UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2012
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: 000-23265
SALIX PHARMACEUTICALS, LTD.
(Exact name of Registrant as specified in its charter)
Delaware | 94-3267443 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
8510 Colonnade Center Drive
Raleigh, NC 27615
(Address of principal executive offices, including zip code)
(919) 862-1000
(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 x 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 registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ¨ NO x
The number of shares of the Registrants Common Stock outstanding as of November 6, 2012 was 58,841,531.
SALIX PHARMACEUTICALS, LTD.
PART I. |
FINANCIAL INFORMATION | |||||
Item 1. |
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Condensed Consolidated Balance Sheets as of September 30, 2012 (unaudited) and December 31, 2011 |
1 | |||||
2 | ||||||
3 | ||||||
Notes to Condensed Consolidated Financial Statements (unaudited) |
4 | |||||
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
21 | ||||
Item 3. |
35 | |||||
Item 4. |
35 | |||||
PART II. |
OTHER INFORMATION | |||||
Item 1. |
Legal Proceedings | 36 | ||||
Item 1A. |
Risk Factors | 37 | ||||
Item 6. |
Exhibits | 46 | ||||
47 |
PART I. FINANCIAL INFORMATION.
SALIX PHARMACEUTICALS, LTD.
Condensed Consolidated Balance Sheets
(U.S. dollars, in thousands, except share amounts)
September 30,
2012 |
December 31,
2011 |
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(unaudited) | ||||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | 775,903 | $ | 292,814 | ||||
Accounts receivable, net |
213,766 | 151,207 | ||||||
Inventory |
71,654 | 49,205 | ||||||
Deferred tax assets |
39,289 | 50,519 | ||||||
Prepaid expenses and other current assets |
22,385 | 23,350 | ||||||
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Total current assets |
1,122,997 | 567,095 | ||||||
Property and equipment, net |
29,772 | 29,540 | ||||||
Goodwill |
180,478 | 187,032 | ||||||
Product rights and intangibles, net |
452,605 | 504,839 | ||||||
Deferred tax assets |
| 2,586 | ||||||
Other assets |
35,049 | 21,877 | ||||||
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Total assets |
$ | 1,820,901 | $ | 1,312,969 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
$ | 22,019 | $ | 21,142 | ||||
Accrued liabilities |
84,968 | 80,398 | ||||||
Income taxes payable |
2,553 | 11,039 | ||||||
Reserve for product returns, rebates and chargebacks |
123,805 | 97,879 | ||||||
Current portion of capital lease obligations |
50 | 188 | ||||||
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Total current liabilities |
233,395 | 210,646 | ||||||
Long-term liabilities: |
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Convertible senior notes |
869,053 | 340,283 | ||||||
Lease incentive obligation |
7,304 | 6,235 | ||||||
Acquisition-related contingent consideration |
101,700 | 119,698 | ||||||
Deferred tax liabilities |
63,280 | 78,637 | ||||||
Other long-term liabilities |
13,574 | 7,833 | ||||||
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Total long-term liabilities |
1,054,911 | 552,686 | ||||||
Stockholders equity: |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized, issuable in series, none outstanding |
| | ||||||
Common stock, $0.001 par value; 150,000,000 shares authorized, 58,823,195 and 59,205,259 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively |
59 | 59 | ||||||
Additional paid-in-capital |
621,474 | 685,315 | ||||||
Other comprehensive income (loss) |
65 | (111 | ) | |||||
Accumulated deficit |
(89,003 | ) | (135,626 | ) | ||||
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Total stockholders equity |
532,595 | 549,637 | ||||||
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Total liabilities and stockholders equity |
$ | 1,820,901 | $ | 1,312,969 | ||||
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The accompanying notes are an integral part of these consolidated financial statements
1
SALIX PHARMACEUTICALS, LTD.
Condensed Consolidated Statements of Comprehensive Income
(unaudited)
(U.S. dollars, in thousands, except per share data)
Three months
ended
September 30, |
Nine months
ended
September 30, |
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2012 | 2011 | 2012 | 2011 | |||||||||||||
Revenues: |
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Net product revenues |
$ | 185,132 | $ | 146,247 | $ | 537,271 | $ | 385,306 | ||||||||
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Costs and expenses: |
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Cost of products sold (excluding amortization of product rights and intangibles of $11,345 and $2,890 for the three-month periods ended September 30, 2012 and 2011, and $34,034 and $8,017 for the nine-month periods ended September 30, 2012 and 2011, respectively) |
26,471 | 24,056 | 93,918 | 67,884 | ||||||||||||
Amortization of product rights and intangible assets |
11,345 | 2,890 | 34,034 | 8,017 | ||||||||||||
Research and development |
32,819 | 24,814 | 86,677 | 85,294 | ||||||||||||
Selling, general and administrative |
61,543 | 41,439 | 187,266 | 132,786 | ||||||||||||
Change in acquisition-related contingent consideration |
(31,398 | ) | | (31,398 | ) | | ||||||||||
Intangible asset impairment charge |
41,600 | | 41,600 | | ||||||||||||
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Total cost and expenses |
142,380 | 93,199 | 412,097 | 293,981 | ||||||||||||
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Income from operations |
42,752 | 53,048 | 125,174 | 91,325 | ||||||||||||
Loss on extinguishment of debt |
| | (14,369 | ) | | |||||||||||
Interest expense |
(15,692 | ) | (8,080 | ) | (39,591 | ) | (23,932 | ) | ||||||||
Interest and other income |
279 | 509 | 10,409 | 2,082 | ||||||||||||
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Income before provision for income tax |
27,339 | 45,477 | 81,623 | 69,475 | ||||||||||||
Income tax expense |
(10,803 | ) | (11,198 | ) | (35,000 | ) | (15,671 | ) | ||||||||
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Net income |
$ | 16,536 | $ | 34,279 | $ | 46,623 | $ | 53,804 | ||||||||
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Net income per share, basic |
$ | 0.28 | $ | 0.58 | $ | 0.79 | $ | 0.92 | ||||||||
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Net income per share, diluted |
$ | 0.26 | $ | 0.55 | $ | 0.73 | $ | 0.89 | ||||||||
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Shares used in computing net income per share, basic |
58,755 | 59,076 | 58,671 | 58,573 | ||||||||||||
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Shares used in computing net income per share, diluted |
62,983 | 65,160 | 63,689 | 65,405 | ||||||||||||
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Comprehensive income |
$ | 21,895 | $ | 34,279 | $ | 51,986 | $ | 19,525 | ||||||||
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The accompanying notes are an integral part of these financial statements.
2
SALIX PHARMACEUTICALS, LTD.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(U.S. dollars, in thousands)
Nine months ended
September 30, |
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2012 | 2011 | |||||||
Cash flows from operating activities |
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Net income |
$ | 46,623 | $ | 53,804 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
39,119 | 10,559 | ||||||
Intangible asset impairment charge |
41,600 | | ||||||
Amortization of debt discount |
22,309 | 12,806 | ||||||
Loss on extinguishment of debt |
14,369 | | ||||||
Gain on adjustment of put option to fair market value |
(9,325 | ) | | |||||
Loss on disposal of property and equipment |
149 | 242 | ||||||
Stock-based compensation expense |
14,902 | 11,540 | ||||||
Changes in operating assets and liabilities: |
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Accounts receivable, inventory, prepaid expenses and other assets |
(80,982 | ) | (83,971 | ) | ||||
Accounts payable, accrued and other liabilities |
13,404 | 15,256 | ||||||
Reserve for product returns, rebates and chargebacks |
25,926 | 25,470 | ||||||
Change in acquisition-related contingent consideration |
(31,398 | ) | | |||||
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Net cash provided by operating activities |
96,696 | 45,706 | ||||||
Cash flows from investing activities |
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Purchases of property and equipment |
(5,466 | ) | (18,038 | ) | ||||
Business acquisition |
(10,000 | ) | (60,000 | ) | ||||
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Net cash used in investing activities |
(15,466 | ) | (78,038 | ) | ||||
Cash flows from financing activities |
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Principal payments on capital lease obligations |
(138 | ) | (633 | ) | ||||
Proceeds from convertible senior note offering |
690,000 | | ||||||
Debt issuance costs |
(21,159 | ) | | |||||
Purchase of call options |
(166,980 | ) | | |||||
Proceeds from sale of warrants |
98,994 | | ||||||
Repurchase of common stock |
(74,822 | ) | | |||||
Extinguishment of 2028 convertible senior notes |
(137,196 | ) | | |||||
Excess tax benefit from stock-based compensation |
9,785 | 11,607 | ||||||
Payments related to net settlement of stock-based awards |
(2,926 | ) | (3,031 | ) | ||||
Proceeds from issuance of common stock upon exercise of stock options |
6,127 | 4,588 | ||||||
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Net cash provided by financing activities |
401,685 | 12,531 | ||||||
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Effect of exchange rate changes on cash |
174 | | ||||||
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Net increase (decrease) in cash and cash equivalents |
483,089 | (19,801 | ) | |||||
Cash and cash equivalents at beginning of period |
292,814 | 518,030 | ||||||
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Cash and cash equivalents at end of period |
$ | 775,903 | $ | 498,229 | ||||
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Supplemental Disclosure of Cash Flow Information |
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Cash paid for income taxes |
$ | 23,651 | | |||||
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Cash paid for interest |
$ | 12,496 | $ | 8,044 | ||||
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The accompanying notes are an integral part of these financial statements.
3
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements
September 30, 2012
(Unaudited)
1. | Organization and Basis of Presentation |
Salix Pharmaceuticals, Ltd., a Delaware corporation (Salix or the Company), is a specialty pharmaceutical company dedicated to acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal diseases, which are those affecting the digestive tract.
These condensed consolidated financial statements are stated in U.S. dollars and are prepared under accounting principles generally accepted in the United States. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant inter-company balances and transactions have been eliminated in the consolidation.
The accompanying condensed consolidated financial statements include all adjustments that, in the opinion of management, are necessary for a fair presentation of financial position, results of operations and cash flows. These financial statements should be read in conjunction with the audited consolidated financial statements included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2011 filed with the Securities and Exchange Commission. The results of operations for interim periods are not necessarily indicative of results to be expected for a full year or any future period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been omitted in accordance with the SECs rules and regulations for interim reporting.
2. | Revenue Recognition |
The Company recognizes revenue when it is realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met: (a) persuasive evidence of an arrangement exists; (b) delivery has occurred or services have been rendered; (c) the Companys price to the buyer is fixed or determinable; and (d) collectibility is reasonably assured.
The Company recognizes revenue from sales transactions where the buyer has the right to return the product at the time of sale only if (1) the Companys price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid the Company, or the buyer is obligated to pay the Company and the obligation is not contingent on resale of the product, (3) the buyers obligation to the Company would not be changed in the event of theft or physical destruction or damage of the product, (4) the buyer acquiring the product for resale has economic substance apart from any provided by the Company, (5) the Company does not have significant obligations for future performance to directly bring about resale of the product by the buyer, and (6) the amount of future returns can be reasonably estimated. The Company recognizes revenues for product sales at the time title and risk of loss are transferred to the customer, which is generally at the time products are shipped. The Companys net product revenue represents the Companys total revenues less allowances for customer credits, including estimated discounts, rebates, chargebacks and product returns.
4
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
The Company establishes allowances for estimated rebates, chargebacks and product returns based on numerous qualitative and quantitative factors, including:
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the number of and specific contractual terms of agreements with customers; |
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estimated levels of inventory in the distribution channel; |
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historical rebates, chargebacks and returns of products; |
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direct communication with customers; |
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anticipated introduction of competitive products or generics; |
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anticipated pricing strategy changes by the Company and/or its competitors; |
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analysis of prescription data gathered by a third-party prescription data provider; |
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the impact of changes in state and federal regulations; and |
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estimated remaining shelf life of products. |
In its analyses, the Company uses prescription data purchased from a third-party data provider to develop estimates of historical inventory channel pull-through. The Company utilizes an internal analysis to compare historical net product shipments to estimated historical prescriptions written. Based on that analysis, management develops an estimate of the quantity of product in the channel which may be subject to various rebate, chargeback and product return exposures. At least quarterly for each product line, the Company prepares an internal estimate of ending inventory units in the distribution channel by adding estimated inventory in the channel at the beginning of the period, plus net product shipments for the period, less estimated prescriptions written for the period. Based on that analysis, the Company develops an estimate of the quantity of product in the channel that might be subject to various rebate, chargeback and product return exposures. This is done for each product line by applying a rate of historical activity for rebates, chargebacks and product returns, adjusted for relevant quantitative and qualitative factors discussed above, to the potential exposed product estimated to be in the distribution channel. The Company regularly adjusts internal forecasts that are utilized to calculate the estimated number of months in the channel based on input from members of the Companys sales, marketing and operations groups. The adjusted forecasts take into account numerous factors including, but not limited to, new product introductions, direct communication with customers and potential product expiry issues. Adjustments to estimates are recorded in the period when significant events or changes in trends are identified.
The Company periodically offers promotional discounts to the Companys existing customer base. These discounts are calculated as a percentage of the current published list price and are treated as off-invoice allowances. Accordingly, the discounts are recorded as a reduction of revenue in the period that the program is offered. In addition to promotional discounts, at the time that the Company implements a price increase, it generally offers its existing customer base an opportunity to purchase a limited quantity of product at the previous list price. Shipments resulting from these programs generally are not in excess of ordinary levels, therefore, the Company recognizes the related revenue upon shipment and includes the shipments in estimating various product related allowances. In the event the Company determines that these shipments represent purchases of inventory in excess of ordinary levels for a given wholesaler, the potential impact on product returns exposure would be specifically evaluated and reflected as a reduction in revenue at the time of such shipments.
Allowances for estimated rebates and chargebacks were $88.9 million and $69.2 million as of September 30, 2012 and December 31, 2011, respectively. These balances exclude amounts related to Colazal, which are included in the reserves discussed below. These allowances reflect an estimate of the Companys liability for items such as rebates due to various governmental organizations under the Medicare/Medicaid regulations, rebates due to managed care organizations under specific contracts and chargebacks due to various organizations purchasing products through federal contracts and/or group purchasing agreements. The Company estimates its liability for rebates and chargebacks at each reporting period based on a methodology of applying quantitative and qualitative assumptions discussed above. Due to the subjectivity of the Companys accrual estimates for rebates and chargebacks, the Company prepares various sensitivity analyses to ensure the Companys final estimate is within a reasonable range as well as review prior period activity to ensure that the Companys methodology continues to be appropriate.
Allowances for product returns were $34.8 million and $27.9 million as of September 30, 2012 and December 31, 2011, respectively. These allowances reflect an estimate of the Companys liability for products that may be returned by the original purchaser in accordance with the Companys stated return policy. The Company estimates its liability for product returns at each reporting period based on historical return rates, estimated inventory in the channel and the other factors discussed above. Due to the subjectivity of the Companys accrual estimates for product returns, the Company prepares various sensitivity analyses and also reviews prior period activity to ensure that the Companys methodology is still reasonable.
5
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
Colazal, the Companys balsalazide disodium capsule, accounted for a majority of the Companys revenue prior to 2008. On December 28, 2007, the Office of Generic Drugs, or OGD, approved three generic balsalazide capsule products. As a result of these generic approvals, sales of this product decreased significantly and the Company expects the future sales of Colazal to be insignificant. At September 30, 2012 and December 31, 2011, respectively, $0.2 million and $0.8 million were recorded as a liability to reflect an estimate of the Companys liability for Colazal that may be returned or charged back by the original purchaser in accordance with the Companys stated policies as a result of these generic approvals. The Company based this estimate on an estimate of Colazal inventory in the channel and related expiration dates of this inventory, estimated erosion of Colazal demand based on the generic approvals and the resulting estimated pull-through of Colazal, and other factors.
The Companys provision for revenue-reducing items such as rebates, chargebacks and product returns as a percentage of gross product revenue in the nine-month periods ended September 30, 2012 and 2011 was 14.7% and 14.3% for rebates, chargebacks and discounts and was 2.4% and 3.8% for product returns, respectively, excluding the Colazal return reserve. The Companys provision for revenue-reducing items such as rebates, chargebacks and product returns as a percentage of gross product revenue in the three-month periods ended September 30, 2012 and 2011 was 13.8% and 13.9% for rebates, chargebacks and discounts and was 1.2% and 5.1% for product returns, respectively, excluding the Colazal return reserve.
During the second quarter of 2011, the Company began recognizing product revenue related to shipments to wholesalers of Relistor, which the Company acquired from Progenics Pharmaceuticals, Inc. in February 2011. Based on historical experience with Relistor obtained from Progenics, and historical experience with the Companys products, specifically Xifaxan 200mg, Xifaxan 500mg and Apriso, which the Company distributes through the same distribution channels and are prescribed by the same physicians as Relistor, management has the ability to estimate returns for Relistor and therefore recognized revenue upon shipment to the wholesalers.
In December 2011, the Company acquired an exclusive worldwide license to Solesta and Deflux with the completion of its acquisition of Oceana Therapeutics, Inc. Solesta and Deflux are medical devices that the Company sells to specialty distributors who then sell the products to end users, primarily hospitals, surgical centers and physicians. The specialty distributors generally do not purchase these products until an end user is identified. Based on historical experience with these products obtained from Oceana, and historical experience with the Companys products, specifically Xifaxan 200mg, Xifaxan 550mg and Apriso, which are prescribed by the same physicians as Solesta, management has the ability to estimate returns for Solesta and Deflux and therefore recognized revenue upon shipment to the specialty distributors.
3. | Commitments |
Purchase Order Commitments
At September 30, 2012, the Company had binding purchase order commitments for inventory purchases expected to be delivered over the next three years aggregating approximately $77.1 million.
Potential Milestone Payments
The Company has entered into collaborative agreements with licensors, licensees and others. Pursuant to the terms of these collaborative agreements, the Company is obligated to make one or more payments upon the occurrence of certain milestones. The following is a summary of the material payments that the Company might be required to make under its collaborative agreements if certain milestones are satisfied.
Amended and Restated License Agreement with Alfa Wassermann S.p.AIn August 2012 the Company amended its 1996 License Agreement with Alfa Wassermann to develop rifaximin. The Restated Agreement provides the Company with an exclusive license to develop and commercialize rifaximin products for Crohns disease in the United States and Canada and a non-exclusive license to develop such products worldwide. The Company paid Alfa a non-refundable upfront fee of $10.0 million in August 2012, and is obligated to make a $25.0 million milestone payment upon receipt of marketing authorization in the United States for a rifaximin product for Crohns, and additional milestone payments of up to $200.0 million based on net sales of rifaximin products for Crohns. No milestone payments had been earned or made as of September 30, 2012.
License Agreement with Dr. Falk Pharma GmbH for budesonideIn March 2008, the Company entered into a license agreement with Dr. Falk Pharma. The agreement provides the Company with an exclusive license to develop and commercialize in the United States Dr. Falk Pharmas budesonide products. The products covered in the license agreement include U.S. patent-protected budesonide rectal foam and budesonide gastro-resistant capsule, patents for which expire in 2015 and 2016, respectively. Pursuant to the license agreement the Company is obligated to make an upfront payment and regulatory milestone payments that could total up to $23.0 million to Dr. Falk Pharma, with the majority contingent upon achievement of U.S. regulatory approval. As of September 30, 2012, the Company had paid $1.0 million of these milestone payments.
6
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
Development, Commercialization and License Agreement with Lupin LtdIn September 2009, the Company entered into a development, commercialization and license Agreement with Lupin for Lupins proprietary drug delivery technology for rifaximin. The Company made an upfront payment of $5.0 million to Lupin upon execution of this agreement.
In March 2011, the Company entered into an Amended and Restated Development, Commercialization and License Agreement (the Amended License Agreement) with Lupin. The Amended License Agreement replaces in its entirety the September 2009 agreement. This agreement provides that the Company is obligated to make an additional upfront payment of $10.0 million and milestone payments to Lupin that could total up to $53.0 million over the term of the agreement. In addition, during the first three years of the Amended License Agreement, the Company must pay Lupin a minimum quarterly payment unless specified payments by the Company to Lupin during that quarter exceed that amount. As of September 30, 2012, the Company had paid the additional $10.0 million upfront payment. The remaining milestone payments are contingent upon achievement of certain clinical and regulatory milestones.
License Agreement with Merck & Co, Inc.In February 2007, the Company entered into a master purchase and sale and license agreement with Merck, paying Merck $55.0 million to purchase the U.S. prescription pharmaceutical product rights to Pepcid ® Oral Suspension and Diuril ® Oral Suspension. Pursuant to the license agreement, the Company is obligated to make additional milestone payments to Merck up to an aggregate of $6.0 million contingent upon reaching certain sales thresholds during any of the five calendar years beginning in 2007 and ending in 2011. None of these sales thresholds had been met at September 30, 2012.
License Agreement with Napo Pharmaceuticals, Inc.In December 2008 the Company entered into a collaboration agreement with Napo. Pursuant to the agreement, the Company has an exclusive, royalty-bearing license to crofelemer for the treatment of HIV-associated diarrhea and additional indications of pediatric diarrhea and acute infectious diarrhea in a specified territory. The Company also has a non-exclusive, worldwide, royalty-bearing license to use Napo-controlled trademarks associated with crofelemer. The Company has made an initial payment of $5.0 million to Napo and will make up to $50.0 million in milestone payments to Napo contingent on regulatory approvals and up to $250.0 million in milestone payments contingent on reaching certain sales thresholds. The Company is responsible for the development costs of crofelemer, but costs exceeding $12.0 million for development of crofelemer used for the HIV-associated diarrhea indication will be credited towards regulatory milestones and thereafter against sales milestones. No milestone payments had been earned or made as of September 30, 2012.
License and Supply Agreement with Norgine B.V.In December 2005, the Company entered into a license and supply agreement with Norgine for the rights to sell NRL944, a bowel cleansing product the Company now markets in the United States under the trade name MoviPrep. Pursuant to the terms of this agreement, the Company is obligated to make upfront and milestone payments to Norgine that could total up to $37.0 million over the term of the agreement. As of September 30, 2012, the Company had paid $27.0 million of milestone payments. The remaining milestone payments are contingent upon reaching sales thresholds.
License Agreement with Photocure ASAIn October 2010, the Company entered into a license agreement with Photocure for the worldwide exclusive rights, excluding the Nordic region, to develop and commercialize Lumacan TM for diagnosing, staging or monitoring gastrointestinal dysplasia or cancer. The Company made an initial payment of $4.0 million to Photocure, and will be responsible for development costs of Lumacan, but Photocure will reimburse the Company up to $3.0 million for certain out-of-pocket costs. In addition, the Company is obligated to make up to $76.5 million in milestone payments to Photocure contingent on development and regulatory milestones, and up to $50.0 million in milestone payments contingent on reaching certain sales thresholds over the term of the agreement. No milestone payments had been earned or made as of September 30, 2012.
License Agreement with Progenics Pharmaceuticals, Inc.In February 2011, the Company acquired an exclusive worldwide license to develop and commercialize the products containing methylnaltrexone bromide, or the MNTX Compound, marketed under the name Relistor ® , from Progenics. The Company paid Progenics an up-front license fee payment of $60.0 million. In addition, the Company is obligated to pay development milestone payments of up to $90.0 million contingent upon achieving specified regulatory approvals and commercialization milestone payments of up to $200.0 million contingent upon achieving specified targets for net sales over the term of the agreement. No milestone payments had been earned or made as of September 30, 2012.
License Agreement with Q-MED ABIn connection with the Companys acquisition of Oceana Therapeutics, Inc. in December 2011, the Company acquired two license agreements with Q-MED AB, which provide it the worldwide right to commercialize Deflux and Solesta. Under the license agreements and a related stock purchase agreement with Q-Med, the Company is obligated to pay commercialization milestone payments of up to $45.0 million contingent upon achieving specified targets for net sales over the term of the agreement. No milestone payments had been earned or made as of September 30, 2012.
License Agreement with Wilmington Pharmaceuticals, LLCIn September 2007, the Company entered into an Exclusive Sublicense Agreement with Wilmington Pharmaceuticals. The agreement provides that the Company is obligated to make upfront and milestone payments up to an aggregate amount of $8.0 million to Wilmington. As of September 30, 2012, the Company had paid these milestone payments in full. The Company also loaned Wilmington $2.0 million, which was netted against the payment of the approval milestone as a result of FDA approval on September 8, 2009.
7
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
4. | Financial Instruments, Recurring and Nonrecurring Fair Value Measurements |
Recurring Fair Value Measurements
The carrying amounts of the Companys financial instruments, which include cash and cash equivalents, approximated their fair values as of September 30, 2012 and December 31, 2011 due to the short-term nature of these financial instruments and are considered Level 1 investments. Level 1 investments are investments where there are quoted prices in active markets available for identical assets or liabilities. Accounts receivable, accounts payable, accrued liabilities and capital lease obligations approximated their fair values at September 30, 2012 and December 31, 2011 due to the short-term nature of these financial instruments.
The Companys convertible senior notes are considered Level 2 instruments, which are defined as those with significant other observable inputs. The fair value of the convertible senior notes was estimated using a Black-Scholes model incorporating the period-ending price of the Companys common stock and other inputs.
The fair value of the contingent consideration liability, consisting of future potential milestone payments related to the Oceana and Progenics acquisitions was $98.7 million as of September 30, 2012 and $119.7 million as of December 31, 2011. The Company considers this liability a Level 3 instrument in the fair value hierarchy which is defined as one with significant unobservable inputs. The Company determined fair values based on the income approach using probability-weighted discounted cash flows that included probability assessments of occurrence of triggering events appropriately discounted considering the uncertainties associated with the obligation, calculated in accordance with the terms of the acquisition agreement based on managements forecasts, and Monte-Carlo simulation models. The most significant unobservable inputs are the probability of receiving FDA approval for the relevant compounds and the subsequent commercial success of these compounds, if approved. The fair value of the related contingent consideration would be minimal if a compound does not receive FDA approval. The Company reviews the fair value of contingent consideration quarterly or whenever events or changes in circumstances occur that indicate there has been a change in the fair value.
Nonrecurring Fair Value Measurements
The fair value of the put option granted to the majority holder of the Companys 2028 Notes, a Level 3 instrument in the fair value hierarchy which is defined as one with significant unobservable inputs, was $5.6 million at March 31, 2012. The Company determined the fair value based on a Black-Scholes model incorporating the period-ending price of the Companys common stock and other inputs. The put option expired unexercised in June 2012.
The Companys non-financial assets, such as intangible assets and property and equipment are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized. As discussed in footnote 7, the Company reassessed the value of the indefinite lived intangible asset related to methylnaltrexone bromide injection for subcutaneous use for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic, non-cancer pain and recorded a non-cash charge to earnings of $41.6 million in the three-month period ended September 30, 2012. The Company determined the fair value of the indefinite lived intangible asset using a discounted cash flow approach, which contains significant unobservable inputs and therefore is considered a Level 3 fair value measurement. The unobservable inputs in the analysis included future cash flow projections and a discount rate.
5. | Cash and Cash Equivalents |
The Company considers all highly liquid investments with maturities from date of purchase of three months or less to be cash equivalents. The Company maintains its cash and cash equivalents in several different financial instruments with various banks and brokerage houses. This diversification of risk is consistent with Company policy to maintain liquidity and ensure the safety of principal. At September 30, 2012, cash and cash equivalents consisted primarily of demand deposits, overnight investments in Eurodollars, certificates of deposit and money market funds at reputable financial institutions and did not include any auction rate securities.
6. | Inventory |
The Company states raw materials, work-in-process and finished goods inventories at the lower of cost (which approximates actual cost on a first-in, first-out cost method) or market value. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time required to sell such inventory, remaining shelf life, and current and expected market conditions, including levels of competition, including generic competition. The Company measures inventory adjustments as the difference between the cost of the inventory and estimated market value based upon assumptions about future demand and charged to the provision for inventory, which is a component of cost of sales. At the point of the loss recognition, the Company establishes a new, lower-cost basis for that inventory, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.
8
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
The Company expenses pre-approval inventory unless the Company believes it is probable that the inventory will be saleable. The Company capitalizes inventory costs associated with marketed products and certain products prior to regulatory approval and product launch, based on managements judgment of probable future commercial use and net realizable value. Capitalization of this inventory does not begin until the product candidate is considered to have a high probability of regulatory approval, which is generally after the Company has analyzed Phase 3 data or filed an NDA. If the Company is aware of any specific risks or contingencies that are likely to impact the expected regulatory approval process or if there are any specific issues identified during the research process relating to safety, efficacy, manufacturing, marketing or labeling of the product candidate, the Company does not capitalize the related inventory. Once the Company capitalizes inventory for a product candidate that is not yet approved, the Company monitors, on a quarterly basis, the status of this candidate within the regulatory approval process. The Company could be required to expense previously capitalized costs related to pre-approval inventory upon a change in its judgment of future commercial use and net realizable value, due to a denial or delay of approval by regulatory bodies, a delay in the timeline for commercialization or other potential factors. On a quarterly basis, the Company evaluates all inventory, including inventory capitalized for which regulatory approval has not yet been obtained, to determine if any lower of cost or market adjustment is required. As it relates to pre-approval inventory, the Company considers several factors including expected timing of FDA approval, projected sales volume and estimated selling price. At September 30, 2012 and December 31, 2011, there were no amounts included in inventory related to pre-approval inventory.
Inventory at September 30, 2012 consisted of $39.0 million of raw materials, $11.7 million of work-in-process, and $21.0 million of finished goods. Inventory at December 31, 2011 consisted of $28.2 million of raw materials, $9.2 million of work-in-process, and $11.8 million of finished goods. On November 3, 2010, the Company received a paragraph IV notification from Novel stating that Novel had filed an ANDA application to seek approval to market a generic version of Metoclopramide Hydrochloride ODT, 5 mg and 10 mg. The notification letter asserted non-infringement of U.S. Patent No. 6,413,549 (the 549 patent). Upon examination of the relevant sections of the ANDA, the Company concluded that the 549 patent would not be enforced against Novel. As a result of this event, the Company evaluated the net realizable value of Metozolv inventory and recorded a $4.0 million reduction to the value of Metozolv inventory.
7. | Intangible Assets and Goodwill |
The Companys intangible assets consist of license agreements, product rights and other identifiable intangible assets, which result from product and business acquisitions. Goodwill represents the excess purchase price over the fair value of assets acquired and liabilities assumed in a business combination.
When the Company makes product acquisitions that include license agreements, product rights and other identifiable intangible assets, it records the purchase price of such intangibles, along with the value of the product related liabilities that it assumes, as intangible assets. The Company allocates the aggregate purchase price to the fair value of the various tangible and intangible assets in order to determine the appropriate carrying value of the acquired assets and then amortizes the cost of finite lived intangible assets as an expense in its consolidated statements of operations over the estimated economic useful life of the related assets. Finite lived intangible assets consist primarily of product rights for currently marketed products and are amortized over their expected economic life. The Company accounts for acquired in-process research and development as indefinite lived intangible assets until regulatory approval or discontinuation. The Company assesses the impairment of identifiable intangible assets whenever events or changes in circumstances indicate that the carrying value might not be recoverable. The Company believes that the following factors could trigger an impairment review: significant underperformance relative to expected historical or projected future operating results; significant changes in the manner of the Companys use of the acquired assets or the strategy for the Companys overall business; approval of generic products; and significant negative industry or economic trends.
In assessing the recoverability of its intangible assets, the Company must make assumptions regarding estimated future cash flows and other factors. If the estimated undiscounted future cash flows do not exceed the carrying value of the intangible assets, the Company must determine the fair value of the intangible assets. If the fair value of the intangible assets is less than the carrying value, the Company will recognize an impairment loss in an amount equal to the difference. The Company reviews goodwill and indefinite lived intangibles for impairment on an annual basis in the fourth quarter, and goodwill and other intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. As discussed below, the Company reassessed the value of the indefinite lived intangible asset related to methylnaltrexone bromide injection for subcutaneous use for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic, non-cancer pain and recorded a non-cash charge to earnings of $41.6 million in the three-month period ended September 30, 2012. At December 31, 2011 there was no impairment to goodwill. As of September 30, 2012, management believed that the reporting unit was not at risk of failing step one of the goodwill impairment test based on its assessment of the relevant qualitative factors.
9
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
The following table reflects the components of all specifically identifiable intangible assets as of September 30, 2012 and December 31, 2011 (in thousands):
September 30, 2012 | December 31, 2011 | |||||||||||||||||||||||
Gross
Amount |
Accumulated
Amortization |
Net
Carrying Value |
Gross
Amount |
Accumulated
Amortization |
Net
Carrying Value |
|||||||||||||||||||
Goodwill |
$ | 180,478 | $ | | $ | 180,478 | $ | 187,032 | $ | | $ | 187,032 | ||||||||||||
Finite lived intangible assets |
490,367 | 93,362 | 397,005 | 490,367 | 59,328 | 431,039 | ||||||||||||||||||
Indefinite lived intangible assets |
55,600 | | 55,600 | 73,800 | | 73,800 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total |
$ | 726,445 | $ | 93,362 | $ | 633,083 | $ | 751,199 | $ | 59,328 | $ | 691,871 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average remaining life of finite lived intangible assets was nine years and eleven years at September 30, 2012 and December 31, 2011, respectively.
The Company calculates amortization expense on a straight-line basis over the estimated useful life of the asset. Amortization expense for the nine-month periods ended September 30, 2012 and 2011 was $34.0 million and $8.0 million, respectively.
In November 2003, the Company acquired from aaiPharma LLC for $2.0 million the exclusive right to sell 25, 75 and 100 milligram dosage strengths of azathioprine tablets in North America under the name Azasan. The purchase price was fully allocated to product rights and related intangibles and is being amortized over a period of ten years. Although Azasan does not have any patent protection, the Company believes ten years is an appropriate amortization period based on established product sales history and managements experience. At September 30, 2012 and December 31, 2011, accumulated amortization for the Azasan intangible was $1.8 million and $1.6 million, respectively.
In June 2004, the Company acquired the exclusive U.S. rights to Anusol-HC 2.5% (hydrocortisone Cream USP), Anusol-HC 25 mg Suppository (Hydrocortisone Acetate), Proctocort Cream (Hydrocortisone Cream USP) 1% and Proctocort Suppositories (Hydrocortisone Acetate Rectal Suppositories, 30 mg) from King Pharmaceuticals, Inc. for $13.0 million. The purchase price was fully allocated to product rights and related intangibles and is being amortized over a period of ten years. Although Anusol-HC and Proctocort do not have any patent protection, the Company believes ten years is an appropriate amortization period based on established product sales history and managements experience. At September 30, 2012 and December 31, 2011, accumulated amortization for the King product intangibles was $10.7 million and $9.7 million, respectively.
In September 2005, the Company acquired InKine Pharmaceutical Company, Inc. for $210.0 million. The Company allocated $74.0 million of the purchase price to in-process research and development, $9.3 million to net assets acquired and $37.0 million to specifically identifiable product rights and related intangibles with an ongoing economic benefit to the Company. The Company allocated the remaining $89.7 million to goodwill, which is not being amortized. The InKine product rights and related intangibles were being amortized over an average period of 14 years, which the Company believed was an appropriate amortization period due to the products patent protection and the estimated economic lives of the product rights and related intangibles. In September 2010, the Company entered into a Sublicense Agreement which granted Novel Laboratories, Inc. a license under the patents covering OsmoPrep such permitting Novel to launch a generic OsmoPrep on November 16, 2019. As a result of this agreement the amortization period was adjusted prospectively, and the remaining net book value of the intangible asset will be amortized through November 16, 2019, which is the Companys revised estimate of its remaining economic life. The Company assessed whether there was an impairment to the carrying value of the related intangible asset due to its reduced economic life and determined that there was no impairment. At September 30, 2012 and December 31, 2011, accumulated amortization for the InKine intangibles was $19.9 million and $18.1 million, respectively.
In December 2005, the Company entered into a License and Supply Agreement with Norgine B.V., granting Salix the exclusive right to sell a patented-protected, liquid PEG bowel cleansing product, NRL 944, in the United States. In August 2006, the Company received U.S. Food and Drug Administration, or FDA, marketing approval for NRL 944 under the branded name of MoviPrep. In January 2007 the United States Patent Office issued a patent providing coverage to September 1, 2024. Pursuant to the terms of the Agreement, Salix paid Norgine milestone payments of $15.0 million in August 2006, $5.0 million in December 2008 and $5.0 million in December 2009. The Company was amortizing these milestone payments over a period of 17.3 years through 2022, which the Company believed was an appropriate amortization period due to the products patent protection and the estimated economic life of the related intangible. In August 2010 the Company entered into a Sublicense Agreement that granted Novel Laboratories, Inc. a license to the patents covering MoviPrep permitting Novel to launch a generic MoviPrep on September 24, 2018. As a result of this agreement the amortization period was adjusted prospectively, and the remaining net book value of the intangible asset will be amortized through September 24, 2018, which is the Companys revised estimate of its remaining economic life. The Company assessed whether there was an impairment to the carrying value of the related intangible asset due to its reduced economic life and determined that there was no impairment. At September 30, 2012 and December 31, 2011, accumulated amortization for the MoviPrep intangible was $11.0 million and $9.2 million, respectively.
10
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
In February 2007, the Company entered into a Master Purchase and Sale and License Agreement with Merck & Co. Inc., to purchase the U.S prescription pharmaceutical product rights to Pepcid Oral Suspension and Diuril Oral Suspension from Merck. The Company paid Merck $55.0 million at the closing of this transaction. The Company fully allocated the purchase price to product rights and related intangibles, and it is being amortized over a period of 15 years. Although Pepcid and Diuril do not have patent protection, the Company believes 15 years was an appropriate amortization period based on established product history and management experience. In May 2010, the FDA approved a generic famotidine oral suspension product, and the Company launched an authorized generic famotidine product. In June 2010 the FDA approved another generic famotidine oral suspension product. As a result of these events, the Company assessed whether there was an impairment to the carrying value of the related intangible asset. Based on this analysis, the Company recorded a $30 million impairment charge to reduce the carrying value of the intangible asset to its estimated fair value during the three-month period ended June 30, 2010. At September 30, 2012 and December 31, 2011, accumulated amortization for the Merck products was $14.8 million and $14.0 million, respectively and the carrying value was $10.2 million at September 30, 2012.
In July 2002, the Company acquired the rights to develop and market a granulated formulation of mesalamine from Dr. Falk Pharma GmbH. On October 31, 2008, the FDA granted marketing approval for Apriso for the maintenance of remission of ulcerative colitis in adults. In November 2008, the Company made a $8.0 million milestone payment to Dr. Falk. The Company is amortizing this milestone payment over a period of 9.5 years, which the Company believes is an appropriate amortization period due to the products patent protection and the estimated economic life of the related intangible. At September 30, 2012 and December 31, 2011, accumulated amortization for the Apriso intangible was $3.3 million and $2.7 million, respectively.
In September 2007, the Company acquired the exclusive, worldwide right to sell metoclopramide-Zydis ® (trade name Metozolv) from Wilmington Pharmaceuticals, LLC. On September 8, 2009 the FDA granted marketing approval for Metozolv ODT (metoclopramide HCl) 5 mg and 10 mg orally disintegrating tablets. Metozolv ODT is indicated for the relief of symptomatic gastroesophageal reflux or short-term (4-12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy and diabetic gastroparesis or the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis. In October 2009, the Company made a $7.3 million milestone payment to Wilmington. The Company was amortizing this milestone payment over a period of eight years, which the Company believed was an appropriate amortization period due to the products patent protection and the estimated economic life of the related intangible. On November 3, 2010, the Company received a paragraph IV notification from Novel stating that Novel had filed an ANDA application to seek approval to market a generic version of Metoclopramide Hydrochloride ODT, 5 mg and 10 mg. The notification letter asserted non-infringement of the 549 patent. Upon examination of the relevant sections of the ANDA, the Company concluded that the 549 patent would not be enforced against Novel Laboratories. As a result of this event, the Company assessed whether there was an impairment to the carrying value of the related intangible asset. Based on this analysis, the Company recorded a $4.6 million impairment charge to reduce the carrying value of the intangible asset to its estimated fair value during the three-month period ended December 31, 2010. At September 30, 2012 and December 31, 2011, accumulated amortization for the Metozolv intangible was $2.5 million and $1.9 million, respectively and the carrying value was $0.2 million at September 30, 2012.
In February 2011, the Company acquired an exclusive worldwide license to develop and commercialize the products containing methylnaltrexone bromide, or the MNTX Compound, marketed under the name Relistor ® , from Progenics Pharmaceuticals, Inc. (except in Japan, where Ono Pharmaceutical Co. Ltd. has previously licensed the subcutaneous formulation of the drug from Progenics) and a non-exclusive license to manufacture the MNTX Compound and products containing that compound in the same territory. Relistor Subcutaneous Injection is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The Company paid Progenics an up-front license fee payment of $60.0 million. The Company also agreed to pay development milestone payments of up to $90.0 million contingent upon achieving specified regulatory approvals and commercialization milestone payments of up to $200.0 million contingent upon achieving specified targets for net sales. The Company must pay Progenics 60% of any revenue received from sublicensees in respect of any country outside the United States. Additionally, the Company must pay Progenics royalties based on a percentage ranging from the mid- to high-teens of net sales by the Company and its affiliates of any product containing the MNTX Compound.
The Company accounted for the Progenics transaction as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, the Company recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date in its consolidated financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. As of the acquisition date, the estimated fair value of the assets acquired was $113.0 million, including the Companys estimate of the fair value of the contingent consideration related to the transaction discussed above of $53.0 million which is included as a long-term liability on the consolidated balance sheet. The Company determined this liability amount using a probability-weighted discounted cash flow model based on the current regulatory status of the methylnaltrexone bromide development programs. The Company assesses the fair value of the contingent consideration quarterly, or whenever events or changes in circumstances indicate that the fair value may have changed, primarily as a result of clinical or regulatory results in the related in-process development programs. In December 2011, the Company announced positive Phase 3 data
11
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
from the opioid-induced constipation, or OIC, Oral development program. Based on this information, the Company reassessed the fair value of the contingent consideration and recorded a $27.0 million increase in the contingent consideration and a corresponding charge to earnings in the fourth quarter of 2011. At September 30, 2012 and December 31, 2011, accumulated amortization for the intangible related to the currently approved indication for Relistor was $3.9 million and $2.0 million, respectively.
On July 27, 2012 the Company received a Complete Response Letter, or CRL, from the FDA following its review of a Supplemental New Drug Application (sNDA) for methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in adult patients with chronic, non-cancer pain. The CRL requested additional clinical data. In October 2012 the Company and Progenics held an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL. Based on the results of this meeting, the Company reassessed the value of the indefinite lived intangible asset related to methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in chronic non-cancer pain and recorded a non-cash charge to earnings of $41.6 million in the three-month period ended September 30, 2012. Based on these events, the Company reassessed the fair value of the contingent consideration related to the Progenics transaction and recorded a $33.0 million decrease in the contingent consideration and a corresponding non-cash charge to earnings in the three-month period ended September 30, 2012. The Company is currently evaluating the oral OIC development program and currently believes it will continue this program. However, additional information and additional guidance from the FDA could result in the termination of the oral OIC development program which would result in impairment of the related intangible asset and a decrease in the related contingent consideration.
In December 2011, the Company completed its acquisition of Oceana Therapeutics, Inc. for a purchase price of approximately $303 million. Under license agreements and a related stock purchase agreement with Q-Med acquired with this acquisition, the Company is obligated to pay development milestone payments of up to $45.0 million contingent upon achieving specified targets for net sales. Additionally, the Company must pay low double-digit royalties under these license agreements based on a percentage of net sales of these products by the Company and its affiliates.
The Company accounted for the Oceana transaction as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, the Company recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date in its consolidated financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. As of the acquisition date, the estimated fair value of the assets acquired was approximately $342.8 million, including the Companys estimate of the fair value of the contingent consideration related to the transaction discussed above of $39.7 million which is included as a long-term liability on the consolidated balance sheet. The Company determined this liability amount using a probability-weighted discounted cash flow model. The Company assesses the fair value of the contingent consideration quarterly, or whenever events or changes in circumstances indicate that the fair value may have changed, primarily as a result of significant changes in our forecast of net sales for Solesta. At September 30, 2012 accumulated amortization for the Deflux intangible was $3.6 million and $21.8 million for the Solesta intangible.
In August 2012 the Company amended its 1996 License Agreement with Alfa Wassermann to develop rifaximin. The new agreement provides the Company with an exclusive license to develop and commercialize rifaximin products for travelers diarrhea (TD), hepatic encephalopathy (HE) or irritable bowel syndrome (IBS) in the United States and Canada. The Company is obligated to pay Alfa royalties, at the same range of rates as under the previous agreement, on net sales of such products. In addition, the Restated Agreement provides the Company with an exclusive license to develop and commercialize rifaximin products for Crohns disease in the United States and Canada and a non-exclusive license to develop such products worldwide. The Company paid Alfa a non-refundable upfront fee of $10.0 million in August 2012, and is obligated to make a $25.0 million milestone payment upon receipt of marketing authorization in the United States for an extended intestinal release, or EIR, formulation product for CD, and additional milestones based on net sales of EIR formulation products for CD of up to $200.0 million. In addition, the Company is required to pay Alfa royalties on sales of rifaximin products for Crohns at percentage rates ranging in the low double digits.
The Company accounted for the Alfa Wassermann transaction as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, the Company recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date in its consolidated financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. As of the acquisition date, the estimated fair value of the assets acquired was $23.4 million which is included as an indefinite lived intangible asset on the consolidated balance sheet, and includes the Companys estimate of the fair value of the contingent consideration related to the transaction discussed above of $13.4 million which is included as a long-term liability on the consolidated balance sheet. The Company determined this liability amount using a probability-weighted discounted cash flow model based on the current regulatory status of the EIR development program. The Company assesses the fair value of the contingent consideration quarterly, or whenever events or changes in circumstances indicate that the fair value may have changed, primarily as a result of clinical or regulatory results in the related in-process development programs.
12
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
8. | Convertible Senior Notes |
Convertible Senior Notes Due 2028
On August 22, 2008 the Company closed an offering of $60.0 million in Convertible Senior Notes due 2028 (2028 Notes). Net proceeds from the offering were $57.3 million. The 2028 Notes are governed by an indenture, dated as of August 22, 2008, between the Company and U.S. Bank National Association, as trustee.
The 2028 Notes bear interest at a rate of 5.5% per year, payable semiannually in arrears on February 15 and August 15 of each year, beginning on February 15, 2009. The 2028 Notes will mature on August 15, 2028, unless previously converted or repurchased in accordance with their terms prior to such date.
The 2028 Notes are senior unsecured obligations, and rank (i) equally to any of the Companys existing and future unsecured senior debt, (ii) senior to any of the Companys future indebtedness that is expressly subordinated to these 2028 Notes, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness.
The Company may redeem the 2028 Notes, in whole or in part, at any time after August 15, 2013 for cash equal to the principal amount of the Notes to be redeemed, plus any accrued and unpaid interest.
On August 15, 2013, August 15, 2018 and August 15, 2023 or upon the occurrence of a fundamental change, as defined in the indenture, the holders may require the Company to repurchase all or a portion of the 2028 Notes for cash at 100% of the principal amount of the Notes being purchased, plus any accrued and unpaid interest.
In March 2012, the Company entered into a note repurchase agreement with the holder of a majority in principal amount of the 2028 Notes. The Company used a portion of the proceeds from its offering of the 2019 Notes discussed below to purchase from this holder and another holder approximately 42.1% of the 2028 Notes for an aggregate purchase price of approximately $137.2 million. In addition, for a period of 90 days after March 12, 2012, the majority holder had the option to require the Company to purchase its remaining 2028 Notes at the same price, which represented approximately 37.1% of the 2028 Notes. This option expired unexercised in June 2012. The Company incurred a loss on extinguishment of debt during the three-month period ended March 31, 2012 of $14.4 million, which primarily consists of $9.3 million in estimated fair market value of the put option granted to the majority holder, $2.5 million in estimated fair market value of the notes extinguished over their book value at the extinguishment date, and $2.0 million paid to the note holder for interest that the note holders would have received through August 2013, the first date we could call the debt under the original debt indenture.
The remaining 2028 Notes are convertible into approximately 3,756,000 shares of the Companys common stock under certain circumstances prior to maturity at a conversion rate of 108.0847 shares per $1,000 principal amount of 2028 Notes, which represents a conversion price of approximately $9.25 per share, subject to adjustment under certain conditions. Holders may convert their 2028 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of August 15, 2028 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after September 30, 2008, if the last reported sale price of the Companys common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2028 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2028 Notes, per $1,000 principal amount of the 2028 Notes, for each such trading day was less than 98% of the product of the last reported sale price of the Companys common stock and the conversion rate of the Notes on such date; (3) if the Company enters into specified corporate transactions; or (4) upon a redemption notice. The first of these conditions was met as of September 30, 2012. The 2028 Notes will be convertible, regardless of whether any of the foregoing conditions have been satisfied, on or after March 15, 2028 at any time prior to the close of business on the business day immediately preceding the stated maturity date of August 15, 2028. Upon conversion, the Company may pay cash, shares of the Companys common stock or a combination of cash and stock, as determined by the Company in its discretion.
Prior to March 2012, as long as the 2028 Notes were outstanding, the Company and its subsidiaries were prohibited from incurring any debt other than permitted debt, as defined in the indenture, except that the Company and its subsidiaries may have incurred debt in certain circumstances, including meeting a consolidated leverage ratio test and a consolidated fixed charge coverage ratio test. The 2015 Notes described below were permitted debt under the indenture. In March 2012, the Company and the holders of a majority in outstanding principal amount of the 2028 Notes amended the indenture to delete this prohibition.
In connection with the issuance of the 2028 Notes, the Company incurred $2.7 million of issuance costs, which primarily consisted of investment banker, legal and other professional fees. These costs are being amortized and are recorded as additional interest expense through August 2013, the first scheduled date on which holders have the option to require the Company to repurchase the 2028 Notes.
The Company has separately accounted for the liability and equity components of the convertible debt instrument by allocating the proceeds from issuance of the 2028 Notes between the liability component and the embedded conversion option, or equity component. This allocation was done by first estimating an interest rate at the time of issuance for similar notes that do not include the embedded conversion option. This interest rate of 12.5% was used to compute the initial fair value of the liability component of $44.1 million.
13
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
The excess of the initial proceeds received from the convertible 2028 Notes over the initial amount allocated to the liability component, of $15.9 million, is allocated to the embedded conversion option, or equity component. This excess is reported as a debt discount and subsequently amortized as interest cost, using the interest method, through August 2013, the first scheduled date on which the holders have the option to require the Company to repurchase the 2028 Notes.
The carrying value of the equity component at September 30, 2012 and December 31, 2011 was $6.4 million. The effective interest rate on the liability component for the three-month and nine-month periods ended September 30, 2012 and 2011 was 12.6%. Total interest cost of $1.1 million and $1.8 million was recognized during the three-month periods ended September 30, 2012 and 2011, respectively, including $0.7 million and $0.8 million of amortization of debt discount, respectively. Total interest cost of $3.9 million and $5.1 million was recognized during the nine-month periods ended September 30, 2012 and 2011, respectively, including $4.3 million and $2.4 million of amortization of debt discount, respectively. The fair value of the 2028 Notes was approximately $160.6 million at September 30, 2012.
Convertible Senior Notes Due 2015
On June 3, 2010 the Company closed an offering of $345.0 million in Convertible Senior Notes due May 15, 2015 (2015 Notes). Net proceeds from the offering were approximately $334.2 million. The 2015 Notes are governed by an indenture, dated as of June 3, 2010 between the Company and U.S. Bank National Association, as trustee.
The 2015 Notes bear interest at a rate of 2.75% per year, payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2010. The 2015 Notes will mature on May 15, 2015, unless earlier converted or repurchased in accordance with their terms prior to such date.
The 2015 Notes are senior unsecured obligations, and rank (i) equally to any of the Companys existing and future unsecured senior debt, (ii) senior to any of the Companys future indebtedness that is expressly subordinated to these 2015 Notes, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness.
The 2015 Notes are convertible into approximately 7,439,000 shares of the Companys common stock under certain circumstances prior to maturity at a conversion rate of 21.5592 shares per $1,000 principal amount of 2015 Notes, which represents a conversion price of approximately $46.38 per share, subject to adjustment under certain conditions. Holders may convert their 2015 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of May 15, 2015 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after June 30, 2010, if the last reported sale price of the Companys common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2015 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2015 Notes, per $1,000 principal amount of the 2015 Notes, for each such trading day was less than 98% of the product of the last reported sale price of the Companys common stock and the conversion rate of the 2015 Notes on such date; or (3) if the Company enters into specified corporate transactions. None of these conditions had been met as of September 30, 2012. The 2015 Notes will be convertible, regardless of whether any of the foregoing conditions have been satisfied, on or after January 13, 2015 at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date of May 15, 2015. Upon conversion, the Company may pay cash, shares of the Companys common stock or a combination of cash and stock, as determined by the Company in its discretion.
The Company is required to separately account for the liability and equity components of the convertible debt instrument by allocating the proceeds from issuance of the 2015 Notes between the liability component and the embedded conversion option, or equity component. This allocation was done by first estimating an interest rate at the time of issuance for similar notes that do not include the embedded conversion option. This interest rate of 8.35% was used to compute the initial fair value of the liability component of $265.6 million. The excess of the initial proceeds received from the convertible 2015 Notes over the initial amount allocated to the liability component, of $79.4 million, is allocated to the embedded conversion option, or equity component. This excess is reported as a debt discount and subsequently amortized as interest cost, using the interest method, through May 2015, the maturity date of the 2015 Notes.
In connection with the issuance of the 2015 Notes, the Company incurred $10.8 million of issuance costs, which primarily consisted of investment banker, legal and other professional fees. The portion of these costs related to the equity component of $2.5 million was charged to additional paid-in capital. The portion of these costs related to the debt component of $8.3 million is being amortized and are recorded as additional interest expense through May 2015, the maturity date of the 2015 Notes.
In connection with the issuance of the 2015 Notes, the Company entered into capped call transactions with certain counterparties covering approximately 7,439,000 shares of the Companys common stock. The capped call transactions have a strike price of $46.38 and a cap price of $62.44, and are exercisable when and if the 2015 Notes are converted. If upon conversion of the 2015 Notes, the price of the Companys common stock is above the strike price of the capped calls, the counterparties will deliver
14
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
shares of the Companys common stock and/or cash with an aggregate value approximately equal to the difference between the price of the Companys common stock at the conversion date (as defined, with a maximum price for purposes of this calculation equal to the cap price) and the strike price, multiplied by the number of shares of the Companys common stock related to the capped call transactions being exercised. The Company paid $44.3 million for these capped calls and charged this to additional paid-in capital.
The carrying value of the equity component related to the 2015 Notes at September 30, 2012 was $79.4 million. The effective interest rate on the liability component for the three-month and nine-month periods ended September 30, 2012 and 2011 was 8.35%. Total interest cost of $6.6 million and $6.3 million was recognized during the three-month periods ended September 30, 2012 and 2011, respectively, including $3.8 million and $3.5 million of amortization of debt discount, respectively. Total interest cost of $19.7 million and $18.8 million was recognized during the nine-month periods ended September 30, 2012 and 2011, respectively, including $11.3 million and $10.4 million of amortization of debt discount, respectively. The fair value of the 2015 Notes was approximately $388.4 million at September 30, 2012.
Convertible Senior Notes Due 2019
On March 16, 2012 the Company closed an offering of $690.0 million in Convertible Senior Notes due March 15, 2019 (2019 Notes). Net proceeds from the offering were approximately $668.3 million. The 2019 Notes are governed by an indenture, dated as of March 16, 2012 between the Company and U.S. Bank National Association, as trustee.
The 2019 Notes bear interest at a rate of 1.50% per year, payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2012. The 2019 Notes will mature on March 15, 2019, unless earlier converted or repurchased in accordance with their terms prior to such date.
The 2019 Notes are senior unsecured obligations, and rank (i) equally to any of the Companys existing and future unsecured senior debt, (ii) senior to any of the Companys future indebtedness that is expressly subordinated to these 2019 Notes, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness.
The 2019 Notes are convertible into approximately 10,484,000 shares of the Companys common stock under certain circumstances prior to maturity at a conversion rate of 15.1947 shares per $1,000 principal amount of 2019 Notes, which represents a conversion price of approximately $65.81 per share, subject to adjustment under certain conditions. Holders may convert their 2019 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of March 15, 2019 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after June 30, 2012, if the last reported sale price of the Companys common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2019 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2019 Notes, per $1,000 principal amount of the 2019 Notes, for each such trading day was less than 98% of the product of the last reported sale price of the Companys common stock and the conversion rate of the 2019 Notes on such date; or (3) if the Company enters into specified corporate transactions. None of these conditions had been met as of September 30, 2012. The 2019 Notes will be convertible, regardless of whether any of the foregoing conditions have been satisfied, on or after November 9, 2018 at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date of March 15, 2019. Upon conversion, the Company may pay cash, shares of the Companys common stock or a combination of cash and stock, as determined by the Company in its discretion.
The Company is required to separately account for the liability and equity components of the convertible debt instrument by allocating the proceeds from issuance of the 2019 Notes between the liability component and the embedded conversion option, or equity component. This allocation was done by first estimating an interest rate at the time of issuance for similar notes that do not include the embedded conversion option. This interest rate of 5.50% was used to compute the initial fair value of the liability component of $529.3 million. The excess of the initial proceeds received from the convertible 2019 Notes over the initial amount allocated to the liability component, of $160.7 million, is allocated to the embedded conversion option, or equity component. This excess is reported as a debt discount and subsequently amortized as interest cost, using the interest method, through March 2019, the maturity date of the 2019 Notes.
In connection with the issuance of the 2019 Notes, the Company incurred $21.7 million of issuance costs, which primarily consisted of investment banker, legal and other professional fees. The portion of these costs related to the equity component of $5.1 million was charged to additional paid-in capital. The portion of these costs related to the debt component of $16.6 million is being amortized and is recorded as additional interest expense through March 2019, the maturity date of the 2019 Notes.
In connection with the issuance of the 2019 Notes, the Company entered into convertible bond hedge transactions with certain counterparties covering approximately 10,484,000 shares of the Companys common stock. The convertible bond hedge transactions have a strike price of $65.81 and are exercisable when and if the 2019 Notes are converted. If upon conversion of the 2019 Notes, the price of the Companys common stock is above the strike price of the convertible bond hedge transactions, the counterparties will
15
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
deliver shares of the Companys common stock and/or cash with an aggregate value approximately equal to the difference between the price of the Companys common stock at the conversion date and the strike price, multiplied by the number of shares of the Companys common stock related to the convertible bond hedge transaction being exercised. The Company paid $167.0 million for these convertible bond hedge transactions and charged this to additional paid-in capital.
Simultaneously with entering into the convertible bond hedge transactions, the Company entered into privately negotiated warrant transactions whereby the Company sold the counterparties to these transactions warrants to acquire, subject to customary adjustments, approximately 10,484,000 shares of the Companys common stock at a strike price of $85.31 per share, also subject to adjustment. The Company received $99.0 million for these warrants and credited this amount to additional paid-in capital.
The carrying value of the equity component related to the 2019 Notes at September 30, 2012 was $160.7 million. The effective interest rate on the liability component for the three-month and nine-month periods ended September 30, 2012 was 5.50%. Total interest cost of $8.0million was recognized during the three-month period ended September 30, 2012, including $4.8 million of amortization of debt discount. Total interest cost of $16.0 million was recognized during the nine-month period ended September 30, 2012, including $9.1 million of amortization of debt discount. The fair value of the 2019 Notes was approximately $658.0 million at September 30, 2012.
The following table summarizes information on the convertible debt (in thousands) as of:
September 30,
2012 |
December 31,
2011 |
|||||||
Convertible Notes due 2028: |
||||||||
Principal amount of the liability component |
$ | 34,750 | $ | 60,000 | ||||
Unamortized discount |
(2,222 | ) | (6,565 | ) | ||||
|
|
|
|
|||||
Net carrying amount |
$ | 32,528 | $ | 53,435 | ||||
|
|
|
|
|||||
Convertible Notes due 2015: |
||||||||
Principal amount of the liability component |
$ | 345,000 | $ | 345,000 | ||||
Unamortized discount |
(46,852 | ) | (58,152 | ) | ||||
|
|
|
|
|||||
Net carrying amount |
$ | 298,148 | $ | 286,848 | ||||
|
|
|
|
|||||
Convertible Notes due 2019: |
||||||||
Principal amount of the liability component |
$ | 690,000 | $ | | ||||
Unamortized discount |
(151,623 | ) | | |||||
|
|
|
|
|||||
Net carrying amount |
$ | 538,377 | $ | | ||||
|
|
|
|
|||||
Total Convertible Senior Notes |
||||||||
Principal amount of the liability component |
$ | 1,069,750 | $ | 405,000 | ||||
Unamortized discount |
(200,697 | ) | (64,717 | ) | ||||
|
|
|
|
|||||
Net carrying amount |
$ | 869,053 | $ | 340,283 | ||||
|
|
|
|
9. | Research and Development |
The Company expenses research and development costs, both internal and externally contracted, as incurred. For nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities, the Company initially capitalizes the advance payment. The Company then recognizes such amounts as an expense as the related goods are delivered or the related services are performed. At September 30, 2012 and December 31, 2011, the net liability related to on-going research and development activities was $13.8 million and $8.1 million, respectively.
10. | Comprehensive Income |
Other comprehensive income is composed entirely of adjustments resulting from the translation into U.S. dollars of the financial statements of the Companys foreign subsidiary, Ocean Therapeutics, Limited, which the Company acquired in December 2011.
16
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
11. | Stockholders Equity |
Additional Paid-In Capital
The following table summarizes the activity in additional paid-in-capital for the nine-month period ended September 30, 2012:
Nine months ended
September 30, 2012 |
||||
Balance at December 31, 2011 |
$ | 685,315 | ||
Issuance of common stock upon exercise of stock options |
6,127 | |||
Payments related to net settlement of stock-based awards |
(2,926 | ) | ||
Income tax benefit from non-qualified stock option exercises |
9,785 | |||
Issuance of convertible debt, net of deferred tax |
92,153 | |||
Extinguishment of 2028 notes |
(109,352 | ) | ||
Purchase of convertible note hedge, net of deferred tax |
(98,702 | ) | ||
Sale of warrants |
98,994 | |||
Repurchase of common stock |
(74,822 | ) | ||
Compensation expense related to restricted stock awards |
14,902 | |||
|
|
|||
Balance at September 30, 2012 |
$ | 621,474 | ||
|
|
Share-Based Compensation
At September 30, 2012, the Company had one active share-based compensation plan, the 2005 Stock Plan, allowing for the issuance of stock options and restricted stock. The Company estimates the fair value of share-based payment awards on the date of the grant. The Company recognizes cost over the period during which an employee is required to provide service in exchange for the award.
Starting in 2006, the Company began issuing restricted shares to employees, executives and directors of the Company. The restrictions on the restricted stock lapse according to one of two schedules. For employees and executives of the Company, restrictions lapse 25% annually over four years or 33% over 3 years. For Board members of the Company, restrictions lapse 100% after approximately one year. The fair value of the restricted stock was estimated using an assumed forfeiture rate of 9.5% and is being expensed on a straight-line basis over the period during which the restrictions lapse. For the three-month periods ended September 30, 2012 and 2011, the Company recognized $5.6 million and $4.1 million in share based compensation expense related to the restricted shares, respectively. For the nine-month periods ended September 30, 2012 and 2011, the Company recognized $14.9 million and $11.5 million in share based compensation expense related to the restricted shares, respectively. As of September 30, 2012, the total amount of unrecognized compensation cost related to nonvested restricted stock awards, to be recognized as expense subsequent to September 30, 2012, was approximately $42.8 million, and the related weighted-average period over which it is expected to be recognized is approximately 3 years.
Aggregate stock plan activity is as follows:
Total Shares
Available For Grant |
Stock Options | Restricted Shares |
Stock Options and
Restricted Shares |
|||||||||||||||||||||||||
Number |
Weighted
Average Price |
Number
Subject to Issuance |
Weighted
Average Price |
Number |
Weighted
Average Price |
|||||||||||||||||||||||
Balance at December 31, 2011 |
1,005,853 | 1,612,451 | $ | 13.54 | 1,620,160 | $ | 29.08 | 3,232,611 | $ | 21.33 | ||||||||||||||||||
Additional shares authorized |
3,000,000 | | | | | | | |||||||||||||||||||||
Granted |
(673,894 | ) | | 673,894 | $ | 50.54 | 673,894 | $ | 50.54 | |||||||||||||||||||
Exercised |
| (647,563 | ) | $ | 9.46 | | | (647,563 | ) | $ | 9.46 | |||||||||||||||||
Vested |
| | | (505,173 | ) | $ | 25.20 | (505,173 | ) | $ | 25.20 | |||||||||||||||||
Canceled |
161,854 | | | (161,854 | ) | $ | 37.07 | (161,854 | ) | $ | 37.07 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at September 30, 2012 |
3,493,813 | 964,888 | $ | 16.28 | 1,627,027 | $ | 38.38 | 2,591,915 | $ | 30.15 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine-month period ended September 30, 2012, the Company issued 0.6 million shares of the Companys outstanding stock with a market value of $32.8 million upon the exercise of stock options. For the nine-month period ended September 30, 2011, the Company issued 0.3million shares of the Companys outstanding stock with a market value of $10.9 million upon the exercise of stock options. The Company recognized no share-based compensation expense related to stock options for the three-month or nine-
17
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
month periods ended September 30, 2012 or 2011 nor any income tax benefit. The total intrinsic value of options exercised for the nine-month periods ended September 30, 2012 and 2011 was $26.7 million and $6.3 million, respectively. As of September 30, 2012, there was no unrecognized compensation cost for stock options due to the fact that all stock options were fully vested as noted above. For the nine-month periods ended September 30, 2012 and 2011 the Company received $6.1 million and $4.6 million in cash from stock option exercises, respectively.
The following table summarizes stock-based compensation expense incurred (in thousands):
Three months ended
September 30, |
Nine months ended
September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Research and development |
$ | 1,239 | $ | 954 | $ | 3,464 | $ | 2,571 | ||||||||
Selling, general and administrative |
4,345 | 3,175 | $ | 11,438 | 8,969 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 5,584 | $ | 4,129 | $ | 14,902 | $ | 11,540 | ||||||||
|
|
|
|
|
|
|
|
12. | Income Taxes |
The Company provides for income taxes under the liability method. This approach requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of differences between the tax basis of assets or liabilities and their carrying amounts in the consolidated financial statements. The Company provides a valuation allowance for deferred tax assets if it is more likely than not that these items will either expire before the Company is able to realize their benefit or if future deductibility is uncertain.
The Company applies the provision of ASC 740-10 with respect to Accounting for Uncertainty in Income Taxes. As of September 30, 2012, the Companys unrecognized tax benefits totaled $13.4 million, all of which would impact the Companys effective tax rate if recognized. During the three months ended September 30, 2012, the Company recorded an additional unrecognized tax benefit of $5.6 million. $0.4 million of this amount related to a prior year position resulting from a provision to return adjustment and $5.2 million is related to a new current year position. The Company recognizes interest and penalties related to unrecognized tax benefits in income tax expense. No interest and penalties have been recorded by the Company during the nine-month period ended September 30, 2012. The Company does not expect the unrecognized tax benefits to change significantly over the next 12 months.
The Company files a consolidated U.S. federal income tax return and consolidated and separate company income tax returns in many U.S. state jurisdictions. Generally, the Company is no longer subject to federal and state income tax examinations by U.S. tax authorities for years prior to 1993. Currently Salix is under audit in certain state jurisdictions and at this time we are not aware of any potential audit adjustments that will materially impact the Companys financial statements.
The provision for income taxes reflects the Companys estimate of the effective tax rate expected to be applicable for the full fiscal year. The Company expects the tax rate for December 31, 2012 to be 42.7% after absorption of discrete items. The Companys effective tax rates for the three-month periods ended September 30, 2012 and 2011 were 39.5% and 24.6%, respectively. Tax expense for the three months ended September 30, 2012 includes a net discrete tax expense resulting from provision to return adjustments, increase in unrecognized tax benefits, change in tax status of a subsidiary, and benefit resulting from the release of a valuation allowance, which resulted in a net increase of income tax expense of $0.6 million. The Companys effective tax rates for the nine-month periods ended September 30, 2012 and 2011 were 42.9% and 22.6%, respectively. The Company re-evaluates this estimate each quarter based on the Companys estimated tax expense for the year. The Companys effective tax rate may fluctuate throughout the year due to various items including, but not limited to, certain transactions the Company enters into, the implementation of tax planning strategies, and changes in the tax law. The Companys effective tax rate differs from the statutory rate of 35% primarily due to state income taxes and expenses and losses which are non-deductible for federal and state income tax purposes.
13. | Net Income per Share |
The Company computes basic net income per share by dividing net income by the weighted average number of common shares outstanding. The Company computes diluted net income per share by dividing net income by the weighted average number of common shares and dilutive common share equivalents then outstanding. Common share equivalents consist of the incremental common shares issuable upon the exercise of stock options and the impact of unvested restricted stock grants. The Company accounts for the effect of the convertible notes on diluted net income per share using the treasury stock method. As a result, the convertible notes have no effect on diluted net income per share until the Companys stock price exceeds the conversion price of $9.25 per share for the 2028 Notes, $46.38 for the 2015 Notes, and $65.81 for the 2019 Notes. For the three-month and nine-month periods ended September 30, 2012 and 2011, weighted average common shares, diluted, includes the effect of approximately 6,486,000 shares issuable upon conversion of the 2028 Notes calculated using the treasury stock method, taking into effect the repurchase in March 2012 of 2028 Notes convertible into approximately 2,730,000 shares, since the Companys average stock price exceeded $9.25 during
18
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
those periods. For the three-month and nine-month periods ended September 30, 2011, the effect of the approximately 7,439,000 shares issuable upon conversion of the 2015 Notes were excluded from the diluted net income per share calculation, because the Companys average stock price did not exceed $46.38 during those periods. For the three-month and nine-month periods ended September 30, 2012, weighted average common shares, diluted, includes the effect of approximately 7,439,000 share issuable upon conversion of the 2015 Notes calculated using the treasury stock method, since the Companys average stock price exceeded $46.38 during that period. For the three-month and nine-month periods ended September 30, 2012, the effect of the approximately 10,484,000 shares issuable upon conversion of the 2019 Notes issued in March 2012 were excluded from the diluted net income per share calculation, because the Companys average stock price did not exceed $65.81 during those periods.
For the three-month periods ended September 30, 2012 and 2011, there were 21,492 and 58,745, respectively, potential common shares outstanding that were excluded from the diluted net income per share calculation because their effect would have been anti-dilutive. For the nine-month periods ended September 30, 2012 and 2011, there were 36,890 and 155,876 , respectively, potential common shares outstanding that were excluded from the diluted net income per share calculation because their effect would have been anti-dilutive.
The following table reconciles the numerator and denominator used to calculate diluted net income per share (in thousands):
Three months ended
September 30, |
Nine months ended
September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Numerator: |
||||||||||||||||
Net income (loss) |
$ | 16,536 | $ | 34,279 | $ | 46,623 | $ | 53,804 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Denominator: |
||||||||||||||||
Weighted average common shares, basic |
58,755 | 59,076 | 58,671 | 58,573 | ||||||||||||
Dilutive effect of restricted stock |
484 | 417 | 667 | 842 | ||||||||||||
Dilutive effect of convertible debt |
3,092 | 4,665 | 3,437 | 4,842 | ||||||||||||
Dilutive effect of stock options |
652 | 1,002 | 914 | 1,148 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Weighted average common shares, diluted |
62,983 | 65,160 | 63,689 | 65,405 | ||||||||||||
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|
|
|
|
|
|
14. | Segment Reporting |
The Company operates in a single industry acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal diseases, which are those affecting the digestive tract. Accordingly, the Companys business is classified as a single reportable segment.
The following table presents net product revenues by product category (in thousands):
Three months ended
September 30, |
Nine months ended
September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Inflammatory Bowel Disease Colazal/Apriso |
$ | 20,381 | $ | 13,886 | $ | 58,608 | $ | 38,480 | ||||||||
Xifaxan |
137,892 | 96,675 | 367,480 | 264,424 | ||||||||||||
Purgatives Visicol/OsmoPrep/MoviPrep |
13,262 | 27,483 | 56,587 | 67,438 | ||||||||||||
Other Anusol/Azasan/Diuril/Pepcid/Proctocort/Relistor/ Deflux/Solesta |
13,597 | 8,203 | 54,596 | 14,964 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net product revenues |
$ | 185,132 | $ | 146,247 | $ | 537,271 | $ | 385,306 | ||||||||
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15. | Recently Issued Accounting Pronouncements |
In June 2011, the FASB issued ASU 2011-05, Comprehensive Income (Topic 220), Presentation of Comprehensive Income in U.S. GAAP. ASU 2011-05 requires that comprehensive income and the related components of net income and of other comprehensive income be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. ASU 2011-05 also requires reclassification adjustments from other comprehensive income to net income be presented on the face of the financial statements. However, in December 2011, the FASB issued ASU 2011-12 Comprehensive Income (Topic 220), Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in ASU 2011-05 to defer the requirement to present reclassification adjustments from other comprehensive income on the face of the financial statements and allow entities to continue to report reclassifications out of accumulated other comprehensive income consistent with the requirements in effect before ASU 2011-05. The Company adopted this guidance on January 1, 2012. Other than a change in presentation, the adoption of this guidance did not have a material impact on the Companys consolidated financial statements.
