Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Sample Clauses

Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Laboratory activities involving recombinant or synthetic nucleic acid molecules research are defined by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, “NIH Guidelines”. Each Recipient and any Recipient institution shall conduct all such work in compliance with the NIH Guidelines. In addition to the documentation referenced above, each facility conducting research activities involving recombinant or synthetic nucleic acid molecules under this Award must submit copies of the following documentation to the CAPO for review prior to the initiation of such activities: a. Institutional Biosafety Committee (IBC) Charter, and/or other available documentation of IBC policies and procedures; b. Most recent Office of Biotechnology Activities (OBA) acknowledgement letter of the annual IBC Report; c. IBC-approved recombinant or synthetic nucleic acid molecules research protocol(s); and d. Documentation of final IBC approval for each recombinant or synthetic nucleic acid molecules research protocol and all subsequent renewals and amendments as they occur
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Related to Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

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  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

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