knowledge without the fault of the receiving party; (iii) is or becomes rightfully available on an unrestricted basis to the receiving party from a source other than a party owing an obligation of confidentiality to the disclosing party; or (iv) is independently developed by employees of the receiving party who have not had direct or indirect access to the disclosing party’s Confidential Information, as evidenced by the receiving party’s written record.

(c)                                   “ FDA ” means the Food and Drug Administration of the U.S. Department of Health and Human Services.

(d)                                  “ Field of Use ”means all applications of the Patent Rights excluding subcutaneous or intramuscular drug delivery implants.

(e)                                   “ Improvements ” means, individually and collectively, all discoveries, inventions, know-how, techniques, methodologies, modifications, improvements, designs and data (whether or not protectable under patent, trade secrecy or similar laws) relating to additions, developments, enhancements, updates and other changes in or to the Patent Rights.

(f)                                     “ Licensed Product ” means any product or device that: (i) is developed, designed, modified, improved, manufactured, used, imported, sold or offered for sale by or on behalf of the Licensee or its Affiliates (or its or their sublicensees) that would, in the absence of this Agreement, infringe a Valid and Enforceable claim in the Patent Rights; or (ii) incorporates the Patent Rights.

(g)                                  “ Patent Rights ” means each and all of the following: (i) all right, title and interest of Licensor and its Affiliates in the Patents, any Valid and Enforceable claim in any patent issuing from any patent applications, and any Valid and Enforceable claim in any issued patent, claiming priority to any of the foregoing, including any reissues, re-examinations, divisionals, continuations and continuations-in-part, and extensions thereof; and (ii) any corresponding foreign patents or patent applications related or claiming priority thereto.

(h)                                  “ Valid and Enforceable ” means, with respect to any patent claim, a claim in any unexpired patent which has not been held invalid or unenforceable by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time period allowed for appeal, or which has not been admitted to be invalid through reissue, reexamination or disclaimer.

2.                                        License .

(a)                                   Grant . Licensor hereby grants to Licensee and its Affiliates an exclusive, worldwide, nontransferable right and license, with the right to grant sublicenses as set forth in Section 2(b), under the Patent Rights (including, without limitation, any Improvements conceived or reduced to practice by an employee, agent, or consultant of Licensor) to develop, design, modify, improve, make, have made, use, import, offer to sell and sell the Licensed Products solely in the Field of Use during the term of this Agreement. Licensee hereby acknowledges that: (i) Licensor is the sole and exclusive

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owner of all right, title and interest in and to the Patent Rights, and (ii) Licensor retains the right to use the Patent Rights for its own purposes and to use and grant to others licenses to use the Patent Rights outside the Field of Use. Except as set forth in this Agreement, Licensee shall not have any right, title or interest in or to the Patent Rights. Licensee and its Affiliates shall have no right to manufacture, use, import, offer to sell or sell Licensed Products outside of the Field of Use. Licensee will own all rights, title and interest in and to any Improvement conceived or reduced to practice by an employee, agent, or consultant of Licensee or its Affiliates.

(b)                                  Sublicenses . Licensee and its Affiliates may grant sublicenses under the Patent Rights without the prior written consent of the Licensor solely in the Field of Use; provided , however, that (i) such sublicenses are no less protective of Licensor’s rights as the provisions set forth in this Agreement, and to the extent applicable, shall include all of the rights and obligations due to Licensor hereunder; and (ii) Licensee makes payments to Licensor based upon milestones and sales of Licensed Products by its Affiliates and such sublicensees in accordance with Section 3, as if such milestones and sales of Licensed Product were reached and/or made by Licensee.

(c)                                   Patent Marking. Licensee, its Affiliates and all sublicensees shall mark all Licensed Products in accordance with the statutes of any country where a patent application has been filed or a patent issued relating to the Patent Rights. To the extent the Licensed Product cannot be marked, such marking shall be included in the literature and/or marketing materials describing the Licensed Product.

3.                                        Payments .

(a)                                   Milestone Payments . In consideration of the licenses granted herein, Licensee shall make the milestone payments to Licensor as set forth in Section 3.2 of the ASA.

(b)                                  Notice of Triggering Events . Licensee shall provide Licensor with prompt written notice of: (i) the commencement of Phase II clinical testing of any Licensed Product; (ii) execution of any agreement by and between Licensee or its Affiliates and any third party with respect to any Patent Rights or a Licensed Product; and (iii) the first commercial sale of each Licensed Product (“ First Commercial Sale ”).

