Compliance with GMP Sample Clauses

Compliance with GMP. Batches will be manufactured and assembled to comply with all current European rules regarding Good Manufacturing Practices (EudraLex, Volume 4, 1997 and 21CFR parts 210 and 211).
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Compliance with GMP. HMRI warrants that all Products will be manufactured in conformity with the regulations of the FDA and any comparable state agency applicable thereto.
Compliance with GMP. All of the manufacturing activities with respect to Clinical Supplies intended for use in humans and Commercial Supplies shall be performed in accordance with GMP. With respect to any facility or site at which a Party conducts manufacturing pursuant this Agreement, including, where commercially reasonable and within the control of the other Party, Third Party facilities or sites, each Party shall have the right, at its expense, upon reasonable written notice and during normal business hours, to inspect such site and facility and any records relating thereto as is reasonably necessary to verify the other Party's compliance with the terms of this Agreement relating to GMP. Such inspection shall be subject to the confidentiality provisions of this Agreement. Each Party agrees to, to the maximum extent possible, to include in any agreement with a Third Party relating to its facilities and sites a clause permitting the other Party to exercise its rights under this Section 7.4.
Compliance with GMP. Evelo shall ensure that Final Product shall be manufactured in accordance with Applicable Law, the applicable specifications to be attached to the relevant Supply Agreement (“Specifications”) and GMP. Evelo shall maintain such records as are necessary and appropriate to demonstrate compliance with Applicable Law, the Specifications and GMP. To the extent permitted under Evelo’s agreements with its contract manufacturers, ALJ will have reasonable rights to audit those records, as well as parts of Facilities used for the manufacture of the Final Product.

Related to Compliance with GMP

  • 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.

  • Compliance with OFAC None of the Company and its Subsidiaries or, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company and its Subsidiaries or any other person acting on behalf of the Company and its Subsidiaries, is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”), and the Company will not, directly or indirectly, use the proceeds of the Offering hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

  • 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.

  • Compliance with ADA The Company and its subsidiaries and each Real Property are currently in compliance with all presently applicable provisions of the Americans with Disabilities Act, as amended, except for any such non-compliance that would not, individually or in aggregate, reasonably be expected to have a Material Adverse Effect.

  • Compliance with TIA Every amendment, waiver or supplement of this Indenture or the Securities shall comply with the TIA as then in effect.

  • 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 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 Policies Each Individual Limited Partner hereby agrees that he shall comply with all policies and procedures adopted by any member of the Och-Ziff Group or which Limited Partners are required to observe by law, or by any recognized stock exchange, or other regulatory body or authority.

  • Compliance with Terms Such Grantor will perform and comply with all obligations in respect of the Collateral owned by it and all agreements to which it is a party or by which it is bound relating to such Collateral.

  • Compliance with Statutes The Borrower and its Subsidiaries are in compliance in all material respects with all applicable statutes, regulations and orders of, and all applicable restrictions imposed by, all governmental bodies and have all necessary permits, licenses and other necessary authorizations with respect to the conduct of their businesses and the ownership and operation of their properties except where the failure to so comply or hold such permits, licenses or other authorizations could not reasonably be expected to have a Material Adverse Effect.

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