19
SALIX PHARMACEUTICALS, LTD.
Notes to Condensed Consolidated Financial Statements Continued
16. | Legal Proceedings |
From time to time, the Company is party to various legal proceedings or claims, either asserted or unasserted, which arise in the ordinary course of business. Management has reviewed pending legal matters and believes that the resolution of such matters will not have a significant adverse effect on the Companys financial condition or results of operations, except as otherwise discussed below.
The Company is currently and might continue to be subject to product liability claims that arise through the testing, manufacturing, marketing and sale of its products, including a number of claims relating to OsmoPrep and Visicol in connection with their respective box label warning. The Company is vigorously defending these claims and intends to continue to do so. The Company currently maintains liability insurance coverage for its products but it is possible that this coverage, and any future coverage, will be insufficient to satisfy any liabilities that arise. The Company would have to assume defense of the lawsuits and be responsible for damages, fees and expenses, if any, that are awarded against it or for amounts in excess of the Companys product liability coverage.
During the fourth quarter of 2011 the Company was notified by its insurer that settlement of OsmoPrep and Visicol claims had exceeded the limits of the policies related to these claims. The Company recorded a $3.5 million charge in the fourth quarter of 2011 as an estimate of the settlements remaining on cases the Company is currently aware of. Actual settlements of these claims could exceed this estimate, and additional claims may be made against the Company that the Company is not currently aware of. In addition, the Company is now responsible for defense costs associated with these claims, and expects to incur additional litigation costs that will be expensed as incurred.
On May 5, 2011, Napo Pharmaceuticals, Inc. filed a lawsuit against the Company in the Supreme Court of the State of New York, County of New York, alleging that the Company had engaged in fraudulent conduct, breached its Collaboration Agreement with Napo dated December 9, 2008, and breached its duty of good faith and fair dealing. Napo also sought a declaratory judgment that Napo had the right to terminate the Collaboration Agreement and sought unspecified damages in excess of $150 million. On or about December 28, 2011, Napo filed an Amended Complaint seeking an unspecified amount of damages for alleged breaches of the Collaboration Agreement by the Company and replacing Napos original Complaint. Napos Amended Complaint no longer seeks a declaratory judgment that Napo has the right to terminate the Collaboration Agreement and removed the need for the Court to rule on the Companys motion to dismiss the original Complaint. The Company believes that Napos allegations continue to be without merit and their lawsuit baseless. The Company filed an Answer to the Amended Complaint and Counterclaims on or about January 17, 2012, and intends to continue to vigorously defend against the lawsuit. Napo filed a Reply to the Companys Counterclaims on or about February 7, 2012. The parties have begun discovery. The Company is moving forward with its development plan for crofelemer in accordance with the existing Collaboration Agreement.
On June 22, 2011, the Company, in its capacity as a shareholder of Napo Pharmaceuticals, Inc., filed a complaint against Napo in the Court of Chancery of the State of Delaware. The complaint sought to compel Napo to allow the Company to inspect certain corporate books and records in connection with possible breaches of fiduciary duty and mismanagement by certain members of Napos board. Napo filed its answer and affirmative defenses to the complaint on July 27, 2011. Napo and the Company exchanged written discovery requests and responses. On or about January 5, 2012, the Company filed a motion for voluntary dismissal of the Delaware lawsuit. On or about January 26, 2012, the Delaware Court granted the Companys motion without penalty or fees being awarded to Napo or the Company.
On September 7, 2012, the Company and Dr. Falk Pharma filed a patent infringement complaint against Lupin Ltd. and Lupin Pharmaceuticals, Inc. in the U.S. District Court for the District of Delaware. The Complaint alleges infringement of U. S. Patent No. 6,551,620, or the 620 patent, based on Lupins filing of an Abbreviated New Drug Application, or ANDA, seeking approval to market and sell a generic version of Apriso before the expiration of the 620 patent. The filing of this suit within the 45 day response period provided by the Hatch Waxman Act imposes an automatic 30 month stay of approval of Lupins ANDA. The Company continues to evaluate its intellectual property protecting Apriso in which it has full confidence. The Company intends to vigorously enforce its intellectual property rights.
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are subject to risks and uncertainties, including those set forth under Part II. Item 1A. Risk Factors herein, under Cautionary Statement in this Part I. Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this report, that could cause actual results to differ materially from historical results or anticipated results. The following discussion should be read in conjunction with our Condensed Consolidated Financial Statements and notes thereto included elsewhere in this report.
OVERVIEW
We are a specialty pharmaceutical company dedicated to acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal disorders, which are those affecting the digestive tract. Our strategy is to:
|
identify and acquire rights to products that we believe have potential for near-term regulatory approval or are already approved; |
|
apply our regulatory, product development, and sales and marketing expertise to commercialize these products; and |
|
market our products through our approximately 300-member specialty sales and marketing team primarily focused on high-prescribing U.S. physicians in the following specialties: gastroenterologists, who are doctors who specialize in gastrointestinal disorders; hepatologists, who are doctors who specialize in liver disease; and colorectal surgeons, who are doctors who specialize in disorders of the colon and rectum. |
Our current products demonstrate our ability to execute this strategy. As of September 30, 2012, our products were:
|
XIFAXAN ® (rifaximin) Tablets 200 mg, indicated for travelers diarrhea; |
|
XIFAXAN ® 550mg (rifaximin) Tablets 550 mg, indicated for overt hepatic encephalopathy, or HE; |
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MOVIPREP ® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older; |
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RELISTOR ® (methylnaltrexone bromide) subcutaneous injection (SI) indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient, which we began promoting in the second quarter of 2011; |
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OSMOPREP (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older; |
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APRISO (mesalamine) delayed and extended-release capsules 0.375g, indicated for the maintenance of remission of ulcerative colitis; |
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SOLESTA ® , which is a biocompatible tissue-bulking agent indicated for the treatment of fecal incontinence, acquired in our purchase of Oceana in December 2011; |
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DEFLUX ® , which is a biocompatible tissue-bulking agent indicated for the treatment of vesicoureteral reflux (VUR), acquired in in our purchase of Oceana in December 2011; |
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METOZOLV ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets, indicated for short-term (4 to 12 weeks) use in adults for treatment of refractory GERD, which is symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy, and for relief of symptoms of acute and recurrent diabetic gastroparesis; |
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AZASAN ® Azathioprine Tablets, USP, 75mg and 100 mg, indicated as an adjunct for the prevention of rejection in renal homotransplantations and to reduce signs and symptoms of severe active rheumatoid arthritis; |
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ANUSOL-HC ® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC ® 25 mg Suppository (Hydrocortisone Acetate), indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; |
21
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PROCTOCORT ® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT ® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; |
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PEPCID ® (famotidine) for Oral Suspension, indicated for the short-term treatment of gastroesophageal reflux disease (GERD), active duodenal ulcer, active benign gastric ulcer, erosive esophagitis due to GERD, and peptic ulcer disease; |
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Oral Suspension DIURIL ® (Chlorothiazide), indicated for the treatment of hypertension and also as adjunctive therapy in edema associated with congestive heart failure, cirrhosis of the liver, corticosteroid and estrogen therapy, and kidney disease; and |
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COLAZAL ® (balsalazide disodium) Capsules 750 mg, indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older. |
We generate revenue primarily by selling our products to pharmaceutical wholesalers. These direct customers resell and distribute our products to and through pharmacies to patients who have had our products prescribed by doctors. We currently market our products, and intend to market future products, if approved by the FDA, to U.S. gastroenterologists, hepatologists, colorectal surgeons and other physicians through our own direct sales force. In December 2000, we established our own field sales force to market Colazal in the United States. As of September 30, 2012, this sales force had approximately 235 sales representatives in the field marketing our approved products. Although the creation of an independent sales organization involved substantial costs, we believe that the financial returns from our direct product sales have been and will continue to be more favorable to us than those from the indirect sale of products through marketing partners. We generally enter into distribution or licensing relationships outside the United States and in certain markets in the U.S. where a larger sales organization is appropriate. As a result of our acquisition of Oceana Therapeutics, Inc. in December 2011, we have approximately ten sales representatives based in Europe who sell Solesta and Deflux there. We also sell Deflux through distributors in approximately 15 countries outside the United States and Europe. As of September 30, 2012, our sales and marketing staff, including our sales representatives, consisted of approximately 337 people.
Because demand for our products originates with doctors, our sales force calls on high-prescribing specialists, primarily gastroenterologists, hepatologists and colorectal surgeons, and we monitor new and total prescriptions for our products as key performance indicators for our business. Prescriptions result in our products being used by patients, requiring our direct customers to purchase more products to replenish their inventory. However, our revenue might fluctuate from quarter to quarter due to other factors, such as increased buying by wholesalers in anticipation of a price increase or because of the introduction of new products. Revenue could be less than anticipated in subsequent quarters as wholesalers increased inventory is consumed.
Our primary product candidates currently under development and their status are as follows:
Compound |
Indication |
Status | ||
Rifaximin |
Irritable bowel syndrome, or IBS |
Supplemental New Drug Application,
or sNDA,
submitted June 7, 2010;
meeting held on June 20, 2011;
Advisory Committee held on
|
||
Crofelemer |
HIV-associated diarrhea |
NDA accepted for filing, received
Priority Review notification, PDUFA action date extended to September 5, 2012; final action not taken on September 5, 2012 |
||
Balsalazide disodium tablet |
Ulcerative colitis |
CRL received April 27, 2010;
submitted response to CRL on
August 2, 2011; approved February 3,
|
||
Budesonide foam |
Ulcerative proctitis | Phase 3 studies | ||
Methylnaltrexone bromide oral |
Opioid induced constipation in patients with chronic non-malignant pain; oral | Phase 3 |
22
CRITICAL ACCOUNTING POLICIES
Critical Accounting Policies
In our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, we identified our most critical accounting policies and estimates upon which our financial status depends as those relating to revenue recognition, allowance for product returns, allowance for rebates and coupons, inventory, intangible assets and goodwill, allowance for uncollectible accounts, cash and cash equivalents, research and development expenses, and deferred tax asset valuation allowance. We reviewed our policies and determined that those policies remained our most critical accounting policies for the three-month period ended September 30, 2012. We did not make any changes in those policies during the quarter.
We recognize revenue from sales transactions where the buyer has the right to return the product at the time of sale only if (1) our price to the buyer is substantially fixed or determinable at the date of sale, (2) the buyer has paid us, or the buyer is obligated to pay us and the obligation is not contingent on resale of the product, (3) the buyers obligation to us would not be changed in the event of theft or physical destruction or damage of the product, (4) the buyer acquiring the product for resale has economic substance apart from any provided by us, (5) we do not have significant obligations for future performance to directly bring about resale of the product by the buyer, and (6) the amount of future returns can be reasonably estimated. We recognize revenues for product sales at the time title and risk of loss are transferred to the customer, which is generally at the time products are shipped. Our net product revenue represents our total revenues less allowances for customer credits, including estimated discounts, rebates, chargebacks and product returns.
We establish allowances for estimated rebates, chargebacks and product returns based on numerous quantitative and qualitative factors, including:
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the number of and specific contractual terms of agreements with customers; |
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estimated levels of inventory in the distribution channel; |
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historical rebates, chargebacks and returns of products; |
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direct communication with customers; |
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anticipated introduction of competitive products or generics; |
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anticipated pricing strategy changes by us and/or our competitors; |
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analysis of prescription data gathered by a third-party prescription data provider; |
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the impact of changes in state and federal regulations; and |
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estimated remaining shelf life of products. |
In our analyses, we use prescription data purchased from a third-party data provider to develop estimates of historical inventory channel pull-through. We use an internal analysis to compare historical net product shipments to estimated historical prescriptions written. Based on that analysis, we develop an estimate of the quantity of product in the channel that might be subject to various rebate, chargeback and product return exposures. At least quarterly for each product line, we prepare an internal estimate of ending inventory units in the distribution channel by adding estimated inventory in the channel at the beginning of the period, plus net product shipments for the period, less estimated prescriptions written for the period. Based on that analysis, we develop an estimate of the quantity of product in the channel that might be subject to various rebate, chargeback and product return exposures. This is done for each product line by applying a rate of historical activity for rebates, chargebacks and product returns, adjusted for relevant quantitative and qualitative factors discussed above, to the potential exposed product estimated to be in the distribution channel. Internal forecasts that are used to calculate the estimated number of months in the channel are regularly adjusted based on input from members of our sales, marketing and operations groups. The adjusted forecasts take into account numerous factors including, but not limited to, new product introductions, direct communication with customers and potential product expiry issues. Adjustments to estimates are recorded in the period when significant events or changes in trends are identified.
Consistent with industry practice, we periodically offer promotional discounts to our existing customers. These discounts are calculated as a percentage of the current published list price and are treated as off-invoice allowances. Accordingly, we record the discounts as a reduction of revenue in the period that we offer the program. In addition to promotional discounts, at the time that we implement a price increase, we generally offer our existing customers an opportunity to purchase a limited quantity of product at the previous list price. Shipments resulting from these programs generally are not in excess of ordinary levels, therefore, we recognize the related revenue upon shipment and include the shipments in estimating our various product related allowances. In the event we determine that these shipments represent purchases of inventory in excess of ordinary levels for a given wholesaler, the potential impact on product returns exposure would be specifically evaluated and reflected as a reduction in revenue at the time of such shipments.
23
Allowances for estimated rebates and chargebacks were $88.9 million and $69.2 million as of September 30, 2012 and December 31, 2011, respectively. These balances exclude amounts related to Colazal, which are included in the reserve discussed below. These allowances reflect an estimate of our liability for items such as rebates due to various governmental organizations under the Medicare/Medicaid regulations, rebates due to managed care organizations under specific contracts and chargebacks due to various organizations purchasing certain of our products through federal contracts and/or group purchasing agreements. We estimate our liability for rebates and chargebacks at each reporting period based on a methodology of applying the relevant quantitative and qualitative assumptions discussed above. Due to the subjectivity of our accrual estimates for rebates and chargebacks, we prepare various sensitivity analyses to ensure our final estimate is within a reasonable range as well as review prior period activity to ensure that our methodology is still reasonable. Had a change in one or more variables in the analyses (utilization rates, contract modifications, etc.) resulted in an additional percentage point change in the trailing average of estimated chargeback and rebate activity for the year ended December 31, 2011, we would have recorded an adjustment to revenues of approximately $7.0 million, or 1.3%, for the year.
Allowances for product returns were $34.8 million and $27.9 million as of September 30, 2012 and December 31, 2011, respectively. These allowances reflect an estimate of our liability for product that may be returned by the original purchaser in accordance with our stated return policy. We estimate our liability for product returns at each reporting period based on historical return rates, the estimated inventory in the channel, and the other factors discussed above. Due to the subjectivity of our accrual estimates for product returns, we prepare various sensitivity analyses as well as review prior period activity to ensure that our methodology is still reasonable.
Colazal, our balsalazide disodium capsule, accounted for a majority of the Companys revenue prior to 2008. On December 28, 2007 OGD approved three generic balsalazide capsule products. As a result of these generic approvals, sales of this product significantly decreased and we expect the future sales of Colazal to be insignificant. At September 30, 2012 and December 31, 2011, respectively, $0.2 million and $0.8 million were recorded as a liability to reflect the Companys estimate of the Companys liability for Colazal that may be returned or charged back by the original purchaser in accordance with the Companys stated policies as a result of these generic approvals. We developed this estimate based on the following:
|
our estimate of the quantity and expiration dates of Colazal inventory in the distribution channel based on historical net product shipments less estimated historical prescriptions written; |
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our estimate of future demand for Colazal based on the actual erosion of product demand for several comparable products that were previously genericized, and the most recent demand for Colazal prior to the generic approvals; |
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the actual demand for Colazal experienced during 2008, 2009, 2010 and 2011 subsequent to the generic approvals; |
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our estimate of chargeback and rebate activity based on price erosion as a result of the generic approvals; and |
|
other relevant factors. |
During 2010 we adjusted our estimate of Colazal returns based on our review of current trends for returns, chargebacks and purchases of Colazal, and recorded approximately $7.0 million as an increase to the reserve and a reduction of revenue during the period.
For the nine-month periods ended September 30, 2012 and 2011, our absolute exposure for rebates, chargebacks and product returns grew primarily as a result of increased sales of our existing products, the approval of new products and the acquisition of products, and also as a result of the approval of generic balsalazide capsule products. Accordingly, reductions to revenue and corresponding increases to allowance accounts have likewise increased. The estimated exposure to these revenue-reducing items as a percentage of gross product revenue in the nine-month periods ended September 30, 2012 and 2011 was 14.7% and 14.3% for rebates, chargebacks and discounts and was 2.4% and 3.8% for product returns excluding the Colazal return reserve, respectively.
During the fourth quarter of 2009 we shipped Metozolv to wholesalers and began promoting this drug to physicians. Because we have limited experience with Metozolvs indication we do not currently have the ability to estimate returns for Metozolv. We will recognize revenue for Metozolv based upon prescription pull-through until we have enough historical information to estimate returns.
During the second quarter of 2010 we began recognizing product revenue related to initial shipments to wholesalers of Xifaxan 550mg, which the FDA approved on March 24, 2010 for reduction in risk of HE recurrence in patients 18 years of age or older, and we launched to physicians in May 2010. Based on our historical experience with Xifaxan 200mg, which we distribute through the same distribution channels and is prescribed by the same physicians as Xifaxan 550mg, we have the ability to estimate returns for Xifaxan 550mg, and therefore we recognize revenue upon shipment to the wholesalers.
24
During the second quarter of 2011, we began recognizing product revenue related to shipments to wholesalers of Relistor, which we acquired from Progenics in February 2011. Based on historical experience with Relistor obtained from Progenics, and historical experience with our products, specifically Xifaxan 200mg, Xifaxan 550mg and Apriso, which we distribute through the same distribution channels and are prescribed by the same physicians as Relistor, management has the ability to estimate returns for Relistor, and therefore we recognize revenue upon shipment to the wholesalers.
In December 2011 we acquired an exclusive worldwide license to Solesta and Deflux with the completion of our acquisition of Oceana. Solesta and Deflux are medical devices that we sell to specialty distributors who then sell the products to end users, primarily hospitals, surgical centers and physicians. The specialty distributors generally do not purchase these products until an end user is identified. Based on historical experience with these products obtained from Oceana, and historical experience with our products, specifically Xifaxan 200mg, Xifaxan 550mg and Apriso, which are prescribed by the same physicians as Solesta, management has the ability to estimate returns for Solesta and Deflux, and therefore we recognize revenue upon shipment to the specialty distributors.
The enactment of the Patient Protection and Affordable Care Act and The Health Care and Education Reconciliation Act of 2010 in March 2010 brings significant changes to U.S. health care. These changes began to take effect in the first quarter of 2010. Changes to the rebates for prescription drugs sold to Medicaid beneficiaries, which increase the minimum statutory rebate for branded drugs from 15.1 percent to 23.1 percent, were generally effective in the first quarter of 2010. This rebate has been expanded to managed Medicaid, a program that provides for the delivery of Medicaid benefits via managed care organizations, under arrangements between those organizations and state Medicaid agencies. Additionally, a prescription drug discount program for outpatient drugs in health care facilities that serve low-income and uninsured patients, known as 340B facilities, has been expanded. The effect of these changes was not material to our financial results for the nine-month periods ended September 30, 2012 and 2011. Based on our current product and payor mix, we believe the effect of these changes should not be material to our future financial results.
Also, there are changes to the tax treatment of subsidies paid by the government to employers who provide their retirees with a drug benefit at least equivalent to the Medicare Part D drug benefit. Beginning in 2013, the federal government will tax the subsidy it provides to such employers. We do not provide retirees with any drug benefits, therefore this change should not affect our financial results.
Beginning in 2011, drug manufacturers will provide a discount of 50 percent of the cost of branded prescription drugs for Medicare Part D participants who are in the doughnut hole coverage gap in Medicare prescription drug coverage. The doughnut hole will be phased out by the federal government between 2011 and 2020. Because of our current product and payor mix, the cost of this discount was less than 1% of our gross revenue for the year ended December 31, 2011; however, the cost of this discount might have a material effect on our results of operations in future periods.
Beginning in 2011, pharmaceutical manufacturers and importers that sell branded prescription drugs to specified government programs will have to pay a non-tax deductible annual fee to the federal government. Companies will have to pay an amount based on their prior calendar year market share for branded prescription drug sales into these government programs. Based on our current product and payor mix, the effect of this tax was not material to our financial results for the nine-month periods ended September 30, 2012 and 2011, and we do not believe the effect of this tax will be material to future periods.
Additionally, the 2010 healthcare reform legislation imposes a 2.3 percent excise tax on U.S. sales of Class I, II and III medical devices beginning in 2013. This tax had no effect on our financial statements for the nine-month periods ended September 30, 2012 and 2011, however, in light of the acquisition of our first medical devices, Solesta and Deflux, in December 2011, the cost of this tax might have a material effect on our results of operations in future periods.
25
Results of Operations
Three-month and Nine-month Periods Ended September 30, 2012 and 2011
Revenues
The following table summarizes net product revenues for the three-month and six-month periods ended September 30:
Three months
ended
September 30, |
Nine months
ended
September 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Inflammatory Bowel Disease Colazal/Apriso |
$ | 20,381 | $ | 13,886 | $ | 58,608 | $ | 38,480 | ||||||||
% of net product revenues |
11 | % | 9 | % | 11 | % | 10 | % | ||||||||
Xifaxan |
137,892 | 96,675 | 367,480 | 264,424 | ||||||||||||
% of net product revenues |
74 | % | 66 | % | 68 | % | 69 | % | ||||||||
Purgatives Visicol/OsmoPrep/ MoviPrep |
13,262 | 27,483 | 56,587 | 67,438 | ||||||||||||
% of net product revenues |
7 | % | 19 | % | 11 | % | 17 | % | ||||||||
Other Anusol/Azasan/Diuril/Pepcid/Proctocort/ Relistor/ Deflux/Solesta |
13,597 | 8,203 | 54,596 | 14,964 | ||||||||||||
% of net product revenues |
8 | % | 6 | % | 10 | % | 4 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net product revenues |
$ | 185,132 | $ | 146,247 | $ | 537,271 | $ | 385,306 | ||||||||
|
|
|
|
|
|
|
|
Net product revenues for the three-month period ended September 30, 2012 were $185.1 million, compared to $146.2 million for the corresponding three-month period in 2011, a 27% increase. The net product revenue increase for the three-month period ended September 30, 2012 compared to the three-month period ended September 30, 2011 was primarily due to:
|
increased unit sales of Xifaxan and Apriso; |
|
sales of Deflux, which we acquired in connection with our acquisition of Oceana in December 2011; and |
|
price increases on our products. |
These increases were partially offset by decreased unit sales of MoviPrep and OsmoPrep.
Total milligrams of Xifaxan prescribed for the three-month period ended September 30, 2012 compared to the corresponding three-month period in 2011 increased 20%. Prescriptions for our purgatives decreased 6% for the three-month period ended September 30, 2012 compared to the corresponding three-month period in 2011. Prescriptions for MoviPrep decreased 3% for the three-month period ended September 30, 2012 compared to the corresponding three-month period in 2011. Prescriptions for OsmoPrep for the three-month period ended September 30, 2012 declined 25% compared to the corresponding three-month period in 2011, probably due to the boxed label warning announced by the FDA on December 11, 2008. Prescriptions for Apriso increased 24% for the three-month period ended September 30, 2012 compared to the corresponding three-month period in 2011.
Net product revenues for the nine-month period ended September 30, 2012 were $537.3 million, compared to $385.3 million for the corresponding nine-month period in 2011, a 39% increase. The net product revenue increase for the nine-month period ended September 30, 2012 compared to the nine-month period ended September 30, 2011 was primarily due to:
|
increased unit sales of Xifaxan, Apriso and OsmoPrep; |
|
sales of Relistor, which we began promoting in the second quarter of 2011; |
|
sales of Deflux, which we acquired in connection with our acquisition of Oceana in December 2011; and |
|
price increases on our products. |
These increases were partially offset by decreased unit sales of MoviPrep.
Total milligrams of Xifaxan prescribed for the nine-month period ended September 30, 2012 compared to the corresponding nine-month period in 2011 increased 23%. Prescriptions for our purgatives decreased 6% for the nine-month period ended September 30, 2012 compared to the corresponding nine-month period in 2011. Prescriptions for MoviPrep decreased 4% for the nine-month period ended September 30, 2012 compared to the corresponding nine-month period in 2011. Prescriptions for OsmoPrep for the nine-month period ended September 30, 2012 declined 20% compared to the corresponding nine-month period in 2011, probably due to the boxed label warning announced by the FDA on December 11, 2008. Prescriptions for Apriso increased 29% for the nine-month period ended September 30, 2012 compared to the corresponding nine-month period in 2011.
26
Costs and Expenses
Costs and expenses for the three-month period ended September 30, 2012 were $142.4 million, compared to $93.2 million for the corresponding three-month period in 2011, and $412.1 million for the nine-month period ended September 30, 2012, compared to 294.0 million for the corresponding nine-month period in 2011. Higher operating expenses in absolute terms were due primarily to increased selling, general and administrative costs due to the acquisition of Oceana in December 2011, increased cost of products sold related to the corresponding increase in product revenue and the intangible impairment charge recorded in the three-month period ended September 30, 2012, partially offset by the change in acquisition-related contingent consideration recorded in the three-month period ended September 30, 2012.
Cost of Products Sold
Cost of products sold for the three-month period ended September 30, 2012 was $26.5 million, compared with $24.1 million for the corresponding three-month period in 2011. Cost of products sold for the nine-month period ended September 30, 2012 was $93.9 million, compared with $67.9 million for the corresponding nine-month period in 2011. The increase in cost of products sold in absolute terms was due to the increase in net product revenues discussed above.
Gross margin on total product revenue, excluding $11.3 million and $2.9 million in amortization of product rights and intangible assets for the three-month periods ended September 30, 2012 and 2011, respectively, was 85.7% for the three-month period ended September 30, 2012 and 83.5% for the three-month period ended September 30, 2011. Gross margin on total product revenue, excluding $34.0 million and $8.0 million in amortization of product rights and intangible assets for the nine-month periods ended September 30, 2012 and 2011, respectively, was 82.5% for the nine-month period ended September 30, 2012 and 82.4% for the nine-month period ended September 30, 2011. The period-to-period changes in gross margin are due to the product revenue mix in the respective periods.
Amortization of Product Rights and Intangible Assets
Amortization of product rights and intangible assets consists of amortization of the costs of license agreements, product rights and other identifiable intangible assets, which result from product and business acquisitions. The increase for the three-month and nine-month periods ended September 30, 2012 compared to the corresponding periods in 2011 was primarily due to amortization of intangibles related to Deflux and Solesta, which we acquired in connection with our acquisition of Oceana in December 2011.
Research and Development
Research and development expenses were $32.8 million for the three-month period ended September 30, 2012, compared to $24.8 million for the comparable period in 2011. The increase in research and development expenses for the three-month period ended September 30, 2012 compared to the corresponding period in 2011 was due primarily to:
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increased expenses related to our development program for rifaximin for irritable bowel syndrome, as we continued our Phase 3 retreatment study; and |
|
increased personnel costs. |
These increases were partially offset by decreased expenses related to our development programs for methylnaltrexone bromide.
Research and development expenses were $86.7 million for the nine-month period ended September 30, 2012, compared to $85.3 million for the comparable period in 2011. The increase in research and development expenses for the nine-month period ended September 30, 2012 compared to the corresponding period in 2011 was due primarily to:
|
increased expenses related to our development programs for crofelemer and rifaximin for irritable bowel syndrome; and |
|
increased personnel costs. |
These increases were partially offset by:
|
the $10.0 million upfront payment for our Amended License Agreement with Lupin in March 2011, which did not recur in 2012; |
|
decreased expenses related to investigator-initiated studies; and |
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decreased expenses related to our development programs for methylnaltrexone bromide, rifaximin for HE and budesonide foam. |
From inception through September 30, 2012, we have incurred research and development expenditures of approximately $41.5 million for balsalazide, $385.4 million for rifaximin, $32.2 million for granulated mesalamine, $34.7 million for crofelemer, $29.6 million for methylnaltrexone bromide and $29.6 million for budesonide foam.
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Due to the significant risks and uncertainties inherent in the clinical development and regulatory approval processes, we cannot reasonably estimate the cost to complete projects and development timelines for their completion. Enrollment in clinical trials might be delayed or occur faster than anticipated for reasons beyond our control, requiring additional cost and time or accelerating spending. Results from clinical trials might not be favorable, or might require us to perform additional unplanned clinical trials, accelerating spending, requiring additional cost and time, or resulting in termination of the project. Further, as evidenced by the Complete Response Letter for rifaximin as a treatment for IBS, data from clinical trials is subject to varying interpretation, and might be deemed insufficient by the regulatory bodies reviewing applications for marketing approvals, requiring additional cost and time, or resulting in termination of the project. Regulatory reviews can also be delayed. For example the PDUFA action dates for Relistor and crofelemer were each extended by three months. Process development and manufacturing scale-up for production of clinical and commercial product supplies might take longer and cost more than our forecasts. As a result, clinical development and regulatory programs are subject to risks and changes that might significantly impact cost projections and timelines.
The following table summarizes costs incurred for our significant projects, in thousands. We consider a project significant if expected spending for any year exceeds 10% of our development project budget for that period.
Project |
Three
Months
Ended September 30, |
Nine
Months
Ended September 30, |
Cumulative
through September 30, 2012 |
|||||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||||||
Rifaximin for hepatic encephalopathy, or HE |
$ | 1,460 | $ | 628 | $ | 2,490 | $ | 2,287 | $ | 43,100 | ||||||||||
Rifaximin for irritable bowel syndrome, or IBS |
5,089 | 149 | 11,397 | 3,717 | 61,216 | |||||||||||||||
Crofelemer for HIV-associated diarrhea |
1,546 | 904 | 7,945 | 1,749 | 34,674 | |||||||||||||||
Budesonide foam for ulcerative proctitis |
2,171 | 2,159 | 4,403 | 6,868 | 29,613 | |||||||||||||||
Methylnaltrexone bromide for opioid induced constipation in patients with chronic pain |
2,979 | 5,848 | 10,526 | 22,885 | 29,580 | |||||||||||||||
Other non-significant rifaximin clinical projects (4 in 2012, 4 in 2011) |
907 | 3,598 | 5,241 | 6,075 | N/A | |||||||||||||||
All other clinical programs (5 in 2012, 6 in 2011) |
2,739 | 1,265 | 6,745 | 2,767 | N/A |
We generally expect research and development costs to increase in absolute terms in future periods as we pursue additional indications and formulations for rifaximin, continue development for our budesonide product candidate, Relistor and crofelemer, and if and when we acquire new products.
Selling, General and Administrative
Selling, general and administrative expenses were $61.5 million for the three-month period ended September 30, 2012, compared to $41.4 million in the corresponding three-month period in 2011. This increase was primarily due to:
|
increased personnel costs, including costs related to our acquisition of Oceana in December 2011 and the addition of 10 sales representatives in the second quarter of 2012 and 22 sales representatives in the third quarter of 2012; |
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increased marketing expenses related to Solesta, which we acquired in December 2011, and Xifaxan 550mg for HE; and |
|
increased legal expenses related to our product liability litigation, which was previously covered by our products liability insurance, the limits of which we exceeded in the fourth quarter of 2011. |
Selling, general and administrative expenses were $187.3 million for the nine-month period ended September 30, 2012, compared to $132.8 million in the corresponding nine-month period in 2011. This increase was primarily due to:
|
increased personnel costs, including costs related to the addition of 25 key account managers in April 2011, our acquisition of Oceana in December 2011 and the addition of 10 sales representatives in the second quarter of 2012 and 22 sales representatives in the third quarter of 2012; |
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increased marketing expenses related to Relistor, which we in-licensed in February 2011 and launched in April 2011, and Solesta, which we acquired in December 2011; and |
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increased legal expenses related to our product liability litigation, which was previously covered by our products liability insurance, the limits of which we exceeded in the fourth quarter of 2011. |
These increases were partially offset by reduced pre-marketing expenses related to Xifaxan 550mg for irritable bowel syndrome incurred in 2011 prior to our receipt of the CRL from the FDA.
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We expect selling, general and administrative expenses to increase in absolute terms as we expand our sales and marketing efforts for our current products, including Relistor, Solesta and Deflux which we acquired in December 2011, and crofelemer and other indications for rifaximin and methylnaltrexone bromide, if approved.
Change in Acquisition-Related Contingent Consideration
We accounted for the Progenics transaction as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, we recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date in our consolidated financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. As of the acquisition date, the estimated fair value of the contingent consideration related to the transaction was $53.0 million, which we included as a long-term liability on the consolidated balance sheet. We determined this liability amount using a probability-weighted discounted cash flow model based on the current regulatory status of the methylnaltrexone bromide development programs. We assess the fair value of the contingent consideration quarterly, or whenever events or changes in circumstances indicate that the fair value might have changed, primarily as a result of clinical or regulatory results in the related in-process development programs. In December 2011 we announced the successful outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioidinduced constipation in subjects with chronic, noncancer pain. As a result of this event, we reassessed the fair value of the contingent consideration and recorded an increase of $27.0 million and a corresponding charge in the fourth quarter of 2011. On July 27, 2012 we received a CRL from the FDA following its review of an sNDA for methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in adult patients with chronic, non-cancer pain. The CRL requested additional clinical data. Salix and Progenics held an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL in October 2012. Based on the results of this meeting, we reassessed the value of the indefinite lived intangible asset related to methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in chronic non-cancer pain and recorded a non-cash charge to earnings of $41.6 million in the three-month period ended September 30, 2012. Based on these events, we reassessed the fair value of the contingent consideration related to the Progenics transaction and recorded a $33.0 million decrease in the contingent consideration and a corresponding non-cash charge to earnings in the three-month period ended September 30, 2012.
Intangible Asset Impairment Charges
On July 27, 2012 we received a CRL from the FDA following its review of an sNDA for methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in adult patients with chronic, non-cancer pain. The CRL requested additional clinical data. Salix and Progenics held an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL in October 2012. Based on the results of this meeting, we reassessed the value of the indefinite lived intangible asset related to methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in chronic non-cancer pain and recorded a non-cash charge to earnings of $41.6 million in the three-month period ended September 30, 2012.
Loss on Extinguishment of Debt
In March 2012, we entered into a note repurchase agreement with the holder of a majority in principal amount of the 2028 Notes. We used a portion of the proceeds from the offering of the 2019 Notes to purchase from this holder and another holder approximately 42.1% of the 2028 Notes for an aggregate purchase price of approximately $137.2 million. In addition, for a period of 90 days after March 12, 2012, the majority holder had the option to require us to purchase its remaining 2028 Notes at the same price, which represents approximately 37.1% of the 2028 Notes. This option expired unexercised in June 2012. Loss on extinguishment of debt primarily consists of $9.3 million in estimated fair market value of the put option granted to the majority holder, $2.5 million in estimated fair market value of the notes extinguished over their book value at the extinguishment date, and $2.0 million paid to the note holder for interest that the note holders would have been received through August 2013, the first date we could call the debt under the original debt indenture.
Interest Expense
Interest expense was $15.7 million for the three-month period ended September 30, 2012, compared to $8.1 million in the corresponding three-month period in 2011. Interest expense for the three-month period ended September 30, 2012 consisted of:
|
$6.6 million of interest expense on our 2015 convertible notes issued in June 2010, including $3.8 million of amortization of debt discount; |
|
$1.1 million of interest expense on our 2028 convertible notes issued in August 2008, including $0.7 million of amortization of debt discount; and |
|
$8.0 million of interest expense on our 2019 convertible notes issued in March 2012, including $4.8 million of amortization of debt discount. |
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Interest expense for the three-month period ended September 30, 2011 consisted of:
|
$6.3 million of interest expense on our 2015 convertible notes issued in June 2010, including $3.5 million of amortization of debt discount; and |
|
$1.8 million of interest expense on our 2028 convertible notes issued in August 2008, including $0.8 million of amortization of debt discount. |
Interest expense was $39.6 million for the nine-month period ended September 30, 2012, compared to $23.9 million in the corresponding nine-month period in 2011. Interest expense for the nine-month period ended September 30, 2012 consisted of:
|
$19.7 million of interest expense on our 2015 convertible notes issued in June 2010, including $11.3 million of amortization of debt discount; |
|
$3.9 million of interest expense on our 2028 convertible notes issued in August 2008, including $4.3 million of amortization of debt discount; and |
|
$16.0 million of interest expense on our 2019 convertible notes issued in March 2012, including $9.1 million of amortization of debt discount. |
Interest expense for the nine-month period ended September 30, 2011 consisted of:
|
$18.8 million of interest expense on our 2015 convertible notes issued in June 2010, including $10.4 million of amortization of debt discount; and |
|
$5.1 million of interest expense on our 2028 convertible notes issued in August 2008, including $1.6 million of amortization of debt discount. |
Interest and Other Income
Interest and other income was $0.3 million for the three-month period ended September 30, 2012 and $0.5 million for the three-month period ended September 30, 2011. Interest and other income was $10.4 million for the nine-month period ended September 30, 2012 and $2.1 million for the nine-month period ended September 30, 2011. Other income for the nine-month period ended September 30, 2012 includes $9.3 million related to the put option granted to the majority holder of the 2028 notes discussed above, which expired unexercised in June 2012.
Due to the current economic climate, we expect 2012 interest rates paid to us on our cash and cash equivalents will be equal to or lower than we experienced during 2011.
Provision for Income Tax
Income tax expense was $10.8 million and $11.2 million for the three-month periods ended September 30, 2012 and 2011, respectively. Our effective tax rate for the three-month periods ended September 30, 2012 and 2011 was 39.5% and 24.6%, respectively. Income tax expense was $35.0 million and $15.7 million for the nine-month period ended September 30, 2012 and 2011, respectively. Our effective tax rate for the nine-month periods ended September 30, 2012 and 2011 was 42.9% and 22.6%, respectively. Our effective tax rate for the nine-month period ended September 30, 2012 differs from the statutory federal income tax rate of 35% due primarily to state income taxes, and expenses and losses that are non-deductible for federal and state income tax purposes. The higher effective tax rate during the three-month period ended September 30, 2012, as compared to the same period of September 30, 2011, is due to the expiration of the federal research and development tax credit, expenses which are non-deductible for federal and state income tax purposes and provision to return adjustments. The higher effective tax rate during the nine-month period ended September 30, 2012, as compared to the corresponding period in 2011, is due primarily to the expiration of the federal research and development tax credit, expenses which are non-deductible for federal and state income tax purposes, provision to return adjustments and the reversal of a valuation allowance which was recorded during the three-month period ended March 31, 2011.
Net Income
Net income was $16.5 million for the three-month period ended September 30, 2012, compared to $34.3 million for the three-month period ended September 30, 2011. Net income was $46.6 million for the nine-month period ended September 30, 2012, compared to $53.8 million for the nine-month period ended September 30, 2011.
Liquidity and Capital Resources
From inception until first achieving profitability in the third quarter of 2004, we financed product development, operations and capital expenditures primarily from public and private sales of equity securities and from funding arrangements with collaborators. Since launching Colazal in January 2001, net product revenue has been a growing source of cash. In August 2008 we closed an offering of $60.0 million in convertible senior notes due 2028 (2028 Notes), with net proceeds of $57.3 million. In November 2009 we closed an offering of 6.3 million shares of our common stock, with net proceeds of $128.4 million. On June 3, 2010 the Company closed an offering of $345.0 million in convertible senior notes due May 15, 2015 (2015 Notes), with net proceeds of approximately
30
$334.2 million. On March 16, 2012 the Company closed an offering of $690.0 million in convertible senior notes due March 15, 2019 (2019 Notes), with net proceeds of approximately $668.3 million. As of September 30, 2012, we had an accumulated deficit of $89.0 million, and $775.9 million in cash and cash equivalents, compared to $292.8 million as of December 31, 2011.
We believe our cash and cash equivalent balances should be sufficient to satisfy our cash requirements for the foreseeable future. At September 30, 2012, our cash and cash equivalents consisted primarily of demand deposits, certificates of deposit, overnight investments in Eurodollars and money market funds at reputable financial institutions, and did not include any auction rate securities. We have not realized any material loss in principal or liquidity in any of our investments to date. However, declines in the stock market and deterioration in the overall economy could lead to a decrease in demand for our marketed products, which could have an adverse effect on our business, financial condition and results of operations. Based on our current projections, we believe that we will continue positive cash flow from operations without requiring additional capital. However, we might seek additional debt or equity financing or both to fund our operations or acquisitions, and our actual cash needs might vary materially from those now planned because of a number of factors including: whether we acquire additional products or companies; risk associated with acquisitions; FDA and foreign regulation and regulatory processes; the status of competitive products, including potential generics in an increasingly global industry; intellectual property and related litigation risks in an increasingly global industry; product liability litigation; our success selling products; the results of research and development activities; establishment of and change in collaborative relationships; general economic conditions; and technological advances by us and other pharmaceutical companies. If we incur more debt, we might be restricted in our ability to raise additional capital and might be subject to financial and restrictive covenants. If we issue additional equity, our stockholders could suffer dilution. We might also enter into additional collaborative arrangements that could provide us with additional funding in the form of equity, debt, licensing, milestone and/or royalty payments. We might not be able to enter into such arrangements or raise any additional funds on terms favorable to us or at all.
Cash Flows
Net cash provided by operating activities was $96.7 million for the nine-month period ended September 30, 2012 and was primarily attributable to our net income for the period, net of non-cash charges, partially offset by increases in accounts receivable and inventory. Net cash provided by operating activities of $45.7 million for the nine-month period ended September 30, 2011 was primarily attributable to our net income for the period, collections of accounts receivable for sales made in the fourth quarter of 2010 and increases in our current liabilities.
Net cash used in investing activities was $15.5 million for the nine-month period ended September 30, 2012 and was primarily due to our $10.0 million upfront payment in connection with our amended agreement with Alfa Wassermann, and purchases of property and equipment. Net cash used in investing activities for the nine-month period ended September 30, 2011 of $78.0 million was primarily for the purchase of product rights from Progenics in February 2011.
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Net cash provided by financing activities of $401.7 million for the nine-month period ended September 30, 2012 related primarily to our offering of $690.0 million in convertible senior notes, including net proceeds of $669.0 million, the receipt of $99.0 million from the sale of warrants, offset by $167.0 million for the purchase of call options, $137.2 million for the repurchase of a portion of our 2028 convertible senior notes, and $74.8 million for the repurchase of common stock. Net cash provided by financing activities for the nine-month period ended September 30, 2011 was $12.5 million consisting primarily of proceeds from the exercise of stock options.
Commitments
As of September 30, 2012, we had non-cancelable purchase order commitments for inventory purchases of approximately $77.1 million, which included any minimum purchase commitments under our manufacturing agreements. We anticipate significant expenditures related to our on-going sales, marketing, product launch efforts and our on-going development efforts for rifaximin, our budesonide product candidates, methylnaltrexone bromide and crofelemer. To the extent we acquire rights to additional products, we will incur additional expenditures.
Our contractual commitments for non-cancelable purchase commitments of inventory, minimum lease obligations for all non-cancelable operating leases, debt and minimum capital lease obligations (including interest) as of September 30, 2012 were as follows (in thousands):
Total | < 1 year | 1-3 years | 3-5 years | > 5 years | ||||||||||||||||
Operating leases |
$ | 33,928 | $ | 2,046 | $ | 6,653 | $ | 7,085 | $ | 18,144 | ||||||||||
Purchase commitments |
77,100 | 77,100 | | | | |||||||||||||||
2028 convertible senior notes(1) |
65,171 | 1,911 | 3,823 | 3,823 | 55,614 | |||||||||||||||
2015 convertible senior notes(2) |
370,301 | 9,488 | 360,813 | | | |||||||||||||||
2019 convertible senior notes(3) |
757,275 | 10,350 | 20,700 | 20,700 | 705,525 | |||||||||||||||
Capital lease obligations |
49 | 49 | | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
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Total |
$ | 1,303,824 | $ | 100,944 | $ | 391,989 | $ | 31,608 | $ | 779,283 | ||||||||||
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(1) | Contractual interest and principal obligations related to our 2028 convertible senior notes total $65.2 million at September 30, 2012, including $1.9 million, $3.8 million, $3.8 million and $55.6 million due in one year or less, one to three years, three to five years, and greater than five years, respectively. If these notes had been converted at September 30, 2012 based on the closing price of our stock of $42.34 per share on that date and we chose to settle them in cash, the settlement amount would have been approximately $159.0 million. |
(2) | Contractual interest and principal obligations related to our 2015 convertible senior notes total $370.3 million at September 30, 2012, including $9.5 million and $360.8 million due in one year or less and one to three years, respectively. |
(3) | Contractual interest and principal obligations related to our 2019 convertible senior notes total $757.3 million at September 30, 2012, including $10.4 million, $20.7 million, $20.7 million and $705.5 million due in one year or less, one to three years, and three to five years, and greater than five years, respectively. |
We enter into license agreements with third parties that sometimes require us to make royalty, milestone or other payments contingent upon the occurrence of certain future events linked to the successful development and commercialization of pharmaceutical products. Some of the payments are contingent upon the successful achievement of an important event in the development life cycle of these pharmaceutical products, which might or might not occur. If required by the agreements, we will make royalty payments based upon a percentage of the sales of a pharmaceutical product if regulatory approval to market this product is obtained and the product is commercialized. Because of the contingent nature of these payments, we have not attempted to predict the amount or period in which such payments would possibly be made and thus they are not included in the table of contractual obligations.
2028 Notes
On August 22, 2008 we closed an offering of $60.0 million in 2028 Notes. Net proceeds from the offering were $57.3 million. The 2028 Notes are governed by an indenture, dated as of August 22, 2008, between us and U.S. Bank National Association, as trustee. The 2028 Notes bear interest at a rate of 5.5% per year, payable semiannually in arrears on February 15 and August 15 of each year, beginning on February 15, 2009. The 2028 Notes will mature on August 15, 2028, unless previously converted or repurchased in accordance with their terms prior to such date. The 2028 Notes are senior unsecured obligations, and rank (i) equally to any of our existing and future unsecured senior debt, (ii) senior to any of our future indebtedness that is expressly subordinated to these 2028 Notes, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness. We may redeem the 2028 Notes, in whole or in part, at any time after August 15, 2013 for cash equal to the principal amount of the 2028 Notes to be redeemed, plus any accrued and unpaid interest. On August 15, 2013, August 15, 2018 and August 15, 2023 or upon the occurrence of a fundamental change, as defined in the Indenture, the holders may require us to repurchase all or a portion of the 2028 Notes for cash at 100% of the principal amount of the 2028 Notes being purchased, plus any accrued and unpaid interest.
32
In March 2012, we entered into a note repurchase agreement with the holder of a majority in principal amount of the 2028 Notes. We used a portion of the proceeds from our offering of the 2019 Notes discussed below to purchase from this holder and another holder approximately 42.1% of the 2028 Notes for an aggregate purchase price of approximately $137.2 million. In addition, for a period of 90 days after March 12, 2012, the majority holder had the option to require us to purchase at the same price its remaining 2028 Notes, which represented approximately 37.1% of the 2028 Notes. This put option expired unexercised in June 2012.
The remaining outstanding 2028 Notes are convertible into approximately 3,756,000 shares of our common stock under certain circumstances prior to maturity at a conversion rate of 108.0847 shares per $1,000 principal amount of 2028 Notes, which represents a conversion price of approximately $9.25 per share, subject to adjustment under certain conditions. Holders of the 2028 Notes may convert their 2028 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of August 15, 2028 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after September 30, 2008, if the last reported sale price of our common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2028 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2028 Notes, per $1,000 principal amount of the 2028 Notes, for each such trading day was less than 98% of the product of the last reported sale price of our common stock and the conversion rate of the 2028 Notes on such date; (3) if we enter into specified corporate transactions; or (4) upon a redemption notice. The first of these conditions was met as of September 30, 2012. The 2028 Notes will be convertible, regardless of whether any of the foregoing conditions has been satisfied, on or after March 15, 2028 at any time prior to the close of business on the business day immediately preceding the stated maturity date of August 15, 2028. Upon conversion, we will pay cash, shares of our common stock or a combination of cash and stock, as determined by us in our discretion.
Prior to March 2012 the 2028 Notes prohibited us from incurring any debt other than permitted debt, as defined in the Indenture, except that we may incur debt in certain circumstances, including meeting a consolidated leverage ratio test and a consolidated fixed charge coverage ratio test. The 2015 Notes described below were permitted debt under the Indenture. In March 2012, the Company and holders of a majority in outstanding principal amount of the 2028 Notes amended the indenture to delete this prohibition.
2015 Notes
On June 3, 2010 we closed an offering of $345.0 million in 2015 Notes. Net proceeds from the offering were $334.2 million. The 2015 Notes are governed by an indenture, dated as of June 3, 2010, between us and U.S. Bank National Association, as trustee. The 2015 Notes bear interest at a rate of 2.75% per year, payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2010. The 2015 Notes will mature on May 15, 2015, unless previously converted or repurchased in accordance with their terms prior to such date. The 2015 Notes are senior unsecured obligations, and rank (i) equally to any of our existing and future unsecured senior debt, (ii) senior to any of our future indebtedness that is expressly subordinated to these 2015 Notes, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness.
The 2015 Notes are convertible into approximately 7,439,000 shares of our common stock under certain circumstances prior to maturity at a conversion rate of 21.5592 shares per $1,000 principal amount of 2015 Notes, which represents a conversion price of approximately $46.38 per share, subject to adjustment under certain conditions. Holders may convert their 2015 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of May 15, 2015 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after June 30, 2010, if the last reported sale price of our common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2015 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2015 Notes, per $1,000 principal amount of the 2015 Notes, for each such trading day was less than 98% of the product of the last reported sale price of our common stock and the conversion rate of the 2015 Notes on such date; or (3) if we enter into specified corporate transactions. None of these conditions had been met as of September 30, 2012. The 2015 Notes will be convertible, regardless of whether any of the foregoing conditions have been satisfied, on or after January 13, 2015 at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date of May 15, 2015. Upon conversion, we may pay cash, shares of our common stock or a combination of cash and stock, as determined by us at our discretion.
In connection with the issuance of the 2015 Notes, we entered into capped call transactions covering approximately 7,439,000 shares of our common stock. The capped call transactions have a strike price of $46.38 and a cap price of $62.44, and are exercisable when and if the 2015 Notes are converted. If upon conversion of the 2015 Notes, the price of our common stock is above the strike price of the capped calls, the counterparties will deliver shares of our common stock and/or cash with an aggregate value approximately equal to the difference between the price of our common stock at the conversion date (as defined, with a maximum price for purposes of this calculation equal to the cap price) and the strike price, multiplied by the number of shares of our common stock related to the capped call transactions being exercised. We paid $44.3 million for these capped calls, and charged that amount to additional paid-in capital.
33
2019 Notes
On March 16, 2012 we closed an offering of $690.0 million in 2019 Notes. Net proceeds from the offering were approximately $668.3 million. The 2015 Notes are governed by an indenture, dated as of March 16, 2012 between the Company and U.S. Bank National Association, as trustee. The 2019 Notes bear interest at a rate of 1.50% per year, payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2012. The 2019 Notes will mature on March 15, 2019, unless earlier converted or repurchased in accordance with their terms prior to such date. The 2019 Notes are senior unsecured obligations, and rank (i) equally to any of our existing and future unsecured senior debt, (ii) senior to any of our future indebtedness that is expressly subordinated to them, and (iii) effectively junior to any secured indebtedness to the extent of the value of the assets securing such indebtedness.
The 2019 Notes are convertible into approximately 10,484,000 shares of our common stock under certain circumstances prior to maturity at a conversion rate of 15.1947 shares per $1,000 principal amount of 2019 Notes, which represents a conversion price of approximately $65.81 per share, subject to adjustment under certain conditions. Holders may convert their 2019 Notes at their option on any day prior to the close of business on the business day immediately preceding the maturity date of March 15, 2019 only if one or more of the following conditions is satisfied: (1) during any fiscal quarter commencing after June 30, 2012, if the last reported sale price of our common stock for at least 20 trading days in the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is equal to or more than 130% of the conversion price of the 2019 Notes on the last day of such preceding fiscal quarter; (2) during the five business day period following any five consecutive trading day period in which the trading price for the 2019 Notes, per $1,000 principal amount of the 2019 Notes, for each such trading day was less than 98% of the product of the last reported sale price of our common stock and the conversion rate of the 2019 Notes on such date; or (3) if we enter into specified corporate transactions. None of these conditions had been met as of September 30, 2012. The 2019 Notes will be convertible, regardless of whether any of the foregoing conditions have been satisfied, on or after November 9, 2018 at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date of March 15, 2019. Upon conversion, we may pay cash, shares of our common stock or a combination of cash and stock, as determined by us at our discretion.
In connection with the issuance of the 2019 Notes, we entered into convertible bond hedge transactions with certain counterparties covering approximately 10,484,000 shares of our common stock. The convertible bond hedge transactions have a strike price of $65.81 and are exercisable when and if the 2019 Notes are converted. If upon conversion of the 2019 Notes, the price of our common stock is above the strike price of the convertible bond hedge transactions, the counterparties will deliver shares of our common stock and/or cash with an aggregate value approximately equal to the difference between the price of our common stock at the conversion date and the strike price, multiplied by the number of shares of our common stock related to the convertible bond hedge transaction being exercised. We paid $167.0 million for these convertible bond hedge transactions and charged this to additional paid-in capital.
Simultaneously with entering into the convertible bond hedge transactions, we entered into privately negotiated warrant transactions whereby we sold the counterparties to these transactions warrants to acquire, subject to customary adjustments, approximately 10,484,000 shares of our common stock at a strike price of $85.31 per share, also subject to adjustment. We received $99.0 million for these warrants and credited this amount to additional paid-in capital.
Cautionary Statement
We operate in a highly competitive environment that involves a number of risks, some of which are beyond our control. The following statement highlights some of these risks. For more detail, see Part II. Item 1A. Risk Factors below.
Statements contained in this Form 10-Q that are not historical facts are or might constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, our expectations might not be attained. Forward-looking statements involve known and unknown risks that could cause actual results to differ materially from expected results. Factors that could cause actual results to differ materially from our expectations expressed in the report include, among others: the high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational New Drug Applications; intense competition, including from generics in an increasingly global market; the possible impairment of, or inability to obtain intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global market; our dependence on our first nine pharmaceutical products, particularly Xifaxan, and the uncertainty of market acceptance of our products; general economic conditions; our need to maintain profitability; the uncertainty of obtaining, and our dependence on, third parties to manufacture and sell our products; results of ongoing and any future litigation and other risk factors detailed from time to time in our other SEC filings.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our purchases of raw materials and finished goods are denominated primarily in U.S. dollars and purchases denominated in currencies other than the U.S. dollar are insignificant. Additionally, our net assets denominated in currencies other than the U.S. dollar are insignificant and have not historically exposed us to material risk associated with fluctuations in currency rates. Given these facts, we have not considered it necessary to use foreign currency contracts or other derivative instruments to manage changes in currency rates. However, these circumstances might change.
We have outstanding $34.8 million of 5.5% convertible senior notes due 2028, $345.0 million of 2.75% convertible senior notes due 2015 and $690.0 million of 1.5% convertible senior notes due 2019. The interest rates on these notes are fixed and therefore they do not expose us to risk related to rising interest rates.
In connection with the June 2010 offering of the 2015 Notes, we paid $44.3 million to purchase capped call options covering approximately 7,439,000 shares of our common stock. If the per share price of our common stock remains below $46.38, these call options will be worthless. If the per share price of our common stock exceeds $62.44, then to the extent of the excess, these call options will not provide us protection against dilution from conversion of the 2015 Notes.
In connection with the March 2012 offering of the 2019 Notes, we paid $167.0 million to purchase convertible bond hedge transactions covering approximately 10,484,000 shares of our common stock. If the per share price of our common stock remains below $65.81, these call options will be worthless. Simultaneously with entering into the convertible bond hedge transactions, we sold warrants to acquire, subject to customary adjustments, approximately 10,484,000 shares of our common stock at a strike price of $85.31 per share, also subject to adjustment. If the per share price of our common stock exceeds $85.31, then to the extent of the excess, these warrants will counter any benefit of the convertible bond hedges we purchased.
Item 4. Controls and Procedures
Disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) are designed only to provide reasonable assurance that information to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms and accumulated and communicated to the issuers management, including its principal financial officer, or persons performing similar functions, as appropriate to allow timely decision regarding required disclosure. As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our President and Chief Executive Officer and Executive VP, Finance and Administration and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon that evaluation, our President and Chief Executive Officer and Executive VP, Finance and Administration and Chief Financial Officer have concluded that our disclosure controls and procedures are effective to provide the reasonable assurance discussed above.
There was no change in our internal control over financial reporting in the quarter ended September 30, 2012 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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From time to time, we are party to various legal proceedings or claims, either asserted or unasserted, which arise in the ordinary course of business. Management has reviewed pending legal matters and believes that the resolution of such matters will not have a significant adverse effect on our financial condition or results of operations, except as otherwise discussed below.
We are currently and might continue to be subject to product liability claims that arise through the testing, manufacturing, marketing and sale of our products, including a number of claims relating to OsmoPrep, Visicol and Metozolv ODT in connection with their respective box label warning. We are vigorously defending these claims and intend to continue to do so. During the fourth quarter of 2011 we recorded a $3.5 million reserve, which is our estimate of the settlements of the remaining claims we are aware of, after being notified by our insurer that settlement of certain OsmoPrep and Visicol lawsuits exceeded the limits of the policies related to these claims. However, the eventual settlement of these claims could exceed this estimate, and we could receive additional claims we are not currently aware of.
On May 5, 2011, Napo Pharmaceuticals, Inc. filed a lawsuit against us in the Supreme Court of the State of New York, County of New York, alleging that we had engaged in fraudulent conduct, breached our Collaboration Agreement with Napo dated December 9, 2008, and breached our duty of good faith and fair dealing. Napo also sought a declaratory judgment that Napo had the right to terminate the Collaboration Agreement and sought unspecified damages in excess of $150 million. On or about December 28, 2011, Napo filed an Amended Complaint seeking an unspecified amount of damages for alleged breaches of the Collaboration Agreement by the Company and replacing Napos original Complaint. Napos Amended Complaint no longer seeks a declaratory judgment that Napo has the right to terminate the Collaboration Agreement and removed the need for the Court to rule on the Companys motion to dismiss the original Complaint. We believe that Napos allegations continue to be without merit and their lawsuit baseless. We filed an Answer to the Amended Complaint and Counterclaims on or about January 17, 2012, and intend to continue to vigorously defend against the lawsuit. Napo filed a Reply to our Counterclaim on or about February 7, 2012. The parties have begun discovery. We are moving forward with our development plan for crofelemer in accordance with the existing Collaboration Agreement.
On June 22, 2011, we, in our capacity as a shareholder of Napo Pharmaceuticals, Inc., filed a complaint against Napo in the Court of Chancery of the State of Delaware. The Complaint sought to compel Napo to allow us to inspect certain corporate books and records in connection with possible breaches of fiduciary duty and mismanagement by certain members of Napos board. Napo filed its Answer and Affirmative Defenses to the Complaint on July 27, 2011. Napo and the Company exchanged written discovery requests and responses. On or about January 5, 2012, we filed a motion for voluntary dismissal of the Delaware lawsuit. The Delaware Court granted our motion, without penalty or fees being awarded to Napo or us.
On September 7, 2012, we and Dr. Falk Pharma filed a patent infringement complaint against Lupin Ltd. and Lupin Pharmaceuticals, Inc. in the U.S. District Court for the District of Delaware. The Complaint alleges infringement of U. S. Patent No. 6,551,620, or the 620 patent, based on Lupins filing of an Abbreviated New Drug Application, or ANDA, seeking approval to market and sell a generic version of Apriso before the expiration of the 620 patent. The filing of this suit within the 45 day response period provided by the Hatch Waxman Act imposes an automatic 30 month stay of approval of Lupins ANDA. We continue to evaluate our intellectual property protecting Apriso in which we have full confidence. We intend to vigorously enforce its intellectual property rights.
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This report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in this report. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this report and in any documents incorporated in this report by reference.
If any of the following risks, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our common stock could decline, and stockholders might lose all or part of their investment.
Future sales of Xifaxan and our other marketed products might be less than expected.
We currently actively market and sell seven primary products. We expect Xifaxan, which was launched in mid-2004 for the treatment of travelers diarrhea, and approved and launched in March 2010 for the treatment of hepatic encephalopathy, or HE, to continue to be our most significant source of revenue in the future. If sales of our marketed products decline or if we experience product returns significantly in excess of estimated amounts recorded, particularly with respect to Xifaxan, it would have a material adverse effect on our business, financial condition and results of operations.
The degree of market acceptance of our products among physicians, patients, healthcare payors and the medical community will depend upon a number of factors including:
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the timing of regulatory approvals and product launches by us or competitors, and including any generic or over-the-counter competitors; |
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perceptions by physicians and other members of the healthcare community regarding the safety and efficacy of the products; |
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price increases, and the price of our products relative to other drugs or competing treatments; |
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patient and physician demand; |
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adverse side effects or unfavorable publicity concerning our products or other drugs in our class; |
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the results of product development efforts for new indications; |
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the scope and timing of additional marketing approvals and favorable reimbursement programs for expanded uses; |
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availability of sufficient commercial quantities of the products; and |
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our success in getting other companies to distribute our products outside of the U.S. gastroenterology, hepatology and colorectal surgery markets. |
Regulatory approval of our product candidates is time-consuming, expensive and uncertain, and could result in unexpectedly high expenses and delay our ability to sell our products.
Development of our products is subject to extensive regulation by governmental authorities in the United States and other countries. In early 2008, the FDA announced that because of its large workload it might not meet its target dates to respond to NDA submissions, and since then we have experienced delays in FDA review of Metozolv, balsalazide tablets, crofelemer, rifaximin for HE and Relistor for chronic pain. This regulation and workload could require us to incur significant unexpected expenses or delay or limit our ability to sell our product candidates, including specifically rifaximin for irritable bowel syndrome, or IBS. In August 2010, the FDA accepted our NDA for rifaximin for IBS, and gave us an action date of December 7, 2010. In October 2010 the FDA informed us they were extending the action date by three months to provide for a full review and extended our action date to March 7, 2011. We received a Complete Response Letter, or CRL, on March 7, 2011. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval. The FDA deems that the Xifaxan 550 mg sNDA is not ready for approval, primarily due to a newly expressed need for retreatment information. We initiated enrollment in a retreatment trial in the first quarter of 2012, but there is no assurance that the FDA will approve rifaximin for IBS in a timely manner, or at all. On July 27, 2012, the FDA issued a CRL following the FDAs review of a Supplemental New Drug Application for Relistor injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. In October 2012 Salix and Progenics held an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL. Based on the results of this meeting, we believe we might terminate our development program for methylnaltrexone bromide injection for subcutaneous use for the treatment of OIC in chronic non-cancer pain. We are currently evaluating the oral OIC development program and currently believe we will continue this program. However, additional information and additional guidance from the FDA could result in the termination of the oral OIC development program. There is no assurance the FDA will approve Relistor injection for oral use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain in a timely manner, or at all.
Our clinical studies might be delayed or halted, or additional studies might be required, for various reasons, including:
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the drug is not effective; |
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patients experience severe side effects during treatment; |
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patients do not enroll in the studies at the rate expected, as was the case with our Xifaxan Phase 3 trial in Thailand for the prevention of travelers diarrhea, and might be the case with our Xifaxan irritable bowel syndrome retreatment study; |
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drug supplies are not sufficient to treat the patients in the studies; or |
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we decide to modify the drug during testing. |
If regulatory approval of any product is granted, it will be limited to those indications for which the product has been shown to be safe and effective, as demonstrated to the FDAs satisfaction through clinical studies. For example, rifaximin has been approved for treatment of travelers diarrhea and HE, but we are developing rifaximin for IBS and other indications. The FDA might not ever approve any of our compounds in the indications we are pursuing, which would mean we cannot market these compounds for use in these indications.
Regulatory approval, even if granted, might entail ongoing requirements or restrictions on marketing that could increase our expenses and limit revenue.
Approval might entail ongoing requirements for post-marketing studies, or limit how or to whom we can sell our products. Even if we obtain regulatory approval, labeling and promotional activities are subject to continual scrutiny by the FDA and state regulatory agencies and, in some circumstances, the Federal Trade Commission. For example, in 2008 the FDA required us to put a black box warning on the OsmoPrep and Visicol labels regarding potential kidney damage that could result from their use, and a black box warning for Metozolv regarding tardive dyskensia which could result from its use. We believe these warnings contributed to reduced sales of those products, and they could limit future sales of those products. In addition, FDA enforcement policy prohibits the marketing of approved products for unapproved, or off-label, uses, and we periodically receive inquiries from regulators, including specifically the Office of Prescription Drug Promotion of the FDA, or OPDP, formerly known as the Division of Drug Marketing, Advertising, and Communications of the FDA, or DDMAC, regarding compliance with marketing and other regulations. These regulations and the FDAs interpretation of them might increase our expenses, impair our ability to effectively market our products, and limit our revenue.
Our intellectual property rights might not afford us with meaningful protection.
The intellectual property rights protecting our products might not afford us with meaningful protection from generic and other competition. In addition, because our strategy is to in-license or acquire pharmaceutical products which typically have been discovered and initially researched by others, future products might have limited or no remaining patent protection due to the time elapsed since their discovery. Competitors could also design around any of our intellectual property or otherwise design competitive products that do not infringe our intellectual property.
Any litigation in which we become involved to enforce intellectual property rights could result in substantial cost to us. In addition, claims by others that we infringe their intellectual property could be costly. Our patent or other proprietary rights related to our products might conflict with the current or future intellectual property rights of others. Litigation or patent interference proceedings, either of which could result in substantial cost to us, might be necessary to defend any patents to which we have rights and our other proprietary rights or to determine the scope and validity of other parties proprietary rights. The defense of patent and intellectual property claims is both costly and time-consuming, even if the outcome is favorable. Any adverse outcome could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties, or require us to cease selling one or more of our products. We might not be able to obtain a license to any third-party technology that we require to conduct our business, or, if obtainable, that technology might not be available at a reasonable cost.
Upon patent expiration, our drugs could be subject to generic competition, which could negatively affect our pricing and sales volume. As previously disclosed, this has already happened to Colazal, which had been our largest selling drug prior to 2008.
The patents for the rifaximin composition of matter (also covering a process of making rifaximin and using rifaximin to treat gastrointestinal infectious diseases) expired in May 2001 in the United States and Canada. Rifaximin was a new chemical entity and was granted a five-year new chemical exclusivity by the FDA when it was approved in May 2004. Rifaximin, therefore, had data exclusivity to May 2009. Rifaximin 550mg, which is approved for the reduction in risk of HE recurrence in patients greater than 18 years of age was granted orphan exclusivity through March 2017. Patents covering several physical states, or polymorphic forms, of rifaximin that provide protection for all indications currently marketed and being assessed are listed below in the table. Alfa Wasserman S.p.a., the owner of the indicated patents, has licensed the rights to Salix in the United States. In July 2006, Salix entered into an agreement with Cedars-Sinai Medical Center, or CSMC, for the right to use its patent and patent applications relating to methods of diagnosis and treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth. The CSMC agreement provides Salix the right to use the patents listed below as well as other members of the patent family indicated as licensed from CSMC. On April 19, 2011, the USPTO issued the method of treatment patent U.S. 7,928,115 to Salix directed to the use of rifaximin in Travelers Diarrhea, which should provide protection until July 2029.
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U.S. Patent No. |
Issue Date | Expiration |
Subject |
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7,045,620* | May-06 | Jun-24 | Composition of matter and process patent covering several physical states of rifaximin | |||
7,612,199* | Nov-09 | Jun-24 | Covers several physical states, or polymorphous forms of rifaximin | |||
7,906,542* | May-11 | Jun-25 | Covers several physical states, or polymorphous forms of rifaximin in pharmaceutical formulations | |||
7,902,206* | Mar-11 | Jun-24 | Covers several physical states, or polymorphous forms of rifaximin | |||
7,452,857** | Nov-08 | Aug-19 | Use of rifaximin for treating irritable bowel syndrome | |||
7,605,240** | Oct-09 | Aug-19 | Treatment of bloating caused by small intestinal bacterial overgrowth associated with irritable bowel syndrome | |||
7,718,608** | May-10 | Aug-19 | Use of rifaximin for treating irritable bowel syndrome | |||
7,935,799** | May-11 | Aug-19 | Use of rifaximin for treating diarrhea | |||
7,928,115 | Apr-11 | Jul-29 | Use of rifaximin for treating travelers diarrhea | |||
8,158,781* | Apr-12 | Jun-24 | Covers physical states, or polymorphous forms of rifaximin | |||
8,158,644* | Apr-12 | Jun-24 | Covers physical states, or polymorphous forms of rifaximin | |||
8,193,196* | Jun-12 | Sept-27 | Covers physical states, or polymorphous forms of rifaximin |
* | Licensed from Alfa Wasserman S.p.a. |
** | Licensed from Cedars-Sinai Medical Center |
The patent for the treatment of the intestinal tract with Apriso, the granulated mesalamine product, provides patent coverage to 2018. In June 2009, U.S. Patent No. 7,547,451 issued, which relates to methods of producing Apriso and provides further protection. In September 2012 the FDA posted draft guidance on mesalamine. The guidance recommends conducting fed and fasted pK studies measuring mesalamine in the plasma of normal healthy subjects as well as an in vitro comparative dissolution study. On September 7, 2012, we and Dr. Falk Pharma filed a patent infringement complaint against Lupin Ltd. and Lupin Pharmaceuticals, Inc. in the District of Delaware. The Complaint alleges infringement of U. S. Patent No. 6,551,620, or the 620 patent, based on Lupins filing of an Abbreviated New Drug Application, or ANDA, seeking approval to market and sell a generic version of Apriso before the expiration of the 620 patent. The filing of this suit within the 45 day response period provided by the Hatch Waxman Act imposes an automatic 30 month stay of approval of Lupins ANDA. We continue to evaluate our intellectual property protecting Apriso in which we have full confidence. We intend to vigorously enforce its intellectual property rights.
The patent application relating to the dosage form for metoclopramide protects the product until July 2017. The patent for crofelemer, relating to enteric formulations and uses thereof provide protection until 2018 and should be entitled to patent term restoration as a new molecular entity. There is no assurance that these patents or the patent term restorations will be issued or granted, respectively.
The patent for balsalazide 1100 mg tablets provides patent coverage to 2018. U.S. Patent Nos. 7,452,872 and 7,625,884, which relate to the use of balsalazide tablets to increase the bioavailability provide coverage for balsalazide 1100 mg tablets until August 2026.
The budesonide rectal foam product has patent coverage in the U.S. until 2015.
Patent expiration dates listed herein, unless otherwise noted, are for U.S. patents and assume there are no patent term adjustments, extensions or other adverse events that could affect the term or scope of a patent. Dates provided herein for the expiration of patent applications are merely estimates based on knowledge at this time and could be altered, for example, by terminal disclaimer or if patent term extensions or adjustments are available. The patents for Lumacan including, U.S. 6,034,267 and U.S. 7,247,655 provide protection until March 2016.
In January 2007, the USPTO issued a patent covering composition of matter and kit claims for MoviPrep. The MoviPrep patent provides coverage to September 2024. Norgine, B.V. and Norgine Europe, B.V., which we refer to collectively as Norgine, own U.S. Patent No. 7,169,381, or the 381 patent. The 381 patent is listed with the FDA as protecting our MoviPrep product. Norgine licensed MoviPrep and the 381 patent to the Company for commercialization in the United States. Novel filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market a generic version of MoviPrep in the United States prior to the September 2024 expiration of the 381 patent. On May 14, 2008, we and Norgine filed a lawsuit in the United States District Court for
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the District of New Jersey against Novel for infringement of the 381 patent. Upon entry by the court on August 30, 2010 of a Consent Judgment included as an exhibit to the Settlement Agreement among the parties and Actavis, Inc., the settlement will resolve all of the parties outstanding claims and defenses in the lawsuit. The Consent Judgment provides that Novels proposed generic product, absent a license as granted to Novel under the settlement, would infringe the 381 patent and further provides that Novel acknowledges and agrees not to contest the validity and enforceability of the 381 patent. In addition to the Settlement Agreement, we have entered into a Sublicense Agreement with Norgine and Novel, as well as a Supply Agreement with Novel and Actavis and a First Amendment to License and Supply Agreement with Norgine. Under the terms of the Sublicense Agreement, we and Norgine have granted Novel a fully paid up license under the MoviPrep patents such that it is permitted to launch a generic MoviPrep product on September 24, 2018.
