The NIH Center for Regenerative Medicine

Public Health Service Biological Materials License Agreement

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This Agreement is entered into between the National Institutes of Health (“NIH”) or the Food and Drug Administration (“FDA”), hereinafter singly or collectively referred to as “PHS”, agencies of the United States Public Health Service within the Department of Health and Human Services (“HHS”) through the Office of Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, U.S.A. and ____________________ (“Licensee”), a corporation of ____________________, having an office at ________________________________________.
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1. Definitions
1. "Materials" means the following biological materials including all progeny, subclones, and derivatives thereof: ____________________________________________________________, as described in ________________________________________________________________________ and developed in the laboratory of ___________________________________________________________.
2. Licensed Products” means the Materials and the Pluripotent Modifications, Non-Pluripotent Modifications, Modified Derivatives of the Materials ________________________.
3. “Net Sales” means the total gross receipts by Licensee for sales of Licensed Products or from income from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions transferring title, whether invoiced or not, less returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they are with independent sales agencies or regularly employed by Licensee, or for the cost of collections.
4. “Licensed Field of Use” means the use, sale, lease, rent, or making available of Licensed Products as research reagents only. For avoidance of doubt, the Licensed Field of Use specifically excludes the use, sale, lease, rent, or making available of Licensed Products for clinical or diagnostic uses _____________________________________.
5. “iPSCs” means induced pluripotent stem cells derived from non-embryonic cells but which are “reprogrammed” to assume an embryonic stem cell-like state, by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells.
6. “Progeny” means unmodified descendants from the Original Material.
7. “Unmodified Derivatives” means substances which constitute an unmodified functional subunit or product expressed by the Original Material.
8. “Non-Pluripotent Modifications” means cells created by Licensee which contain or incorporate the Materials or which are created through the use of the Materials, but only if such substances do not remain capable of self renewal in culture and cannot differentiate into various cell types from each of the three embryonic germ layers (endoderm, ectoderm, mesoderm).
9. “Pluripotent Modifications” means cells created by Licensee that contain or incorporate the Materials, but only if such substances are capable of self-renewal in culture and can differentiate into various cell types from each of the three embryonic germ layers (endoderm, ectoderm, mesoderm), including genetically modified and cloned cell lines.
10. “Modified Derivatives” means substances that are isolated or derived from Non-Pluripotent Modifications and Pluripotent Modifications by Licensee and that could not have been isolated or derived from Original Material or Progeny.
2. Licensee desires to obtain a license from PHS to use the Materials provided under this Agreement in its commercial research or product development and marketing activities. Licensee represents that it has the facilities, personnel, and expertise to use the Materials or the Licensed Products for commercial purposes and agrees to expend reasonable efforts and resources to develop the Materials or the Licensed Products for commercial use or commercial research.
3. PHS hereby grants to Licensee:
1. a worldwide, non-exclusive license to make, have made, and use the Materials or the Licensed Products; and
2. a worldwide, non-exclusive license to sell and have
4. In consideration of the grant in Paragraph 3, Licensee hereby agrees to make the following payments to PHS:
1. Within sixty (60) days of its execution of this Agreement, a noncreditable, nonrefundable license issue royalty of __________ dollars ($X).
2. A nonrefundable minimum annual royalty of _________ dollars ($X) which shall be due and payable on January 1 of each calendar year and may be credited against earned royalties for sales made in that year. The minimum annual royalty for the first calendar year of this Agreement is due and payable within sixty (60) days from the effective date of this Agreement and may be prorated according to the fraction of the calendar year remaining between the effective date of this Agreement and the next subsequent January 1.
3. An earned royalty of ______________ percent (X%) of Net Sales, which shall be due and payable within sixty (60) days of the end of each calendar year.
4. All payments required under this Agreement shall be paid in U.S. dollars and payment options are listed in Appendix C. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted in The Wall Street Journal on the day that the payment is due.
1. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Licensee; and
2. Additional royalties may be assessed by PHS on any payment that is more than ninety (90) days overdue at the rate of one percent (1%) per month. This one percent (1%) per month rate may be applied retroactively from the original due date until the date of receipt by PHS of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent PHS from exercising any other rights it may have as a consequence of the lateness of any payment.
5. Upon receipt by PHS of the license issue royalty and the prorated first year minimum annual royalty and verification of these royalties, PHS agrees to provide Licensee with samples of the Materials, as available, and to replace these Materials, as available, at reasonable cost, in the event of their unintentional destruction. PHS shall provide the Materials to Licensee at Licensee’s expense and as specified in Appendix A.
6. Licensee agrees to make written reports to PHS within sixty (60) days of December 31 for each calendar year. This report shall state: the number, description, and aggregate Net Sales of Licensed Products made, sold, or otherwise disposed of; the total gross income received by Licensee from leasing, renting, or otherwise making Licensed Products available to others without sale or other disposition transferring title, during the calendar year; and the resulting calculation of earned royalties due PHS pursuant to Paragraph 4(c) and as shown in the example in Appendix B. The report shall also include the name, address and contact information of the individuals and/or entities to which Licensee has made available the Materials and Licensed Products. Licensee shall submit each report to PHS at the Mailing Address for Agreement notices indicated on the Signature Page.
7. Licensee agrees to lease, sell, license, rent or make available the Materials or Licensed Products to third parties only after such third parties agree, in writing that:
1. the Materials or Licensed Products shall be used as research reagents only;
2. the Materials or Licensed Products shall be used in compliance with all applicable statutes, regulations, and guidelines, including PHS and HHS regulations and guidelines, or if the use is in a location outside of the United States, the use shall be in compliance with the applicable laws and regulations of that country;
3. the Materials or Licensed Products shall be used only in compliance with the most current U.S. National Institutes of Health guidelines on human stem cell research;
4. the Materials or Licensed Products shall not be used in research in which human iPS cells or derivatives thereof are introduced into non-human primate blastocysts;
5. no ownership rights to the Materials or Licensed Products, including to any of the Materials contained or incorporated in Non-Pluripotent Modifications or Pluripotent Modifications are conveyed;
6. not to identify or contact the donor subject from whom the Materials or the Licensed Products were derived;
7. notify PHS (at the address provided) of any transfer or distribution of the Materials or Licensed Products; and
8. not to use the Materials or the Licensed Products for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46.
8. Licensee agrees to supply the laboratory of Dr. _____________, at PHS, at no charge, reasonable quantities of the Licensed Products that Licensee makes, uses, sells, or offers for sale or otherwise makes available for public use. Licensee also agrees to supply, to the Mailing Address for Agreement notices indicated on the Signature Page, the Office of Technology Transfer, NIH with inert samples of the Licensed Products or their packaging for educational and display purposes only.
9. This Agreement shall become effective on the date when the last party to sign has executed this Agreement, unless the provisions of Paragraph 25 are not fulfilled, and shall expire __________________ (X) years from this effective date, unless previously terminated under the terms of Paragraphs 16 or 17.
10. As part of Licensee's performance under this Agreement, Licensee agrees to make the Licensed Products available to the public within ________ (X) months from the effective date of this Agreement.
11. Licensee agrees to retain control over the Materials and the Licensed Products, and not to distribute them to third parties without the prior written consent of PHS except as provided in Paragraph 3.
12. This Agreement does not preclude PHS from distributing the Materials or the Licensed Products to third parties for research or commercial purposes.
13. Licensee agrees not to identify or contact the donor subject from whom the Materials or the Licensed Products were derived.
14. By this Agreement, PHS grants no patent rights expressly or by implication to any anticipated or pending PHS patent applications or issued patents.
