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).
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. Licensor and Licensee will use good faith to negotiate and enter into a non-exclusive clinical supply agreement for the API and Licensed Products for clinical use (the “Clinical Supply Agreement”) within [***] days of the Effective Date. The Clinical Supply Agreement shall, at a minimum, (i) provide for the supply of API as being on the effective date of the Agreement, and (ii) include customary representations and warranties and indemnifications. Initially, Licensee will order [***] of API without any compensation to Licensor. For future clinical supplies, if Licensor or any of its other licensees is using a third party manufacturer for API or Licensed Product tablets, Licensor shall allow Licensee to get supply of such API or tablets for Licensee from such third party manufacturer, including at any prices negotiated by Licensor. The Clinical Supply Agreement will contemplate a price of API and/or tablets which shall be no greater than Licensor’s cost of manufacturing such API or tablets. However, the cost for the required analytical works and the Licensor’s cost of handling solely for Licensee shall be charged to Licensee. [***] 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.||
Clinical Supply. Within the JSC the Parties shall decide whether CureVac should ensure Manufacture and supply to GSK of doses of Products required for use by GSK in accordance with this Agreement for the Clinical Studies or whether GSK in lieu of CureVac should Manufacture clinical materials on its own following a transfer of the CureVac Manufacturing Technology, or whether and how the Manufacturing capability of both Parties should be combined, such decision to be based on the respective Manufacturing capacities available as declared by the respective Party, the context of the respective clinical trial material portfolios and batches across all projects, and to be aligned with the Parties’ intention to ensure the Manufacture of Drug Product conforming to the required quality standards, the agreed specifications and the estimated timelines for Development of Products defined in the R&D Plans, and that supports the competitiveness of the Products. Where the Product for use in Clinical Studies is Manufactured by CureVac, its Affiliates and/or any CMO appointed by CureVac, one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) will be negotiated and agreed between GSK and either or both CureVac, the CureVac Affiliate and/or CMO supplying the Products to GSK, and in accordance with the terms and conditions set forth in Exhibit 5.3(A) PART 2 ("Clinical Supply Agreement"). To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s). In the event of a transfer of the CureVac Manufacturing Technology for clinical supply under this Section 5.3 (excluding the transfer to [*****]), such transfer shall only be made to GSK, and only to one site at GSK designated by GSK and approved by CureVac (which approval is hereby already given if GSK designates its vaccines manufacturing site in Wavre / Rixensart, Belgium), and GSK shall have no right to subsequently transfer the CureVac Manufacturing Technology to another GSK site or a Third Party without the prior written consent of CureVac. Unless otherwise provided herein, Section 5.5 below shall apply mutatis mutandis. The Parties acknowledge and agree that GSK has designated and CureVac has approved [*****] as a CMO of GSK for Manufacture and supply of doses of Products for Clini...
Clinical Supply medac agrees to provide ERYtech Pharma with Product from the same batch if possible for each clinical trial.
Clinical Supply. The price for supply will be: Pilot scale: [***] € [***] / vial Norm scale: Approximately € [***] / vial, whereby the final price will be determined by the Parties in good faith once the development of the norm scale process is finalised, however no later than [***] (hereinafter referred to as “Norm scale price”). This is the price for clinical trial purposes only. At the request of medac the Norm scale price could be rediscussed between the Parties [***] following the final determination of the Norm scale price. If justified by industrial cost increases it could be revised and increased up to a maximum of [***]. This price will remain for the next [***]. At the end of this period ([***] from date of signature of the Agreement) a new discussion between the parties will redefined the new Norm scale price for the next [***]. medac shall inform ERYtech Pharma about the change from Pilot Scale into Norm Scale [***] in advance.
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. (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.
