Validation Services. Prior to the execution of this Agreement by the parties, the parties entered into that certain Quotation entitled “Process Validation of Pirfenidone Manufacture Capsulation ([ * ]) dated July 28, 2009, a copy of which is attached hereto as Attachment A (the “Validation Services Quotation”), whereby Catalent shall perform for Client the qualification and Process validation services set forth therein (the “Validation Services”). The parties acknowledge and agree that pursuant to the terms of the Validation Services Quotation, upon execution of this Agreement, Catalent shall manufacture the fully compounded bulk pharmaceutical product containing API in accordance with the terms and conditions set forth in the Validation Services Quotation. The parties hereby agree that upon completion of the manufacture of the [ * ] batches of such product referred to as “Campaign I” in the Validation Services Quotation by Catalent, release of such batches by Catalent, final release of such batches by Client, and completion of all the other services all as set forth in the Validation Services Quotation, such batches shall be referred to herein as “Commercial Validation Batches” and the products within such batches shall be deemed “Products” for purposes of this Agreement and shall be available for Catalent’s fulfillment of Client’s Purchase Orders under Article 4 of this Agreement. For purposes of clarity, all the activities set forth in the Validation Services [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Quotation shall be governed by the existing terms and conditions thereunder and this Agreement shall have no legal effect thereon; provided, however that when the products within the Commercial Validation Batches become Products for purposes of this Agreement, this Agreement shall then govern.
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Sources: Commercial Manufacturing Agreement
Validation Services. Prior to the execution of this Agreement by the parties, the parties entered into that certain Quotation entitled “Process Validation of Pirfenidone Manufacture Capsulation ([ * ]) dated July 28, 2009, a copy of which is attached hereto as Attachment A (the “Validation Services Quotation”), whereby Catalent shall perform for Client the qualification and Process validation services set forth therein (the “Validation Services”). The parties acknowledge and agree that pursuant to the terms of the Validation Services Quotation, upon execution of this Agreement, Catalent shall manufacture the fully compounded bulk pharmaceutical product containing API in accordance with the terms and conditions set forth in the Validation Services Quotation. The parties hereby agree that upon completion of the manufacture of the [ * ] batches of such product referred to as “Campaign I” in the Validation Services Quotation by Catalent, release of such batches by Catalent, final release of such batches by Client, and completion of all the other services all as set forth in the Validation Services Quotation, such batches shall be referred to herein as “Commercial Validation Batches” and the products within such batches shall be deemed “Products” for purposes of this Agreement and shall be available for Catalent’s fulfillment of Client’s Purchase Orders under Article 4 of this Agreement. For purposes of clarity, all the activities set forth in the Validation Services [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Quotation shall be governed by the existing terms and conditions thereunder and this Agreement shall have no legal effect thereon; provided, however that when the products within the Commercial Validation Batches become Products for purposes of this Agreement, this Agreement shall then govern.
Appears in 1 contract