Governmental Inspections and Inquiries. Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority: Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor. Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response. Rev 111717 137478606.3 In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority. The Distributor shall, at its discretion and to the extent legally permissible, provide Subd...
Governmental Inspections and Inquiries. Kyowa Kirin will advise Reata promptly, but in no event later than [***] days after Kyowa Kirin’s receipt of notice thereof, of any planned Regulatory Authority visit to the portion of the facilities of Kyowa Kirin or its Affiliates where Licensed Product is stored or handled or any material written inquiries by a Regulatory Authority concerning such facilities, the procedures of Kyowa Kirin or its Affiliates for the storage or handling of Licensed Products, or the Commercialization of Licensed Product in the Territory. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. If the Regulatory Authority makes an unannounced or unplanned visit, or if Kyowa Kirin does not have at least [***] days notice of the visit, Kyowa Kirin will inform Reata of the visit as soon as reasonably practicable, but in no event later than [***] Business Days after Kyowa Kirin obtains actual knowledge of the visit. Kyowa Kirin will inform Reata, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Reata copies of any minutes of the inspection generated by Kyowa Kirin (in English if available, without any obligation to translate) promptly following such inspection and any report or correspondence (in English if available, without any obligation to translate) provided by Kyowa Kirin, or any Affiliate, as the case may be, to the Regulatory Authority or issued by or provided by the Regulatory Authority to Kyowa Kirin, or any Affiliate, as the case may be, in connection with such visit or inquiry. If English translations of these materials are not available, then Kyowa Kirin will advise Reata of the material aspects of such minutes and correspondence at the JSC meetings.
Governmental Inspections and Inquiries. Each Party shall advise the other Party promptly, but in no event later than [***] days after such Party’s receipt of notice thereof, of any planned Regulatory Authority visit to the portion of the facilities of the receiving Party or its Affiliates where Licensed Products are Developed, stored or handled or any material written inquiries by a Regulatory Authority concerning such facilities, the procedures of the receiving Party or its Affiliates for the Development, storage or handling of Licensed Products, or the Commercialization of Licensed Products in the Territory or the European Territory, as applicable. If the Regulatory Authority makes an unannounced or unplanned visit, or if the receiving Party does not have at least [***] days notice of the visit, the receiving Party shall inform the other Party of the visit within one (1) Business Day after the receiving Party obtains actual knowledge of the visit. The receiving Party shall inform the other Party as soon as practicable regarding the purpose and result of such visit or inquiry, and shall provide to the other Party copies of any minutes of the inspection generated by the receiving Party promptly following such inspection and any report or correspondence provided by the receiving Party, or any Affiliate, as the case may be, to the Regulatory Authority or issued by or provided by the Regulatory Authority to the receiving Party, or any Affiliate, as the case may be, in connection with such visit or inquiry. The receiving Party shall advise the other Party of the material aspects of such minutes and correspondence at the next JSC meeting.
Governmental Inspections and Inquiries. If either Party receives notice of an inspection, audit, or inquiry by a Governmental Authority relating to the Product(s), arising from any activities under this Agreement, or concerning either Party’s compliance with Applicable Laws in connection with its activities under this Agreement, the Party will notify the other Party as soon as possible, but in no event later than one (1) business day after receipt of such notice or notification. The Parties agree to cooperate with each other during any inspection, investigation or other inquiry, including by providing information or documentation as requested by the Governmental Authority.
Governmental Inspections and Inquiries. (a) Access and its Affiliates shall promptly, and in any event within [***] after the date of receipt of notice, notify AMAG in writing of, and shall provide AMAG with copies of, any correspondence and other documentation received or prepared by Access in connection with any of the following events to the extent necessary to meet the requirements of FDA or other Governmental Authority:
Governmental Inspections and Inquiries. (a) Each Collaborator shall advise the Management Committee of any governmental visits to, or written or oral inquiries about, any facilities or procedures for the manufacture, storage or handling of a Product in the Territory, promptly (but in no event later than fifteen (15) calendar days) after such visit or inquiry. Each Collaborator shall furnish to the Management Committee, within fifteen (15) 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 or proprietary information that is unrelated to the Products or the activities under this Agreement.
