Regulatory Inspections. The ACCEPTOR shall allow foreign and local governmental authorities to inspect and review their facilities, operations and quality systems as necessary in order to facilitate, obtain or maintain the required registration in those countries where CONTRACT GIVER and ACCEPTOR desire to sell PRODUCT(s). Each party acknowledges that the other party may respond independently to any correspondence or inquiry from any Regulatory Authority. The ACCEPTOR shall however agree to the following: • To notify the CONTRACT GIVER promptly of any inspection or inquiry by any Regulatory Authority concerning one or more of the PRODUCT(s). The responsible contact persons are listed in Enclosure B. • To forward to the CONTRACT GIVER copies of any correspondence from any Regulatory Authority relating to one or more of the PRODUCT(s). The ACCEPTOR agrees that, during an inspection by a Regulatory Authority concerning one or more of the PRODUCT(s) that it will not disclose information and materials that are not required to be disclosed to such a Regulatory Authority, without the prior consent of the CONTRACT GIVER, which shall not be unreasonably withheld. The ACCEPTOR will immediately inform the responsible contact persons of the CONTRACT GIVER as listed in Enclosure B concerning any critical or major issues encountered during any Regulatory Authority inspection that might adversely affect the quality of one or more of the PRODUCT(s). The ACCEPTOR shall submit to CONTRACT GIVER, within 5 business days of receipt of the official report, a copy of the relevant parts of the report issued by the authorities and the proposed corrective actions that the ACCEPTOR will undertake. The report and the proposed corrective actions should be in English if requested by CONTRACT GIVER. CONTRACT PROVIDER should provide the ACCEPTOR with all the necessary information to carry out the contracted operations correctly in accordance with the pharmaceutical registration and any other legal requirements. The Contract Giver should ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other products. ACCEPTOR shall have a procedure in place to ensure that the qualified person releasing every batch ensures that each batch has been manufactured and checked in compliance with the requirements of pharmaceutical registration.
Regulatory Inspections. Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.
Regulatory Inspections. If any Regulatory Authority conducts, or gives notice to GCLC of its intent to conduct, an inspection at GCLC’s facilities where any Project or Services are being performed or to take any other regulatory action with respect to any Project or Services, then except to the extent prohibited by law or otherwise impracticable, GCLC shall use best efforts to notify Artiva in writing prior to complying with such demand or request, and Artiva shall have the right to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required. GCLC shall promptly provide Artiva with a copy of the results from any regulatory inspection. Artiva shall bear any costs, fees, penalties and other imposts levied by any Regulatory Authority, if any, as a result of [***], in each case other than [***].
Regulatory Inspections. (a) Supplier agrees to host inspections from any federal, state or provincial regulatory authority responsible for the supervision of Supplier's operations, even after the termination of this Agreement.
Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Exelixis Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Exelixis of any such inspection and shall supply Exelixis with all information pertinent thereto. Licensee shall use Commercially Reasonable Efforts to allow an Exelixis representative to attend any such inspection with the presence of Licensee. Exelixis shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of Exelixis, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP for the Licensee Territory, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Exelixis shall promptly notify Licensee of any such inspection and shall supply Licensee with all information pertinent thereto. Exelixis shall use Commercially Reasonable Efforts to allow a Licensee representative to attend any such inspection with the presence of Exelixis.
Regulatory Inspections. ASL shall promptly notify Reliant of any FDA or other US regulatory inspections of the facilities which supply the Active Ingredient.
Regulatory Inspections. Enzon shall make its facilities and all records relating to the Product manufacture available to the Regulatory Authorities at times agreed with such authorities and shall notify Savient if the Regulatory Authority begins or schedules an inspection of Enzon’s records, facilities, or manufacturing processes related to the manufacture of Product and provide Savient access to any documentation related to or resulting from the inspection as described in the Quality Agreement.
Regulatory Inspections. If GSK is notified that either the Product or the Facility (for reasons directly related to either Product) will be subject to an inspection by any Governmental Authority, GSK promptly shall advise Prometheus of such investigation and fully cooperate with and allow any such inspection to the extent required by Applicable Laws. GSK shall promptly notify Prometheus of the results of such investigation and, subject to the last sentence of Section 7.6, shall provide copies of any letter or notices provided by the Governmental Authority unless the results of such investigation are not directly related to the Product.
Regulatory Inspections. Each Party shall allow representatives of the U.S. FDA and any other regulatory agency or authority with jurisdiction over the manufacture, marketing and distribution of the Licensed Product to tour and inspect all facilities utilized by such Party in the manufacture, testing, packaging, storage, and shipment of Licensed Product sold under this Agreement, and shall co-operate with such representatives in every reasonable manner. Each Party shall also provide the other Party with a copy of any U.S. FDA Form 483 notices of adverse findings, regulatory letters or similar notifications it receives from any other governmental authority setting forth adverse findings or non compliance with any applicable laws, regulations or standards relating to the items supplied by it hereunder within five (5) days of its own receipt thereof. Each Party shall also provide the other Party with a copy of its proposed written response to such governmental authority before submission and shall incorporate any changes thereto which the other Party may reasonably request.
Regulatory Inspections. Each Party shall promptly notify the other Party of any FDA or other regulatory inspections of its facilities or operations relating to the Study of which it becomes aware relating to Test Article. Collaborator and ICD shall each have the opportunity to receive a copy of any response to FDA relating to such inspection. Add the following Article 3.13:
