XLRS Product Sample Clauses

XLRS Product. (a) AGTC will initially own all INDs and Orphan Drug Designations and related documentation submitted to any Regulatory Authorities anywhere in the Territory with respect to the XLRS Product, and the Marketing Application, related documentation and initial Regulatory Approval in the United States with respect to the XLRS Product, subject to Section 3.1.3. AGTC will be primarily responsible, in consultation with Biogen, for (a) all regulatory matters and interactions with Regulatory Authorities relating to the conduct of Clinical Trials for the XLRS Product worldwide including (i) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect to the conduct of Clinical Trials for the XLRS Product; (ii) interfacing, corresponding and meeting with Regulatory Authorities with respect to the conduct of Clinical Trials for the XLRS Product; (iii) submitting and maintaining all regulatory filings with respect to Clinical Trials for the XLRS Product, other than any Marketing Applications, and (iv) maintaining and submitting all records required to be maintained or required to be submitted to any Regulatory Authority with respect to Clinical Trials for the XLRS Product and (b) all other regulatory matters in the United States through Regulatory Approval of the XLRS Product, including (i) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the FDA with respect to marketing authorization for the XLRS Product; (ii) interfacing, corresponding and meeting with the FDA with respect to the XLRS Product; (iii) submitting and maintaining all regulatory filings with respect to the XLRS Product in the United States; and (iv) maintaining and submitting all records required to be maintained or required to be submitted to the FDA with respect to the XLRS Product, provided that Biogen will have final decision-making authority with respect to any decisions regarding the BLA for the XLRS Product, the content of the label for the XLRS Product or post-marketing commitments with respect to the XLRS Product, subject to Section 2.1.4(a)(v) or Section 2.1.4(b)(ii), as applicable.
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Related to XLRS Product

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Combination Product The term “

  • Product The term “

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

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