(c)                                   Books and Records . Licensee agrees to keep, and shall cause its Affiliates and sublicensees to keep, complete and accurate books of account and records covering all transactions relating to this Agreement, including Annual Net Sales as reported pursuant to Section 3.2 of the ASA. All such books of account and records shall be kept available for at least two (2) years after the termination or expiration of this Agreement.

(d)                                  Expenses . Unless otherwise specifically set forth herein, all fees, costs and expenses incurred by Licensee in developing, manufacturing, promoting, marketing and selling Licensed Products or otherwise incurred under this Agreement shall be borne solely by Licensee.

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4.                                        Regulatory Approval and Commercialization .

(a)                                   Regulatory Approvals . Licensee shall be responsible, at its expense, for filing, obtaining, and maintaining all necessary authorizations from the FDA and any comparable foreign regulatory authorities for the marketing and sale of Licensed Products in the United States and such foreign countries as Licensee, in its sole discretion, determines. Licensee’s obligations under this Section 4(b) shall include the preparation and filing of any required submissions and the establishment and oversight of any required clinical investigations and clinical follow-up relating to future commercial sale of the Licensed Products.

(b)                                  Manufacturing and Sales . Upon receipt of a substantially equivalent letter from the FDA clearing the Licensed Product for marketing, Licensee shall be responsible for manufacturing, marketing and selling such Licensed Product and Licensee shall use commercially reasonable efforts to market and sell such Licensed Product.

5.                                        Licensee’s Representations and Warranties . Licensee hereby represents and warrants to Licensor that as of the date hereof:

(a)                                   Licensee is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and this Agreement has been duly authorized by all necessary corporate action on the part of Licensee.

(b)                                  This Agreement is the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms.

(c)                                   Neither the execution and delivery of this Agreement nor the compliance with the terms and conditions hereof will conflict with, result in a breach or violation by Licensee of or constitute a default under any of the terms, conditions or provisions of any contract, agreement or other instrument to which Licensee is or may be bound or affected.

(d)                                  Licensee will comply with all applicable laws in performing its obligations under this Agreement.

6.                                        Licensor’s Representations and Warranties . Licensor hereby represents and warrants to Licensee that as of the date hereof:

(a)                                   Licensor is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and this Agreement has been duly authorized by all necessary corporate action on the part of Licensor.

(b)                                  This Agreement is the legal, valid and binding obligation of Licensor, enforceable against Licensor in accordance with its terms.

(c)                                   Neither the execution and delivery of this Agreement nor the compliance with the terms and conditions hereof will conflict with, result in a breach or violation by

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Licensor of or constitute a default under any of the terms, conditions or provisions of any contract, agreement or other instrument to which Licensor is or may be bound or affected.

(d)                                  Licensor will comply with all applicable laws in performing its obligations under this Agreement.

EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES IN SECTIONS 5 AND 6, THE PATENT RIGHTS ARE LICENSED ON AN “AS IS” BASIS, AND NO PARTY MAKES ANY OTHER EXPRESS OR IMPLIED WARRANTY HEREUNDER, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF TITLE, NON-INFRINGEMENT, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND EACH HEREBY DISCLAIMS THE SAME.

7.                                        Term and Termination .

(a)                                   Term . The term of this Agreement shall commence on the Effective Date and shall remain in force, unless terminated earlier in accordance with Section 7(b), until the last to expire of the Patent Rights.

(b)                                  Termination . Notwithstanding the provisions of Section 7(a), this Agreement may be terminated upon mutual written agreement of the parties.

(c)                                   Rights and Obligation on Termination . In the event of termination or expiration of this Agreement for any reason, the parties shall have the following rights and obligations:

(i)                                      Licensee shall remain responsible for any payment due to Licensor that has accrued prior to the effective date of termination.

(ii)                                   The licenses granted to Licensee under Sections 2(a) and 2(b) above shall immediately terminate and be of no further force and effect. Licensor, at its sole discretion, shall determine whether any or all sublicenses entered into by and between Licensee and its sublicensees prior to the effective date of termination of this Agreement shall be canceled or assigned to Licensor.

(iii)                                Sections 1, 2(c), 3, 5, 6, 7, 8, 9, 10, 11 and 12 shall survive termination of this Agreement.

(iv)                               Subject to its obligations under Section 3, Licensee, its Affiliates and sublicensees shall be permitted to sell any inventory of Licensed Product in fully-finished form on hand at the effective date of termination.

(v)                                  Each p