Common use of Raw Materials Clause in Contracts

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials from suppliers qualified by Catalent as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment, and (iii) used commercially reasonable efforts to procure such Raw Materials from alternative suppliers. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Section 4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor to be used for Raw Material, which supplier, manufacturer or vendor has not been qualified by Catalent (“Vendor”). In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed Client-supplied Materials for purposes of Sections 1.42, 3.1(B), 12.1, 12.2A, 12.2E and 13.2. If the cost of the Raw Material from any such Vendor is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all preapproved costs associated with qualification of any such Vendor who has not been previously qualified by Catalent.

Appears in 3 contracts

Samples: Commercial Supply Agreement, Commercial Supply Agreement (Kala Pharmaceuticals, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)

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Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials from suppliers qualified by Catalent as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties Parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment, and (iii) used commercially reasonable efforts to procure such Raw Materials from alternative suppliers. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties Parties will negotiate in good faith an appropriate amendment to this Agreement, including Section 4.2Sections 6.4 and 7.1. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for Raw Material, which supplier, manufacturer or vendor has not been qualified Material and such Supplier shall be used by Catalent (“Vendor”)Catalent. In such an event, (i) such Vendor Supplier will be identified in the Specifications Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, (iii) Catalent shall not be liable for any defects in Raw Materials from such Supplier, or in Product as a result of such defective Raw Materials unless Catalent failed to properly perform any testing required by the Specifications, and (iiiv) the Raw Materials from such Vendor Supplier shall be deemed deemed, for purposes of liability hereunder, Client-supplied Materials for purposes of Sections 1.42, 3.1(B), 12.1, 12.2A, 12.2E and 13.2Materials. If the cost of the Raw Material from any such Vendor Supplier is greater than Catalent’s costs for the same raw material of equal quality from other vendorssuppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the VendorSupplier’s cost of the Raw Material to the Unit Batch Pricing. Client will be responsible for all preapproved costs associated with qualification of any such Vendor Supplier who has not been previously qualified by Catalent.

Appears in 1 contract

Samples: Build Out and Commercial Supply Agreement (Pharmacyclics Inc)

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