system: You are a contract-analysis assistant performing a span-extraction task. You are given an excerpt from a commercial contract and the name of a clause type to locate within it.

Return the exact text of the requested clause, copied verbatim from the excerpt — identical wording and punctuation, with no paraphrasing, summarising, explanation, or added commentary.

The excerpt is one window of a much longer contract and often will not contain the requested clause. If the requested clause does not appear in this excerpt, respond with exactly: Not found.

Output only the extracted clause text, or the exact string `Not found.` — nothing else.

user: Contract excerpt:
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Exhibit 10.1 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH "[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. AMENDMENT NO. 2 TO MANUFACTURING AND SUPPLY AGREEMENT THIS AMENDMENT NO. 2 (this "Amendment") to the Manufacturing and Supply Agreement dated as of December 8, 2009 (as amended by an amendment agreement dated 31 December 2013) (the "Existing Agreement"), by and between Columbia Laboratories, (Bermuda) Ltd., a limited company existing and organised under the laws of Bermuda, having a place of business at Canon's Court, 22 Victoria Street, Hamilton HM12, Bermuda ("Columbia"), and Fleet Laboratories Limited, a limited private company existing and organised under the laws of England, having a place of business at 94 Rickmansworth Road, Watford Herts, WD18 7JJ, United Kingdom ("Fleet") is entered into on 2018 (the "Effective Date"). WHEREAS, Columbia and Fleet entered into the Existing Agreement pursuant to which Fleet has agreed to manufacture and supply to Columbia, and Columbia has agreed to purchase, certain Products; and WHEREAS, Columbia and Fleet wish to amend the Existing Agreement in accordance with the terms of this Amendment. NOW THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Columbia and Fleet agree as follows: General Capitalised terms used but not defined in this Amendment shall have the same meanings ascribed to such terms in the Existing Agreement. The following amendments to the Existing Agreement shall have effect on and from the Effective Date. 1. The following definitions shall be added to Section 1 of the Existing Agreement: ""Ares Agreement" means the supply agreement entered into between Columbia and Ares Trading S.A. (a subsidiary of Merck Serono S.A.) dated 7 January 2018." "GDP" means the EU guidelines for current Good Distribution Practice guidelines 2013/C 343/01 as amended." 2. The definition of "batch" in Section 1 of the Existing Agreement shall be deleted in its entirety and replaced with the following: ""Batch" means a quantity of [***] kilograms of material (or such other quantity as the Parties may agree in writing from time to time) produced in a process or series of processes that is expected to be homogeneous within specified limits." 3. The following shall be added to Section 2.1 of the Existing Agreement (Regulatory Requirements) as a new Section 2.1 (d): "2.1 (d) Subject to the prior written consent of Columbia (such consent not to be unreasonably withheld, delayed or conditioned), Fleet may subcontract all or part of the activities to be performed by it under this Agreement to any subcontractor provided that the subcontracting of any activities shall not relieve Fleet of, and Fleet shall remain solely liable for, its obligations under this Agreement. Columbia may subcontract all or any part of the activities performed by it under this Agreement to any subcontractor without the consent of Fleet." 1 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH "[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 4. The following new Sections 2.2 (b), 2.2 (c) and 2.2 (d) shall be added to Section 2.2 of the Existing Agreement (Regulatory Requirements): "2.2 (b) Compliance with Brazilian Regulatory Authorities Regulations. Fleet hereby warrants that the facilities where the Product is manufactured complies in full with the relevant standards stipulated by the Brazil National Health Surveillance Agency ("ANVISA") and undertakes to ensure the facilities will continue to do so throughout the Term. 2.2 (c) Compliance with Regulatory Approvals. To the extent required for regulatory purposes, Fleet grants to Columbia the right to refer to, and to grant any purchasers of Columbia's products containing the Product the right to refer to Fleet's batch manufacturing records relating to the Product. Fleet undertakes to notify Columbia and to provide Columbia with specific details of any changes to be made to the batch manufacturing records and any other filings made by Fleet with the Regulatory Authorities to the extent that they relate to the Product. 2.2 (d) Material Change in Manufacturing Process. Fleet shall provide reasonable notice to Columbia and shall consult with Columbia before Fleet makes any material change in any manufacturing
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Extract the exact clause related to "Document Name" from the excerpt above.