The patent for Visicol and OsmoPrep will expire in 2013. U.S. 7,687,075 issued 30 March 2010 and provides protection for OsmoPrep until June 2028. CDC III, LLC, owns U.S. Patent No. 5,616,346, or the 346 patent. The 346 patent is listed with the FDA as protecting our OsmoPrep product. CDC licensed OsmoPrep and the 346 patent to us for commercialization in the United States. In addition, we own U.S. Patent No. 7,687,075, or the 075 patent, protecting OsmoPrep. Novel Laboratories, Inc., filed an ANDA with the FDA seeking approval to market a generic version of OsmoPrep in the United States prior to the May 2013 expiration of the 346 patent and the 2028 expiration of the 075 patent. On September 8, 2008, we filed a lawsuit in the United States District Court for the District of New Jersey against Novel for the infringement of the 346 patent and seeking a declaratory judgment confirming the validity of the patent. The lawsuit also joined CDC as a party. With the entry by the court of a Consent Judgment, the settlement will resolve all of the parties outstanding claims and defenses in the lawsuit. The Consent Judgment provides that Novels proposed generic product, absent a license as granted to Novel under the Sublicense Agreement described below, would infringe the 346 patent and further provides that Novel acknowledges and agrees not to contest the validity and enforceability of the 346 patent. In connection with the settlement, we entered into: a Settlement Agreement with CDC, Novel, Actavis Inc. and the general partnership of Craig Aronchick, William H. Lipshutz and Scott H. Wright (the General Partnership) that was the initial licensor of the 346 patent to Salix; a Sublicense Agreement with CDC, the General Partnership and Novel; a Supply Agreement with Novel; and, a Second Amendment to Supply Agreement with CDC and the General Partnership. Under the terms of the Sublicense Agreement, we, CDC and the General Partnership have granted Novel a fully paid up, non-exclusive license under the OsmoPrep patents such that it is permitted to launch a generic OsmoPrep product on November 16, 2019.
Rifaximin is a new chemical entity and was granted five-year new chemical entity exclusivity by the FDA when it was approved in May 2004. Rifaximin, therefore, had data exclusivity until May 2009. Accordingly, the Office of Generic Drugs of the U.S. Food and Drug Administration, or OGD, would have been able to accept an ANDA for Xifaxan tablets on or any time subsequent to May 2008, if the applicant made certifications of patent non-infringement or invalidity. If this occurred, a Paragraph IV notification would have to be provided to us by the applicant. Although we do not possess any specific knowledge of any such filing at the current time, the expiration of data exclusivity could result in a challenge to the related intellectual property rights of Xifaxan 200mg tablets at any time in the future. In May 2008 we submitted a Citizen Petition, requesting the director of OGD impose scientifically appropriate standards for the demonstration of bioequivalence for abbreviated new drug applications citing Xifaxan as the reference listed drug. Rifaximin 550mg, which is approved for the reduction in risk of HE recurrence in patients 18 years of age and older, was granted orphan exclusivity through March 2017. Accordingly OGD would have been able to accept an ANDA for Xifaxan 550mg tablets on or any time subsequent to March 2010, if the applicant made certifications of patent non-infringement or invalidity. If this occurred, a Paragraph IV notification would have to be provided to us by the applicant. Although we do not possess any specific knowledge of any such filing at the current time, the orphan exclusivity period does not prohibit the filing of an ANDA and thus, an ANDA filing could result in a challenge to the related intellectual property rights of Xifaxan 550mg tablets at any time in the future. The OGD would be unable to finally approve an ANDA until the expiration of the orphan exclusivity in March 2017. On November 29, 2011 the FDA posted draft bioequivalence guidance for rifaximin 200mg tablets for the treatment of travelers diarrhea. This guidance recommends conducting a randomized, double blind, parallel placebo controlled clinical trial in humans with clinical endpoints in order to file an ANDA for approval of a generic rifaximin 200mg tablet for the treatment of travelers diarrhea.
On November 3, 2010, we received a paragraph IV notification from Novel Laboratories, Inc. stating that Novel had filed an ANDA application to seek approval to market a generic version of Metoclopramide Hydrochloride ODT, 5 mg and 10 mg. The notification letter asserted non-infringement of U.S. Patent No. 6,413,549, or the 549 patent. Upon examination of the relevant sections of the ANDA, we concluded that the 549 patent would not be enforced against Novel Laboratories. On March 15, 2001 we received a paragraph IV notification from Zydus Pharmaceuticals stating that Zydus had filed an ANDA application to seek approval to market a generic version of Metoclopramide Hydrochloride ODT, 5 mg and 10 mg. The notification letter asserted non-infringement of the 549 patent. Upon examination of the relevant sections of the ANDA, we concluded that the 549 patent would not be enforced against Zydus.
In February 2011, Salix licensed exclusive worldwide (except Japan) rights to Relistor (methylnaltrexone bromide). The Relistor subcutaneous injection product was granted five year regulatory new chemical entity exclusivity until April 24, 2013. The exclusivity prevents the FDA from approving an ANDA until April 24, 2013; however, an ANDA may be filed after April 24, 2012. The Relistor subcutaneous injection has patent protection to November 2017. In August 2012 the USPTO issued U.S. Patent No.
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8,247,425 covering Relistor subcutaneous injection in a prefilled syringe. The patent provides coverage until December 2030.There are other patents pending on the formulation, that if issued will provide protection to April 2024. Patent application for an oral version of Relistor, if issued, should provide protection to March 2031.
In December 2011, Salix acquired licensed rights to Solesta and Deflux through the acquisition of Oceana Therapeutics, Inc. Deflux and Solesta are protected by U.S. Patent No. 5,633,001, which is directed to composition and method claims and provides protection to May 2014 and U.S. Patent No. 5,827,937, which is directed to methods of manufacturing and provides protection to July 2015.
Because Azasan, Anusol-HC, Pepcid and Proctocort are mature products, there are no patents or data exclusivity rights available which subjects us to greater risk of generic competition for those products.
We also rely on trade secrets, proprietary know-how and technological advances, which we seek to protect, in part, through confidentiality agreements with collaborative partners, employees and consultants. These agreements might be breached and we might not have adequate remedies for any such breach. In addition, our trade secrets and proprietary know-how might otherwise become known or be independently developed by others.
Intense competition might render our products noncompetitive or obsolete.
Competition in our business is intense and characterized by extensive research efforts and rapid technological progress. Technological developments by competitors, regulatory approval for marketing competitive products, including potential generic or over-the-counter products, or superior marketing resources possessed by competitors could adversely affect the commercial potential of our products and could have a material adverse effect on our revenue and results of operations. Generic competition is an increasing risk, as we have experienced with Colazal and Pepcid, and with challenges to our bowel-cleansing products intellectual property noted above. We believe that there are numerous pharmaceutical and biotechnology companies, including large well-known pharmaceutical companies, as well as academic research groups throughout the world, engaged in research and development efforts with respect to pharmaceutical products targeted at gastrointestinal diseases and conditions addressed by our current and potential products. In particular, we are aware of products in research or development by competitors that address the diseases being targeted by our products. Developments by others might render our current and potential products obsolete or noncompetitive. Competitors might be able to complete the development and regulatory approval process sooner and, therefore, market their products earlier than we can.
Many of our competitors have substantially greater financial, marketing and personnel resources and development capabilities than we do. For example, many large, well-capitalized companies already offer products in the United States and Europe that target the indications for:
|
Xifaxan for HE, including lactulose (various manufacturers); |
|
Xifaxan for travelers diarrhea, including ciprofloxacin, commonly known as Cipro (Bayer AG); |
|
OsmoPrep and MoviPrep, including Colyte, Golytely, Halflytely, SuPrep, and Nulytely (Braintree) and Trilyte (Alaven Pharmaceutical LLC), as well as potential generics from Novel Laboratories or others; |
|
Apriso, including Asacol (Warner Chilcott), sulfasalazine (Pfizer), Dipentum (Alaven Pharmaceutical LLC), Pentasa (Shire Pharmaceuticals Group, plc), once-a-day Lialda (Shire), and three generic balsalazide capsule products; |
|
Relistor for OIC, including OTC laxatives (various manufacturers), Amitiza (Takeda), Kristalose (Cumberland) and Entereg (Cubist); |
|
Solesta, including various OTC antidiarrheals, fiber, stool softeners and laxatives (various manufacturers), biofeedback, the medical device Inter Stim (Medtronic) and sphincteroplasty surgery; |
|
Xifaxan under development, including Lotronex ® (Prometheus) and Amitiza (Sucampo Pharmaceuticals, Inc.) for IBS; and |
|
Metozolv ODT, including Reglan (Alaven Pharmaceutical LLC), and various generics. |
In addition, other products are in research or development by competitors that address the diseases and diagnostic procedures being targeted by these and our other products.
We could be exposed to significant product liability claims that could prevent or interfere with our product commercialization efforts.
We have been in the past and might continue to be subjected to product liability claims that arise through the testing, manufacturing, marketing and sale of our products. For example, we are currently and might continue to be subject to a number of product liability claims relating to OsmoPrep and Visicol in connection with their box label warning. We intend to defend these claims vigorously. During the fourth quarter of 2011 we settled a number of the OsmoPrep and Visicol lawsuits and were notified by our insurer that settlement of these claims exceeded the limits of the policies related to these claims. As a result, we recorded a $3.5 million reserve, which is our estimate of the costs of the remaining claims we are aware of. However, the eventual settlement of these claims could exceed this estimate, and we could receive additional claims we are not currently aware of.
41
We have exceeded the limits of our liability coverage related to the claims discussed above, so we are responsible for additional damages, fees and expenses, if any. We currently maintain liability coverage for both clinical trials and the commercialization of our products other than the claims discussed above, but it is possible that this coverage and any future coverage will be insufficient to satisfy any liabilities that arise. We would have to assume defense of the lawsuits and be responsible for damages, fees and expenses, if any, that are awarded against us or for amounts in excess of our product liability coverage. These claims could expose us to significant liabilities that could prevent or interfere with our product commercialization efforts. Product liability claims could require us to spend significant time and money in litigation or to pay significant damages. In the future, we might not be able to obtain adequate coverage at an acceptable cost or might be unable to obtain adequate coverage at all.
If government and other third-party payors do not provide coverage or reimburse patients for our products, our ability to derive revenues might suffer.
Our success will depend in part on the extent to which government and health administration authorities, private health insurers and other third-party payors will pay for our products. Reimbursement for newly approved healthcare products is uncertain. We acquired our first medical devices in December 2011, one of which was launched in 2011, and we are navigating the complex medical device reimbursement system. In the United States and elsewhere, third-party payors, such as Medicaid, are increasingly challenging the prices charged for medical products and services. Government and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new therapeutic products. In the United States, a number of legislative and regulatory proposals aimed at changing the healthcare system have been passed in recent years, including the Patient Protection and Affordable Care Act. Many significant changes in this legislation do not take effect until 2014 . These changes to the healthcare system could increase our costs and reduce the amount we can charge for our drugs. In addition, an increasing emphasis on managed care in the United States has and will continue to increase pressure on pharmaceutical pricing. While we cannot predict whether legislative or regulatory proposals will be adopted or what effect those proposals or managed care efforts, including those relating to Medicaid payments, might have on our business, the announcement and/or adoption of such proposals or efforts could increase costs and reduce or eliminate profit margins, which could have a material adverse effect on our business, financial condition and results of operations. Third-party insurance coverage might not be available to patients for our products. If government and other third-party payors do not provide adequate coverage and reimbursement levels for our products, the market acceptance of these products might be reduced.
Our ability to increase revenue in the future will depend in part on our success in in-licensing or acquiring additional pharmaceutical products or medical devices.
We currently intend to in-license or acquire additional pharmaceutical products or medical devices, as we did with crofelemer and budesonide, that have been developed beyond the initial discovery phase and for which late-stage human clinical data is already available, or as we did with Relistor, Deflux and Solesta, that has already received regulatory approval. These kinds of pharmaceutical products and medical devices might not be available to us on attractive terms or at all. To the extent we acquire rights to additional products, we might incur significant additional expense in connection with the development and, if approved by the FDA, marketing of these products.
We are dependent on third parties to supply us with products.
We rely entirely on third parties to supply us with our commercially marketed products and our products under development.
For example, Glenmark Pharmaceuticals, Ltd., a corporation organized and located in India, manufactures and supplies us with drug substance for crofelemer, an anti-secretory agent that we are developing for the treatment of HIV-associated diarrhea. The raw material used in production of the crofelemer drug substance grows in select countries in South America. The amount of resources Glenmark devotes to these activities and its ability to successfully obtain raw material is not within our control. Failure by Glenmark to manufacture and supply us with crofelemer drug substance, whether due to international, political or economic conditions or otherwise, could delay development, increase expenses, delay regulatory approval, or eventually prevent us from generating revenue from crofelemer, if approved, any of which could have a material adverse effect on our business. A key raw material for Relistor grows in Tasmania. Our inability to obtain this raw material, whether due to international, political or economic conditions or otherwise, could delay development, increase expenses, delay regulatory approval, or eventually prevent us from generating revenue from additional indications for Relistor, if approved, which could have a material adverse effect on our business. Likewise, interruption of supply of any of our other products, whether for clinical use or commercial use, could have a material adverse effect on our business.
42
We are dependent on third parties to manufacture our products.
We own no manufacturing facilities, and we have limited capabilities in manufacturing pharmaceutical products. We do not generally expect to engage directly in the manufacturing of products, but instead contract with and rely on third-party vendors for these services. A limited number of contract manufacturers exist which are capable of manufacturing our marketed products and our product candidates. We might fail to contract with the necessary manufacturers or might contract with manufacturers on terms that may not be entirely acceptable to us. For example, in April 2010 we received a complete response letter from the FDA on our NDA for balsalazide tablets. The sole issue raised in this letter concerned a deficiency of the manufacturing facility for this application, which delayed FDA approval almost two years. Given our ongoing dependence on third party vendors for supply of material for use in clinical trials and for commercial product, our manufacturing strategy presents the following risks:
|
the manufacture of products might be difficult to scale up when required and result in delays, inefficiencies and poor or low yields of quality products; |
|
some of our contracts contain purchase commitments that require us to make minimum purchases that might exceed our needs or limit our ability to negotiate with other manufacturers, which might increase costs; |
|
the cost of manufacturing certain products might make them prohibitively expensive; |
|
delays in scale-up to commercial quantities and any change in manufacturers could delay clinical studies, regulatory submissions and commercialization of our products; |
|
manufacturers are subject to the FDAs current Good Manufacturing Practices, or cGMP, regulations and similar foreign standards, and we do not have control over compliance with these regulations by the third-party manufacturers; |
|
if we need to change manufacturers, transfers of technical expertise would be required which would include educating the new manufacturer in the processes necessary for the production of our products, which might not be successful; and |
|
if we need to change manufacturers, FDA and comparable foreign regulators might require additional testing and compliance inspections prior to the new manufacturer being qualified for the production of our products. |
Failure to comply with manufacturing regulation could harm us financially and could hurt our reputation.
We and our third-party manufacturers, such as Glenmark Pharmaceuticals, Ltd. that produces crofelemer drug substance, are also required to comply with the applicable cGMP regulations which include requirements relating to manufacturing, packaging, documentation, quality control, and quality assurance. Further, manufacturing facilities must be approved by the FDA before they can be used to manufacture our products. For example, in April 2010 we received a complete response letter from the FDA regarding our NDA for our balsalazide tablet. In the complete response letter there were no requests for new preclinical or clinical trials. The sole issue raised in this letter concerned a deficiency of the manufacturing facility for this application. The manufacturer has responded to the FDA and continues to work with the FDA to resolve the matter, however the manufacturer has not resolved these issues and we have been unable to receive approval or launch our balsalazide tablet. Such facilities are subject to periodic FDA inspection. Manufacturing regulations can increase our expenses and delay production, either of which could reduce our margins. In addition, if we fail to comply with any of FDAs continuing regulations, we could be subject to reputational harm and sanctions, including:
|
delays, warning letters and fines; |
|
product recalls or seizures and injunctions on sales; |
|
refusal of the FDA to review pending applications; |
|
total or partial suspension of production; |
|
withdrawals of previously approved marketing applications; and |
|
civil penalties and criminal prosecutions. |
In addition, the occurrence of manufacturing-related compliance issues could cause subsequent withdrawal of the drug approval, reformulation of the drug product, additional testing or changes in labeling of the finished product.
Because our business and industry are highly regulated and scrutinized, and subject to litigation risks, our long-term strategy and success is dependent upon compliance with applicable regulations and maintaining our business integrity.
Our business and industry are highly regulated and scrutinized, and subject to litigation risks, including product liability risks described above and other risks. We are subject to extensive and complex laws and regulation, including but not limited to, health care fraud and abuse laws, such as the federal False Claims Act, the federal Anti-Kickback Statute, and other state and federal laws and regulations. While we have developed and implemented a corporate compliance program designed to promote compliance with applicable U.S. laws and regulations, we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure or alleged failure to be in compliance with such laws or regulations. There appears to be a heightened risk of such investigations in the current environment, as evidenced by recent enforcement activity and pronouncements by
43
the Office of Inspector General of the Department of Health and Human Services that it intends to continue to vigorously pursue fraud and abuse violations by pharmaceutical companies, including through the use of a legal doctrine that could impose criminal penalties on pharmaceutical company executives. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
Our research, development and manufacturing efforts, and those of third parties that research, develop and manufacture our products and product candidates on our behalf or in collaboration with us, involve the controlled use of hazardous materials, including chemicals, viruses, bacteria and various radioactive compounds, and are therefore subject to numerous U.S. and international environmental and safety laws and regulations and to periodic inspections for possible violations of these laws and regulations. In addition, we, and our collaborators and third-party manufacturers may also become subject to laws and regulations related to climate change, including the impact of global warming. The costs of compliance with environmental and safety laws and regulations are significant, and the costs of complying with climate change laws could also be significant. Any violations, even if inadvertent or accidental, of current or future environmental, safety or climate change laws or regulations could subject us to substantial fines, penalties or environmental remediation costs, or cause us to lose permits or other authorizations to operate affected facilities, any of which could adversely affect our operations.
The laws and regulations applicable to our relationships with our employees and contractors are complex, extensive and fluid, and are subject to evolving interpretations by regulatory and judicial authorities. Failure to comply with these laws and regulations could result in significant damages, orders and/or fines and therefore could adversely affect our operations. For example, a 2010 decision by the U.S. Court of Appeals for the Second Circuit, In re Novartis Wage & Hour Litigation , in a split from an earlier decision from the U.S. Court of Appeals for the Third Circuit, held that pharmaceutical sales representatives were non-exempt employees under the Fair Labor Standards Act. The Second Circuits decision might trigger additional litigation against pharmaceutical companies, including us. An adverse result in any such litigation could result in significant damages to us and could therefore have a material adverse effect on our business and results of operations.
Failure to integrate acquired businesses into our operations successfully could adversely affect our business.
Our strategy is to identify and acquire rights to products that we believe have potential for near-term regulatory approval or are already approved, through the purchase or license of products and purchase of companies. Our integration of the operations of acquired products and businesses, including Oceana, which we acquired in December 2011 and which includes foreign employees and operations, requires significant efforts, including the coordination of information technologies, research and development, sales and marketing, operations, manufacturing and finance. These efforts result in additional expenses and involve significant amounts of managements time. Factors that will affect the success of our acquisitions include the strength of the acquired companies or products underlying technology and ability to execute, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, our ability to adequately fund acquired in-process research and development projects and retain key employees, and our ability to achieve synergies with our acquired companies and products, such as increasing sales of our products, achieving cost savings and effectively combining technologies to develop new products. Our failure to manage successfully and coordinate the growth of these acquisitions could have an adverse impact on our business. In addition, we cannot be certain that the businesses or products we acquire will become profitable or remain so and if our acquisitions are not successful, we may record related asset impairment charges in the future.
Our results of operations might fluctuate from period to period, and a failure to meet the expectations of investors or the financial community at large could result in a decline in our stock price.
As they have in the past, our results of operations might fluctuate significantly on a quarterly and annual basis due to, among other factors:
|
the timing of regulatory approvals and product launches by us or competitors, including potential generic or over-the-counter competitors; |
|
the level of revenue generated by commercialized products, including potential increased purchases of inventory by wholesalers in anticipation of potential price increases or introductions of new dosages or bottle sizes, and subsequent lower than expected revenue as the inventory is used; |
|
the timing of any up-front payments that might be required in connection with any future acquisition of product rights; |
|
the timing of milestone payments that might be required to our current or future licensors; |
|
fluctuations in our development and other costs in connection with ongoing product development programs; |
|
the level of marketing and other expenses required in connection with product launches and ongoing product growth; |
|
the timing of the acquisition and integration of businesses, assets, products and technologies; and |
|
general and industry-specific business and economic conditions. |
44
We expect to be profitable and have positive cash flow during 2012, but we might need additional capital.
We expect to be profitable and have positive cash flow during 2012, and believe that our current cash and cash equivalents together with cash generated from the sale of our products will be sufficient to fund our operations for 2012 and beyond, but that might not be the case. Our future capital requirements will depend on many factors, including but not limited to:
|
our business development activities, including potential acquisition of products or companies, or entry into additional collaborative arrangements; |
|
the results, costs and timing of our research and development activities, regulatory approvals and product launches; |
|
the status of competitive products, including current and potential generics; |
|
the cost and number of products we acquire or in-license; |
|
any impact on us of current conditions and uncertainties in the economy generally and the financial markets; |
|
patient and physician demand for our products; and |
|
our ability to reduce our costs in the event product demand is less than expected, or regulatory approvals are delayed or more expensive than expected. |
If we need additional capital, we might seek additional debt or equity financing or both to fund our operations or acquisitions. If we incur more debt, we might be restricted in our ability to raise additional capital and might be subject to financial and restrictive covenants. If we issued additional equity, our stockholders could suffer dilution. We might also enter into additional collaborative arrangements that could provide us with additional funding in the form of equity, debt, licensing, milestone and/or royalty payments. We might not be able to enter into such arrangements or raise any additional funds on terms favorable to us or at all, especially in the current economic environment. Our common stock is likely to decrease in value if the market believes that we will be required to raise additional capital.
Our stock price is volatile.
Our stock price has been extremely volatile and might continue to be, making owning our stock risky. Between January 1, 2010 and October 31, 2012, the price of a share of our common stock varied from a low of $23.53 to a high of $55.99. Our stock price increased or decreased by 5% or more on 15 days in 2011 and 4 days in 2012.
The securities markets have experienced significant price and volume fluctuations unrelated to the performance of particular companies, including as a result of the current credit and economic crisis. In addition, the market prices of the common stock of many publicly traded pharmaceutical and biotechnology companies have in the past been and can in the future be expected to be especially volatile. Announcements of prescription trends, technological innovations or new products by us or our competitors, generic approvals, developments or disputes concerning proprietary rights, publicity regarding actual or potential medical results relating to products under development by us or our competitors, regulatory developments in both the United States and other countries, public concern as to the safety of pharmaceutical products, and economic and other external factors, as well as period-to-period fluctuations in financial results, might have a significant impact on the market price of our common stock.
Antitakeover provisions could discourage a takeover that stockholders consider to be in their best interests or prevent the removal of our current directors and management.
We have adopted a number of provisions that could have antitakeover effects or prevent the removal of our current directors and management. We have adopted a stockholder protection rights plan, commonly referred to as a poison pill, which expires in January 2013. The rights plan is intended to deter an attempt to acquire us in a manner or on terms not approved by our board of directors. The rights plan will not prevent an acquisition that is approved by our board of directors. We believe our rights plan assisted in our successful defense against a hostile takeover bid earlier in 2003. Our charter authorizes our board of directors to determine the terms of up to 5,000,000 shares of undesignated preferred stock and issue them without stockholder approval. The issuance of preferred stock could make it more difficult for a third party to acquire, or discourage a third party from acquiring, voting control in order to remove our current directors and management. Our bylaws also eliminate the ability of the stockholders to act by written consent without a meeting or make proposals at stockholder meetings without giving us advance written notice, which could hinder the ability of stockholders to quickly take action that might be opposed by management. These provisions could make more difficult the removal of current directors and management or a takeover of Salix, even if these events could be beneficial to stockholders. These provisions could also limit the price that investors might be willing to pay for our common stock.
45
Exhibit Number |
Description of Document |
Registrants Form |
Dated |
Exhibit Number |
Filed Herewith |
|||||||
10.95* | Amended and Restated License Agreement, dated August 6, 2012, with Alfa Wassermann S.p.A. | X | ||||||||||
10.96* | EIR Supply Agreement, dated August 6, 2012, with Alfa Wassermann S.p.A. | X | ||||||||||
10.97* | Amendment Number Two to Supply Agreement, dated August 6, 2012, with Alfa Wassermann S.p.A. | X | ||||||||||
10.98* | Trademark License Agreement (Alfa to Salix), dated August 6, 2012, with Alfa Wassermann Hungary Kft. | X | ||||||||||
10.99* | Trademark License Agreement (Salix to Alfa), dated August 6, 2012, with Alfa Wassermann S.p.A. | X | ||||||||||
10.100* | Letter Amendment, dated September 5, 2012, with Alfa Wassermann S.p.A. | X | ||||||||||
31.1 | Certification by the Chief Executive Officer pursuant to Section 240.13a-14 or Section 240.15d-14 of the Securities and Exchange Act of 1934, as amended. | X | ||||||||||
31.2 | Certification by the Chief Financial Officer pursuant to Section 240.13a-14 or Section 240.15d-14 of the Securities and Exchange Act of 1934, as amended. | X | ||||||||||
32.1 | Certification by the Chief Executive Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||
32.2 | Certification by the Chief Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||
101 | Financials in XBRL format | X |
* | The registrant has requested confidential treatment with respect to portions of this exhibit. Those portions have been omitted from the exhibit and filed separately with the U.S. Securities and Exchange Commission. |
46
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.
SALIX PHARMACEUTICALS, LTD. | ||||||
Date: November 8, 2012 | By: | /s/ Carolyn J. Logan | ||||
Carolyn J. Logan | ||||||
President and Chief Executive Officer |
Date: November 8, 2012 | By: | /s/ Adam C. Derbyshire | ||||
Adam C. Derbyshire | ||||||
Executive Vice President, Finance & Administration and Chief Financial Officer |
47
Exhibit 10.95
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
AMENDED AND RESTATED LICENSE AGREEMENT
dated August 6, 2012
by and between
A LFA W ASSERMANN S. P .A.
and
S ALIX P HARMACEUTICALS , I NC .
TABLE OF CONTENTS
Page | ||||
Article 1 RECITALS |
1 | |||
Article 2 EFFECT ON 1996 LICENSE AGREEMENT |
1 | |||
Article 3 CERTAIN DEFINITIONS |
2 | |||
Article 4 LICENSE GRANTS AND COMPENSATION |
17 | |||
4.1 Alfa Grant of Licenses to Salix |
17 | |||
4.1.1 Existing Indications License (Excluding EIR Formulation) |
17 | |||
4.1.2 Crohns EIR License |
19 | |||
4.1.3 Existing Indications EIR License |
21 | |||
4.1.4 Salix New Indications License |
22 | |||
4.1.5 Trademark Licenses to Salix |
23 | |||
4.1.6 Sublicense Rights; Further Rights of Reference |
23 | |||
4.1.7 Third Party Sublicenses |
24 | |||
4.1.8 Manufacturing License to Salix |
24 | |||
4.2 Salix Grant of Licenses to Alfa |
24 | |||
4.2.1 License for Existing Indications and New Indications (Excluding [*] Formulation or Other New Formulations). |
24 | |||
4.2.2 Salix Designated Indication License |
25 | |||
4.2.3 [*] / Other New Formulation License for Existing Indications and New Indications |
28 | |||
4.2.4 Salix Sublicense to Alfa under [*] License Agreement |
30 | |||
4.2.5 Trademark Licenses to Alfa |
30 | |||
4.2.6 Sublicense Rights; Further Rights of Reference |
30 | |||
4.2.7 Third Party Sublicenses |
31 | |||
4.3 Rights and Obligations With Respect to the [*] Patent Family |
32 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
i
4.3.1 Overview |
32 | |||
4.3.2 Ownership |
32 | |||
4.3.3 Salix Grant of License to Alfa - [*] Claims |
32 | |||
4.3.4 Further Licenses by Salix |
34 | |||
4.4 Royalty Step-Down. |
35 | |||
4.4.1 Royalties Payable by Salix |
35 | |||
4.4.2 Royalties Payable by Alfa |
36 | |||
4.5 Third Party Licenses Required for Exploitation of the Compound or Rifaximin Products |
37 | |||
4.5.1 Salixs Exploitation of the Compound or Rifaximin Products |
37 | |||
4.5.2 Alfas Exploitation of the Compound or Rifaximin Products |
38 | |||
4.6 Royalty Reports |
38 | |||
4.7 Taxes |
39 | |||
4.8 Records |
39 | |||
4.9 [*] Agreement |
40 | |||
4.10 Rights Outside the Field |
40 | |||
4.11 Products Approved for More Than One Indication |
40 | |||
Article 5 GOVERNING PRINCIPLES OF COLLABORATION BETWEEN THE PARTIES |
41 | |||
5.1 Cooperation |
41 | |||
5.2 Licenses and Export Control |
42 | |||
Article 6 PRODUCT DEVELOPMENT |
42 | |||
6.1 General Principles |
42 | |||
6.2 Crohns EIR Product Development Plan |
43 | |||
6.2.1 Development Plan |
43 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
ii
6.2.2 Salixs Duties |
43 | |||
6.2.3 Alfas Duties |
44 | |||
6.2.4 Regulatory Matters |
45 | |||
6.2.5 Steering Committee |
46 | |||
6.3 [*] Committee |
48 | |||
6.4 Effect of Change of Control |
48 | |||
6.5 Certain Restrictions |
49 | |||
Article 7 SUPPLY |
50 | |||
Article 8 NEW INDICATIONS |
50 | |||
8.1 Notification of New Indication Within the Field |
50 | |||
8.2 Indications Outside the Field |
50 | |||
Article 9 REGULATORY MATTERS AND EXCHANGE OF INFORMATION AND ASSISTANCE |
51 | |||
9.1 Regulatory Responsibilities; Attendance at Meetings |
51 | |||
9.1.1 Regulatory Responsibilities |
51 | |||
9.1.2 Attendance at Meetings |
51 | |||
9.2 Rights of Reference; Ownership of Regulatory Documentation |
52 | |||
9.3 Exchange of Data and Regulatory Information |
53 | |||
9.4 Facilities Inspection |
54 | |||
9.5 Adverse Event Reporting and Notifications |
54 | |||
Article 10 MARKETING |
54 | |||
10.1 Salixs Marketing Obligations |
54 | |||
10.2 Cooperation Regarding Marketing Matters |
55 | |||
10.3 Packaging |
55 | |||
Article 11 PATENT MATTERS AND INTELLECTUAL PROPERTY RIGHTS |
56 | |||
11.1 No Assignment of Ownership Rights |
56 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
iii
11.2 Preparation, Filing, Maintenance and Prosecution of Patents |
56 | |||
11.2.1 Alfa Licensed Patents |
56 | |||
11.2.2 Alfa [*] Patent Application |
57 | |||
11.2.3 Salix Licensed Patents; [*] Patent Family |
57 | |||
11.2.4 Joint Patents |
58 | |||
11.2.5 Cooperation |
59 | |||
11.3 Patent Applications |
59 | |||
11.4 Ownership of Intellectual Property |
59 | |||
11.4.1 Ownership of Intellectual Property Created Exclusively by a Single Party |
59 | |||
11.4.2 Ownership of Intellectual Property Created Jointly by the Parties |
60 | |||
11.4.3 United States Law |
60 | |||
11.4.4 [*] Patent Family |
60 | |||
11.5 Dispute Resolution |
60 | |||
11.6 Infringement Claims by Third Parties |
61 | |||
11.6.1 Defense of Third Party Claims |
61 | |||
11.6.2 Settlement of Third Party Claims |
61 | |||
11.6.3 Assistance |
61 | |||
11.7 Enforcement of Patents |
62 | |||
11.7.1 Infringement in Salix Territory |
62 | |||
11.7.2 Infringement in Alfa Territory |
62 | |||
11.7.3 Infringement of Joint Patents |
63 | |||
11.7.4 Infringement of [*] Patent Family |
64 | |||
11.7.5 Patent Challenges |
64 | |||
11.8 Restrictions on Settlement with Third Parties |
64 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
iv
11.9 Patent Defense Agreement |
65 | |||
11.10 Disclaimers |
65 | |||
Article 12 CONFIDENTIALITY |
65 | |||
12.1 Confidentiality, Use and Non-Disclosure Obligations |
65 | |||
12.1.1 Confidentiality, Use and Non-Disclosure Obligations of Salix |
65 | |||
12.1.2 Confidentiality, Use and Non-Disclosure Obligations of Alfa |
65 | |||
12.2 Exceptions to Confidentiality and Non-Disclosure Obligations |
66 | |||
12.3 Permitted Disclosures |
66 | |||
12.4 Return of Confidential Information |
67 | |||
12.5 Injunctive Relief |
67 | |||
12.6 Disclosure of Agreement; Press Releases |
68 | |||
12.7 Restrictions on Publication |
68 | |||
Article 13 REPRESENTATIONS AND WARRANTIES; COVENANTS |
69 | |||
13.1 General Representations |
69 | |||
13.1.1 Duly Organized |
69 | |||
13.1.2 Due Execution |
70 | |||
13.1.3 No Third Party Approval |
70 | |||
13.1.4 Binding Agreement |
70 | |||
13.2 Salixs Representations |
70 | |||
13.3 Alfas Representations |
71 | |||
13.4 Covenants |
72 | |||
13.5 Disclaimers of Representations and Warranties |
72 | |||
Article 14 INDEMNIFICATION |
72 | |||
14.1 Indemnification by Alfa |
72 |
v
14.2 Indemnification by Salix |
73 | |||
14.3 Insurance |
74 | |||
14.4 Indemnification Procedures |
74 | |||
14.4.1 Notice of Claim |
74 | |||
14.4.2 Control of Defense |
74 | |||
14.4.3 Settlement |
74 | |||
14.4.4 Cooperation |
75 | |||
14.4.5 Expenses |
75 | |||
14.5 Limitations on Liability |
75 | |||
Article 15 FORCE MAJEURE |
76 | |||
Article 16 COMMENCEMENT, DURATION AND TERMINATION |
76 | |||
16.1 Term of Agreement |
76 | |||
16.2 Term of Certain Payment Obligations |
76 | |||
16.3 Patent Challenges |
77 | |||
16.4 Termination of the Agreement |
78 | |||
16.5 License Survival During Bankruptcy |
79 | |||
Article 17 PERIOD SUBSEQUENT TO THE TERMINATION OF THE AGREEMENT |
80 | |||
17.1 Effect of Termination |
80 | |||
17.2 Effect of Termination by Salix or Alfa in Respect of Crohns EIR Product |
81 | |||
17.3 Effect of Termination on Sublicenses |
82 | |||
17.4 Survival |
83 | |||
17.5 Accrued Rights |
83 | |||
Article 18 DISPUTE RESOLUTION |
83 | |||
18.1 Good Faith Discussions |
83 |
vi
18.2 Arbitration |
84 | |||
18.3 Exceptions |
84 | |||
Article 19 ASSIGNMENT |
85 | |||
19.1 Binding Effect |
85 | |||
19.2 Assignment by Alfa |
85 | |||
19.3 Assignment by Salix |
85 | |||
Article 20 ENTIRE AGREEMENT AND MODIFICATION |
85 | |||
Article 21 LANGUAGE AND GOVERNING LAW |
85 | |||
Article 22 WAIVER |
86 | |||
Article 23 NOTICES |
86 | |||
Article 24 SEVERABILITY |
88 | |||
Article 25 HEADINGS AND CONSTRUCTION |
88 | |||
Article 26 COUNTERPARTS |
88 | |||
Article 27 MUTUAL DRAFTING |
88 | |||
Article 28 THIRD PARTY RIGHTS |
89 | |||
Article 29 RELATIONSHIP OF THE PARTIES |
89 | |||
Article 30 PERFORMANCE BY AFFILIATES |
89 | |||
Article 31 FURTHER ASSURANCE |
90 | |||
Article 32 SUBCONTRACTORS |
90 | |||
APPENDIX 1 | ||||
EXHIBIT A - Alfa Patents |
||||
EXHIBIT B - Salix Patents |
||||
EXHIBIT C - Joint Patents |
vii
EXHIBIT D - [*] Report |
||
EXHIBIT E - [*] Agreement |
||
EXHIBIT F - Development Plan |
||
EXHIBIT G - Alfa Intellectual Property Exceptions |
||
EXHIBIT H - Section 13.2.1 Salix Patents |
||
EXHIBIT I - Salix Sublicenses |
||
EXHIBIT J - Alfa Sublicenses |
||
EXHIBIT K - EIR Patent Applications |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
viii
AMENDED AND RESTATED LICENSE AGREEMENT
AMENDED AND RESTATED LICENSE AGREEMENT (this Agreement ) dated August 6, 2012 (the Amendment Effective Date ) by and between Alfa Wassermann S.p.A., a corporation incorporated under the laws of Italy ( Alfa ), and Salix Pharmaceuticals, Inc., a corporation incorporated under the laws of the State of California, United States of America ( Salix ) (each, a Party and, collectively, the Parties ).
WITNESSETH:
WHEREAS, Alfa and Salix are parties to a certain License Agreement, dated June 24, 1996 (the 1996 License Agreement ); and
WHEREAS, in order to address the agreements of the Parties regarding certain relevant developments that have occurred since the execution of the 1996 License Agreement, the Parties have determined to amend and restate the 1996 License Agreement in its entirety as set forth herein;
NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties hereby agree as follows:
Article 1
RECITALS
It is acknowledged and agreed that the recitals to this Agreement and the Exhibits to this Agreement form an integral part hereof and are expressly incorporated in this Agreement.
Article 2
EFFECT ON 1996 LICENSE AGREEMENT
This Agreement amends and supersedes the 1996 License Agreement in its entirety. Upon the execution of this Agreement by both Parties, the 1996 License Agreement shall have no further force or effect.
Article 3
CERTAIN DEFINITIONS
In this Agreement:
[*] License has the meaning set forth in Section 4.3.3(a).
[*] Patent Family has the meaning set forth in Section 4.3.1.
[*] Application has the meaning set forth in Section 11.2.2.
Acceptable Product Profile means in respect of a particular pharmaceutical product for a particular indication [ * ].
Additional Crohns Product has the meaning set forth in Section 4.1.2(b)(vi).
Adverse Event has the meaning set forth in the Safety Data Exchange Agreement, as it may be amended from time to time. The current versions of all definitions used in this Agreement that are incorporated herein by reference to the Safety Data Exchange Agreement are set forth in Appendix 1.
Affiliate means with respect to Alfa, Salix or a Third Party, as the case may be, any Person or other entity that directly or indirectly controls, is controlled by or is under common control with such other Person. For the purpose of this definition and the definition of Controlling Third Party, control means (a) the possession of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract or otherwise, or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of such Person.
Alfa Confidential Information has the meaning set forth in Section 12.1.1.
Alfa Know-How means all Know-How (a) related to the composition of matter of the Compound insofar as relevant to uses within the Field or (b) related to the methods of use of the Compound within the Field that is Controlled by Alfa or its Affiliates as of the Amendment Effective Date or at any time during the term of this Agreement, whether or not patented or patentable, but only to the extent not claimed in or covered by any published or otherwise publicly available Alfa Licensed Patent or Joint Patent. Alfa Know-How shall not include Alfas interest in (y) any Joint Know-How or (z) Know-How Controlled by a Controlling Third Party of Alfa to the extent such Controlling Third Partys Know-How was Controlled by such Controlling Third Party (and not by Alfa) prior to the completion of such transaction or series of related transactions through which the Controlling Third Party acquired such status.
Alfa Licensed Patents means
(a) the Patents listed in Exhibit A and any continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, divisionals, reexaminations, reissues, revalidations, substitutes, extensions, and renewals of any of the foregoing Patents, including any Patents claiming priority to such Patents or applications; and
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
2
(b) all Patents (i) related to the composition of matter of the Compound insofar as relevant to uses within the Field or (ii) related to the methods of use of the Compound within the Field that are Controlled by Alfa or its Affiliates as of the Amendment Effective Date or at any time during the term of this Agreement;
but excluding Alfas interest in (y) any Joint Patents or (z) any Patents Controlled by a Controlling Third Party of Alfa to the extent such Controlling Third Partys Patents were Controlled by such Controlling Third Party (and not by Alfa) prior to the completion of such transaction or series of related transactions through which the Controlling Third Party acquired such status.
Alfa Licensed Product means a Rifaximin Product which as of the Amendment Effective Date or at any time during the term of this Agreement is covered by or uses or employs one or more rights within the Alfa Technology Rights or Joint Technology Rights, including a product which (a) as of the Amendment Effective Date or at any time during the term of this Agreement is covered by at least one Valid Claim of an Alfa Licensed Patent or Joint Patent, (b) as of the Amendment Effective Date or at any time during the term of this Agreement is Manufactured with or uses or employs a process covered by at least one Valid Claim of an Alfa Licensed Patent or Joint Patent, or (c) as of the Amendment Effective Date or at any time during the term of this Agreement utilizes or includes Alfa Know-How or Joint Know-How.
Alfa Licensed Trademarks has the meaning set forth in the Trademark License Agreement (Alfa to Salix).
Alfa Technology Rights means all Alfa Licensed Patents, all Alfa Know-How and all Clinical Data Controlled by Alfa or its Affiliates that relates to the Exploitation of Rifaximin Products in the Field.
Alfa Territory means the entire world excluding the Salix Territory.
Amendment Effective Date means the effective date of this Agreement as set forth in the first paragraph hereof.
[*] Claims means those claims set forth in the [*] Patent Family that claim an [*] of the Compound.
ANDA has the meaning set forth in the definition of Prescription Competitive Generic Product.
API has the meaning set forth in the definition of Net Sales.
[*] Agreement has the meaning set forth in Section 4.9.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
3
Business Day means any day other than a Saturday or a Sunday on which banking institutions in both New York, New York and Bologna, Italy are open for the conduct of routine banking business at their counters in the said cities.
Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31.
[*] has the meaning set forth in Section 4.2.7(b).
cGLP means the current Good Laboratory Practice standards promulgated or endorsed by the FDA, HPFB or the EMA, including those regulatory requirements set forth in 21 C.F.R. (part 58) and associated guidelines, as amended from time to time.
cGMP means the current Good Manufacturing Practice standards promulgated or endorsed by the FDA, HPFB or the EMA, including those regulatory requirements set forth in the FFDCA and 21 C.F.R. (parts 210, 211, 600 and 610) and associated guidelines, in each case as amended from time to time.
Change of Control means the occurrence of any of the following event:
(a) the acquisition of Salix by a Competitor, whether pursuant to a purchase of all or a majority of the issued and outstanding capital stock of Salix, merger, consolidation, purchase of all or substantially all of Salixs assets, or otherwise,
(b) if a Competitor acquires or controls (by proxy or otherwise) a sufficient quantity of Salixs stock to elect a majority of Salixs board of directors or a key committee of the board of directors, such as its audit committee or executive committee;
(c) if a Competitor obtains the ability to direct or control the policies of Salix;
(d) the acquisition by Salix of a Competitor, whether pursuant to a purchase of all or a majority of the issued and outstanding capital stock of a Competitor, merger, consolidation, purchase of all or substantially all of Salixs assets, or otherwise;
(e) if Salix acquires or controls (by proxy or otherwise) a sufficient quantity of a Competitors stock to elect a majority of the Competitors board of directors or a key committee of the board of directors, such as its audit committee or executive committee; or
(f) if Salix obtains the ability to direct or control the policies of a Competitor.
[*] means [*] located in [*].
[*] Territory means [*] and each of their respective possessions and territories and such other countries as may be added in writing from time to time under Section [*] of the [*] License Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
4
Claimant has the meaning set forth in Section 14.4.
Clinical Data means, in respect of a pharmaceutical product, all Know-How with respect to the product made, collected or otherwise generated under or in connection with the Clinical Trials for the product, including (a) any data, reports and results with respect to Clinical Trials; (b) protocols, statistical analysis plans, investigator brochures, and other background documents/roadmaps for performance of the Clinical Trials (as each of them may be amended from time to time); (c) information such as qualifications of the investigators; (d) assessments of the Clinical Trials (e.g., monitoring reports of the sponsor, audit protocols and audit results, regulatory inspection observations and follow-up (these are tools used to judge whether a study was performed as intended)); and (e) regulatory and IRB/ethics committee submissions or communications related to a Clinical Trial (e.g., IND submissions, IRB reports).
Clinical Trial means (a) any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal product(s), or to identify any adverse reactions to one or more investigational medicinal product(s) or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety or efficacy and (b) post-approval studies of an approved pharmaceutical product, including investigations to monitor or elucidate characteristics of the drug (e.g. post-approval observational studies to look for safety signals).
Commercialization means, in respect of a particular pharmaceutical product, any and all activities (whether before or after receipt of Marketing Approval in respect of the product) directed to the marketing, detailing and Promotion of the product after Marketing Approval for such product has been obtained, and includes marketing, Promoting, detailing, marketing research, distributing, offering to commercially sell and commercially selling the product, importing, exporting or transporting the product for commercial sale, and regulatory affairs with respect to the foregoing. When used as a verb, Commercializing means engaging in Commercialization and Commercialize and Commercialized shall have corresponding meanings.
Commercialization Milestone Payment(s) has the meaning set forth in Section 4.1.2(b)(iii).
Commercially Reasonable Efforts means, with respect to the efforts to be expended by any Party with respect to any objective, reasonable, diligent, good faith efforts to accomplish such objective as such Party would use in its ordinary course of business to accomplish a similar objective under similar circumstances. With respect to any objective relating to the Development and Commercialization of a [*] by either Party, Commercially Reasonable Efforts means [*]. Without limiting the generality of the foregoing, Commercially Reasonable Efforts as it applies to the Development of a [*]. In the event that a Party has such a reasonable basis to so diverge from the Development Plan, such Party shall [*].
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
5
Competitor means any business enterprise engaged in the Development, registration, Promotion, Commercialization or Manufacturing of the Compound, Rifaximin Products, or products that directly compete against Rifaximin Products in the Field).
Completion of Phase II Clinical Trials in respect of a pharmaceutical product means the completion of each of the following: (a) delivery of the final report and presentation of the analysis and results of the Phase II Clinical Trial including the raw data underlying the report, and (b) a sufficient period of time after last dosing of the last patient in a Clinical Trial of such product so as to observe any patient response and Adverse Effects, the principal purpose of which is a determination of safety and efficacy in the target patient population.
Compound means the chemical compound known as rifaximin, which is [*]. For the avoidance of doubt, [*] shall constitute Compound.
Compound Supply Agreement means that certain Supply Agreement between Alfa and Salix related to the supply of the Compound, dated June 24, 1996, as amended [*], and as further amended by Amendment Number Two being entered into simultaneous with this Agreement.
Confidential Information means all information provided by or on behalf of one Party to the other Party, whether before or after the Amendment Effective Date, including, information relating to Rifaximin Products, the Compound, any Development or Commercialization of Rifaximin Products, and the information, findings, data, and files developed or maintained by a Party or its Affiliates in connection with obtaining or maintaining Regulatory Approvals for the Compound for Existing Indications or New Indications, original documents, patent applications, data analysis, drawings, models, samples, compounds, devices, specifications, flow sheets, descriptions, submissions to regulatory authorities, and other tangible material and copies thereof, whether or not such information is identified as confidential or proprietary. Without limiting the generality of the foregoing, all draft patent applications or other documents intended to be filed in a patent office and forwarded by the disclosing Party to the receiving Party shall be Confidential Information, whether or not such documents are so indicated.
Control means, with respect to any Intellectual Property Right, Regulatory Documentation, Clinical Data, trademark or trade name, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by operation of any license and other grants hereunder, under the Supply Agreements, or under the Trademark License Agreements), to assign or grant a license, sublicense or other right to or under such Intellectual Property Right, Regulatory Documentation, Clinical Data, trademark or trade name as provided for herein or any other agreement or other instrument contemplated hereby without violating the terms of any agreement or other arrangement with any Third Party.
Controlling Third Party means, in respect of a particular Person, a Third Party that becomes an Affiliate of such Person pursuant to a transaction or series of related transactions as a result of which such Third Party is able to elect a majority of the members of the board of directors of such Person (or its successor company) or any of its controlling Affiliates.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
6
Crohns EIR License has the meaning set forth in Section 4.1.2(a).
Crohns EIR Product means a Crohns Rifaximin Product that contains the EIR Formulation.
Crohns EIR Trademark has the meaning set forth in the Trademark License Agreement (Alfa to Salix).
Crohns Rifaximin Product means a pharmaceutical product that is (a) for the prevention, treatment or amelioration of Crohns disease and (b) contains the Compound.
Development means, in respect of a particular pharmaceutical product, all activities related to pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, Manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Trials, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Regulatory Documentation, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining, maintaining or modifying a Regulatory Approval in respect of such product. When used as a verb, Develop means to engage in Development.
Development Milestone Payment has the meaning set forth in Section 4.1.2(b)(ii)(A).
Development Milestone Reduction has the meaning set forth in Section 4.1.2(b)(ii)(B).
Development Plan has the meaning set forth in Section 6.2.1(a).
Discoverer has the meaning set forth in Section 8.1.1.
Dollars or $ means United States Dollars.
Drug Master File means, in respect of a particular pharmaceutical product, any drug master file filed with the FDA or any other Regulatory Authority with respect to any intermediate of such product.
EIR Formulation means the Compound in the form of extended intestinal release, [*], including the descriptions set forth in the patent applications listed in Exhibit K.
EIR Supply Agreement means that certain Supply Agreement between Alfa and Salix, of even date herewith, relating to the supply of the Crohns EIR Product and Other EIR Products.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
7
EMA means the European Medicines Agency, or any successor agency.
EOP2 means the end of Phase II meeting conducted with a Regulatory Authority in the Salix Territory.
European Union or EU means the economic, scientific and political organization of European member states, as its membership may be altered from time to time, and any successor thereto, and which, as of the Amendment Effective Date, consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, and that certain portion of Cyprus included in such organization.
Existing Indications mean (a) travelers diarrhea, (b) hepatic encephalopathy and (c) irritable bowel syndrome.
Existing Indications License has the meaning set forth in Section 4.1.1(a).
Existing Indications EIR License has the meaning set forth in Section 4.1.3(a).
Exploit means, in respect of a particular pharmaceutical product, to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), use, have used, export, transport, distribute, Promote, or otherwise dispose of such product, and Exploitation means the act of Exploiting a product or process.
FDA means the United States Food and Drug Administration, or any successor agency.
FFDCA means the United States Federal Food, Drug, and Cosmetic Act, as amended.
Field means the prevention, treatment, amelioration, diagnosis or monitoring of human (a) gastrointestinal and respiratory tract diseases and conditions and (b) hepatic encephalopathy.
Hatch-Waxman Act means the Drug Price Competition and Patent Term Restoration Act of 1984, as amended.
HPFB means the Canadian Health Products and Food Branch, or any successor agency thereto.
IND means an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformity with the requirements of such Regulatory Authority.
Indemnitor has the meaning set forth in Section 14.4.
Initial U.S. Marketing Approval of a particular pharmaceutical product for a particular indication means the approval of such product by the FDA for commercial sale and marketing for such indication in the United States.
8
Intellectual Property Rights means any and all rights in any invention, whether or not patentable, discovery or Know-How, including Patents, copyrights, trade secrets or any other proprietary information protectable by statutory provision or common law doctrine, but specifically excluding trademarks and trade names.
IRB means an institutional review board as defined in 21 C.F.R. Part 56.
Joint Clinical Data means all Clinical Data developed jointly by or on behalf of Salix or its Affiliates or Sublicensees and Alfa or its Affiliates or Sublicensees.
Joint Know-How means all Know-How created or developed jointly by or on behalf of Salix or its Affiliates or Sublicensees and Alfa or its Affiliates or Sublicensees, but only to the extent not claimed in or covered by any published or otherwise publicly available Joint Patent. Joint Know-How shall not include any Salix Know-How or Alfa Know-How.
Joint Patents means (a) the Patents set forth on Exhibit C and (b) any other Patent that claims or covers any invention, development or discovery and which Patent names at least one inventor from both (i) Salix or its Affiliates, Sublicensees or any Person acting on Salixs behalf, and (ii) Alfa or its Affiliates, Sublicensees or any Person acting on Alfas behalf, and any continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, divisionals, reexaminations, reissues, revalidations, substitutes, extensions, and renewals of any of the foregoing Patents or applications, including any Patents or patent applications claiming priority to such Patents or patent applications.
Joint Technology Rights means the Joint Patents, the Joint Know-How, and the Joint Clinical Data.
Know-How means any and all data, information, technology, specifications, processes, methods, designs, raw materials, results, assistance, trade secrets, special ability, formulations, compositions, discoveries, and developments and Manufacturing techniques (in the case of all of the foregoing whether or not confidential, proprietary and whether in written, electronic or any other form now known or hereafter developed during the term of this Agreement).
Launch Date means (a) with respect to an Alfa Licensed Product for an Existing Indication, July 12, 2004, and (b) with respect to an Alfa Licensed Product for a New Indication or a Crohns EIR Product, the Putting into Commerce of the first Alfa Licensed Product for a New Indication or Crohns EIR Product, as applicable, that is Put into Commerce after the Amendment Effective Date; provided that for purposes of the definition of Launch Date only, any Alfa Licensed Product containing the EIR Formulation would be considered to be for a New Indication, regardless of the disease or disorder for which it is prescribed or labeled.
Licensed Patents means the Alfa Licensed Patents or the Salix Licensed Patents.
Licensed Product(s) means the Alfa Licensed Products or Salix Licensed Products.
Licensee means the Party to whom a license has been granted pursuant to Article 4 of this Agreement.
Licensor has the meaning set forth in Section 4.6.
9
[*] Committee has the meaning set forth in Section 6.3.1.
Losses has the meaning set forth in Section 14.1.
MAA means a Marketing Authorization Application filed with the EMA in the European Union or other Regulatory Authority in another jurisdiction of the Alfa Territory.
Manufacture and Manufacturing means, in respect of a particular pharmaceutical product, and without limitation, all activities related to the production, manufacture, processing, formulation, filling, finishing, packaging, labeling, shipping, handling, holding, storage and warehousing of such product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
Marketing Approval means, with respect to a particular pharmaceutical product and a particular country or other jurisdiction, any and all approvals, registrations, certificates, licenses or authorizations of any Regulatory Authority necessary to Commercialize such product in such country or jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or jurisdiction, (b) pre- and post-approval manufacturing and marketing authorizations (including any prerequisite marketing approval), (c) drug naming approvals and Product Labeling approval, and (d) technical, medical and scientific licenses.
NDA means a New Drug Application as defined in the FFDCA (and the regulations promulgated thereunder) filed with the FDA, including supplemental NDAs, and equivalent applications or submissions in other jurisdictions.
Net Sales means [*]. With respect to sales of a Crohns EIR Product or Licensed Product which is sold as a combination product containing at least one other active pharmaceutical ingredient ( API ) beside the Compound, Net Sales shall be calculated [*]
[*].
If the other API(s) included in the combination product are not sold by the Licensee, Net Sales for the combination product shall be calculated by [*].
If a Crohns EIR Product or Licensed Product is not sold on arms length terms but is used or otherwise disposed of on a commercial basis by a Third Party, the price that would have been charged (after the deductions set forth above) on an arms length sale in such country shall be deemed the Net Sales for the sale of such Crohns EIR Product or Licensed Product, provided that any Crohns EIR Product or Licensed Product supplied and used in Clinical Trials or for other research or Development activities or reasonably and customarily supplied for promotional care purposes as samples or for charitable or indigent care purposes shall not be treated as being disposed of on a commercial basis and shall be ignored for the purpose of calculating Net Sales.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
10
For clarification, for the purpose of calculating Net Sales of a Crohns EIR Product or Licensed Product, if a Crohns EIR Product or Licensed Product is sold as part of a package offering with one or more other products that are not Crohns EIR Products or Licensed Products, any discounts or other price concessions of the types referred to above which are directed to the other products but not to the Crohns EIR Product or Licensed Product shall not be taken as a deduction against gross sales.
New Indication means any condition, disorder or disease within the Field excluding Existing Indications.
New Indication Trademarks has the meaning set forth in the Trademark License Agreement (Alfa to Salix). For clarity, New Indication Trademarks shall not include the Crohns EIR Trademark or the Other EIR Trademarks.
Orange Book means the Approved Drug Products with Therapeutic Equivalence Evaluation published by the FDAs Center for Drug Evaluation and Research, as updated and modified from time to time.
Other EIR Products means Rifaximin Products having the EIR Formulation, excluding the Crohns EIR Product.
Other EIR Trademarks has the meaning set forth in the Trademark License Agreement (Alfa to Salix).
Other Forms Claims means the claims set forth in the [*] Patent Family but excluding the [*] Claims.
Other New Formulation means a novel formulation of the Compound other than the [*] Formulation discovered by or on behalf of Salix or its Affiliates after the Amendment Effective Date, which is distinct from any of the formulations of the Compound currently included in Rifaximin Products.
Other New Formulation Product has the meaning set forth in Section 4.2.5(a).
Other New Formulation Trademarks has the meaning set forth in Section 4.2.5(a).
Patents means all national, regional and international patents and patent applications, including provisional patent applications, utility models, petty patents, design patents, certificates of invention and other similar rights, so-called pipeline protection, any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions.
Patent Defense Agreement means the agreement between the Parties, [*], pertaining to the allocation of responsibilities and sharing of expenses related to challenges to and actions for infringement of Alfa Licensed Patents in the Salix Territory.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
11
Person means any individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
[*] Report means the report of [*] to Alfa, dated [*], pertaining to the valuation of a Crohns EIR Product, a copy of which is annexed hereto as Exhibit D.
Prescription Competitive Product means, in respect of a particular Crohns EIR Product or Alfa Licensed Product or a particular Salix Licensed Product, as the case may be, and a particular country, any Rifaximin Product (excluding Rifaximin Products made by or for a Party or any of its Affiliates, licensees, Sublicensees or other parties with whom the Party has a business relationship) that is labeled, advertised, marketed, promoted or intended for use within the Field in such country for any indication that is the same as any indication for which the applicable Crohns EIR Product or Licensed Product is labeled, advertised, marketed, promoted or intended for use in such country within the Field, but excluding (a) any Rifaximin Product that is sold as an over-the-counter product or a dietary supplement or food product, (b) any product which Salix or Alfa, as the case may be, has authorized to be sold as a generic product and (c) any such Rifaximin Product that infringes a Valid Claim of an Alfa Licensed Patent, Salix Licensed Patent, Joint Patent, or, in the case of Rifaximin Product containing [*] of the Compound, Valid Claims of the [*] Patent Family or patents issued from it and excluding Prescription Competitive Generic Products.
Prescription Competitive Generic Product means, in respect of a particular Crohns EIR Product or Alfa Licensed Product or a particular Salix Licensed Product, as the case may be, and a particular country, any Rifaximin Product (excluding Rifaximin Products made by or for a Party or any of its Affiliates, licensees or Sublicensees) that has
(a) received Marketing Approval in such country under an Abbreviated New Drug Application ( ANDA ) (or foreign equivalent) in which the particular Crohns EIR Product or Alfa Licensed Product or Salix Licensed Product is the reference product for the Rifaximin Product approved under such ANDA (or foreign equivalent), or
(b)(i) has the same active ingredient, dosage form, dosage strength, route of administration, and labeling (with due allowance for differing trade dress and similar variations) for use within the Field in such country as the applicable Crohns EIR Product or Licensed Product that has received Marketing Approval in such country, and for which the competitive Rifaximin Product has received Marketing Approval within the Field or (ii) received Marketing Approval in such country under an application filed under FFDCA Section 505(b)(2) (or foreign equivalent) and with respect to both of the preceding clauses (ii) and (ii), has been shown to be bioequivalent to the Crohns EIR Product Licensed Product,
but excluding (x) any such Rifaximin Product that is sold as an over-the-counter product or a dietary supplement or food product, (y) any product which Salix or Alfa, as the case may be, has
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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authorized to be sold as a generic product, and (z) any such Rifaximin Product that infringes a Valid Claim of an Alfa Licensed Patent, Salix Licensed Patent, Joint Patent, or, in the case of Rifaximin Product containing [*] of the Compound, Valid Claims of the [*] Patent Family or patents issued from it.
Product Failure has the meaning set forth in Section 4.1.2(b)(vi).
Product Labeling means, with respect to a particular pharmaceutical product, a particular indication, and a particular country or other jurisdiction, (a) the Regulatory Authority-approved full prescribing information for such product for such indication for such country or jurisdiction, including any required patient information, and (b) all labels and other written, printed or graphic matter upon a container, wrapper or otherwise, including any package insert, utilized with or for the marketing, sale or other Commercialization of such product for such indication in such country or jurisdiction.
Promotion means those activities normally undertaken by a pharmaceutical companys sales force (including electronic detailing, advertising and meeting with physicians, whether undertaken by the companys sales force or not) to implement marketing plans and strategies aimed at encouraging the appropriate use of a product. When used as a verb, Promote means to engage in such activities. With respect to Salixs Promotion of a Crohns EIR Product or Alfa Licensed Product, Promotion includes those activities actually undertaken by Salixs sales force to implement marketing plans and strategies aimed at encouraging the appropriate use of the Crohns EIR Product or Alfa Licensed Product.
Promotional Materials means, with respect to a particular pharmaceutical product, all [*] materials with respect to such product and all [*] intended for use or used by a Party or its Affiliates in connection with any Promotion of such product, except Product Labeling for such product.
Put into Commerce means the first commercial sale of a Crohns EIR Product or Licensed Product to Third Parties (excluding Sublicensees) by or on behalf of a Licensee or any Sublicensee of a Licensee under the terms of this Agreement made in any part of the Salix Territory (where Salix is the Licensee) or the Alfa Territory (where Alfa is the Licensee), as applicable, after all relevant Marketing Approvals shall have been granted by the relevant Regulatory Authorities in respect of the Crohns EIR Product or Licensed Product in the Salix Territory or Alfa Territory, as applicable.
Recipient has the meaning set forth in Section 8.1.1.
Regulatory Approval means, in respect of a particular country, the technical, medical and scientific licenses, registrations, authorizations and approvals of any Regulatory Authority necessary for the Development, clinical testing, Manufacture, distribution, marketing, promotion, offering for sale, use, import, export, sale or other Commercialization of a drug product in such country, including Marketing Approvals, INDs, NDAs, biologic license applications, supplements and amendments, pre- and post-approvals, pricing or reimbursement approvals, drug naming approvals, and Product Labeling approvals.
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Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entity, including the FDA, EMA and the HPFB, regulating or otherwise exercising authority with respect to the Development, Commercialization, Manufacturing and Promotion (including the determination of pricing/reimbursement) of pharmaceutical products in any country or other jurisdiction.
Regulatory Documentation means, with respect to a particular pharmaceutical product, all Regulatory Approvals and applications therefor, all correspondence submitted to or received from the Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), and all supporting documents and all Clinical Trials, in each case, relating to such product, and all data contained in any of the foregoing, including Promotional Materials, Clinical Data, periodic safety update reports, adverse event files and complaint files, Manufacturing records (including any chemistry, Manufacturing or control data) and, if applicable, any updates or supplements to any of the foregoing.
Regulatory Exclusivity means, with respect to any country, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country which confers an exclusive Commercialization period during which a Licensee or its Affiliates or Sublicensees have the exclusive right to market, price, and sell a Crohns EIR Product or Licensed Product in such country through a regulatory exclusivity right, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity.
Related Agreements mean (a) the Supply Agreements, (b) the [*] Agreement, (c) the Safety Data Exchange Agreement, (e) the Trademark License Agreement (Alfa to Salix), (e) the Trademark License Agreement (Salix to Alfa), and (f) the Quality Agreement between the Parties referenced in the EIR Supply Agreement.
Rifaximin Product means any pharmaceutical, biological or other composition, preparation or other type of product (including any over-the-counter product) that contains the Compound (including any such product that contains the Compound together with one or more other active ingredients (which may be either combined in a single formulation or bundled with separate formulations but sold as one product)).
Safety Data Exchange Agreement means the agreement between the Parties, dated [*], pertaining to the safety policies and procedures regarding the Compound or the Rifaximin Products, as it may be amended from time to time.
[*] License Agreement has the meaning set forth in Section 4.2.7(b).
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[*] means those Patents and Know-How that are licensed by [*] to Salix pursuant to the [*] License Agreement.
[*] License Agreement means that certain Exclusive License Agreement, dated [*], between [*].
Salix Confidential Information has the meaning set forth in Section 12.1.2.
Salix Designated Indication has the meaning set forth in Section 4.2.2.
Salix Designated Indication License has the meaning set forth in Section 4.2.2.
Salix Designated Indication Product means a product Developed by or for Salix for the Salix Designated Indication and designated by Salix pursuant to the provisions of Section 4.2.2 to be available for license to Alfa pursuant to the Salix Designated Indication License.
Salix Designated Indication Trademark has the meaning set forth in Section 4.2.5(a).
Salix Know-How means all Know-How (a) related to the composition of matter of the Compound insofar as relevant to uses within the Field or (b) related to the methods of use of the Compound within the Field that is Controlled by Salix or its Affiliates as of the Amendment Effective Date or at any time during the term of this Agreement, whether or not patented or patentable, but only to the extent not claimed in or covered by any published or otherwise publicly available Salix Licensed Patent or Joint Patent. Salix Know-How shall not include Salixs interest (x) in the [*], (y) any Joint Know-How, (z) any Know-How Controlled by a Controlling Third Party of Salix to the extent such Controlling Third Partys Know-How was Controlled by such Controlling Third Party (and not by Salix) prior to the completion of such transaction or series of related transactions through which the Controlling Third Party acquired such status.
Salix Licensed Patents means
(a) all Patents listed in Exhibit B and any continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, divisionals, reexaminations, reissues, revalidations, substitutes, extensions, and renewals of any of the foregoing Patents or applications, including any Patents or patent applications claiming priority to such Patents or patent applications; and
(b) all Patents pertaining to the Compound (i) related to the composition of matter of the Compound insofar as relevant to uses within the Field or (ii) related to the methods of use of the Compound within the Field that are Controlled by Salix or its Affiliates as of the Amendment Effective Date or at any time during the term of this Agreement;
but excluding Salixs interest in (w) the [*], (x) Joint Patents, (y) the [*] Patent Family, or (z) Patents Controlled by a Controlling Third Party of Salix to the extent such Controlling Third Partys Patents were Controlled by such Controlling Third Party (and not by Salix) prior to the completion of such transaction or series of related transactions through which the Controlling Third Party acquired such status.
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Salix Licensed Product means a Rifaximin Product which as of the Amendment Effective Date or at any time during the term of this Agreement is covered by or uses or employs one or more rights within the Salix Technology Rights, Other Forms Claims of the [*] Patent Family, or Joint Technology Rights, including a product which (a) as of the Amendment Effective Date or at any time during the term of this Agreement is covered by at least one Valid Claim of a Salix Licensed Patent, Other Forms Claim of the [*] Patent Family, or Joint Patent, (b) as of the Amendment Effective Date or at any time during the term of this Agreement is Manufactured with or uses a process covered by at least one Valid Claim of a Salix Licensed Patent, Other Forms Claim of the [*] Patent Family, or Joint Patent, or (c) as of the Amendment Effective Date or at any time during the term of this Agreement utilizes or includes Salix Know-How or Joint Know-How.
Salix Licensed Trademarks has the meaning set forth in the Trademark License Agreement (Salix to Alfa).
Salix New Indications License has the meaning set forth in Section 4.1.4(a).
Salix Technology Rights means all Salix Licensed Patents, all Salix Know-How, and all Clinical Data Controlled by Salix or its Affiliates that relates to the Exploitation of Rifaximin Products in the Field.
Salix Territory means the United States (including its territorial possessions, territories and the Commonwealth of Puerto Rico) and Canada.
[*] Formulation means the Compound in the form of [*] currently being pursued by Salix as described in documents previously delivered by Salix to Alfa. Upon completion by Salix of Phase I studies in respect of [*] formulations of the Compound, the Parties shall mutually agree, in good faith, to a revised definition of [*] Formulation that reflects the lead [*] formulation that has been developed by Salix at that point. Such revised definition of [*] Formulation shall be memorialized by the Parties in a writing executed by both Parties and thereupon shall be and become the definition of [*] Formulation.
[*] / Other New Formulation License has the meaning set forth in Section 4.2.3(a).
Steering Committee has the meaning set forth in Section 6.2.5(a).
Sublicensee means a Person, other than an Affiliate, that is granted a sublicense by a Party under the license grants hereunder, as provided in Sections 4.1.6, 4.2.6 or 4.3.3(b), as the case may be, or that was granted a similar sublicense under the 1996 License Agreement.
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Supply Agreements means (a) the Compound Supply Agreement and (b) the EIR Supply Agreement.
Third Party means any Person or entity other than Salix, Alfa, or their respective Affiliates.
Trademark License Agreement (Alfa to Salix) has the meaning set forth in Section 4.1.5.
Trademark License Agreement (Salix to Alfa ) has the meaning set forth in Section 4.2.5(b).
Trademark License Agreements means (a) the Trademark License Agreement (Alfa to Salix) and (b) the Trademark License Agreement (Salix to Alfa).
Valid Claim means, in respect of any country:
(a) any claim of an issued and unexpired Patent in such country that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable or disclaimer;
(b) a claim of a pending patent application in such country that was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application; provided that such prosecution has not been ongoing for more than [*] years.
Valuation Principles has the meaning set forth in Section 4.2.2(b).
Xifaxan Trademark has the meaning set forth in the Trademark License Agreement (Alfa to Salix).
Article 4
LICENSE GRANTS AND COMPENSATION
4.1 Alfa Grant of Licenses to Salix
4.1.1 Existing Indications License (Excluding EIR Formulation)
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(a) License Grant . Subject to the terms and conditions of this Agreement, Alfa hereby grants to Salix (i) an exclusive (including with respect to Alfa and its Affiliates), non-transferable (save as provided herein), royalty-bearing license (with the right to sublicense as set forth herein) under the Alfa Technology Rights and Alfas rights in the Joint Technology Rights, excluding in each case Alfa Technology Rights and Joint Technology Rights pertaining to the EIR Formulation (which is addressed in Sections 4.1.2, 4.1.3 and 4.1.4), to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products for Existing Indications within the Field in the Salix Territory and (ii) a non-exclusive right and license (with the right to sublicense as set forth herein) under the Alfa Technology Rights and Alfas rights in the Joint Technology Rights to Develop Rifaximin Products for Existing Indications within the Field in the Alfa Territory (the Existing Indications License ).
(b) Consideration . With respect to the Existing Indications License, Salix shall pay to Alfa royalties at the following royalty rates calculated on Net Sales of Alfa Licensed Products not having the EIR Formulation for Existing Indications in the Salix Territory (during the term specified in Section 16.2.1) by Salix and its Affiliates and Sublicensees based on the total quantity of Compound in the Alfa Licensed Products not having the EIR Formulation for Existing Indications sold in the Salix Territory by Salix and its Affiliates and Sublicensees in each Calendar Year:
Quantity of Compound in the Alfa Licensed Products Not Having the EIR
|
Royalty Rate as
a
Percentage (%) of Net Sales of Net Sales |
|
On the first [*] |
[*]% | |
On amounts greater than [*] but less than or equal to [*] |
[*]% | |
On amounts greater than [*] but less than or equal to [*] |
[*]% | |
On amounts greater than [*] |
[*]% |
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4.1.2 Crohns EIR License .
