Master Alliance Provisions Guide (MAPGuide)

NIH – MPP (C-TAP), COVID-19 Technologies, Patent and Biological Material License Agreement

  • Intellectual Property | License Grants
  • Intellectual Property | Ownership of IP

Definitions

Licensed Fields of Use” means the fields of use identified in Appendix B.

Licensed Materials” means the tangible materials listed in Appendix B including all progeny, subclones, and unmodified derivatives thereof and products expressed by such tangible materials. 

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 2.13(a):

(i) continuations–in–part of 2.13(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 2.13(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 2.13(a): all counterpart foreign and U.S. patent applications and patents to 2.13(a) and 2.13(b), including those listed in Appendix A; and 

(d) Licensed Patent Rights shall not include 2.13(b) or 2.13(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.13(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. 

Licensed Products” means:

(a) tangible materials, which in the course of manufacture, use, sale, or importation, 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; and 

(b) tangible materials made from or derived, in whole or in part, by the Licensee from the Licensed Materials, whether or not included within the scope of one or more Valid Claims of the Licensed Patent Rights that are used, manufactured, sold or imported

Licensed Territory” means the geographical area identified in Appendix B. 

3. Grant of Rights

3.1 IC hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, a nonexclusive right to grant Sublicenses under the Licensed Patent Rights in the Licensed Territory that include the right of the Sublicensee 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 IC hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, a nonexclusive right to grant Sublicenses to Licensed Materials in the Licensed Territory that include the right of the Sublicensee 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.

3.3 This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of IC 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 IC, and which shall not be unreasonably withheld, the Licensee may enter into sublicensing agreements for the Licensed Patent Rights and Licensed Materials. These sublicenses will not have a further right of sublicense and must be granted in accordance with the WHO C–TAP Development Plan as described in Appendix C. Sublicenses must also be issued by the Licensee without discrimination to any sublicensee with the demonstrated commitment, ability, and readiness to use the sublicense but in no instance shall a sublicense be issued for use in a country under Government sanction.

4.2 The Licensee agrees that any sublicenses granted by it shall provide that the obligations to the IC of Paragraphs 5.1, 5.2, 8.1, 10.1, 10.2, 12.6, and 13.7–13.9 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 the Licensee shall provide for the termination of the sublicense, or the conversion to a license directly between the sublicensees and IC, at the option of the sublicensee, upon termination of this Agreement under Article 13. This conversion is subject to the IC approval and contingent upon acceptance by the sublicensee of the remaining provisions of this Agreement.

5. Statutory and NIH Requirements and Reserved Government Rights

5.1 Upon request and prior to the First Commercial Sale, the Licensee agrees to require the Sublicensee to provide IC with reasonable quantities of Licensed Products or materials made through the Licensed Processes for IC research use.

5.2 The Licensee will require any Sublicensee to agree that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States unless a written waiver is obtained in advance from IC.

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 WHO C–TAP Development Plan in Appendix E and performance of the Benchmarks in Appendix D.

10.2 Upon the First Commercial Sale in the United States, 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: 

SARS–CoV–2 products for the WHO C–TAP program 

II. Licensed Territory: 

Worldwide 

III. Least Developed Countries: 

Africa (34): Angola, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gambia, Guinea, Guinea–Bissau, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, São Tomé and Príncipe, Senegal, Sierra Leone, Somalia, South Sudan, Sudan, Togo, Uganda, United Republic of Tanzania, Zambia 

Asia (14): Afghanistan, Bangladesh, Bhutan, Cambodia, Kiribati, Lao People’s Democratic Republic, Myanmar, Nepal, Samoa, Solomon Islands, Timor–Leste, Tuvalu, Vanuatu, Yemen 

Latin America and the Caribbean (1): Haiti 

(Source: United Nations Office of the High Representative (UN–OHRLLS) as of October 23, 2013)