Warner-LeukoSite Product Sample Clauses

Warner-LeukoSite Product. For each Warner-LeukoSite Product, pre-clinical and clinical Development thereof will be pursued jointly under the direction of the Development Committee to the extent necessary or desirable for regulatory approval in each Designated Co-Promotion Country. The preparation, filing and prosecution of Investigational New Drug Applications, New Drug Applications and other regulatory filings required to be filed with the * Confidential treatment requested: material has been omitted and filed separately with the Commission. 20 20 FDA and its foreign equivalents in regard to any Warner-LeukoSite Product will be in the name of and at the responsibility of Warner, subject, in the case of Designated Co-Promotion Countries, to the advice of LeukoSite. The costs incurred by Warner or LeukoSite (and approved by the Development Committee) in the preparation, filing and submission of such regulatory filings in Designated Co-Promotion Countries and all costs of Development related to regulatory approvals in such countries (not including the costs of Pharmacoeconomic Studies incurred after initiation of the Term of Co-Promotion, Phase IV Studies, Phase V Studies or any other clinical studies not reasonably necessary for authorization by relevant regulatory authorities to sell such Product for its first approved indication in each country), will be borne *** by Warner and *** by LeukoSite (whether incurred by Warner or LeukoSite), retroactive to the date the Warner-LeukoSite Product was designated a Development Candidate. LeukoSite within its sole discretion at the time of designation of a Development Candidate as a Warner-LeukoSite Product may elect to pay less than ***************** of such costs of Development but in no event less than ********************* thereof. LeukoSite may not thereafter change the percentage of Development costs borne by it without Warner's consent. Neither party warrants that any regulatory filings will actually be filed or, if filed, will be approved. All such costs shall be paid/reimbursed on a current basis. Cost of Development shall mean the following insofar as they are reasonably charged directly to Development of the Product: salaries, fringe benefits, overtime, chemicals, lab supplies, animals and other direct charges, all at actual cost plus an overhead allocation of 25% (cost X 1.25). In addition, costs of Development will also include actual costs for travel (other than costs relating to committee meetings referred to in Section 2.5), ...
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Warner-LeukoSite Product. For each Warner-LeukoSite Product, Development thereof will be, pursued under the direction of the Development Committee to the extent necessary or desirable for regulatory approval. The preparation, filing and prosecution of Investigational New Drug Applications, New Drug Applications and other regulatory filings required to be filed with the FDA and its foreign equivalents in regard to any Warner-LeukoSite Product will be in the name of and at the responsibility of Warner, subject to the advice of LeukoSite. The costs incurred by Warner (and approved by the Development Committee) in the preparation, filing and submission of such regulatory filings in the Territory and all Development Costs related to regulatory approvals in such countries (not including the costs of clinical studies not reasonably necessary for authorization by relevant regulatory authorities to sell such Warner-LeukoSite Product for its first approved indication in each country), will be borne *** by Warner and *** by LeukoSite, retroactive to the date the Warner-LeukoSite Product was

Related to Warner-LeukoSite Product

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

  • Existing Products Except as set forth below, Contractor shall retain all rights, title and interest in Existing Products.

  • 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.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • SINGLE-USE PRODUCTS The Board of County Commissioners has established a single-use products and plastic bags policy intended to reduce the use of products which have become globally recognized as having lasting negative impacts on the environment. Neither single-use products nor plastic bags may be sold or disbursed on County property by staff or contracted vendors, except as set forth in Orange County Administrative Regulation 9.01.03. Failure to comply with the Regulation may result in termination of the contract or other contractual remedies, and may affect future contracting with the County. The use of reusable, recyclable, biodegradable, or compostable materials is encouraged.

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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.

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

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