(a) License Grant . Subject to the terms and conditions of this Agreement, Alfa hereby grants to Salix (i) an exclusive (including with respect to Alfa and its Affiliates), non-transferable (save as provided herein), royalty-bearing license (with the right to sublicense as set forth herein) under the Alfa Technology Rights (including those pertaining to the EIR Formulation) and Alfas rights in the Joint Technology Rights (including those pertaining to the EIR Formulation) to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products for the treatment, prevention or amelioration of Crohns disease in the Salix Territory and (ii) a non-exclusive right and license (with the right to sublicense as set forth herein) under the Alfa Technology Rights and Alfas rights in the Joint Technology Rights to Develop anywhere in the world Rifaximin Products for the treatment, prevention or amelioration of Crohns disease (collectively, the licenses granted under clauses (i) and (ii) are referred to herein as the Crohns EIR License ).
(b) Consideration . The consideration to be paid by Salix to Alfa with respect to the Crohns EIR License shall be as follows:
(i) License Fee . Within [*] Business Days following the execution of this Agreement, Salix shall make a non-refundable and non-creditable payment to Alfa of ten million Dollars ($10,000,000).
(ii) Development Milestone .
(A) Salix shall pay to Alfa a one-time, non-refundable and non-creditable payment of twenty-five million Dollars ($25,000,000) (the Development Milestone Payment ) within [*] Business Days of receipt by Salix from Alfa of an invoice for the payment of the Development Milestone Payment following the issuance of the Initial U.S. Marketing Approval for the Crohns EIR Product, provided that the Crohns EIR Product has an Acceptable Product Profile. The Development Milestone Payment is payable one time only, regardless of the number of Crohns EIR Products for which the condition is satisfied. For the avoidance of doubt, the maximum aggregate value of all Development Milestone Payments is twenty-five million Dollars ($25,000,000).
(B) In the event that the specified condition for the Development Milestone Payment as specified above is achieved but in circumstances where the Crohns EIR Product does not have an Acceptable Product Profile in connection with its Initial U.S. Marketing Approval, then the amount of the Development Milestone Payment shall be reduced to [*] (the Development Milestone Reduction ) and the Commercialization Milestone Payment of [*] payable upon [*] provided for in Section 4.1.2(b)(iii) shall be applicable.
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(iii) Commercialization Milestones . In partial consideration for the grant of the Crohns EIR License, Salix shall pay to Alfa upon the satisfaction of the specified conditions in this Section 4.1.2(b)(iii) the following one-time, non-refundable, and non-creditable payments ( Commercialization Milestone Payments ) within [*] Business Days of receipt by Salix from Alfa of an invoice for the payment of the applicable Commercialization Milestone Payment. Salix shall notify Alfa within [*] Business Days after the achievement of each milestone set forth in this Section 4.1.2(b)(iii). Each Commercialization Milestone Payment is payable one time only, regardless of the number of times the condition is satisfied. For the avoidance of doubt, the maximum aggregate value of all Commercialization Milestone Payments is two hundred five million Dollars ($205,000,000), and up to all seven (7) Commercialization Milestone Payments could be made with respect to a single Calendar Year.
Milestone |
Payment |
|
[*] |
In the event (but only in the event) the [*] has then occurred, [*]. If the [*] has not then occurred, then no Commercialization Milestone Payment is due in respect of the satisfaction of the condition set forth in this row. | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] | |
[*] |
[*] |
(iv) Royalties . With respect to the Crohns EIR License, Salix shall pay to Alfa royalties at the following royalty rates on Net Sales of the Crohns EIR Product in the Salix Territory (during the term specified in Section 16.2.1) by Salix and its Affiliates and Sublicensees based on aggregate Net Sales of the Crohns EIR Product in the Salix Territory by Salix and its Affiliates and Sublicensees in each Calendar Year:
Aggregate Net Sales of Crohns EIR Product in the
|
Royalty Rate |
|
[*] |
[*]% | |
Above [*] to [*] |
[*]% | |
Above [*] |
[*]% |
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(v) Compensation Methodology . The Parties acknowledge that (A) the foregoing financial compensation package for the Crohns EIR License [*], (B) [*], (C) [*], and (D) [*].
(vi) Additional Crohns Product . In the event Salix at any time undertakes the Commercialization in the Salix Territory of a Crohns Rifaximin Product that is not a Crohns EIR Product (an Additional Crohns Product ), whether prior to or following the receipt of Initial U.S. Marketing Approval for the Crohns EIR Product, then (A) for the purposes of Section 4.1.2(b)(iii), all sales of the Additional Crohns Product shall be treated as if they were sales of the Crohns EIR Product and (B) for the purposes of Section 4.1.2(b)(iv), all sales of the Additional Crohns Product shall be treated as if they were sales of the Crohns EIR Product, and Salix shall be obligated to pay royalties to Alfa on such sales of the Additional Crohns Product as well as sales of the Crohns EIR Product under Section 4.1.2(b)(iv). For the avoidance of doubt, however, if Salix terminates the Agreement with respect to the Crohns EIR Product pursuant to Section 16.4.4, then only sales of the Additional Crohns Product (and not sales of the Crohns EIR Product by Alfa or its Affiliates, licensees, sublicensees or sales agents) in the Salix Territory by Salix and its Affiliates and Sublicensees shall count for purposes of Salixs obligation to pay commercialization milestones and royalties as set forth above in Section 4.1.2(b)(vi)(A) and (B). In the event an Additional Crohns Product receives U.S. Marketing Approval for more than one indication, including Crohns disease, then for the purpose of this Section 4.1.2(b)(vi), only sales of the Additional Crohns Product labeled for the treatment, prevention or amelioration of Crohns disease shall be applied to the calculation of Net Sales for the purpose of Section 4.1.2(b)(iii) and 4.1.2(b)(iv). Nothing in this Section 4.1.2(b)(vi) shall affect Alfas right to be compensated for sales of the Additional Crohns Product pursuant to the other terms of this Agreement. [*] The provisions of this Section 4.1.2(b)(vi) shall not in any way limit or qualify Salixs obligations under Section 6.2 in respect of the Development of the Crohns EIR Product. This Section 4.1.2(b)(vi) shall survive the exercise by Salix of its right under Section 16.4.4 to terminate this Agreement with respect to the Crohns EIR Product, whether such exercise is made prior to or after the Initial U.S. Marketing Approval for the Crohns EIR Product is obtained, except in the situation where the [*].
4.1.3 Existing Indications EIR License .
(a) License Grant . Subject to the terms and conditions of this Agreement, Alfa hereby grants to Salix an exclusive (including with respect to Alfa and its Affiliates), non-transferable (save as provided herein), royalty-bearing license (with the right to sublicense as set forth herein) under the Alfa Technology Rights (including those pertaining to the
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EIR Formulation) and Alfas rights in the Joint Technology Rights (including those pertaining to the EIR Formulation) to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products for Existing Indications within the Field in the Salix Territory (the Existing Indications EIR License ).
(b) Consideration . The consideration payable by Salix to Alfa for the Existing Indications EIR License shall consist of royalties [*] in an amount to be mutually agreed by the Parties; provided that in no event shall [*]. If Salix desires to Commercialize an Alfa Licensed Product that has the EIR Formulation for an Existing Indication in the Salix Territory, then Salix shall deliver a written notice to Alfa. During a period of [*] days following Alfas receipt of such notice, the Parties shall use good faith efforts to reach agreement on the royalty rate applicable to the Existing Indications EIR License for such Alfa Licensed Product for such Existing Indication. If the Parties are unable to agree on the terms for such royalties during such [*] day period, the matter shall be referred to a Third Party consultant, such as [*], who shall make recommendations and assist the Parties in attempting to resolve the matter for an additional period of [*] days from the date such Third Party is engaged, or such longer period as the Parties may agree upon. The fees and expenses of any such consultant shall be shared by the Parties equally. If the Parties are unable to resolve the matter within such additional period, it shall be resolved by arbitration pursuant to the procedures set forth in Section 18.2. In any such arbitration, the Parties shall provide to the arbitrator a copy of the relevant provisions of this Agreement setting out the principles on which the royalty rate for the Existing Indication EIR License for the relevant Alfa Licensed Product for the specified Existing Indication is to be based and each Party shall submit to the arbitrators what it considers to be an appropriate royalty rate for the Existing Indications EIR License for the relevant Alfa Licensed Product for the specified Existing Indication subject to the parameters described in the first sentence of this Section 4.1.3(b). The Parties shall jointly direct the arbitrators to select which of the two submitted rates it determines to be closest to fair market value for the Existing Indications EIR License.
4.1.4 Salix New Indications License .
(a) License Grant . Subject to the terms and conditions of this Agreement, Alfa hereby grants to Salix an exclusive (including with respect to Alfa and its Affiliates), non-transferable (save as provided herein), royalty-bearing license (with the right to sublicense as set forth herein) under the Alfa Technology Rights (including those pertaining to the EIR Formulation) and Alfas rights in the Joint Technology Rights (including those pertaining to the EIR Formulation) to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products for New Indications within the Field in the Salix Territory, excluding the treatment, prevention or amelioration of Crohns disease (the Salix New Indications License ).
(b) Consideration . The consideration payable by Salix to Alfa for the Salix New Indications License shall consist of royalties [*] at a rate to be agreed upon by the Parties. If Salix desires to Commercialize an Alfa Licensed Product for a New Indication (except for Crohns disease, which is governed by the Crohns EIR License in Section 4.1.2) within the
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Field in the Salix Territory, Salix shall deliver a written notice to Alfa during the [*]-day period following the delivery by a Party of a notice of the discovery of a New Indication, as provided for in Section 8.1.1. Following Salixs delivery of its notice to so Commercialize an Alfa Licensed Product for a New Indication, the Parties shall use good faith efforts to reach agreement on the royalty rate applicable to the Salix New Indications License. If the Parties are unable to agree on the terms for such royalties within such [*] day period, or such longer period as the Parties may agree upon in writing, the matter shall be referred to a Third Party consultant, such as [*], who shall be engaged by the Parties to make recommendations and assist the Parties in attempting to resolve the matter for an additional period of [*] days from the date such Third Party is engaged, or such longer period as the Parties may agree upon. The fees and expenses of any such consultant shall be shared by the Parties equally. If the Parties are unable to resolve the matter within such additional period, it shall be resolved by arbitration pursuant to the procedures set forth in Section 18.2. In any such arbitration, the Parties shall provide to the arbitrator a copy of the relevant provisions of this Agreement setting out the principles on which the royalty rate for the Salix New Indications License is to be based, and each Party shall submit to the arbitrators what it considers to be an appropriate royalty rate for the Salix New Indications License for such Alfa Licensed Product for the specific New Indication. The Parties shall jointly direct the arbitrators to select which of the two submitted rates it determines to be closest to fair market value for the Salix New Indications License for such Alfa Licensed Product for the specific New Indication.
4.1.5 Trademark Licenses to Salix . Simultaneously with the execution of this Agreement, Alfas Affiliate, Alfa Wassermann Hungary Kft. and Salix are entering into a trademark license agreement (the Trademark License Agreement (Alfa to Salix) ).
4.1.6 Sublicense Rights; Further Rights of Reference . The rights and licenses granted by Alfa to Salix under Sections 4.1.1 - 4.1.4, Section 4.1.8 and Section 9.2.1 shall include the right to grant sublicenses (or further rights of reference) through multiple tiers of Sublicensees, subject to the following:
(a) The terms of any such sublicense or further rights of reference shall be in accordance with the terms and conditions of this Agreement. With regard to all Sublicenses granted by Salix pursuant to the rights granted to it by Alfa under this Agreement, (i) Salix may not grant to any Sublicensee any right to maintain Alfa Licensed Patents, defend claims brought by Third Parties that the Exploitation of Alfa Technology Rights infringes the Third Partys Intellectual Property Rights, or commence any legal action against any Third Party for infringement of Alfa Licensed Patents and (ii) Salix shall notify Alfa of its entry into a sublicense, identifying the Sublicensee, and the territory and the scope of the rights granted to the sublicensee, not later than [*] Business Days after such sublicense is executed. A list of all existing sublicenses granted by Salix to Alfa Technology Rights is set forth as Exhibit I;
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(b) Notwithstanding the grant of any such sublicense or further rights of reference hereunder, Salix shall remain solely responsible to Alfa for the performance of its obligations under the terms hereof and for any breach of such obligations, whether such breach shall be caused by Salix or any Sublicensee; and
(c) For the avoidance of doubt it is hereby acknowledged that the appointment by Salix of any distributor for Crohns EIR Products or Alfa Licensed Products, any manufacturer to Manufacture Compound or Rifaximin Products to the extent permitted herein, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for Crohns EIR Products or Alfa Licensed Products shall not be deemed to constitute the appointment of a Sublicensee or the sublicense by Salix of any rights hereunder.
4.1.7 Third Party Sublicenses . Prior to entering into any license with a Third Party to any Patent or other Intellectual Property Rights in the Salix Territory that pertains to the Compound for use within the Field, Alfa shall use its good faith efforts to ensure that such license is sublicensable to Salix, and if Alfa obtains such a license with the Third Party, then, without limiting the scope of the licenses granted by Alfa to Salix pursuant to Sections 4.1.1 - 4.1.4, Alfa shall, to the extent permitted to do so under such license, grant to Salix a sublicense to such Patent or Intellectual Property Rights for the purposes set forth in Sections 4.1.1 - 4.1.4.
4.1.8 Manufacturing License to Salix . Subject to the terms of the Supply Agreements, Alfa hereby grants to Salix a non-exclusive license, with the right to grant sublicenses in accordance with Section 4.1.6, under the Alfa Technology Rights and Alfas rights in the Joint Technology Rights to Manufacture or have Manufactured, anywhere in the world, (a) Rifaximin Products for use and sale by Salix and its Affiliates and Sublicensees under the license grants in Sections 4.1.1 - 4.1.4, (b) the current formulation of the Compound for incorporation into such Rifaximin Products and (c) the EIR Formulation; provided, however , that in the case of clause (a) as it relates to Rifaximin Products containing the EIR Formulation and clause (c), Salix may not exercise its rights set forth in this Section 4.1.8 unless Alfa fails to fulfill its supply obligations to Salix and does not cure such failure as set forth in the EIR Supply Agreement.
4.2 Salix Grant of Licenses to Alfa .
4.2.1 License for Existing Indications and New Indications (Excluding [*] Formulation or Other New Formulations) .
(a) Subject to the terms and conditions of this Agreement, Salix hereby grants to Alfa an exclusive (including with respect to Salix and its Affiliates), non-transferable (save as provided herein), royalty-free, fully paid-up license (with the right to sublicense as set forth herein) under the Salix Technology Rights, Salixs rights in the Other
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Forms Claims of the [*] Patent Family and Salixs rights in the Joint Technology Rights, to Exploit Rifaximin Products for Existing Indications and New Indications within the Field in the Alfa Territory, excluding only (A) Salix Technology Rights, Other Forms Claims of the [*] Patent Family, and Joint Technology Rights pertaining to the [*] Formulation or Other New Formulations, which are addressed in Section 4.2.2 and Section 4.2.3 and (B) Salix Technology Rights, Other Forms Claims of the [*] Patent Family, and Joint Technology Rights relevant to the Manufacturing of Rifaximin Products having the [*] Formulation or Other New Formulation, the rights to which are addressed in Section 4.2.1(b).
(b) In the event that Alfa licenses rights to the Salix Licensed Products with the [*] Formulation or Other New Formulations contemplated in Section 4.2.2 and Section 4.2.3, the Parties shall discuss in good faith whether Alfa or Salix shall be responsible for Manufacturing such Salix Licensed Products having the [*] Formulation or Other New Formulation.
4.2.2 Salix Designated Indication License . Alfa shall have the right to obtain a license (the Salix Designated Indication License ) under the Salix Technology Rights, Salixs rights in the Other Forms Claims of the [*] Patent Family, and Salixs rights in the Joint Technology Rights to Exploit (but not to Manufacture or have Manufactured) a Rifaximin Product that constitutes a Salix Licensed Product and includes the [*] Formulation or an Other New Formulation for one Existing Indication or New Indication to be chosen by Salix in its sole and absolute discretion and designated by notice from Salix to Alfa (the Salix Designated Indication ) within the Field in the Alfa Territory for compensation to be agreed upon by the Parties as set forth in Section 4.2.2(b) - (d). Salix shall have the right, but not the obligation, except as described below, to present a Salix Designated Indication Product to Alfa for licensing pursuant to this Section 4.2.2. Salix has initially selected a product having the [*] Formulation and to be Developed for a Salix Designated Indication still to be designated to license to Alfa as the Salix Designated Indication Product. Once Salix designates the Salix Designated Indication Product, which it shall do by written notice to Alfa, it may, subject to the terms of this Section 4.2.2 (but it is not required to), substitute a different Salix Designated Indication Product for the first Salix Designated Indication Product, but may do so only one time. For clarification, in connection with any such substitution, Salix may, at the time it makes the substitution, select either (a) a substitute Salix Designated Indication Product with a different formulation of the Compound (so long as it is an Other New Formulation) for the same indication as the original Salix Designated Indication Product, (b) a substitute Salix Designated Indication Product that has the same formulation of the Compound as the original Salix Designated Indication Product but is for a different indication in the Field, or (c) a substitute Salix Designated Indication Product with a different formulation of the Compound (so long as it is an Other New Formulation) and for a different indication within the Field. Once Salix designates a second Salix Designated Indication Product, it may not subsequently change the formulation of the Compound of the Salix Designated Indication Product or the indication it is directed at. If Salix carries out Development work with respect to a Salix Licensed Product that it has initially designated as the Salix Designated Indication Product
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through the Completion of Phase II Clinical Trials, then Salix may upon such Completion of Phase II Clinical Trials either (a) present the Salix Designated Indication Product to Alfa for licensing pursuant to this Section 4.2.2 and deliver to Alfa the information required under Section 4.2.2(a) or (b) opt not to present such Salix Designated Indication Product for licensing to Alfa. If Salix abandons the Development of the first Salix Designated Indication Product prior to the Completion of Phase II Clinical Trials, it shall have no obligation to present such first Salix Designated Indication Product to Alfa for licensing under this Section 4.2.2. If Salix designates a second Salix Designated Indication Product to replace the first Salix Designated Indication Product, it shall notify Alfa in writing of such designation, and Salix must present such second Salix Designated Indication Product to Alfa for licensing under this Section 4.2.2 on the earlier of Completion of Phase II Clinical Trials or the abandonment by Salix of Development of such second Salix Designated Indication Product. In connection with any such presentation, Salix shall deliver to Alfa such information as Alfa may reasonably request in order to enable Alfa to assess its interest in obtaining the Salix Designated Indication License, including the information required under Section 4.2.2(a) if Phase II Clinical Trials have been completed for the second Salix Designated Indication Product. For clarity, Alfas rights to Other New Formulations and the [*] Formulation (excluding rights to the Salix Designated Indication Product) shall be governed by Section 4.2.3. Salix shall notify Alfa in writing promptly upon the occurrence of any of the following: (a) its selection of the indication that will be the Salix Designated Indication, (b) its selection of the Salix Designated Indication Product, (c) its substitution of an alternative Salix Designated Indication Product and its substitution, if any, of a different Salix Designated Indication; (d) any decision by Salix to abandon the Development of the [*] Formulation; and (e) if the [*] Formulation is abandoned, Salixs designation of an Other New Formulation to license under this Section 4.2.2. The following procedures shall be applied to the Salix Designated Indication Product:
(a) Information Delivery . Upon the Completion of Phase II Clinical Trials for the Salix Designated Indication Product, Salix shall deliver to Alfa such information regarding the Salix Designated Indication and Salix Designated Indication Product as Alfa may reasonably request in order to enable Alfa to assess its interest in obtaining a license to the Salix Designated Indication Product; provided, however , that as provided above in this Section 4.2.2, Salix may elect not to present its initial Salix Designated Indication Product to Alfa upon the Completion of Phase II Clinical Trials, and in such case would not have to provide the information required by this Section 4.2.2(a) with regard to the initial Salix Designated Indication Product. Such information shall include, but not be limited to, Phase II Clinical Data of the same type and having substantially the same level of detail of information that Alfa provided to Salix with respect to Crohns disease and the Crohns EIR Product prior to the Amendment Effective Date. If Salix designates a second Salix Designated Indication Product in replacement for the first Salix Designated Indication Product as described above, then Salix shall deliver to Alfa such information regarding such Salix Designated Indication and Salix Designated Indication Product as Alfa may reasonably request in order to enable Alfa to assess its interest in obtaining the Salix Designated Indication License for such second Salix Designated Indication Product upon the earlier of the Completion of Phase II Clinical Trials for such second Salix Designated Indication Product and the abandonment by Salix of the Development of such second Salix Designated Indication Product.
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(b) Alfa Option . Alfa shall have the option to choose to negotiate for an exclusive license under the Salix Technology Rights, Other Forms Claims of the [*] Patent Family and Salixs rights in the Joint Technology Rights to Exploit (but not to Manufacture or have Manufactured) the Salix Designated Indication Product within the Field in the Alfa Territory, or to reject the offer. Alfa shall exercise its option by delivering written notice to Salix not later than [*] days after Alfas receipt of all of the information it reasonably requests regarding the Salix Designated Indication and the Salix Designated Indication Product pursuant to Section 4.2.2(a). If Alfa does not exercise the option within such time period, then so long as Salix had provided Alfa with the information required under Section 4.2.2(a), including Phase II Clinical Data of the same type and having substantially the same level of detail of information that Alfa provided to Salix with respect to Crohns disease and the Crohns EIR Product prior to the Amendment Effective Date, Salix shall be free to license the Salix Designated Indication Product to a Third Party for Exploitation in the Field in the Alfa Territory, or to itself Exploit the Salix Designated Indication Product in the Field in the Alfa Territory, subject to the terms of this Agreement. If Alfa exercises the option, then the Parties shall use good faith efforts to agree on the terms of the Salix Designated Indication License, including the compensation payable by Alfa to Salix, a development plan setting forth in reasonable detail the specific activities to be performed by each Party with respect to the Development of the Salix Designated Indication Product, and Alfas diligence obligations with respect to the Exploitation of the Salix Designated Indication Product within the Field in the Alfa Territory. In determining the compensation payable by Alfa to Salix for, and other terms of, the Salix Designated Indication License, the Parties shall [*] (the Valuation Principles ). In addition, in the case where Alfa had been independently Developing an Other New Formulation that is included in the Salix Designated Indication Product prior to Salixs presentation of the Salix Designated Indication Product for licensing to Alfa, [*]. Furthermore if Salix abandons the Development of the first Salix Designated Indication Product and selects an alternate Salix Designated Indication Product, [*].
(c) Third Party Evaluation . As part of the process described in Section 4.2.2(b), or if the Parties cannot otherwise agree on the compensation payable to Salix by Alfa for, and other terms of, the Salix Designated Indication License, the Parties shall engage [*], or another independent Third Party mutually agreed by both Alfa and Salix, to provide an evaluation of the market potential of the Salix Designated Indication Product, and an estimate or range of potential licensing terms by applying the Valuation Principles. The Parties shall share the fees and expenses of any Third Party providing an evaluation and other services pursuant to this Section 4.2.2 equally.
(d) Dispute Resolution . The Parties shall use the Third Party evaluation provided for in Section 4.2.2(c), if one is obtained, as a frame of reference for negotiating compensation payable by Alfa to Salix for, and other terms of, the license for the Salix Designated Indication Product, including applying the Valuation Principles. During a period of [*] days following receipt of such evaluation, the Parties shall use good faith efforts to
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reach agreement on the compensation payable by Alfa to Salix for, and other terms of, the license to the Salix Designated Indication Product. If the Parties so agree, such independent Third Party may also help facilitate the Parties in reaching agreement on the compensation payable by Alfa to Salix and other terms of the proposed license. If the Parties are unable to resolve the matter within such [*] day period, or if the Parties cannot reach agreement on the license terms and do not agree to engage the services of a Third Party pursuant to Section 4.2.2(c), then the Parties shall submit the matter for resolution by arbitration pursuant to the procedures set forth in Section 18.2. In any such arbitration, each Party shall submit to the arbitrators what it considers to be the appropriate compensation to be paid to Salix by Alfa for, and other terms of, the Salix Designated Indication License, and in so doing shall apply the Valuation Principles, and give consideration to the terms of the Crohns EIR License and the [*] Report. The Parties shall provide the Valuation Principles and the [*] Report to the arbitrator, and a copy of the relevant provisions of this Agreement setting out the principles on which the compensation for the Salix Designated Indication License is based. The Parties shall jointly instruct the arbitrator to select between their two submissions, and in so doing to select the submission that most closely applies the Valuation Principles.
4.2.3 [*] / Other New Formulation License for Existing Indications and New Indications .
(a) License Grant . Subject to the terms and conditions of this Agreement, Salix hereby grants to Alfa an exclusive (including with respect to Salix and its Affiliates), non-transferable (save as provided herein), royalty-bearing license (with the right to sublicense as set forth herein) under the Salix Technology Rights (including those pertaining to the [*] Formulation and Other New Formulations), Salixs rights in the Other Forms Claims of the [*] Patent Family, and Salixs rights in the Joint Technology Rights to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products for Existing Indications and New Indications within the Field in the Alfa Territory, excluding the Salix Designated Indication Product (collectively, the [*] / Other New Formulation License ). Notwithstanding the foregoing, if Alfa elects not to exercise its option to take a license to the Salix Designated Indication Product as contemplated in Section 4.2.2, then the [*]/ Other New Formulation License shall terminate, unless the Salix Designated Indication Product presented by Salix to Alfa for licensing under Section 4.2.2 was abandoned by Salix prior to the Completion of Phase II Clinical Trials, or if the data made available to Alfa by Salix with respect to such Salix Designated Indication Product did not include Phase II Clinical Data a comparable to the Phase II Clinical Data regarding the Crohns EIR Product made available by Alfa to Salix, in which case the license granted under this Section 4.2.3 shall not terminate and shall continue in accordance with the terms set forth herein regardless of whether Alfa exercises its right to take a license to the Salix Designated Indication Product.
(b) Consideration . The consideration payable by Alfa to Salix for the [*]/ Other New Formulation License shall consist of royalties in an amount to be mutually agreed
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by the Parties; provided that in no event shall [*]; and provided , further, that if Salix presents the Salix Designated Indication Product to Alfa for licensing under Section 4.2.2 prior to Completion of Phase II Clinical Trials and Alfa elects not to take the Salix Designated Indication License, then the applicable royalty rate under this Section 4.2.3(b) shall be mutually agreed by the Parties but [*]. If Alfa desires to Commercialize a Salix Licensed Product covered by Salix Technology Rights, Salixs rights in the Other Forms Claims of the [*] Patent Family, or Salixs rights in the Joint Technology Rights, in each case relating to the [*] Formulation or Other New Formulation (except for the Salix Designated Indication Product, which is governed by Section 4.2.2), Alfa shall deliver a written notice to Salix. During a period of [*] days following Salixs receipt of such notice, the Parties shall use good faith efforts to reach agreement on the royalty rate applicable to such indication. If the Parties are unable to agree on the terms for such royalties during such [*] day period, the matter shall be referred to a Third Party consultant, such as [*], who shall make recommendations and assist the Parties in attempting to resolve the matter for an additional period of [*] days from the date such Third Party is engaged, or such longer period as the Parties may agree upon. The Parties shall share the fees and expenses of any Third Party providing recommendations and other services pursuant to this Section 4.2.3 equally. If the Parties are unable to resolve the matter within such additional period, it shall be resolved by arbitration pursuant to the procedures set forth in Section 18.2. In any such arbitration, the Parties shall provide to the arbitrator a copy of the relevant provisions of this Agreement setting out the principles on which the royalty rate for the [*]/ Other New Formulation License is to be based, and each Party each Party shall submit to the arbitrators what it considers to be an appropriate royalty rate for the [*]/ Other New Formulations License for the specific indication subject to the parameters described in the first sentence of this Section 4.2.3(b). The Parties shall jointly direct the arbitrators to select which of the two submitted rates it determines to be closest to fair market value for the [*]/ Other New Formulations License for the specific indication. Alfa shall not Commercialize a Salix Licensed Product covered by Salix Technology Rights, Salixs rights in the Other Forms Claims of the [*] Patent Family, or Salixs rights in the Joint Technology Rights, in each case relating to the [*] Formulation or Other New Formulation of the Compound for an Existing Indication or New Indication (except for the Salix Designated Indication Product, which is governed by Section 4.2.2), unless and until the consideration payable by Alfa to Salix for the [*] / Other New Formulation License in respect of such Salix Licensed Product has been determined in accordance with the provisions of this Section 4.2.3(b).
(c) Manufacturing License to Alfa . If Alfa exercises its option under Section 4.2.2(b) to take a license to the Salix Designated Indication Product, Salix shall grant to Alfa a license under Salix Technology Rights to Manufacture and have Manufactured Rifaximin Products containing the [*] Formulation (or Other New Formulation, as the case may be), of the same type and scope as the manufacturing rights granted to Salix in the EIR Supply Agreement and having the same restrictions. The provisions of this Section 4.2.3(c) are not intended to limit or qualify the provisions of Section 4.2.1(b).
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4.2.4 Salix Sublicense to Alfa under [*] License Agreement . Effective upon the Amendment Effective Date, Salix hereby grants to Alfa and Alfa hereby accepts an exclusive sublicense under the licenses granted by [*] to Salix pursuant to the [*] License Agreement to Exploit Rifaximin Products in the [*] Territory (a) within [*] but outside [*]; and (b) within [*]. In compliance with the terms of the [*] License Agreement, Alfa hereby agrees to comply with, and not exceed the scope of, the terms and conditions of the [*] License Agreement and acknowledges that the provisions of this Section 4.2.4, and the sublicenses and other rights granted by Salix to Alfa hereunder, are in all respects subject to and limited by the provisions of the [*] License Agreement. Alfa agrees to make, for and on behalf of Salix, all payments required to be made by Salix to [*] under the [*] License Agreement to the extent the same are attributable to the Exploitation by Alfa of the rights sublicensed by Salix to it under this Section 4.2.4 and further agrees to cooperate with Salix in respect of the determination, reporting, and verification of all such amounts, both as between Salix and Alfa and as between Salix and [*], and to comply with the provisions of Section [*] of the [*] License Agreement in respect of the keeping of appropriate records and [*] right to inspect the same. Alfa shall be entitled to deduct from royalties it is otherwise required to payable to Salix under this Agreement an amount equal to the payments made by Alfa to [*] on behalf of Salix under this Section 4.2.4.
4.2.5 Trademark Licenses to Alfa .
(a) [*] Trademark License . Salix, in consultation with Alfa, shall select the trademark for the Salix Designated Indication Product (the Salix Designated Indication Trademark ) and the trademarks for all other Salix Licensed Products having the [*] Formulation or an Other New Formulation ( Other New Formulation Products ) to be used in the Alfa Territory within the Field (the Other New Formulation Trademarks ). Such trademarks shall be owned by Salix.
(b) Trademark License Agreement (Salix to Alfa) . Simultaneously with the execution of this Agreement, Salix shall, or shall cause its relevant Affiliate(s) to, enter into a trademark license agreement with Alfa pursuant to which Salix (or its Affiliate(s)) shall grant to Alfa an exclusive (and sublicensable) license to use and exploit the Salix Designated Indication Trademark and the Other New Formulation Trademarks in the Alfa Territory in connection with the Exploitation of the Salix Designated Indication Product and the Other New Formulation Products, respectively, within the Field only (the Trademark License Agreement (Salix to Alfa) ).
(c) Ownership of Licensed Marks . Alfa acknowledges and agrees that Salix shall have and retain full and complete ownership of the Salix Licensed Trademarks during the entire term of this Agreement.
4.2.6 Sublicense Rights; Further Rights of Reference . The rights and licenses granted by Salix to Alfa under this Section 4.2 and Section 9.2.2 shall include the right to grant sublicenses (or further rights of reference) through multiple tiers of Sublicensees, subject to the following:
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(a) The terms of any such sublicense or further right of reference shall be in accordance with the terms and conditions of this Agreement. With regard to all sublicenses granted by Alfa pursuant to the rights granted to it by Salix under this Agreement, (i) Alfa may not grant to any Sublicensee any right to maintain Salix Licensed Patents, defend claims brought by Third Parties that the Exploitation of Salix Technology Rights infringes the Third Partys Intellectual Property Rights, or commence any legal action against any Third Party for infringement of Salix Licensed Patents and (ii) Alfa shall notify Salix not later than [*] Business Days after such sublicense is executed, identifying the Sublicensee and the territory and scope of the rights granted to the Sublicensee. A list of all existing sublicenses granted by Alfa to Salix Technology Rights is set forth as Exhibit J;
(b) Notwithstanding the grant of any such sublicense of further rights of reference hereunder, Alfa shall remain solely responsible to Salix for the performance of its obligations under the terms hereof and for any breach of such obligations, whether such breach shall be caused by Alfa or any Sublicensee;
(c) For the avoidance of doubt it is hereby acknowledged that the appointment by Alfa of any distributor for the Salix Licensed Products, any manufacturer to Manufacture Compound or Rifaximin Products to the extent permitted herein, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for the Salix Licensed Products shall not be deemed to constitute the appointment of any Sublicensee or the sublicense by Alfa of any rights hereunder; and
(d) The provisions of this Section 4.2.6, insofar as they apply to the sublicense granted by Salix to Alfa pursuant to Section 4.2.4, are limited by, and subject to, the provisions of the [*] License Agreement.
4.2.7 Third Party Sublicenses .
(a) Prior to entering into any license with a Third Party to any Patent or other Intellectual Property Rights in the Alfa Territory that pertains to the Compound for use within the Field, Salix shall use its good faith efforts to ensure that such license is sublicensable to Alfa, and if Salix obtains such a license with the Third Party, then, without limiting the scope of the licenses granted by Salix to Alfa pursuant to Sections 4.2.1 4.2.4 and Section 4.3, Salix shall, to the extent permitted to do so under such license, grant to Alfa a sublicense to such Patent or Intellectual Property Rights for the purposes set forth in this Agreement.
(b) In the event that Alfa should at any time notify Salix of its desire to enter into an agreement pursuant to which Intellectual Property Rights licensed to Salix by [*] ( [*] ), under that certain License Agreement between [*] and Salix, dated [*], as the same has been amended through the date of this Agreement, and as it may be further amended from time to time (the [*] License Agreement ), would be included as part of the Salix Technology Rights for purposes hereof, then Salix shall cooperate with Alfa in good faith to cause an appropriate agreement providing for Salix to have the right to grant such a sublicense under Salixs license
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under the [*] License Agreement to be negotiated, executed and delivered by [*], Alfa and Salix as promptly as possible following Alfas notice to Salix of its desire to enter into such an agreement and, in connection therewith, an appropriate amendment to be made by Salix and Alfa to this Agreement. Alfa acknowledges that (i) any such sublicense would be subject to, and conditioned in all respects upon, the terms and conditions of the [*] License Agreement, a copy of which has been provided by Salix to Alfa, and (ii) any agreement among [*], Alfa and Salix providing for such a sublicense would provide for consideration and other terms in respect of such sublicense and the Exploitation by Alfa, its Affiliates or its Sublicensees of Rifaximin Products pursuant thereto satisfactory to [*] and sufficient to permit Salix, without additional cost or expense to itself, to fulfill its obligations to [*] under the [*] License Agreement in respect of the sublicense and the Exploitation by Alfa or its Affiliates of Rifaximin Products pursuant thereto. For the avoidance of doubt, the provisions of Section 4.5.2 shall not apply in respect of any payment that Alfa may be required to make to Salix or [*] in respect of or in connection with any sublicense under Salixs license under the [*] License Agreement
4.3 Rights and Obligations With Respect to the [*] Patent Family .
4.3.1 Overview . The Parties have agreed to the provisions set forth in this Section 4.3 regarding U.S. Provisional Patent Application [*] filed [*] (together with any Patents that issue from such application or Patents (both U.S. and foreign) that issue from patent applications which claim priority to such application) (collectively, the [*] Patent Family ).
4.3.2 Ownership . As between the Parties, the [*] Patent Family shall be owned by Salix. The provisions of this Section 4.3.2 do not in any way modify or negate the respective rights and obligations of the Parties in respect of the [*] Patent Family for which provision is otherwise made in this Agreement.
4.3.3 Salix Grant of License to Alfa [*] Claims .
(a) Salix hereby grants to Alfa an exclusive, non-transferable, royalty-free, fully paid-up license (with the right to sublicense as set forth herein) under Salixs rights in the [*] Claims of the [*] Patent Family to Exploit Rifaximin Products (i) within the Field in the Alfa Territory and (ii) outside the Field on a worldwide basis (the [*] License ).
(b) The rights and licenses granted by Salix to Alfa under Section 4.3.3(a) shall include the right to grant sublicenses through multiple tiers of Sublicensees, subject to the following:
(i) The terms of any such sublicense shall be in accordance with the terms and conditions of this Agreement and shall be subject to the prior approval of Salix, such approval not to be unreasonably withheld or delayed;
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(ii) Notwithstanding the grant of any such sublicense hereunder, Alfa shall remain solely responsible to Salix for the performance of its obligations under the terms hereof and for any breach of such obligations, whether such breach shall be caused by Alfa or any Sublicensee; and
(iii) For the avoidance of doubt it is hereby acknowledged that the appointment by Alfa of any distributor for Rifaximin Products, any manufacturer to Manufacture Compound or Rifaximin Products, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for Rifaximin Products shall not be deemed to constitute the appointment of any Sublicensee or the sublicense by Alfa of any rights hereunder.
(c) Alfa shall cooperate with all reasonable requests by Salix for assistance or cooperation with regard to the [*] Patent Family, including consultation or assistance in connection with the prosecution of Patents, defense of challenges to Patents, or actions taken by Salix against Third Parties that infringe Salix Patents, in each case, relating to the [*] Patent Family. If Salix requests any such assistance or cooperation from Alfa, Salix shall reimburse Alfa on request for its reasonable expenses incurred in connection with such matters.
(d) The [*] License shall survive the termination of this Agreement for any reason.
(e) Alfas [*] Application is [*] in the United States Patent and Trademark Office with claims [*]. Regarding this patent application the Parties agree as follows:
(i) Following the Amendment Effective Date, Alfa shall [*] of the [*] Application as set forth in Section 11.2.2; and
(ii) Salix shall pay to Alfa royalties on Net Sales of Rifaximin Products containing [*] of the Compound by Salix or its Affiliates, licensees or Sublicensees whether within or outside the Field and anywhere in the world (and for purposes of the definition of Net Sales as used in this Section 4.3.3(e)(ii), a Rifaximin Product containing [*] of the Compound shall be treated as an Alfa Licensed Product without regard to whether the Rifaximin Product containing [*] of the Compound [*], [*] an Alfa Technology Right or Joint Technology Right). The applicable royalty rate on Net Sales of Rifaximin Product containing [*] of the Compound within the Field shall be based on the indication for which the Rifaximin Product containing the [*] of the Compound is approved and shall be [*] the royalty rate that is set forth in the Section from among Sections 4.1.1 4.1.4 that addresses the corresponding indication. For the avoidance of doubt, royalties payable with respect to a Rifaximin Product containing [*] of the Compound under this Section 4.3.3(e)(ii) shall be [*] with royalties payable with respect to the relevant Rifaximin Product under Sections 4.1.1 4.1.4. With respect to sales of Rifaximin Products containing [*] of the Compound outside the Field, the Parties shall act in good faith to agree upon the applicable royalty rate. If the Parties are unable to agree on the royalty rate, the matter shall be referred to a Third Party
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consultant, such as [*], who shall make recommendations and assist the Parties in attempting to resolve the matter for an additional period of [*] days from the date such Third Party is engaged, or such longer period as the Parties may agree upon. The Parties shall share the fees and expenses of any Third Party providing recommendations and other services pursuant to this Section 4.3.3(e)(ii) equally. If the Parties are unable to resolve the matter within such additional period, it shall be resolved by arbitration pursuant to the procedures set forth in Section 18.2. In any such arbitration each Party shall submit to the arbitrators what it considers to be an appropriate royalty rate. The Parties shall jointly direct the arbitrators to select which of the two submitted rates it determines to be closest to [*] for sales of Rifaximin Products containing [*] of the Compound outside the Field. The term of such royalty payment to Alfa for sales by Salix or any of its Affiliates, licensees or Sublicensees of Rifaximin Products containing [*] of the Compound shall expire on a product-by-product and country-by-country basis on the earlier of (A) [*] and (B) the date of the [*] by a Person other than Salix or its Affiliates or Sublicensees in the country of a Prescription Competitive Generic Product in respect of such Rifaximin Product containing [*] of the Compound (and for purposes of the definition of Prescription Competitive Generic Product, as used in this Section 4.3.3(e)(ii), a Rifaximin Product containing [*] of the Compound shall be treated as an Alfa Licensed Product [*] to whether the Rifaximin Product containing [*] of the Compound is [*], [*] an Alfa Technology Right or Joint Technology Right). Notwithstanding the foregoing, this Section 4.3.3(e)(ii) shall not limit any payments due to Alfa for use by Salix of Alfa Know-How as stated elsewhere in this Agreement. The rights granted to Alfa under this Section 4.3.3(e)(ii) shall survive the termination of this Agreement.
(iii) Royalty payments under this Section 4.3.3(e) are subject to the royalty reduction set forth in Section 4.4.1(b) (and for that purpose, (A) all Rifaximin Products that are subject to this Section 4.3.3(e) shall be treated (including for purposes of the definition of Prescription Competitive Product) as if they were Alfa Licensed Products without regard to whether such Rifaximin Product is [*], [*] an Alfa Technology Right or Joint Technology Right and (B) in order to determine the amount of royalty reduction the references in the last sentence of Section 4.4.1 and the proviso clause immediately preceding it shall be deemed to include a reference to Section 4.4.3(e)(ii)).
4.3.4 Further Licenses by Salix . Salixs right to transfer the [*] Patent Family, or license its rights therein, to a Third Party shall be subject to the following:
(a) The terms of any such transfer or license shall be in accordance with the terms and conditions of this Agreement and shall be subject to the prior approval of Alfa, such approval not to be unreasonably withheld or delayed;
(b) Notwithstanding any such transfer or license, Salix shall remain solely responsible to Alfa for the performance of its obligations under the terms hereof and for any breach of such obligations, whether such breach shall be caused by Salix or any transferee or licensee; and
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(c) For the avoidance of doubt it is hereby acknowledged that the appointment by Salix of any distributor for Rifaximin Products, any manufacturer to Manufacture Compound or Rifaximin Products, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for Rifaximin Products shall not be deemed to constitute a transfer or license by Salix of its rights in the [*] Patent Family.
4.4 Royalty Step-Down .
4.4.1 Royalties Payable by Salix . The royalty rates applicable to Net Sales by Salix, its Affiliates and Sublicensees pursuant to Sections 4.1.2 and 4.1.4 with respect to a particular Crohns EIR Product or Alfa Licensed Product in a particular country shall be reduced:
(a) by [*] percent ([*]%) during any period in which there are both (i) no Valid Claims of any Alfa Licensed Patent or Joint Patent that would be infringed by the Exploitation of such Crohns EIR Product or Alfa Licensed Product in such country in the absence of the license grants under Section 4.1 and, in addition, (ii) no Regulatory Exclusivity in favor of Salix in respect of such Crohns EIR Product or Alfa Licensed Product in such country, or, in the alternative ,
(b) by the following amounts:
(i) by [*] percent ([*]%) if, following the first commercial sale (by a Third Party (other than Salixs Sublicensees)) in such country of a product that constitutes a Prescription Competitive Product with respect to such Crohns EIR Product or Alfa Licensed Product, aggregate quarterly commercial sales of units of the Crohns EIR Product or Alfa Licensed Product in such country (as determined by a reliable data source that is mutually agreed by the Parties by mutual written consent) in any [*] consecutive calendar quarters during the first [*] years following such first commercial sale in such country of such Prescription Competitive Product are less than [*] percent ([*]%) of the average aggregate quarterly commercial sales of units of the Crohns EIR Product or Alfa Licensed Product in such country for the [*] calendar quarters immediately preceding such first commercial sale in such country of a product that constitutes a Prescription Competitive Product with respect to such Crohns EIR Product or Alfa Licensed Product; and
(ii) by an additional [*] percent ([*]%) if, following the first commercial sale (by a Third Party (other than Salixs Sublicensees)) in such country of a product that constitutes a Prescription Competitive Product with respect to such Crohns EIR Product or Alfa Licensed Product, aggregate quarterly commercial sales of units of the Crohns EIR Product or Alfa Licensed Product in such country (as determined by a reliable data source that is mutually agreed by the Parties by mutual written consent)in any [*] consecutive calendar quarters during the first [*] years following such first commercial sale in such country of such Prescription Competitive Product are less than [*] percent ([*]%) of the average aggregate quarterly commercial sales of units of the Crohns EIR Product or Alfa Licensed Product in such
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country for the [*] calendar quarters immediately preceding such first commercial sale in such country of a product that constitutes a Prescription Competitive Product with respect to such Crohns EIR Product or Alfa Licensed Product;
provided that in no event shall the total royalty reduction for any Crohns EIR Product or Alfa Licensed Products pursuant to this Section 4.4.1 exceed [*] percent ([*]%) of the royalties otherwise payable by Salix to Alfa pursuant to Section 4.1.2(b)(iv) or 4.1.4(b), as applicable. In order to account for any reduction of royalties for a country made pursuant to this Section 4.4.1, the royalty rates on Net Sales in such country that are applicable pursuant to Section 4.1.2(b)(iv) or 4.1.4(b), as applicable, shall be reduced by the appropriate percentage as specified in this Section 4.4.1.
4.4.2 Royalties Payable by Alfa . The royalty rates applicable to Net Sales by Alfa, its Affiliates and Sublicensees pursuant to Section 4.2.2 and Section 4.2.3 with respect to a particular Salix Licensed Product, in a particular country shall be reduced:
(a) by [*] percent ([*]%) during any period in which there are both (i) no Valid Claims of any Salix Licensed Patent, Other Forms Claim of the [*] Patent Family, or Joint Patent that would be infringed by the Exploitation of such Salix Licensed Product in such country in the absence of the license grants under Section 4.2 and, in addition, (ii) no Regulatory Exclusivity in favor of Alfa in respect of such Salix Licensed Product in such country, or, in the alternative ,
(b) by the following amounts:
(i) [*] percent ([*]%) if, following the first commercial sale (by a Third Party (other than Alfas Sublicensees)) in such country of a product that constitutes a Prescription Competitive Product with respect to such Salix Licensed Product, aggregate quarterly commercial sales of units of the Salix Licensed Product in such country (as determined by a reliable data source that is mutually agreed by the Parties by mutual written consent)in any [*] consecutive calendar quarters during the first [*] years following such first commercial sale in such country of such Prescription Competitive Product are less than [*] percent ([*]%) of the average aggregate quarterly commercial sales of units of the Salix Licensed Product in such country for the [*] calendar quarters immediately preceding such first commercial sale in such country of a product that constitutes a Prescription Competitive Product with respect to such Salix Licensed Product; and
(ii) by an additional [*] percent ([*]%) if, following the first commercial sale (by a Third Party (other than Alfas Sublicensees)) in such country of a product that constitutes a Prescription Competitive Product with respect to such Salix Licensed Product, aggregate quarterly commercial sales of units of the Salix Licensed Product in such country (as determined by a reliable data source that is mutually agreed by the Parties by mutual written consent) in any [*] consecutive calendar quarters during the first [*] years following such first
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commercial sale in such country of such Prescription Competitive Product are less than [*] percent ([*]%) of the average aggregate quarterly commercial sales of units of the Salix Licensed Product in such country for the [*] calendar quarters immediately preceding such first commercial sale in such country of a product that constitutes a Prescription Competitive Product with respect to such Salix Licensed Product;
provided that in no event shall the total royalty reduction for any Salix Licensed Products pursuant to this Section 4.4.2 exceed [*] percent ([*]%) of the royalties otherwise payable by Alfa to Salix pursuant to Section 4.2.2 or Section 4.2.3, as applicable. In order to account for any reduction of royalties for a country made pursuant to this Section 4.4.2, the royalty rates on Net Sales in such country that are applicable pursuant to Section 4.2.2 or Section 4.2.3, as applicable, shall be reduced by the appropriate percentage as specified in this Section 4.4.2.
4.5 Third Party Licenses Required for Exploitation of the Compound or Rifaximin Products .
4.5.1 Salixs Exploitation of the Compound or Rifaximin Products . In the event that [*], then Salix shall inform Alfa of Salixs desire to negotiate a license from the Third Party for the Salix Territory. Salix and Alfa shall then consider and discuss in good faith the terms that would be acceptable to Salix for a license for the Salix Territory. To the extent the Parties determine that such a license need cover only matters relating to the Exploitation of Alfa Licensed Products or Crohns EIR Products by Salix or its Affiliates or Sublicensees in the Field in the Salix Territory, then Salix (or its Affiliates or Sublicensees) shall have the first right, but not the obligation, to take the lead in negotiating the terms of an appropriate license from such Third Party, provided that if Salix (or its Affiliates or Sublicensees) does not take such lead, then Alfa may do so. To the extent the Parties determine that such a license should cover matters relating to the Exploitation of Rifaximin Products outside the Field or in the Alfa Territory, then the Parties shall in good faith develop a strategy for obtaining such a license, the manner in which such license should be negotiated, and the Party that should take the lead in negotiating such license. In such case, if the Parties cannot agree then Alfa shall have the right, but not the obligation, to take the lead in negotiating the terms of an appropriate license from the Third Party, and if Alfa chooses not to do so then Salix may not take any such action without Alfas consent. The negotiation of such license by either Salix or Alfa shall be subject to consultation with the other Party, with regard to the structuring and negotiation of such license and to the other Partys consent prior to entering into such license (such consent not to be unreasonably withheld or delayed) if such a license affects the Field and the other Partys territory. Alfa shall not interfere with the acquisition by Salix of a license from a Third Party limited to the Salix Territory, unless such license adversely affects Alfas interest in Rifaximin Products for the Field in the Alfa Territory, in which case Alfas prior written consent shall be required. Salix shall be entitled to deduct from royalties otherwise payable to Alfa under Sections 4.1.1 4.1.4 and Section 4.3.3 an amount equal to [*] percent ([*]%) of the amount of royalties and other payments (including milestone payments) that Salix is required to make to the Third Party under
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such license in respect of the Exploitation by Salix or its Affiliates or Sublicensees of Crohns EIR Products or Alfa Licensed Products in the Field in the Salix Territory, subject to a quarterly cap of [*] percent ([*]%) of the royalties otherwise payable by Salix to Alfa under Sections 4.1.1 4.1.4 and Section 4.3.3, with any excess to be carried forward to subsequent quarters.
4.5.2 Alfas Exploitation of the Compound or Rifaximin Products . In the event that [*], then Alfa shall inform Salix of Alfas desire to negotiate a license from the Third Party for the Alfa Territory. Salix and Alfa shall then consider and discuss in good faith the terms that would be acceptable to Alfa for a license for the Alfa Territory. To the extent the Parties determine that such a license need cover only matters relating to the Exploitation of Salix Licensed Products by Alfa or its Affiliates or Sublicensees in the Field in the Alfa Territory, then Alfa (or its Affiliates or Sublicensees) shall have the first right, but not the obligation, to take the lead in negotiating the terms of an appropriate license from such Third Party, provided that if Alfa (or its Affiliates or Sublicensees) does not take such lead, then Salix may do so. To the extent the Parties determine that such a license should cover matters relating to the Exploitation of Rifaximin Products in the Field in the Salix Territory, then the Parties shall in good faith develop a strategy for obtaining such a license, the manner in which such license should be negotiated, and the Party that should take the lead in negotiating such license. In such case, if the Parties cannot agree then Salix shall have the right, but not the obligation, to take the lead in negotiating the terms of an appropriate license from the Third Party, and if Salix chooses not to do so then Alfa may not take any such action without Salixs consent. The negotiation of such license by either Salix or Alfa shall be subject to consultation with the other Party, with regard to the structuring and negotiation of such license, and to the other Partys consent prior to entering into such license (such consent not to be unreasonably withheld or delayed) if such license affects the Field and the other Partys territory. Salix shall not interfere with the acquisition by Alfa of a license from a Third Party limited to the Alfa Territory, unless such license adversely affects Salixs interest in Rifaximin Products for the Field in the Salix Territory, in which case Salixs prior written consent shall be required. Alfa shall be entitled to deduct from royalties otherwise payable to Salix under Sections 4.2.2 and 4.2.3 an amount equal to [*] percent ([*]%) of the amount of royalties and other payments (including milestone payments) that Alfa is required to make to the Third Party under such license in respect of the Exploitation by Alfa or its Affiliates or Sublicensees of Salix Licensed Products outside the Field or in the Alfa Territory, subject to a quarterly cap of [*] percent ([*]%) of the royalties otherwise payable by Alfa to Salix under Sections 4.2.2 and 4.2.3, with any excess to be carried forward to subsequent quarters.
4.6 Royalty Reports . Within [*] days of the end of each calendar quarter (such quarters to end on the last days of March, June, September and December in each Calendar Year), each Licensee shall submit to the other Party (the Licensor ) a written report setting out the details of all of its Net Sales in such calendar quarter that are subject to a royalty under this Agreement. Such report shall include a calculation of the Net Sales and the royalties payable thereon. Following receipt of such report, the Licensor shall
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issue to the Licensee an invoice for the amount of royalties set forth in the Licensees report, plus all applicable taxes, including VAT, if any. Invoices shall be due and payable not later than [*] days after receipt of such invoice by the Licensee. In the event that any payment due hereunder (whether an initial up front license fee, milestone payments or royalties) shall not be paid by the due date, then such payment shall from the due date until the actual date of payment bear interest at the annual rate of [*] percent ([*]%) above the official prime rate published by [*], or, if [*] ceases to publish a prime rate, such other United States banking institution as the Parties shall agree upon. All payments to be made hereunder shall be made in United States Dollars by [*] wire transfer to such bank as Alfa and Salix, respectively, shall designate in writing. Except as expressly stated in this Agreement, neither Party shall be entitled in any circumstances to withhold any money due to the other Party under the terms of this Agreement in respect of any possible (justified or unjustified) claims against the other Party related to this Agreement or any of the Related Agreements.
4.7 Taxes . All payments under this Agreement shall be made without any deduction or withholding of or on account of any tax, duties, levies, or other charges by the paying Party unless such deduction or withholding is required by applicable law to be assessed against the non-paying Party. If the paying Party is so required to make any deduction or withholding from payments due to the non-paying Party, the paying Party shall (a) promptly notify the non-paying Party of such requirement, (b) pay to the relevant authorities on the non-paying Partys behalf the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against the non-paying Party, and (c) promptly forward to the non-paying Party an official receipt (or certified copy) or other documentation reasonably acceptable to the non-paying Party evidencing such payment to such authorities.
4.8 Records . Each Party shall, and shall cause its Affiliates and Sublicensees to, maintain during the term of this Agreement normal accounting books (in accordance with normal United States accounting practice, in the case of Salix, and normal Italian accounting practice, in the case of Alfa) containing accurate details of all sales of Crohns EIR Products and Alfa Licensed Products by Salix and its Affiliates and Sublicensees and Salix Licensed Products by Alfa and its Affiliates and Sublicensees and of the calculation of Net Sales and the royalty payments due hereunder. Alfa or Salix, respectively, shall have the right, during the term of the Agreement and for [*] following the expiration or termination of the Agreement, upon reasonable notice during normal working hours to cause qualified professional accountants of its choice to inspect the books and records and any other documentation and records maintained by Licensee or its Affiliates or Sublicensees relevant to the calculation of any royalty payable under this Agreement. The accountants shall provide a copy of their report to each Party. The cost of the above accountants inspections shall be borne by the Party requesting the inspection save only where any such inspection reveals a discrepancy in excess of [*] percent ([*]%) of royalties due and payable, in which event the costs shall be borne by the Licensee, provided that:
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4.8.1 such inspection shall not take place more than [*]; and
4.8.2 such inspection shall only be in respect of records and accounts for the period of [*] years preceding the date of such inspection and the Licensee shall not be required to retain records for any period exceeding [*] years.
If any such inspection reveals that there has been an underpayment or overpayment of royalties, the Licensee shall promptly pay to the Licensor the full amount of the underpayment or the Licensor shall promptly pay to the Licensee the full amount of the overpayment, as applicable; provided, however, that if the Licensee or Licensor has a reasonable good faith objection to the calculation of the underpayment or overpayment, the Parties shall discuss the dispute in good faith and seek to reach resolution on whether there was an underpayment or overpayment of royalties, and if so, the amount of such underpayment or overpayment. If the Parties are unable to resolve such dispute, then it shall be resolved through the dispute resolution procedures set forth in Article 18.
4.9 [*] Agreement . The Parties confirm that the agreement between the Parties, dated [*], a copy of which is annexed to this Agreement as Exhibit E (the [*] Agreement ), is superseded and replaced by this Agreement, except for [*] of the [*] Agreement, which remain in full force and effect in their entirety, subject to such modification that the Parties may agree upon from time to time.
4.10 Rights Outside the Field . Subject always to (a) Salixs interest in the Salix Technology Rights, the Other Forms Claims of the [*] Patent Family and the Joint Technology, and (b) Alfas interest in the Alfa Technology Rights, the [*] Claims and the Joint Technology, and without implying any license or other grant or transfer of rights other than those explicitly set forth herein, in the Supply Agreements or in the Trademark License Agreements, except for the restriction on unauthorized sales set forth in Section 5.1, nothing set forth in this Agreement is intended to (y) place any restrictions on Alfa and its Affiliates from Exploiting the Alfa Technology Rights for any purpose outside the Field in any geographic territory or (z) place any restrictions on Salix and its Affiliates from Exploiting the Salix Technology Rights for any purpose outside the Field in any geographic territory (subject to Alfas exclusive rights granted hereunder with respect to the [*] Patent Family). Not to limit the generality of the foregoing, Salix acknowledges that Alfa has Developed or will Develop formulations of the Compound which may be useful for [*] and also [*] uses, which are outside of the Field. Salix agrees that the activities which Alfa or its licensees undertake in the fields of [*] and [*] applications do not adversely affect Salixs ability to Exploit the rights granted to it in this Agreement.
4.11 Products Approved for More Than One Indication . Except as provided in Section 4.1.2(b)(vi) with respect to Additional Crohns Products, in the event that a Licensed Product or a Crohns EIR Product is approved for more than one indication, the Parties shall use good faith efforts to
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reasonably agree on the allocation of consideration payable for such Crohns EIR Product or Licensed Product. If the Parties cannot reasonably agree on the appropriate consideration payable for such Crohns EIR Product or Licensed Product, either Party may seek final resolution of the matter through binding arbitration pursuant to the procedures set forth in Section 18.2. For clarity, a Licensed Product approved only for the Existing Indications in the Field shall not trigger the requirement that the Parties use good faith efforts to reasonably agree on the allocation of consideration payable for such Licensed Product.
Article 5
GOVERNING PRINCIPLES OF COLLABORATION BETWEEN THE PARTIES
5.1 Cooperation . The intention of the Parties is that Salix shall have exclusive rights to the Compound for the Field within the Salix Territory, and that Alfa shall have exclusive rights to the Compound for the Field within the Alfa Territory. Alfa shall not take any action to adversely affect Salixs rights. Salix shall not take any action to adversely affect Alfas rights. Not to limit the generality of the foregoing:
5.1.1 Salix shall not, and Salix shall cause its Affiliates not to, during the term of this Agreement (a) sell, offer for sale, distribute, market, Promote or supply the Compound or any Rifaximin Products, whether alone or in combination with other molecules or compounds, whether as a raw material or as a finished product, and whether at wholesale or retail, in the Alfa Territory for use within the Field, or, (b) knowingly sell or otherwise supply the Compound or any Rifaximin Products, whether alone or in combination with other molecules or compounds, whether as a raw material or as a finished product, and whether at wholesale or retail, to any Third Party that intends to sell, offer for sale, distribute, market, Promote or supply the Compound or the Rifaximin Product in the Alfa Territory for use within the Field. Salix shall refer all orders for Rifaximin Products for the Field in the Alfa Territory to Alfa. Salix confirms and acknowledges that to the extent legally enforceable, it shall use Commercially Reasonable Efforts to impose similar restrictions on its Affiliates and licensees and Sublicensees to restrict them from directly or indirectly selling, offering for sale, distributing, marketing, Promoting or supplying the Compound or Rifaximin Products to any Third Party in the Alfa Territory for use within the Field. Salix undertakes to use reasonable efforts to prevent any breach or continuation of any breach by any such Affiliate or licensee or Sublicensee of such terms. Notwithstanding the foregoing, the provisions of this Section 5.1.1 shall not apply to the Salix Designated Indication Product if Alfa elects not to obtain the Salix Designated Indication License.
5.1.2 Alfa shall not, and Alfa shall cause its Affiliates not to, during the term of this Agreement (a) sell, offer for sale, distribute, market, Promote or supply the Compound or any Rifaximin Products, whether alone or in combination with other molecules or compounds, whether as a raw material or as a finished product, and whether at wholesale or retail, for use within the Field within the Salix Territory (save only for the supply of Compound to Manufacturers located in the Salix Territory for the Manufacture of Rifaximin Products to be Commercialized in the Alfa Territory or the Manufacture of Rifaximin Products to be Exploited
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in the Salix Territory outside the Field), and (b) knowingly, sell or otherwise supply the Compound or Rifaximin Products, whether alone or in combination with other molecules or compounds, whether as a raw material or as a finished product, and whether at wholesale or retail, to any Third Party that intends to sell, offer for sale, distribute, market, Promote or supply the Compound or Rifaximin Product within the Salix Territory for use within the Field. Alfa shall refer all orders for Rifaximin Products for the Field in the Salix Territory to Salix. Alfa confirms and acknowledges that to the extent legally enforceable, it shall use Commercially Reasonable Efforts to impose similar restrictions on its Affiliates and Sublicensees to restrict them from directly or indirectly selling, offering for sale, distributing, marketing, Promoting or supplying the Compound or Rifaximin Products to any Third Party in the Salix Territory for use within the Field. Alfa undertakes to use reasonable efforts to prevent any breach or continuation of any breach by any such Affiliate, licensee or Sublicensee of such terms.
5.1.3 Subject to the terms and conditions of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.
5.2 Licenses and Export Control .
5.2.1 This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with applicable law.
5.2.2 Each Party shall procure and maintain all export and other governmental licenses and permits required for the grant to the other Party of the rights and licenses granted in Article 4, the performance of its duties set forth in Article 6, the supply to the other Party of all documentation required to be provided under Article 9 (including all Regulatory Documentation), and the supply to the other Party of all Know-How and Clinical Data required to be delivered to the other Party hereunder, and shall comply with all other laws and regulations and government directives relating to the grant of rights under the terms of this Agreement to ensure that the other Party shall be entitled to exercise the rights granted to it free of any restriction, other than the restrictions expressly set forth in this Agreement.
Article 6
PRODUCT DEVELOPMENT
6.1 General Principles . Salix and Alfa shall discuss and coordinate studies, trials and regulatory activities involving the Compound and Licensed Products, including the completion of Clinical Trials with regard to the Crohns EIR
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Product, in order to generate a package of information satisfactory to the Regulatory Authorities of both the United States and the European Union. The general operating principle shall be for each Partys activities to also benefit the other Party if possible, but at a minimum to be coordinated so as to avoid or minimize any problems, difficulties or harm to the other Party. Procedures for advance notice and regular communications regarding these activities shall be implemented. Both Parties shall (a) participate in the development of the regulatory strategy for the Crohns EIR Product and Licensed Products, (b) have the right to attend meetings with Regulatory Authorities (as provided in Sections 6.2.4(b) and 9.1.2) pertaining to the Crohns EIR Product and Licensed Products for use within the Field, and (c) discuss and coordinate all studies, Clinical Trials and regulatory activities pertaining to the Crohns EIR Product and Licensed Products for use within the Field.
6.2 Crohns EIR Product Development Plan .
6.2.1 Development Plan .
(a) The Parties acknowledge that it is their current intent to conduct the Development of the Crohns EIR Product in accordance with the development plan attached as Exhibit F (the Development Plan ). The Parties shall at all times conduct their activities in respect of the Development of the Crohns EIR Product in accordance with the Development Plan as it is then in effect. The Parties acknowledge that the Development Plan is subject to modification, in accordance with and subject to the procedures set forth in Section 6.2.1(b), following meetings with the FDA and European Union Regulatory Authorities and that the final Development Plan, as amended, shall be substituted for the version of the Development Plan that has been originally attached as Exhibit F .
(b) In the event that either Party desires any change to the Development Plan during the term of this Agreement, such Party shall provide written notice to the other Party specifying the requested change. The Parties shall consider any such change that is requested in good faith. If the Parties are unable to reach agreement on a change, the matter shall be referred to the Steering Committee for resolution; provided, however, that if the Steering Committee is unable to reach agreement on adjustments to be made to the Development Plan and a Party has such a reasonable basis to so diverge from the Development Plan, final decision-making authority regarding the Development Plan shall be governed by Section 6.2.5(f). All changes to the Development Plan, whether agreed between the Parties, approved by the Steering Committee, or effected pursuant to the final decision making authority set forth in Section 6.2.5(f), shall be set forth in a written document and shall be deemed incorporated into the Development Plan.
6.2.2 Salixs Duties . Without limiting the generality of the matters set forth in the Development Plan, Salix shall carry out the following duties with respect to the Development of the Crohns EIR Product:
(a) Salix shall use Commercially Reasonable Efforts to carry out the Development of the Crohns EIR Product in accordance with the Development Plan and may propose such adjustments to the Development Plan as may from time to time be necessary or appropriate as contemplated in Section 6.2.1.
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(b) Without limiting the provisions of Section 6.2.2(a):
(i) Salix shall use Commercially Reasonable Efforts to perform and complete (or procure the performance or completion on its behalf), at its sole expense and direction (except as otherwise herein set forth), all work, Clinical Trials and other studies and formalities necessary to complete all Phase III clinical requirements for the Crohns EIR Product and follow-up studies requested by the FDA or European Union Regulatory Authorities.
(ii) Salix shall at its sole expense and direction (except as otherwise set forth in this Agreement) use Commercially Reasonable Efforts to ensure that its Clinical Trials and studies on the Crohns EIR Product are adequate for the purposes of obtaining Regulatory Approvals for the sale and use of the Crohns EIR Product (including Marketing Approvals) from Regulatory Authorities in the European Union and shall provide Alfa with access to or copies of, as Alfa may determine, all information Controlled by Salix or its Affiliates as necessary or useful for the purpose of obtaining Regulatory Approvals for the sale and use of the Crohns EIR Product (including Marketing Approvals) from Regulatory Authorities in the European Union. For the avoidance of doubt, Alfa shall be solely responsible, at its sole expense and direction (except as otherwise herein set forth), for the preparation, filing and prosecution of NDAs, MAAs or other Regulatory Documentation with the EMA or with any other Regulatory Authority in the Alfa Territory.
(iii) Salix shall, at its sole expense and direction (except as otherwise set forth in this Agreement) use Commercially Reasonable Efforts to perform and complete all Development activities within the time periods provided for in the Development Plan, and submit all required materials with the NDA submitted to the FDA, including any further materials requested by the FDA after the initial NDA is submitted or accepted for filing.
(iv) Salix shall use Commercially Reasonable Efforts to obtain the Initial U.S. Marketing Approval for the Crohns EIR Product. Salix shall affirmatively contact the necessary personnel of the FDA to request meetings in order to facilitate all NDAs and NDA approval for the Crohns EIR Product, coordinating with Alfa as provided in Section 6.2.4.
(c) Salix shall comply with all local, state and federal laws and regulations applicable to its performance of the Development activities, including, where appropriate, cGLP and cGMP, and with all applicable regulations of the FDA and other Regulatory Authorities in jurisdictions in which Development activities are being carried out.
6.2.3 Alfas Duties .
(a) Alfa shall supply to Salix amounts of the Crohns EIR Product and placebo as reasonably needed in order for Salix to conduct the Phase III Clinical Trials provided for in the Development Plan and all other Development activities necessary for the submission of the applications and any post-submission work required by the relevant Regulatory Authorities. Such supply shall be made at no cost to Salix.
(b) Alfa shall provide to Salix all data, test results and other information pertaining to Clinical Trials and studies regarding the Crohns EIR Product which were conducted prior to the Amendment Effective Date or which may be conducted for or on behalf of Alfa in respect of the Crohns EIR Product during the term of this Agreement.
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6.2.4 Regulatory Matters .
(a) Information Exchange .
(i) Salix shall promptly inform Alfa of all developments pertaining to the United States regulatory approval process (and, if conducted by Salix, the Canadian regulatory approval process) for the Crohns EIR Product and provide to Alfa copies of [*] promptly as such materials become available to Salix. All such materials shall constitute Confidential Information of Salix and accordingly shall be subject to the provisions of Article 12. For clarification, the designation by Salix of any information as confidential which is based on or derived from source information provided by Alfa shall not result in any transfer of the ownership of or right to the underlying information from Alfa to Salix.
(ii) Alfa shall promptly inform Salix of all developments pertaining to the [*] and [*] regulatory approval process for the Crohns EIR Product and provide to Salix copies of all [*] promptly as such materials become available to Alfa. All such materials shall constitute Confidential Information of Alfa and accordingly shall be subject to the provisions of Article 12. For clarification, the designation by Alfa of any information as confidential which is based on or derived from source information provided by Salix shall not result in any transfer of the ownership of or right to the underlying information from Salix to Alfa.
(b) Attendance at Meetings with Regulatory Authorities .
(i) Alfa shall have the right, but not the obligation, to attend all meetings with the FDA, and, if any, HPFB, regarding the Crohns EIR Product.
(ii) Salix shall have the right, but not the obligation, to attend all meetings with Regulatory Authorities in [*] or [*] and, at Alfas reasonable discretion, in [*]; provided that in the case of [*], the consent of Alfas licensee in [*] will be required and Alfa shall use its good faith Commercially Reasonable Efforts to obtain such consent.
(iii) Each Party shall give the other Party at least [*] days advance written notice of the scheduling of all such meetings, or if that is not feasible, as much advance notice as is practical under the circumstances.
(iv) The rights granted to Salix under this Section 6.2.4(b) shall terminate when the Crohns EIR License terminates.
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6.2.5 Steering Committee .
(a) Formation . Within [*] days following the Amendment Effective Date, the Parties shall establish a Steering Committee (the Steering Committee ), which shall oversee and coordinate the Development of the Crohns EIR Product as contemplated by this Section 6.2.
(b) Functions . Without limiting the foregoing or any other functions the Parties agree to delegate to the Steering Committee, the Steering Committee shall:
(i) review and approve [*];
(ii) review [*];
(iii) review [*];
(iv) facilitate the exchange of [*];
(v) discuss [*];
(vi) establish [*]; and
(vii) otherwise facilitate [*].
(c) Membership . The Steering Committee shall be comprised of [*] senior representatives from each of Alfa and Salix, selected by such Party. At least [*] of each Party shall have expertise in pharmaceutical development and at least [*] of each Party shall have expertise in pharmaceutical commercialization. Each of Alfa and Salix may replace either or both of its Steering Committee representatives at any time by providing prior written notice to the other Party. Other representatives of Alfa and Salix may attend Steering Committee meetings as non-voting attendees; provided that such representatives are bound by obligations of confidentiality and non-use with respect to any Confidential Information disclosed in the course of such meetings at least as stringent as those set forth in Article 12.
(d) Meetings .
(i) Prior to the receipt of Initial U.S. Marketing Approval for the Crohns EIR Product, the Steering Committee shall meet no less than [*], and as otherwise requested by any of the Steering Committee members. Such meetings shall be conducted in person or by videoconference or teleconference; provided that at least [*] of the Steering Committee each [*] shall be conducted in person. Such in-person meetings shall [*].
(ii) Following receipt of Initial U.S. Marketing Approval for the Crohns EIR Product, the Steering Committee shall meet no less than twice in each Calendar
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Year and as otherwise requested by any of the Steering Committee members. Such meetings shall be conducted in person or by videoconference or teleconference; provided that at least [*] of the Steering Committee each Calendar Year shall be conducted in person. Such in-person meetings shall [*].
(iii) A quorum of the Steering Committee shall exist whenever there is present at or participating in a meeting at least [*] appointed by each Party.
(iv) Each Party shall bear its own personnel and travel costs and expenses relating to Steering Committee meetings.
(v) If for any reason a Steering Committee meeting is cancelled or postponed, the Steering Committee shall endeavor to meet no later than [*] days following the original date of such cancelled or postponed meeting. The Steering Committee shall follow such other administrative procedures as it may adopt for the efficient conduct of its meetings and other matters.
(e) Steering Committee Officers; Minutes . Salix shall select the chairperson of the Steering Committee, who shall convene and chair meetings of the Steering Committee. Except as otherwise provided herein, the chairperson shall have no additional powers or rights beyond those held by the other Steering Committee representatives. Alfa shall select a secretary to prepare and circulate the meeting agendas and minutes. Such minutes shall be distributed in draft form not later than [*] days following each meeting and shall be deemed accepted and effective unless the other Party has objected to the same within [*] days of its receipt of such minutes; final minutes shall be promptly distributed to the Parties.
