Generic License for Gilead Global Access Program. JT has provided consents to Gilead entering into Generic Licenses with Generic Licensees under the Gilead Global Access Program in accordance with the terms and conditions set forth in Schedule 6.2.
Generic License for Gilead Global Access Program Sample Clauses
Related to Generic License for Gilead Global Access Program
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
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.
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.
Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:
Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
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.
Research License Following Selection of each CGI Antigen (or exercise of a Buy-In Right for each CGI Antigen) and subject to the terms and conditions of this Agreement, ABX agrees to grant, and hereby grants, to CGI a nonexclusive sublicense under the Licensed Technology to develop, make, have made, use, import or export or otherwise transfer physical possession of (but not to sell, lease, offer to sell or lease, or otherwise transfer title to) Covered Products related to such CGI Antigen and cells that express or secrete Antibodies to such CGI Antigen, in each case solely for purposes relating to or in connection with research or development (i) of Covered Products for use in the field of Gene Therapy or (ii) involving Genetic Material when used with viral or nonviral gene transfer systems. CGI shall have the right to sublicense the rights granted under this Section 2.5 upon the approval of ABX, which approval shall not be unreasonably withheld. In the event that ABX refuses to approve such a sublicense, ABX shall, to the extent that ABX has the right to do so, grant at CGI's request a nonexclusive sublicense of such rights directly to a non-Affiliate third party designated by CGI on terms and conditions substantially identical to the applicable terms and conditions of this Agreement. The sublicense granted by ABX under this Section 2.5 with respect to a CGI Antigen (and the further sublicenses, if any, granted by CGI under this Section 2.5 with respect to such CGI Antigen) shall terminate at such time as (A) CGI sends ABX an Abandonment Notice pursuant to Section 2.4.1 above regarding such CGI Antigen or (B) CGI enters into a CGI Product Sublicense related to such CGI Antigen; provided, however, that termination of a sublicense under this Section 2.5 with respect to a CGI Antigen pursuant to (B) above shall not affect the duration or survival of a grant of similar rights or sublicense under the CGI Product Sublicense with respect to such CGI Antigen, which rights or sublicense shall terminate or expire only in accordance with the terms of such CGI Product Sublicense. In the event that ABX enters into a Product Sublicense with respect to a CGI Antigen and CGI has not within six (6) months thereafter entered into a CGI Product Sublicense with respect to such CGI Antigen, the sublicense granted under this Section 2.5 with respect to such CGI Antigen shall terminate. It is understood and agreed that (x) as to ABX-Controlled Rights, the grant of rights under this Section 2.5 shall be subject to and limited in all respects by the terms of the applicable ABX In-License(s) pursuant to which such ABX-Controlled Rights were granted to ABX and (y) the rights and sublicenses granted to CGI under this Section 2.5 or any other provision of this Agreement shall be subject in all respects to the GenPharm Cross License.
Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:
For clarity Research Tools are subject to the license grants in Sections 2.1-2.3, Section 2.8, the retained rights set forth in Sections 2.9, and the due diligence requirements in Section 6.
