Inspections by Regulatory Authorities. Seres shall give GenIbet advance notice, to the extent that advance notice is given to Seres, of any site visit to the Facility by any Government Authority, the ||| purpose of which is to inspect the Manufacture of any Product or the compliance status of the Facility under Applicable Law, in accordance with the terms and conditions of the Quality Agreements. In any event, GenIbet shall advise Seres of the occurrence of any such visit immediately upon such visit, and GenIbet shall furnish to Seres all material information supplied to, or supplied by, any Government Authority, including the Form 483 (and foreign equivalent) observations and responses, to the extent that such information relates to such Product or the ability of GenIbet to comply with the terms of this Agreement or Applicable Law. In addition, and without limitation on the foregoing, to the extent permitted by the applicable Government Authority, representatives of Seres shall be permitted to participate in any such site visit by a Government Authority, and GenIbet shall provide Seres with a reasonable opportunity to review and comment upon any response to the Government Authority to the extent the response relates to Product prior to delivery to the Government Authority.
Inspections by Regulatory Authorities. 4.2.1. POZEN shall notify Licensee within [* * *] following notice from any Regulatory Authority or the CMO of a visit to any POZEN facility or any facility of a Third Party contractor of POZEN wherein the Development or Manufacture of the Initial Products is conducted. A representative of Licensee (or its Third Party contractor reasonably acceptable to POZEN) shall have the right to be present as an observer at any announced visits to POZEN’s facility and the facilities of Third Party contractors (to the extent POZEN is entitled to attend such visits) by any Regulatory Authority relating to the Development of the Initial Products.
4.2.2. POZEN shall send to Licensee copies of notifications from any Regulatory Authority (including any Form No. 483 notification, Enforcement Inspection Reports, Notice of Adverse Finding, etc.) within [* * *] Business Days of POZEN’s receipt of such notifications, whether received from a Regulatory Authority or from the CMO. Licensee shall treat all information subject to review under this Section 4.2.2 (Inspections) in accordance with the provisions of Section 12 (Confidentiality) and shall cause any Third Party auditor retained by Licensee (and reasonably acceptable to POZEN) to enter into a confidentiality agreement reasonably acceptable to Licensee with POZEN obligating such auditor to maintain all such information in confidence pursuant to such confidentiality agreement.
Inspections by Regulatory Authorities. MSRx shall allow representatives of any Regulatory Authority to inspect the relevant parts of the facility where the Supply of Product is carried out and to inspect the lot, batch and other manufacturing records to verify compliance with cGMP and other Applicable Law and practices and shall promptly notify Galena of the scheduling of any such inspection relating to Supply. MSRx shall promptly send to Galena a copy of any reports, citations, or warning letters received by MSRx in connection with an inspection by a Regulatory Authority to the extent such documents relate to or affect Supply.
Inspections by Regulatory Authorities. For any competent authority's audit and/or inspection of Hapila's facilities involved in the manufacture, supply or shipment of the Product the relevant provisions in the Quality Agreement shall apply.
Inspections by Regulatory Authorities. The ARC shall allow representatives of any Regulatory Authority or other governmental agency with jurisdiction over the manufacture and/or clinical testing of the Batches and/or Products to tour and inspect all facilities utilized by the ARC in the manufacture, testing, packaging, storage, and shipment of the Batches and/or Products under this Agreement and will cooperate with such representatives in every reasonable request. If any Regulatory Authority schedules an inspection of ARC facilities relating to the Batches and/or Products, ARC shall contact MacroCure immediately and inform MacroCure in writing within twenty-four (24) hours of receiving notification from the Regulatory Authority. If any Regulatory Authority initiates an unscheduled inspection of ARC’s facilities relating to the Batches, ARC shall contact MacroCure immediately, Without derogating from the other provisions of Article 7, Macrocure’s representative shall be entitled to be present at any inspection activity of any Regulatory Authority.