(f) Decision-Making . The members of the Steering Committee shall endeavor to reach a consensus on all decisions within its jurisdiction. Except as set forth below, all actions, decisions or rulings of the Steering Committee with respect to the Crohns EIR Product must be made by a consensus of the members of the Steering Committee or in a writing signed by all of the members of the Steering Committee. If the members of the Steering Committee cannot agree with respect to any action, decision or ruling relating to the Crohns EIR Product within [*] days (or such shorter time as may be reasonable under the circumstances) following the day that the Steering Committee first considers such matter, then such issue shall be referred to a senior executive or board of directors member designated by each Party. Such senior executives or board of directors members shall meet for attempted resolution by good faith negotiations within [*] days after such issue is referred to them. In the event such designated senior executives or board of directors members are not able to resolve such issue within such [*]-day period, then such issue shall be finally and definitively resolved by Salix casting the deciding vote, while being guided by the principle that all Development efforts with respect to the Crohns EIR Product shall be geared towards producing a regulatory submission for the Crohns EIR Product that is satisfactory to both the FDA and Regulatory Authorities in the European Union.
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(g) Limitations on Authority . Each Party shall retain the rights, powers and discretion granted to it under this Agreement, and no such rights, powers or discretion shall be delegated to or vested in the Steering Committee unless the Parties expressly so agree in writing. The Steering Committee shall not have the power to amend, modify or waive compliance with this Agreement, which may only be amended or modified as provided in Article 20 or compliance with which may only be waived as provided in Article 22. The Steering Committee shall not have the power to determine compliance with this Agreement.
(h) Termination of Responsibilities for Crohns EIR Product . Upon the receipt of (i) the Initial U.S. Marketing Approval for the Crohns EIR Product and Marketing Approval from Regulatory Authorities of the European Union and its member countries (and Canada, if applicable), and (ii) upon receipt of confirmation from Regulatory Authorities in the United States (and Canada, if applicable) and the European Union and its member countries that the Parties have fully complied with all post-marketing requirements for the Crohns EIR Product, unless otherwise mutually agreed in writing, the Steering Committee shall no longer have the powers and responsibilities with respect to the Crohns EIR Product set forth in this Section 6.2.5 but shall serve as a general forum for Alfa and Salix to discuss global Development, Commercialization and other Exploitation of the Crohns EIR Product.
6.3 [*] Committee .
6.3.1 The Parties shall establish, not later than [*] days following the Amendment Effective Date, a [*] committee (the [*] Committee ). The [*] Committee shall be composed of the same number of members as the Steering Committee. Salix shall select the chairperson of the [*] Committee initially. Thereafter, the chairperson of the [*] Committee shall alternate between the Parties on an annual basis. Except for the power to convene and chair meetings of the [*] Committee, the chairperson shall have no additional powers or rights beyond those held by the other [*] Committee representatives. The [*] Committee may meet simultaneously with and as part of the meetings of the Steering Committee.
6.3.2 The [*] Committee shall serve as a general forum to discuss [*]. Each of the Parties shall use its Commercially Reasonable Efforts to cause the [*] Committee to function effectively and efficiently so as to [*]. For clarity, the [*] Committee shall not have the power to bind the Parties in any way nor to amend, modify or waive compliance with this Agreement. The [*] Committee shall exist only to [*].
6.4 Effect of Change of Control . In the event a Change of Control occurs, Alfa shall have the right, but not the obligation, by notice given by Alfa to Salix within [*] days following the date on which such Change of Control becomes effective, to assume control of all Development activities pertaining to the Crohns EIR Product and to make all decisions related to the Development of the Crohns EIR Product, provided that Salix, or its successor, shall continue to be responsible for the entire funding of (including reimbursing Alfa for) all expenses associated with the Development of the Crohns EIR Product but only to the extent set forth in the then most current version of the
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Development Plan agreed upon by the Parties. If, pursuant to the preceding sentence, Alfa assumes control of all Development activities pertaining to the Crohns EIR Product following a Change of Control, (a) Alfa shall consult in good faith with Salix with respect to matters addressed in Section 6.2 insofar as they relate to or could reasonably be expected to affect the Development, Manufacturing, Commercialization or other Exploitation of the Crohns EIR Product in the Salix Territory so as to make effective use of Salixs experience and expertise in respect of such matters and such work as Salix may have undertaken prior to the Change of Control in respect of such matters and (b) Salix shall cooperate with Alfa in good faith in respect of the management of all such matters.
6.5 Certain Restrictions .
6.5.1 Salix Development of EIR Formulation .
(a) Salix shall be authorized to pursue Development of the Crohns EIR Product as contemplated by the Development Plan.
(b) Salix shall be free to pursue Development work in respect of the EIR Formulation in addition to that contemplated by clause (a), but in respect of any Development work in respect of the EIR Formulation beyond that contemplated by clause (a) Salix shall consult with Alfa on an ongoing basis and coordinate any such Development work with Alfas ongoing Development activities in respect of the EIR Formulation so as to avoid duplication of effort and facilitate the Development of the EIR Formulation as viable pharmaceutical products.
6.5.2 Alfa Development of [*] Formulation . Alfa shall be free to pursue Development work in respect of the [*] Formulation or Other New Formulations; provided that notwithstanding the grant of the [*] / Other New Formulation License, Alfa shall consult with Salix on an ongoing basis and coordinate any Development work carried out by Alfa on the [*] Formulation or any Other New Formulation with Salixs ongoing Development activities in respect of the [*] Formulation or Other New Formulations, as applicable, so as to avoid duplication of effort and facilitate the Development of the [*] Formulation or Other New Formulations as viable pharmaceutical products; provided, however , that (a) if and when Alfa exercises its right to take a license to the Salix Designated Indication Product pursuant to Section 4.2.2, Alfa can exercise its right to carry out Development on the [*] Formulation or Other New Formulation, and (b) if Alfa had been conducting Development on an Other New Formulation prior to Salix identifying the Other New Formulation to Alfa pursuant to Section 4.2.2 as a Salix Designated Indication Product, then Alfa and Salix shall discuss in good faith the best manner of proceeding with the Development.
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Article 7
SUPPLY
Simultaneously with the execution of this Agreement, the Parties shall enter into Amendment Number Two to the Compound Supply Agreement and the EIR Supply Agreement.
Article 8
NEW INDICATIONS
8.1 Notification of New Indication Within the Field .
8.1.1 In the event that Alfa discovers or identifies a New Indication for Rifaximin Products within the Field, or if Salix discovers or identifies any New Indication for Rifaximin Products within the Field, such Party (the Discoverer ) shall promptly (but not later than [*] days after having made such discovery or identification) notify the other Party (the Recipient ) in writing of its discovery or identification of such New Indication. The Discoverer shall promptly provide any and all information relevant to the Field regarding the New Indication that the Recipient may reasonably request. All such information shall be treated by the Recipient as Confidential Information of the Discoverer in accordance with the provisions of Article 12. Salixs Exploitation of an Alfa Licensed Product for a New Indication (excluding the treatment, prevention or amelioration of Crohns disease) in the Salix Territory shall be governed by the provisions of Section 4.1.4 and Alfas Exploitation of a Salix Licensed Product for a New Indication in the Alfa Territory shall be governed by the provisions of Sections 4.2.1, 4.2.2 or 4.2.3, as applicable. For clarity, this Section 8.1 shall not give the Discoverer any rights to or in respect of such New Indication beyond those rights set forth in Sections 4.1.4, 4.2.1, 4.2.2, and 4.2.3, as applicable.
8.1.2 The inventor and owner of any Intellectual Property Rights related to such newly discovered or identified New Indication shall be determined pursuant to Section 11.4. Disputes regarding inventorship, ownership or validity of Intellectual Property Rights (including those related to newly discovered or identified New Indications) shall be resolved as set forth in Section 11.5.
8.2 Indications Outside the Field . There shall be no limitation on either Partys right to Exploit any indication outside the Field, either independently or in cooperation with any of its Affiliates or any Third Party, so long as such Exploitation does not infringe the Intellectual Property Rights of the other Party. If either (a) Salix desires to obtain a license to the Alfa Technology Rights for use in humans outside the Field in the Salix Territory or (b) Alfa desires to obtain a license to the Salix Technology Rights for use in humans outside the Field in the Alfa Territory, the Parties shall in good faith enter into negotiations with respect to the terms of such licenses, provided that neither Party is obligated to enter into any such arrangement.
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Article 9
REGULATORY MATTERS AND EXCHANGE OF INFORMATION AND ASSISTANCE
9.1 Regulatory Responsibilities; Attendance at Meetings . Without limiting the provisions of Section 6.2.4 in respect of the Crohns EIR Product:
9.1.1 Regulatory Responsibilities .
(a) Salix shall be responsible for dealings with the FDA and the HPFB (if applicable) with respect to Rifaximin Products within the Field. Salix shall promptly inform Alfa of all developments pertaining to the United States (and if applicable, Canadian) Regulatory Approval process (including pre-Regulatory Approval processes and all post-Regulatory Approval and regulatory maintenance activities) for Rifaximin Products in the Field.
(b) Alfa shall be responsible for dealing with Regulatory Authorities in the Alfa Territory with respect to Rifaximin Products within the Field. Alfa shall promptly inform Salix of all developments pertaining to the [*] and [*] regulatory approval process (including pre-Regulatory Approval processes and all post-Regulatory Approval and regulatory maintenance activities) for the Rifaximin Products in the Field.
9.1.2 Attendance at Meetings .
(a) Alfa shall have the right, but not the obligation, to attend all meetings with the FDA and the HPFB regarding Rifaximin Products in the Field.
(b) Salix shall have the right, but not the obligation, to attend all meetings with Regulatory Authorities in [*] or [*], and in Alfas reasonable discretion, in [*]; provided that (i) in the case of [*], the consent of Alfas licensee in [*] will be required, which consent Alfa agrees to use its good faith Commercially Reasonable efforts to obtain and (ii) in the case of meetings with Regulatory Authorities pertaining to the [*] Formulation (which for this purpose includes any variation on the [*] Formulation developed by or for Salix and licensed to Alfa pursuant to this Agreement) or any Rifaximin Products containing the [*] Formulation, Salix shall have the right, but not the obligation, to attend all meeting with Regulatory Authorities anywhere in the world.
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(c) Each Party shall give the other Party at least [*] days advance written notice of the scheduling of all such meetings, or if that is not feasible, as much advance notice as is practical under the circumstances.
(d) This Section 9.1.2 does not apply to meetings with Regulatory Authorities regarding the Crohns EIR Product, which is governed by Section 6.2.4(b).
(e) The rights granted under this Section 9.1.2 shall terminate when this Agreement terminates.
9.2 Rights of Reference; Ownership of Regulatory Documentation .
9.2.1 Alfa shall own all Regulatory Documentation on a worldwide basis for all Rifaximin Products within the Field other than the Salix Designated Indication Product and the Other New Formulation Products. Salix shall have a right of reference (with the right to grant further rights of reference through multiple tiers in accordance with Section 4.1.6) to (a) all Regulatory Documentation Controlled by Alfa (or its Affiliates or its future Sublicensees (to the extent Alfa obtains the right to share Regulatory Documentation controlled by future Sublicensees with Salix (as set forth below)) that relates to the Compound or Rifaximin Products within the Field and (b) all Regulatory Documentation relating to safety data with respect to the Compound or Rifaximin Products outside the Field Controlled by Alfa (or its Affiliates or its future Sublicensees (to the extent Alfa obtains the right to share Regulatory Documentation controlled by future Sublicensees with Salix (as set forth below)), in each case, that is necessary or useful to support any applications for Regulatory Approvals or other regulatory filings that Salix or its Affiliates or Sublicensees may make in respect of Rifaximin Products within the Field in the Salix Territory or pursuant to or in exercise of Salixs rights under this Agreement. For clarification, Alfas ownership of Regulatory Documentation pursuant to this Section 9.2.1 does not in any way affect Salixs obligations to develop Regulatory Documentation for submission to the FDA. For clarification, Salixs right of reference provided for in this Section 9.2.1 shall also apply to Regulatory Documentation Controlled by future Sublicensees of Alfa, provided that Alfa is able to obtain such rights from its Sublicensee. Alfa shall use good faith Commercially Reasonable Efforts to obtain its Sublicensees agreement to grant such rights, along with the right to sublicense to Salix such Sublicensees Know-How and Patents that are relevant to Salixs Exploitation of the licenses granted to it in this Agreement, but will not be prohibited from entering into a sublicense agreement if the prospective Sublicensee refuses to grant such rights.
9.2.2 Salix shall own all Regulatory Documentation on a worldwide basis for the Salix Designated Indication Product and the Other New Formulation Products. Alfa shall have a right of reference (with the right to grant further rights of reference through multiple tiers in accordance with Section 4.2.6) to (a) all Regulatory Documentation Controlled by Salix (or its Affiliates or future Sublicensees (to the extent Salix obtains the right to share Regulatory Documentation controlled by future Sublicensees with Alfa (as set forth below)) that relates to the Salix Designated Indication Product and Other New Formulation Products within the Field, and (b) all Regulatory Documentation relating to safety data with respect to the Compound or Rifaximin Products outside the Field Controlled by Salix (or its Affiliates or future Sublicensees (to the extent Salix obtains the right to share Regulatory Documentation controlled by future
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Sublicensees with Alfa (as set forth below)), which rights may be exercised by Alfa (y) with respect to the Salix Designated Indication Product, only if and when Salix and Alfa have agreed on the terms of a license for the Salix Designated Indication Product, including the compensation payable by Alfa to Salix, pursuant to Section 4.2.2(b) or (z) with respect to an Other New Formulation Product, only if and when Salix and Alfa have agreed on the compensation payable by Alfa to Salix for such Other New Formulation Product, pursuant to Section 4.2.3(b); provided, however , that Alfa shall be entitled to the right of reference to safety data referenced above in this Section 9.2.2, regardless of whether or not the foregoing conditions are met. For clarification, Alfas right of reference provided for in this Section 9.2.2 shall also apply to Regulatory Documentation Controlled by future Sublicensees of Salix, provided that Salix is able to obtain such rights from its Sublicensee. Salix shall use good faith Commercially Reasonable Efforts to obtain its Sublicensees agreement to grant such rights, along with the right to sublicense to Alfa such Sublicensees Know-How and Patents that are relevant to Alfas Exploitation of the licenses granted to it in this Agreement, but will not be prohibited from entering into a sublicense agreement if the prospective Sublicensee refuses to grant such rights.
9.3 Exchange of Data and Regulatory Information .
9.3.1 Each Party shall provide copies, without charge, to the other Party all (a) [*], when and as [*] are issued, (b) [*], and (c) [*] promptly upon the other Partys request, but in no event later than [*] days after receipt of such request, provided that Salix shall be obligated to provide such [*] (y) with respect to the Salix Designated Indication Product, only if and when Salix and Alfa have agreed on the terms of a license for the Salix Designated Indication Product, including the compensation payable by Alfa to Salix, pursuant to Section 4.2.2(b) or (z) with respect to an Other New Formulation Product, only if and when Salix and Alfa have agreed on the compensation payable by Alfa to Salix for such Other New Formulation Product, pursuant to Section 4.2.3(b). All such [*] shall be subject to the confidentiality provisions set forth in Article 12. For clarification, (i) the designation by Salix of any information as confidential which is based on or derived from source information provided by Alfa shall not result in any transfer of the ownership of or right to the underlying information from Alfa to Salix and (ii) the designation by Alfa of any information as confidential which is based on or derived from source information provided by Salix shall not result in any transfer of the ownership of or right to the underlying information from Salix to Alfa.
9.3.2 Each Party shall continue to have access to (a) [*] and (b) [*] following the granting of Marketing Approvals by the relevant Regulatory Authorities, provided that under either subsection (a) or (b), Alfas right to access such [*] may be exercised (y) with respect to the Salix Designated Indication Product, only if and when Salix and Alfa have agreed on the terms of a license for the Salix Designated Indication Product, including the compensation payable by Alfa to Salix, pursuant to Section 4.2.2(b) or (z) with respect to an Other New Formulation Product, only if and when Salix and Alfa have agreed on the compensation payable by Alfa to Salix for such Other New Formulation Product, pursuant to Section 4.2.3(b).
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9.3.3 Alfas obligations under Sections 9.3.1 and 9.3.2 are limited to information submitted to Regulatory Authorities in [*] and [*].
9.3.4 The respective rights and obligations of the Parties granted under this Section 9.3 shall terminate when the Agreement terminates.
9.4 Facilities Inspection . Representatives of either Party may upon reasonable notice, and at times reasonably acceptable to the other Party, visit any facilities where any pre-clinical or clinical tests or Clinical Trials are being carried out in respect of the Crohns EIR Product or Licensed Products and any facilities where the Compound or the Crohns EIR Product or Licensed Products licensed by the inspecting Party to the other Party hereunder are being Manufactured under license from the inspecting Party hereunder and shall be entitled to consult informally during any such visit or by telephone or facsimile communication with personnel at any such facilities. The rights granted to a Party under this Section 9.4 are supplemental to and do not limit or modify the inspection rights granted to such Party (or its Affiliates) in the Supply Agreements, the Trademark License Agreement (Alfa to Salix) or the Trademark License Agreement (Salix to Alfa), as appropriate.
9.5 Adverse Event Reporting and Notifications . The Parties respective obligations regarding reporting Adverse Events relating to the Compound or any Rifaximin Product and notifying the other Party of any information concerning Adverse Events are set forth in the Safety Data Exchange Agreement.
Article 10
MARKETING
10.1 Salixs Marketing Obligations . Salix shall use Commercially Reasonable Efforts to introduce, Promote and maximize the Commercialization of the Crohns EIR Product throughout the Salix Territory following receipt of the Initial U.S. Marketing Approval. For the avoidance of doubt, the Parties acknowledge and agree that the provisions of the preceding sentence do not necessarily require Salix to Commercialize the Crohns EIR Product in Canada. Other than in the case of the Exploitation of authorized generic products by Salix or its Affiliates or Sublicensees, Salix shall carry out such activities (a) with respect to Alfa Licensed Products for the Existing Indications under the Xifaxan Trademark, (b) with respect to the Crohns EIR Product, under the Crohns EIR Trademark, (c) with respect to the Other EIR Products under the Other EIR Trademarks selected by Alfa, and (d) with respect to other Alfa Licensed Products for the New Indications under the New Indication Trademarks selected by Alfa, and, in each such case, in accordance with the usual practice in the pharmaceutical field of the Salix Territory.
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10.2 Cooperation Regarding Marketing Matters .
10.2.1 Salix and Alfa shall consult and exchange information concerning marketing strategies and market information within the Salix Territory and Alfa Territory in an effort to produce homogeneity in the marketing of the Crohns EIR Products and Alfa Licensed Products and Salix Licensed Products worldwide. The Parties shall provide to each other samples of all Promotional Materials for the Crohns EIR Products and Alfa Licensed Products and Salix Licensed Products (recognizing that use of certain materials may be limited to a specific country or region), and all data which support promotional claims for the Crohns EIR Products and Licensed Products. Each Party, at its own cost, may translate and reproduce such Promotional Materials or publications as legally and contractually permissible and distribute them, at its sole discretion, in the course of its promotional and marketing activities. The provisions of the preceding sentence shall not alter or affect copyright ownership in respect of any Promotional Materials provided by a Party and shall, in respect of such Promotional Materials as may be provided by a Party constitute a limited license under such Partys right, title and interest in the provided Promotional Materials to use such Promotional Materials as therein permitted. Notwithstanding the foregoing, the Party originally providing such Promotional Materials to the other Party shall not be liable in any manner whatsoever in respect of any such translations or reproductions or other use thereof by the other Party and shall be indemnified and held harmless against any loss or claim arising in connection with the same, as set forth in more detail in Sections 14.1 and 14.2.
10.2.2 If there is a Change of Control that results in any Competitor acquiring control of Salix, Alfa shall have the right, at its option, to cease providing all or any part of the information that it is otherwise required to provide to Salix pursuant to Sections 9.1.2(b), 9.2.1, 9.3, 9.4, 10.2.1 or otherwise under this Agreement with regard to any forward looking plans, projects or research involving the Compound or any Rifaximin Products. For clarity, following a Change of Control that results in any Competitor acquiring control of Salix, Alfa shall continue to provide Salix (or its successor) with information (including rights of reference set forth in Article 9) required in order for Salix (or its designee) to maintain existing regulatory approvals for Crohns EIR Products and Alfa Licensed Products for the Field then being sold by Salix, its Affiliates and Sublicensees in the Salix Territory; provided, however , that Alfa, in its discretion and to the extent permitted by applicable laws and regulations, may submit updates to the relevant regulatory files in a manner that will keep such information confidential from Salix, and in such cases Salix shall cooperate with Alfas efforts to have this information treated on a confidential basis.
10.3 Packaging .
10.3.1 Without limiting the provisions of the Trademark License Agreement (Alfa to Salix), Salix undertakes to print on the packaging of and on all Promotional Materials relating to the Alfa Licensed Products the words Licensed by Alfa Wassermann or similar language to the extent permitted under any applicable law and agreed to by Alfa (such agreement not to be unreasonably withheld). Alfa hereby grants to Salix a non-exclusive (with the right to sublicense as set forth herein), royalty-free license to use Alfas corporate name in such form only for such purpose within the Field in the Salix Territory.
10.3.2 Without limiting the Trademark License Agreement (Salix to Alfa), Alfa undertakes to print on the packaging of and on all Promotional Materials relating to the Salix Licensed Products the words Licensed by Salix Pharmaceuticals or similar language to the
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extent permitted under any applicable law and agreed to by Salix (such agreement not to be unreasonably withheld). Salix hereby grants to Alfa a non-exclusive (with the right to sublicense as set forth herein), royalty-free license to use Salixs corporate name in such form only for such purpose within the Field in the Alfa Territory.
Article 11
PATENT MATTERS AND INTELLECTUAL PROPERTY RIGHTS
11.1 No Assignment of Ownership Rights .
11.1.1 The licenses granted pursuant to this Agreement shall not constitute an assignment of the Alfa Licensed Patents, the Alfa Licensed Trademarks or any other Alfa Technology Rights to Salix, nor a grant of any ownership right or title therein or any other right other than the rights specifically granted to the Alfa Licensed Patents, Alfa Licensed Trademarks and other Alfa Technology Rights in accordance with the terms of this Agreement, the Trademark License Agreement (Alfa to Salix), and the Supply Agreements. Nothing contained in this Agreement shall be construed as conferring upon Salix by implication, estoppel or otherwise any license, express or implied, or other rights under any trademark, service mark, copyright, Patent or unpatented technology belonging to Alfa, except the rights expressly granted to Salix hereunder, in the Trademark License Agreement (Alfa to Salix), and the Supply Agreements.
11.1.2 The licenses granted pursuant to this Agreement shall not constitute an assignment of the Salix Licensed Patents, the Salix Licensed Trademarks, Salixs interest in the [*] Patent Family or any other Salix Technology Rights to Alfa, nor a grant of any ownership right or title therein or any other right other than the rights specifically granted to the Salix Licensed Patents, Salix Licensed Trademarks, Salixs interest in the [*] Patent Family and other Salix Technology Rights in accordance with the terms of this Agreement and the Trademark License Agreement (Salix to Alfa). Nothing contained in this Agreement shall be construed as conferring upon Alfa by implication, estoppel or otherwise any license, express or implied, or other rights under any trademark, service mark, copyright, Patent or unpatented technology belonging to Salix, except the rights expressly granted to Alfa hereunder and in the Trademark License Agreement (Salix to Alfa).
11.2 Preparation, Filing, Maintenance and Prosecution of Patents .
11.2.1 Alfa Licensed Patents . Alfa shall have the right, but not the obligation, to prepare, file, prosecute and maintain the Alfa
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Licensed Patents; provided that, in the case of Alfa Licensed Patents filed in the United States, Canada, [*] and any other country in which an official patent office action on the merits is first given with respect to any particular family of Patents constituting Alfa Licensed Patents, Alfa shall (a) provide to Salix copies of all communications sent or to be sent to or received from any patent office pertaining to such Alfa Licensed Patents, [*]; (b) keep Salix reasonably informed on a continuous basis in respect of its actions under this Section 11.2.1; and (c) solicit and reasonably consider any Salix proposals in respect of Alfas actions under this Section 11.2.1. Whenever possible, Salix shall be afforded at least [*] Business Days prior to the earlier of the expiration of any shortened statutory period for response or the anticipated filing date to review and comment upon the text of any such communication. Alfa shall also keep Salix advised on the maintenance of any Alfa Licensed Patents that are reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field and provide Salix with reasonable opportunity to comment upon such maintenance. In the event the Parties respective patent counsel, after good faith discussions, cannot agree with respect to any decision to be made with respect to the preparation, filing, prosecution or maintenance of any Alfa Licensed Patent that is reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field (including decisions relating to [*]), Alfa shall have the final decision-making authority regarding such Alfa Licensed Patents. In the event that Alfa decides to abandon or discontinue the filing, prosecution or maintenance, in whole or in part, of any of Alfa Licensed Patents that is reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field (including decisions relating to [*]), it shall provide prompt written notice to Salix. In such case, Salix may elect to continue the maintenance or prosecution of such Alfa Licensed Patents or patent application at its expense, provided, however, that the ownership of such Alfa Licensed Patent or patent application shall be retained by Alfa.
11.2.2 Alfa [*] Patent Application . Following the Amendment Effective Date, Alfa shall [*] United States patent application no. [*] (the [*] Application ) and any other claim to [*] rifaximin in a Patent [*] to the [*] Application, and any other patent claim to [*] rifaximin [*] the disclosure of the [*] Application [*]. Alfa shall [*] patent rights to [*] rifaximin [*] which [*] the [*] Application [*] claims to [*] rifaximin, or any other patent rights [*] to an application [*] by the [*] Application [*] a claim to [*] rifaximin. Notwithstanding the above, nothing herein shall limit Alfas rights to [*] claims relating to [*] rifaximin in a patent application that [*] of the [*] Application, or any of the [*] of a Patent in the [*] of the [*] Application.
11.2.3 Salix Licensed Patents; [*] Patent Family . Salix shall have the right, but not the obligation, to prepare, file, prosecute and maintain the Salix Licensed Patents and [*] Patent Family; provided that, in the case of Salix Licensed Patents that are reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field and the [*] Patent Family, Salix shall (a) provide to Alfa copies of all communications sent or to be sent
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to or received from any patent office pertaining to such Salix Licensed Patents and the [*] Patent Family, [*]; (b) keep Alfa reasonably informed on a continuous basis in respect of its actions under this Section 11.2.3; and (c) solicit and reasonably consider any Alfa proposals in respect of Salixs actions under this Section 11.2.3. Whenever possible, Alfa shall be afforded at least [*] Business Days prior to the earlier of the expiration of any shortened statutory period for response or the anticipated filing date to review and comment upon the text of any such communication. Salix shall also keep Alfa advised on the maintenance of any Salix Licensed Patents that are reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field and the [*] Patent Family and provide Alfa with reasonable opportunity to comment upon maintenance. In the event the Parties respective patent counsel, after good faith discussions, cannot agree with respect to any decision to be made with respect to the preparation, filing, prosecution or maintenance of any Salix Licensed Patent that is reasonably expected to cover Rifaximin Products in the Field or necessary for the Exploitation of Rifaximin Products in the Field or the [*] Patent Family (including decisions relating to [*]), Salix shall have the final decision-making authority regarding such Salix Licensed Patents or the [*] Patent Family, as the case may be. In the event that Salix decides to abandon or discontinue the filing, prosecution or maintenance, in whole or in part, of any Salix Licensed Patents that are reasonably expected to cover Rifaximin Products in the Field or necessary for Exploitation of Rifaximin Products in the Field or the [*] Patent Family, it shall provide prompt written notice to Alfa. In such case, Alfa may, subject to the restrictions set forth in Section 11.2.2, elect to continue the maintenance or prosecution of such Salix Licensed Patent or the [*] Patent Family, as the case may be, at its expense, provided, however, that the ownership of such Salix Licensed Patent or the [*] Patent Family, as the case may be, shall be retained by Salix.
11.2.4 Joint Patents . The Parties shall discuss in good faith, and thereupon implement, a mutually agreeable patent strategy with respect to all Joint Patents and Joint Know-How that may be patentable. With respect to all Joint Patents and Joint Know-How for which the Parties agree patent prosecution should be sought, the Parties shall cooperate in the preparation, filing and prosecution of patent applications (including provoking, instituting or defending interference, opposition, revocation, reexamination, derivation, and similar proceedings related to the Joint Patents), and shall discuss and agree on the content and form of relevant patent applications and any other relevant matters before such applications are made. Each Party shall consider in good faith any comments from the other Party regarding steps to be taken to strengthen any Joint Patent. Salix shall serve as the lead Party to prosecute and maintain all applications covering Joint Patents in the Salix Territory (including provoking, instituting or defending interference, opposition, revocation, reexamination and similar proceedings related to the Joint Patents), at Salixs expense, unless otherwise agreed by the Parties; and Alfa shall serve as the lead Party to prosecute and maintain all applications covering Joint Patents in the Alfa Territory (including provoking, instituting or defending interference, opposition, revocation, reexamination and similar proceedings related to the Joint Patents), at Alfas expense, unless otherwise agreed by the Parties. In the event that the Parties respective patent counsel, after good faith discussions, cannot agree with respect to any decision to be made regarding the prosecution and maintenance of the Joint Patents, Alfa shall
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make the decision to the extent the matter in dispute relates to the Alfa Territory and Salix shall make the decision to the extent the matter in dispute relates to the Salix Territory. Notwithstanding the foregoing, neither Party shall prosecute a Joint Patent in their respective territory (Alfa in the Alfa Territory and Salix in the Salix Territory) in a manner that would be inconsistent with the prosecution of a corresponding Joint Patent in the other Partys respective territory. In all cases, the other Party shall, at its own expense, provide reasonable assistance to the lead Party for prosecution and maintenance of a particular Joint Patent with respect to the prosecution and maintenance of such Joint Patent.
11.2.5 Cooperation . The Parties respective intellectual property counsel shall discuss and suggest the best ways to strengthen the overall patent position related to the Compound and the Crohns EIR Products and Licensed Products for the benefit of both Parties.
11.3 Patent Applications . Salix shall promptly disclose to Alfa in writing the filing of all Patent applications by Salix or its Affiliates regarding any invention, development or discovery that constitutes Salix Technology reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field or Joint Technology Rights; and Alfa shall promptly disclose to Salix in writing the filing of all Patent applications by Alfa or its Affiliates regarding of any invention, development or discovery that constitutes Alfa Technology reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field or Joint Technology Rights.
11.4 Ownership of Intellectual Property .
11.4.1 Ownership of Intellectual Property Created Exclusively by a Single Party . As between the Parties, each Party shall own all right, title and interest in and to all Patents, Know-How and other Intellectual Property Rights created or conceived solely by or on behalf of such Party or its Affiliates and their respective employees, agents or independent contractors, or its Sublicensees (other than the other Party and its Affiliates). Within [*] days after the Amendment Effective Date, each Party shall deliver to the other Party all of its Know-How relevant to the Field that has been reduced to practice which has not previously been provided to the other Party for the limited purpose of enabling each Party to exercise the licenses to such Know-How granted to it under this Agreement. Thereafter, each Party shall promptly disclose to the [*] Committee and the other Party in writing all Patents and Know-How relevant to the Field that has been reduced to practice (and may, but is not obligated to, disclose to the [*] Committee and the other Party other Know-How and other Intellectual Property Rights) created or conceived solely by or on behalf of it, its Affiliates and their respective employees, agents or independent contractors, and its Sublicensees (other than the other Party and its Affiliates) in connection with the performance of their responsibilities or the exercise of their rights under this Agreement and that are necessary or reasonably useful for the Manufacture, research and Development, and Commercialization of Rifaximin Products within the Field and are within the
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scope of the licenses granted by this Agreement. Alfa shall exercise Commercially Reasonable Efforts to periodically update Salix regarding improvements to the Alfa Know-How relevant to the Field that have been reduced to practice. Salix shall exercise Commercially Reasonable Efforts to periodically update Alfa regarding improvements to the Salix Know-How relevant to the Field that have been reduced to practice.
11.4.2 Ownership of Intellectual Property Created Jointly by the Parties . As between the Parties, the Parties shall each own an equal, undivided interest in Joint Patents, Joint Know-How, and any other Intellectual Property Rights discovered, created or authored jointly by employees or agents of Salix or its Affiliates or Sublicensees, on the one hand, and employees or agents of Alfa or its Affiliates or Sublicensees, on the other hand. Such ownership by a Party of joint ownership of Joint Technology Rights shall not modify, limit or otherwise affect any rights of exclusivity in respect of Joint Technology Rights that may have been granted by such Party to the other Party hereunder. Except pursuant to such licenses and other rights as are granted by each Party to the other Party under this Agreement, neither Party shall license or otherwise Exploit any Joint Technology Rights anywhere in the world without the prior written consent of the other Party.
11.4.3 United States Law . For purposes of this Agreement, the determination of the inventorship of any invention, development or discovery and any Patent claiming such invention, development or discovery and the authorship or creation of any copyright material shall be made in accordance with applicable law in the United States. In the event that United States law does not apply to the conception, discovery, development or making of any invention, development or discovery or copyright material, each Party shall, and does hereby, assign, and shall cause its Affiliates, Sublicensees and other rights holders in respect of the Compound or Rifaximin Products to so assign, to the other Party, without additional compensation, such right, title and interest in and to any invention, development or discovery or copyright material, and any Intellectual Property Rights with respect thereto, as is necessary to fully effect ownership as contemplated by this Section 11.4.
11.4.4 [*] Patent Family . The provisions of this Section 11.4 are without prejudice to the provisions of Section 4.3.2 regarding the ownership of the [*] Patent Family.
11.5 Dispute Resolution . If there is a difference of view between the Parties regarding the inventorship, ownership or validity of any Intellectual Property Rights pertaining to the Compound or Rifaximin Products, the Parties shall endeavor to resolve the matter without litigation or other legal proceedings. Such efforts shall include a presentation by each Party to the chief executive officers of the Parties (or their designees) in an effort to reach resolution of the matter, unless such presentation would materially prejudice the presenting Party. If a Party concludes that the dispute cannot be
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resolved by the chief executive officers (or their designees) of the Parties, that Party shall provide a written demand for arbitration to the other Party and such dispute shall thereafter be resolved by arbitration pursuant to the procedures set forth in Section 18.2.
11.6 Infringement Claims by Third Parties .
11.6.1 Defense of Third Party Claims . If a Third Party asserts that a Patent or other Intellectual Property Right (other than trademarks, which shall be governed by the applicable Trademark License Agreement) owned or controlled by the Third Party is infringed by the Exploitation of Rifaximin Products as contemplated by this Agreement, then the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim along with the related facts in reasonable detail. Each Party shall be responsible for defending itself in any litigation in which it is a named defendant. If only one Party is a named defendant in any litigation commenced by a Third Party and the other Party is not a named defendant, the right to raise counterclaims against the plaintiff with regard to Patents owned by the other Party shall be governed by Section 11.7.1, provided that the Party that is not a named defendant shall not object if the Party which is a named defendant files an impleader action to join the other Party into the litigation. If both Alfa and Salix are named as joint defendants, Alfa and Salix shall cooperate with each other to develop a defense strategy for the Salix Territory and the Alfa Territory, including the decision to assert possible counterclaims, provided, however , that with respect to any Alfa Licensed Patent that is covered by Section 11.7, if the Parties, acting in good faith, cannot reach agreement with respect resolution, to the determination of whether to assert a counterclaim with regard to rights arising under any such Patent, then Salix shall have the right to determine whether or not to assert such counterclaim. The Parties shall confer with each other to decide which Party shall control the defense of litigation in which Salix and Alfa are both named as defendants. In respect of any defense of an action pursuant to this Section 11.6.1, the defending Party shall solicit and reasonably consider the other Partys proposals in respect of litigation strategy. In any such action, the non-controlling Party shall have the right, at its own expense, to be represented in such action by counsel of its own choice. Except as otherwise contemplated above in this Section 11.6.1, the Party with primary responsibility for defense under this Section 11.6.1 shall bear the cost of any such action and shall be entitled to 100% of the recovery, if any, from the Third Party arising from any counter-claims.
11.6.2 Settlement of Third Party Claims . The Party that controls the defense of a given claim or counterclaim shall also have the right to control settlement of such claim, subject to the restrictions set forth in Section 11.8.
11.6.3 Assistance . Each Party shall provide to the other Party all reasonable assistance requested by the other Party in connection with any action, claim or suit under this Section 11.6, at the requesting Partys expense, including allowing such other Party access to the assisting Partys files and documents and to the assisting Partys personnel who may have possession of relevant information. In particular, the assisting Party shall promptly make available to the other Party all information in its possession or control that it is aware shall assist the other Party in responding to any such action, claim or suit.
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11.7 Enforcement of Patents .
11.7.1 Infringement in Salix Territory .
(a) In the event that any Third Party infringes or allegedly infringes in the Salix Territory any Salix Licensed Patent or any Alfa Licensed Patent that is Orange Book-listed in respect of any Rifaximin Product in the Field or that otherwise is reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field in the Salix Territory, Salix shall have the right, but not the obligation, to prosecute any infringement by such Third Party at its expense or, subject to the provisions of this Section 11.7.1 and Section 11.8, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities. For clarity, if Salix elects not to take any action against a Third Party pursuant to this Section 11.7.1, then Alfa shall have no right to do so.
(b) In respect of any enforcement pursuant to Section 11.7.1(a) by Salix of a Salix Licensed Patent that is Orange Book-listed in respect of any Rifaximin Product in the Field or that otherwise is reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field or any Alfa Licensed Patent, Salix shall (i) keep Alfa reasonably informed on a continuous basis in respect of Salixs actions with respect to the enforcement of such Patent; (ii) promptly provide Alfa with copies of all documents and other materials filed by any party to such enforcement action with the court before which such enforcement action is pending; and (iii) solicit and reasonably consider Alfas proposals in respect of litigation strategy Alfa shall provide reasonable cooperation in connection with any such action brought by Salix against a Third Party, including becoming party to the legal action, allowing its name to be used in connection therewith, and making its personnel and records available to Salix and its representatives for the purpose of considering and prosecuting the case against the Third Party.
(c) Salix shall bear the cost of any such action and shall be entitled to [*] of the recovery, if any, from the Third Party; provided, however , that if such recovery includes the grant of sublicenses wherein the Third Party shall thereafter be a Sublicensee, such ongoing recovery shall be subject to Salixs royalty obligations set forth in Section 4.1.
11.7.2 Infringement in Alfa Territory .
(a) In the event that any Third Party infringes or allegedly infringes in the Alfa Territory any Alfa Licensed Patent or any Salix Licensed Patent that is reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field in the Alfa Territory, Alfa shall have the right, but not the obligation, to prosecute any such infringement at its expense or, subject to the provisions of this Section 11.7.2 and Section 11.8, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities. For clarity, if Alfa elects not to take any action against a Third Party pursuant to this Section 11.7.2, then Salix shall have no right to do so.
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(b) In respect of any enforcement by Alfa of a foreign counterpart of an Alfa Licensed Patent that is Orange Book-listed in respect of a Rifaximin Product in the Field or that otherwise is reasonably useful or necessary for the Exploitation of Rifaximin Products in the Field or a Salix Licensed Patent, Alfa shall (i) keep Salix reasonably informed on a continuous basis in respect of Alfas actions with respect to the enforcement of such Patent; (ii) promptly provide Alfa with copies of all documents and other materials filed by any party to such enforcement action with the court before which such enforcement action is pending; and (iii) solicit and consider in good faith any Salix proposals in respect of Alfas actions with respect to the enforcement of such Patent. Salix shall provide reasonable cooperation in connection with any such action brought by Alfa against a Third Party, including becoming party to the legal action, allowing its name to be used in connection therewith, and making its personnel and records available to Alfa and its representatives for the purpose of considering and prosecuting the case against the Third Party.
(c) Alfa shall bear the cost of any such action and shall be entitled to [*] of the recovery, if any, from the Third Party, provided, however , that if such recovery includes the grant of sublicenses wherein the Third Party shall thereafter be a Sublicensee, such ongoing recovery shall be subject to Alfas royalty obligations set forth in Section 4.2.
11.7.3 Infringement of Joint Patents . Alfa shall have the right, but not the obligation, at its expense, to control the prosecution of any infringement or alleged infringement by a Third Party of a Joint Patent in the Alfa Territory or, subject to the provisions of this Section 11.7.3 and Section 11.8, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities; and Salix shall have the right, but not the obligation, at its expense, to control the prosecution of any infringement or alleged infringement by a Third Party of a Joint Patent in the Salix Territory or, subject to the provisions of this Section 11.7.3 and Section 11.8, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities. In respect of any enforcement of a Joint Patent pursuant to this Section 11.7.3, the controlling Party shall (a) keep the other Party reasonably informed on a continuous basis in respect of the controlling Partys actions with respect to the enforcement of such Patent; (b) promptly provide the other Party with copies of all documents and other materials filed by any party to such enforcement action with the court before which such enforcement action is pending; and (c) solicit and reasonably consider the other Partys proposals in respect of litigation strategy. In either case, both Parties shall provide reasonable cooperation in any action brought against a Third Party with respect to a Joint Patent, including becoming party to the legal action, allowing its name to be used in connection therewith, and making its personnel and records available to the other Party and its representatives for the purpose of considering and prosecuting the case against the Third Party. The Party bringing the legal action shall bear the cost of any such action and shall be entitled to 100% of the recovery, if any, from the Third Party. In any enforcement action involving the Joint Patents, the Parties shall not take inconsistent positions to those taken by the other Party in its territory with regard to the corresponding Joint Patent. The non-controlling Party shall have the right, at its own expense, to be represented by counsel of its own choice in any action brought under this Section 11.7.3.
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11.7.4 Infringement of [*] Patent Family . Salix shall have the right, but not the obligation, at its expense, to control the prosecution of any infringement or alleged infringement anywhere in the world by a Third Party of the [*] Patent Family or, subject to the provisions of this Section 11.7.4 and Section 11.8, to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities. For clarity, if Salix elects not to take any action against a Third Party pursuant to this Section 11.7.4, then Alfa shall have no right to do so. In respect of any enforcement of the [*] Patent Family pursuant to this Section 11.7.4, Salix shall (a) keep Alfa reasonably informed on a continuous basis in respect of Salixs actions with respect to the enforcement of such Patent; (b) promptly provide Alfa with copies of all documents and other materials filed by any party to such enforcement action with the court before which such enforcement action is pending; and (c) solicit and reasonably consider Alfas proposals in respect of litigation strategy. In either case, both Parties shall provide reasonable cooperation in any action brought against a Third Party with respect to the [*] Patent Family, including becoming party to the legal action, allowing its name to be used in connection therewith, and making its personnel and records available to the other Party and its representatives for the purpose of considering and prosecuting the case against the Third Party. Salix shall bear the cost of any such action and shall be entitled to [*] of the recovery, if any, from the Third Party. Alfa shall have the right, at its own expense, to be represented by counsel of its own choice in any action brought under this Section 11.7.4.
11.7.5 Patent Challenges . For the avoidance of doubt, the provisions of this Section 11.7 shall apply in respect of challenges by a Third Party of the validity or enforceability (whether pursuant to the Hatch-Waxman Act or any other relevant regulatory or statutory framework that may govern) of Patents addressed in this Section 11.7 as though such challenge of the validity or enforceability of such Patents constituted an infringement or alleged infringement of such Patents.
11.8 Restrictions on Settlement with Third Parties . The Party that controls the defense or prosecution of a given claim under Sections 11.6 or 11.7 shall also have the right to control settlement of such claim; provided , however , that (a) no settlement shall be entered into by such controlling Party without the prior written consent of the non-controlling Party if such settlement would adversely affect or diminish the rights and benefits of the non-controlling Party under this Agreement, impose any new obligations or adversely affect any obligations of the non-controlling Party under this Agreement, or adversely affect the validity or enforceability of the Patents or other Intellectual Property Rights of such non-controlling Party and (b) the controlling Party shall not be entitled to settle any such Third Party claim by granting a license or covenant not to sue under or with respect to the non-controlling Partys Intellectual Property Rights without the prior written consent of the non-controlling Party.
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11.9 Patent Defense Agreement . This Agreement supersedes and replaces the Patent Defense Agreement and the Patent Defense Agreement shall have no further force or effect after the Amendment Effective Date.
11.10 Disclaimers . Nothing in this Agreement shall be construed as an obligation for either Party to bring or prosecute actions or suits against Third Parties for infringement.
Article 12
CONFIDENTIALITY
12.1 Confidentiality, Use and Non-Disclosure Obligations .
12.1.1 Confidentiality, Use and Non-Disclosure Obligations of Salix . During the term of this Agreement and for a period of [*] years after termination or expiration hereof, Salix shall keep secret and confidential, and shall use all reasonable efforts to ensure that the same is kept confidential by its Affiliates and Sublicensees, all Alfa Technology Rights and other Confidential Information disclosed to it by Alfa and all Joint Technology Rights ( Alfa Confidential Information ) and shall not use the same for any purpose other than the exercise of the licenses and other rights granted to it by Alfa under this Agreement or the performance of its obligations under this Agreement or disclose the same to any Third Party other than (a) as may be required in connection with the performance of its obligations under this Agreement or any of the Related Agreements or (b) as otherwise set forth in Section 12.3. Without limiting the foregoing, Salix agrees that it shall take the same level of measures to protect the confidentiality of Alfa Confidential Information which it takes with respect to Salixs own confidential and proprietary information, but not less than reasonable care.
12.1.2 Confidentiality, Use and Non-Disclosure Obligations of Alfa . During the term of this Agreement and for a period of [*] years after termination or expiration hereof, Alfa shall keep secret and confidential, and shall use all reasonable efforts to ensure that the same is kept confidential by its Affiliates and Sublicensees all Salix Technology Rights and other Confidential Information disclosed to Alfa by Salix and all Joint Technology Rights ( Salix Confidential Information ) and shall not use the same for any purpose other than the exercise of the licenses and other rights granted to it by Salix under this Agreement or the performance of its obligations under this Agreement or disclose the same to any Third Party other than (a) as may be required in connection with the performance of its obligations under this Agreement or any of the Related Agreement (b) as otherwise set forth in Section 12.3. Without limiting the foregoing, Alfa agrees that it shall take the same level of measures to protect the confidentiality of Salix Confidential Information which it takes with respect to Alfas own confidential and proprietary information, but not less than reasonable care.
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12.2 Exceptions to Confidentiality and Non-Disclosure Obligations . Notwithstanding the obligations contained in Section 12.1.1 and Section 12.1.2, Confidential Information shall not include any information that:
12.2.1 shall be in the public domain prior to disclosure to the receiving Party, or shall enter the public domain after the Amendment Effective Date otherwise than by reason of the fault, negligence or wrongful act of the receiving Party;
12.2.2 the receiving Party can show was in its possession free of any obligation of confidentiality prior to the date of receipt or was independently developed by employees of the receiving Party without reference to the information disclosed by the disclosing Party; or
12.2.3 is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to said information;
Specific aspects or details of Alfa Confidential Information or Salix Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
12.3 Permitted Disclosures . Each Party may disclose Confidential Information to the extent that such disclosure is:
12.3.1 Made pursuant to a valid and effective subpoena or order issued by a court of competent jurisdiction or other legal process or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Partys legal counsel, such disclosure is otherwise required by law, provided that it shall (a) immediately notify the other Party that it is subject to such legally required disclosure, (b) consult with the other Party on the advisability of taking legally available steps to resist or narrow such compelled disclosure, (c) reasonably assist the other Party, at its request, in its efforts to obtain an appropriate protective order or other reliable assurance that confidential treatment shall be accorded to its Confidential Information, to the extent such assistance is commercially reasonable, and (d) limit disclosure to the information that its legal counsel advises must be disclosed to comply with the legal requirement.
12.3.2 Made by the receiving Party to Regulatory Authorities as required in connection with any filing in relation to a Regulatory Approval or the prosecution or maintenance of any Patent; provided , however , that (a) such Party shall clearly mark its submission to the Regulatory Authorities with a notation making it clear that the filing contains confidential commercial information and trade secrets that are not for disclosure and (b)
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reasonable measures shall be taken, to the extent available, to assure confidential treatment of such information and that where a receiving Party intends to disclose Confidential Information of the disclosing Party in relation to the prosecution or maintenance of any Patent, notice shall be provided to the disclosing Party prior to disclosure by the receiving Party.
12.3.3 Made by the receiving Party for purposes of enforcing claims that it may have against the other Party or its Affiliates, whether under this Agreement or otherwise; provided , however , that reasonable measures shall be taken, to the extent available, to assure confidential treatment of such information.
12.3.4 Made by the receiving Party or its Affiliates or Sublicensees to its or their respective attorneys, auditors, advisors, consultants, licensees, Sublicensees, and service providers that provide services relevant to the Partys Exploitation of Rifaximin Product as contemplated in this Agreement (including contract manufacturers, or otherwise in connection with the performance by the receiving Party of its obligations or exercise of its rights as contemplated by this Agreement; provided , however , that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 12 and the disclosing Party shall cause each such Person to sign a standard non-disclosure agreement of the type that the disclosing Party requires unaffiliated Third Parties to sign prior to disclosing its own confidential and proprietary information; provided further that each Party shall remain responsible for any failure by its Affiliates or Sublicensees or its or their respective attorneys, auditors, advisors, consultants, licensees, Sublicensees or service providers to treat such Confidential Information as required under this Article 12 (as if such Affiliates, attorneys, auditors, advisors, consultants, licensees, Sublicensees or service providers were Parties directly bound to the requirements of this Article 12).
12.3.5 Made by the receiving Party to [*], each of whom prior to disclosure must be bound by obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 12.
12.4 Return of Confidential Information . Upon the termination of this Agreement, each Party shall return or destroy or make inaccessible all tangible copies of any Confidential Information provided to it by the other Party, provided, that their respective legal counsel may retain one (1) copy of such Confidential Information for use solely for the purpose of determining their respective rights and obligations under this Agreement.
12.5 Injunctive Relief . Each Party acknowledges and agrees that the other Partys Confidential Information constitutes unique and valuable trade secrets and that the unauthorized disclosure or use of the other Partys Confidential Information would result in irreparable harm to the other Party for which monetary damages would be inadequate. Accordingly, the Parties agree that in the event of any breach or
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threatened breach of this Article 12, the non-breaching Party shall be entitled to obtain injunctive or other equitable relief from any court of competent jurisdiction in addition to all other remedies available to it, and the breaching Party shall not claim as a defense thereto that the non-breaching Party has an adequate remedy at law. In any such action for injunctive or equitable relief, the non-breaching Party shall not be required to post a bond or other security. The Parties hereby irrevocably consent to the jurisdiction of the courts of the State of New York and the United States District Court for the Southern District of New York, in either case sitting in the Borough of Manhattan in the City of New York, over any legal action brought under this Section 12.5.
12.6 Disclosure of Agreement; Press Releases .
12.6.1 To the extent, if any, that a Party determines in good faith that it is required by applicable law to file or register this Agreement or a notification in respect thereof with any governmental authority, including the U.S. Securities and Exchange Commission or, in connection with the prosecution or maintenance of any Patent, the U.S. Patent and Trademark Office, such Party may do so, and the other Party shall cooperate in such filing or notification and shall execute all documents reasonably required in connection therewith. In such situation, the filing Party shall request confidential treatment of sensitive provisions of the Agreement, to the extent permitted by applicable law and in consultation with the other Party, and shall not otherwise disclose this Agreement except under circumstances otherwise contemplated by this Agreement. The Parties shall promptly inform each other as to the activities or inquiries of any such governmental authority relating to this Agreement, and shall cooperate to respond to any request for further information therefrom.
12.6.2 Press releases or other similar public communication by either Party relating to this Agreement or the arrangements contemplated hereby, including the Manufacturing, Development or Commercialization of any Rifaximin Product within the Field, shall be approved in advance by the other Party, which approval shall not be unreasonably withheld or delayed, except for those communications required by applicable law ( provided that the other Party is given a reasonable opportunity to review and comment on any such press release or public communication in advance thereof), disclosures of information for which consent has previously been obtained, information that has been previously disclosed publicly in accordance with this Agreement, or as otherwise set forth in this Agreement.
12.7 Restrictions on Publication . Each Party recognizes that the publication of papers regarding results of and other information regarding activities under this Agreement, including oral presentations and abstracts, may be beneficial to both Parties, provided such publications are subject to reasonable controls to protect each Partys Confidential Information. Without limiting the disclosures permitted by Section 12.3, it is the intent of the Parties to maintain the confidentiality of any Confidential Information of the non-publishing Party included in any patent application until such patent application has been filed. Accordingly, each Party shall have the right to review and approve any paper proposed for publication by the other Party, including any oral presentation or abstract, that contains Clinical Data, or pertains to results of Clinical Trials or other studies, with respect to Rifaximin Products or includes other data generated under this Agreement or which includes Confidential Information of the other Party. Before any such paper is submitted for publication or an oral presentation is made, the publishing or presenting Party shall deliver a complete copy
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of the paper or materials for oral presentation to the other Party. The other Party shall review any such paper and give its comments to the publishing Party within [*] days of the delivery of such paper to the other Party. With respect to oral presentation materials and abstracts, the other Party shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to the publishing or presenting Party with appropriate comments, if any, but in no event later than [*] days from the date of delivery to the other Party. If the other Party does not respond by the end of such [*] day period, its consent to publication of such papers or presentation of such materials shall be deemed to have been given. Notwithstanding anything to the contrary set forth herein, neither Party may publish any data or information of the other Party that is the other Partys Confidential Information without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed, except as permitted by Section 12.3. A Partys consent to publication or presentation may be conditioned on the publishing or presenting Party (a) complying with the other Partys request to delete references to such other Partys Confidential Information in any such paper and (b) withholding publication of any such paper or any presentation of same for an additional [*] days in order to permit the other Party to obtain patent protection if the other Party deems it necessary. Any publication shall include recognition of the contributions of the other Party according to standard practice for assigning scientific credit, either through authorship or acknowledgement, as may be appropriate. Each Party shall use Commercially Reasonable Efforts to cause investigators and institutions participating in Clinical Trials for Rifaximin Products with which it contracts to agree to terms substantially similar to those set forth in this Section 12.7, which efforts shall satisfy such Partys obligations under this Section 12.7 with respect to such investigators and institutions.
Article 13
REPRESENTATIONS AND WARRANTIES; COVENANTS
13.1 General Representations . Each Party hereby represents and warrants to the other as of the Amendment Effective Date as follows:
13.1.1 Duly Organized . It is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification, and has all requisite power and authority, corporate or otherwise, to conduct its business as now being conducted, to own, lease and operate its properties, to execute, deliver and perform this Agreement, and to grant the rights and licenses granted in this Agreement.
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13.1.2 Due Execution . The execution, delivery and performance by it of this Agreement have been duly authorized by all necessary corporate action and do not and will not (a) require any consent or approval of its stockholders, (b) violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree, determination or award presently in effect having applicability to it or any provision of its charter or by-laws, or (c) result in a breach of or constitute a default under any agreement, mortgage, lease, license, permit, patent or other instrument or obligation to which it is presently a party or by which it or its assets may be bound or affected.
13.1.3 No Third Party Approval . Except as contemplated herein, no authorization, consent, approval, license, exemption of, or filing or registration with, any court or governmental authority or regulatory body is required for the due execution, delivery or performance by it of this Agreement.
13.1.4 Binding Agreement . This Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms and conditions, except to the extent that enforcement may be limited by bankruptcy laws or other laws affecting the rights of creditors generally, and rules of law governing equitable remedies. Such Party is not under any obligation to any Person, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.
13.2 Salixs Representations . Salix represents and warrants to Alfa as of the Amendment Effective Date that:
13.2.1 Salix is the sole owner of the entire right, title and interest in and to those Salix Licensed Patents set forth on Exhibit H , free and clear of any liens, claims, encumbrances, restrictions and other legal or equitable claims of any kind or nature.
13.2.2 Salix has the right to grant to Alfa the rights and licenses set forth in this Agreement.
13.2.3 To the actual knowledge of [*] without any obligation to make any further inquiry or to examine files or other information in Salixs possession, there is no infringement by a Third Party of any of the Salix Licensed Patents set forth on Exhibit H in [*] or [*].
13.2.4 The Salix Licensed Patents set forth on Exhibit H exist or are pending.
13.2.5 To Salixs knowledge, there are no pending or threatened claims, judgments or settlements asserted against Salix relating to the Salix Licensed Patents.
13.2.6 Neither Salix nor any of its Affiliates has been debarred or is subject to debarment and neither Salix nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. Salix shall inform Alfa in writing immediately if it or any Person who is performing services
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hereunder is debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Salixs knowledge, is threatened, relating to the debarment or conviction of Salix or any Person performing services hereunder.
13.2.7 Except for the [*] License Agreement and the [*] License Agreement, Salix has not entered into any agreement prior to the Amendment Effective Date that would require Salix to pay any royalties to a Third Party licensor pursuant as a result of the Exploitation of the Compound or Salix Licensed Product by Alfa, its Affiliates or its Sublicensees under the Salix Technology Rights in the Alfa Territory.
13.3 Alfas Representations . Alfa represents and warrants to Salix that:
13.3.1 As of the Amendment Effective Date, Alfa is the sole owner of the entire right, title and interest in and to the Alfa Licensed Patents, free and clear of any liens, claims, encumbrances, restrictions and other legal or equitable claims of any kind or nature.
13.3.2 Alfa has the right to grant to Salix the rights and licenses set forth in this Agreement.
13.3.3 Alfa, to its knowledge, is not aware of any infringement by a Third Party of any of the Alfa Licensed Patents, except as set forth on Exhibit G .
13.3.4 As of the date of this Agreement: (a) the Alfa Licensed Patents exist and are pending, and (b) to Alfas knowledge, there are no pending or threatened claims, judgments or settlements asserted against Alfa relating to the Alfa Licensed Patents.
13.3.5 Neither Alfa nor any of its Affiliates has been debarred or is subject to debarment and neither Alfa nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section. Alfa shall inform Salix in writing immediately if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Alfas knowledge, is threatened, relating to the debarment or conviction of Alfa or any Person performing services hereunder.
13.3.6 Alfa has not entered into any agreement prior to the Amendment Effective Date that would require Alfa to pay any royalties to a Third Party licensor pursuant as a result of the Exploitation of the Compound or Crohns EIR Product or Alfa Licensed Product by Salix, its Affiliates or its Sublicensees under the Alfa Technology Rights in the Salix Territory.
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13.4 Covenants .
13.4.1 Salix shall comply with all applicable laws, rules and regulations relevant to the Exploitation of the Alfa Licensed Products.
13.4.2 Alfa shall comply with all applicable laws, rules and regulations relevant to the Exploitation of the Salix Licensed Products and products covered by the [*] Claims.
13.5 Disclaimers of Representations and Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT.
Article 14
INDEMNIFICATION
14.1 Indemnification by Alfa . Alfa shall indemnify, defend and hold harmless Salix, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all costs, claims, damages and expenses (including reasonable attorneys fees and other expenses of legal proceedings) (collectively, Losses ), in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of;
14.1.1 any default by Alfa of its obligations under this Agreement;
14.1.2 any breach by Alfa of any of its representations and warranties set forth in this Agreement;
14.1.3 any negligent act or omission of Alfa in connection with the performance of its obligations under this Agreement;
14.1.4 the Exploitation by Alfa or its Affiliates, licensees (other than Salix) or Sublicensees of Rifaximin Products; provided, however, that Alfas liability arising from or occurring as a result of its Manufacture or supply of the Compound, the Crohns EIR Product, Other EIR Products or any other Rifaximin Products to Salix shall be governed by the Supply Agreements and not this Section 14.1.4; or
14.1.5 the use by Alfa or its Affiliates, licensees (other than Salix) or Sublicensees of any Salix-provided Promotional Materials, or translations or reproductions thereof, pursuant to Section 10.2.1.
Notwithstanding the foregoing, Alfa shall not be required to indemnify Salix, its Affiliates, and their respective officers, directors, employees and agents for any Losses to the
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extent such Losses are attributable to any of the matters as to which Salix has an obligation to indemnify Alfa pursuant to Section 14.2 hereof or under any Supply Agreement or Trademark License Agreement.
14.2 Indemnification by Salix . Salix shall indemnify, defend and hold harmless Alfa, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all Losses in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
14.2.1 any default by Salix of its obligations under this Agreement;
14.2.2 any breach by Salix of any of its representations and warranties set forth in this Agreement;
14.2.3 any negligent act or omission of Salix in connection with the performance of its obligations under this Agreement;
14.2.4 subject to Alfas liability under the Supply Agreement arising from or occurring as a result of its Manufacture or supply of the Compound, the Crohns EIR Product, Other EIR Products or any other Rifaximin Products to Salix, the Exploitation by Salix or its Affiliates or Sublicensees of Rifaximin Products;
14.2.5 the use by Salix or its Affiliates or Sublicensees of any Alfa-provided Promotional Materials, or translations or reproductions thereof, pursuant to Section 10.2.1; or
14.2.6 any matter arising from or related to (a) Alfa entering into the provisions contained in this Agreement relating to its commitment to abandon the [*] Application and obtain rights under the [*] Patent Family; (b) claims by a Third Party asserting that Alfas Exploitation of any Rifaximin Products containing [*] of the Compound in the Field in the United States pursuant to the [*] Patent Family infringes any of the Third Partys Intellectual Property rights (but excluding infringement claims based on the Exploitation of Rifaximin Products containing [*] of the Compound outside the Salix Territory or outside the Field); (c) claims made against Alfa by a Third Party in connection with the assertion or enforcement by Alfa and/or Salix of any Patent issuing from the [*] Patent Family claiming [*] of the Compound and (d) claims made against Alfa by a Third Party in connection with the assertion or enforcement by Alfa or Salix of any Third Partys Patents claiming [*] of the Compound that are sublicensed to Alfa by Salix.
Notwithstanding the foregoing, Salix shall not be required to indemnify Alfa, its Affiliates, and their respective officers, directors, employees and agents for (y) any Losses to the extent such Losses are attributable to any of the matters as to which Alfa has an obligation to indemnify Salix pursuant to Section 14.1 hereof or under any Supply Agreement or Trademark License Agreement or (z) any Losses arising from a claim by a Third Party that Alfas Exploitation of Rifaximin Products containing [*] of the Compound or any other product covered or claimed by the [*] Patent Family infringes the Third Partys Patents.
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14.3 Insurance . Each Party undertakes to effect and maintain appropriate and adequate insurance coverage to cover any and all matters for which it has agreed to provide indemnification to the other Party pursuant to this Agreement and shall, if and when required by the other Party, provide to the other Party evidence of such insurance coverage.
14.4 Indemnification Procedures .
14.4.1 Notice of Claim . In the event of any claim, action or proceeding for which a Person is entitled to indemnity hereunder, the Person seeking indemnity ( Claimant ) shall promptly notify the relevant Party ( Indemnitor ) of such matter in writing, but in no event shall the Indemnitor be liable for any Losses that result from any delay in providing such notice.
14.4.2 Control of Defense . As its option, Indemnitor may then assume responsibility for and shall have full control of such matter by giving notice to Claimant within [*] days after the Indemnitors receipt of notice from Claimant. The assumption of the defense of a Third Party claim by the Indemnitor shall not be construed as an acknowledgment that Indemnitor is liable to indemnify Claimant in respect of the Third Party claim, nor shall it constitute a waiver by Indemnitor of any defenses it may assert against Claimants claim for indemnification. Upon assuming the defense of a Third Party claim, Indemnitor may appoint as lead counsel in the defense of the Third Party claim any legal counsel selected by Indemnitor. In the event Indemnitor assumes the defense of a Third Party claim, Claimant shall immediately deliver to Indemnitor all original notices and documents (including court papers) received by Claimant in connection with the Third Party claim. Should Indemnitor assume the defense of a Third Party claim, except as provided below, Indemnitor shall not be liable to Claimant for any legal expenses subsequently incurred by such Claimant in connection with the analysis, defense or settlement of the Third Party claim. In the event that it is ultimately determined that Indemnitor is not obligated to indemnify, defend or hold harmless Claimant from and against the Third Party claim, Claimant shall reimburse Indemnitor for any and all costs and expenses (including attorneys fees and costs of suit) and any Third Party claims incurred by Indemnitor in its defense of the Third Party claim. Without limiting the foregoing, any Claimant shall be entitled to participate in, but not control, the defense of such Third Party claim and to employ counsel of its choice for such purpose; provided , however , that such employment shall be at Claimants own expense unless (a) the employment thereof has been specifically authorized by Indemnitor in writing, (b) Indemnitor has failed to assume the defense and employ counsel in accordance with this Section 14.4.2 (in which case Claimant shall control the defense) or (c) the interests of Claimant and Indemnitor with respect to such Third Party claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable law, ethical rules or equitable principles.
14.4.3 Settlement . With respect to any Losses relating solely to the payment of money damages in connection with a Third Party claim and that shall not result in Claimants becoming subject to injunctive or other relief or otherwise
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adversely affecting the business of Claimant in any manner, and as to which Indemnitor shall have acknowledged in writing the obligation to indemnify Claimant hereunder, Indemnitor shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as Indemnitor, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party claims, where Indemnitor has assumed the defense of the Third Party claim in accordance with Section 14.4.2, Indemnitor shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, provided it obtains the prior written consent of Claimant (which consent shall not be unreasonably withheld or delayed). Indemnitor shall not be liable for any settlement or other disposition of a Loss by Claimant that is reached without the written consent of Indemnitor. Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, no Claimant shall admit any liability with respect to or settle, compromise or discharge, any Third Party claim without the prior written consent of Indemnitor, such consent not to be unreasonably withheld or delayed.
14.4.4 Cooperation . Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, Claimant shall cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to Indemnitor to, and reasonable retention by Claimant of, records and information that are reasonably relevant to such Third Party claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and Indemnitor shall reimburse Claimant for all its reasonable out-of-pocket expenses in connection therewith.
14.4.5 Expenses . Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by Claimant in connection with any claim shall be reimbursed on a calendar quarter basis by Indemnitor, without prejudice to Indemnitors right to contest Claimants right to indemnification and subject to refund in the event Indemnitor is ultimately held not to be obligated to indemnify Claimant.
14.5 Limitations on Liability . UNDER NO CIRCUMSTANCES SHALL A PARTY HERETO BE LIABLE TO THE OTHER PARTY HEREOF FOR CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES IN RESPECT OF PERFORMANCE OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT ALL AMOUNTS THAT AN INDEMNIFIED PERSON IS REQUIRED TO PAY TO ANY THIRD PARTY AS THE RESULT OF A MATTER FOR WHICH SUCH INDEMNIFIED PERSON IS ENTITLED TO BE INDEMNIFIED UNDER THIS ARTICLE 14 SHALL BE CONSIDERED TO BE DIRECT DAMAGES WHICH ARE INDEMNIFIABLE HEREUNDER.
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Article 15
FORCE MAJEURE
15.1 Neither Party shall be liable to the other Party for any failure or delay in performing any obligation under this Agreement (other than any payment or confidentiality obligations) when such failure or delay is caused by events beyond its reasonable control, including fire, flood, other natural disasters, acts of God, war, labor disturbances, interruption of transit, accident, explosion and civil commotion; provided that the Party so affected shall give prompt notice thereof to the other Party and shall use reasonable efforts to mitigate the adverse consequences thereof. No such failure or delay shall terminate this Agreement, and each Party shall complete its obligations hereunder as promptly as reasonably practicable following cessation of the cause or circumstances of such failure or delay.
Article 16
COMMENCEMENT, DURATION AND TERMINATION
16.1 Term of Agreement . This Agreement shall come into force and effect on the date first stated above and, unless and until earlier terminated in accordance with the provisions set out below, shall continue until neither Party is obligated to pay royalties in respect of Rifaximin Products hereunder, at which point the Agreement shall expire.
16.2 Term of Certain Payment Obligations .
16.2.1 The obligations of Salix to pay royalties in respect of Net Sales of a Crohns EIR Product or Alfa Licensed Product under the applicable provisions of Sections 4.1.1 4.1.4 shall commence on the date when such Crohns EIR Product or Alfa Licensed Product is Put into Commerce in a particular country in the Salix Territory and shall continue on a product-by-product, country-by-country basis until the earlier of (a) the date of the first commercial sale by a Person other than Salix or its Affiliates or Sublicensees in such country of a Prescription Competitive Generic Product in respect of such Crohns EIR Product or Alfa Licensed Product and (b) the later of (i) the tenth anniversary of the Launch Date and (ii) the first date on which there is no longer (A) an Alfa Licensed Patent or Joint Patent that includes or constitutes a Valid Claim in such country that would be infringed by Salixs Exploitation of the Crohns EIR Product or Alfa Licensed Product in such country in the absence of the licenses granted in Section 4.1 or (B) Regulatory Exclusivity in favor of Salix in respect of such Crohns EIR Product or Alfa Licensed Product in such country.
16.2.2 The obligations of Alfa to pay royalties in respect of a Salix Licensed Product under the provisions of Sections 4.2.2 and 4.2.3 shall commence on the date when such Salix Licensed Product is Put into Commerce in a particular country in the Alfa Territory and shall continue on a product-by-product, country-by-country basis until the earlier of (a) the date
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of the first commercial sale (by a Person other than Alfa or its Affiliates or Sublicensees) in such country of a Prescription Competitive Generic Product in respect of such Salix Licensed Product, and (b) the first date on which there is no longer (i) a Salix Licensed Patent, Other Forms Claim of the [*] Patent Family, or Joint Patent that includes or constitutes a Valid Claim in such country that would be infringed by Alfas Exploitation of the Salix Licensed Product in such country in the absence of the licenses granted in Section 4.2 or (ii) Regulatory Exclusivity in favor of Alfa in respect of such Salix Licensed Product in such country.
16.2.3 Upon the termination of the obligation of a Party to pay royalties in respect of a particular product in a particular country: (a) the amount of Net Sales in respect of such product in such country shall be ignored for purposes of determining the satisfaction of any royalty threshold or commercialization milestone threshold amounts for the applicable period in respect of the Partys payment obligations to the other Party; and (b) the Party shall have no obligation to pay any development or regulatory milestones that would otherwise be payable in respect of such product in such country.
16.2.4 For the avoidance of doubt, (a) upon termination of the royalty and other payment obligations of Salix or Alfa under the provisions of Sections 4.1.1 4.1.4 or Sections 4.2.2 and 4.2.3, or Section 4.3.3(e), as applicable, with respect to a product in a particular country, this Agreement shall continue thereafter in accordance with its terms until its termination or expiration; (b) upon termination of Salixs royalty obligations under the applicable provisions of Sections 4.1.1 4.1.4 with respect to a Crohns EIR Product or Alfa Licensed Product in a particular country, the licenses granted to Salix under Sections 4.1.1 4.1.4 and the rights of reference granted to Salix under Section 9.2.1 with respect to such Crohns EIR Product or Alfa Licensed Product shall continue thereafter as non-exclusive, irrevocable, royalty-free, perpetual, and fully paid-up licenses and rights of reference (with the right to sublicense and grant further rights of reference) in such country, except as expressly provided in respect of the Alfa Licensed Trademarks under the Trademark License Agreement (Alfa to Salix); and (c) upon termination of Alfas royalty obligations under the applicable provisions of Sections 4.2.2 and 4.2.3 with respect to a Salix Licensed Product in a particular country, the licenses granted to Alfa under Sections 4.2.2 and 4.2.3 and Section 4.3.3 and the rights of reference granted to Alfa under Section 9.2.2 with respect to such Salix Licensed Product shall continue thereafter as non-exclusive, irrevocable, royalty-free, perpetual, and fully paid-up licenses and rights of reference (with the right to sublicense and grant further rights of reference) in such country, except as expressly provided in respect of the Salix Licensed Trademarks under the Trademark License Agreement (Salix to Alfa).
16.3 Patent Challenges . If at any time either Party commences an action to challenge the validity or scope of any of the other Partys Licensed Patents, the following shall apply:
16.3.1 The Party challenging the other Partys Licensed Patents shall continue to pay to the other Party all fees and royalties payable under Article 4 of this Agreement during the period that its challenge of the scope or validity of such Patents is pending. The Party challenging the other Partys Licensed Patents may not pay any such amounts into an escrow account.
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16.3.2 Whether or not the Partys challenge of the validity or scope of the other Partys Licensed Patents is successful, such challenging Party shall not be entitled to recoup any amounts paid by it to the other Party under this Agreement whether payment was made prior to the commencement of such challenge or during the period that such challenge was pending.
16.3.3 In the event that the challenging Partys challenge of the validity or scope of the other Partys Licensed Patents has been successful in a particular country, such challenging Party shall be exempted from the obligation to pay any royalty in such country unless the Exploitation of the applicable Licensed Products by the challenging Party would infringe any of the remaining Licensed Patents of the other Party unless the minimum royalty term in Section 16.2 applies.
