Common use of Records Regulatory Matters Clause in Contracts

Records Regulatory Matters. 7.1 Circa will maintain complete and accurate records relating to the Product and the manufacture, packaging, and testing thereof for the period required by applicable Regulatory Standards, and Circa shall provide copies thereof to Customer upon Customer's request. Without limiting the generality of the foregoing, Circa shall (i) perform quality assurance and control tests on each lot of Final Product manufactured before delivery and shall prepare and deliver to Customer a written report of the results of such tests, with each report setting forth for each lot delivered the items tested, specifications and results in a certificate of analysis containing the type of information which is required by the Federal Food and Drug Administration ("FDA") and (ii) prepare and maintain for a period of no less than five (5) years and for so long as required under applicable requirements of the FDA for each lot of Final Product manufactured a certificate of manufacturing compliance containing the types of information that is required by the FDA, which certificate will certify that the lot of Final Product was manufactured in accordance with the Final Specifications and GMPs. 7.2 Circa will supply for each batch of Final Product, including each pilot batch, complete batch production and control records. 7.3 Circa shall ensure that the Production Facility and the equipment and personnel used to manufacture Product are now, and at the time each batch of Final Product is produced shall be, maintained in a professional and workmanlike manner, consistent with generally accepted industry standards. Circa represents and warrants that (i) the Production Facility is in compliance with all applicable material requirements of the Regulatory Standards, and (ii) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Production Facility which would cause the Final Product to be misbranded or adultered within the meaning of the Act. 7.4 In addition to any authorizations required under Section 7.3, Circa has obtained all other licenses, authorizations and approvals required by any federal, state or local governmental authority for the production of the Product, and the Production Facility complies with all laws, rules and regulations applicable to it,

Records Regulatory Matters. 7.1 Circa will Except as otherwise provided in this Agreement, Wats▇▇ ▇▇▇l maintain complete and accurate records relating to the Final Product and the manufacture, packaging, and testing thereof for the period required by applicable Regulatory Standards, and Circa shall Wats▇▇ ▇▇▇ll provide copies thereof to Customer upon Customer's request. Without limiting the generality of the foregoing, Circa shall (i) prior to release of each batch, Wats▇▇ ▇▇▇ll perform quality assurance and control tests on each lot of Final Product manufactured before delivery and shall prepare and deliver to Customer a written report of the results of such tests, with each report setting forth for each lot delivered the items tested, specifications and results in a certificate of analysis containing the type of information which is required by the Federal Food and Drug Administration ("FDA") and (ii) prepare and maintain for a period of no less than five (5) years and for so long as required under applicable requirements of the FDA for each lot of Final Product manufactured a certificate of manufacturing compliance containing the types of information that is required by the FDA, which certificate will certify that the lot of Final Product was manufactured in accordance with the Final Specifications and GMPsRegulatory Standards. 7.2 Circa will Wats▇▇ ▇▇▇l supply for each batch of Final Product, including each pilot batch, complete batch production and control records. 7.3 Circa shall Wats▇▇ ▇▇▇ll ensure that the Production Facility and the equipment and personnel used to manufacture Final Product are now, and at the time each batch of Final Product is produced shall be, maintained in a professional and workmanlike manner, consistent with generally accepted industry standards. Circa represents Wats▇▇ ▇▇▇resents and warrants that (i) the Production Facility is in compliance with all applicable material requirements of the Regulatory Standards, and (ii) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Production Facility which would cause the Final Product to be misbranded or adultered within the meaning of the Actadulterated. 7.4 In addition to any authorizations required under Section 7.3, Circa has Wats▇▇ ▇▇▇ obtained all other licenses, authorizations and approvals required by any federal, state or local governmental authority for the production of the Final Product, and the Production Facility complies with all laws, rules and regulations applicable to it,. 7.5 Wats▇▇ ▇▇▇ll promptly notify Customer if the FDA or other regulatory authority visits or makes written or oral inquiries about the Production Facility or Wats▇▇'▇ ▇▇▇cedures, to the extent such inquiries relate to the production, testing, packaging, storage or handling of API or Final Product. Wats▇▇ ▇▇▇ll furnish Customer, within thirty (30) days after receipt, a copy of any report or correspondence issued by the governmental authority in connection with such visit or inquiry, purged only of confidential information that is unrelated to the API or Final Product or the activities under this Agreement. 7.6 In the event that either Wats▇▇ ▇▇ Customer determine that the Final Product should be recalled, the parties shall discuss the issues and take all appropriate corrective actions, and shall cooperate in the investigations surrounding the situation. Only Customer shall have the right to order a recall, provided however, that if Wats▇▇ ▇▇▇ieves such a recall is necessary and Customer declines to do so, Wats▇▇ ▇▇▇ contact the relevant regulatory agencies regarding such matter.