Inspections by Regulatory Authorities. Each Party agrees ------------------------------------- to notify the other within two (2) business days of its receipt of notification of any inquiries, notifications, or inspection activity by any Regulatory Authority, governmental agency or authority in regard to the Licensed Product or the manufacturing facilities therefor. Zonagen shall provide a reasonable description to Schering of any such governmental inquiries, notifications or inspections promptly (but in no event later than five (5) calendar days) after notification of completion of such visit or inquiry. Zonagen shall furnish to Schering, (i) within two (2) business days after receipt, any report or correspondence issued by the Regulatory Authority or governmental authority in connection with such visit or inquiry, including but not limited to, any *** This portion has been omitted based on a request for confidential treatment pursuant to Rule 24b-2 of the Exchange Act. The omitted portion has been separately filed with the Commission. FDA form 483, Establishment Inspection Reports or warning letters and (ii) at the same time it provides to any Regulatory Authority or governmental authority, copies of any and all documents, responses or explanations relating to items set forth above, in each case purged only of trade secrets of Zonagen or its third party manufacturers that are unrelated to the obligations under this Agreement or are unrelated to the Licensed Product. In the event such governmental agency or authority requests or requires any action to be taken to address any citations, Zonagen agrees, after consultation with Schering, to take such action as necessary to address such citations, and agrees to cooperate with Schering with respect to any such citation and/or action taken with respect thereto.
Inspections by Regulatory Authorities. UCB shall promptly give Buyer advance notice, to the extent that advance notice is given to UCB, of any site visit to its manufacturing facility by any Regulatory Authority, the purpose of which is to inspect the manufacture, testing, storage, disposal or transportation of the Finished Product, in accordance with the terms and conditions of the Quality Agreement. In any event, UCB shall advise Buyer of the occurrence of any such visit immediately following such visit, and UCB shall furnish to Buyer all material information supplied to, or supplied by, any Regulatory Authority, including the Form 483 observations and responses, to the extent that such information relates to the Finished Product or the ability of UCB to comply with the terms of this Agreement.
Inspections by Regulatory Authorities. PCAS shall promptly notify ViroPharma if FDA or any foreign equivalent inspects PCAS regarding activities under this Agreement. PCAS shall provide ViroPharma with a written report of any such inspection, noting with specificity any record or document reviewed by the regulatory inspector. When a copy of a document or record is supplied to the inspector on request, that fact will be noted in the report. PCAS shall keep copies of each of these records or documents in a separate inspection file and, on ViroPharma's request, will provide ViroPharma with copies of any or all of these records or documents.
Inspections by Regulatory Authorities. MonoSol shall promptly give Buyer advance notice, to the extent that advance notice is given to MonoSol, of any site visit to its manufacturing facility by any Regulatory Authority, the purpose of which is to inspect the manufacture, testing, storage, disposal or transportation of the Finished Product, in accordance with the terms and conditions of the Quality Agreement. In any event, MonoSol shall advise Buyer of the occurrence of any such visit immediately following such visit, and MonoSol shall furnish to Buyer all material information supplied to, or supplied by, any Regulatory Authority, including the Form 483 observations and responses, to the extent that such information relates to the Finished Product or the ability of MonoSol to comply with the terms of this Agreement. In the event that any such Regulatory Authority finds that MonoSol’s manufacturing facility fails to meet any applicable laws, rules or regulations, MonoSol shall cure such deficiencies within any applicable cure period permitted by the Regulatory Authority or applicable law, rule or regulation. If at any time, MonoSol is prevented from delivering the Finished Product to Buyer for a period exceeding forty-five (45) consecutive days, Buyer shall have the option to manufacture the Finished Product [at the alternate site, in accordance with Section 10 above,] until the MonoSol is able once again to deliver the Finished Product.
Inspections by Regulatory Authorities. Medstar shall notify Sponsor, as soon as reasonably practicable, of all inspections or anticipated inspections of its facility conducted by any regulatory authority, including, without limitation, the Food and Drug Administration, that in any way directly relates to the Study. Medstar shall promptly provide copies of all reports, emotions, violations, warnings, and notices of deficiency received by Medstar with such inspections.