16.3.4 In the event that a Party challenges the validity or scope of any of the other Partys Licensed Patents, or cooperates with a Third Party in any way to challenge the validity or scope of such other Partys Licensed Patents, the other Party, at its sole discretion, may terminate within [*] days the Agreement (as provided in Section 17.1.1) or convert this Agreement from an exclusive license to a non-exclusive license by licensing rights granted to the challenging Party herein to Third Parties.
16.4 Termination of the Agreement .
16.4.1 Either Party may terminate this Agreement following the material breach of any material provision hereof if the breaching Party shall have failed to remedy such breach within [*] days of receipt of written notice from the non-breaching Party specifying such breach and requesting remedy (or, if such breach cannot be cured within such [*] day period, if the breaching Party does not commence actions to cure such default within such period and thereafter diligently continues such actions or if such breach is not otherwise cured within [*] days after receipt of such notice, except in the case of a payment default, as to which the breaching Party shall have only a [*] day cure period). The Parties acknowledge and agree that, without limiting Alfas rights to seek damages or injunctive relief, Alfa shall not have the right to terminate this Agreement solely as a result of the breach by Salix of the provisions of Sections 6.2.1 or 6.2.2.
16.4.2 Either Party may terminate this Agreement upon written notice to the other Party should the other Party become the subject of proceedings involving bankruptcy, receivership, administration, insolvency, moratorium of payment, reorganization or liquidation, make any assignment for the benefit of the creditors or any equivalent measures in any relevant jurisdiction or admit in writing its inability to meet its financial obligations as they fall due in the ordinary course of business.
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16.4.3 Salix may terminate this Agreement immediately upon notice to Alfa in the event that the FDA requires or causes the withdrawal of a Rifaximin Product that is Promoted, marketed, distributed, offered for sale or sold by Salix or its Affiliates or Sublicensees but excluding any such product that is an over-the-counter product or a dietary supplement or food product.
16.4.4 Salix may terminate this Agreement with respect to the Crohns EIR Product without cause at any time by giving [*] days written notice to Alfa, provided that Alfas rights and Salixs obligations under Section 4.1.2(b)(vi) with respect to any Additional Crohns Product shall survive any such termination, subject to the provisions of Section 4.1.2(b)(vi).
16.4.5 Alfa may terminate this Agreement with respect to the Crohns EIR Product, the Crohns EIR License, the Existing Indications EIR License and the Salix New Indications License (as it pertains to the EIR Formulation) if Salix abandons Development of the Crohns EIR Product and does not recommence such Development within [*] days of any notice in writing served on it by Alfa. In the case of such abandonment of Development of the Crohns EIR Product by Salix, all rights to the Crohns EIR Product and all rights granted to Salix under the Crohns EIR License, the Existing Indications EIR License and the Salix New Indications License (as it pertains to the EIR Formulation) shall revert to Alfa. Notwithstanding the forgoing, Salix shall not be deemed to have abandoned Development of the Crohns EIR Product if it is prevented from performing its work under the Development Plan due to circumstances in which Salixs failure is attributable to a force majeure event (as described in Article 15), provided that (a) in the event of such a force majeure event Salix shall promptly notify Alfa of the circumstances causing the interruption of Salixs performance of the Development Plan and (b) Salix shall use Commercially Reasonable Efforts to resume its performance of the Development Plan as soon as reasonably practicable and (c) Salixs lack of available funds to carry out the Development Plan shall not be deemed to be a force majeure event. For the avoidance of doubt the provisions of this Section 16.4.5 shall not affect in any manner the obligations of Salix under Section 17.2.
16.5 License Survival During Bankruptcy . All rights and licenses granted under or pursuant to this Agreement by Alfa or Salix are, and shall otherwise be deemed to be, for purposes of Paragraph 365(n) of the United States Bankruptcy Code, licenses of rights to intellectual property as defined under Paragraph 101(35A) of the United States Bankruptcy Code. The Parties agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party, including under the United States Bankruptcy Code, the Party hereto that is not a party to such proceeding shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code or any similar provision of law of any jurisdiction outside the United States, subject to performance by the non-subject Party of its obligations under this Agreement. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party, including under the United States Bankruptcy Code, the non-subject Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, if not already in such non-subject Partys
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possession, and that such materials shall be promptly delivered to such non-subject Party upon any such commencement of a bankruptcy proceeding upon written request therefor by such non-subject Party.
Article 17
PERIOD SUBSEQUENT TO THE TERMINATION OF THE AGREEMENT
17.1 Effect of Termination . Upon the termination of this Agreement:
17.1.1 Subject to Section 4.3.3(a) and 16.2:
(a) If the termination is effected by Salix pursuant to Section 16.3.4, 16.4.1 or 16.4.2, all licenses and rights of reference granted hereunder by Salix to Alfa shall terminate but all licenses and rights of reference granted by Alfa to Salix shall survive such termination and continue in full force and effect;
(b) If the termination is effected by Alfa pursuant to Section 16.3.4, 16.4.1 or 16.4.2, all licenses granted hereunder by Alfa to Salix shall terminate but all licenses and rights of reference granted by Salix to Alfa shall survive such termination and continue in full force and effect; and
(c) If the termination is effected by Salix pursuant to Section 16.4.3, all licenses and rights of reference granted hereunder by Alfa to Salix shall terminate but all licenses and rights of reference granted by Salix to Alfa shall survive such termination and continue in full force and effect.
17.1.2 Each Party shall return the other Partys Confidential Information (as set forth in Section 12.4), except, if termination is by either Party pursuant to Section 16.3.4, 16.4.1 or Section 16.4.2, such terminating Party may retain the Confidential Information provided to it by the other Party to the extent reasonably required by such Party to continue to exploit the licenses and rights of reference granted to it by the other Party hereunder.
17.1.3 If the termination is effected by Alfa pursuant to Section 16.3.4, 16.4.1 or 16.4.2 or by Salix pursuant to Section 16.4.3, Alfa may at its sole discretion require Salix to:
(a) Transfer to Alfa or to a company named by Alfa the Regulatory Approvals and other Regulatory Documentation Controlled by Salix for the Crohns EIR Product and Alfa Licensed Products, provided that upon any such transfer Salix shall be entitled to reimbursement of all provable government fees incurred by Salix in connection with the transferred Regulatory Approvals or the applications therefor and all reasonable costs in transferring the Regulatory Approvals and other Regulatory Documentation to Alfa or to a company named by Alfa;
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(b) Transfer to Alfa or a company named by Alfa, at cost, all unsold quantities of the Crohns EIR Product and Alfa Licensed Products, provided that to the extent not transferred to Alfa Salix shall have the right to continue its selling activities in the Salix Territory in order to dispose of said Crohns EIR Product and Alfa Licensed Products (and in such a case Salix shall continue to pay the royalties due in respect thereof pursuant to Article 4); and
(c) Accept delivery of any quantities of Compound and the Crohns EIR Product ordered from Alfa prior to the date of termination under the terms of the Supply Agreements.
17.1.4 If the termination is effected by Salix pursuant to Section 16.3.4, 16.4.1, or 16.4.2, Salix may at its sole discretion require Alfa to:
(a) Transfer to Salix or to a company named by Salix the Regulatory Approvals and other Regulatory Documentation Controlled by Alfa for the Salix Licensed Products, provided that upon any such transfer Alfa shall be entitled to reimbursement of all provable government fees incurred by Alfa in connection with the transferred Regulatory Approvals or the applications therefor and all reasonable costs in transferring the Regulatory Approvals and other Regulatory Documentation to Salix or to a company named by Salix;
(b) Transfer to Salix or a company named by Salix, at cost, all unsold quantities of the Salix Licensed Products, provided that to the extent not transferred to Salix, Alfa shall have the right to continue its selling activities in the Alfa Territory in order to dispose of said Salix Licensed Products (and in such a case Alfa shall continue to pay the royalties due in respect thereof pursuant to Article 4); and
(c) Deliver any quantities of Compound and the Crohns EIR Product ordered from Alfa prior to the date of termination under the terms of the Supply Agreements or accept delivery of any quantity of Salix Licensed Products ordered from Salix prior to the date of termination under the terms of any supply arrangements that may have been concluded between Salix and Alfa in respect of Salix Licensed Products.
17.2 Effect of Termination by Salix or Alfa in Respect of Crohns EIR Product . Upon Salixs termination of this Agreement with respect to the Crohns EIR Product pursuant to Section 16.4.4 or Alfas termination of this Agreement with respect to the Crohns EIR Product, the Crohns EIR License, the Existing Indication EIR License and the Salix New Indications License (as it pertains to the EIR Formulation) pursuant to Section 16.4.5:
17.2.1 the licenses set forth in Sections 4.1.2, 4.1.3 and 4.1.4 (as it pertains to the EIR Formulation) and all other rights and obligations of Salix and obligations of Alfa under this Agreement insofar as they relate to the Crohns EIR Product, Other EIR Products, the EIR Formulation and all underlying Alfa Technology Rights (including rights granted to Salix under clause (b) of Section 16.2.4) shall terminate (other than the obligations of Salix set forth in this Section 17.2 and Section 4.1.2(b)(vi), which survive any such termination);
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17.2.2 Salix shall transfer to Alfa all data, files, records and other materials in its possession or control produced within the scope of the activities performed pursuant to the Development Plan relating to the Crohns EIR Product;
17.2.3 if Salix has not then finished Development of the Crohns EIR Product as set forth in the then-current Development Plan, Salix shall provide Alfa with sufficient funding (as specified in the then-current Development Plan and the budget constituting part thereof) to complete the Development of the Crohns EIR Product as contemplated in such Development Plan and budget;
17.2.4 Alfa shall be free to Exploit the EIR Formulation and Rifaximin Products containing the EIR Formulation anywhere in the world, including the Salix Territory, itself or, may license such rights to one or more licensees;
17.2.5 all rights granted to Salix under this Agreement with respect to the receipt of information, data, Regulatory Documentation and the like, and the right to participate in meetings with Regulatory Authorities, shall terminate with regards to all matters pertaining to the Crohns EIR Product, Other EIR Products, the EIR Formulation and Rifaximin Products containing the EIR Formulation; and
17.2.6 the Salix Designated Indication License and [*]/Other New Formulation License shall not be affected thereby but shall remain in effect in accordance with their respective terms set forth in this Agreement.
17.3 Effect of Termination on Sublicenses .
17.3.1 Termination by Salix .
(a) Any and all sublicense agreements entered into by Salix or any of its Affiliates with a Sublicensee pursuant to Section 4.1.6 shall survive the termination of this Agreement by Salix pursuant to Section 16.4.1 or 16.4.2 except to the extent that any such Sublicensee under any such sublicense agreement is in material breach of this Agreement or such sublicense agreement, in which case Alfa shall have the right to terminate any such sublicense agreement.
(b) Any and all sublicense agreements entered into by Alfa or any of its Affiliates with a Sublicensee pursuant to Section 4.2.6 shall survive the termination of this Agreement by Salix pursuant to Section 16.4.1 or 16.4.2, except to the extent that any such Sublicensee under any such sublicense agreement is in material breach of this Agreement or such sublicense agreement, in which case Salix shall have the right to terminate any such sublicense agreement in its entirety. Following any such termination of this Agreement by Salix pursuant to Section 16.4.1 or 16.4.2, Alfa shall, at the request of Salix, assign any such sublicense agreement (to the extent not terminated pursuant to the preceding sentence) to Salix or its designated Affiliate and, upon such assignment, Salix or its Affiliate, as applicable, shall assume such sublicense agreement, as applicable. For clarity, any sublicense agreement entered into by Alfa in respect of its rights hereunder with any of its Affiliates shall terminate upon the termination of this Agreement by Salix pursuant to Section 16.4.1 or 16.4.2.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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17.3.2 Termination by Alfa .
(a) Any and all sublicense agreements entered into by Alfa or any of its Affiliates with a Sublicensee pursuant to Section 4.2.6 shall survive the termination of this Agreement by Alfa pursuant to Section 16.4.1 or 16.4.2 except to the extent that any such Sublicensee under any such sublicense agreement is in material breach of this Agreement or such sublicense agreement, in which case Salix shall have the right to terminate any such sublicense agreement.
(b) Any and all sublicense agreements entered into by Salix or any of its Affiliates with a Sublicensee pursuant to Section 4.1.6 shall survive the termination of this Agreement by Alfa pursuant to Section 16.4.1 or 16.4.2, except to the extent that any such Sublicensee under any such sublicense agreement is in material breach of this Agreement or such sublicense agreement, in which case Alfa shall have the right to terminate any such sublicense agreement in its entirety. Following any such termination of this Agreement by Alfa pursuant to Section 16.4.1 or 16.4.2, Salix shall, at the request of Alfa, assign any such sublicense agreement (to the extent not terminated pursuant to the preceding sentence) to Alfa or its designated Affiliate and, upon such assignment, Alfa or its Affiliate, as applicable, shall assume such sublicense agreement, as applicable. For clarity, any sublicense agreement entered into by Salix in respect of its rights hereunder with any of its Affiliates shall terminate upon the termination of this Agreement by Alfa pursuant to Section 16.4.1 or 16.4.2.
17.4 Survival . The following provisions shall survive the expiration of this Agreement or the termination of this Agreement in its entirety: Article 3, Sections 4.1.6(b) (subject to Section 17.3), 4.2.6(b) (subject to Section 17.3), 4.3, 4.4, 4.6 4.9, 8.1.2, 11.1, 11.2.2 11.2.4, 11.4, 11.5, 11.7.3 11.7.5, 11.8 (to the extent it relates to surviving Sections of Article 11), 11.9, Article 12, Sections 13.2, 13.3, and 13.5, Article 14, Section 16.2.4, and Articles 17 31. Without limiting the foregoing, all such other provisions which by their terms are intended to survive the expiration or termination of this Agreement shall so survive in accordance with their terms.
17.5 Accrued Rights . Termination or expiration of this Agreement for any reason shall be without prejudice to any right which shall have accrued to the benefit of either Party prior to such termination or expiration, including damages arising from any breach under this Agreement. Such termination or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement.
Article 18
DISPUTE RESOLUTION
18.1 Good Faith Discussions . In the event that any controversy or claim shall arise between the Parties under, out of, in connection with, or relating to this Agreement or the breach thereof, the Party initiating such controversy or making such claim shall provide to the other Party written notice containing a brief and concise
83
statement of the initiating Partys claims, together with relevant facts supporting them. During a period of [*] days, or such longer period as may be mutually agreed upon in writing by the Parties, following the date of said notice, the Parties shall make good faith efforts to settle the dispute. Such efforts may include, but shall not be limited to, full presentation of both Parties claims and responses, with or without the assistance of counsel, before the chief executive officers (or their designees) of the Parties. Notwithstanding anything set forth in this Article 18 to the contrary, disputes with respect to inventorship, ownership or validity of any Intellectual Property Right pertaining to the Compound or the Crohns EIR Products or Licensed Products shall be resolved in the manner set forth in Section 11.5, and actions pertaining to breaches of Article 12 shall be governed by Section 12.5.
18.2 Arbitration . In the event that the Parties have been unable to reach accord using the procedures set forth in Section 18.1 and only if such is the case, either Party may seek final resolution of the matter through binding arbitration, and only through binding arbitration. The failure of a Party to comply with the provisions of Section 18.1 with respect to any controversy or claim shall constitute an absolute bar to the institution of any proceedings, by arbitration or otherwise, with respect to such controversy or claim. Any such arbitration shall be held in Paris, France in the English language before a panel of three (3) arbitrators in accordance with the then existing Rules of Arbitration of the International Chamber of Commerce (the ICC ) and judgment upon the award rendered by the arbitrators may be entered or enforced in any court having jurisdiction thereof. In any arbitration proceeding hereunder, each Party shall select one arbitrator and the arbitrators selected by the Parties shall then select a third arbitrator, who shall have at least [*] years experience in pharmaceutical patent licensing. The arbitrators shall permit the Parties to have discovery to the extent permitted by the rules of the ICC. The decision of the arbitrators shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrators explaining the arbitrators rationale for their decision. Except as may otherwise be determined by the arbitrators in their award to be just and appropriate in light of the particular circumstances and outcome of the arbitration, the Party losing the arbitration shall pay all fees and costs of the arbitrators and the ICC and reimburse the prevailing Party for its reasonable attorneys fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses). The intent of the Parties is that except for the entering of an arbitration order in a court of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse to litigation in the courts.
18.3 Exceptions . Notwithstanding the foregoing provisions of Sections 11.5, 18.1 and 18.2, either Party may initiate an action before any court having competent jurisdiction in order to obtain interim or conservatory relief, such as an order to preserve the status quo and to avoid incurring irreparable harm pending the resolution of any dispute that is submitted to arbitration, to prevent or enjoin a breach or threatened breach of confidentiality or to enforce provisions of this Agreement relating to ownership rights in intellectual property without complying with the procedures set forth in Sections 11.5, 18.1 and 18.2.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 19
ASSIGNMENT
19.1 Binding Effect . This Agreement shall be binding upon and inure to the benefit of Parties hereto and their respective successors and permitted assigns.
19.2 Assignment by Alfa . Alfa shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom the Alfa Licensed Patents and Alfa Technology Rights are transferred, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Salix hereby acknowledges and accepts any such assignment, but Alfa shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Salix, such consent not to be unreasonably withheld or delayed.
19.3 Assignment by Salix . Salix shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom the Salix Licensed Patents and Salix Technology Rights are transferred, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Alfa hereby acknowledges and accepts any such assignment, but Salix shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Alfa, such consent not to be unreasonably withheld or delayed.
Article 20
ENTIRE AGREEMENT AND MODIFICATION
This Agreement together with the Related Agreements constitute the final and complete understanding existing between Alfa and Salix relating to the subject matter hereof. The terms of this Agreement cannot be substituted, superseded, waived or modified in any manner except by written agreement executed for and on behalf of each of Alfa and Salix. In the event of any conflict between the terms of this Agreement and any of the Related Agreements, this Agreement and the Related Agreements shall be read as a single whole so as to accomplish the intent of the Parties as it so manifests itself.
Article 21
LANGUAGE AND GOVERNING LAW
21.1 All communications notices and proceedings required to be given hereunder shall be in the English language.
21.2 This Agreement shall be governed by and construed in accordance with the laws of Switzerland, without giving effect to any conflict of laws principles or rules. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
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Article 22
WAIVER
No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver.
Article 23
NOTICES
Except as otherwise herein provided, all notices to be served or notified to the Parties hereunder shall (a) be mailed by internationally recognized courier service or by registered airmail return receipt requested to their respective addresses listed below or to any other address subsequently communicated in writing, or (b) delivered by e-mail marked as being of high importance to the e-mail address set forth below (to be confirmed by written notice sent in the manner set forth in clause (a)), and shall be deemed to have been given [*] Business Days after the day on which such mailing is made, or on the next Business Day after the day on which it is sent in the case of any e-mail which is followed by written notice as aforesaid.
If to Salix, to :
Salix Pharmaceuticals, Inc.
Attn: General Counsel
8510 Colonnade Center Drive
Raleigh, North Carolina 27615
United States
with copies (which shall not constitute notice) to:
Salix Pharmaceuticals, Inc.
Attn: Executive Vice President Business Development
8510 Colonnade Center Drive
Raleigh, North Carolina 27615
United States
E-Mail: [*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
86
and
Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, D.C. 20004
United States
Attention: Edward C. Britton, Esq.
E-mail: ebritton@cov.com
If to Alfa, to :
Alfa Wassermann S.p.A
Attn. Mr. Andrea Golinelli
Via Ragazzi del 99 no. 5
40133 Bologna, Italy
E-mail: [*]
with copies(which shall not constitute notice) to:
Alfa Wassermann S.p.A
Attn. Andrea Montanari
Via Ragazzi del 99 no. 5
40133 Bologna, Italy
E-mail: [*]
and
Alfa Wassermann, Inc.
4 Henderson Drive
West Caldwell, New Jersey 07006
U.S.A.
Attention: Ira S. Nordlicht, President and Chief Executive Officer
E-mail: [*]
and
Nordlicht& Hand
800 Westchester Avenue
Rye Brook, New York 10514
U.S.A.
Attention: Brian M. Hand, Esq.
E-mail: [*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
87
Article 24
SEVERABILITY
If any part of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of the invalid or unenforceable part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the Parties hereto.
Article 25
HEADINGS AND CONSTRUCTION
25.1 Headings are inserted for convenience and shall not by themselves define, describe, extend, limit or determine the interpretation of this Agreement.
25.2 References in this Agreement to Sections, Articles and Exhibits refer to Sections and Articles of, and Exhibits to, this Agreement except as otherwise specifically noted.
25.3 Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders. The term including as used herein shall mean including, without limiting the generality of any description preceding such term. The word or shall be interpreted in accordance with its ordinary meaning as the context indicates.
Article 26
COUNTERPARTS
This Agreement may be executed in two or more counterparts each of which shall be deemed an original and which together shall constitute one and the same instrument.
Article 27
MUTUAL DRAFTING
This Agreement constitutes the joint product of the Parties hereto. Each provision has been subject to the mutual consultation and agreement of such Parties and shall not be construed for or against either of them based on authorship.
88
Article 28
THIRD PARTY RIGHTS
No provision of this Agreement is intended to be enforceable by any Person other than the Parties hereto, their permitted assigns, and Persons entitled to indemnification pursuant to Article 14.
Article 29
RELATIONSHIP OF THE PARTIES
It is expressly agreed that Alfa, on the one hand, and Salix, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Alfa, on the one hand, nor Salix, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
Article 30
PERFORMANCE BY AFFILIATES
Each of Alfa and Salix acknowledges that its performance of its obligations and its exercise of rights under this Agreement may be performed or exercised, respectively, by Affiliates of Alfa and Salix. Each of Alfa and Salix guarantees performance of this Agreement by any of its Affiliates.
89
Article 31
FURTHER ASSURANCE
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
Article 32
SUBCONTRACTORS
Salix and Alfa shall each have the right to subcontract any of its Development and Commercialization activities with respect to Rifaximin Products to a Third Party. Each Party shall remain solely responsible for all costs and expenses associated with its use of subcontractor(s) hereunder.
(Signatures appear on the next page.)
90
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first written above.
SALIX PHARMACEUTICALS, INC. | ALFA WASSERMANN S.p.A. | |||||||
By: | /s/ Rick Scruggs | By: | /s/ Andrea Golinelli | |||||
Name: | Rick Scruggs | Name: | Andrea Golinelli | |||||
Title: | EVP Business Development | Title: | Chief Strategy Officer |
[Signature page for Amended and Restated License Agreement]
APPENDIX 1
Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject who has been administered a medicinal product, where the untoward medical occurrence is temporally associated with the use of the medicinal product whether or not considered related to the product; it does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
EXHIBIT A
ALFA PATENTS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT B
SALIX PATENTS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT C
JOINT PATENTS
None known at this time.
EXHIBIT D
[*] REPORT
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT E
[*] AGREEMENT
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT F
DEVELOPMENT PLAN
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT G
ALFA INTELLECTUAL PROPERTY EXCEPTIONS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT H
SECTION 13.2.1 SALIX PATENTS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT I
SALIX SUBLICENSES
There are no granted sublicenses.
EXHIBIT J
ALFA SUBLICENSES
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
EXHIBIT K
EIR PATENT APPLICATIONS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Exhibit 10.96
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
EIR SUPPLY AGREEMENT
dated August 6, 2012
by and between
A LFA W ASSERMANN S. P .A.
and
S ALIX P HARMACEUTICALS , I NC .
TABLE OF CONTENTS
Page | ||||||
ARTICLE 1 |
RECITALS |
1 | ||||
ARTICLE 2 |
CERTAIN DEFINITIONS |
2 | ||||
ARTICLE 3 |
SUPPLY OF EIR PRODUCTS |
8 | ||||
3.1 |
Supply of Products |
8 | ||||
3.2 |
Specifications |
8 | ||||
3.3 |
Packaging |
9 | ||||
3.4 |
Alfas Obligations |
9 | ||||
3.5 |
Selection of Manufacturers |
9 | ||||
3.6 |
Salixs Obligations |
10 | ||||
3.7 |
Compliance with Applicable Laws |
11 | ||||
3.8 |
Retention of Manufacturing Records and Samples |
11 | ||||
3.9 |
Regulatory Cooperation of Alfa |
12 | ||||
3.10 |
Maintenance of Manufacturing Facility |
12 | ||||
3.11 |
Recalls and Withdrawals |
13 | ||||
3.12 |
Shortages |
13 | ||||
ARTICLE 4 |
TERMS AND CONDITIONS OF SUPPLY |
14 | ||||
4.1 |
Pricing |
14 | ||||
4.2 |
Shipping Terms |
14 | ||||
4.3 |
Payment Terms |
14 | ||||
4.4 |
Taxes |
14 | ||||
4.5 |
Samples |
15 | ||||
ARTICLE 5 |
ORDERS |
15 | ||||
5.1 |
Delivery Date Lead Time |
15 | ||||
5.2 |
Forecasts |
15 | ||||
5.3 |
Orders |
15 | ||||
ARTICLE 6 |
QUALITY ASSURANCE |
16 | ||||
6.1 |
Quality Agreement |
16 | ||||
6.2 |
Quality Assurance |
16 | ||||
ARTICLE 7 |
WARRANTIES AND INSPECTION |
16 | ||||
7.1 |
Alfa Warranties |
16 | ||||
7.2 |
Inspection Rights |
17 | ||||
7.3 |
Reporting |
18 | ||||
7.4 |
Quality Control Evaluation and Non-Conforming Product |
18 | ||||
7.5 |
Safety Data Exchange Agreement |
20 | ||||
ARTICLE 8 |
INDEMNIFICATION AND DAMAGES |
20 | ||||
8.1 |
In Favor of Salix |
20 | ||||
8.2 |
In Favor of Alfa |
20 | ||||
8.3 |
Notice; Defense |
21 |
- i -
TABLE OF CONTENTS
Page | ||||||
8.4 |
Right to Participate in Defense |
22 | ||||
8.5 |
Insurance |
22 | ||||
8.6 |
Limitations on Liability |
22 | ||||
ARTICLE 9 |
INTELLECTUAL PROPERTY AND IMPROVEMENTS |
23 | ||||
9.1 |
License to Alfa |
23 | ||||
9.2 |
No Transfer of Intellectual Property Rights |
23 | ||||
9.3 |
Manufacturing Records and Process Improvements |
23 | ||||
ARTICLE 10 |
CONFIDENTIALITY |
23 | ||||
10.1 |
Salixs Obligations |
23 | ||||
10.2 |
Alfas Obligations |
24 | ||||
10.3 |
Exceptions to Confidentiality and Non-Disclosure Obligations |
24 | ||||
10.4 |
Permitted Disclosures |
25 | ||||
10.5 |
Return of Confidential Information |
26 | ||||
10.6 |
Injunctive Relief |
26 | ||||
10.7 |
Disclosure of Agreement |
26 | ||||
ARTICLE 11 |
LICENSE TO MANUFACTURE |
27 | ||||
ARTICLE 12 |
TERMINATION |
27 | ||||
12.1 |
Term |
27 | ||||
12.2 |
Termination |
27 | ||||
12.3 |
Survival |
28 | ||||
ARTICLE 13 |
FORCE MAJEURE |
28 | ||||
ARTICLE 14 |
DISPUTE RESOLUTION |
28 | ||||
14.1 |
Good Faith Discussions |
28 | ||||
14.2 |
Arbitration |
29 | ||||
14.3 |
Exceptions |
29 | ||||
ARTICLE 15 |
ASSIGNMENT |
30 | ||||
15.1 |
Binding Effect |
30 | ||||
15.2 |
Assignment by Alfa |
30 | ||||
15.3 |
Assignment by Salix |
30 | ||||
ARTICLE 16 |
ENTIRE AGREEMENT AND MODIFICATION |
30 | ||||
ARTICLE 17 |
LANGUAGE AND GOVERNING LAW |
30 | ||||
17.1 |
English Language |
30 | ||||
17.2 |
Governing Law |
30 | ||||
ARTICLE 18 |
WAIVER |
31 | ||||
ARTICLE 19 |
NOTICES |
31 |
- ii -
TABLE OF CONTENTS
Page | ||||||
ARTICLE 20 |
SEVERABILITY |
32 | ||||
ARTICLE 21 |
HEADINGS AND CONSTRUCTION |
33 | ||||
21.1 |
Headings |
33 | ||||
21.2 |
References |
33 | ||||
21.3 |
Rules of Construction |
33 | ||||
ARTICLE 22 |
COUNTERPARTS |
33 | ||||
ARTICLE 23 |
MUTUAL DRAFTING |
33 | ||||
ARTICLE 24 |
THIRD PARTY RIGHTS |
33 | ||||
ARTICLE 25 |
RELATIONSHIP OF THE PARTIES |
34 | ||||
ARTICLE 26 |
PERFORMANCE BY AFFILIATES |
34 | ||||
ARTICLE 27 |
FURTHER ASSURANCE |
34 | ||||
ARTICLE 28 |
SUBCONTRACTORS |
34 | ||||
EXHIBIT A |
- Patents |
|||||
EXHIBIT B |
- Pricing Methodology |
- iii -
EIR SUPPLY AGREEMENT
EIR SUPPLY AGREEMENT (this Agreement ) dated August 6, 2012 (the Effective Date ) by and between Alfa Wassermann S.p.A., a corporation incorporated under the laws of Italy ( Alfa ), and Salix Pharmaceuticals, Inc., a corporation incorporated under the laws of the State of California, United States of America ( Salix ) (each, a Party and, collectively, the Parties ).
WITNESSETH:
WHEREAS, simultaneously with the execution of this Agreement, Alfa and Salix are entering into (a) an Amended and Restated License Agreement (the Amended and Restated License Agreement ) which amends and restates in its entirety a certain License Agreement entered into by the Parties, dated June 24, 1996 (the 1996 License Agreement ), and which provides in part for (i) the license by Alfa to Salix of certain patent rights and unpatented technology rights pertaining to the EIR Formulation for the purpose of enabling Salix to sell Rifaximin Products with the EIR Formulation in the Field in the Salix Territory, and (ii) the development of a Rifaximin Product having the EIR Formulation for the treatment, prevention or amelioration of Crohns disease (the Crohns EIR Product ), and (b) an Amendment to the Supply Agreement between Alfa and Salix, dated June 24, 1996, as amended [*], dealing with Alfas supply to Salix of rifaximin; and
WHEREAS, pursuant to the terms of the Amended and Restated License Agreement, the Parties have agreed that Alfa shall be the exclusive supplier to Salix of Rifaximin Products with the EIR Formulation, including the Crohns EIR Product, following the development of such products and the grant of regulatory approval in the Salix Territory for the sale and use of such products;
NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties hereby agree as follows:
ARTICLE 1
RECITALS
It is acknowledged and agreed that the recitals to this Agreement and the Exhibits to this Agreement form an integral part hereof and are expressly incorporated in this Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
ARTICLE 2
CERTAIN DEFINITIONS
The following words and expressions used in this Agreement shall have the following meanings:
(a) Affiliate(s) means with respect to Alfa or Salix, as the case may be, any Person or other entity that directly or indirectly controls, is controlled by or is under common control with such Party. For the purpose of this definition, control means the (i) possession of the power to direct or cause the direction of the management and policies of such Party, whether through ownership of voting securities, by contract or otherwise or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of such Party.
(b) Alfa Indemnified Party has the meaning set forth in Section 8.2.
(c) Alfa Know-How means all Know-How Controlled by Alfa or its Affiliates or Sublicensees as of the date hereof or at any time during the Term of this Agreement pertaining to Manufacturing, whether or not patented or patentable, but only to the extent not claimed in or covered by any published or otherwise publicly available Alfa Licensed Patent.
(d) Alfa Licensed Patents means
(i) all Patents listed in Exhibit A and any continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, divisionals, reexaminations, reissues, revalidations, substitutes, extensions, and renewals of any of the foregoing Patents or applications, including any Patents or patent applications claiming priority to such Patents or patent applications; and
(ii) all Patents that are Controlled by Alfa or its Affiliates or Sublicensees as of the date hereof or at any time during the Term pertaining to Manufacturing.
(e) Alfa Licensed Product means a Rifaximin Product which at any time during the Term is covered by or uses or employs one or more rights within the Alfa Technology Rights or Joint Technology Rights.
(f) Alfa Technology Rights means the Alfa Licensed Patents and the Alfa Know-How.
(g) Batch means a uniquely or identifiable quantity of Product which has been processed in one process or series of processes to the extent that such quantity could be expected to be homogenous.
(h) Business Day means any day other than a Saturday or Sunday on which banking institutions in both New York, New York and Bologna, Italy are open for the conduct of routine banking business at their counters in the said cities.
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(i) Calendar Year means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31.
(j) Certificate of Analysis means a document signed by the Manufacturer stating and confirming that the Product to which such document refers has been Manufactured in accordance with the Specifications for such Product and cGMP.
(k) cGMP means the current Good Manufacturing Practice standards promulgated or endorsed by the FDA or other Regulatory Authorities, including those procedures expressed or implied in the Marketing Approvals and other regulatory filings made with the Regulatory Authorities.
(l) CMC Data means the chemistry, manufacturing and controls data required by applicable law to be included in a New Drug Application ( NDA ) (as defined in the FFDCA and the regulations promulgated thereunder) for a Product.
(m) Compound means the chemical compound known as rifaximin, which is [*]. For the avoidance of doubt, [*] shall constitute Compound.
(n) Confidential Information means all information provided by or on behalf of one Party to the other Party, whether before or after the Effective Date, including original documents, patent applications, data analysis, drawings, models, samples, compounds, devices, specifications, flow sheets, descriptions, submissions to Regulatory Authorities, and other tangible material and copies thereof, whether or not such information is identified as confidential or proprietary.
(o) Control means, with respect to any Intellectual Property right, trademark or trade name, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise (other than by operation of any license and other grants hereunder, under the Amended and Restated License Agreement, or under the Trademark License Agreements), to assign or grant a license, sublicense or other right to or under such Intellectual Property right, trademark or trade name as provided for herein or any other agreement or other instrument contemplated hereby without violating the terms of any agreement or other arrangement with any third party.
(p) Crohns EIR Product has the meaning set forth in the preamble hereof.
(q) Designated Expert has the meaning set forth in Section 4.1.
(r) EIR Formulation means the Compound in the form of extended intestinal release, [*], including the descriptions set forth in the patent applications listed in Exhibit A.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(s) Excluded Lists means (i) the U.S. Department of Health and Human Service and Office of Inspector Generals List of Excluded Individuals/Entities that are excluded from participation in Medicare, Medicaid and all other Federal health care programs and (ii) the Excluded Parties List System maintained by the U.S. General Services Administration.
(t) Exploit means, in respect of a particular pharmaceutical product, to make, have made, import, use, sell or offer for sale, including to research, develop, commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), use, have used, export, transport, distribute, promote, or otherwise dispose of such product, and Exploitation means the act of Exploiting a product or process.
(u) FDA means the United States Food and Drug Administration or any successor agency.
(v) FFDCA has the meaning set forth in Section 7.1(g).
(w) Field means the prevention, treatment, amelioration, diagnosis or monitoring of human (i) gastrointestinal and respiratory tract diseases and conditions and (ii) hepatic encephalopathy.
(x) ICC has the meaning set forth in Section 14.2.
(y) Intellectual Property means any rights in any invention, whether or not patentable, discovery, Know-How, Patent, copyright, trade secret or trademark or any other proprietary information protectable by statutory provision or common law doctrine, but specifically excluding trademarks and trade names.
(z) Know-How means any and all data, information, technology, specifications, processes, methods, designs, Raw Materials, results, assistance, trade secrets, special ability, formulations, compositions, discoveries, developments and Manufacturing techniques (in the case of all of the foregoing whether or not confidential, proprietary and whether in written, electronic or any other form now known or hereafter developed during the Term).
(aa) Legal Requirements has the meaning set forth in Section 3.2(a).
(bb) Losses has the meaning set forth in Section 8.1.
(cc) Manufacture , Manufacturing and Manufactured mean, in respect of a particular pharmaceutical product, and without limitation, all activities related to the production, manufacture, processing, formulation, filling, finishing, packaging, labeling, shipping, handling, holding, storage and warehousing of such product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
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(dd) Manufacturers means the manufacturers designated by Alfa to perform Manufacturing on behalf of Alfa (which, for the avoidance of doubt, may, but is not required to, include Alfa or one of its Affiliates as a designated manufacturer), which manufacturers shall be changed only as provided in Section 3.5.
(ee) Manufacturing Deadline has the meaning set forth in Section 3.5.
(ff) Manufacturing Facility means, the plant(s) where the Products shall be Manufactured for the purposes of supplying Salix hereunder.
(gg) Marketing Approval means, with respect to a particular pharmaceutical product and a particular country or other jurisdiction, any and all approvals, registrations, certificates, licenses or authorizations of any Regulatory Authority necessary to Commercialize such product in such country or jurisdiction, including, where applicable, (i) pricing or reimbursement approval in such country or jurisdiction, (ii) pre- and post-approval manufacturing and marketing authorizations (including any prerequisite marketing approval), (iii) drug naming approvals and product labeling approval, and (iv) technical, medical and scientific licenses.
(hh) Net Sales means [*].
With respect to sales of a Crohns EIR Product or Other EIR Product which is sold as a combination product containing at least one other active pharmaceutical ingredient ( API ) beside the Compound, Net Sales shall be calculated on the basis of [*]:
(i) [*], or
(ii) [*].
If the other API(s) included in the combination product are not sold by Salix, Net Sales for the combination product shall be calculated by [*].
If a Crohns EIR Product or Other EIR Product is not sold on arms length terms but is used or otherwise disposed of on a commercial basis by a Third Party, the price that would have been charged (after the deductions set forth above) on an arms length sale in such country shall be deemed the Net Sales for the sale of such Crohns EIR Product or Other EIR Product, provided that any Crohns EIR Product or Other EIR Product supplied and used in clinical trials or for other research or development activities or reasonably and customarily supplied for promotional care purposes as samples or for charitable or indigent care purposes shall not be treated as being disposed of on a commercial basis and shall be ignored for the purpose of calculating Net Sales.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(ii) Other EIR Products means Rifaximin Products containing the EIR Formulation, but excluding the Crohns EIR Product.
(jj) Patents means all national, regional and international patents and patent applications, including provisional patent applications, utility models, petty patents, design patents, certificates of invention and other similar rights, so-called pipeline protection, any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions.
(kk) Person means any individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
(ll) Process Improvements means all improvements, modifications or adaptations to any process employed by Alfa or any Manufacturer used in Manufacturing.
(mm) Products means finished pharmaceutical products employing the EIR Formulation for the treatment of indications within the Field. For clarity, Products shall include only the Crohns EIR Product and Other EIR Products.
(nn) Putting into Commerce means the date of the first commercial sale to third parties (excluding sublicensees) of a Product by or on behalf of Salix or any Sublicensees of Salix under the terms of the Amended and Restated License Agreement made in any part of the Salix Territory after all relevant Marketing Approvals shall have been granted by the relevant Regulatory Authorities in respect of the Products in such part of the Salix Territory.
(oo) Quality Agreement has the meaning set forth in Section 6.1, as such agreement shall be amended from time to time.
(pp) Raw Materials means the raw materials stated in the Specifications and any other raw material ingredients and excipients and packaging or other components needed for Manufacturing.
(qq) Regulatory Approval means, in respect of a particular country, the technical, medical and scientific licenses, registrations, authorizations and approvals of any Regulatory Authority necessary for the development, clinical testing, Manufacture, distribution, marketing, promotion, offering for sale, use, import, export, sale or other commercialization of a drug product in such country, including Marketing Approvals, NDAs, Product License Approvals ( PLA ), Investigational New Drug ( IND ) applications, biologic license applications, supplements and amendments, pre- and post-approvals, pricing or reimbursement approvals, drug naming approvals, product labeling approvals, and drug master files.
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(rr) Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entity, including the FDA and HPFB, regulating or otherwise exercising authority with respect to the development, commercialization, Manufacturing and promotion (including the determination of pricing/reimbursement) of pharmaceutical products in the Salix Territory.
(ss) Rifaximin Product means any pharmaceutical, biological or other composition, preparation or other type of product (including any over-the-counter product) that contains the Compound (including any such product that contains the Compound together with one or more other active ingredients (which may be either combined in a single formulation or bundled with separate formulations but sold as one product)).
(tt) Salix Indemnified Party has the meaning set forth in Section 8.1.
(uu) Salix Know-How means all Know-How Controlled by Salix or its Affiliates or Sublicensees as of the date hereof or at any time during the Term of this Agreement pertaining to Manufacturing, whether or not patented or patentable, but only to the extent not claimed in or covered by any published or otherwise publicly available Salix Licensed Patent.
(vv) Salix Licensed Patents means all Patents that are Controlled by Salix or its Affiliates or Sublicensees as of the date hereof or at any time during the Term pertaining to Manufacturing.
(ww) Salix Technology Rights means the Salix Licensed Patents and the Salix Know-How.
(xx) Salix Territory means the United States (including its territorial possessions, territories and the Commonwealth of Puerto Rico) and Canada.
(yy) Specifications means the specifications for each Product as identified in the respective regulatory filings (i.e. IND, NDA, etc.) for procedures, Raw Materials, Standards, and quality control testing to ensure compliance of Manufacturing with the Product requirements, as the same may be changed from time to time pursuant to the procedures set forth in Section 3.2, which shall be incorporated in this Agreement by this reference and made a part hereof as if fully restated herein.
(zz) Sublicensee means a Person, other than an Affiliate, that is granted a sublicense by a Party under the license grants under the Amended and Restated License Agreement or that was granted a similar sublicense under the 1996 License Agreement.
(aaa) Term has the meaning set forth in Section 12.1.
Capitalized terms used in this Agreement and not otherwise defined have the meanings set forth in the Amended and Restated License Agreement.
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ARTICLE 3
SUPPLY OF EIR PRODUCTS
3.1 Supply of Products . Subject to the terms hereof, Salix hereby appoints Alfa as its exclusive manufacturer for all of Salixs requirements of the Products for sale by Salix pursuant to the Amended and Restated License Agreement in the Salix Territory within the Field, and Alfa accepts such appointment. During the Term, Alfa or another Manufacturer shall Manufacture each Product for Salix in accordance with each Products respective Specifications, and Salix shall acquire all of its commercial requirements for the Products from Alfa. Alfa shall have the right to appoint [*] or more Manufacturers for the Products as contemplated in Section 3.5, but shall remain primarily responsible for the supply of the Products to Salix in compliance with the terms of this Agreement.
3.2 Specifications . The Specifications for each Product shall be agreed upon in writing by the Parties and incorporated into this Agreement. The Specifications may be modified from time to time as set forth below:
(a) If either Alfa or Salix determines that it is necessary to amend, modify or supplement the Specifications, the Manufacturing process, or the test methods for any Product in order for such Product to comply with any Regulatory Approval for the Product, request from any Regulatory Authority, cGMP or changes in any applicable law or regulation (collectively, Legal Requirements ), the Parties shall discuss in good faith whether any such amendment, modification or supplement to the Specifications is required, and if so, the manner in which the amendment, modification or supplement will be implemented. Salix promptly shall provide Alfa with appropriate documentation relating to any such changes to the Specifications or Manufacturing process that it believes are necessary.
(b) Except to the extent required to comply with any Legal Requirement, Alfa shall not amend, modify or supplement the Specifications, the Manufacturing process, or the test methods for the Product or any Raw Materials used in connection with Manufacturing Product, without the prior written consent of Salix, such approval not to be unreasonably withheld or delayed.
(c) Salix shall reimburse Alfa for reasonable expenses that are actually incurred by Alfa in connection with any material amendment, modification or supplement of the Specifications or the Manufacturing process for the Product necessitated by a Legal Requirement, including reasonable costs of capital equipment and process upgrades and obsolescence of Raw Materials, goods-in-process, and finished goods not suitable for other use in the business or operations of Alfa or any of its Affiliates;
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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provided , however , that Salixs liability for such reimbursement shall be limited to levels of inventory that are consistent with the most recent forecast and binding orders submitted by Salix; and further provided , that Salix and Alfa shall engage in good faith discussions regarding the amount of such expenses.
(d) Alfa shall be solely responsible for any and all increased costs or expenses incurred by it or Salix as a result of any amendment of the Specifications or the Manufacturing process for Product requested by Alfa and consented to in writing by Salix.
No change to the Specifications for a Product shall be implemented unless the prior written approval of the Regulatory Authorities to the change, if and to the extent required, has been obtained.
3.3 Packaging .
(a) Salix shall select the packaging requirements for each Product for the Salix Territory, subject to approval by the relevant Regulatory Authorities. Salix shall provide all artwork for labels to Alfa. Alfa shall be responsible for imprinting the lot numbers and expiration dates on the label for each Product. In the event Salix makes changes to Product labeling thereafter, Salix shall pay Alfa the costs of unused Salix specific packaging materials for the Product to the extent that such packaging materials were intended to meet Salixs most recent forecast for the succeeding [*] months. Salix shall provide Alfa with at least [*] days lead time to implement any changes to Product packaging that Salix requests.
(b) The Manufacturers shall have the right to subcontract the packaging of the Products.
3.4 Alfas Obligations . Alfa, at its sole expense, shall provide all labor, utilities, equipment, Raw Materials and components necessary for Manufacturing, shipping and storage of the Products. The Products shall be Manufactured by Manufacturers to the Specifications for each Product. The Manufacturer shall retain such Manufacturing records and samples of the Products as set forth in Section 3.8.
3.5 Selection of Manufacturers . Alfa shall qualify at least [*] Manufacturers for the Products, one of which shall be qualified prior to the date on which the FDA is expected to approve the NDA for the first Product, and the other shall be qualified not later than[*] months after the date on which the FDA approves the NDA for the first Product (the Manufacturing Deadline ), and shall at all times thereafter during the Term ensure that there are at least [*] sources of supply of the Products available to Salix pursuant to the terms of this Agreement that are fully qualified to Manufacture the Products pursuant to FDA regulations. In selecting the Manufacturers and the Manufacturing Facilities,
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Alfa shall give consideration that the purpose of having a [*] source of supply is to be able to maintain supply of the Products in the event that Manufacturing is interrupted at the other Manufacturing Facility. Subject to the previous sentence, the prior written notice to Salix and receipt of any necessary approvals of the Regulatory Authorities, Alfa may designate and change either or both Manufacturers or the Manufacturing Facilities. If Alfa fails to qualify [*] of the Products by [*], then Salix may deliver a written notice of such breach to Alfa. In the event that Alfa has been making Commercially Reasonable Efforts to qualify the [*] prior to [*], Alfa shall have up to an additional [*] months from its receipt of such notice to qualify [*], provided that Alfa continues to use Commercially Reasonable Efforts to so qualify [*] during such [*]-month period. In such case, Alfa shall keep Salix informed of all material developments pertaining to the qualification of [*] Facility. If Alfa does not qualify [*] by the end of such [*] month period or fails to use Commercially Reasonable Efforts to qualify [*] prior to or following [*], then Salix may designate and qualify a party of its own selection to Manufacture Products for Salix and commit to purchasing not more than [*] percent ([*]%) of its requirements from such manufacturer for a commercially reasonable period of time. If Alfa subsequently notifies Salix that Alfa has qualified [*] and establishes to Salixs reasonable satisfaction that Alfas Manufacturers are capable of fulfilling [*] percent ([*]%) of Salixs requirements of the Products, then Salix shall use Commercially Reasonable Efforts to resume purchasing [*] of its requirements of the Products from Alfa as soon as practicable, subject to any commitment that Salix may have made to a Third Party supplier consistent with the preceding sentence and without any requirement that Salix purchase duplicate supplies of the Products. In the event that Alfa ceases to supply the Products to Salix under this Agreement and such failure continues for a period of [*] consecutive months, Salix shall have a step-in right to assume Alfas rights and obligations under any agreement with such other Manufacturers to ensure that there are at least [*] sources of supply of the Products available to Salix pursuant to the terms of this Agreement that are fully qualified to Manufacture the Products pursuant to FDA regulations. Notwithstanding anything to the contrary set forth above, the Parties recognize that that in certain circumstances there may not be a need for [*] of supply of the Products and that the Steering Committee may at any time determine by mutual agreement that only [*] is required. For the avoidance of doubt, Salix shall have the right to exercise the manufacturing license granted to Salix by Alfa pursuant to Section 4.1.7 of the Amended and Restated License Agreement as and to the extent necessary to exercise its rights under this Section 3.5.
3.6 Salixs Obligations . Salix shall:
(a) sell and distribute Products supplied hereunder only in accordance with applicable law; and
(b) notify Alfa of any special requirements in respect of record keeping that may be necessary for Alfa to comply with legal or regulatory requirements in the Salix Territory and its obligations hereunder.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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3.7 Compliance with Applicable Laws . Alfa shall comply, and shall cause each of its Raw Materials suppliers and each Manufacturer to comply, with cGMP and all other applicable laws in all material respects in carrying out the Manufacturing of Raw Materials and Product, including, to the extent applicable, those relating to environmental matters, public health, wages, hours and conditions of employment, subcontractor selection, discrimination and occupational health/safety. The Parties agree that no child, or any form of forced or involuntary, labor shall be utilized in the Manufacture of the Product or any component or intermediate thereof or services under this Agreement. Upon Salixs request (which may be made at such times that Salix reasonably believes that it has good reason to ask for confirmation of Alfas compliance), Alfa shall certify in writing its compliance with this Section 3.7.
3.8 Retention of Manufacturing Records and Samples .
(a) Alfa shall, and shall cause each Manufacturer to, generate (as and to the extent required by applicable law), retain and maintain, both during the Term and thereafter:
(i) all records necessary to comply with cGMP and all other applicable law relating to the Manufacture of the Product or any component or intermediate thereof;
(ii) all Manufacturing records, standard operating procedures, equipment log books, batch manufacturing records, laboratory notebooks and all raw data relating to the Manufacturing of the Product and any component or intermediate thereof;
(iii) samples of each Batch and Raw Materials. Samples shall include a quantity of representative material of each Batch and Raw Materials sufficient to perform at least full duplicate quality control testing, and shall specify the dates of Manufacture and packaging thereof. Samples so retained shall be selected at random from either final container material or from bulk and final containers; provided that they include at least one final container as a final package, or package-equivalent of such filling of each Batch. Such sample shall be stored at temperatures and under conditions which will maintain the identity and integrity of the relevant sample; and
(iv) such other records and samples as Salix reasonably may require in order to ensure compliance by Alfa with the terms of this Agreement and applicable law.
(b) Without prejudice to Alfas obligations pursuant to Section 3.8(a), Alfa shall, and shall cause each Manufacturer to, diligently complete the master batch record for each Product during the Manufacture of such Product.
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(c) All materials, samples, records and other items referred to in Sections 3.8(a) and 3.8(b) shall be retained by Alfa for the longer of (i) such period as may be required by cGMP and all other applicable law and (ii) [*] years.
3.9 Regulatory Cooperation of Alfa . Alfa shall cooperate, and shall cause each Manufacturer to cooperate, with any reasonable requests for assistance from Salix with respect to obtaining and maintaining any and all Regulatory Approvals required in connection with the sourcing of the Products by Salix hereunder and the sale of the Products in the Salix Territory, including by:
(a) at Alfas own cost, making its (and each of its Manufacturers) relevant employees, consultants and other staff available upon reasonable notice during normal business hours to attend meetings where there may be substantive discussions with Regulatory Authorities related to obtaining approval of a Product in the Salix Territory at which Alfas and/or the Manufacturers attendance is required or would be useful, including any Marketing Approval and supplements and amendments thereto;
(b) at Alfas own cost, except for Alfas reasonable, documented out-of-pocket expenses, which shall be reimbursed by Salix, making its (and each of its Manufacturers) relevant employees, consultants and other staff available upon reasonable notice during normal business hours to attend meetings where there may be substantive discussions with Regulatory Authorities concerning Raw Materials or Product or any component or intermediate thereof but unrelated to matters subject to Section 3.9(a) at which Alfas and/or the Manufacturers attendance is required or would be useful; and
(c) at Alfas own cost, disclosing and making available to Salix (subject to ARTICLE 10), in whatever form Salix may reasonably request, copies of all Manufacturing and quality control data, CMC Data and other information related to Raw Materials or Products and the Manufacturing process therefor as is reasonably necessary or desirable to prepare, file, obtain and maintain any Regulatory Approval required in connection with the sale of Product in the Salix Territory.
3.10 Maintenance of Manufacturing Facility .
(a) Except as otherwise approved in writing by Salix, Alfa or a Manufacturer shall Manufacture Product exclusively at the Manufacturing Facility(ies).
(b) Alfa shall ensure that any and all licenses, registrations, and Regulatory Authority approvals required by applicable law to be obtained in connection with any Manufacturing Facility and equipment used in connection with the Manufacture of Product by Alfa or any Manufacturer so as to permit Alfa or any Manufacturer to Manufacture Product and supply it to Salix as contemplated hereunder have been obtained and are in all respects current and in full force and effect.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(c) Alfa shall at all times during the Term maintain, and shall cause each Manufacturer to maintain, the Manufacturing Facility(ies) and such equipment in a state of repair and operating efficiency consistent with the requirements of the Specifications, the Regulatory Approvals, cGMP and all other applicable law.
(d) Alfa shall maintain, and shall cause each Manufacturer to maintain, in the Manufacturing Facility(ies) adequate and segregated holding accommodations for the Product manufactured for Salix hereunder as and to the extent required by the Specifications, the Regulatory Approvals, cGMP and all other applicable law.
(e) Alfa shall, and shall cause each Manufacturer to, only use disposal services or sites that are in compliance with applicable law in all material respects.
3.11 Recalls and Withdrawals . Alfa promptly shall reimburse Salix for all costs incurred by Salix in connection with recalls, market withdrawals, and returns and destruction of Product as and to the extent such recalls, market withdrawals, and returns and destruction of Product result from Alfas breach of its obligations under this Agreement or negligence or willful misconduct. In the event Alfa files for protection from creditors under applicable bankruptcy laws or becomes subject to an involuntary bankruptcy proceeding, makes an assignation for the benefit of creditors, becomes insolvent or takes any equivalent measures in any relevant jurisdiction, Salix shall have the right to offset any costs it incurs of the type described in this Section 3.11 against any payment owed by Salix to Alfa under this Agreement.
3.12 Shortages . In the event that the amount of Product (or any component thereof) which Alfa (or any Manufacturer) Manufactures is less than the amount required to meet the requirements of all Persons permitted to be supplied Product (or any component thereof) by Alfa the total supply of Product (or any component thereof) Manufactured by Alfa (or any Manufacturer) shall be apportioned in such manner as Alfa shall determine in its reasonable discretion, taking into consideration the country-by-country percentage of total worldwide demand for the Products over the [*] month period immediately preceding the submission of a Salix purchase order for Products that the Manufacturers are unable to fulfill due to shortages.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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ARTICLE 4
TERMS AND CONDITIONS OF SUPPLY
4.1 Pricing . The price to be paid by Salix to Alfa for the Crohns EIR Product shall be determined by the Parties pursuant to the methodology set forth in Exhibit B , which is based on the pricing set forth in the report of [*] to Alfa, dated [*], pertaining to the valuation of the Crohns EIR Product, and shall also take into account the cost of any special packaging requirements requested by Salix. Pricing for other Products shall be based on a similar formula but shall be determined by agreement of the Parties. If the Parties are unable to agree on the price for the supply of a Product, then the price shall be determined by a third party having expertise in such matters that is mutually acceptable to Salix and Alfa (the Designated Expert ), whose decision shall be binding on the Parties. The fees charged by the Designated Expert for any service required under this Section 4.1 shall be equally shared by the Parties. The pricing for each Product shall be set forth in an addendum to this Agreement to be entered into by the Parties prior to the date when all Marketing Approvals in the United States for such Product have been obtained.
4.2 Shipping Terms . All shipments of Products pursuant to this Agreement shall be made Ex Works (INCOTERMS 2010). Title and risk of loss shall be deemed to have passed to Salix when the Product is delivered to a common carrier at the Manufacturers warehouse. All Product shall be labeled in accordance with applicable law and packed for shipping in accordance with packing instructions provided by Salix. Salix may designate in its purchase orders the carrier that it requires the Manufacturer to use, provided that any additional expense incurred by the Manufacturer attributable to the use of such carrier shall be added to the invoice price for the Products.
4.3 Payment Terms . Salix shall pay each invoice delivered by Alfa in respect of a shipment of Product within [*] days after the date Salix completes its initial inspection of a shipment as contemplated herein, which initial inspection shall occur no later than within [*] days of receipt of Product by Salix; provided, however , that Salix shall not be obligated to pay for any Product that Salix determines during such initial inspection is non-conforming. Payment shall be made by [*] wire transfer in U.S. dollars to such bank and account in Italy as is designated by Alfa in writing for such purpose. Alfa shall be responsible for securing any governmental permits or making any filings with the Italian government required in connection with such payment.
4.4 Taxes . Any federal, state, county or municipal sales or use tax, value added tax or international sales tax, excise or similar charge, or other assessment (other than that assessed against income), import or export fee, duty or other charge assessed or charged on the manufacture, sale or transportation of a Product as contemplated
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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hereunder and not otherwise recovered by Alfa shall be paid by Salix. Alfas invoices shall include all information required by law. Alfa agrees to use good faith efforts to recover any tax, charge or assessment otherwise payable by Salix under this Section 4.4 from the relevant governmental authority or other third party, as and to the extent contemplated by applicable law.
4.5 Samples . During the initial two (2) years after the Putting Into Commerce of the Crohns EIR Product, Alfa shall supply Salix with a reasonable quantity of such Product to be distributed by Salix as promotional samples only. The quantities and price for the Batches to be used as samples shall be agreed upon by the Parties prior to the Putting Into Commerce of such Product.
ARTICLE 5
ORDERS
5.1 Delivery Date Lead Time . Salix shall place firm orders for Products in Batches, with a delivery date of not less than [*] days after Alfas receipt thereof. A minimum Batch order shall be agreed upon by the Parties prior to submission by Salix of its initial purchase order for each Product. Salix shall submit its initial purchase order for a Product not later than [*] days following approval of the relevant NDA for such Product. Products shall be shipped to Salix within the time frame requested in the applicable purchase order, provided that Alfa has at least a [*]-day lead time. In case of any delay of shipment, Salix is not deemed to have waived its right for delivery. The Manufacturers obligation to meet the lead times required under this Section 5.1 is subject to Salix fulfilling its obligations under Section 3.3, including providing artwork for labels, in a timely manner.
5.2 Forecasts . Not later than [*] months after the submission of an NDA to the FDA for a particular Product, Salix shall provide to Alfa an initial [*] month forecast of its requirements for such Product, which forecast shall be updated quarterly until the first Putting into Commerce of such Product. Thereafter, Salix shall provide an updated rolling [*] month forecast by the fifteenth (15th) day of each month. After the first [*] months after such Product is Put into Commerce in the United States, the Parties shall review the forecasting and ordering procedures set forth in this Agreement.
5.3 Orders . Following the initial order referenced in Section 5.1, Salix shall submit a binding purchase order with each forecast for Product equal to the amount set forth in the first [*] months of each forecast. Alfa shall not be required to fill any Salix purchase order to the extent that the units ordered are greater than [*] percent ([*]%) of Salixs most recent forecast for the relevant period to which the order pertains. Within [*] Business Days of receipt of a purchase order, Alfa shall notify Salix in writing of its acceptance of such purchase order as a binding order. Such confirmation shall also confirm the desired delivery date and the desired quantities. Dispatch of such confirmation shall constitute the acceptance of a binding order for the amount of Product covered by such confirmation,
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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provided that Alfa may not reject any order consistent with this Agreement that lies within [*] percent ([*]%) of the then most recent forecast previously submitted by Salix. If Alfa fails to make any such notification to Salix within [*] Business Days of receipt of a purchase order, such purchase order shall be deemed to have been accepted. Alfa shall use commercially reasonable efforts to fulfill Salixs purchase orders to the extent such orders exceed Salixs forecast for the relevant forecast period by more than [*] percent ([*]%).
ARTICLE 6
QUALITY ASSURANCE
6.1 Quality Agreement . At such time as the Parties mutually agree, and in any event prior to the Putting into Commerce of a Product, Salix and Alfa shall prepare and enter into a reasonable and customary quality assurance agreement that shall set forth the terms and conditions upon which Alfa will conduct its quality activities in connection with this Agreement (the Quality Agreement ). Each Party shall duly and punctually perform all of its obligations under the Quality Agreement
6.2 Quality Assurance . Alfa, at its sole expense, shall be responsible for conducting all quality control analyses of the Manufacturing and Raw Materials in a normal commercially acceptable manner. Alfa shall supply, or cause the Manufacturer to supply, a Certificate of Analysis with each Batch of Product and any other documentation required by law or the Quality Agreement. Complete copies of all test results or assays called for in the Specifications shall be submitted to Salix promptly following any request therefor.
ARTICLE 7
WARRANTIES AND INSPECTION
7.1 Alfa Warranties . Alfa represents and warrants that:
(a) as at the date of delivery to Salix, each Product delivered by Alfa pursuant to this Agreement shall comply fully with the Specifications for such Product and the Certificate of Analysis therefor provided pursuant to Section 6.1;
(b) as at the date of delivery to Salix, all Products delivered by Alfa pursuant to this Agreement shall have been Manufactured, packaged, stored and shipped fully in accordance with all relevant cGMP, all applicable laws and regulations, all requirements, commitments and undertakings made in the applicable Marketing Approval for the relevant Product, this Agreement and the Quality Agreement;
(c) it shall prepare and maintain all such Batch records and samples as may be required for the Manufacture of chemical compounds for pharmaceutical use of this type by any relevant Regulatory Authority, for the full period required under any applicable regulations or as otherwise set forth in Section 3.8(c);
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(d) title to all Product shall pass to Salix free and clear of any security interest, lien or other encumbrance, other than those to which Salix has consented and those arising by operation of law, if any;
(e) all Product shall be Manufactured in facilities that are in compliance in all material respects with all applicable material laws in effect at the time of such Manufacture (including applicable inspection requirements of FDA and other Regulatory Authorities);
(f) the expiration date of the Product is no earlier than the shorter of [*] months and the maximum shelf life permitted by applicable Regulatory Approvals, with such expiration date requirements to be adjusted in good faith by the Parties to take account of the results of any ongoing stability studies;
(g) the Product has not been adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, as amended (the FFDCA ), and similar provisions of other applicable law;
(h) the Product may be introduced into interstate commerce pursuant to the FFDCA and similar provisions of other applicable law;
(i) neither Alfa nor any Affiliates of Alfa that control Alfa have been debarred or are subject to debarment proceedings pursuant to Section 306 of the FFDCA or listed on either of the Excluded Lists, and neither Alfa nor any Affiliates of Alfa that control Alfa will be debarred or will be subject to debarment proceedings during the Term or will be listed on either of the Excluded Lists; and
(j) Alfa and any Affiliates of Alfa that control Alfa have not and will not use in any capacity relevant to the Manufacturing and supply of Products hereunder the service of any Person that has been debarred or is subject to debarment proceedings pursuant to Section 306 of the FFDCA or that is listed on either of the Excluded Lists.
7.2 Inspection Rights . Alfa confirms that it shall grant to Salix and its authorized representatives (so long as such representatives have entered into binding confidentiality and non-use agreements with Salix providing for obligations no less strict than Salixs confidentiality obligations to Alfa hereunder) full access to all records (including all permits, certificates and licenses), documentation and data of Alfa or its Manufacturer(s), as Salix may reasonably require for the purpose of confirming the compliance by Alfa with the warranties set out in Section 7.1; provided, however , that such inspection shall take place not more than twice each Calendar Year and shall take place upon reasonable notice and during normal working hours. Subject to the foregoing and any requirements arising pursuant to applicable laws and regulations, Alfa shall arrange for Salix to have access to inspect any Manufacturing Facility within the control of Alfa or any Manufacturer as well as the
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Manufacturing of the Products and any component or intermediate thereof, including inspection of (a) Raw Materials, (b) the holding facilities for Raw Materials or a Product or any component or intermediate thereof, (c) the equipment used in the Manufacture of a Product or any component or intermediate thereof, and (d) all records relating to such Manufacturing and the Manufacturing Facility (to the extent they relate to a Product or any component or intermediate thereof). All Confidential Information of Alfa or any Manufacturer to which Salix and its representatives are given access pursuant to this Section 7.2 is subject to ARTICLE 10. Following such audit, Salix shall discuss its observations and conclusions with Alfa and the Parties shall in good faith and as soon as commercially reasonable determine whether any corrective actions are required, and if so, the manner and schedule for such corrective actions to be implemented, with the goal of implementing any such corrective actions as soon as commercially reasonable.
7.3 Reporting . Alfa shall, to the extent permitted by applicable law, (a) notify Salix in writing within [*] Business Days after learning of any proposed governmental inspection of a Manufacturing Facility by the FDA or any other Regulatory Authority which relates to or could adversely affect the Manufacture or supply of Products hereunder and promptly by telephone after learning of any unannounced visit to, or inspection of, the Manufacturing Facility by the FDA or any other Regulatory Authority which relates to or could adversely affect the Manufacture or supply of Products hereunder, and (b) supply Salix with all reports and written communications to or from any Regulatory Authority relating to the foregoing within [*] Business Days after receipt thereof and shall consult with Salix concerning the response of Alfa to each such communication. Alfa shall provide Salix with a copy of all draft responses for comment as soon as reasonably practicable and all final responses for review and comment as soon as reasonably practicable. The Parties acknowledge and agree that Alfa has the sole right to determine the contents and form of any communication with, or response to, FDA regarding the Manufacturing Facility.
7.4 Quality Control Evaluation and Non-Conforming Product .
(a) In the event that Salix determines within [*] days of receipt of each shipment of Product(s) (or within [*] days after discovery of any nonconformity that could not reasonably have been detected by a customary inspection on delivery), that any shipment fails to conform to the Specifications for such Product, or shall have been Manufactured or shipped under conditions which do not comply with this Agreement (including the warranties contained in Section 7.1), Salix shall give prompt written notice to Alfa within such [*]-day period, specifying the manner in which it fails to meet the requirements hereof. If Salix fails to give such notice within such period, Salix shall be deemed to have waived its right to reject such shipment due to failure to meet
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Specifications or to have been Manufactured or shipped under conditions which do not comply with this Agreement (including the warranties contained in Section 7.1). Upon receipt of such notice from Salix, Alfa shall undertake appropriate evaluation of such sample and shall notify Salix whether it has confirmed such nonconformity within [*] days after receipt of such notice from Salix. If Alfa notifies Salix that it has not confirmed such nonconformity, the Parties shall submit the dispute to an independent testing organization of recognized repute within the U.S. pharmaceutical industry agreed upon by the Parties, the appointment of which shall not be unreasonably withheld or delayed by either Party. Both Parties shall cooperate with the testing laboratorys reasonable requests for assistance in connection with its evaluation hereunder. The findings of the testing laboratory shall be binding on the Parties, absent manifest error. The cost of such independent testing organization shall be paid by the Party in error with respect to such shipment. If the testing laboratory or Alfa confirms that a lot of Product does not conform to the warranty set forth in Section 7.1 and Salix has provided the required notice (as set forth above), Alfa, at Alfas option, promptly shall (i) supply Salix with a conforming quantity of Product at Alfas expense or (ii) reimburse Salix for any amounts paid by Salix with respect to such nonconforming Product if already paid; provided, however , that in such situation Salix has the right to require that Alfa supply conforming product rather than a refund. Salix shall have the right to offset any such reimbursement against any payments owed by Salix to Alfa under this Agreement in the event Alfa files for protection from creditors under applicable bankruptcy laws or becomes subject to an involuntary bankruptcy proceeding, makes an assignation for the benefit of creditors, becomes insolvent or takes any equivalent measures in any relevant jurisdiction. Alfa shall promptly notify Salix if at any time it discovers that any Product delivered hereunder does not conform to the warranty set forth in Section 7.1. The provisions of Arts. 201 and 210 of the Swiss Code of Obligations are hereby waived and replaced by the above to the extent permitted by law, it being understood that a notice given by Salix within the said [*]-day period as provided above shall be sufficient to prevent Salix from being precluded from obtaining the remedy provided for in this Section 7.4(a) due to the application of any applicable statute of limitations or similar provision of law if such claim is pursued by Salix by filing a court action within [*] months after presentation of the finding of the testing laboratory.
(b) The rights and remedies provided in this Section 7.4 shall be without prejudice to Salixs rights in connection with any latent defect contained in the Products that could not be discovered with the [*]-day period described in Section 7.4(a) following Salixs receipt of a shipment of Product(s) upon a reasonable and customary inspection and testing on delivery, or any breach by Alfa of the warranties contained in Section 7.1.
(c) Disposal . Salix shall not dispose of any non-conforming shipment of Product without written authorization and instructions from Alfa. Alfa shall promptly notify Salix as to the disposal thereof (at Alfas sole cost and expense) at the conclusion of any investigation by Alfa or the independent testing organization, as set forth in Section 7.4.
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7.5 Safety Data Exchange Agreement . Each Party shall comply fully with the Safety Data Exchange Agreement dated [*] (which is incorporated in this Agreement by reference as if fully restated herein) in regard to the safety policies and procedures regarding the Products, including their respective obligations regarding reporting adverse events relating to the Products and notifying the other Party of any information concerning adverse events.
ARTICLE 8
INDEMNIFICATION AND DAMAGES
8.1 In Favor of Salix . Alfa shall defend, indemnify and hold Salix, its Affiliates and their respective officers, directors, employees and agents (the Salix Indemnified Parties ) harmless from and against any and all claims, demands, losses, damages, liabilities (including product liability), settlement amounts, cost or expenses whatsoever (including reasonable legal fees and costs and court costs) (collectively, Losses ) arising from or relating to any claim, action or proceeding made or brought against such Person by a third party as a result of:
(a) Alfas breach of any of its representations, warranties or covenants set forth in this Agreement;
(b) Alfas negligence or willful misconduct in connection with the performance of its obligations under this Agreement; and
(c) the storage, release, or disposal of any hazardous or regulated material or any waste by Alfa;
except, in each case, for those Losses for which Salix has an obligation to indemnify the Alfa Indemnified Parties pursuant to Section 8.2, as to which Losses each Party shall indemnify the other Party to the extent of its respective liability for such Losses.
8.2 In Favor of Alfa . Salix shall defend, indemnify and hold Alfa, its Affiliates and their respective officers, directors, employees and agents (the Alfa Indemnified Parties ) harmless from and against any and all Losses arising from or relating to any claim, action or proceeding made or brought against such Person by a third party as a result of:
(a) Salixs breach of any of its representations, warranties or covenants set forth in this Agreement;
(b) Salixs negligence or willful misconduct in connection with the performance of its obligations under this Agreement; and
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(c) any third party claim made by any Person relating to or arising out of death, personal injury, or other product liability related to Salixs Manufacture of the Products (if it exercises its right to Manufacture Products under ARTICLE 11) or the use, sale or distribution of the Products and, in each case, caused by the negligence of Salix or its subcontractors or agents, including Salixs manufacturers (other than Alfa or the Manufacturers), warehousers or distributors;
except, in each case, for those Losses for which Alfa has an obligation to indemnify the Salix Indemnified Parties pursuant to Section 8.1, as to which Losses each Party shall indemnify the other Party to the extent of its respective liability for such Losses.
8.3 Notice; Defense . In the event of any claim, action or proceeding for which a Person is entitled to indemnification hereunder, the Person seeking indemnification ( Claimant ) shall promptly notify the relevant Party ( Indemnitor ) of any Losses or discovery of facts upon which such Claimant intends to base a request for indemnification under Section 8.1 or 8.2, but in no event shall the Indemnitor be liable for any Losses that result from any delay in providing such notice. Each such notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). The Claimant shall furnish promptly to the Indemnitor copies of all papers and official documents received in respect of any Losses. Indemnitor shall then promptly assume responsibility for and shall have full control of such matter, including settlement negotiations and any legal proceedings, and shall appoint any legal counsel selected by the Indemnitor, which shall be reasonably acceptable to the Claimant. Claimant shall fully cooperate in Indemnitors handling and defense thereof (including by delivering to the Indemnitor all original notices and documents (including court papers) received by the Claimant in connection with the third party claim), provided that Indemnitor shall keep Claimant fully informed of the progress and conduct of any such negotiations or legal proceedings (which shall include providing copies of all court filings) and shall not in any settlement or defense of the same make any admission or otherwise act in such manner as may prejudice the continuing business or reputation of Claimant or rights to Exploit the Products without the prior written consent of Claimant (such consent not to be unreasonably withheld or delayed). The Indemnitor shall not be liable for any settlement or other disposition of a Loss by the Claimant that is reached without the written consent of the Indemnitor. Regardless of whether the Indemnitor chooses to defend or prosecute any third party claim, no Claimant shall admit any liability with respect to, or settle, compromise or dispose of, any third party claim without the prior written consent of the Indemnitor (which consent shall not be unreasonably withheld, conditioned or delayed). The assumption of the defense of a third party claim by the Indemnitor shall not be construed as an acknowledgment that the Indemnitor is liable to indemnify the Claimant in respect of the third party claim, nor shall it constitute a waiver by the Indemnitor of any defenses it may assert against any Claimants claim for indemnification. Subject to Section 8.4, if the Indemnitor assumes the defense of a third party claim, the Indemnitor shall not be liable to the Claimant for any legal expenses subsequently incurred by such Claimant in connection with the analysis, defense or settlement of the third party claim. In the event that it is ultimately determined that the Indemnitor is not obligated to indemnify, defend or hold harmless the Claimant from and against the third party claim, the Claimant shall reimburse the Indemnitor for any and all costs and expenses (including reasonable attorneys fees and costs of suit) and any Losses incurred by the Indemnitor in its defense of the third party claim with respect to such Claimant.
