Exhibit 10.5
Portions of this exhibit (indicated by “[**]”) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K.
DEVELOPMENT AND LICENSE AGREEMENT
This Development and License Agreement (“Agreement”) is entered into effective as of May 15, 2000 (the “Effective Date”) between Alkermes Controlled Therapeutics Inc. II (“ACTII”) and Amylin Pharmaceuticals, Inc. (“Amylin”).
RECITALS
WHEREAS, ACTII owns or has licensed from third parties certain intellectual property rights relating to injectable, sustained release formulation systems, including the Medisorb® microsphere system (the “System,” as defined below);
WHEREAS, Amylin owns or has licensed from third parties certain intellectual property rights relating to Field Products (as defined below);
WHEREAS, ACTII and Amylin previously entered into a Feasibility Study Agreement dated as of June 24, 1999 between ACTII and Amylin, as extended pursuant to the Feasibility Study Extension Agreement dated February 15, 2000 (collectively, the “Feasibility Agreement”);
WHEREAS, based upon the results to date of the study performed pursuant to the Feasibility Agreement, the Parties have determined that the use of ACTII’s System formulations for AC2993 shows sufficient promise to justify further development pursuant to this Agreement; and,
WHEREAS, ACTII and Amylin wish to enter into this Agreement, in accordance with the terms set forth herein.
NOW THEREFORE, in consideration of the mutual covenants and promises contained herein, the parties hereto, intending to be legally bound hereby, agree as follows:
and confirmations thereof, and any other patent or patent application that covers an Invention which is owned (either jointly or solely by ACTII) or controlled by ACTII. ACTII Patents does not include ACTII Know How.
If ACTII is receiving royalties under this Agreement from any Product sold in a form containing Product and at least one other ingredient, product or component which is Therapeutically Active, Net Sales for such combination Product will be calculated by multiplying actual Net Sales of such combination Product by the fraction A/(A+B) where A is the invoice price of the Product if sold separately, and B is the invoice price of any other ingredient which is Therapeutically Active in the combination, if sold separately. If, on a country-by-country basis, the other ingredient which is Therapeutically Active in the combination is not sold separately in said country, Net Sales for the purpose of determining royalties of the combination Product shall be calculated by multiplying actual Net Sales of such
combination Product by the fraction A/C where A is the invoice price of the Product, if sold separately, and C is the invoice price of the combination Product. If, on a country-by-country basis, neither the Product nor the other ingredient which is Therapeutically Active of the combination Product is sold separately in said country, Net Sales for the purpose of determining royalties of the combination Product shall be determined by the Parties in good faith. In general, the Parties agree to negotiate in good faith for an equitable determination of Net Sales of Product, on a country-by-country basis, in the event that Amylin or its Affiliates, sublicensees or Co-Marketers sell Product in such a manner that gross sales of the same are not readily identifiable.
| Milestone |
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| Milestone Payment |
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| [**] |
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| [**] |
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| Enrollment of first patient in a Phase III Clinical Trial |
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| $5,000,000 |
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| First commercial sale of a Product in the United States |
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| $7,000,000 |
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| First commercial sale of a Product in a Major European Market Country |
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| $7,000,000 |
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All milestone payments are non-refundable and non-creditable.
be deemed Confidential Information of Amylin. The rate of exchange to be used in any currency conversion to United States Dollars shall be the rate reported in the Wall Street Journal for the purchase of United States Dollars with such currency on the last business day in Geneva, Switzerland for the quarter for which the report is being prepared. All royalty and transfer price payments hereunder shall be made to ACTII in United States Dollars by bank wire transfer in immediately available funds to a bank account designated by ACTII. All payments hereunder shall be made net of any withholding taxes, duties, levies, fees or charges required to be withheld under the law on behalf of ACTII. Amylin shall make any withholding payment due on behalf of ACTII and shall promptly provide ACTII with written documentation of any such payment.
plan (“Product Development Plan”). The Product Development Plan shall be based on an initial product development plan, a first draft of which is attached as Exhibit B to this Agreement. The Product Development Plan shall be completed to the satisfaction of the Parties prior to the time set forth in Section 3.1 above. and prior to the time that Amylin elects to make the payment and issue the Warrants as provided therein. The product to be the subject of the initial product development plan shall be AC2993. Should Amylin determine at any time during the course of this Agreement that it wishes to develop and commercialize an additional Field Product, or that it wishes to discontinue development and commercialization of AC2993 and instead develop and commercialize a different Field Product, the Parties will negotiate in good faith whether to develop such additional or different Field Product and, if so, any appropriate alterations or additions to the provisions of this Agreement, including but not limited to its financial provisions. In the event that Amylin discontinues the development and commercialization of AC2993 and the Parties are unable to agree upon the development of a different Field Product within 180 days of such discontinuation, then this Agreement shall terminate as if Amylin had terminated this Agreement under Section 9.2(b). The Project Working Team shall be responsible for implementing the Product Development Plan, addressing fully the appropriate strategy for development and Regulatory Approval of Product, developing the responsibilities and procedures for handling any and all regulatory issues related to a Product and for addressing all issues that develop during the course of implementing the Product Development Plan. Such implementation efforts shall include: (A) establishing comprehensive and detailed plans designed to accomplish the goals of the Product Development Plan, including a plan pursuant to which ACTII will perform technical and scientific work under this Agreement, (B) allocating tasks and coordinating activities required to carry out the objectives of the Product Development Plan, (C) monitoring progress of the Product Development Plan, (D) monitor the FTEs worked and expenditures made under the Product Development Plan and (E) discharging such other obligations as are assigned to the Project Working Team under this Agreement or by the Steering Committee.
