LICENSE AND CLINICAL TRIALS AGREEMENT
Agreement (“AGREEMENT”), effective as of February 27, 1995 (“Effective Date”) between VIRUS RESEARCH INSTITUTE, INC., a Delaware corporation, with its principal place of business at 61 Moulton Street, Cambridge, Massachusetts 02138 (hereinafter referred to as “VRI”) and the JAMES N. GAMBLE INSTITUTE OF MEDICAL RESEARCH, an Ohio non-profit corporation, with its principal place of business at 2141 Auburn Avenue, Cincinnati, Ohio 45219 (hereinafter referred to as “GAMBLE”).
WHEREAS, GAMBLE is the owner of certain rights in technology as defined herein; and
WHEREAS, GAMBLE desires to have such rights utilized to promote the public interest by granting a license thereunder;
WHEREAS, VRI is engaged in the development, production, marketing and sale of products similar to the technology which is the subject of this AGREEMENT and has the strategic commitment to facilitate the transfer of such technology for the public interest; and
WHEREAS, VRI desires to obtain a license to said rights upon the terms and conditions hereinafter set forth;
WHEREAS, VRI desires to utilize GAMBLE’s services with respect to the conduct of certain of the clinical trials and laboratory services needed to obtain FDA approval for GAMBLE’S rotavirus vaccines.
NOW THEREFORE, in consideration of the mutual covenants herein contained and intending to be legally bound hereby, the parties hereto agree as follows:
1.1 “Invention(s)” shall mean rotavirus vaccines, developed from rotavirus strain 89-12, including that which was safety tested by Lou Potash, Ph.D. of PRI/DynCorp for GAMBLE and received by GAMBLE on 12/2/93 or modification of rotavirus strain 89-12 generated by natural or site-directed mutagenesis, that stimulate neutralizing antibody to multiple serotypes of human rotavirus, and methods for vaccinating humans against rotavirus illness caused by rotaviruses of different serotypes using rotavirus strain 89-12 and for expanding the titers and memory of the cells that express the pre-existing neutralizing antibodies induced following primary vaccination against rotavirus disease using solely rotavirus strain 89-12. The Invention(s) include inactivated vaccines using rotavirus strain 89-12.
1.2 “Technical Information” shall mean vaccine production information and the results of the safety and identity testing conducted by Lou Potash, Ph.D., of PRI/DynCorp and received by GAMBLE on 12/2/93 and information regarding the history, culture, adaptation and attenuation of rotavirus strain 89-12; and scientific, technical and medical information related to 89-12, generated by or on behalf of GAMBLE or obtained from Dr. Potash as part of the quality assurance process during the term of this AGREEMENT.
1.3 “Patent Rights” shall mean any current or future United States or foreign patent applications which are set forth in Appendix A attached hereto and arising from Inventions owned by or assigned to GAMBLE, together with any divisions and continuations (related to rotavirus strain 89-12) continuations-in-part (related solely to rotavirus strain 89-12 and improvements thereto), patents issuing thereon and reissues thereof and extensions thereof; provided that in the case of future patent applications and patents, inclusion in Patent Rights shall be subject to reimbursement by VRI to GAMBLE of the cost of Research and Development with respect thereto. Nothing in this Agreement gives VRI rights to Improvements in a vaccine which does not employ rotavirus strain 89-12.
1.4 “Licensed Products” shall mean any product which is covered in whole or in part by a Valid Claim in the Patent Rights and/or which incorporates or utilizes to a significant degree Technical Information.
1.5 “Licensed Process” shall mean any process which is covered in whole or in part by a Valid Claim in the Patent Rights and/or which incorporates or utilizes to a significant degree Technical Information.
1.6 “Territory” shall mean the entire world.
1.7 “Net Sales” shall mean the gross revenue received by VRI, its Affiliates from the sales of Licensed Products or Licensed Processes to independent third parties less:
(a) Transportation charges or allowances separately stated and invoiced;
(b) Trade, quantity, cash, rebates or other allowances and discounts and brokers’, distributors’, or agents’ commissions actually allowed and taken;