INITIAL DRUG PRODUCT Sample Clauses

INITIAL DRUG PRODUCT. Using the initial drug substance provided by Schering pursuant to Section 4.4 above, Schering or a Schering Affiliate will also supply BioMedicines, as and when reasonably requested by BioMedicines and where amounts and timing are agreed upon in the JDC but subject always to a notice period of at least 6 months, with tested, released and packaged one hundred (100) mg [*] produced in accordance with the current manufacturing process in use at the Effective Date at Schering. If Schering or a Schering Affiliate is unable or unwilling to produce such Initial Drug Product, Schering may sub-contract the production of such Initial Drug Product to a third party subject to the consent of BioMedicines such consent not to be unreasonably withheld. {In this case, "100 mg" is understood to be the amount of active Atamestane drug substance in the [*] exclusive of excipients.} In the event that Schering is manufacturing initial drug product, costs for manufacturing these [*] from drug substance will be the Actual Manufacturing Costs to Schering and will be paid by BioMedicines in accordance with Section 4.7 below Such costs are subject to verification according to the principles of Section 8.10 of this Agreement. In the event that Schering does not, within the notice period referred to in the preceding paragraph, elect to manufacture or have manufactured the initial drug product required by BioMedicines, BioMedicines may obtain such initial drug product from a third party subject to Schering's consent, such consent not to be unreasonably withheld. In the event that such a third party is manufacturing initial drug product for BioMedicines, the terms of the agreement governing the third party activities will be the subject of joint approval by Schering and BioMedicines. The costs related to said jointly approved third party sub-contractor activities will be paid by BioMedicines and will be included in CMC Costs. Schering and BioMedicines also agree that periodic on-site monitoring of the activities of the third party sub-contractor by BioMedicines or a designated BioMedicines representative (with or without a Schering representative at the discretion of Schering) will be accommodated in all instances.
Sample 1
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Related to INITIAL DRUG 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.

  • 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.

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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