Supply of Compounds. From time to time during the term of this Agreement or upon the reasonable request of Radius, Ipsen shall supply Radius with reasonable quantities of compounds generated or formulated by Ipsen in the course of performing its research tasks and activities under the Work Plan for purposes of enabling Radius to test such compounds and the formulation thereof and for purposes of allowing Radius to assess the extent to which such compounds meet the specifications for a New Formulation Licensed Product. The supply of New Formulation Licensed Product by Ipsen to Radius for use in phase II clinical trials will be managed under the terms agreed in Appendix D of the License Agreement dated September 27 2005 “Clinical Supply and Technical Transfer Agreement BIM 44058 injection clinical supplies and technology transfer” (hereinafter the “Clinical Supply Agreement”). All terms of such Clinical Supply Agreement apply to the supply by Ipsen to Radius of New Formulation Licensed Product for phase II clinical trials to the exception of the Technical Specifications, Manufacturing and Analytical Procedure and Safety Agreement and the price for the clinical supplies and work associated and quantities of clinical batches. For the New Formulation Licensed Product for phase II clinical trials the following will apply: The relevant Technical Specifications will be set by the Joint Steering Committee; the price for the clinical supplies of New Formulation Licensed Product for phase II clinical trials and work associated * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. and quantities of clinical batches of New Formulation Licensed Product for phase II clinical trials will be as provided in the Work Plan, as amended from time to time; the Manufacturing and Analytical Procedure and the Safety Agreement applicable to New Formulation Licensed Product for phase II clinical trials will be mutually agreed by the Parties. Under the Clinical Supply Agreement, Ipsen will manufacture or have manufactured and tested the bulk product and devices applicable to the New Formulation Licensed Product for phase II clinical trials, and will provide the analytical control data, with suitable documentation from contract manufacturing company, and Radius will complete final clinical packaging/labeling, and final Quality Assurance release of the clinical supplies of New Formulation Licensed Product for phase II clinical trials.
Supply of Compounds. 3.3.1. Upon request of ENS, ROCHE shall supply to ENS existing reference sample of Compounds for research purposes only at the following prices: **** 20 g - 1000 CHF pro g (note: quantities of Compounds for development purposes cost 40 CHF pro g) **** 20 g - 2.000 CHF pro g **** 0.5 g - 2.000 CHF pro g **** 50 g -2.000 CHF pro g **** 20 g - 2.000 CHF pro g **** 1 g - 5.000 CHF pro g **** 61 g (pre-step for XX0000000) - 1.000 CHF pro g
Supply of Compounds. 3.3.1. Upon request of EVOTEC by December 31, 2006, ROCHE shall supply to EVOTEC free of charge, to the extent available and existing, up to 5 gr reference sample of Compounds for research purposes. * Portions of this document marked with **** have been omitted pursuant to a request for confidential treatment submitted with the SEC.
Supply of Compounds. 15 7. MARKETING, SALE AND DISTRIBUTION OF DIAGNOSTIC..........................................................15 8. MARKETING/TRADE DRESS...................................................................................17 9.
Supply of Compounds. 6.1 Biota agrees to sell and BioStar agrees to exclusively purchase from Biota such quantity of Compounds as may be required by BioStar for the purposes of manufacturing the Diagnostic under clause 5.2. Biota must use all reasonable commercial efforts to produce any Compounds used in the Diagnostic as efficiently and at as low a cost as possible consistent with good manufacturing practice and other applicable regulations.
Supply of Compounds. MIP shall have manufactured Compounds during the period that FRI requires MIP to supply Compounds to FRI. The terms and conditions of supply shall apply as well:
Supply of Compounds. The source of the Compounds to be provided by the Parties during the Term may change. In such event, the supplying Party will ensure that all Compound supplied by such Party will be from an approved source and the table above will be updated as applicable Regulatory Authorities approve the change to the Manufacturing Site. Ideaya will provide Pfizer written orders [***] days before delivery of the crizotinib Drug Product. Pfizer will provide Ideaya with [***]. Delivery timelines and Compound quantities are based on the Phase II study plan in place at the time of the Effective Date. Compound quantities are subject to modification based on Study conduct (due, for example, to the addition of Study sites or countries, patients with durable responses, etc). If the quantity of compounds set forth are not sufficient to complete the Study, Ideaya shall so notify Pfizer and the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided and the schedule on which such additional quantities may be provided. Following are estimates of the demand for the supply of the Pfizer Compound for the Study. The supply chain teams from Pfizer and Ideaya will meet regularly to review demand and supply requirements and adjust the delivery schedule to ensure continuous supply for the Study. Study Assumptions [***] The source of the Compounds to be provided by the Parties during the Term may change. In such event, the supplying Party will ensure that all Compounds supplied by such Party will be from an approved source and the table above will be updated as applicable Regulatory Authorities approve the change to the Manufacturing Site. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. The responsibilities of both parties are summarised in table below: CLINICAL SUPPLIES TABLE OF ROLES AND RESPONSIBILITIES Documentation will be transferred between the Clinical Supply Chain contacts or designee. [***] [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. DATA SHARING AND SAMPLE TESTING SCHEDULE 37 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Su...
Supply of Compounds. In accordance with a schedule determined by the JMC, ARRAY will provide to ONO an agreed amount of each Compound, up to [*].
