Clinical Supply Sample Clauses

Clinical Supply. Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).
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Clinical Supply. ZOGENIX shall be the exclusive supplier of all of DESITIN’s requirements for Clinical Trial Materials in the Territory at ZOGENIX’s Cost of Goods Manufactured. DESITIN shall purchase all of its requirements of Clinical Trial Materials in the Territory from ZOGENIX. Additional terms under which ZOGENIX shall supply Clinical Trial Materials in the Territory are set forth on Appendix 3. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Clinical Supply. (i) Any costs and expenses incurred by either Party in carrying out the Manufacturing of Clinical Supply Requirements for the first Phase I Clinical Trial of any Product shall be borne solely by Sanofi-Aventis, including expenses for Exelixis’ transfer to Sanofi-Aventis of any Product (or related active pharmaceutical ingredients) that may exist prior to the Transfer Date and that was Manufactured for use in the Development of such Product.
Clinical Supply. Immediately upon termination of this Agreement, Brii Bio shall, at its own cost, return to VBI any unused Licensed Product supplied by VBI for use in Clinical Trials hereunder.
Clinical Supply. Each Manufacturing Party shall Manufacture a clinical supply of bulk or finished Collaboration Products pursuant to a plan and on terms set by the Manufacturing Party, as approved by the JSC (a “Supply Plan”). Notwithstanding the aforementioned, [****] shall ensure a supply of [****] necessary to complete dosing in the [****] as of the Effective Date, provided that such supply shall be not less than [****]. *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions.
Clinical Supply. Eagle shall use Commercial Reasonable Efforts to Manufacture or cause to be Manufactured all Clinical Supplies of the Existing Product and the Next Products for the Development Program, including the completion of pre-clinical work and human clinical trials. Eagle shall not supply the Products to any Person, other than MDCO or its designee, for use or Exploitation in the Territory.
Clinical Supply. Unless Arena terminates this Agreement pursuant to Section 12.2(a)(ii), 12.2(a)(iii) or 12.6, Arena shall reimburse Eisai for the amount paid by Eisai to Arena pursuant to Section 3.6 with respect to any remaining clinical supply of Products, to the extent such remaining clinical supply is still usable by Arena over the six-month period after such termination. Upon termination for any reason, if any such clinical supply of Products is in Eisai’s or any of its Affiliates’ possession, at Arena’s request and expense of transportation, Eisai shall return such clinical supply of Products to Arena.
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Clinical Supply. The Company or its Subsidiaries have good and marketable title to its clinical supply free and clear of all Liens (other than Permitted Liens).Such clinical supply has been manufactured in accordance with the specifications therefor as set forth in the applicable manufacturing documentation, the applicable Permit and other Laws. The clinical supply has been properly stored in accordance with the relevant specifications.
Clinical Supply. Within [***] following the Effective Date, the Parties shall enter into an agreement for clinical supply, as required to ensure the Clinical Trials planned can proceed on the timelines set forth in the binding parts of the Research and Development Plan. All clinical supply of Candidates and Products shall be charged at the Manufacturing Costs. In addition, the Parties will negotiate in good faith and mutually agree on a Quality Agreement with respect to such clinical supply agreement.
Clinical Supply. Inovio will provide Delivery Devices and VGX-3100 at Inovio's actual out-of-pocket cost, including reimbursement for out-of-pocket shipping costs, for Delivery Devices and VGX-3100 manufactured by any Third Party and, if manufactured by Inovio, Inovio’s fully burdened manufacturing cost (to be calculated in accordance with U.S. generally accepted accounting principles, consistently applied by Inovio) to support preclinical development and clinical studies in the Territory. Upon Apollo’s reasonable request, the Parties agree to negotiate in good faith the terms and conditions of a supply of Delivery Devices and/or VGX-3100 manufactured by or on behalf of Inovio (the “Clinical Supply Agreement”).
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