Provision Language
Definitions
“Exclusive Licensed Field of Use“: (i) Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to be delivered to the brain or liver for treatment of human diseases originating in the brain or liver; (ii) Note that arthritis related diseases are expressly excluded.
“Licensed Patent Rights” shall mean:
(a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all these patents;
(b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in [part] (a):
(i) continuations-in-part of [part] (a);
(ii) all divisions and continuations of these continuations-in-part;
(iii) all patents issuing from these continuations-in-part, divisions, and continuations;
(iv) priority patent application(s) of [part] (a); and
(v) any reissues, reexaminations, and extensions of all these patents;
(c) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in [part] (a): all counterpart foreign and U.S. patent applications and patents to [part] (a) and [part] (b), including those listed in Appendix A; and
(d) Licensed Patent Rights shall not include [part] (b) or [part] (c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in [part] (a).
“Licensed Processes” means processes, which in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
“Non-Exclusive Licensed Field of Use” (per Amendment 2): Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat any human disease in any manner, where the treatment of such disease in such manner is not included in the Exclusive Licensed Field of Use.
“Practical Application” means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under these conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.
3. GRANT OF RIGHTS
3.1 PHS hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement , an exclusive license and non-exclusive license, as specified in Appendix B, under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.
3.2 This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of PHS other than the Licensed Patent Rights regardless of whether these patents are dominant or subordinate to the Licensed Patent Rights.
4. SUBLICENSING
4.1 Upon written approval, which shall include prior review of any sublicense agreement by PHS and which shall not be unreasonably withheld, the Licensee may enter into sublicensing agreements under the Licensed Patent Rights.
4.2 The Licensee agrees that any sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement. The Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements.
4.3 Any sublicenses granted by Licensee shall provide for the termination of the sublicense, or the conversion to a license directly between the sublicensees and PHS, at the option of the sublicensee, upon termination of this Agreement under Article 13. This conversion is subject to PHS approval (not to be unreasonably withheld) and contingent upon acceptance by the sublicensee of the remaining provisions of this Agreement.
4.4 The Licensee agrees to forward to PHS a complete copy of each fully executed sublicense agreement postmarked within thirty (30) days of the execution of the agreement. To the extent permitted by law, PHS agrees to maintain each sublicense agreement in confidence.
5. STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
5.1
(a) PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale, the Licensee agrees to provide PHS with reasonable quantities of the Licensed Products or materials made through the Licensed Processes for PHS research use; and
(b) in the event that the Licensed Patent Rights are Subject Inventions made under CRADA, the Licensee grants to the Government, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up license to practice the Licensed Patent Rights or have the Licensed Patent Rights practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale, the Licensee agrees to provide the PHS with reasonable quantities of the Licensed Products or materials made through the Licensed Processes for PHS research use.
5.2 The Licensee agrees that products used or sold in the United States embodying the Licensed Products or produced through use of the Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.
5.3 The Licensee acknowledges that PHS may enter into future CRADAs under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. The Licensee agrees not to unreasonably deny requests for a Research License from future collaborators with PHS when acquiring these rights is necessary in order to make a CRADA project feasible. The Licensee may request an opportunity to join as a party to the proposed CRADA.
5.4
(a) in addition to the reserved license of Paragraph 5.1, PHS reserves the right to grant Research Licenses directly or to require the Licensee to grant Research Licenses on reasonable terms. The purpose of these Research Licenses is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall consult with the Licensee before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes; and
(b) in exceptional circumstances, and in the event that the Licensed Patent Rights are Subject Inventions made under a CRADA, the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in the Licensed Field of Use on terms that are reasonable under the circumstances, or if the Licensee fails to grant this license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall only be in exceptional circumstances and only if the Government determines:
(i) the action is necessary to meet health or safety needs that are not reasonably satisfied by the Licensee;
(ii) the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by the Licensee; or
(iii) the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B); and
(c) the determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b).
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
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9.10 In the event PHS receives a license application from a Third Party Applicant for commercial development of one or more Licensed Products or Licensed Processes in the exclusive Licensed Fields of Use, as they pertain to Licensed Patent Rights for which the proposed commercial development is not specifically addressed in Licensee’s then-current Commercial Development Plan (“Third Party Applications”), PHS shall notify Licensee , in writing, of the existence of the Third Party Applicant ’s license application. Upon receipt of the written notice, Licensee shall respond in writing by either:
(a) amending its Commercial Development Plan within one hundred and twenty (120) days in a manner acceptable to PHS to include a clinical research and development program for the proposed commercial development of the Third Party Applications including revised Benchmarks to be incorporated into Appendix E, and acceptance of the amendment to the Commercial Development Plan by PHS shall take into account if Licensee has already carried out work in respect of such Third Party Applications prior to notification by PHS; or
(b) amending its Commercial Development Plan within one-hundred eighty (180) days (or such longer period agreed by Licensee and such Third Party Applicant) in a manner acceptable to PHS to include a joint pre-clinical research and development program with the Third Party Applicant for the proposed commercial development of the Third Party Applications; or
(c) granting an exclusive or non-exclusive sublicense under commercially reasonable terms to the Third Party Applicant under Licensed Patent Rights in respect of the Third Party Applications within one-hundred eighty (180) days (or such longer period agreed by Licensee and such Third Party Applicant);
or both (b) and (c).
If Licensee does not respond to the written notice as described in this Paragraph 9.10, and after thirty (30) days of final notice being sent to Licensee, PHS may remove the Licensed Products or Licensed Processes in respect of the Third Party Applications from the exclusive Licensed Field of Use in this Agreement, and PHS shall be free to grant a license to the Third Party Applicant under the Licensed Patent Rights in respect of the Third Party Applications.
10. PERFORMANCE
10.1 The Licensee shall use its reasonable commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Reasonable commercial efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D.
10.2 Upon the First Commercial Sale, until the expiration or termination of this Agreement, the Licensee shall use its reasonable commercial efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.
APPENDIX B – LICENSED FIELDS OF USE AND TERRITORY
I. Licensed Fields of Use:
(a) Exclusive Licensed Field of Use: (i) Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to be delivered to the brain or liver for treatment of human diseases originating in the brain or liver; (ii) Note that arthritis related diseases are expressly excluded.
(b) Non-Exclusive Licensed Field of Use: Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat human diseases other than the ones covered under (a)(i). Updated under Amendment 2: Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat any human disease in any manner, where the treatment of such disease in such manner is not included in the Exclusive Licensed Field of Use.
II. Licensed Territory:
(a) Worldwide.