AGREEMENT

Exhibit No. 10.27

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

 

AGREEMENT

 

This License Agreement (this “Agreement”), effective as of December 4, 2002 (“Effective Date”), is made by and between Curis Inc., a Delaware corporation (“Curis”), having a place of business at 601 Moulton Street, Cambridge, Massachusetts 02138-1118, and Amylin Pharmaceuticals, Inc., a Delaware corporation (“Amylin”), having a place of business at 9373 Towne Centre Drive, Suite 250, San Diego, California 92121.

 

R E C I T A L S

 

Whereas, Curis owns certain intellectual property relating to peptide YY (“PYY”);

 

Whereas, Amylin desires to secure the exclusive right and license to use, develop, manufacture, market and exploit such intellectual property;

 

Whereas, Curis has determined that the exploitation of such intellectual property by Amylin is in the best interest of Curis; and

 

Now, Therefore, in consideration of the premises and of the promises and covenants contained herein and intending to be legally bound hereby, the parties agree as follows:

 

1.	Definitions.

 

A. “Amylin” shall mean Amylin Pharmaceuticals, Inc. and its Affiliates.

 

B. “Affiliate” means, when used with reference to a party, any Entity directly or indirectly controlling, controlled by or under common control with such party. For purposes of this Agreement, “control” means the direct or indirect ownership of over fifty percent (50%) of the outstanding voting securities of an Entity, or the right to receive over fifty percent (50%) of the profits or earnings of an Entity, or the right to control the policy decisions of an Entity.

 

C. “Bankruptcy Event” means voluntary or involuntary proceedings by or against an Entity are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for such Entity, or proceedings are instituted by or against such Entity for corporate reorganization or the dissolution of such Entity, which proceedings, if involuntary, shall not have been dismissed within 60 days after the date of filing, or such Entity makes an assignment for the benefit or creditors, or substantially all of the assets of such Entity are seized or attached and not released within 60 days thereafter.

D. “Confidential Information” means and includes all technical information, inventions, trade secrets, developments, discoveries, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas, whether or not patentable or copyrightable, that the disclosing party identifies as confidential or proprietary at the time it is delivered or communicated to the receiving party.

 

E. “Curis” means Curis, Inc.

 

F. “Curis Patents” means those (i) patents and patent applications (including provisional applications and applications for certificates of invention) listed in Exhibit A attached hereto and made a part hereof; (ii) any patents issuing from such patent applications (including certificates of invention); (iii) all patents and patent applications based on, corresponding to, or claiming the priority date(s) of any of the foregoing; (iv) any reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any of the foregoing; and (v) term extensions, supplementary protection certificates and other governmental action which provide exclusive rights beyond the original patent expiration date, which are owned or controlled by Curis as of the Effective Date or during the Term.

 

G. “Entity” means a corporation, an association, a joint venture, a partnership, a trust, a business, an individual, a government or political subdivision thereof, including an agency, or any other organization which can exercise independent legal standing.

 

H. “FDA” means the Food and Drug Administration of the United States.

 

I. “Field” means in vivo use of Products for treating metabolic disorders in humans and conducting research in humans and animals.

 

J. “IND” means an Investigational New Drug Application (together with all additions, deletions, and supplements thereto) filed with the FDA, or its foreign equivalent.

 

K. “License” means the license or licenses granted pursuant to Section 2(A).

 

L. “Marketing Approval” means the act of a Regulatory Authority necessary for the manufacture, marketing and sale of Products in a country or regulatory jurisdiction, including, without limitation, the approval of the new drug application by the FDA, and approval of Products for marketing in the European Union by the European Commission, and satisfaction of all applicable regulatory and notification requirements.

