Conformance with cGMP Sample Clauses

Conformance with cGMP. Takeda shall supply the Drug Substance and Drug Product that conforms to GMPs, Applicable Laws and the TAK-385 Licensed Product INDs. Takeda shall be entitled, at its cost and expense, to modify the Specifications, Manufacturing, and testing processes, in each case, employed with regard to the Manufacture of the Drug Substance or Drug Product from time to time, subject to approval, solely to the extent required by Applicable Laws or Regulatory Authorities.
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Conformance with cGMP. Supplier shall Formulate the Products in accordance with applicable Current Good Manufacturing Practices. Each Party shall promptly notify the other of knowledge of any new instructions or specifications required in order to comply with Current Good Manufacturing Practices, and shall reasonably cooperate in agreeing on the best means to comply with any new requirements.

Related to Conformance with cGMP

  • Conformance with Sample(s Submission of a sample (whether or not such sample is tested by, or for, the Commissioner) and approval thereof shall not relieve the Contractor from full compliance with all terms and conditions, performance related and otherwise, specified in the Bid Specifications. If in the judgment of the Commissioner the sample or product submitted is not in accordance with the specifications or testing requirements prescribed in the Bid Specifications, the Commissioner may reject the Bid. If an award has been made, the Commissioner may cancel the Contract at the expense of the Contractor.

  • Compliance with Rules To comply with, and to require the Contractors to comply with, all rules, regulations, ordinances and laws bearing on the conduct of the work on the Improvements, including the requirements of any insurer issuing coverage on the Project and the requirements of any applicable supervising boards of fire underwriters.

  • Performance and Compliance with Collateral The Borrower will, at the Borrower’s expense, timely and fully perform and comply (or, by exercising its rights thereunder, cause the Seller to perform and comply pursuant to the Sale Agreement) with all provisions, covenants and other promises required to be observed by it under the Collateral, the Transaction Documents and all other agreements related to such Collateral.

  • Compliance with Record Keeping Requirements Participating Dealer agrees to comply with the record keeping requirements of the Exchange Act, including but not limited to, Rules 17a-3 and 17a-4 promulgated under the Exchange Act. Participating Dealer further agrees to keep such records with respect to each customer who purchases Primary Shares, his suitability and the amount of Primary Shares sold, and to retain such records for such period of time as may be required by the Commission, any state securities commission, FINRA or the Company.

  • Compliance with Xxxxx Xxxxx and Related Act requirements. All rulings and interpretations of the Xxxxx- Xxxxx and Related Acts contained in 29 CFR parts 1, 3, and 5 are herein incorporated by reference in this contract.

  • Compliance with Equal Benefits Ordinance With respect to the provision of employee benefits, Contractor shall comply with the County Ordinance which prohibits contractors from discriminating in the provision of employee benefits between an employee with a domestic partner and an employee with a spouse.

  • Compliance with Rule 15c2-8 In the case of a Registered Offering and any other Offering to which the provisions of Rule 15c2-8 under the 1934 Act are made applicable pursuant to the AAU or otherwise, you will comply with such Rule in connection with the Offering. In the case of an Offering other than a Registered Offering, you will comply with applicable Federal and state laws and the applicable rules and regulations of any regulatory body promulgated thereunder governing the use and distribution of offering circulars by underwriters.

  • Compliance with Conditions All of the terms, covenants, conditions and obligations of this Agreement and each other Transaction Document required to be complied with and performed by Seller on or prior to the Closing Date shall have been duly complied with and performed in all material respects.

  • Compliance with Standards Although the standards for workmanship, material, and equipment have been selected in these specifications as a basis of reference, standards and specifications of the other bank member countries and recommendations of standards international organizations will be acceptable provided they are substantially equivalent to the designated standards and provided furthermore that the contractor submits for approval detailed specifications which he proposes to use. Reference to brand names or catalog numbers if any in these specifications have been made only for that equipment for which it has been determined that a degree of standardization is necessary to maintain certain essential features. And in certain cases such references have also been made for purposes of convenience to specify the requirements, in either case offers of alternative goods, which have similar characteristics and provide performance and quality at lease equal to those specified are acceptable. If the contractor offers materials, equipment, design calculations or tests, which conform to standards other than those specified, full details of the differences between the proposed standards and that specified in so far as they affect the design or purpose of the equipment, are to be supplied by the contractor if called upon to do so by the engineer, where required by the engineer for approval purposes, the contractor shall supply, without charge, duplicate copies of the proposed standards with English translations of the relevant portions. The contractor shall have available in his place of business (or in his supplier’s works) the relevant copies of standards or codes used for the use of the Engineer.

  • Compliance with FCPA Each of the Credit Parties and their Subsidiaries is in compliance with the Foreign Corrupt Practices Act, 15 U.S.C. §§ 78dd-1, et seq., and any foreign counterpart thereto. None of the Credit Parties or their Subsidiaries has made a payment, offering, or promise to pay, or authorized the payment of, money or anything of value (a) in order to assist in obtaining or retaining business for or with, or directing business to, any foreign official, foreign political party, party official or candidate for foreign political office, (b) to a foreign official, foreign political party or party official or any candidate for foreign political office, and (c) with the intent to induce the recipient to misuse his or her official position to direct business wrongfully to such Credit Party or its Subsidiary or to any other Person, in violation of the Foreign Corrupt Practices Act, 15 U.S.C. §§ 78dd-1, et seq.

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