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, [***] Licensed Products in tablets, and [***] Licensed Products in tablets as being on the effective date of the Agreement and any other tableted formulations as may be available at closing and as requested by Licensee, (ii) include customary representations and warranties and indemnifications, and (iii) guarantee all of the API provided are GMP compliant and fully qualified and sufficient for use in an FDA monitored study to prove safety and efficacy in Licensee’s target species. Initially, Licensee will order [***] of API, [***] Licensed Product tablets, [***] Licensed Product tablets and any other tableted formulations as may be available on the effective date of the Agreement 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.
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. 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. Intercept shall, by itself or through its Third Party contract manufacturers, supply to DSP (or its Affiliates, sublicensees or sub-contractors) all quantities of Clinical Supplies of the Product (packaged or prepackaged) required by DSP to Develop the Product in the Field in the Territory and for quality control analysis. The Parties shall discuss in good faith and cooperate with each other with respect to the negotiation of a manufacturing and clinical supply agreement (the “Clinical Supply Agreement”) governing the supply of Clinical Supplies of the Product (packaged or pre-packaged). Intercept undertakes to improve quality assurance system and /or organization to supply DSP (or its Affiliates, sublicensees or sub-contractors) with Clinical Supply, including permitting and causing any of its Third Party sub-contractors to permit, an audit by DSP for quality assurance purposes. The Clinical Supply Agreement shall include, among other customary provisions, the following or substantially equivalent provisions:
Clinical Supply. ARES TRADING shall be responsible for manufacturing and supplying Products for Development use after Phase 1 Clinical Trial in the Field in the Territory, provided that ARES TRADING may request Intrexon to conduct such manufacture and supply at least 18 months prior to the anticipated initiation of the first Phase 2 Clinical Trial for the first Indication with respect to a Product. If ARES TRADING notifies Intrexon in writing of its desire to consider Intrexon for manufacture and supply of such Product for clinical use ARES TRADING and Intrexon shall negotiate in good faith the terms thereof. Upon ARES TRADING’s and Intrexon’s agreement, the Parties shall enter into a separate supply agreement containing such mutually agreed terms with respect to such clinical supply (each, a “Clinical Supply Agreement”).
Clinical Supply. All Licensed Vaccines required for use by BI in accordance with this Agreement for the Non-clinical and Clinical Development of the Licensed Vaccines up to and including Phase II Clinical Trials shall be Manufactured by CureVac in accordance with Applicable Laws and the terms and conditions of the Clinical Supply Agreement attached hereto as Exhibit 6.1 ("Clinical Supply Agreement").
Clinical Supply. Except as has not had and would not reasonably expected to have, individually or in the aggregate, a Material Adverse Effect, (a) each Acquired Company has good and marketable title to its inventory of clinical drug product for its clinical trial of its product candidate VTS-270 that is currently being conducted free and clear of all Encumbrances (other than Permitted Encumbrances) and (b) no Acquired Company has received written notice from the party conducting the clinical trial of product candidate CPP-1X that there is an inadequate supply of the clinical drug product for such clinical trial.