Common use of Governmental Inspections and Inquiries Clause in Contracts

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. 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 Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority. In the event any Governmental Authority, detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.

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 Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority. In the event any Governmental Authority, Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.

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. 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 Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority. In the event any Governmental Authority, Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.

Governmental Inspections and Inquiries. Subdistributor (a) Access and its Affiliates shall promptly, and in any event within three (3) business days [***] after the date of receipt of notice, notify Distributor AMAG in writing of, and shall provide Distributor AMAG with copies of, any correspondence and other documentation received or prepared by the Subdistributor Access in connection with any of the following events to the extent necessary to meet the requirements of any FDA or other Governmental or Regulatory Authority: Receipt : i. receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection FDA or similar communication from any other Governmental or Regulatory Authority in connection with the design, manufacture, storage, marketing, advertisement, sale and/or purchasing distribution of the Product(s)Devices; and Any and ii. any FDA or other Governmental or Regulatory Authority’s Authority comments relating to the Product(s) Devices that may require a response or action by Distributor. Access or its Affiliates. (b) Without limiting the generality of the foregoing, in the event that the Subdistributor AMAG or any of its Representatives receive agents receives a letter or comments from any such FDA or other Governmental or Regulatory Authority in connection with any of the Product(s) Devices that requires a response or action by Distributor and/or its SuppliersAMAG, the Subdistributor Access shall promptly provide to Distributor AMAG any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing distribution of the Product(s)Devices, and the Subdistributor Access will cooperate fully with Distributor AMAG in preparing such response. . (c) In the event any facility that is used by the Subdistributor Access or any of its Representatives Affiliates to manufacture, store, market market, advertise, distribute or sell any of the Product(s) Devices is inspected by representatives of any FDA or other Governmental or Regulatory Authority, the Subdistributor Access shall notify the Distributor AMAG promptly upon learning of such inspection and shall supply Distributor AMAG with copies of any correspondence [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. that relates to such inspection. Distributor AMAG may, at its election, send representatives to such facility and may participate in observe any portion of such inspection that relates to any of the Product(s)Device and provide input to Access. The Subdistributor Access 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 Subdistributor AMAG with a copy of any response related to such visit or inspection for SubdistributorAMAG’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, Access shall provide Subdistributor AMAG with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority. In the event any FDA or such other Governmental Authority, detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.

Governmental Inspections and Inquiries. Subdistributor Distributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor Company in writing of, and shall provide Distributor Company with copies of, any correspondence and other documentation received or prepared by the Subdistributor Distributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority: : (i) Receipt of a regulatory letter (such 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 distribution of the Product(s); and and (ii) Any Governmental or Regulatory Authority’s 's comments relating to the Product(s) that may require a response or action by Distributor. Company. (iii) Without limiting the generality of the foregoing, in the event that the Subdistributor Company or any of its Representatives receive Agent receives 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 SuppliersCompany, the Subdistributor Distributor shall promptly provide to Distributor Company any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing distribution of the Product(s), and the Subdistributor Distributor will cooperate fully with Distributor Company in preparing such response. . (iv) In the event any facility that is used by the Subdistributor Distributor or any of its Representatives Agent to store, market market, advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor Distributor shall notify the Distributor Company promptly upon learning of such inspection and shall supply Distributor Company with copies of any correspondence that relates to such inspection. Distributor Company 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 Distributor shall (to the extent legally permissible) furnish to Distributor Company copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with within five (5) business days after the delivery of such information by the Governmental or Regulatory Authority. . (v) The Company shall provide Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s Company's review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, Distributor shall provide Subdistributor Company with a copy of the final response promptly after it is submitted to the Governmental of or Regulatory Authority. . (vi) In the event any Governmental Authority, Authority detains or seizes any of the Product(s) from the Subdistributor Distributor or any of its RepresentativesAgent, the Subdistributor shall, to the extent legally permissible, Distributor shall promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.Company, provided that such action does not violate any applicable laws, statutes, ordinances or regulations