Common use of Clinical Supply Clause in Contracts

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 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. Takeda will 6.1.1 CARDIOME shall provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed MERCK, as requested by Licensee to complete all MERCK, Materials and/or Product for use in Clinical Trials contemplated by and otherwise in the TAK-385 Development Plan Program, subject to CARDIOME’s reasonable requirements to retain samples of same (estimated by Licensee as the “Clinical Supplies”). The description, quantities, indicated date of manufacture, current expiry date, and out-of-pocket cost to CARDIOME of Clinical Supplies MERCK desires to purchase after the Effective Date on a date mutually agreed between the Parties are identified in Exhibit 6.1. 1. During the Technology Transfer Period, MERCK will identify to CARDIOME in writing any additional Clinical Supplies that MERCK desires to purchase from CARDIOME. Thereafter CARDIOME shall make Commercially Reasonable Efforts to deliver to MERCK such Clinical Supplies on a date mutually agreed between the Parties. Notwithstanding the foregoing, MERCK shall have no obligation to purchase any Clinical Supplies incorporating API manufactured at [Redacted - third party manufacturers] unless [Redacted - qualification to obligation to purchase]. 6.1.2 The purchase price for such Clinical Supplies shall be CARDIOME’s out-of-pocket cost. Delivery shall be [***]Redacted - commercial terms] (Incoterms 2000) MERCK’s designated site (“Delivery”). CARDIOME shall within five (5) days of Delivery issue an invoice to MERCK for the delivered Clinical Supplies. Within thirty (30) days from Delivery of the Clinical Supplies MERCK shall pay CARDIOME the invoiced amount for such Clinical Supplies. Each Delivery of Clinical Supplies shall, solely to the extent that Takeda can supply such TAK-385 Licensed Compound or TAK-385 Licensed Products (a) from its supply applicable, be accompanied by copies of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as a certificate of the Effective Date analysis and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) copies of completed batch records, and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide any other documentation agreed 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 in 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 deliveryquality agreement. The Parties will negotiate complete a quality agreement governing the terms Clinical Supplies for use in Clinical Trials prior to the transfer of any inventory of Clinical Supplies. 6.1.3 CARDIOME represents and conditions warrants that, to the extent applicable, the Clinical Supplies shall, at the time of Delivery: [Redacted - representations in respect of Clinical Supplies] MERCK’s sole remedy for breach of the representations and warranties set out in this Section 6.1.3 in respect of any batch of Clinical Supplies shall be that, with respect to such batch: [Redacted - remedies] 6.1.4 [Redacted - obligations in respect of third party agreements] 6.1.5 CARDIOME shall maintain complete and accurate records of all relevant data and information relating to the supply of Clinical Supplies to MERCK under this Section. CARDIOME shall maintain copies of batch records for seven (7) years or, if CARDIOME intends to dispose of such Takeda Clinical Manufacturing batch records prior to such time, CARDIOME shall notify MERCK in advance, 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 shall permit MERCK, at its discretion, 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 take possession of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree)batch records.