Exhibit 10.1
PUBLIC HEALTH SERVICE
COMMERCIAL EVALUATION LICENSE AGREEMENT
ThisAgreement is entered into between the National Institutes of Health ("NIH"), the Centers for Disease Control and Prevention ("CDC"), 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 ("DHHS") through the Office of Technology Transfer, National Institutes of Health, having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, U.S.A. and U.S. Biodefense, Inc. ("Licensee"), a corporation of Utah, having an office at 13674 East Valley Blvd., City of Industry, CA 91746.
1.
Definitions:
a.
"Licensed Patent Rights" means PCT or U.S. patent application(s) (including provisional patent application(s)) and/or patents and all foreign counterparts as follows: U.S. Patent Application Serial No./U.S. Provisional Patent Application Serial No. 60/555,268 filed March 22, 2004 entitled “Cellular and Viral Inactivation”.
b.
"Licensed Products" meanstangible materials which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of theLicensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
c.
“Licensed Processes” meansprocesses which, in the course of being practiced would be within the scope of one or more claims of theLicensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
2.
Licensee wishes to obtain a license to evaluate the commercial applications of theLicensed Products andLicensed Processesand any inventions claimed in theLicensed Patent Rights.
3.
Licensee intends to conduct laboratory experiments under thisAgreement to evaluate the suitability for commercial development of inventions encompassed by theLicensed Patent Rights and theLicensed Products andLicensed Processesin theField(s) of Use of ________________________.
4.
Licensee represents that it has the facilities, personnel, and expertise to evaluate the commercial applications of theLicensed Products,Licensed Processes, and the inventions encompassed by theLicensed Patent Rights, and that it will expend reasonable efforts and resources on research and development of potential commercial products using theLicensed Products,Licensed Processes, and the inventions encompassed by theLicensed Patent Rights.
5.
PHS hereby grants toLicensee a nonexclusive license for evaluation purposes to make and usebut not to sell theLicensed Products andLicensed Processesand products and processes encompassed within the scope of a claim in theLicensed Patent Rights. Licensee agrees that any commercial or industrial use or sale of any such products or processes, including any formalized in-house screening programs, other than for evaluation purposes, will be made only pursuant to the terms of a commercialization license to be negotiated in good faith by the parties. The rights provided herein are provided for theevaluation of commercial applications only and not for commercial use.
6.
Licensee agrees to retain control over theLicensed Products andLicensed Processes, and not to distribute them to third parties without the prior written consent ofPHS.
7.
Licensee agrees that thisAgreement does not precludePHS from distributing theLicensed Products andLicensed Processesto third parties for research or commercial purposes.
8.
In consideration of the grant in Paragraph 5,Licensee hereby agrees to payPHS a royalty in the sum of U.S. $3,500 (Three Thousand Five Hundred Dollars). Payment is due within thirty (30) days ofLicensee's execution of thisAgreement. This royalty shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New York foreign exchange rate quoted inThe Wall Street Journal on the day that the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable, as appropriate, to "NIH/Patent Licensing." All such payments shall be sent to the following address: NIH, P.O. Box 360120, Pittsburgh, PA 15251-6120. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dol lars shall be paid entirely byLicensee. Interest and penalties may be assessed byPHS on any overdue payments in accordance with the Federal Debt Collection Act. The payment of such late charges shall not preventPHS from exercising any other rights it may have as a consequence of the lateness of any payment.
9.
ThisAgreement shall become effective on the date when the last party to sign has executed thisAgreement and shall expire six (6) months from its effective date. Upon termination or expiration of thisAgreement,Licensee shall return allLicensed Products toPHS or providePHS with certification of their destruction, unlessLicensee has executed a commercialization license for theLicensed Patent Rights.
10.
In the event thatLicensee is in default in the performance of any material obligation under thisAgreement, and if the default has not been remedied within ninety (90) days after the date of written notice of such default,PHS may terminate thisAgreement by written notice.
11.
