Guarantors agree as follows:
1. The Guarantees . Each Guarantor hereby, jointly and severally, unconditionally guarantees the full and punctual payment (whether at stated maturity, upon acceleration or otherwise) of all amounts payable by the Obligor from time to time pursuant to the Amended Collaboration Agreement (collectively, the Guaranteed Obligations ). Upon failure by the Obligor to pay punctually any Guaranteed Obligation, the Guarantors shall forthwith on demand pay the amount not so paid at the place and in the manner specified in the Amended Collaboration Agreement.
2. Guarantees Unconditional . The obligations of the Guarantors hereunder shall be unconditional and absolute and, without limiting the generality of the foregoing, shall not be released, discharged or otherwise affected by:
(a) any extension, renewal, settlement, compromise, waiver or release in respect of any obligation of the Obligor under the Amended Collaboration Agreement, by operation of law or otherwise;
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(b) any modification or amendment of or supplement to the Amended Collaboration Agreement;
(c) any release, impairment, non-perfection or invalidity of any direct or indirect security for any obligation of the Obligor under the Amended Collaboration Agreement;
(d) any change in the corporate existence, structure or ownership of the Obligor, or any insolvency, bankruptcy, reorganization or other similar proceeding affecting the Obligor or its assets or any resulting release or discharge of any obligation of the Obligor contained in the Amended Collaboration Agreement;
(e) the existence of any claim, set-off or other rights which any Guarantor may have at any time against the Obligor, the Beneficiary or any other entity, whether in connection herewith or with any unrelated transactions, provided that nothing herein shall prevent the assertion of any such claim by separate suit or compulsory counterclaim;
(f) any invalidity or unenforceability relating to or against the Obligor for any reason of the Amended Collaboration Agreement or any provision of applicable law or regulation purporting to prohibit the payment by the Obligor of any amounts payable pursuant to the Amended Collaboration Agreement; or
(g) any other act or omission to act or delay of any kind by the Obligor, the Beneficiary or any other person or any other circumstance whatsoever which might, but for the provisions of this paragraph, constitute a legal or equitable discharge of or defense to the Guarantors obligations hereunder.
3. Limit of Liability . Any term or provision of this Agreement or the Amended Collaboration Agreement to the contrary notwithstanding, the maximum aggregate amount of the obligations for which the Subsidiary Guarantor shall be liable shall not exceed the maximum amount for which the Subsidiary Guarantor can be liable without rendering this Agreement or the Amended Collaboration Agreement, as it relates to the Subsidiary Guarantor, subject to avoidance under applicable law relating to fraudulent conveyance or fraudulent transfer (including Section 548 of the Bankruptcy Code or any applicable provisions of comparable state law) (collectively, Fraudulent Transfer Laws ), in each case after giving effect (a) to all other liabilities of the Subsidiary Guarantor, contingent or otherwise, that are relevant under such Fraudulent Transfer Laws (specifically excluding, however, any liabilities of the Subsidiary Guarantor in respect of intercompany indebtedness to the Obligor to the extent that such indebtedness would be discharged in an amount equal to the amount paid by the Subsidiary Guarantor hereunder) and (b) to the value as assets of the Subsidiary Guarantor (as determined under the applicable provisions of such Fraudulent Transfer Laws) of any rights to subrogation, contribution, reimbursement, indemnity or similar rights held by the Subsidiary Guarantor pursuant to (i) applicable requirements of law or (ii) any other contractual obligations providing for an equitable allocation among the Subsidiary Guarantor and the other Subsidiaries or Affiliates of the Obligor of obligations arising under this Agreement or other guaranties of the Guaranteed Obligations by such parties.
4. Discharge Only Upon Payment in Full; Reinstatement in Certain Circumstances. The Guarantors obligations hereunder shall remain in full force and effect until all Guaranteed Obligations shall have been paid in full. If at any time any payment of any Guaranteed
G-2
Obligation is rescinded or must be otherwise restored or returned upon the insolvency, bankruptcy or reorganization of the Borrower or otherwise, the Guarantors obligations hereunder with respect to such payment shall be reinstated as though such payment had been due but not made at such time.
5. Waiver by the Guarantors . Each Guarantor irrevocably waives acceptance hereof, presentment, demand, protest and any notice not provided for herein, as well as any requirement that at any time any action be taken by any person or entity against any Guarantor, the Obligor or any other person or entity.
6. Subrogation . Upon making full payment with respect to any obligation of the Obligor hereunder, the Guarantors shall be subrogated to the rights of the payee against the Obligor with respect to such obligation; provided that the Guarantors shall not enforce any payment by way of subrogation so long as any Guaranteed Obligation remains unpaid.
7. Representations and Warranties . Each Guarantor represents and warrants to the Beneficiary that:
(a) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization;
(b) the execution, delivery and performance by it of this Guarantee are within its corporate powers and have been duly authorized by all necessary corporate and, if required, stockholder action;
(c) this Guarantee has been duly executed and delivered by it and constitutes its legal, valid and binding obligation, enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, and other laws affecting creditors rights generally and subject to general principles of equity, regardless of whether considered in a proceeding in equity or at law; and
(d) the execution, delivery and performance by it of this Guarantee (i) do not require any consent or approval of, registration or filing with, or other action by, any governmental authority, except such as have been obtained and are in full force and effect, (ii) will not violate any law or regulation applicable to it or its charter, by-laws or other organizational documents or any order of any court or governmental authority applicable to it, and (iii) will not violate or result in a default under any indenture, agreement or other instrument binding upon it or any of its properties or give rise to a right thereunder to require it to make any payment.