(ii) The Project Working Team may propose modifications to the Product Development Plan to the Steering Committee for its approval. No modification may be implemented unless approved by the Steering Committee.
more, ACTII shall pay all costs of such examination. In the event such accountant or scientific expert concludes that an overpayment was made by Amylin under Section 4.7, ACTII will credit such overpayment amount against future amount owed by Amylin to ACTII. This Section 4.7(d) shall survive any termination of this Agreement for two (2) years.
Amylin to ACTII. The agreement shall also include provisions regarding the manufacturing options provided to Amylin in Sections 6.2 and 6.3 below.
court of competent jurisdiction. To ACTII’s knowledge, none of the ACTII Know-How is subject to any proceedings alleging misappropriation of any of said ACTII Know-How from a third party. ACTII agrees that, at a time not later than the time Amylin elects to make the payment and issue the Warrants provided in Section 3.1 above, it will agree to amend this Agreement to include its further representation and warranty that at least one Valid Claim, or at least one claim of a pending patent application within ACTII Patents, in each Major Market Country will cover a System formulation of AC2993 to be developed and commercialized under this Agreement.
advisors to ACTII who are unaffiliated with and who are not compensated by Amylin or any of its affiliates, directly or indirectly.
protect its own proprietary and confidential information, to protect the confidentiality of the Disclosing Party’s Confidential Information. Each Receiving Party shall protect and keep confidential and shall not use, publish or otherwise disclose to any third party, except as contemplated by this Agreement or with the Disclosing Party’s written consent, the Disclosing Party’s Confidential Information for a period of five (5) years following the termination of this Agreement. Joint Inventions shall constitute Confidential Information.
initial consultation or notice of intention to publish, then the requesting Party shall be free to publish as proposed. This Section 8.4 does not control the filing of any patent application or other patent-related filing; instead, Section 10.2 shall control the parties’ obligations with regard to prior notification, consultation, disclosure and publication when filing any patent application or other patent-related filing which incorporates any Confidential Information.
and elections under the Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against ACTII under the Bankruptcy Code that is not dismissed within sixty (60) days after it is filed, Amylin 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, including without limitation all intellectual property necessary or useful to give Amylin the capability of manufacturing Products, and the same, if not already in its possession, shall be promptly delivered to Amylin (i) upon any such commencement of a bankruptcy proceeding upon written request therefor by Amylin, unless ACTII elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of ACTII, upon written request therefor by Amylin.
Each Party shall cooperate with the other in completing any patent applications relating to both solely and jointly developed Inventions that will be owned by the other Party. Each Party shall also cooperate with the other in executing and delivering any instrument required to assign, convey or transfer to such other Party its interest should such assignment, conveyance or transfer be required by the terms of this Agreement.
Furthermore, upon the discovery, generation or development of a particular Invention, the Party so discovering, generating or developing shall promptly disclose to the other Party the particular Invention at issue and in no event shall a Party file a patent on such particular
Invention until ownership as described in this Section 10.1 is determined by the Parties after such Parties have had a reasonable opportunity to review and discuss the particular Invention at issue.
Inventions in the Field or any claim of a third party that any of the ACTII Patents are invalid or unenforceable shall promptly notify the other Party of such activities or such claim.
Agreement by Amylin, (b) the marketing, packaging, testing, labeling, manufacture, use or sale of Field Products or Products or (c) the performance of the Product Development Plan by Amylin (except that Amylin shall not indemnify ACTII for Losses resulting from the Product Development Plan or flaws or omissions in the Product Development Plan itself) except to the extent such Losses are required to be indemnified by ACTII pursuant to Section 11.2 hereof, and except to the extent such Losses are attributable to the gross negligence or willful misconduct of any ACTII Indemnitee.
class insurance carrier with at least a BBB rating by Standard & Poors. Promptly after execution and delivery of this Agreement, each Party shall furnish a certificate of insurance to the other Party evidencing the foregoing endorsements, coverage and limits, and providing that such insurance shall not expire or be canceled or modified without at least thirty (30) days prior notice to the other Party.
If to Amylin:
General Counsel
Amylin Pharmaceuticals, Inc.
9373 Towne Centre Drive
San Diego, CA 92121
Fax: 858-552-1936
If to ACTII:
President
Alkermes Controlled Therapeutics Inc. II
64 Sidney Street
Cambridge, MA 02139
Fax: 617-494-9263
or to such other addresses as may from time to time be given in writing by either Party to the other pursuant to the terms hereof.
employee, servant, joint venturer or partner of the other for any purpose which could impose liability upon one Party for the act or failure to act of the other Party.
make any disclosure or written dissemination with respect to this Agreement or its terms without giving the other Party a reasonable opportunity to comment thereon and obtaining the other Party’s prior written consent, which consent will not be unreasonably withheld, provided that such opportunity and such consent will not be required where such disclosure or dissemination (a) is required by law; or (b) is reasonably necessary in connection with any potential transaction referred to in Section 12.9 or contemplated by this Agreement.
The arbitrator or arbitrators shall be accredited by the AAA and shall be individuals with knowledge of and experience with the pharmaceutical industry.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized officers as of the day and year first above written.
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| ALKERMES CONTROLLED | ||
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| By: |
| /s/ Michael Landine |
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| Title: |
| Vice President |
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| AMYLIN PHARMACEUTICALS, INC. | ||
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| By: |
| /s/ Daniel M. Bradbury |
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| Title: |
| Senior Vice President, Corporate Development |
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List of Exhibits and Schedules
Exhibit A – ACTII Patents
Exhibit B – Program Development Plan
Exhibit C – Pre-Approved Information for Press Release