 

M. “Net Sales” means, with respect to a Product:

 

The gross amount invoiced for sales of Products by Amylin or its sublicensees to third persons (excluding Amylin’s sublicensees), less:

 

(i) trade, quantity and cash discounts and rebates and retroactive price reductions or allowances actually granted from the billed amount;

 

(ii) credits or allowances actually granted upon claims, rejections or returns of such sales of Products, including recalls;

 

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(iii) prepaid transportation insurance premiums and prepaid outbound transportation expenses;

 

(iv) taxes imposed on the production, sale, delivery or use of Products (including, without limitation, sales, use, excise or value added taxes but excluding income taxes), duties or other governmental charges levied on or measured by the billing amount when included in billing, as adjusted for rebates and refunds; and

 

(v) a provision for uncollectible accounts determined in accordance with Amylin or its sublicensees’ normal accounting procedures consistently applied within and across its/their pharmaceutical operating units.

 

N. “Phase 3 Clinical Trial” means large scale human clinical trials conducted in patients anywhere in the world in accordance with good clinical practice to generate data concerning the efficacy and a level of safety in the particular indication tested sufficient to obtain Marketing Approval.

 

O. “Product” means any pharmaceutical product containing or incorporating a PYY receptor ligand or a PYY peptide, fragment, analogue or derivative, the making, using or selling of which, in the absence of this Agreement, would infringe at least one claim in the Field of any Curis Patent.

 

P. “Regulatory Authority” means, in a particular country or jurisdiction, any applicable government regulatory authority involved in granting Marketing Approval and/or, to the extent required in such country or jurisdiction, Pricing Approval of a Product in such country or jurisdiction, including without limitation, (a) in the U.S., the FDA, and any other applicable governmental or regulatory authority in the U.S. having jurisdiction over a Product, and any successor government authority having substantially the same function, and (b) any foreign equivalent thereof.

 

Q. “Sale” means any bona fide third party commercial sale of a Product after Marketing Approval.

 

R. “Term” means the term of this Agreement as defined in Section 7(A).

 

2.	Licenses Granted and Development Reports.

 

A. Curis hereby grants to Amylin during the Term, an exclusive (even as to Curis), worldwide right and license, under the Curis Patents, to make, have made, use and sell Products for use in the Field, with the right to grant sublicenses. Curis hereby grants a non-exclusive license on any future patents in the Field which come under its ownership or control to make, have made, use and sell Products for use in the Field.

 

B. Amylin shall use commercially reasonable efforts to develop and market Products. On or before the first anniversary of this Agreement and annually thereafter until Amylin markets a Product, Amylin will submit a report on the progress Amylin has made in the preceding year toward commercial use of Products.

 

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3.	License Fees, Royalties and Milestones.

 

A. In partial consideration of the License and any assignment of Divided Patents granted herein, Amylin shall pay to Curis an amount equal to [**] Dollars ($[**]) (“License Fee”). The License Fee shall be paid within thirty (30) days of the parties’ signing of this Agreement.

 

B. In further consideration of the License and any assignment of Divided Patents granted herein, beginning upon the first Sale of each Product in a country, Amylin shall pay Curis a royalty equal to [**]% of Net Sales of such Product, provided that (i) a Curis Patent or Divided Patent with claims covering the Product has issued in such country and is in force, or (ii) if Curis or its licensee is prosecuting an undivided application in such country for a Curis Patent or Divided Patent, such application has been pending for no more than seven (7) years from its earliest filing date and Curis or its licensee has diligently pursued prosecution and issuance of claims in the Field during such time, or (iii) if Amylin is prosecuting an application in such country for a Divided Patent, such application is pending. In the event that seven years transpires according to (ii) above, and a Curis Patent or Divided Patent with claims in the Field subsequently issues in a country where Product is sold, any obligation of Amylin to pay royalties shall cease in the intervening time, and Amylin’s royalty obligations shall begin again upon issuance of the Curis Patent or Divided Patent for the remainder of the Term.

 

(a) In applying the royalty terms of Section 3(B), the royalty terms shall be applied on a country-by-country basis, it being the intention of the parties that the royalty in this Section 3(B) shall only apply if a Curis Patent or Divided Patent either has issued or is being prosecuted in accordance with the first paragraph of this Section 3(B) in any one country in which a Product is made, used or sold, having claims that cover the particular making, using, or selling that occurred in such country.