Licensee acknowledges that third parties also may be evaluating theLicensed Patent Rights, theLicensed Products, or theLicensed Processes for a variety of commercial purposes, and no guarantee can be made, shouldLicensee apply for a license, that such a license would be available for any particular field of use. PHS agrees to notifyLicensee promptly if it receives from another company an exclusive license application in theField(s) of Use described in Paragraph 3.
12.
Licensee is encouraged to publish the results of its research projects using theLicensed Products or theLicensed Processes. In all oral presentations or written publications concerning theLicensed Products or theLicensed Processes,Licensee will acknowledge the contribution by the named inventors to theLicensed Products or theLicensed Processes, unless requested otherwise byPHS or the named inventors.
13.
Licensee agrees to submit in confidence a final report toPHS within thirty (30) days of termination or expiration of thisAgreement outlining in general its results of commercial evaluation of theLicensed Patent Rights, theLicensed Products, and theLicensed Processes provided by thisAgreement.
14.
PHS agrees, to the extent permitted by law, to treat in confidence for a period of three (3) years from the date of disclosure any ofLicensee's written information about theLicensed Patent Rights, theLicensed Products, or theLicensed Processes that is stamped "CONFIDENTIAL" except for information that was previously known toPHS, or that is or becomes publicly available, or that is disclosed toPHS by a third party without an obligation of confidentiality.
15.
NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE FITNESS FOR ANY PURPOSE OF THELICENSED PROCESSES ORLICENSED PRODUCTS PROVIDED TOLICENSEE UNDER THISAGREEMENT, OR THAT THELICENSED PATENT RIGHTS MAY BE EXPLOITED WITHOUT INFRINGING OTHER PATENT RIGHTS. LICENSEE accepts license rights to theLicensed Patent Rights, theLicensed Products, and theLicensed Processes "as is", andPHS does not offer any guarantee of any kind.
16.
Licensee agrees to indemnify and hold harmlessPHS and the Government of the United States of America from any claims, costs, damages, or losses that may arise from the practice of theLicensed Patent Rights or through the use of theLicensed Products or theLicensed Processes.
17.
Neither party shall have any obligation to take any action with regard to an infringement ofLicensed Patent Rights by a third party.
18.
Licensee agrees in its use of anyPHS-supplied materials to comply with all applicable statutes, regulations, and guidelines, includingPHS andDHHS regulations and guidelines. Licensee agrees not to use theLicensed Processes or theLicensed Products for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. Licensee agrees not to use theLicensed Processes orLicensed Products for research involving human subjects or clinical trials outside of the United States without notifyingPHS, in writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification toPHS of research involving human subjects or clinical trials outside of the Un ited States shall be given no later than sixty (60) days prior to commencement of such research or trials.
19.
ThisAgreement 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 will preempt any conflicting or inconsistent provisions in thisAgreement. Licensee agrees to be subject to the jurisdiction of U.S. courts.
20.
ThisAgreement constitutes the entire understanding ofPHS andLicensee and supersedes all prior agreements and understandings with respect to theLicensed Patent Rights, theLicensed Products, and theLicensed Processes.
21.
The provisions of thisAgreement are severable, and in the event that any provision of thisAgreement shall be determined to be invalid or unenforceable under any controlling body of law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions of thisAgreement.
22.
Paragraphs 12, 14, 15, and 16 of thisAgreement shall survive termination of thisAgreement.
SIGNATURES BEGIN ON NEXT PAGE
PHS COMMERCIAL EVALUATION LICENSE AGREEMENT
SIGNATURE PAGE
In Witness Whereof, the parties have executed thisAgreement on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.
ForPHS:
_____________________________________________
_______________
Steven M. Ferguson
Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.
ForLicensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements ofLicensee made or referred to in this document are truthful and accurate.):
by:
_____________________________________________
_______________
Signature of Authorized Official
Date
_____________________________________________
Printed Name
_____________________________________________
Title
Official and Mailing Address for Notices:
_____________________________________________
_____________________________________________
_____________________________________________
Any false or misleading statements made, presented, or submitted to theGovernment, including any relevant omissions, under thisAgreement and during the course of negotiation of thisAgreement 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).