15. Exclusive of any PHS or any third-party rights therein, Licensee retains ownership of: (a) Non-Pluripotent Modifications, (b) Pluripotent Modifications, and (c) those substances created through the use of the Materials, Non-Pluripotent Modifications or Pluripotent Modifications of the Materials.
16. NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE MATERIALS PROVIDED TO LICENSEE UNDER THIS AGREEMENT, OR THAT THE MATERIALS OR THE LICENSED PRODUCTS MAY BE EXPLOITED WITHOUT INFRINGING THE PATENT RIGHTS OF ANY THIRD PARTIES. Licensee accepts license rights to the Materials and the Licensed Products “as is”, and PHS does not offer any guarantee of any kind.
17. Licensee agrees to indemnify and hold harmless the United States Government from any claims, costs, damages, or losses that may arise from or through Licensee's use of the Materials or the Licensed Products. Licensee further agrees that it shall not by its action bring the United States Government into any lawsuit involving the Materials or the Licensed Products.
18. Licensee may terminate this Agreement upon sixty (60) days written notice to PHS.
19. PHS may terminate this Agreement if Licensee is in default in the performance of any material obligation under this Agreement, and if the default has not been remedied within ninety (90) days after the date of written notice by PHS of the default.
20. Within thirty (30) days of the termination or expiration of this Agreement, Licensee agrees to return all Materials and the Licensed Products to PHS, or provide PHS with written certification of their destruction.
21. Within ninety (90) days of termination or expiration of this Agreement, Licensee agrees to submit a final report to PHS, and to submit to PHS payment of any royalties due. Licensee may not be granted additional PHS licenses if this final reporting requirement is not fulfilled.
22. Licensee is encouraged to publish the results of its research projects using the Materials or the Licensed Products. In all oral presentations or written publications concerning the Materials or the Licensed Products, Licensee shall acknowledge the contribution of Dr. ____________________ and the PHS agency supplying the Materials, unless requested otherwise by PHS or Dr. ________________________.
23. This Agreement shall be construed in accordance with U.S. Federal law, as interpreted and applied by the U.S. Federal courts in the District of Columbia. Federal law and regulations shall preempt any conflicting or inconsistent provisions in this Agreement. Licensee agrees to be subject to the jurisdiction of U.S. courts.
24. This Agreement constitutes the entire understanding of PHS and Licensee and supersedes all prior agreements and understandings with respect to the Materials or the Licensed Products.
25. The provisions of this Agreement are severable, and in the event that any provision of the Agreement shall be determined to be invalid or unenforceable under any controlling body of law, the invalidity or unenforceability of any provision of this Agreement, shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement.
26. Paragraphs 7, 13, 16, 17, 20, 21 and 22 of this Agreement shall survive termination or expiration of this Agreement.
27. The terms and conditions of this Agreement shall, at PHS’ sole option, be considered by PHS to be withdrawn from Licensee’s consideration and the terms and conditions of this Agreement, and the Agreement itself to be null and void, unless this Agreement is executed by the Licensee and a fully executed original is received by PHS within sixty (60) days from the date of PHS signature found at the Signature Page.

"PHS BIOLOGICAL MATERIALS LICENSE AGREEMENT

SIGNATURE PAGE

In Witness Whereof, the parties have executed this Agreement on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.

For PHS:

_________DRAFT__________________________

_____________
Date

Richard U. Rodriguez
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mail.nih.gov For Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.):

by:

___________________        DRAFT ______________
Signature of Authorized Official

_____________________

Date

___________________________________

Printed Name

___________________________________

Title

1. Official and Mailing Address for Agreement notices:

Name

Title

Mailing Address

Email Address:

Phone:

Fax:

2. Official and Mailing Address for Financial notices (Licensee’s contact person for royalty payments)

Name

Title

Mailing Address:

Email Address:

Phone:

Fax:

Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) and/or imprisonment)
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APPENDIX A – SHIPPING INFORMATION

Licensee’s Shipping Contact: information or questions regarding shipping should be directed to Licensee’s Shipping Contact at:

Shipping Contact’s Name Title

Phone: () Fax: () E-mail:

Shipping Address: Name & Address to which Materials should be shipped (please be specific):

Company Name & Department

Address:

Licensee’s shipping carrier and account number to be used for shipping purposes:
__________________________________________________________________