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8.4 Right to Participate in Defense . Without limiting Section 8.3, any Claimant shall be entitled to participate in, but not control, the defense of such third party claim and to employ counsel of its choice for such purpose; provided , however , that such employment shall be at the Claimants own expense unless (a) the employment thereof has been specifically authorized by the Indemnitor in writing, (b) the Indemnitor has failed to assume the defense and employ counsel in accordance with Section 8.3 (in which case the Claimant shall control the defense), or (c) the interests of the Claimant and the Indemnitor with respect to such third party claim are sufficiently adverse to prohibit the representation by the same counsel of both parties under applicable law, ethical rules or equitable principles.
8.5 Insurance .
(a) Insurance Requirements . Each Party represents that it currently maintains, and agrees that it will, during the Term, maintain insurance adequate to cover such Partys obligations under this Agreement. Each Party shall provide the other Party with evidence of such insurance, upon request.
(b) Policies . Each Party shall maintain comprehensive general liability insurance and product liability/completed operations coverage in the amount of not less [*] Euros ([*]). The insurance policies shall be provided by an insurance carrier(s) reasonably acceptable to the other Party. Certificates of insurance for such policies shall be furnished to the other Party within forty-five (45) days after the Effective Date. Such policies shall remain in effect throughout the Term (and, if written on a claims made basis, for no less than [*] years thereafter) and shall not be canceled or subject to a reduction of coverage or any other modification without not less than [*] days prior written notification of the other Party.
8.6 Limitations on Liability .
(a) Notwithstanding anything to the contrary set forth in this Agreement, and to the extent permitted by law, any and all liability of each Party to the other Party howsoever arising under this Agreement shall be limited (except for death or personal injury caused by the negligence or willful misconduct of the Party or its employees) to [*] Euros ([*]).
(b) UNDER NO CIRCUMSTANCES SHALL A PARTY HERETO BE LIABLE TO THE OTHER PARTY HEREOF FOR CONSEQUENTIAL, INCIDENTAL,
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PUNITIVE OR SPECIAL DAMAGES IN RESPECT OF PERFORMANCE OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT ALL AMOUNTS THAT AN INDEMNIFIED PERSON IS REQUIRED TO PAY TO ANY THIRD PARTY AS THE RESULT OF A MATTER FOR WHICH SUCH INDEMNIFIED PERSON IS ENTITLED TO BE INDEMNIFIED UNDER THIS ARTICLE 8 SHALL BE CONSIDERED TO BE DIRECT DAMAGES WHICH ARE INDEMNIFIABLE HEREUNDER.
ARTICLE 9
INTELLECTUAL PROPERTY AND IMPROVEMENTS
9.1 License to Alfa . Salix hereby grants to Alfa, with the right to grant sublicenses to its designated third party Manufacturers for the sole purpose of allowing Alfa to perform its obligations hereunder, (a) a non-exclusive, royalty-free license to use the Salix Technology Rights and (b) a non-exclusive, royalty-free license to use any trademarks Controlled by Salix relating to the Products and other Intellectual Property rights Controlled by Salix relating to the Products, in each case, for the sole purpose of exercising its rights and performing its obligations under this Agreement. Except for the license grants to Alfa in this Section 9.1 and as otherwise necessary for the performance of this Agreement, no license, express or implied, is granted pursuant to this Agreement by either Party to the other under any of its Intellectual Property rights.
9.2 No Transfer of Intellectual Property Rights . Salix acknowledges that it shall not acquire any rights in respect of the Alfa Technology Rights or the goodwill associated therewith by virtue of the execution or performance of this Agreement, other than the limited license rights explicitly granted herein.
9.3 Manufacturing Records and Process Improvements . Title to and rights in all manufacturing records (including Batch records and validation data) and Process Improvements generated by Alfa or its Manufacturers shall be and remain at all times exclusively vested in Alfa, and Salix disclaims any right thereto.
ARTICLE 10
CONFIDENTIALITY
10.1 Salixs Obligations . During the Term and for a period of [*] years after the expiration or termination of this Agreement or the Amended and Restated License Agreement, if the Amended and Restated License Agreement remains in effect after the expiration or termination of this Agreement, Salix shall keep secret
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and confidential and shall use all reasonable efforts to ensure that the same is kept confidential by its Affiliates and Sublicensees, all Alfa Technology Rights and other Confidential Information disclosed to it by Alfa (the Alfa Confidential Information ) and shall not use the same for any purpose other than the exercise of the rights granted to it by Alfa under this Agreement or the performance of its obligations under this Agreement or disclose the same to any third party other than (a) as may be required in connection with the performance of its obligations hereunder or (b) as otherwise set forth in Section 10.4. Without limiting the foregoing, Salix agrees that it shall take the same level of measures to protect the confidentiality of Alfa Confidential Information which it takes with respect to Salixs own confidential and proprietary information, but not less than reasonable care.
10.2 Alfas Obligations . During the Term and for a period of [*] years after the expiration or termination of this Agreement or the Amended and Restated License Agreement, if the Amended and Restated License Agreement remains in effect after the expiration or termination of this Agreement, Alfa shall keep secret and confidential and shall use all reasonable efforts to ensure that the same is kept confidential by its Affiliates and Sublicensees all Salix Technology Rights and other Confidential Information disclosed to it by Salix (the Salix Confidential Information ), and shall not use the same for any purpose other than the exercise of the rights granted to it by Salix under this Agreement or the performance of its obligations under this Agreement or disclose the same to any third party other than (a) as may be required in connection with the performance of its obligations under this Agreement or (b) as otherwise set forth in Section 10.4. Without limiting the foregoing, Alfa agrees that it shall take the same level of measures to protect the confidentiality of Salix Confidential Information which it takes with respect to Alfas own confidential and proprietary information, but not less than reasonable care.
10.3 Exceptions to Confidentiality and Non-Disclosure Obligations . Notwithstanding the obligations contained in Sections 10.1 and 10.2, Confidential Information shall not include any data, information or documentation which:
(a) shall be in the public domain prior to disclosure to the receiving Party, or shall enter the public domain after the Amendment Effective Date otherwise than by reason of the fault, negligence or wrongful act of the receiving Party;
(b) the receiving Party can show was in its possession free of any obligation of confidentiality prior to the date of receipt or was independently developed by employees of the receiving Party without reference to the information disclosed by the disclosing Party; or
(c) is subsequently received by the receiving Party from a third party who is not bound by any obligation of confidentiality with respect to said information.
Specific aspects or details of Alfa Confidential Information or Salix Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of
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Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
10.4 Permitted Disclosures . Each Party may disclose Confidential Information to the extent that such disclosure is:
(a) Made pursuant to a valid and effective subpoena or order issued by a court of competent jurisdiction or other legal process or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Partys legal counsel, such disclosure is otherwise required by law, provided that it shall (i) immediately notify the other Party that it is subject to such legally required disclosure, (ii) consult with the other Party on the advisability of taking legally available steps to resist or narrow such compelled disclosure, (iii) reasonably assist the other Party, at its request, in its efforts to obtain an appropriate protective order or other reliable assurance that confidential treatment shall be accorded to the Confidential Information, to the extent such assistance is commercially reasonable, and (iv) limit disclosure to the information its legal counsel advises must be disclosed to comply with the legal requirement.
(b) Made by the receiving Party to Regulatory Authorities as required in connection with any filing in relation to a Regulatory Approval or the prosecution or maintenance of any patent; provided , however , that reasonable measures shall be taken, to the extent available, to assure confidential treatment of such information and that where a receiving Party intends to disclose Confidential Information of the disclosing Party in relation to the prosecution or maintenance of any patent, notice be provided to the disclosing Party prior to disclosure by the receiving Party.
(c) Made by the receiving Party for purposes of enforcing claims that it may have against the other Party or its Affiliates, whether under this Agreement or otherwise; provided , however , that reasonable measures shall be taken, to the extent available, to assure confidential treatment of such information.
(d) Made by the receiving Party or its Affiliates or Sublicensees to its or their respective attorneys, auditors, advisors, consultants, licensees, Sublicensees and Manufacturers, or as may be necessary or useful in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided , however , that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10 and the disclosing Party shall cause each such Person to sign a standard non-disclosure agreement of the type that the disclosing Party requires unaffiliated third parties to sign prior to disclosing its own confidential and proprietary information; provided further that each Party shall remain responsible for any failure by its Affiliates or Sublicensees or its or their respective attorneys, auditors, advisors, consultants or Manufacturers to treat such Confidential Information as required under this ARTICLE 10 (as if such Affiliates, Sublicensees, licensees, attorneys, auditors, advisors, consultants or Manufacturers, were Parties directly bound to the requirements of this ARTICLE 10).
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(e) Made by the receiving Party to [*], each of whom prior to disclosure must be bound by obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10.
10.5 Return of Confidential Information . Upon the termination of this Agreement, each Party shall return or destroy or make inaccessible all tangible copies of any Confidential Information provided to it by the other Party, provided, that their respective legal counsel may retain one (1) copy of the Confidential Information for use solely for the purpose of determining their respective rights and obligations under this Agreement.
10.6 Injunctive Relief . Each Party acknowledges and agrees that the other Partys Confidential Information constitutes unique and valuable trade secrets and that the unauthorized disclosure or use of the other Partys Confidential Information would result in irreparable harm to the other Party for which monetary damages would be inadequate. Accordingly, the Parties agree that in the event of any breach or threatened breach of this ARTICLE 10, the non-breaching Party shall be entitled to obtain injunctive or other equitable relief from any court of competent jurisdiction in addition to all other remedies available to it, and the breaching Party shall not claim as a defense thereto that the non-breaching Party has an adequate remedy at law. In any such action for injunctive or equitable relief the non-breaching Party shall not be required to post a bond or other security. The Parties hereby irrevocably consent to the jurisdiction of the courts of the State of New York and the United States District Court for the Southern District of New York, in either case sitting in the Borough of Manhattan in the City of New York, over any legal action brought by a Party to enforce its rights under this ARTICLE 10.
10.7 Disclosure of Agreement . To the extent, if any, that a Party determines in good faith that it is required by applicable law to file or register this Agreement or a notification in respect thereof with any governmental authority, including the U.S. Securities and Exchange Commission or, in connection with the prosecution or maintenance of any patent, the U.S. Patent and Trademark Office, such Party may do so, and the other Party shall cooperate in such filing or notification and shall execute all documents reasonably required in connection therewith. In such situation, the filing Party shall request confidential treatment of sensitive provisions of the Agreement, to the extent permitted by applicable law and in consultation with the other Party, and shall not otherwise disclose this Agreement except under circumstances otherwise contemplated by this Agreement. The Parties shall promptly inform each other as to the activities or inquiries of any such governmental authority relating to this Agreement, and shall cooperate to respond to any request for further information therefrom.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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ARTICLE 11
LICENSE TO MANUFACTURE
In the event that for any reason whatsoever (including, for the avoidance of doubt, an event of force majeure as described in ARTICLE 13) Alfa shall fail to supply Salix in accordance with confirmed written orders placed by Salix with Alfa for the Product under the terms of this Agreement more than [*] during a [*] day period, Salix may exercise the manufacturing license granted to Salix by Alfa pursuant to Section 4.1.7 of the Amended and Restated License Agreement; provided, however , that
(a) Salixs right under this Article 11 to exercise the manufacturing license will terminate at such time as Alfa establishes to Salixs reasonable satisfaction that it is able to resume fulfilling Salixs orders for Products and thereafter (without limiting Salixs rights under Section 3.5) Salix will resume purchasing from Alfa as soon as practicable; provided, however , that, without limiting Salixs rights under Section 3.5, Salix will be permitted for a commercially reasonable period of time to continue to purchase up to [*] percent ([*]%) of its requirement for Products from other manufacturer(s) it qualified prior to the date Alfa is able to resume its supply obligations hereunder (for clarification the Parties agree that in no event shall the remedies under Section 3.5 and under this Article 11, taken together, result in Salix being entitled to purchase from a third party manufacturer more than [*] percent ([*]%) of its requirements of Products at any time when Alfa has established to Salixs reasonable satisfaction that it is able to fulfill in full Salixs orders for Products);
(b) Salix shall be permitted to exercise its manufacturing license for the sole purpose of fulfilling its requirement of Products for sale within the Salix Territory for use within the Field; and
(c) for the avoidance of doubt, Salix shall continue to pay all sums due under the provisions of the Amended and Restated License Agreement with respect to sales of Products.
ARTICLE 12
TERMINATION
12.1 Term . The term of this Agreement (the Term ) shall commence on the date hereof and shall continue for so long as Salix is commercializing a Product.
12.2 Termination . In addition to any other rights or remedies a Party may have, either Party may terminate this Agreement upon the occurrence of any of the following events of default which is not cured within [*] days after written notice thereof is received by the other Party:
(a) breach by the other Party of any of its material obligations hereunder, which, if capable of being cured, is not cured by the breaching Party within [*] days after receipt of a written notice specifying the breach and requiring remedy;
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(b) should the other Party become subject of proceedings involving bankruptcy, receivership, administration, insolvency, moratorium of payment, reorganization or liquidation, or make any assignation for the benefit of the creditors or any equivalent measures in any relevant jurisdiction; or
(c) if the licenses granted to Salix pursuant to the Amended and Restated License Agreement terminate.
12.3 Survival . The obligations under Sections 3.8(c), 3.11, 4.3, 6.2, 7.1, 7.2, 7.4, 7.5, ARTICLE 8, Sections 9.2, 9.3, ARTICLE 10, this Section 12.3, and ARTICLE 14 to ARTICLE 24 shall survive any expiration or other termination of this Agreement in accordance with their terms. Without limiting the foregoing, all such other provisions which by their terms are intended to survive the expiration or termination of this Agreement shall so survive in accordance with their terms.
ARTICLE 13
FORCE MAJEURE
Neither Party shall be liable to the other Party for any failure or delay in performing any obligation under this Agreement (other than any payment or confidentiality obligations) when such failure or delay is caused by events beyond its reasonable control, including fire, flood, other natural disasters, acts of God, war, labor disturbances, interruption of transit, accident, explosion and civil commotion; provided that the Party so affected shall give prompt notice thereof to the other Party and shall use reasonable efforts to mitigate the adverse consequences thereof. No such failure or delay shall terminate this Agreement, and each Party shall complete its obligations hereunder as promptly as reasonably practicable following cessation of the cause or circumstances of such failure or delay.
ARTICLE 14
DISPUTE RESOLUTION
14.1 Good Faith Discussions . In the event that any controversy or claim shall arise between the Parties under, out of, in connection with, or relating to this Agreement or the breach thereof, the Party initiating such controversy or
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making such claim shall provide to the other Party written notice containing a brief and concise statement of the initiating Partys claims, together with relevant facts supporting them. During a period of [*] days, or such longer period as may be mutually agreed upon in writing by the Parties, following the date of said notice, the Parties shall make good faith efforts to settle the dispute. Such efforts may include full presentation of both Parties claims and responses, with or without the assistance of counsel, before the chief executive officers (or their designees) of the Parties.
14.2 Arbitration . In the event that the Parties have been unable to reach accord using the procedures set forth in Section 14.1 and only if such is the case, either Party may seek final resolution of the matter through binding arbitration, and only through binding arbitration. The failure of a Party to comply with the provisions of Section 14.1 with respect to any controversy or claim shall constitute an absolute bar to the institution of any proceedings, by arbitration or otherwise, with respect to such controversy or claim. Any such arbitration shall be held in Paris, France in the English language before a panel of three (3) arbitrators in accordance with the then existing Rules of Arbitration of the International Chamber of Commerce (the ICC ) and judgment upon the award rendered by the arbitrators may be entered in any court having jurisdiction thereof. In any arbitration proceeding hereunder, each Party shall select one (1) arbitrator and the arbitrators selected by the Parties shall then select a third arbitrator, who shall have at least [*] years experience in pharmaceutical patent licensing. The arbitrators shall permit the Parties to have discovery within the rules of the ICC. The decision of the arbitrators shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrators explaining the arbitrators rationale for their decision. Except as may otherwise be determined by the arbitrators in their award to be just and appropriate in light of the particular circumstances and outcome of the arbitration, the Party losing the arbitration shall pay all fees and costs of the arbitrators and the ICC and reimburse the prevailing Party for its reasonable attorneys fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses). The intent of the Parties is that except for the entering of an arbitration order in a court of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse to litigation in the courts.
14.3 Exceptions . Notwithstanding the foregoing provisions of this ARTICLE 14, either Party may initiate an action before any court having competent jurisdiction in order to obtain an order to preserve the status quo and avoid incurring irreparable harm pending the resolution of any dispute that is submitted to arbitration, to prevent or enjoin a breach or threatened breach of confidentiality or to enforce provisions of this Agreement relating to ownership rights in Intellectual Property without complying with the procedures set forth in this ARTICLE 14.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
- 29 -
ARTICLE 15
ASSIGNMENT
15.1 Binding Effect . This Agreement shall be binding upon and inure to the benefit of Parties hereto and their respective successors and permitted assigns.
15.2 Assignment by Alfa . Alfa shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom the Alfa Technology Rights are transferred, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Salix hereby acknowledges and accepts any such assignment, but Alfa shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Salix, such consent shall not be unreasonably withheld or delayed.
15.3 Assignment by Salix . Salix shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom Salix assigns its rights under the Amended and Restated License Agreement, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Alfa hereby acknowledges and accepts any such assignment, but Salix shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Alfa, such consent not to be unreasonably withheld or delayed.
ARTICLE 16
ENTIRE AGREEMENT AND MODIFICATION
This Agreement constitutes the final and complete understanding existing between Alfa and Salix relating to the subject matter hereof. The terms of this Agreement cannot be substituted, superseded, waived or modified in any manner except by written agreement executed for and on behalf of each of Alfa and Salix.
ARTICLE 17
LANGUAGE AND GOVERNING LAW
17.1 English Language . All communications notices and proceedings required to be given hereunder shall be in the English language.
17.2 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of Switzerland, without giving effect to any conflict of laws principles or rules. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
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ARTICLE 18
WAIVER
No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver.
ARTICLE 19
NOTICES
Except as otherwise herein provided, all notices to be served or notified to the Parties hereunder shall (a) be mailed by internationally recognized courier service or by registered airmail return receipt requested to their respective addresses listed below or to any other address subsequently communicated in writing, or (b) delivered by e-mail marked as being of high importance to the e-mail address set forth below (to be confirmed by written notice sent in the manner set forth in clause (a)), and shall be deemed to have been given [*] Business Days after the day on which such mailing is made, or on the next Business Day after the day on which it is sent in the case of any e-mail which is followed by written notice as aforesaid.
Party |
Address |
|
to Salix: |
Salix Pharmaceuticals, Inc. Attn: General Counsel 8510 Colonnade Center Drive Raleigh, North Carolina 27615 USA |
|
With copies (which shall not constitute notice) to: | ||
Salix Pharmaceuticals, Inc. Attn: Executive Vice President Business Development 8510 Colonnade Center Drive Raleigh, North Carolina 27615 USA E-Mail: [*] |
||
and | ||
Covington & Burling LLP 1201 Pennsylvania Avenue, N.W. Washington, D.C. 20004 E-Mail: ebritton@cov.com |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
- 31 -
to Alfa: |
Alfa Wassermann S.p.A Attn: Mr. Andrea Golinelli Via Ragazzi del 99 no. 5 40133 Bologna, Italy E-mail: [*] |
|
with copies (which shall not constitute notice) to: | ||
Alfa Wassermann S.p.A Attn: Andrea Montanari Via Ragazzi del 99 no. 5 40133 Bologna, Italy E-mail: [*] |
||
and | ||
Alfa Wassermann, Inc. 4 Henderson Drive West Caldwell, New Jersey 07006 U.S.A. Attention: Ira S. Nordlicht, Chief Executive Officer E-mail: [*] |
||
and | ||
Nordlicht & Hand 800 Westchester Avenue Rye Brook, New York 10514 U.S.A. Attention: Brian M. Hand, Esq. E-mail: [*] |
ARTICLE 20
SEVERABILITY
If any part of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of the invalid or unenforceable part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the Parties hereto.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
- 32 -
ARTICLE 21
HEADINGS AND CONSTRUCTION
21.1 Headings . Headings are inserted for convenience and shall not by themselves determine the interpretation of this Agreement.
21.2 References . References in this Agreement to Sections, Articles and Exhibits refer to Sections and Articles of, and Exhibits to, this Agreement except as otherwise specifically noted.
21.3 Rules of Construction . Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders. The term including as used herein shall mean including, without limiting the generality of any description preceding such term. The word or shall be interpreted in accordance with its ordinary meaning as the context indicates.
ARTICLE 22
COUNTERPARTS
This Agreement may be executed in two or more counterparts each of which shall be deemed an original and which together shall constitute one and the same instrument.
ARTICLE 23
MUTUAL DRAFTING
This Agreement constitutes the joint product of the Parties hereto. Each provision has been subject to the mutual consultation and agreement of such Parties and shall not be construed for or against either of them based on authorship.
ARTICLE 24
THIRD PARTY RIGHTS
No provision of this Agreement is intended to be enforceable by any Person other than the Parties hereto, their permitted assigns, and parties entitled to indemnification pursuant to ARTICLE 8.
- 33 -
ARTICLE 25
RELATIONSHIP OF THE PARTIES
It is expressly agreed that Alfa, on the one hand, and Salix, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Alfa, on the one hand, nor Salix, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
ARTICLE 26
PERFORMANCE BY AFFILIATES
Each of Alfa and Salix acknowledges that its performance of its obligations and its exercise of rights under this Agreement may be performed or exercised, respectively, by Affiliates of Alfa and Salix. Each of Alfa and Salix guarantees performance of this Agreement by any of its Affiliates.
ARTICLE 27
FURTHER ASSURANCE
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
ARTICLE 28
SUBCONTRACTORS
Salix and Alfa shall each have the right to subcontract any of its Manufacturing activities with respect to Rifaximin Products to a third party. Each Party shall remain solely responsible for all costs and expenses associated with its use of subcontractor(s) hereunder.
(Signatures appear on the next page.)
- 34 -
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first written above.
SALIX PHARMACEUTICALS, INC. | ALFA WASSERMANN S.p.A. | |||||||
By: | /s/ Rick Scruggs | By: | /s/ Andrea Golinelli | |||||
Name: |
Rick Scruggs |
Name: |
Andrea Golinelli |
|||||
Title: |
EVP Business Development |
Title: |
Chief Strategy Officer |
[Signature page for EIR Supply Agreement]
EXHIBIT A
EIR PATENT APPLICATIONS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
A-1
EXHIBIT B
PRICING METHODOLOGY
Definitions
For the purposes of this Exhibit B:
Cost of Goods Sold means the fully-burdened aggregate reasonable direct and indirect costs and expenses incurred and recorded by Alfa in manufacturing the Crohns EIR Product consisting solely of: (a) [*]; (b) [*]; (c) [*]; (d) [*]; (f) [*]; (g) [*]; and (h) [*], in each case ((a) through (h)), to the extent specifically identifiable to the Manufacture of the Crohns EIR Product as determined in accordance with either (i) [*], or (ii) [*].
Floor Price means [*].
Net Selling Price means the aggregate Net Sales of Salix and its Affiliates for the Crohns EIR Product divided by the number of units of the Crohns EIR Product sold (for this purpose, the Net Selling Price of different dosage sizes of the Crohns EIR Product shall be calculated separately).
Supply Price means the price at which Alfa shall sell the Crohns EIR Product to Salix, which shall be [*], subject to adjustment as set forth below.
Determination of Supply Price
Not later than [*] months prior to the commercial launch of the Crohns EIR Product in the Salix Territory, Salix and Alfa shall act in good faith to agree upon the Supply Price for the Crohns EIR Product, which shall be based on Salixs best estimate of its Net Selling Price. The same procedure shall be used to adjust the Supply Price for each subsequent Calendar Year.
Audit of Net Selling Price
Alfa shall have the right to request an annual audit of Salixs Net Selling Price, to be conducted by an independent third party mutually acceptable to the Parties. Such audit shall follow the procedures for determining the Net Selling Price set forth above, and shall include consideration of any adjustment resulting from the Reconciliation of Supply Price as set forth below in this Exhibit C. The actual Net Selling Price determined by the auditor is referred to as the Adjusted Net Selling Price. If the Adjusted Net Selling Price is greater than the estimated Net Selling Price at which the Crohns EIR Product was sold to Salix, Salix shall reimburse Alfa for the full difference between the amount that had been charged to Salix for quantities of the Crohns EIR Product during the period under audit, and the amount that Salix should have paid for such quantities of the Crohns EIR Product, with such amount to be added to Alfas next invoice to Salix. Furthermore, if such difference is greater than [*]% of the total amount that Alfa Wassermann should have been paid by Salix for the supply of the Crohns EIR Product during the period under audit, Salix shall reimburse Alfa for the cost of the audit.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
B-1
Supply Price Adjustment (Minimum Floor Price)
Notwithstanding the foregoing, in no event shall the Supply Price be less than the Floor Price.
In the event that the Floor Price mechanism is activated, Salix shall be entitled to request [*] audit of Alfas Cost of Goods Sold, to be conducted by an independent third party mutually acceptable to the Parties. The cost of such audit shall be borne by Salix unless the audit reveals that Cost of Goods Sold applied by Alfa to setting the price for the Crohns EIR Product exceeded the actual Cost of Goods Sold by more than [*] percent ([*]%), in which case Alfa shall pay for the cost of the audit. If and to the extent that the audit establishes that the Cost of Goods Sold as applied by Alfa in setting the Supply Price exceeded the actual Cost of Goods Sold, Alfa shall, at the option of Salix, either grant Salix (i) a credit to be applied towards future purchases of the Crohns EIR Product or (ii) a refund, in either case, [A] in an amount equal to the amount by which Salix was overcharged for its supply of the Crohns EIR Product and [B] to be applied in the subsequent Calendar Year.
Reconciliation of Supply Price
After the end of each Calendar Year, the Parties shall jointly conduct a reconciliation of the Supply Price for that year. The purpose of such reconciliation shall be to determine the actual Net Selling Price charged by Salix to its customers and to use that as a basis for determining whether the Supply Price for the year was too high or too low. The reconciliation shall compare (i) [*]% of the actual aggregate Net Selling Price charged to Salix customers for all sales of the Crohns EIR Product for the year (the Adjusted Total Net Selling Price ) against (ii) the total amount charged by the Manufacturers to Salix for the supply of Crohns EIR Product delivered to Salix during such year (the Total Salix Supply Charges ). If the Adjusted Total Net Selling Price for a year exceeds the Total Salix Supply Charges for such year, the difference shall be charged to Salix and added to the first invoice submitted to Salix for orders in the succeeding Calendar Year. On the other hand, if the Adjusted Total Net Selling Price for a year was less than the Total Salix Supply Charges for such year, Alfa shall, at the option of Salix, either grant Salix a credit to be applied toward future purchases of the Crohns EIR Product or (ii) a refund, in either case, in an amount equal to the amount by which the Total Salix Supply Charges exceeded the Adjusted Total Net Selling Price.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
B-2
Exhibit 10.97
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
AMENDMENT NUMBER TWO
TO
SUPPLY AGREEMENT
This Amendment Number Two to Supply Agreement (this Amendment ), dated August 6, 2012 (the Amendment Number Two Effective Date ), is made by and between Alfa Wassermann S.p.A., an Italian company ( Alfa ), and Salix Pharmaceuticals, Inc., a California corporation ( Salix ).
Recitals
WHEREAS, Alfa and Salix are parties to that certain Supply Agreement, dated June 24, 1996 and amended on [*] (the Supply Agreement );
WHEREAS, Alfa and Salix have on this date entered into an Amended and Restated License Agreement (the License Agreement ); and
WHEREAS, in connection with the execution of the License Agreement and certain of the matters referenced therein, Alfa and Salix desire to enter into this Amendment for the purpose of modifying certain of their agreements set forth in the Supply Agreement;
NOW THEREFORE, in consideration of the foregoing and the mutual promises of the parties set forth herein and in the License Agreement, Alfa and Salix, intending to be legally bound, agree to the following:
1. Capitalized terms used in this Amendment and not otherwise defined shall have the meanings set forth in the Supply Agreement.
2. Article 1 of the Supply Agreement is hereby amended by adding thereto the following definitions:
Amendment Number One means that certain Amendment to Supply Agreement, dated [*], between ALFA and SALIX.
Amendment Number Two shall mean that certain Amendment Number Two to Supply Agreement, dated August 6, 2012, between ALFA and SALIX.
Amendment Number Two Effective Date shall mean August 6, 2012.
Current Compound Formulation shall mean the formulation of the Compound manufactured and supplied by ALFA to SALIX pursuant to this Agreement as of the Amendment Number Two Effective Date, as described in the Specifications.
Initial Termination Date shall mean July 12, 2014.
Third Party shall mean any individual or entity other than ALFA and SALIX and their respective Affiliates.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
3. The following definitions contained in Article 1 of the Supply Agreement are hereby amended as follows:
(a) The definition of Compound is hereby amended by adding the following sentence at the end thereof:
Compound shall not, for purposes of this Agreement, include the EIR Formulation (as such term is defined in the License) nor any rifaximin required for the production of the EIR Formulation or any product containing the same, as it is the parties intent that the manufacture of EIR Formulation and products containing the same by ALFA and their supply by ALFA to SALIX shall be governed solely and exclusively by the EIR Supply Agreement (as such term is defined in the License).
(b) The definition of License is hereby amended to read in its entirety as follows:
License shall mean that certain Amended and Restated License Agreement, dated the Amendment Number Two Effective Date, between ALFA and SALIX, as the same may be amended from time to time following the Amendment Number Two Effective Date.
(c) The definition of Specifications is hereby amended to read in its entirety as follows:
Specifications shall mean the requirements, standards and other items for Compound attached as Exhibit A to Amendment Number Two, as amended from time to time in accordance with the provisions hereof to comply with the Applications.
4. Article 2.1 of the Supply Agreement is hereby amended by adding at the end thereof the following sentence:
Notwithstanding the provisions of the preceding sentence, from and after the Initial Termination Date
(a) SALIX shall be entitled to deplete [*] its inventory of Compound on hand as of the Initial Termination Date (including, for the avoidance of doubt, Compound scheduled as of the Initial Termination Date for delivery following the Initial Termination Date), that Salix has acquired from any Third Party pursuant to contractual obligations existing between SALIX and such Third Party as of the Amendment Number Two Effective Date and,
(b) following the depletion of inventory of Compound as contemplated in clause (a), SALIXs obligation to purchase Compound from ALFA shall be limited to an obligation to purchase from ALFA [*] percent of the quantities of the Current Compound Formulation that are required by SALIX for use in the manufacture of Product for sale in the Territory in exercise of the rights granted to SALIX by ALFA under the License [*].
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
2
For the avoidance of doubt and by way of example, in the event that SALIX were to be obligated during any period covered by clause (b) of the preceding sentence to purchase [*] percent of its requirements of Current Compound Formulation from a Third Party, then [*].
5. Article 3.1 of the Supply Agreement is hereby amended by adding at the end thereof the following sentences:
Notwithstanding the provisions of the preceding sentence (or, for the avoidance of doubt, the provisions of Amendment Number One), the price to be paid by SALIX to ALFA for Compound ordered for delivery from and after the Initial Termination Date shall be as determined from time to time by agreement between SALIX and ALFA. In the event that at any time ALFA and SALIX are unable to reach agreement with respect to the price to be paid by SALIX to ALFA for Compound ordered for delivery following the Initial Termination Date, then [*].
6. Article 5.2 of the Supply Agreement is hereby amended by adding at the end thereof the following new paragraph:
In respect of the period that begins on the Initial Termination Date and continues thereafter, (a) the provisions of the first paragraph of this Article 5.2 shall cease to apply and (b) SALIX shall provide to ALFA a 12-month forecast of its expected purchases of Compound hereunder, which forecast will be updated monthly.
7. Article 6.1.1 of the Supply Agreement is hereby amended by adding at the end thereof, but before the semi-colon, the following provisions:
and the Certificate of Analysis therefor provided pursuant to Article 5.4
8. Article 6.1.2 of the Supply Agreement is hereby amended by adding at the end thereof, but before the semi-colon, the following provisions:
, title to such Compound shall pass to SALIX free and clear of any security interest, lien or other encumbrance, the expiration date of such Compound as defined in the Specifications shall be no earlier than [*] months after such date of delivery assuming storage in conformance with the Specifications, such Compound shall not have been adulterated or misbranded under any Act, and neither ALFA nor any of its Affiliates has been debarred or is subject to disbarment for regulatory or government contracting purposes or listed on any regulatory or government contracting exclusion list of any Government
9. Article 9.2 of the Supply Agreement is hereby amended by adding at the end thereof the following sentence:
From and after the Initial Termination Date, the provisions of the preceding provisions of this Article 9.2 shall have no further force or effect.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
3
10. Article 10.1 of the Supply Agreement is hereby amended to read in its entirety as follows:
This Agreement shall come into force and effect as at the last date of execution of these presents and, subject to Article 10.2, shall continue thereafter until the date of the first commercial sale of a generic of any Product by a third party in any part of the Territory that may occur prior to the Initial Termination Date, but otherwise for so long as SALIX continues to commercialize a Product. Following the Initial Termination Date, SALIX and ALFA shall meet periodically to discuss in good faith [*].
11. The Supply Agreement is hereby amended by adding immediately after Article 18 thereof a new Article 19, such new Article to read as follows:
ARTICLE 19 - AMENDMENT NUMBER ONE From and after the Initial Termination Date, the provisions of Amendment Number One shall have no further force or effect and the Supply Agreement shall continue thereafter as though ALFA and SALIX had never entered into Amendment Number One.
12. This Amendment shall be governed by and construed in accordance with the laws of Scotland, without giving effect to any conflict of laws principles or rules. The parties agree to exclude the application to this Amendment of the United Nations Convention on Contracts for the International Sale of Goods.
13. This Amendment, along with any exhibits, schedules and agreements referenced herein, states the entire agreement reached between the parties hereto with respect to the transactions contemplated hereby. This Amendment replaces and supersedes any and all previous agreements and understandings between the parties regarding the subject matter hereof, whether written or oral.
14. The Supply Agreement, as amended by this Amendment, shall remain in full force and effect.
15. This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which taken together shall constitute one and the same instrument. This Amendment may be executed by the electronic delivery of facsimiles of executed signature pages hereto with the same effect as the delivery of originally executed signature pages.
16. The parties acknowledge and agree that: (a) each party and its counsel reviewed and negotiated the terms and provisions of this Amendment and have contributed to its revision, (b) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Amendment, and (c) the terms and provisions of this Amendment shall be construed fairly as to all parties hereto and not in a favor of or against any party, regardless of which party was generally responsible for the preparation of this Amendment.
[Signatures appear on next page.]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
4
IN WITNESS WHEREOF, each of the undersigned has caused this Amendment to be duly executed and delivered to be effective as of the Amendment Number Two Effective Date.
ALFA WASSERMANN S.p.A. | SALIX PHARMACEUTICALS, INC. | |||||||
By: | /s/ Andrea Golinelli | By: | /s/ Rick Scruggs |
Name: | /s/ Andrea Golinelli | Name: | Rick Scruggs |
Title: | Chief Strategy Officer | Title: | EVP Business Development |
5
EXHIBIT A
SPECIFICATIONS
[*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Exhibit 10.98
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
TRADEMARK LICENSE AGREEMENT (ALFA TO SALIX)
dated August 6, 2012
by and between
A LFA W ASSERMANN H UNGARY K FT .
and
S ALIX P HARMACEUTICALS , I NC .
TABLE OF CONTENTS
Page | ||||||
Article 1 - CERTAIN DEFINITIONS |
1 | |||||
Article 2 - LICENSE GRANT AND COMPENSATION |
2 | |||||
2.1 |
Xifaxan Trademark License |
2 | ||||
2.2 |
Crohns EIR Trademark License |
3 | ||||
2.3 |
Other EIR Trademarks License |
4 | ||||
2.4 |
New Indication Trademark License |
4 | ||||
2.5 |
[*] Trademark License |
5 | ||||
2.6 |
Sublicenses |
6 | ||||
2.7 |
Availability of Xifaxan Trademark |
6 | ||||
2.8 |
Trademark Royalties |
7 | ||||
2.9 |
Records |
8 | ||||
Article 3 - SALIXS OBLIGATIONS |
9 | |||||
3.1 |
Acknowledgment |
9 | ||||
3.2 |
Salixs Obligations |
10 | ||||
Article 4 - XIFAXAN DOMAIN NAMES |
10 | |||||
4.1 |
Xifaxan Domain Name |
10 | ||||
4.2 |
Other Alfa Domain Names |
13 | ||||
Article 5 - COVENANTS |
13 | |||||
5.1 |
Registration of Alfa Licensed Trademarks |
13 | ||||
5.2 |
Infringement of Alfa Licensed Trademarks |
14 | ||||
5.3 |
Acknowledgments |
15 | ||||
5.4 |
Creative Works |
15 | ||||
5.5 |
Goodwill |
15 | ||||
Article 6 - REPRESENTATIONS AND WARRANTIES |
16 | |||||
6.1 |
AWHs Representations |
16 | ||||
6.2 |
Disclaimers of Representations and Warranties |
16 | ||||
Article 7 - FORCE MAJEURE |
17 | |||||
Article 8 - COMMENCEMENT, DURATION AND TERMINATION |
17 | |||||
8.1 |
Term of Agreement |
17 | ||||
8.2 |
Termination |
17 | ||||
8.3 |
Effect of Termination |
18 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
i
Article 9 - INDEMNIFICATION AND DAMAGES |
19 | |||||
9.1 |
In Favor of Salix |
19 | ||||
9.2 |
In Favor of AWH |
19 | ||||
9.3 |
Indemnification Procedures |
19 | ||||
Article 10 - DISPUTE RESOLUTION |
21 | |||||
10.1 |
Good Faith Discussions |
21 | ||||
10.2 |
Arbitration |
21 | ||||
10.3 |
Exceptions |
22 | ||||
Article 11 - ASSIGNMENT |
22 | |||||
11.1 |
Binding Effect |
22 | ||||
11.2 |
Assignment by AWH |
22 | ||||
11.3 |
Assignment by Salix |
22 | ||||
Article 12 - ENTIRE AGREEMENT AND MODIFICATION |
23 | |||||
Article 13 - LANGUAGE AND GOVERNING LAW |
23 | |||||
13.1 |
English Language |
23 | ||||
13.2 |
Governing Law |
23 | ||||
Article 14 - WAIVER |
23 | |||||
Article 15 - NOTICES |
23 | |||||
Article 16 - SEVERABILITY |
25 | |||||
Article 17 - HEADINGS AND CONSTRUCTION |
25 | |||||
17.1 |
Headings |
25 | ||||
17.2 |
References |
25 | ||||
17.3 |
Rules of Construction |
25 | ||||
Article 18 - COUNTERPARTS |
25 | |||||
Article 19 - MUTUAL DRAFTING |
25 | |||||
Article 20 - THIRD PARTY RIGHTS |
25 | |||||
Article 21 - RELATIONSHIP OF THE PARTIES |
26 | |||||
Article 22 - PERFORMANCE BY AFFILIATES |
26 | |||||
Article 23 - FURTHER ASSURANCE |
26 |
ii
TRADEMARK LICENSE AGREEMENT
TRADEMARK LICENSE AGREEMENT (this Agreement ) dated August 6, 2012 by and among Alfa Wassermann Hungary Kft., a corporation organized under the laws of Hungary ( AWH ), and Salix Pharmaceuticals, Inc., a corporation incorporated under the laws of the State of California, United States of America ( Salix ) (each, a Party and, collectively, the Parties ).
WITNESSETH:
WHEREAS, Salix and Alfa Wassermann S.p.A., a corporation incorporated under the laws of Italy ( AWSPA ) and an Affiliate of AWH, have entered into an Amended and Restated License Agreement of even date herewith (the Amended and Restated License Agreement );
WHEREAS, the Amended and Restated License Agreement provides in part for the license by AWSPA to Salix of certain patent rights and unpatented technology rights for the purpose of enabling Salix to sell Alfa Licensed Products within the Field in the Salix Territory; and
WHEREAS, pursuant to the licenses granted herein by AWH to Salix, Salix wishes to use certain AWH trademarks to Exploit the Alfa Licensed Products and Rifaximin Products containing [*] of the Compound in the Salix Territory within the Field and AWH desires to license such trademarks to Salix;
NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties hereby agree as follows:
Article 1 - CERTAIN DEFINITIONS
All capitalized terms used herein without definitions have the respective meanings set forth in the Amended and Restated License Agreement and are incorporated in this Agreement by reference.
Alfa Licensed Trademarks means the Xifaxan Trademark, the Crohns EIR Trademark, the Other EIR Trademarks, the New Indication Trademarks and [*] Trademarks.
Alfa Standards has the meaning set forth in Section 4.1(g).
[*] Trademarks has the meaning set forth in Section 2.5(a).
Claimant has the meaning set forth in Section 9.3(a).
Continuing Trademark License Option has the meaning set forth in Section 2.8.
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Creative Works has the meaning set forth in Section 5.4.
Crohns EIR Trademark has the meaning set forth in Section 2.2(a).
ICC has the meaning set forth in Section 10.2.
Indemnitor has the meaning set forth in Section 9.3(a).
Losses has the meaning set forth in Section 9.1.
New Indication Trademarks has the meaning set forth in Section 2.4(a).
Other Alfa Domain Names means all Internet domain names containing any Crohns EIR Trademark, Other EIR Trademark, New Indication Trademark or [*] Trademark, or any alternative spellings of any such Alfa Licensed Trademark.
Other EIR Trademarks has the meaning set forth in Section 2.3(a).
Salix Non-Royalty Product means, on a country-by-country and Rifaximin Product-by-Rifaximin Product basis, an Alfa Licensed Product, a Crohns EIR Product or a Rifaximin Product containing [*] of the Compound, as applicable, as to which Salixs obligation to pay royalties to AWSPA pursuant to Section 4.1 or Section 4.3.3(e)(ii), respectively, of the Amended and Restated License Agreement in the relevant country has expired or terminated pursuant to Section 16.2.1 or Section 4.3.3(e)(ii), respectively, of the Amended and Restated License Agreement.
Xifaxan Domain Names has the meaning set forth in Section 4.1(a).
Xifaxan Trademark means the XIFAXAN and XIFAXAN 550 marks and any current or future registrations or applications for the registration thereof, including (i) [*], (ii) [*], (iii) [*], and (iv) [*].
Xifaxan Web Site has the meaning set forth in Section 4.1(e).
Article 2 - LICENSE GRANT AND COMPENSATION
2.1 Xifaxan Trademark License .
(a) AWH hereby grants to Salix (i) an exclusive (including with respect to AWH, AWSPA and their Affiliates) license (with the right to sublicense as set forth herein) to use the Xifaxan Trademark to Exploit (but not to Manufacture or have Manufactured) the Alfa Licensed Products (other than the Crohns EIR Product and Other EIR Products) for Existing Indications within the Field in the Salix Territory and (ii) a non-exclusive license (with the right
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to sublicense as set forth herein) to use the Xifaxan Trademark in connection with the Manufacture of Alfa Licensed Products (other than the Crohns EIR Product and Other EIR Products) solely for purposes of Exploitation of such Alfa Licensed Products for Existing Indications within the Field in the Salix Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement, the Supply Agreements, and the Amended and Restated License Agreement.
(b) Salix shall have the right to sublicense the rights granted to it in Section 2.1(a) through multiple tiers of sublicensees to any party to whom Salix (or its sublicensee) grants a sublicense under the Existing Indications License in Section 4.1.1 of the Amended and Restated License Agreement, subject to Section 2.6 of this Agreement.
(c) The term of the license granted under Section 2.1(a) shall continue on a country-by-country and Alfa Licensed Product-by-Alfa Licensed Product basis until the relevant Alfa Licensed Product becomes a Salix Non-Royalty Product in the relevant country, at which time Salix shall have an option to retain the license granted under Section 2.1(a) for such Alfa Licensed Product in such country, as set forth in Section 2.8.
2.2 Crohns EIR Trademark License .
(a) AWH, in consultation with Salix, shall select the trademark to be used in connection with the Exploitation of the Crohns EIR Product in the Salix Territory (the Crohns EIR Trademark ). The Crohns EIR Trademark shall be owned by AWH.
(b) AWH hereby grants to Salix (i) an exclusive (including with respect to AWH, AWSPA and their Affiliates) license (with the right to sublicense as set forth herein) to use the Crohns EIR Trademark to Exploit (but not to Manufacture or have Manufactured) the Crohns EIR Product within the Field in the Salix Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the Crohns EIR Trademark in connection with the Manufacture of Crohns EIR Product solely for purposes of Exploitation of Crohns EIR Product within the Field in the Salix Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Salix shall have the right to sublicense the rights granted to it in Section 2.2(b) through multiple tiers of sublicensees to any party to whom Salix (or its sublicensee) grants a sublicense under the Crohns EIR License, subject to Section 2.6 of this Agreement.
(d) The term of the license granted under Section 2.2(b) shall continue on a country-by-country and product-by-product basis until the relevant Crohns EIR Product becomes a Salix Non-Royalty Product in the relevant country, at which time Salix shall have an option to retain the license granted under Section 2.2(b) for such Crohns EIR Product in such country, as set forth in Section 2.8. Without limiting the generality of the foregoing, the license granted under Section 2.2(b) shall terminate if Salix elects to terminate its license to Exploit the Crohns EIR Product pursuant to Section 16.4.4 of the Amended and Restated License Agreement or if AWSPA terminates Salixs rights with respect to the Crohns EIR Product and the Crohns EIR License pursuant to Section 16.4.5 of the Amended and Restated License Agreement.
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2.3 Other EIR Trademarks License .
(a) AWH, in consultation with Salix, shall select the trademarks to be used in connection with the Exploitation of the Other EIR Products in the Salix Territory (the Other EIR Trademarks ). The Other EIR Trademarks shall be owned by AWH.
(b) AWH hereby grants to Salix (i) an exclusive (including with respect to AWH, AWSPA and their Affiliates) license (with the right to sublicense as set forth herein) to use the Other EIR Trademarks to Exploit (but not to Manufacture or have Manufactured) the Other EIR Products within the Field in the Salix Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the Other EIR Trademarks in connection with the Manufacture of Other EIR Products solely for purposes of Exploitation of Other EIR Products within the Field in the Salix Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Salix shall have the right to sublicense the rights granted to it in Section 2.3(b) through multiple tiers of sublicensees to any party to whom Salix (or its sublicensees) grants a sublicense under the Existing Indications EIR License or the Salix New Indications License, subject to Section 2.6 of this Agreement.
(d) The term of the license granted under Section 2.3(b) shall continue on a country-by-country and Alfa Licensed Product-by-Alfa Licensed Product basis until the relevant Alfa Licensed Product becomes a Salix Non-Royalty Product in the relevant country, at which time Salix shall have an option to retain the license granted under Section 2.3(b) for such Alfa Licensed Product in such country, as set forth in Section 2.8. Without limiting the generality of the foregoing, the license granted under Section 2.3(b) shall terminate if Salix elects to terminate its license to Exploit the Crohns EIR Product pursuant to Section 16.4.4 of the Amended and Restated License Agreement or if AWSPA terminates Salixs rights with respect to the Existing Indications EIR License pursuant to Section 16.4.5 of the Amended and Restated License Agreement.
2.4 New Indication Trademark License .
(a) AWH, in consultation with Salix, shall select the trademarks to be used in connection with the Exploitation of Alfa Licensed Products (other than Crohns EIR Product or Other EIR Products) for New Indications in the Salix Territory (the New Indication Trademarks ). For clarity, New Indication Trademarks shall not include the Crohns EIR Trademark or the Other EIR Trademarks. The New Indication Trademarks shall be owned by AWH.
(b) AWH hereby grants to Salix (i) an exclusive (including with respect to AWH, AWSPA and their Affiliates) license (with the right to sublicense as set forth herein) to use the New Indication Trademarks to Exploit (but not to Manufacture or have Manufactured)
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Alfa Licensed Products (other than Crohns EIR Product or Other EIR Products) for New Indications within the Field in the Salix Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the New Indications Trademarks in connection with the Manufacture of Alfa Licensed Products (other than Crohns EIR Product or Other EIR Products) for New Indications solely for purposes of Exploitation of such Alfa Licensed Products within the Field in the Salix Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Salix shall have the right to sublicense the rights granted in Section 2.4(b) through multiple tiers of sublicensees to any party to whom Salix (or its sublicensee) grants a sublicense under the Salix New Indications License, subject to Section 2.6 of this Agreement.
(d) The term of the license granted under Section 2.4(b) shall continue on a country-by-country and Alfa Licensed Product-by-Alfa Licensed Product basis until the relevant Alfa Licensed Product becomes a Salix Non-Royalty Product in the relevant country, at which time Salix shall have an option to retain the license granted under Section 2.4(b) for such Alfa Licensed Product in such country, as set forth in Section 2.8.
2.5 [*] Trademark License .
(a) AWH, in consultation with Salix, shall select the trademarks to be used in connection with the Exploitation of Rifaximin Products containing [*] of the Compound in the Field in the Salix Territory (the [*] Trademarks ). The [*] Trademarks shall be owned by AWH.
(b) AWH hereby grants to Salix (i) an exclusive (including with respect to AWH, AWSPA and their Affiliates) license (with the right to sublicense as set forth herein) to use the [*] Trademarks to Exploit (but not to Manufacture or have Manufactured) Rifaximin Products containing [*] of the Compound within the Field in the Salix Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the [*] Trademarks in connection with the Manufacture of Rifaximin Products containing [*] of the Compound solely for purposes of Exploitation of such Rifaximin Products within the Field in the Salix Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Salix shall have the right to sublicense the rights granted in Section 2.5(b) through multiple tiers of sublicensees to any party to whom Salix (or its sublicensee) grants a license to Exploit Rifaximin Products containing [*] of the Compound in the Field in the Salix Territory, subject to Section 2.6 of this Agreement.
(d) The term of the license granted under Section 2.5(b) shall continue on a country-by-country and Rifaximin Product-by-Rifaximin Product basis until the relevant Rifaximin Product becomes a Salix Non-Royalty Product in the relevant country, at which time Salix shall have an option to retain the license granted under Section 2.5(b) for such Rifaximin Product in such country, as set forth in Section 2.8.
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2.6 Sublicenses .
(a) The terms of any sublicense granted by Salix under the rights granted to it in this Agreement shall be in accordance with the terms of the particular license granted to Salix hereunder. Salix shall comply with the provisions of Section 4.1.6 of the Amended and Restated License Agreement (which is incorporated in this Agreement by reference) in connection with all such sublicenses.
(b) Salix shall be responsible to AWH for its sublicensees compliance with the terms of this Agreement. Any failure by a sublicensee to comply with such terms shall be deemed to be a breach of this Agreement by Salix.
(c) For the avoidance of doubt, it is hereby acknowledged that the appointment by Salix of a distributor for Rifaximin Products, any manufacturer to Manufacture Compound (including EIR Formulation) or Rifaximin Products to the extent permitted under the Amended and Restated License Agreement and the Supply Agreements, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for Rifaximin Products shall not be deemed to constitute the appointment of any sublicensee or the sublicense by Salix of any rights under this Agreement.
2.7 Availability of Xifaxan Trademark .
(a) With respect to the trademarks to be used in connection with the Exploitation of Alfa Licensed Products or Crohns EIR Products by Salix in the Field in the Salix Territory under Sections 2.2 through 2.4 or the Exploitation of Rifaximin Products containing [*] of the Compound by Salix in the Field in the Salix Territory under Section 2.5, the Parties agree that the Xifaxan Trademark shall be available for use by Salix as a Crohns EIR Trademark, an Other EIR Trademark, a New Indication Trademark, or an [*] Indication Trademark, as the case may be.
(b) With respect to the trademarks to be used in connection with the Exploitation by Salix in the Field in the Salix Territory of Rifaximin Products licensed by Salix to AWSPA pursuant to Section 4.2.1 of the Amended and Restated License Agreement, the Salix Designated Indication Product or Other New Formulation Products, the Parties will, subject to the following sentence, determine by mutual agreement whether the Xifaxan Trademark shall be available for such use by Salix. In the event that any Regulatory Authority in the Salix Territory requires the use of the Xifaxan Trademark in connection with the Exploitation by Salix in the Field in the Salix Territory of Rifaximin Products licensed by Salix to AWSPA pursuant to Section 4.2.1 of the Amended and Restated License Agreement, the Salix Designated Indication
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Product or Other New Formulation Products or the Parties determine that the commercial potential of any such product would be enhanced in the Field in the Salix Territory by the use of the Xifaxan Trademark in connection with the Exploitation by Salix in the Field in the Salix Territory of the relevant product, then the Parties shall cooperate and negotiate in good faith to structure arrangements pursuant to which the Xifaxan Trademark will be made available for the Exploitation of the relevant product by Salix in the Field in the Salix Territory on terms that preserve the relative economic arrangements envisioned by the Amended and Restated License Agreement and the Trademark License Agreements had a trademark other than the Xifaxan Trademark been used for purposes of the Exploitation of the relevant product by Salix in the Field in the Salix Territory.
(c) In the event that the Parties determine to use the Xifaxan Trademark in connection with the Exploitation by AWSPA in the Field in the Alfa Territory of Rifaximin Products licensed by Salix to AWSPA pursuant to Section 4.2.1 of the Amended and Restated License Agreement, the Salix Designated Indication Product or Other New Formulation Products, then the Parties shall cooperate and negotiate in good faith to structure arrangements pursuant to which the Xifaxan Trademark will be made available for the Exploitation of the relevant product by AWSPA in the Field in the Alfa Territory on terms that preserve the relative economic arrangements envisioned by the Amended and Restated License Agreement and the Trademark License Agreements had a trademark other than the Xifaxan Trademark been used for purposes of the Exploitation of the relevant product by AWSPA in the Field in the Alfa Territory.
2.8 Trademark Royalties .
(a) No royalty shall be payable by Salix to AWH with respect to any of the licenses granted under Sections 2.1 through 2.5, except as set forth in this Section 2.8. With respect to each Alfa Licensed Product, Crohns EIR Product or Rifaximin Product containing [*] of the Compound that becomes a Salix Non-Royalty Product in a particular country, Salix shall have the option to continue to use the respective Alfa Licensed Trademarks associated with such Rifaximin Product in such country (the Continuing Trademark License Option ). Salix may exercise the Continuing Trademark License Option by delivering a written notice of exercise to AWH within [*] days following the date of notice given by AWPSA to Salix that Salixs obligation to pay royalties on the relevant Rifaximin Product in a particular country has expired or terminated pursuant to Section 16.2.1 or Section 4.3.3(e)(ii), as applicable, of the Amended and Restated License Agreement. If the Continuing Trademark License Option is exercised by Salix, the exclusive (and sublicensable) license granted to Salix with respect to such Alfa Licensed Trademark(s) pursuant to Sections 2.1 through 2.5 above, as applicable, shall continue in respect of such Salix Non-Royalty Product until terminated as provided herein, provided that Salix shall pay royalties for the continued use of such Alfa Licensed Trademark(s) thereafter in respect of such Salix Non-Royalty Product in such country in an amount equal to [*] percent ([*]%) of the Net Sales of the Salix Non-Royalty Product in such country. Salix may at any time thereafter notify AWH or its Affiliate (including AWSPA) in writing that it wishes to terminate
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the specific license granted under Sections 2.1 through 2.5 above for the applicable Alfa Licensed Trademark(s) with respect to the Salix Non-Royalty Product in any country, in which case Salix shall have no further right to use such respective Alfa Licensed Trademark(s) in connection with such Salix Non-Royalty Product in such country, and Salix shall timely pay all royalties due on Net Sales made up to and including the date of termination and thereafter shall have no further obligation to pay royalties in respect of such Salix Non-Royalty Product in such country.
(b) Within [*] days of the end of each calendar quarter (such quarters to end on the last days of March, June, September and December in each Calendar Year), Salix shall submit to AWH a written report setting out the details of all of its Net Sales in such calendar quarter that are subject to a royalty under this Agreement. Such report shall include a calculation of the Net Sales on a country-by-country and product-by-product basis and the royalties payable thereon. Following receipt of such report, AWH shall issue to Salix an invoice for the amount of royalties set forth in Salixs report. Invoices shall be due and payable not later than [*] days after receipt of such invoice by Salix. In the event that any payment due hereunder shall not be paid by the due date, then such payment shall from the due date until the actual date of payment bear interest at the annual rate of [*] percent ([*]%) above the official prime rate published by [*], or, if [*] ceases to publish a prime rate, such other United States banking institution as the Parties shall agree upon. All payments to be made hereunder shall be made in United States Dollars by [*] wire transfer to such bank as AWH shall designate in writing. Except as expressly stated in this Agreement, Salix shall not be entitled in any circumstances to withhold any money due to AWH under the terms of this Agreement in respect of any possible (justified or unjustified) claims against AWH or AWSPA related to this Agreement, the Amended and Restated License Agreement, or any of the other Related Agreements. All bank transfer and wire charges imposed on payments made by Salix under this Agreement shall be borne by Salix.
(c) All payments under this Agreement shall be made without any deduction or withholding of or on account of any tax, duties, levies, or other charges by Salix unless such deduction or withholding is required by applicable law to be assessed against AWH. If Salix is so required to make any deduction or withholding from payments due to AWH, Salix shall (i) promptly notify AWH of such requirement, (ii) pay to the relevant authorities on AWHs behalf the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against AWH, and (iii) promptly forward to AWH an official receipt (or certified copy) or other documentation reasonably acceptable to AWH evidencing such payment to such authorities.
2.9 Records . At all times following the exercise by Salix of the Continuing Trademark License Option and until such time that Salix elects to exercise its right to terminate all extended licenses with regard to Salix Non-Royalty Products pursuant to Section 2.8, Salix shall, and shall cause its Affiliates and sublicensees to, maintain during the term of this Agreement normal accounting books (in accordance with normal United States accounting practice) containing accurate details of all sales of Salix Non-Royalty Products
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that are subject to a royalty under this Agreement and of the calculation of Net Sales and the royalty payments due hereunder. AWH shall have the right, during the term of the Agreement and for [*] year following the expiration or termination of the Agreement, upon written notice, during normal working hours to cause qualified professional accountants of its choice to inspect the books and records and any other documentation and records maintained by Salix or its Affiliates or sublicensees relevant to the calculation of any royalty payable under this Agreement. The accountants shall provide a copy of their report to each Party. The cost of the above accountants inspections shall be borne by AWH save only where any such inspection reveals a discrepancy in excess of [*] percent ([*]%) of royalties due and payable, in which event the costs shall be borne by Salix, provided that:
(a) such inspection shall not take place more than [*]; and
(b) such inspection shall only be in respect of records and accounts for the period of [*] years preceding the date of such inspection and Salix shall not be required to retain records for any period exceeding [*] years.
If any such inspection reveals that there has been an underpayment or overpayment of royalties, Salix shall promptly pay to AWH the full amount of the underpayment or AWH shall promptly pay to Salix the full amount of the overpayment, as applicable; provided, however , that if Salix or AWH has a reasonable good faith objection to the calculation of the underpayment or overpayment, the Parties shall discuss the dispute in good faith and seek to reach resolution on whether there was an underpayment or overpayment of royalties, and if so, the amount of such underpayment or overpayment. If the Parties are unable to resolve such dispute, then it shall be resolved through the dispute resolution procedures set forth in Article 10 -.
2.10 Ownership of Licensed Marks . Salix acknowledges and agrees that AWH shall have and retain, directly or indirectly, through its Affiliates, full and complete ownership of the Alfa Licensed Trademarks during the entire term of this Agreement, and Salix agrees that nothing contained herein shall vest or otherwise give to Salix any right, title or interest in or to any of the Alfa Licensed Trademarks, except the right to use the same in accordance with the terms of this Agreement and the Amended and Restated License Agreement.
Article 3 - SALIXS OBLIGATIONS
3.1 Acknowledgment . Salix recognizes that, as a result of many years of advertising, investment and providing dependable products to the consuming public, the Xifaxan Trademark has acquired a high degree of favorable recognition and goodwill with the purchasing public in connection with the goods with which the Xifaxan Trademark has been used.
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3.2 Salixs Obligations . Salix shall:
(a) use commercially reasonable efforts to maintain high standards with regard to the nature and quality of Rifaximin Products sold under any of the Alfa Licensed Trademarks by Salix or its Affiliates or sublicensees during the term of this Agreement;
(b) use commercially reasonable efforts to preserve the high standards and goodwill of the Alfa Licensed Trademarks and to exercise such supervision and control with respect to all Rifaximin Products sold under any of the Alfa Licensed Trademarks by Salix or its Affiliates or sublicensees so as to preserve and enhance the goodwill of the Alfa Licensed Trademarks and the high and favorable recognition with the purchasing public that the Alfa Licensed Trademarks now (and will) carry and to otherwise protect the public from confusion and deception;
(c) not use the Alfa Licensed Trademarks in a descriptive or generic manner;
(d) not (i) assert any claim adverse to AWHs right, title or interest in or to any of the Alfa Licensed Trademarks or (ii) use any of the Alfa Licensed Trademarks in any way that could injure the goodwill associated with the Alfa Licensed Trademarks or prejudice AWHs rights therein;
(e) not apply to register the Alfa Licensed Trademarks in its own name in any part of the Salix Territory or outside the Salix Territory;
(f) not, during or after the term of this Agreement, unlawfully use in its business any trademark or trade name which is confusingly similar to, or so nearly resembles any of the Alfa Licensed Trademarks, as to be likely to cause deception or confusion, except as otherwise specifically contemplated by this Agreement;
(g) not (i) misuse any of the Alfa Licensed Trademarks or take any other action to bring them into disrepute or (ii) use the Alfa Licensed Trademarks in violation of any trademark usage guidelines that AWH may from time to time provide to Salix in writing;
(h) maintain a degree of continuity respecting the appearance, design and usage of the Alfa Licensed Trademarks in accordance with the common standards and procedures of trademark practice;
(i) use the ® symbol (with the use of any registered mark) or the TM symbol (with the use of any unregistered mark) or such other appropriate notice as AWH may specify to Salix in writing in connection with Salixs use of the Alfa Licensed Trademarks; and
(j) provide all such assistance as AWH may reasonably request in relation to any application to register AWH as the owner of any trademark applications for the Alfa Licensed Trademarks, including the prosecution of such applications, and provide reasonable cooperation with all maintenance activities conducted by AWH regarding the Alfa Licensed Trademarks.
Article 4 - XIFAXAN DOMAIN NAMES
4.1 Xifaxan Domain Name .
(a) Representations . Salix represents and warrants that it (i) is the registrant listed in the records of Network Solutions as the owner of the Internet domain name XIFAXAN.COM and other related domains using the name XIFAXAN or
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variations thereon listed in Exhibit A attached hereto (hereafter the Xifaxan Domain Names ), (ii) is the holder of said Xifaxan Domain Names, free from any and all encumbrances, (iii) is free to transfer or sell said Xifaxan Domain Names, and (iv) has all necessary legal authority to make such transfer.
(b) Transfer of Xifaxan Domain Names . Salix agrees to sell, convey, assign and otherwise transfer to AWH all of its right, title and interest in, to and associated with the Xifaxan Domain Names (but not any content associated with any website at such Xifaxan Domain Names), upon the terms and conditions set forth in this Agreement. Promptly after the Amendment Effective Date, Salix shall (i) take such action as required or necessary to effect the transfer of the Xifaxan Domain Names to AWH including, without limitation, releasing any lock placed on the Xifaxan Domain Names, obtaining the authorization codes and providing such codes to AWH, confirming the requested transfer upon receipt of a request to do so from the registrar used by AWH for the Xifaxan Domain Names, executing and delivering all authorizations necessary to effectuate electronic transfer of the Xifaxan Domain Names, and executing and delivering all further documents and instruments as AWH may reasonably request to effectuate the assignment and transfer of the Xifaxan Domain Names, and (ii) do and cause to be done such further acts and things as may be necessary or as AWH may reasonably request to effectuate the assignment and transfer of the Xifaxan Domain Names to AWH. Salix shall work diligently and in good faith with AWH or AWHs designated registrar to facilitate, coordinate, and complete the transfer of the Xifaxan Domain Names from Salix to AWH.
(c) Maintenance; Costs. AWH shall be responsible for all registration fees charged by its registrar or any third parties in connection with the transfer of the Xifaxan Domain Names, and AWH shall be responsible for all renewal fees necessary for maintaining the continued registration of the Xifaxan Domain Names. AWH shall also pay for any costs and expenses incidental to the transfer of the Xifaxan Domain Names, including all registration or transfer fees and other costs and expenses. Salix shall pay all of its own expenses and charges, legal fees, and any delinquent charges due and owing for the Xifaxan Domain Names through the date of transfer, and AWH shall be responsible for all such fees incurred after the transfer. AWH and Salix agree to cooperate and to take all steps necessary to affect the transfer of the Xifaxan Domain Names and to otherwise achieve the goals contemplated by this Agreement.
(d) Rights and Responsibilities . Salix shall not claim ownership of the Xifaxan Domain Names as of the Amendment Effective Date, nor shall Salix challenge, interfere, solicit, encourage or assist others to challenge or otherwise interfere with AWHs title, interest, right or use of the Xifaxan Domain Names.
(e) License . Effective immediately after the transfer of the Xifaxan Domain Names from Salix to AWH, AWH hereby grants to Salix an exclusive right and license to use, and control the content of any websites associated with any of, the Xifaxan Domain Names (collectively, the Xifaxan Web Site ) in connection with the Exploitation of Alfa Licensed Products for Existing Indications for the Field in the Salix Territory or for any other Rifaximin Product for which the Parties may agree to use the Xifaxan Trademarks as provided herein, in such latter event in a manner consistent with and limited to Salixs permitted use of the Xifaxan
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Trademarks. To give Salix control over such Xifaxan Web Site content, AWH shall use the same technical contact and server information used by Salix for each Xifaxan Domain Name prior to their transfer to AWH following the transfer of such Xifaxan Domain Name. From time to time, during the term of this Agreement, Salix may request that AWH change or update the technical contact and/or server information for a particular Xifaxan Domain Name. Promptly upon receipt of such a request from Salix, AWH shall contact the domain name registrar for such Xifaxan Domain Name and revise the information accordingly. During the term of this Agreement, AWH shall not change the technical contact or server information for any Xifaxan Domain Names or take any action to direct Internet traffic to any of the Xifaxan Domain Names to any servers or IP addresses other than those identified by Salix. AWH and Salix agree to cooperate in ensuring that access to the Xifaxan Web Site is maintained and all the technical requirements are complied with during the course of this Agreement. The content of the Xifaxan Web Site(s) shall be directed at information pertaining exclusively to the Rifaximin Products for Existing Indications sold by Salix or to any other Rifaximin Product for which the Parties may agree to use the Xifaxan Trademarks as provided herein. Salix shall be permitted to upload, publish, display or otherwise include or use content on the Xifaxan Web Site(s), so long as such content is in compliance with applicable U.S. Federal laws and regulations. AWH shall not require prior approval of content changes to the Xifaxan Web Site(s). Salix agrees that it shall provide AWH with a status report on any content changes to the Xifaxan Web Site(s) (and reasons for such changes) every [*] months or after major changes to the Xifaxan Web Site(s). If no changes are made the report shall so indicate. The report should be sent to: Dr. Emília Zubornyák, Alfa Wassermann Hungary Kft., Garibaldi u.4. Budapest 1054 Hungary.
(f) AWH shall rely upon the expertise and experience of Salix for determining the information and content that shall be included on the Xifaxan Web Site(s). AWHs review of the status report shall not be construed as AWHs representation or warranty that such content is accurate, complete, truthful or correct.
(g) Salix agrees that its use of the Xifaxan Domain Names and Xifaxan Trademark, including the use of the Xifaxan Trademark on the Xifaxan Web Site(s), shall be in accordance with the guidelines or specifications issued by AWH (collectively referred to as the Alfa Standards ).
(h) Salix agrees that its use of the Xifaxan Domain Names shall be in the form and style conforming to the Alfa Standards, as updated from time to time, and as approved by AWH in writing, such approval not to be unreasonably withheld. Salix shall submit to AWH for review and approval, at least [*] Business Days prior to Salixs proposed use, any planned changes to the representation of the Xifaxan Domain Names that have not been previously approved by AWH.
(i) AWH shall (i) use Commercially Reasonable Efforts to maintain, and to take all acts required to maintain, the Xifaxan Domain Names, including timely renewing the Xifaxan Domain Names registration, and (ii) not assign any of the Xifaxan Domain Names to
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any Third Party without Salixs prior written consent, such consent not to be unreasonably conditioned, withheld or delayed except in connection with any assignment of this Agreement permitted under Section 11.2, or unless the assignee agrees in writing to assume AWHs obligations under this Agreement with respect to the Xifaxan Domain Names.
4.2 Other Alfa Domain Names . All Other Alfa Domain Names shall be the property of AWH. Salix shall execute any documentation reasonably requested by AWH necessary to assign to AWH or its designee the rights set forth in this Section 4.2.
Article 5 - COVENANTS
5.1 Registration of Alfa Licensed Trademarks .
(a) AWH undertakes to take all such steps as may be required at its own expense to obtain registration of the Xifaxan Trademark throughout the Salix Territory for use of the Xifaxan Trademark on Alfa Licensed Products (other than the Crohns EIR Product and Other EIR Products) for Existing Indications within the Field in the Salix Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.1(a) shall remain in effect.
(b) Forthwith upon agreement between Salix and AWH of any Crohns EIR Trademark, AWH undertakes to take all such steps as may be required at its own expense to obtain registration of such Crohns EIR Trademark throughout the Salix Territory for use of the Trademark on Crohns EIR Products within the Field in the Salix Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.2(b) shall remain in effect.
(c) Forthwith upon agreement between Salix and AWH of any Other EIR Trademark, AWH undertakes to take all such steps as may be required at its own expense to obtain registration of such Other EIR Trademark throughout the Salix Territory for use of the Other EIR Trademark on Other EIR Products within the Field in the Salix Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.3(b) shall remain in effect.
(d) Forthwith upon agreement between Salix and AWH of any New Indication Trademark, AWH undertakes to take all such steps as may be required at its own expense to obtain registration of such New Indication Trademark throughout the Salix Territory for use of the New Indication Trademark on Alfa Licensed Products for New Indications within the Field in the Salix Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.4(b) shall remain in effect.
(e) Forthwith upon agreement between Salix and AWH of any [*] Trademark, AWH undertakes to take all such steps as may be required at its own expense to obtain registration of such [*] Trademark throughout the Salix Territory for use of the [*] Trademark on Rifaximin Products containing [*] of the Compound within the Field in the Salix Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.5(b) shall remain in effect.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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5.2 Infringement of Alfa Licensed Trademarks .
(a) In the event that any Third Party infringes or allegedly infringes in the Salix Territory any Alfa Licensed Trademark, and AWH becomes aware of any such infringement, AWH shall have the first right, but not the obligation, promptly and at its sole expense, either directly or indirectly through a duly authorized agent, to prevent any violation or infringement of the Alfa Licensed Trademarks within the Salix Territory and to procure that any such infringement or violation is discontinued. AWH shall bear the cost of any such action and shall be entitled to [*]% of the recovery, if any, from the Third Party.
(b) AWHs right to control the prosecution of a claim under Section 5.2(a) shall also include the right to control settlement of such claim; provided, however , that (i) no settlement shall be entered into by AWH without the prior written consent of Salix if such settlement would adversely affect or diminish the rights and benefits of Salix under this Agreement, impose any new obligations on Salix under this Agreement, or adversely affect the validity or enforceability of the Alfa Licensed Trademarks and (ii) AWH shall not be entitled to settle any such Third Party claim by granting a license or covenant not to sue under or with respect to the Alfa Licensed Trademarks without the prior written consent of Salix.