Governmental Inspections and Inquiries. Row 44 will advise Southwest promptly after it first has Knowledge thereof, but in no event later than *** after Row 44 first has Knowledge thereof, of any planned Regulatory Authority visit to the facilities of Row 44 or its Affiliates or subcontractors where System Units or components thereof are produced, stored or handled or any written or oral inquiries by a Regulatory Authority concerning such facilities, the procedures of Row 44 or its Affiliates or subcontractors for the production, storage or handling of the System Units or components thereof, or the use of the Broadband System. If a Regulatory Authority makes an unannounced or unplanned visit, or if Row 44 does not have at least *** of the visit, Row 44 will inform Southwest of the visit as soon as reasonably practicable after it first has Knowledge thereof, but in no event later than *** after Row 44 has Knowledge of the visit. Row 44 shall cause all of its contractual agreements with its subcontractors to include a requirement that each such subcontractor shall provide to Row 44 advance notice of any planned Regulatory Authority visit, and notice as soon as reasonably practicable of any unannounced or unplanned Regulatory Authority visit, to such subcontractor’s facilities relating to the production or operation of the System Units or components thereof or that is generally applicable to production of commercial aviation equipment. If a visit by a Regulatory Authority relates to the production or operation of System Units or components thereof or is generally applicable to production of commercial aviation equipment, Row 44 will furnish to Southwest (a) minutes of the inspection generated by Row 44 promptly following such inspection and (b) any report or correspondence provided by Row 44, or any Affiliate or subcontractor of Row 44, or their respective representatives, as the case may be, to the Regulatory Authority or issued by or provided by the Regulatory Authority to Row 44, or any Affiliate or subcontractor of Row 44, or any of their respective representatives, as the case may be, in connection with such visit or inquiry as soon as reasonably practicable thereafter. Row 44 shall enter into agreements with each of its subcontractors that require such subcontractors to provide the notices and other materials and information contemplated by this Section 2.2.4. *** Confidential treatment requested.
Governmental Inspections and Inquiries. BeiGene shall advise Mirati promptly after BeiGene’s receipt of notice thereof, of (i) any planned Regulatory Authority visit to the portion of the facilities of BeiGene and/or the facilities of Mirati or their respective Affiliates where the Compound or any Licensed Product is manufactured, stored or handled, or (ii) any material written inquiries by a Regulatory Authority concerning such facilities, BeiGene’s or its Affiliates’ procedures with respect to the manufacture, storage or handling of the Compound or any Licensed Product. If a Regulatory Authority makes an unannounced or unplanned visit, BeiGene shall inform Mirati of the visit as soon as reasonably practicable after BeiGene obtains actual knowledge of the visit. BeiGene shall inform Mirati, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Mirati copies of any minutes or other records of the inspection generated by BeiGene promptly following such inspection, and any report, response or correspondence provided by BeiGene or its Affiliate, as the case may be, to such Regulatory Authority or issued by or provided by 23 *** Confidential Treatment Requested Execution such Regulatory Authority to BeiGene or its Affiliate, as the case may be, in connection with such visit or inquiry. The Parties will discuss in good faith whether any of the documents to be provided by BeiGene under this Section 5.7 should be translated into English and the allocation of responsibility for paying the costs of any such translations between the Parties.
Governmental Inspections and Inquiries. Licensee shall advise Mirati promptly after Licensee’s receipt of notice thereof, of (i) any planned Regulatory Authority visit to the portion of the facilities of Licensee or the facilities of Mirati or their respective Affiliates where the Compound or any Licensed Product is manufactured, stored or handled, as applicable, or (ii) any material written inquiries by a Regulatory Authority concerning such facilities, Licensee’s or its Affiliates’ procedures with respect to the manufacture, storage or handling of the Compound or any Licensed Product. If a Regulatory Authority makes an unannounced or unplanned visit, Licensee shall inform Mirati of the visit as soon as practicable after Licensee obtains actual knowledge of the visit. Licensee shall inform Mirati, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Mirati copies of [***] generated by Licensee promptly following such inspection, and any [***] provided by Licensee [***], as the case may be, to such [***] or issued by or provided by such [***] to Licensee [***] in connection with such visit or inquiry, provided that, if such [***] provide Mirati a written English translation of such [***]. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
Governmental Inspections and Inquiries. 12.1 PACIFIC PHARMA shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify SUNEVA in writing of, and shall provide SUNEVA with copies of, any correspondence and other documentation received or prepared by PACIFIC PHARMA in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Territory Regulatory Authority, as it relates to the Product(s):