 

(b) The payment of royalties to Curis on any particular Product shall terminate in each country on the expiration date of the last-to-expire issued Curis Patent or Divided Patent covering such Product in such country.

 

(c) Amylin may at any time, effective upon providing 30 days prior written notice to Curis, cease to develop, market or sell any Product in a country and delete such Product from the License in such country. Effective as of the date of such notice, all royalties and other fees on such Product in such country shall thereafter cease to accrue.

 

C. Exhibit B attached hereto and made a part hereof, lists mutually agreed upon performance milestones (“Milestones”) along with the corresponding milestone payments due for completion of each such milestone. Amylin will notify Curis when any Milestone is achieved and pay Curis the milestone payment due within thirty (30) days after achievement of such Milestone. For Milestone Numbers 6 through 8, their respective milestone payments shall only be paid one time for the first Product to achieve such Milestone.

 

4.	Reports And Records.

 

A. After Amylin commences the Sale of Products, Amylin shall, within sixty (60) days of the end of each calendar quarter, deliver to Curis a report, certified by the chief financial officer of Amylin, that sets forth in reasonable detail the calculation of the royalties due to Curis for such calendar quarter.

 

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B. Royalties payable under Section 3(B) hereof shall be paid within 60 days following the last day of the calendar quarter in which the royalties accrue.

 

C. Amylin will maintain and cause its sublicensees to maintain, complete and accurate books and records which enable the royalties payable hereunder to be verified. The records for each calendar quarter shall be maintained for three years after the submission of each report under Section 4(A) hereof. Upon reasonable prior notice to Amylin (but in no event less than ten business days), Curis and its accountants shall have access to all books and records relating to the Net Sales of Products by Amylin and its sublicensees to conduct a review or audit thereof. Such access shall be available not more than once each calendar year, during normal business hours, and for each of three years after the expiration or termination of this Agreement; provided that once a calendar year has been audited, it may not thereafter be audited again in that calendar year. If the audit reveals 5% or more under reporting of royalties due Curis, Amylin will pay the audit costs, as well as any additional sum that would have been payable to Curis had Amylin reported correctly, plus 5% interest.

 

5.	Currency, Place Of Payment.

 

A. All dollar amounts referred to in this Agreement are expressed in United States dollars. All payments to Curis under this Agreement shall be made in United States dollars.

 

B. If Amylin receives revenues from Sales of Products in currency other than United States dollars, revenues shall be converted into United States dollars at the conversion rate used by sublicensees in any agreement with Amylin, or if there is no such agreement, such conversion shall be at the conversion rate for the foreign currency as published in the eastern edition of The Wall Street Journal as of the last business day of the applicable calendar quarter.

 

6.	Confidentiality.

 

A. Each party agrees to maintain in confidence and not to disclose to any third party any Confidential Information of the disclosing party received pursuant to this Agreement and to use such Confidential Information solely for purposes of carrying out its obligations under this Agreement. The receiving party agrees to ensure that its employees and agents have access to Confidential Information only on a need-to-know basis and are obligated in writing to abide by the obligations hereunder. Further, each party agrees to return to the disclosing party tangible materials containing Confidential Information upon the expiration or any earlier termination of this Agreement. The confidentiality obligation under this Section 6 shall remain in effect during the Term and for a period of five (5) years thereafter. The foregoing obligations shall not apply to any Confidential Information that is:

 

(i) publicly known prior to disclosure or has become publicly known, without fault on the part of receiving party, subsequent to disclosure hereunder; or

 

(ii) otherwise known by the receiving party prior to disclosure hereunder or is generated for the receiving party by persons who have not had access to or knowledge of the Confidential Information; or

 

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(iii) hereafter received by the receiving party at any time from a source other than the disclosing or its agents, lawfully having possession of such information and under no obligation of confidentiality with respect to such information; or