8. Notices . All notices and other communications provided for herein shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail, or sent by telecopy, as follows: (i) if to any Guarantor, to it, at c/o Warner Chilcott Corporation, 100 Enterprise Drive, Rockaway, New Jersey 07866, Attention: Izumi Hara, Senior Vice President, General Counsel and Corporate Secretary, Telecopy No. (973) 442-3283 and (ii) if to the Beneficiary, to it at Aventis Pharmaceuticals Inc., 300 Somerset Boulevard, Bridgewater, New Jersey 08807, Attention: General Counsel, Telecopy no. (908) 927-8610. Each party hereto may change its address or telecopy number for notices and other communications hereunder by notice to the other party. All notices and other communications given in accordance with the provisions of this Guarantee will be deemed to have been given on the date of receipt.
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9. No Waiver . No failure or delay by the Beneficiary in exercising any right, power or privilege under this Guarantee or the Amended Collaboration Agreement shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
10. Amendments and Waivers . Any provision of this Guarantee may be amended or waived if, but only if, such amendment or waiver is in writing and is signed by the Beneficiary and each Guarantor
11. Release . If (a) the rights and obligations of the Obligor under the Amended Collaboration Agreement are transferred to a Person (as defined in the Amended Collaboration Agreement) that is not an Affiliate (as defined in the Amended Collaboration Agreement) of a Guarantor or (b) the Obligor shall cease to be an Affiliate (as so defined) of a Guarantor, in each case pursuant to a transaction not prohibited under the Amended Collaboration Agreement, this Guarantee shall terminate as to such Guarantor and such Guarantor shall thereupon cease to have any further obligations hereunder.
12. Successors and Assigns . This Guarantee shall be binding upon each Guarantor and its successors and assigns, for the benefit of the Beneficiary and its successors and assigns, except that no Guarantor may transfer or assign any or all of its rights or obligations hereunder without the prior written consent of the parties hereto; provided that any Guarantor may merge into or consolidate with any Person (as defined in the Amended Collaboration Agreement) or permit any other Person (as so defined) to merge into or consolidate with it so long as the Person (as so defined) surviving such merger or consolidation continues to be obligated as a Guarantor hereunder.
13. Expenses . Each Guarantor hereby agrees to pay all reasonable out-of-pocket costs and expenses of the Beneficiary incurred in connection with the enforcement of this Guarantee and the protection of the Beneficiarys rights hereunder (including, in each case, the reasonable fees and disbursements of counsel employed by the Beneficiary).
14. Governing Law . The construction, validity and performance of this Guarantee shall be governed in all respects by the laws of the State of Ohio without reference to the choice of law provisions thereof, whether common law or statutory. Any dispute arising under this Guarantee shall be resolved in accordance with the terms set forth in Article XVI of the Amended Collaboration Agreement.
[Remainder of Page Intentionally Left Blank]
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|
GIVEN under the official seal of WARNER CHILCOTT PLC in the presence of: |
|
|
| AUTHORISED SIGNATORY |
Witness signature:
Name:
Address:
Occupation:
|
|
||
|
WARNER CHILCOTT PHARMACEUTICALS INC. |
||
| By: |
|
|
| Name: | ||
| Title: | ||
| Agreed to and accepted by: | ||
|
|
||
| SANOFI-AVENTIS U.S. LLC | ||
| By: |
|
|
| Name: | ||
| Title: | ||
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT
I, Roger M. Boissonneault, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Warner Chilcott Public Limited Company;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: May 7, 2010
|
/s/ Roger M. Boissonneault |
||
|
Name: |
Roger M. Boissonneault | |
|
Title: |
President and Chief Executive Officer | |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT
I, Paul Herendeen, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Warner Chilcott Public Limited Company;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: May 7, 2010
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/s/ Paul Herendeen |
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| Name: | Paul Herendeen | |
| Title: | Executive Vice President and Chief Financial Officer | |
Exhibit 32
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT
The certification set forth below is being submitted in connection with Warner Chilcott Public Limited Companys Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2010 (the Report) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the Exchange Act) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
Roger M. Boissonneault, the Chief Executive Officer and Paul Herendeen, the Chief Financial Officer of Warner Chilcott Public Limited Company, each certifies that, to the best of his knowledge:
| 1. | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
| 2. | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Warner Chilcott Public Limited Company. |
Date: May 7, 2010
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/s/ Roger M. Boissonneault |
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| Name: | Roger M. Boissonneault | |
| Title: | President and Chief Executive Officer | |
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/s/ Paul Herendeen |
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| Name: | Paul Herendeen | |
| Title: | Executive Vice President and Chief Financial Officer | |
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Warner Chilcott Public Limited Company and will be retained by Warner Chilcott Public Limited Company and furnished to the Securities and Exchange Commission or its staff upon request.