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. 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 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.

Appears in 5 contracts

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.), Stocking and Subdistribution Agreement (Fuse Medical, Inc.), Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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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 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.

Appears in 3 contracts

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.), Stocking and Subdistribution Agreement (Fuse Medical, Inc.), And Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.60 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.59 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.62 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.57 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.56 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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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 EXHIBIT 10.61 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.52 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.48 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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 EXHIBIT 10.58 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.

Appears in 1 contract

Samples: Stocking and Subdistribution Agreement (Fuse Medical, Inc.)

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