(c) If AWH does not initiate such an infringement action as contemplated by Section 5.2(a) within [*] days of notice from Salix of the relevant infringement, then Salix shall have the right, at its sole expense, either directly or indirectly through a duly authorized agent, to prevent such violation or infringement of the Alfa Licensed Trademarks within the Salix Territory and to procure that such infringement or violation is discontinued. Salix shall bear the cost of any such action and shall be entitled to [*]% of the recovery, if any, from the Third Party.
(d) Salixs right to prosecute a claim under Section 5.2(c) shall also include the right to control settlement of such claim; provided, however , that no settlement in respect of any Alfa Licensed Trademark or AWHs rights therein shall be entered into by Salix without the prior written consent of AWH.
(e) Salix shall promptly notify AWH in writing if Salix determines or reasonably believes that any of the Alfa Licensed Trademarks are being infringed or are adversely affected by any unauthorized and unlawful use by any Third Party, and, except as contemplated by Section 5.2(c), shall refrain from taking any action with respect to such infringement or adverse use, except in accordance with the express written authorization of
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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AWH. Each Party shall provide to the other such assistance as the prosecuting Party may reasonably require in connection with the prosecution of a claim under this Section 5.2, provided that the requesting Party shall reimburse to the other Party all reasonable costs incurred by such other Party in providing such assistance.
5.3 Acknowledgments . Salix shall include in its web sites, press releases, product packaging, product literature, SEC filings and all other public documents which use or reference any of the Alfa Licensed Trademarks, acknowledgments in form and substance satisfactory to AWH of the ownership of the Alfa Licensed Trademarks by AWH and that the Alfa Licensed Trademarks are used pursuant to a license granted to Salix by AWH. Salix undertakes to print on the packaging of and on all promotional and advertising material relating to the Alfa Licensed Products, Crohns EIR Products or Rifaximin Products containing [*] of the Compound under the Alfa Licensed Trademarks the words Licensed by Alfa Wassermann or similar language to the extent permitted under any applicable law and agreed to by AWH, and AWH hereby grants to Salix a non-exclusive (with the right to sublicense as set forth herein), royalty-free license to use AWHs or AWSPAs corporate name in such form only for such purpose during the term of this Agreement. For clarity, AWH shall obtain no ownership right or title therein or any other right to the Salix corporate name (or any associated mark) as a result of any Salix corporate name (or any associated mark) appearing on a label for a Rifaximin Product Exploited under the Amended and Restated License Agreement or using an Alfa Licensed Trademark licensed hereunder. Salix shall abide by and comply with all applicable laws, rules, regulations and orders applicable to the marketing and packaging of Rifaximin Products sold under the Alfa Licensed Trademarks, including all local laws applicable to the marking of goods with respect to shipping, advertising, sale and distribution or any other commercial activity.
5.4 Creative Works . Salix expressly agrees that, except as otherwise provided herein, all artwork for any logo associated with an Alfa Licensed Trademark and designs for the Alfa Licensed Trademarks created or invented by or for Salix or its sublicensees (collectively the Creative Works ) shall be owned by AWH, and Salix shall assign, and shall cause its sublicensees (and its and their employees and contractors) to assign, to AWH all right, title and interest in and to such Creative Works. Further, the Creative Works may, in AWHs sole discretion, be registered in the U.S. Copyright Office or in the U.S. Patent and Trademark Office, as appropriate, in the name of AWH or its assignee or, if registered in the name of Salix, such Creative Works shall be assigned to AWH.
5.5 Goodwill . Salixs use of the Alfa Licensed Trademarks under this Agreement and the goodwill associated with such use shall inure to the benefit of AWH, and Salix agrees to execute any and all documents requested by AWH confirming the same, or confirming AWHs title and ownership of the Alfa Licensed Trademarks.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 6 - REPRESENTATIONS AND WARRANTIES
6.1 AWHs Representations . AWH represents and warrants to Salix that:
(a) AWH is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification, and has all requisite power and authority, corporate or otherwise, to conduct its business as now being conducted, to own, lease and operate its properties, to execute, deliver and perform this Agreement, and to grant the rights and licenses granted in this Agreement;
(b) the execution, delivery and performance by AWH of this Agreement have been duly authorized by all necessary corporate action and do not and will not (i) require any consent or approval of its stockholders, (ii) violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree, determination or award presently in effect having applicability to it or any provision of its charter or by-laws, or (iii) result in a breach of or constitute a default under any agreement, mortgage, lease, license, permit, patent or other instrument or obligation to which it is presently a party or by which it or its assets may be bound or affected;
(c) except as contemplated herein, no authorization, consent, approval, license, exemption of, or filing or registration with, any court or governmental authority or regulatory body is required for the due execution, delivery or performance by it of this Agreement;
(d) as of the date hereof, AWH is the sole owner of the entire right, title and interest in and to the Xifaxan Trademark, free and clear of any liens, claims, encumbrances, restrictions, options, licenses, and other legal or equitable claims of any kind or nature;
(e) as of the date hereof, AWH is the record owner of registrations and applications for the Xifaxan Trademark described in the definition of Xifaxan Trademark set forth in Article 1 and all such registrations and applications are in full force and effect, are valid and to AWHs knowledge, enforceable, have not lapsed, expired or been forfeited, cancelled or abandoned, and all maintenance and renewal fees, as applicable, due as of the date hereof in respect thereof have been timely paid;
(f) AWH has the right to grant to Salix the rights and licenses set forth in this Agreement;
(g) AWH, to its knowledge, is not aware of any infringement by a Third Party of the Xifaxan Trademark in the Salix Territory; and
(h) as of the date of this Agreement there are no pending or, to AWHs knowledge, threatened claims, judgments or settlements asserted against AWH relating to the Xifaxan Trademark.
6.2 Disclaimers of Representations and Warranties . With respect to the licenses and rights granted to Salix under this Agreement and the Alfa Licensed Trademarks, AWH makes no other representation, express or implied, other than those set forth in Section 6.1.
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Article 7 - FORCE MAJEURE
Neither Party shall be liable to the other Party for any failure or delay in performing any obligation under this Agreement (other than any payment obligations) when such failure or delay is caused by events beyond its reasonable control, including fire, flood, other natural disasters, acts of God, war, labor disturbances, interruption of transit, accident, explosion and civil commotion; provided that the Party so affected shall give prompt notice thereof to the other Party and shall use reasonable efforts to mitigate the adverse consequences thereof. No such failure or delay shall terminate this Agreement, and each Party shall complete its obligations hereunder as promptly as reasonably practicable following cessation of the cause or circumstances of such failure or delay.
Article 8 - COMMENCEMENT, DURATION AND TERMINATION
8.1 Term of Agreement . This Agreement shall come into force and effect on the date first stated above and shall continue thereafter unless and until terminated in accordance with the provisions set out below.
8.2 Termination .
(a) Either Party may terminate this Agreement following the material breach of any material provision hereof if the breaching Party shall have failed to remedy such breach within [*] days of receipt of written notice from the non-breaching Party specifying such breach and requesting remedy (or, if such breach cannot be cured within such [*]-day period, if the breaching Party does not commence actions to cure such default within such period and thereafter diligently continues such actions or if such breach is not otherwise cured within [*] days after receipt of such notice, except in the case of a payment default, as to which the breaching Party shall have only a [*]-day cure period).
(b) Either Party may terminate this Agreement upon written notice to the other Party should the other Party become the subject of proceedings involving bankruptcy, receivership, administration, insolvency, moratorium of payment, reorganization or liquidation, make any assignment for the benefit of the creditors or any equivalent measures in any relevant jurisdiction or admit in writing its inability to meet its financial obligations as they fall due in the ordinary course of business.
(c) This Agreement shall immediately terminate in its entirety if (i) AWSPA terminates the Amended and Restated License Agreement pursuant to Sections 16.3.4, 16.4.1 or 16.4.2 of the Amended and Restated License Agreement; or (ii) Salix terminates the Amended and Restated License Agreement pursuant to Section 16.4.3 of the Amended and Restated License Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(d) This Agreement shall immediately terminate with respect to the Crohns EIR Trademark, Other EIR Trademarks and the New Indication Trademarks (to the extent pertaining to the EIR Formulation) in the event that either (i) Salix terminates its license to Exploit the Crohns EIR Product pursuant to Section 16.4.4 of the Amended and Restated License Agreement or (ii) AWSPA terminates the Amended and Restated License Agreement with respect to the Crohns EIR Product, the Crohns EIR License, the Existing Indications EIR License and the Salix New Indication License (to the extent it pertains to the EIR Formulation) pursuant to Section 16.4.5 of the Amended and Restated License Agreement.
8.3 Effect of Termination .
(a) Upon the termination of this Agreement, Salix shall cease all use of the Alfa Licensed Trademarks for any purpose whatsoever, except in connection with the sale of the then-existing inventory of Alfa Licensed Products, Crohns EIR Products or Rifaximin Products containing [*] of the Compound to the extent permitted in the Amended and Restated License Agreement. The following provisions shall survive the termination of this Agreement in its entirety: Sections 2.6 (subject to Section 8.3(c)), 2.8(b), 2.8(c), 2.9, and 2.10, 4.1(d), 4.2, 5.4, 5.5, and 6.2, and Article 1 - Article 8 - and Article 9 - through Article 23 -. Without limiting the foregoing, all such other provisions which by their terms are intended to survive the termination of this Agreement shall so survive in accordance with their terms.
(b) Upon the termination of this Agreement in respect of some but not all of the Alfa Licensed Trademarks, Salix shall cease all use of the Alfa Licensed Trademarks as to which such termination has occurred for any purpose whatsoever, except in connection with the sale of the then-existing inventory of Alfa Licensed Products, Crohns EIR Products or Rifaximin Products containing [*] of the Compound bearing the relevant Alfa Licensed Trademarks to the extent permitted in the Amended and Restated License Agreement. All provisions of this Agreement which by their terms are intended to survive the termination of this Agreement in respect of the Alfa Licensed Trademarks as to which termination has occurred shall so survive in accordance with their terms.
(c) Upon termination of this Agreement, whether in whole or in part, any sublicenses that may have been granted pursuant to Section 2.6 shall be handled in a manner consistent with the intent and purpose of Section 17.3 of the Amended and Restated License Agreement so that use of Alfa Licensed Trademarks shall continue to be available to any sublicensee holding a sublicense granted pursuant to Section 2.6 to the extent necessary or appropriate to permit such sublicensee to exercise any surviving rights that it may have under any sublicense granted to it under and in respect of rights granted by AWSPA to Salix under the Amended and Restated License Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 9 - INDEMNIFICATION AND DAMAGES
9.1 In Favor of Salix . AWH shall indemnify, defend and hold harmless Salix, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all costs, claims, damages and expenses (including but not limited to reasonable attorneys fees and other expenses of legal proceedings) (collectively, Losses ), in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
(a) any default by AWH of its obligations under this Agreement; and
(b) any breach by AWH of any of its representations and warranties set forth in this Agreement.
Notwithstanding the foregoing, AWH shall not be required to indemnify Salix, its Affiliates, and their respective officers, directors, employees and agents for any Losses to the extent such Losses are attributable to any of the matters as to which Salix has an obligation to indemnify (i) AWH or any other Persons pursuant to Section 9.2 hereof, or (ii) AWSPA or any other Persons pursuant to the Amended and Restated License Agreement or any of the other Related Agreements.
9.2 In Favor of AWH . Salix shall indemnify, defend and hold harmless AWH, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all Losses, in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
(a) any default by Salix of its obligations under this Agreement; and
(b) any breach by Salix of any of its representations and warranties set forth in this Agreement.
Notwithstanding the foregoing, Salix shall not be required to indemnify AWH, its Affiliates, and their respective officers, directors, employees and agents for Losses to the extent such Losses are attributable to any of the matters as to which (i) AWH has an obligation to indemnify Salix or any other Persons pursuant to Section 9.1 hereof or (ii) AWSPA has an obligation to indemnify Salix or any other Persons pursuant to the Amended and Restated License Agreement or any of the other Related Agreements.
9.3 Indemnification Procedures .
(a) Notice of Claim . In the event of any claim, action or proceeding for which a Person is entitled to indemnity hereunder, the Person seeking indemnity ( Claimant ) shall promptly notify the relevant Party ( Indemnitor ) of such matter in writing, but in no event shall the Indemnitor be liable for any Losses that result from any delay in providing such notice.
(b) Control of Defense . As its option, Indemnitor may then assume responsibility for and shall have full control of such matter by giving written notice to Claimant
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within [*] days after the Indemnitors receipt of notice from Claimant. The assumption of the defense of a Third Party claim by the Indemnitor shall not be construed as an acknowledgment that Indemnitor is liable to indemnify Claimant in respect of the Third Party claim, nor shall it constitute a waiver by Indemnitor of any defenses it may assert against Claimants claim for indemnification. Upon assuming the defense of a Third Party claim, Indemnitor may appoint as lead counsel in the defense of the Third Party claim any legal counsel selected by Indemnitor. In the event Indemnitor assumes the defense of a Third Party claim, Claimant shall immediately deliver to Indemnitor all original notices and documents (including court papers) received by Claimant in connection with the Third Party claim. Should Indemnitor assume the defense of a Third Party claim, except as provided below, Indemnitor shall not be liable to Claimant for any legal expenses subsequently incurred by such Claimant in connection with the analysis, defense or settlement of the Third Party claim. In the event that it is ultimately determined that Indemnitor is not obligated to indemnify, defend or hold harmless Claimant from and against the Third Party claim, Claimant shall reimburse Indemnitor for any and all costs and expenses (including attorneys fees and costs of suit) and any Third Party claims incurred by Indemnitor in its defense of the Third Party claim. Without limiting the foregoing, any Claimant shall be entitled to participate in, but not control, the defense of such Third Party claim and to employ counsel of its choice for such purpose; provided, however , that such employment shall be at Claimants own expense unless (i) the employment thereof has been specifically authorized by Indemnitor in writing, (ii) Indemnitor has failed to assume the defense and employ counsel in accordance with this Section 9.3(b) (in which case Claimant shall control the defense) or (iii) the interests of Claimant and Indemnitor with respect to such Third Party claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable law, ethical rules or equitable principles.
(c) Settlement . With respect to any Losses relating solely to the payment of money damages in connection with a Third Party claim and that shall not result in Claimants becoming subject to injunctive or other relief or otherwise adversely affecting the business of Claimant in any manner, and as to which Indemnitor shall have acknowledged in writing the obligation to indemnify Claimant hereunder, Indemnitor shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as Indemnitor, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party claims, where Indemnitor has assumed the defense of the Third Party claim in accordance with Section 9.3(b), Indemnitor shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, provided it obtains the prior written consent of Claimant (which consent shall not be unreasonably withheld or delayed). Indemnitor shall not be liable for any settlement or other disposition of a Loss by Claimant that is reached without the written consent of Indemnitor. Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, no Claimant shall admit any liability with respect to or settle, compromise or discharge, any Third Party claim without the prior written consent of Indemnitor, such consent not to be unreasonably withheld or delayed.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(d) Cooperation . Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, Claimant shall cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to Indemnitor to, and reasonable retention by Claimant of, records and information that are reasonably relevant to such Third Party claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and Indemnitor shall reimburse Claimant for all its reasonable out-of-pocket expenses in connection therewith.
(e) Expenses . Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by Claimant in connection with any claim shall be reimbursed on a calendar quarter basis by Indemnitor, without prejudice to Indemnitors right to contest Claimants right to indemnification and subject to refund in the event Indemnitor is ultimately held not to be obligated to indemnify Claimant.
(f) Limitations on Liability . UNDER NO CIRCUMSTANCES SHALL A PARTY HERETO BE LIABLE TO THE OTHER PARTY HEREOF FOR CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES IN RESPECT OF PERFORMANCE OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT ALL AMOUNTS THAT AN INDEMNIFIED PERSON IS REQUIRED TO PAY TO ANY THIRD PARTY AS THE RESULT OF A MATTER FOR WHICH SUCH INDEMNIFIED PERSON IS ENTITLED TO BE INDEMNIFIED UNDER THIS ARTICLE 9 - SHALL BE CONSIDERED TO BE DIRECT DAMAGES WHICH ARE INDEMNIFIABLE HEREUNDER.
Article 10 - DISPUTE RESOLUTION
10.1 Good Faith Discussions . In the event that any controversy or claim shall arise between the Parties under, out of, in connection with, or relating to this Agreement or the breach thereof, the Party initiating such controversy or making such claim shall provide to the other Party written notice containing a brief and concise statement of the initiating Partys claims, together with relevant facts supporting them. During a period of [*] days, or such longer period as may be mutually agreed upon in writing by the Parties, following the date of said notice, the Parties shall make good faith efforts to settle the dispute. Such efforts may include, but shall not be limited to, full presentation of both Parties claims and responses, with or without the assistance of counsel, before the chief executive officers (or their designees) of the Parties.
10.2 Arbitration . In the event that the Parties have been unable to reach accord using the procedures set forth in Section 10.1 and only if such is the case, either Party may seek final resolution of the matter through binding arbitration, and only through binding arbitration. The failure of a Party to comply with the provisions of Section 10.1 with respect to any controversy or claim shall constitute an absolute bar to the institution of any proceedings, by arbitration or otherwise, with respect to such controversy or claim. Any such arbitration shall be held in Paris, France in the English language before a panel of three (3) arbitrators in accordance with the then existing Rules of Arbitration of the International Chamber
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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of Commerce (the ICC ) and judgment upon the award rendered by the arbitrators may be entered or enforced in any court having jurisdiction thereof. In any arbitration proceeding hereunder, each Party shall select one arbitrator and the arbitrators selected by the Parties shall then select a third arbitrator, who shall have at least [*] years experience in pharmaceutical patent licensing. The decision of the arbitrators shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrators explaining the arbitrators rationale for their decision. Except as may otherwise be determined by the arbitrators in their award to be just and appropriate in light of the particular circumstances and outcome of the arbitration, the Party losing the arbitration shall pay all fees and costs of the arbitrators and the ICC and reimburse the prevailing Party for its reasonable attorneys fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses). The intent of the Parties is that except for the entering of an arbitration order in a court of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse to litigation in the courts, to the fullest extent allowed by law.
10.3 Exceptions . Notwithstanding the foregoing provisions of this Article 10, either Party may initiate an action before any court having competent jurisdiction in order to obtain emergency interim or conservatory relief, such as an order to preserve the status quo and to avoid incurring irreparable harm pending the resolution of any dispute that is submitted to arbitration, to prevent or enjoin a breach or threatened breach of confidentiality, or to enforce provisions of this Agreement relating to ownership rights in intellectual property without complying with the procedures set forth in this Article 10.
Article 11 - ASSIGNMENT
11.1 Binding Effect . This Agreement shall be binding upon and inure to the benefit of Parties hereto and their respective successors and permitted assigns.
11.2 Assignment by AWH . AWH shall have the right to assign this Agreement as it relates to any specific Alfa Licensed Trademark to any Affiliate of its choice to whom ownership of such Alfa Licensed Trademark is transferred, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Salix hereby acknowledges and accepts any such assignment, but AWH shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Salix, such consent not to be unreasonably withheld or delayed.
11.3 Assignment by Salix . Salix shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom Salix assigns its rights under the Amended and Restated License Agreement, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and AWH hereby acknowledges and accepts any such assignment, but Salix shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of AWH, such consent not to be unreasonably withheld or delayed.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 12 - ENTIRE AGREEMENT AND MODIFICATION
This Agreement together with the Amended and Restated License Agreement and other Related Agreements constitutes the final and complete understanding existing between AWH and Salix relating to the subject matter hereof. The terms of this Agreement cannot be substituted, superseded, waived or modified in any manner except by written agreement executed for and on behalf of each of AWH and Salix. In the event of any conflict between the terms of this Agreement, the Amended and Restated License Agreement and the other Related Agreements, this Agreement and the Amended and Restated License Agreement and the other Related Agreements shall be read as a single whole so as to accomplish the intent of the Parties as it so manifests itself.
Article 13 - LANGUAGE AND GOVERNING LAW
13.1 English Language . This Agreement is written and undersigned in two originals in the English language. All communications notices and proceedings required to be given hereunder shall be in the English language.
13.2 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of Switzerland, without giving effect to any conflict of laws principles or rules. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
Article 14 - WAIVER
No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the party granting the waiver.
Article 15 - NOTICES
Except as otherwise herein provided, all notices to be served or notified to the Parties hereunder shall (a) be mailed by internationally recognized courier service or by registered airmail return receipt requested to their respective addresses listed below or to any other address subsequently communicated in writing, or (b) delivered by e-mail marked as being of high importance to the e-mail address set forth below (to be confirmed by written notice sent in the manner set forth in clause (a)), and shall be deemed to have been given [*] Business Days after the day on which such mailing is made, or on the next Business Day after the day on which it is sent in the case of any e-mail which is followed by written notice as aforesaid.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Party |
Address |
to Salix : |
Salix Pharmaceuticals, Inc. |
Attn: General Counsel
8510 Colonnade Center Drive
Raleigh, North Carolina 27615 United States
with copies (which shall not constitute notice) to:
Salix Pharmaceuticals, Inc. |
Attn: Executive Vice President Business Development
8510 Colonnade Center Drive
Raleigh, North Carolina 27615 United States
E-Mail: [*]
and |
Covington & Burling LLP |
1201 Pennsylvania Avenue, N.W.
Washington, D.C. 20004 United States
Attention: Edward C. Britton, Esq.
E-mail: ebritton@cov.com
to AWH : |
Alfa Wassermann Hungary Kft. |
Attn: Dr. Emília Zubornyák
Garibaldi u.4.
Budapest 1054 Hungary
Email: [*]
with copies (which shall not constitute notice) to:
Alfa Wassermann, Inc. |
4 Henderson Drive
West Caldwell, New Jersey 07006 United States
Attention: Ira S. Nordlicht, President and Chief Executive Officer
E-mail: [*]
and
Nordlicht & Hand |
800 Westchester Avenue
Rye Brook, New York 10514 United States
Attention: Brian M. Hand, Esq.
E-mail: [*]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 16 - SEVERABILITY
If any part of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of the invalid or unenforceable part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the Parties hereto.
Article 17 - HEADINGS AND CONSTRUCTION
17.1 Headings . Headings are inserted for convenience and shall not by themselves define, describe, extend, limit or determine the interpretation of this Agreement.
17.2 References . References in this Agreement to Sections, Articles and Exhibits refer to Sections and Articles of, and Exhibits to, this Agreement except as otherwise specifically noted.
17.3 Rules of Construction . Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or shall be interpreted in accordance with its ordinary meaning as the context indicates. The term including as used herein shall mean including, without limiting the generality of any description preceding such term.
Article 18 - COUNTERPARTS
This Agreement may be executed in two or more counterparts each of which shall be deemed an original and which together shall constitute one and the same instrument.
Article 19 - MUTUAL DRAFTING
This Agreement constitutes the joint product of the Parties hereto. Each provision has been subject to the mutual consultation and agreement of such Parties and shall not be construed for or against either of them based on authorship.
Article 20 - THIRD PARTY RIGHTS
No provision of this Agreement is intended to be enforceable by any person other than the Parties hereto and their permitted assigns, and Parties entitled to indemnification pursuant to Article 9 -.
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Article 21 - RELATIONSHIP OF THE PARTIES
It is expressly agreed that AWH, on the one hand, and Salix, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither AWH, on the one hand, nor Salix, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
Article 22 - PERFORMANCE BY AFFILIATES
Each of AWH and Salix acknowledges that its performance of its obligations and its exercise of rights under this Agreement may be performed or exercised, respectively, by Affiliates of AWH and Salix. Each of AWH and Salix guarantees performance of this Agreement by any of its Affiliates.
Article 23 - FURTHER ASSURANCE
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
(Signatures appear on the next page)
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first written above.
SALIX PHARMACEUTICALS, INC. | ALFA WASSERMAN HUNGARY KFT. | |||||
By: | /s/ Rick Scruggs | By: | /s/ Dr. Emília Zubornyák | |||
Name: | Rick Scruggs | Name: | Dr. Emília Zubornyák | |||
Title: | EVP Business Development | Title: | Managing Director |
Alfa Wassermann S.p.A., a corporation incorporated under the laws of Italy, hereby guarantees to Salix Pharmaceuticals, Inc., one of the two parties to the foregoing agreement, the full and timely performance by Alfa Wassermann Hungary Kft., the other party to the foregoing agreement and an Affiliate of the said Alfa Wassermann S.p.A, of all of the said Alfa Wassermann Hungary Kft.s obligations under the said agreement. This is a guarantee of performance and not merely of payment.
ALFA WASSERMANN S.p.A | ||
By: | /s/ Andrea Golinelli | |
Name: | Andrea Golinelli | |
Title: | Chief Strategy Officer |
[Signature page for Trademark License Agreement (Alfa to Salix)]
EXHIBIT A
Domain Names
[ *]
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
28
Exhibit 10.99
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
TRADEMARK LICENSE AGREEMENT (SALIX TO ALFA)
dated August 6, 2012
by and between
A LFA W ASSERMANN S. P .A.
and
S ALIX P HARMACEUTICALS , I NC .
TABLE OF CONTENTS
Article 1 - CERTAIN DEFINITIONS |
1 | |||||
Article 2 - LICENSE GRANT AND COMPENSATION |
2 | |||||
2.1 |
Salix Designated Indication Trademark License |
2 | ||||
2.2 |
Other New Formulation Trademarks License |
3 | ||||
2.3 |
Sublicenses |
3 | ||||
2.4 |
Availability of Xifaxan Trademark |
4 | ||||
2.5 |
Trademark Royalties |
4 | ||||
2.6 |
Records |
5 | ||||
2.7 |
Ownership of Salix Licensed Trademarks |
6 | ||||
Article 3 - ALFAS OBLIGATIONS |
6 | |||||
3.1 |
Alfas Obligations |
6 | ||||
Article 4 - DOMAIN NAMES |
7 | |||||
4.1 |
Domain Names |
7 | ||||
Article 5 - COVENANTS |
8 | |||||
5.1 |
Infringement of Salix Licensed Trademarks |
8 | ||||
5.2 |
Acknowledgments |
9 | ||||
5.3 |
Creative Works |
9 | ||||
5.4 |
Goodwill |
9 | ||||
5.5 |
Registration of Salix Licensed Trademarks |
9 | ||||
Article 6 - REPRESENTATIONS AND WARRANTIES |
10 | |||||
6.1 |
Salixs Representations |
10 | ||||
6.2 |
Disclaimers of Representations and Warranties |
10 | ||||
Article 7 - FORCE MAJEURE |
11 | |||||
Article 8 - COMMENCEMENT, DURATION AND TERMINATION |
11 | |||||
8.1 |
Term of Agreement |
11 | ||||
8.2 |
Termination |
11 | ||||
8.3 |
Effect of Termination |
12 | ||||
Article 9 - INDEMNIFICATION AND DAMAGES |
12 | |||||
9.1 |
In Favor of Alfa |
12 | ||||
9.2 |
In Favor of Salix |
13 | ||||
9.3 |
Indemnification Procedures |
13 |
i
Article 10 - DISPUTE RESOLUTION |
15 | |||||
10.1 |
Good Faith Discussions |
15 | ||||
10.2 |
Arbitration |
15 | ||||
10.3 |
Exceptions |
16 | ||||
Article 11 - ASSIGNMENT |
16 | |||||
11.1 |
Binding Effect |
16 | ||||
11.2 |
Assignment by Salix |
16 | ||||
11.3 |
Assignment by Alfa |
16 | ||||
Article 12 - ENTIRE AGREEMENT AND MODIFICATION |
16 | |||||
Article 13 - LANGUAGE AND GOVERNING LAW |
17 | |||||
13.1 |
English Language |
17 | ||||
13.2 |
Governing Law |
17 | ||||
Article 14 - WAIVER |
17 | |||||
Article 15 - NOTICES |
17 | |||||
Article 16 - SEVERABILITY |
18 | |||||
Article 17 - HEADINGS AND CONSTRUCTION |
19 | |||||
17.1 |
Headings |
19 | ||||
17.2 |
References |
19 | ||||
17.3 |
Rules of Construction |
19 | ||||
Article 18 - COUNTERPARTS |
19 | |||||
Article 19 - MUTUAL DRAFTING |
19 | |||||
Article 20 - THIRD PARTY RIGHTS |
19 | |||||
Article 21 - RELATIONSHIP OF THE PARTIES |
19 | |||||
Article 22 - PERFORMANCE BY AFFILIATES |
20 | |||||
Article 23 - FURTHER ASSURANCE |
20 |
ii
TRADEMARK LICENSE AGREEMENT
TRADEMARK LICENSE AGREEMENT (this Agreement) dated August 6, 2012 by and among Alfa Wassermann S.p.A., a corporation organized under the laws of Italy ( Alfa ), and Salix Pharmaceuticals, Inc., a corporation incorporated under the laws of the State of California, United States of America ( Salix ) (each, a Party and, collectively, the Parties ).
WITNESSETH :
WHEREAS, Alfa and Salix have entered into an Amended and Restated License Agreement of even date herewith (the Amended and Restated License Agreement ); and
WHEREAS, the Amended and Restated License Agreement provides in part for the license by Salix and its Affiliates to Alfa of certain patent rights and unpatented technology rights for the purpose of enabling Alfa to sell Salix Licensed Products within the Field in the Alfa Territory; and
WHEREAS, pursuant to the licenses granted herein by Salix to Alfa, Alfa wishes to use certain Salix trademarks to Exploit the Salix Designated Indication Product and Other New Formulation Products in the Alfa Territory within the Field and Salix desires to license such trademarks to Alfa;
NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties hereby agree as follows:
Article 1 - CERTAIN DEFINITIONS
All capitalized terms used herein without definitions have the respective meanings set forth in the Amended and Restated License Agreement. The following words and expressions used in this Agreement shall have the following meanings:
(a) Alfa Non-Royalty Product means, on a country-by-country and Salix Licensed Product-by-Salix Licensed Product basis, a Salix Licensed Product as to which Alfas obligation to pay royalties to Salix pursuant to Section 4.2 of the Amended and Restated License Agreement in the relevant country has expired or terminated pursuant to Section 16.2.2 of the Amended and Restated License Agreement.
(b) Claimant has the meaning set forth in Section 9.3(a).
(c) Continuing Trademark License Option has the meaning set forth in Section 2.5(a).
(d) Creative Works has the meaning set forth in Section 5.3.
(e) ICC has the meaning set forth in Section 10.2.
(f) Indemnitor has the meaning set forth in Section 9.3(a).
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(g) Losses has the meaning set forth in Section 9.1.
(h) Other New Formulation Trademarks has the meaning set forth in Section 2.2(a).
(i) Salix Designated Indication Trademark has the meaning set forth in Section 2.1(a).
(j) Salix Domain Names has the meaning set forth in Section 4.1(a).
(k) Salix Licensed Trademarks means the Salix Designated Indication Trademark and the Other New Formulation Trademarks.
Article 2 - LICENSE GRANT AND COMPENSATION
2.1 Salix Designated Indication Trademark License .
(a) Salix, in consultation with Alfa, shall select the trademark to be used in connection with the Exploitation of the Salix Designated Indication Product within the Field in the Alfa Territory (the Salix Designated Indication Trademark ). The Salix Designated Indication Trademark shall be owned by Salix.
(b) Salix hereby grants to Alfa (i) an exclusive (including with respect to Salix and its Affiliates) license (with the right to sublicense as set forth herein) to use the Salix Designated Indication Trademark to Exploit (but not to Manufacture or have Manufactured) the Salix Designated Indication Product within the Field in the Alfa Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the Salix Designated Indication Trademark in connection with the Manufacture of the Salix Designated Indication Product solely for purposes of Exploitation of the Salix Designated Indication Product within the Field in the Alfa Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Alfa shall have the right to sublicense the rights granted to it in Section 2.1(b) through multiple tiers of sublicensees to any party to whom Alfa (or its sublicensees) grants a sublicense under the Salix Designated Indication License, subject to Section 2.3 of this Agreement.
(d) The term of the license granted under Section 2.1(b) shall continue on a country-by-country basis until the Salix Designated Indication Product becomes an Alfa Non-Royalty Product in the relevant country, at which time Alfa shall have an option to retain the license granted under Section 2.1(b) for the Salix Designated Indication Product in such country, as set forth in Section 2.5. For clarity, Alfa may not exercise or sublicense the license to the Salix Designated Indication Trademark granted under Section 2.1(b) unless and until Alfa exercises its option to license the Salix Designated Indication Product pursuant Section 4.2.2 of the Amended and Restated License Agreement.
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2.2 Other New Formulation Trademarks License .
(a) Salix, in consultation with Alfa, shall select the trademarks to be used in connection with the Exploitation of the Other New Formulation Products within the Field in the Alfa Territory (the Other New Formulation Trademarks ). The Other New Formulation Trademarks shall be owned by Salix.
(b) Salix hereby grants to Alfa (i) an exclusive (including with respect to Salix and its Affiliates) license (with the right to sublicense as set forth herein) to use the Other New Formulation Trademarks to Exploit (but not to Manufacture or have Manufactured) the Other New Formulation Products within the Field in the Alfa Territory and (ii) a non-exclusive license (with the right to sublicense as set forth herein) to use the Other New Formulation Trademarks in connection with the Manufacture of Other New Formulation Products solely for purposes of Exploitation of Other New Formulation Products within the Field in the Alfa Territory, subject in each case ((i) and (ii)) to compliance with the terms of this Agreement and the Amended and Restated License Agreement.
(c) Alfa shall have the right to sublicense the rights granted to it in Section 2.2(b) through multiple tiers of sublicensees to any party to whom Alfa (or its sublicensees) grants a sublicense under the [*]/Other New Formulation License, subject to Section 2.3 of this Agreement.
(d) The term of the license granted under Section 2.2(b) shall continue on a country-by-country and Salix Licensed Product-by-Salix Licensed Product basis until the relevant Salix Licensed Product becomes an Alfa Non-Royalty Product in the relevant country, at which time Alfa shall have an option to retain the license granted under Section 2.2(b) for such Salix Licensed Product in such country, as set forth in Section 2.5. For clarity, Alfas right to exercise or sublicense the license to the Other New Formulation Trademarks granted under Section 2.2(b) shall terminate if Alfas license to Exploit Other New Formulation Products under the [*]/Other New Formulation License terminates under the circumstances set forth in Section 4.2.3(a) of the Amended and Restated License Agreement.
2.3 | Sublicenses . |
(a) The terms of any sublicense granted by Alfa under the rights granted to it in this Agreement shall be in accordance with the terms of the particular license granted to Alfa hereunder. Alfa shall comply with the provisions of Section 4.2.6 of the Amended and Restated License Agreement (which is incorporated in this Agreement by reference) in connection with all such sublicenses.
(b) Alfa shall be responsible to Salix for its sublicensees compliance with the terms of this Agreement. Any failure by a sublicensee to comply with such terms shall be deemed to be a breach of this Agreement by Alfa.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
3
(c) For the avoidance of doubt, it is hereby acknowledged that the appointment by Alfa of any distributor for the Salix Licensed Products, any manufacturer to Manufacture Compound (including the [*] Formulation or Other New Formulations) or Rifaximin Products to the extent permitted under the Amended and Restated License Agreement, or of any Third Party to assist in the Development and the obtaining of Marketing Approvals for the Salix Licensed Products shall not be deemed to constitute the appointment of any sublicensee or the sublicense by Alfa of any rights under this Agreement.
2.4 Availability of Xifaxan Trademark . The provisions of this Agreement, including Sections 2.1 and 2.2, are in all respects subject to, and are to be implemented in conformity with, the provisions of Section 2.7(c) of the Trademark License Agreement (Alfa to Salix), to the extent relevant. The Parties agree to cooperate and negotiate in good faith so as to accomplish such purpose.
2.5 Trademark Royalties .
(a) No royalty shall be payable by Alfa to Salix with respect to any of the licenses granted under Sections 2.1 and 2.2, except as set forth in this Section 2.5. With respect to each Salix Licensed Product that becomes an Alfa Non-Royalty Product in a particular country, Alfa shall have the option to continue to use the respective Salix Licensed Trademarks associated with such Salix Licensed Product in such country (the Continuing Trademark License Option ). Alfa may exercise the Continuing Trademark License Option by delivering a written notice of exercise to Salix within [*] days following the date of notice given by Salix to Alfa that Alfas obligation to pay royalties on such Salix Licensed Product in a particular country has expired or terminated pursuant to Section 16.2.2 of the Amended and Restated License Agreement. If the Continuing Trademark License Option is exercised by Alfa, the exclusive (and sublicensable) license granted to Alfa with respect to such Salix Licensed Trademark(s) pursuant to Section 2.1 or 2.2, as applicable, shall continue in respect of such Alfa Non-Royalty Product until terminated as provided herein, provided that Alfa shall pay royalties for the continued use of such Salix Licensed Trademark(s) thereafter in respect of such Alfa Non-Royalty Product in such country in an amount equal to [*] percent ([*]%) of the Net Sales of the Alfa Non-Royalty Product in such country. Alfa may at any time thereafter notify Salix in writing that it wishes to terminate the specific license granted under Sections 2.1 and 2.2 above for the applicable Salix Licensed Trademark(s) with respect to the Alfa Non-Royalty Product in any country, in which case Alfa shall have no further right to use such respective Salix Licensed Trademark(s) in connection with such Alfa Non-Royalty Product in such country, and Alfa shall timely pay all royalties due on Net Sales made up to and including the date of termination and thereafter shall have no further obligation to pay royalties thereafter in respect of such Alfa Non-Royalty Product in such country.
(b) Within [*] days of the end of each calendar quarter (such quarters to end on the last days of March, June, September and December in each Calendar Year), Alfa shall submit to Salix a written report setting out the details of all of its Net Sales in such calendar
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
4
quarter that are subject to a royalty under this Agreement. Such report shall include a calculation of the Net Sales on a country-by-country and product-by-product basis and the royalties payable thereon. Following receipt of such report, Salix shall issue to Alfa an invoice for the amount of royalties set forth in Alfas report. Invoices shall be due and payable not later than [*] days after the receipt of such invoice by Alfa. In the event that any payment due hereunder shall not be paid by the due date, then such payment shall from the due date until the actual date of payment bear interest at the annual rate of [*] percent ([*]%) above the official prime rate published by [*], or, if [*] ceases to publish a prime rate, such other United States banking institution as the Parties shall agree upon. All payments to be made hereunder shall be made in United States Dollars by [*] wire transfer to such bank as Salix shall designate in writing. Except as expressly stated in this Agreement, Alfa shall not be entitled in any circumstances to withhold any money due to Salix under the terms of this Agreement in respect of any possible (justified or unjustified) claims against Salix related to this Agreement, the Amended and Restated License Agreement, or any of the other Related Agreements. All bank transfer and wire charges imposed on payments made by Alfa under this Agreement shall be borne by Alfa.
(c) All payments under this Agreement shall be made without any deduction or withholding of or on account of any tax, duties, levies, or other charges by Alfa unless such deduction or withholding is required by applicable law to be assessed against Salix. If Alfa is so required to make any deduction or withholding from payments due to Salix, Alfa shall (i) promptly notify Salix of such requirement, (ii) pay to the relevant authorities on Salixs behalf the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against Salix, and (iii) promptly forward to Salix an official receipt (or certified copy) or other documentation reasonably acceptable to Salix evidencing such payment to such authorities.
2.6 Records . At all times following the exercise by Alfa of the Continuing Trademark License Option and until such time that Alfa elects to exercise its right to terminate all extended licenses with regard to Alfa Non-Royalty Products pursuant to Section 2.5(a), Alfa shall, and shall cause its Affiliates and sublicensees to, maintain during the term of this Agreement normal accounting books (in accordance with normal Italian accounting practice) containing accurate details of all sales of Alfa Non-Royalty Products by Alfa and its Affiliates and sublicensees that are subject to a royalty under this Agreement and of the calculation of Net Sales and the royalty payments due hereunder. Salix shall have the right, during the term of the Agreement and for [*] following the expiration or termination of the Agreement, upon reasonable notice during normal working hours to cause qualified professional accountants of its choice to inspect the books and records and any other documentation and records maintained by Alfa, its Affiliates, or sublicensees having sales of Salix Licensed Products relevant to the calculation of any royalty payable under this Agreement. The accountants shall provide a copy of their report to each Party. The cost of the above accountants inspections shall be borne by Salix save only where any such inspection reveals a discrepancy in excess of [*] percent ([*]%) of royalties due and payable, in which event the costs shall be borne by Alfa, provided that:
(a) such inspection shall not take place more than [*]; and
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
5
(b) such inspection shall only be in respect of records and accounts for the period of [*] years preceding the date of such inspection and Alfa shall not be required to retain records for any period exceeding [*] years.
If any such inspection reveals that there has been an underpayment or overpayment of royalties, Alfa shall promptly pay to Salix the full amount of the underpayment or Salix shall promptly pay to Alfa the full amount of the overpayment, as applicable; provided, however , that if Alfa or Salix has a reasonable good faith objection to the calculation of the underpayment or overpayment, the Parties shall discuss the dispute in good faith and seek to reach resolution on whether there was an underpayment or overpayment of royalties, and if so, the amount of such underpayment or overpayment. If the Parties are unable to resolve such dispute, then it shall be resolved through the dispute resolution procedures set forth in Article 10 - .
2.7 Ownership of Salix Licensed Trademarks . Alfa acknowledges and agrees that Salix shall have and retain, directly or indirectly, through its Affiliates, full and complete ownership of the Salix Licensed Trademarks during the entire term of this Agreement, and Alfa agrees that nothing contained herein shall vest or otherwise give to Alfa any right, title or interest in or to any of the Salix Licensed Trademarks, except the right to use the same in accordance with the terms of this Agreement and the Amended and Restated License Agreement.
Article 3 - ALFAS OBLIGATIONS
3.1 | Alfas Obligations . Alfa shall: |
(a) use commercially reasonable efforts to maintain high standards with regard to the nature and quality of Rifaximin Products sold under any of the Salix Licensed Trademarks by Alfa or its Affiliates or sublicensees during the term of this Agreement;
(b) use commercially reasonable efforts to preserve the high standards and goodwill of the Salix Licensed Trademarks and to exercise such supervision and control with respect to all Rifaximin Products sold under any of the Salix Licensed Trademarks by Alfa or its Affiliates or sublicensees so as to preserve and enhance the goodwill of the Salix Licensed Trademarks and the high and favorable recognition with the purchasing public that the Salix Licensed Trademarks now (and will) carry and to otherwise protect the public from confusion and deception;
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
6
(c) not use the Salix Licensed Trademarks in a descriptive or generic manner;
(d) not (i) assert any claim adverse to Salixs right, title or interest in or to any of the Salix Licensed Trademarks or (ii) use any of the Salix Licensed Trademarks in any way that could injure the goodwill associated with the Salix Licensed Trademarks or prejudice Salixs rights therein;
(e) not apply to register the Salix Licensed Trademarks in its own name in any part of the Alfa Territory or outside the Alfa Territory;
(f) not, during or after the term of this Agreement, unlawfully use in its business any trademark or trade name which is confusingly similar to, or so nearly resembles any of the Salix Licensed Trademarks, as to be likely to cause deception or confusion, except as otherwise specifically contemplated by this Agreement;
(g) not (i) misuse any of the Salix Licensed Trademarks or take any other action to bring them into disrepute or (ii) use the Salix Licensed Trademarks in violation of any trademark usage guidelines that Salix may from time to time provide Alfa in writing;
(h) maintain a degree of continuity respecting the appearance, design and usage of the Salix Licensed Trademarks in accordance with the common standards and procedures of trademark practice;
(i) use the ® symbol (with the use of any registered mark) or the TM symbol (with the use of any unregistered mark) or such other appropriate notice as Salix may specify to Alfa in writing in connection with Alfas use of the Salix Licensed Trademarks; and
(j) provide all such assistance as Salix may reasonably request in relation to any application to register Salix as owner of any trademark applications for the Salix Licensed Trademarks, including the prosecution of such applications, and provide reasonable cooperation with all maintenance activities conducted by Salix regarding the Salix Licensed Trademarks.
Article 4 - DOMAIN NAMES
4.1 Domain Names .
(a) All Internet domain names containing any of the Salix Licensed Trademarks or any alternative spellings of the Salix Licensed Trademarks ( Salix Domain Names ) shall be the property of Salix. Alfa shall execute any documentation reasonably requested by Salix necessary to assign to Salix or its designee the rights set forth in this Section 4.1.
(b) Salix shall (i) use Commercially Reasonable Efforts to maintain, and to take all acts required to maintain, the Salix Domain Names, including timely renewing the Salix Domain Names registration, and (ii) not assign any of the Salix Domain Names to any Third Party without Alfas prior written consent, such consent not to be unreasonably conditioned, withheld or delayed except in connection with any assignment of this Agreement permitted under Section 11.2.
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Article 5 - COVENANTS
5.1 Infringement of Salix Licensed Trademarks .
(a) In the event that any Third Party infringes or allegedly infringes in the Alfa Territory any Salix Licensed Trademark, and Salix becomes aware of any such infringement, Salix shall have the first right, but not the obligation, promptly and at its sole expense, either directly or indirectly through a duly authorized agent, to prevent any violation or infringement of the Salix Licensed Trademarks within the Alfa Territory and to procure that any such infringement or violation is discontinued. Salix shall bear the cost of any such action and shall be entitled to [*]% of the recovery, if any, from the Third Party.
(b) Salixs right to control the prosecution of a claim under Section 5.1(a) shall also include the right to control settlement of such claim; provided, however , that (i) no settlement shall be entered into by Salix without the prior written consent of Alfa if such settlement would adversely affect or diminish the rights and benefits of Alfa under this Agreement, impose any new obligations on Alfa under this Agreement, or adversely affect the validity or enforceability of the Salix Licensed Trademarks and (ii) Salix shall not be entitled to settle any such Third Party claim by granting a license or covenant not to sue under or with respect to the Salix Licensed Trademarks without the prior written consent of Alfa.
(c) If Salix does not initiate such an infringement action as contemplated by Section 5.1(a) within [*] days of notice from Alfa of the relevant infringement, then Alfa shall have the right, at its sole expense, either directly or indirectly through a duly authorized agent, to prevent such violation or infringement of the Salix Licensed Trademarks within the Alfa Territory and to procure that such infringement or violation is discontinued. Alfa shall bear the cost of any such action and shall be entitled to [*]% of the recovery, if any, from the Third Party.
(d) Alfas right to prosecute a claim under Section 5.1(c) shall also include the right to control settlement of such claim; provided, however , that no settlement in respect of any Salix Licensed Trademark or Salixs rights therein shall be entered into by Alfa without the prior written consent of Salix.
(e) Alfa shall promptly notify Salix in writing if Alfa determines or reasonably believes that any of the Salix Licensed Trademarks are being infringed or are adversely affected by any unauthorized and unlawful use by any Third Party, and, except as contemplated by Section 5.1(c), shall refrain from taking any action with respect to such infringement or adverse use, except in accordance with the express written authorization of Salix. Each Party shall provide to the other such assistance as the prosecuting Party may reasonably require in connection with the prosecution of a claim under this Section 5.1, provided that the requesting Party shall reimburse to the other Party all reasonable costs incurred by such other Party in providing such assistance.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
8
5.2 Acknowledgments . Alfa shall include in its web site, press releases, product packaging, product literature and all other public documents which use or reference any of the Salix Licensed Trademarks, acknowledgments in form and substance reasonably satisfactory to Salix of the ownership of the Salix Licensed Trademarks by Salix and that the Salix Licensed Trademarks are used pursuant to a license granted to Alfa by Salix. Alfa undertakes to print on the packaging of and on all promotional and advertising material relating to the Salix Licensed Products under the Salix Licensed Trademarks the words Licensed by Salix Pharmaceuticals or similar language to the extent permitted under any applicable law and agreed to by Salix, and Salix hereby grants to Alfa a non-exclusive (with the right to sublicense as set forth herein), royalty-free license to use its corporate name in such form only for such purpose during the term of this Agreement. For clarity, Salix shall obtain no ownership right or title therein or any other right to the Alfa corporate name (or any associated mark) as a result of any Alfa corporate name (or any associated mark) appearing on a label for a Rifaximin Product Exploited under the Amended and Restated License Agreement and using a Salix Licensed Trademark licensed hereunder. Alfa shall abide by and comply with all applicable laws, rules, regulations and orders applicable to the marketing and packaging of Rifaximin Products sold under the Salix Licensed Trademarks including all local laws applicable to the marking of goods with respect to shipping, advertising, sale and distribution or any other commercial activity.
5.3 Creative Works . Alfa expressly agrees that, except as otherwise provided herein, all artwork for any logo associated with a Salix Licensed Trademark and designs for the Salix Licensed Trademarks created or invented by or for Alfa or its sublicensees (collectively the Creative Works ) shall be owned by Salix, and Alfa shall assign, and shall cause its sublicensees (and its and their employees and contractors) to assign, to Salix all right, title and interest in and to such Creative Works to Salix. Further, the Creative Works may, in Salixs sole discretion, be registered in the U.S. Copyright Office or in the U.S. Patent and Trademark Office, as appropriate, in the name of Salix or its assignee or, if registered in the name of Alfa, such Creative Works shall be assigned to Salix.
5.4 Goodwill . Alfas use of the Salix Licensed Trademarks under this Agreement and the goodwill associated with such use shall inure to the benefit of Salix, and Alfa agrees to execute any and all documents requested by Salix confirming the same, and/or confirming Salixs title and ownership of the Salix Licensed Trademarks.
5.5 Registration of Salix Licensed Trademarks .
(a) Forthwith upon agreement between Salix and Alfa of the Salix Designated Indication Trademark, Salix shall take all such steps as may be required at its own expense to obtain registration of such Salix Designated Indication Trademark in [*] and such other countries in the Alfa Territory as the Parties may from time to time agree for use of the Salix Designated Indication Trademark on the Salix Designated Indication Product within the Field in the Alfa Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.1(b) shall remain in effect.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
9
(b) Forthwith upon agreement between Salix and Alfa of any Other New Formulation Trademark, Salix undertakes to take all such steps as may be required at its own expense to obtain registration of such Other New Formulation Trademark in [*] and such other countries in the Alfa Territory as the Parties may from time to time agree for use of the Other New Formulation Trademark on Other New Formulation Products within the Field in the Alfa Territory and to maintain and renew all such registrations as required throughout the period in which the license granted under Section 2.2(b) shall remain in effect.
Article 6 - REPRESENTATIONS AND WARRANTIES
6.1 Salixs Representations . Salix represents and warrants to Alfa that:
(a) Salix is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification, and has all requisite power and authority, corporate or otherwise, to conduct its business as now being conducted, to own, lease and operate its properties, to execute, deliver and perform this Agreement, and to grant the rights and licenses granted in this Agreement;
(b) the execution, delivery and performance by Salix of this Agreement have been duly authorized by all necessary corporate action and do not and will not (i) require any consent or approval of its stockholders, (ii) violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree, determination or award presently in effect having applicability to it or any provision of its charter or by-laws, or (iii) result in a breach of or constitute a default under any agreement, mortgage, lease, license, permit, patent or other instrument or obligation to which it is presently a party or by which it or its assets may be bound or affected;
(c) except as contemplated herein, no authorization, consent, approval, license, exemption of, or filing or registration with, any court or governmental authority or regulatory body is required for the due execution, delivery or performance by it of this Agreement; and
(d) Salix has the right to grant to Alfa the rights and licenses set forth in this Agreement.
6.2 Disclaimers of Representations and Warranties . With respect to the licenses and rights granted to Alfa under this Agreement and the Salix Licensed Trademarks, Salix makes no other representation, express or implied, other than those set forth in Section 6.1.
[*] | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 7 - FORCE MAJEURE
Neither Party shall be liable to the other Party for any failure or delay in performing any obligation under this Agreement (other than any payment obligations) when such failure or delay is caused by events beyond its reasonable control, including fire, flood, other natural disasters, acts of God, war, labor disturbances, interruption of transit, accident, explosion and civil commotion; provided that the Party so affected shall give prompt notice thereof to the other Party and shall use reasonable efforts to mitigate the adverse consequences thereof. No such failure or delay shall terminate this Agreement, and each Party shall complete its obligations hereunder as promptly as reasonably practicable following cessation of the cause or circumstances of such failure or delay.
Article 8 - COMMENCEMENT, DURATION AND TERMINATION
8.1 Term of Agreement . This Agreement shall come into force and effect on the date first stated above and shall continue thereafter unless and until terminated in accordance with the provisions set out below.
8.2 Termination .
(a) Either Party may terminate this Agreement following the material breach of any material provision hereof if the breaching Party shall have failed to remedy such breach within [*] days of receipt of written notice from the non-breaching Party specifying such breach and requesting remedy (or, if such breach cannot be cured within such [*]-day period, if the breaching Party does not commence actions to cure such default within such period and thereafter diligently continues such actions or if such breach is not otherwise cured within [*] days after receipt of such notice, except in the case of a payment default, as to which the breaching Party shall have only a [*] day cure period).
(b) Either Party may terminate this Agreement upon written notice to the other Party should the other Party become the subject of proceedings involving bankruptcy, receivership, administration, insolvency, moratorium of payment, reorganization or liquidation, make any assignment for the benefit of the creditors or any equivalent measures in any relevant jurisdiction or admit in writing its inability to meet its financial obligations as they fall due in the ordinary course of business.
(c) This Agreement shall immediately terminate in its entirety if the Amended and Restated License Agreement is terminated in its entirety for any reason.
(d) This Agreement shall immediately terminate with respect to the Salix Designated Indication Trademark in the event that Alfa declines to exercise its option to take a license to the Salix Designated Indication Product pursuant to Section 4.2.2 of the Amended and Restated License Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(e) This Agreement shall immediately terminate with respect to the Other New Formulation Trademarks in the event that the [*]/Other New Formulation License terminates pursuant to Section 4.2.3 of the Amended and Restated License Agreement.
8.3 Effect of Termination .
(a) Upon the termination of this Agreement, Alfa shall cease all use of the Salix Licensed Trademarks for any purpose whatsoever, except in connection with the sale of the then-existing inventory of the Salix Licensed Products to the extent permitted in the Amended and Restated License Agreement. The following provisions shall survive the termination of this Agreement in its entirety: Sections 2.3 (subject to Section 8.3(c)), 2.5(b), 2.5(c), 2.6, 2.7, 4.1(a) 5.3, 5.4 and 6.2, and Article 1 - Article 8 - and Article 9 - through Article 23 - . Without limiting the foregoing, all such other provisions which by their terms are intended to survive the termination of this Agreement shall so survive in accordance with their terms.
(b) Upon the termination of this Agreement in respect of some but not all of the Salix Licensed Trademarks, Alfa shall cease all use of the Salix Licensed Trademarks as to which such termination has occurred for any purpose whatsoever, except in connection with the sale of the then-existing inventory of Salix Licensed Products bearing the relevant Salix Licensed Trademarks to the extent permitted in the Amended and Restated License Agreement. All provisions of this Agreement which by their terms are intended to survive the termination of this Agreement in respect of the Salix Licensed Trademarks as to which termination has occurred shall so survive in accordance with their terms.
(c) Upon termination of this Agreement, whether in whole or in part, any sublicenses that may have been granted pursuant to Section 2.3 shall be handled in a manner consistent with the intent and purpose of Section 17.3 of the Amended and Restated License Agreement so that use of Salix Licensed Trademarks shall continue to be available to any sublicensee holding a sublicense granted pursuant to Section 2.3 to the extent necessary or appropriate to permit such sublicensee to exercise any surviving rights that it may have under any sublicense granted to it under and in respect of rights granted by Salix to Alfa under the Amended and Restated License Agreement.
Article 9 - INDEMNIFICATION AND DAMAGES
9.1 In Favor of Alfa . Salix shall indemnify, defend and hold harmless Alfa, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all costs, claims, damages and expenses (including but not limited to reasonable attorneys fees and other expenses of legal proceedings) (collectively, Losses ), in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
(a) any default by Salix of its obligations under this Agreement; and
(b) any breach by Salix of any of its representations and warranties set forth in this Agreement.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Notwithstanding the foregoing, Salix shall not be required to indemnify Alfa, its Affiliates, and their respective officers, directors, employees and agents for Losses to the extent such Losses are attributable to any of the matters as to which Alfa has an obligation to indemnify Salix or any other Persons pursuant to (i) Section 9.2 hereof or (ii) the Amended and Restated License Agreement or any of the other Related Agreements.
9.2 In Favor of Salix . Alfa shall indemnify, defend and hold harmless Salix, its Affiliates, and their respective officers, directors, employees and agents, from and against any and all Losses, in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of:
(a) any default by Alfa of its obligations under this Agreement; and
(b) any breach by Alfa of any of its representations and warranties set forth in this Agreement.
Notwithstanding the foregoing, Alfa shall not be required to indemnify Salix, its Affiliates, and their respective officers, directors, employees and agents for Losses to the extent such Losses are attributable to any of the matters as to which Salix has an obligation to indemnify Alfa or any other Persons pursuant to (i) Section 9.1 hereof or (ii) the Amended and Restated License Agreement or any of the other Related Agreements.
9.3 Indemnification Procedures .
(a) Notice of Claim . In the event of any claim, action or proceeding for which a Person is entitled to indemnity hereunder, the Person seeking indemnity ( Claimant ) shall promptly notify the relevant Party ( Indemnitor ) of such matter in writing, but in no event shall the Indemnitor be liable for any Losses that result from any delay in providing such notice.
(b) Control of Defense . As its option, Indemnitor may then assume responsibility for and shall have full control of such matter by giving written notice to Claimant within [*] days after the Indemnitors receipt of notice from Claimant. The assumption of the defense of a Third Party claim by the Indemnitor shall not be construed as an acknowledgment that Indemnitor is liable to indemnify Claimant in respect of the Third Party claim, nor shall it constitute a waiver by Indemnitor of any defenses it may assert against Claimants claim for indemnification. Upon assuming the defense of a Third Party claim, Indemnitor may appoint as lead counsel in the defense of the Third Party claim any legal counsel selected by Indemnitor. In the event Indemnitor assumes the defense of a Third Party claim, Claimant shall immediately deliver to Indemnitor all original notices and documents (including court papers) received by Claimant in connection with the Third Party claim. Should Indemnitor assume the defense of a Third Party claim, except as provided below, Indemnitor shall not be liable to Claimant for any legal expenses subsequently incurred by such Claimant in connection with the analysis, defense
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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or settlement of the Third Party claim. In the event that it is ultimately determined that Indemnitor is not obligated to indemnify, defend or hold harmless Claimant from and against the Third Party claim, Claimant shall reimburse Indemnitor for any and all costs and expenses (including attorneys fees and costs of suit) and any Third Party claims incurred by Indemnitor in its defense of the Third Party claim. Without limiting the foregoing, any Claimant shall be entitled to participate in, but not control, the defense of such Third Party claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at Claimants own expense unless (i) the employment thereof has been specifically authorized by Indemnitor in writing, (ii) Indemnitor has failed to assume the defense and employ counsel in accordance with this Section 9.3(b) (in which case Claimant shall control the defense) or (iii) the interests of Claimant and Indemnitor with respect to such Third Party claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable law, ethical rules or equitable principles.
(c) Settlement . With respect to any Losses relating solely to the payment of money damages in connection with a Third Party claim and that shall not result in Claimants becoming subject to injunctive or other relief or otherwise adversely affecting the business of Claimant in any manner, and as to which Indemnitor shall have acknowledged in writing the obligation to indemnify Claimant hereunder, Indemnitor shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as Indemnitor, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party claims, where Indemnitor has assumed the defense of the Third Party claim in accordance with Section 9.3(b), Indemnitor shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, provided it obtains the prior written consent of Claimant (which consent shall not be unreasonably withheld or delayed). Indemnitor shall not be liable for any settlement or other disposition of a Loss by Claimant that is reached without the written consent of Indemnitor. Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, no Claimant shall admit any liability with respect to or settle, compromise or discharge, any Third Party claim without the prior written consent of Indemnitor, such consent not to be unreasonably withheld or delayed.
(d) Cooperation . Regardless of whether Indemnitor chooses to defend or prosecute any Third Party claim, Claimant shall cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to Indemnitor to, and reasonable retention by Claimant of, records and information that are reasonably relevant to such Third Party claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and Indemnitor shall reimburse Claimant for all its reasonable out-of-pocket expenses in connection therewith.
(e) Expenses . Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by Claimant in connection with any claim shall be reimbursed on a calendar quarter basis by Indemnitor, without prejudice to Indemnitors right to contest Claimants right to indemnification and subject to refund in the event Indemnitor is ultimately held not to be obligated to indemnify Claimant.
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(f) Limitations on Liability . UNDER NO CIRCUMSTANCES SHALL A PARTY HERETO BE LIABLE TO THE OTHER PARTY HEREOF FOR CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES IN RESPECT OF PERFORMANCE OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT ALL AMOUNTS THAT AN INDEMNIFIED PERSON IS REQUIRED TO PAY TO ANY THIRD PARTY AS THE RESULT OF A MATTER FOR WHICH SUCH INDEMNIFIED PERSON IS ENTITLED TO BE INDEMNIFIED UNDER THIS ARTICLE 9 - SHALL BE CONSIDERED TO BE DIRECT DAMAGES WHICH ARE INDEMNIFIABLE HEREUNDER.
Article 10 - DISPUTE RESOLUTION
10.1 Good Faith Discussions . In the event that any controversy or claim shall arise between the Parties under, out of, in connection with, or relating to this Agreement or the breach thereof, the Party initiating such controversy or making such claim shall provide to the other Party written notice containing a brief and concise statement of the initiating Partys claims, together with relevant facts supporting them. During a period of [*] days, or such longer period as may be mutually agreed upon in writing by the Parties, following the date of said notice, the Parties shall make good faith efforts to settle the dispute. Such efforts may include, but shall not be limited to, full presentation of both Parties claims and responses, with or without the assistance of counsel, before the chief executive officers (or their designees) of the Parties.
10.2 Arbitration . In the event that the Parties have been unable to reach accord using the procedures set forth in Section 10.1 and only if such is the case, either Party may seek final resolution of the matter through binding arbitration, and only through binding arbitration. The failure of a Party to comply with the provisions of Section 10.1 with respect to any controversy or claim shall constitute an absolute bar to the institution of any proceedings, by arbitration or otherwise, with respect to such controversy or claim. Any such arbitration shall be held in Paris, France in the English language before a panel of three (3) arbitrators in accordance with the then existing Rules of Arbitration of the International Chamber of Commerce (the ICC ) and judgment upon the award rendered by the arbitrators may be entered or enforced in any court having jurisdiction thereof. In any arbitration proceeding hereunder, each Party shall select one arbitrator and the arbitrators selected by the Parties shall then select a third arbitrator, who shall have at least [*] years experience in pharmaceutical patent licensing. The decision of the arbitrators shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrators explaining the arbitrators rationale for their decision. Except as may otherwise be determined by the arbitrators in their award to be just and appropriate in light of the particular circumstances and outcome of the arbitration, the Party losing the arbitration shall pay all fees and costs of the arbitrators and the ICC and reimburse the prevailing Party for its reasonable attorneys fees, costs and disbursements
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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(including, for example, expert witness fees and expenses, photocopy charges and travel expenses). The intent of the Parties is that except for the entering of an arbitration order in a court of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse to litigation in the courts, to the fullest extent allowed by law.
10.3 Exceptions . Notwithstanding the foregoing provisions of this Article 10 - , either Party may initiate an action before any court having competent jurisdiction in order to obtain emergency interim or conservatory relief, such as an order to preserve the status quo and to avoid incurring irreparable harm pending the resolution of any dispute that is submitted to arbitration, to prevent or enjoin a breach or threatened breach of confidentiality, or to enforce provisions of this Agreement relating to ownership rights in intellectual property without complying with the procedures set forth in this Article 10 - .
Article 11 - ASSIGNMENT
11.1 Binding Effect . This Agreement shall be binding upon and inure to the benefit of Parties hereto and their respective successors and permitted assigns.
11.2 Assignment by Salix . Salix shall have the right to assign this Agreement as it relates to any specific Salix Licensed Trademark to any Affiliate of its choice to whom ownership of such Salix Licensed Trademark is transferred, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Alfa hereby acknowledges and accepts any such assignment, but Salix shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Alfa, such consent not to be unreasonably withheld or delayed.
11.3 Assignment by Alfa . Alfa shall have the right to assign this Agreement, in whole or in part, to any Affiliate of its choice to whom Alfa assigns its rights under the Amended and Restated License Agreement, whether by way of sale and assignment, merger or consolidation, operation of law or otherwise, and Salix hereby acknowledges and accepts any such assignment, but Alfa shall not otherwise assign or purport to assign this Agreement (in whole or in part) without the prior consent in writing of Salix, such consent not to be unreasonably withheld or delayed.
Article 12 - ENTIRE AGREEMENT AND MODIFICATION
This Agreement together with the Amended and Restated License Agreement and other Related Agreements constitutes the final and complete understanding existing between Salix and Alfa relating to the subject matter hereof. The terms of this Agreement cannot be substituted, superseded, waived or modified in any manner except by written agreement executed for and on behalf of each of Salix and Alfa. In the event of any conflict between the terms of this Agreement, the Amended and Restated License Agreement and the other Related Agreements, this Agreement and the Amended and Restated License Agreement and the other Related Agreements shall be read as a single whole so as to accomplish the intent of the Parties as it so manifests itself.
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Article 13 - LANGUAGE AND GOVERNING LAW
13.1 English Language . This Agreement is written and undersigned in two originals in the English language. All communications notices and proceedings required to be given hereunder shall be in the English language.
13.2 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of Switzerland, without giving effect to any conflict of laws principles or rules. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
Article 14 - WAIVER
No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the party granting the waiver.
Article 15 - NOTICES
Except as otherwise herein provided, all notices to be served or notified to the Parties hereunder shall (a) be mailed by internationally recognized courier service or by registered airmail return receipt requested to their respective addresses listed below or to any other address subsequently communicated in writing, or (b) delivered by e-mail marked as being of high importance to the e-mail address set forth below (to be confirmed by written notice sent in the manner set forth in clause (a)), and shall be deemed to have been given [*] Business Days after the day on which such mailing is made, or on the next Business Day after the day on which it is sent in the case of any e-mail which is followed by written notice as aforesaid.
Party | Address | |
to Salix: |
Salix Pharmaceuticals, Inc. Attn: General Counsel 8510 Colonnade Center Drive Raleigh, North Carolina 27615 United States |
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with copies (which shall not constitute notice) to: | ||
Salix Pharmaceuticals, Inc. Attn: Executive Vice President Business Development 8510 Colonnade Center Drive Raleigh, North Carolina 27615 United States E-Mail: [*] |
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and |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Covington & Burling LLP 1201 Pennsylvania Avenue, N.W. Washington, D.C. 20004 United States Attention: Edward C. Britton, Esq. E-mail: ebritton@cov.com |
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to Alfa : |
Alfa Wassermann S.p.A Attn. Andrea Montanari Via Ragazzi del 99 no. 5 40133 Bologna, Italy E-mail: [*] |
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and | ||
Alfa Wassermann, Inc. 4 Henderson Drive West Caldwell, New Jersey 07006 United States Attention: Ira S. Nordlicht, President and Chief Executive Officer E-mail: [*] |
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and | ||
Nordlicht & Hand 800 Westchester Avenue Rye Brook, New York 10514 United States Attention: Brian M. Hand, Esq. E-mail: [*] |
Article 16 - SEVERABILITY
If any part of this Agreement is held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible, the original business purpose of the invalid or unenforceable part or provision in a valid and enforceable manner, and the remainder of this Agreement shall remain binding upon the Parties hereto.
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
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Article 17 - HEADINGS AND CONSTRUCTION
17.1 Headings . Headings are inserted for convenience and shall not by themselves define, describe, extend, limit or determine the interpretation of this Agreement.
17.2 References . References in this Agreement to Sections, Articles and Exhibits refer to Sections and Articles of, and Exhibits to, this Agreement except as otherwise specifically noted.
17.3 Rules of Construction . Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or shall be interpreted in accordance with its ordinary meaning as the context indicates. The term including as used herein shall mean including, without limiting the generality of any description preceding such term.
Article 18 - COUNTERPARTS
This Agreement may be executed in two or more counterparts each of which shall be deemed an original and which together shall constitute one and the same instrument.
Article 19 - MUTUAL DRAFTING
This Agreement constitutes the joint product of the Parties hereto. Each provision has been subject to the mutual consultation and agreement of such Parties and shall not be construed for or against either of them based on authorship.
Article 20 - THIRD PARTY RIGHTS
No provision of this Agreement is intended to be enforceable by any person other than the Parties hereto and their permitted assigns, and Parties entitled to indemnification pursuant to Article 9 - .
Article 21 - RELATIONSHIP OF THE PARTIES
It is expressly agreed that Salix, on the one hand, and Alfa, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Salix, on the one hand, nor Alfa, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.
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Article 22 - PERFORMANCE BY AFFILIATES
Each of Salix and Alfa acknowledges that its performance of its obligations and its exercise of rights under this Agreement may be performed or exercised, respectively, by Affiliates of Salix and Alfa. Each of Salix and Alfa guarantees performance of this Agreement by any of its Affiliates.
Article 23 - FURTHER ASSURANCE
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
(Signatures appear on the next page)
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first written above.
SALIX PHARMACEUTICALS, INC. | ALFA WASSERMANN S.p.A. | |||||||
By: | /s/ Rick Scruggs | By: | /s/ Andrea Golinelli | |||||
Name: | Rick Scruggs | Name: | Andrea Golinelli | |||||
Title: | EVP Business Development | Title: | Chief Strategy Officer |
[Signature page for Trademark License Agreement (Salix to Alfa)]
Exhibit 10.100
Execution Version
Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.
Salix Pharmaceuticals, Inc.
8510 Colonnade Center Drive
Raleigh, North Carolina 27615
United States of America
5 September 2012
Alfa Wassermann S.p.A.
Via Ragazzi del 99 no. 5
40133 Bologna
Italy
Gentlemen:
We refer to Section 11.7.2(b) of that certain Amended and Restated License Agreement, dated 6 August 2012, between us. The reference to Alfa contained in clause (ii) of the first sentence of the said section was in error and is hereby deleted and replaced by a reference to Salix.
We refer to Section 8.5 of that certain EIR Supply Agreement, dated 6 August 2012, between us. The final sentence of clause (b) of the said section is hereby amended to read in its entirety as follows:
Each party shall exercise Commercially Reasonable Efforts to cause any insurance policies required by the first sentence of this Section 8.5(b) to be carried by it that are written on a claims made basis to remain in effect for no less than [*] years following the end of the Term. Each party shall promptly, and in any event within [*] days, notify the other party of any notice that the first party may receive from its insurance carriers of any proposed reduction of coverage or other material modification of any of the insurance policies required to be carried by such first party pursuant to the first sentence of this Section 8.5(b).
If you are in agreement with the terms of this letter, kindly so indicate by causing a copy to be signed in the space indicated below and returned by facsimile or .pdf transmission to the undersigned, whereupon such terms will become a legally binding agreement between us.
Very truly yours, |
SALIX PHARMACEUTICALS, INC. |
/s/ Rick Scruggs |
Rick Scruggs |
Executive Vice President Business Development |
Agreed:
ALFA WASSERMANN S.p.A. | ||
By | /s/ Andrea Golinelli | |
Andrea Golinelli | ||
Title | Chief Strategy Officer | |
Date | October 10, 2012 |
* | Confidential treatment requested; certain information omitted and filed separately with the SEC. |
Exhibit 31.1
CERTIFICATION
I, Carolyn J. Logan, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Salix Pharmaceuticals, Ltd.; |
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: November 8, 2012 | By: | /s/ Carolyn J. Logan | ||||
Carolyn J. Logan | ||||||
President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION
I, Adam C. Derbyshire, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Salix Pharmaceuticals, Ltd.; |
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: November 8, 2012 | By: | /s/ Adam C. Derbyshire | ||||
Adam C. Derbyshire | ||||||
Executive Vice President and Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Salix Pharmaceuticals, Ltd. (the Company) for the period ended September 30, 2012 as filed with the Securities and Exchange Commission on or about the date hereof (the Report), I, Carolyn J. Logan, President and Chief Executive Officer, hereby certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of, and for, the periods presented in the Report. |
Date: November 8, 2012 | By: | /s/ Carolyn J. Logan | ||||
Carolyn J. Logan | ||||||
President and Chief Executive Officer |
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Salix Pharmaceuticals, Ltd. (the Company) for the period ended September 30, 2012 as filed with the Securities and Exchange Commission on or about the date hereof (the Report), I, Adam C. Derbyshire, Executive Vice President, Finance and Administration, and Chief Financial Officer, hereby certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of, and for, the periods presented in the Report. |
Date: November 8, 2012 | By: | /s/ Adam C. Derbyshire | ||||
Adam C. Derbyshire | ||||||
Executive Vice President and Chief Financial Officer |