RECALLS; COMPLAINTS Sample Clauses
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RECALLS; COMPLAINTS. 12.1 The Company shall be responsible for the handling of all recalls and field actions relating to Products, and MDT shall provide such cooperation to the Company in regard to such events as the Company may reasonably request. Within forty-eight (48) hours (excluding weekends and national holidays) of any Product recall, MDT shall provide the Company a list (in hard copy and sortable electronic format) of MDT customers who are or may be affected by such recall, or with respect to which the Company is required by applicable law to take any action, and such list shall include customer contact information and the lot numbers, quantities by lot number and models of Products purchased by such customers. In this regard, MDT agrees to advise the Company within forty-eight (48) hours (excluding weekends and national holidays) of each complaint that MDT may receive or become aware of concerning the Products, including any complaint that any of the Products may have been associated in any way with an injury or death to a user or patient or may have been associated with an incident that could likely cause serious health problems or death. MDT agrees to work with and cooperate with the Company to resolve complaints. In the event of a Product recall, the Company shall promptly reimburse MDT for all reasonable costs and expenses (including the cost of the recalled Products) incurred by MDT in connection with any such recall. Each of the Company and MDT shall notify the other of any reportable product incident of which either the Company or MDT becomes aware.
12.2 MDT shall handle all customers’ complaints with a view of securing and maintaining the goodwill of the Company and of the Products, and shall record all complaints in detail and promptly submit the same to the Company for its review, as set forth above. The Company shall be responsible for investigation of the reports of such complaints it is made aware of, by MDT or otherwise, and submission of U.S. Medical Device Reports (21 CFR Part 803), and/or other governmental agency reports as required by applicable law or regulation within the Territory.
12.3 If any of the Products sold by MDT is recalled from the market or withdrawn from sale within the Territory for reasons of product safety or quality as determined by any applicable governmental authority or by mutual agreement of the Parties, any minimum purchase commitment or Quota with respect to such Product shall be suspended until 90 days after the date on wh...
RECALLS; COMPLAINTS. 11.1 MDTX shall provide the Company, on a quarterly basis, a list of MDTX customers, including customer contact information and the lot numbers and models of Products purchased by such customers, for the purpose of being able to track Products in the event of a Product recall otherwise to ensure that the Company is able to comply with any statutory or other obligation in respect of Products sold hereunder. In the event of a recall, MDTX must provide the above-mentioned information within forty-eight (48) hours. In this regard, MDTX agrees to advise the Company within forty-eight (48) hours of each complaint that MDTX may receive or become aware of concerning the Products, including any complaint that any of the Products may have been associated in any way with an injury or death to a user or patient or may have been associated with an incident that could likely cause serious health problems or death. MDTX agrees to work with and cooperate with the Company to resolve complaints. In the event of a Product recall, Company shall promptly reimburse MDTX for all reasonable costs and expenses incurred by MDTX in connection with any such recall. Each of the Company and MDTX shall notify the other and the appropriate governmental agencies within the Territory of any reportable product incident of which either the Company or MDTX becomes aware.
11.2 MDTX shall handle all customers’ complaints with a view of securing and maintaining the goodwill of the Company and of the Products, and shall record all complaints in detail and promptly submit the same to the Company for its review, as set forth above. Company shall be responsible for investigation of the reports and submission of U.S. Medical Device Reports (21 CFR Part 803), and/or other governmental agency reports as required by applicable law or regulation within the Territory.
RECALLS; COMPLAINTS. Except as otherwise provided in the Supply Agreement, if any Governmental Authority with applicable jurisdiction shall order, or it shall otherwise become necessary to perform, any corrective action or market action with respect to Products sold by Caraco following the Closing (including, without limitation, any recall, field correction, market withdrawal, stock recovery, customer notice or restriction), while Caraco shall have the exclusive responsibility to appropriately manage such action and shall be responsible for the costs of management of such action, this will not alter the liability of the Party responsible for the recall under this Agreement (including, but not limited to, as set forth in Section 2.04(c)). Caraco shall also be exclusively responsible for handling all customer complaints, inquiries and similar communications, and, with respect to Product manufactured by Forest, Forest shall cooperate with Caraco, including the completion of an investigation and the preparation and submission of a complaint report to Caraco or its designees. The preceding shall not be in lieu or limitation of any obligation of indemnity of a Party pursuant to Section 9.02.
RECALLS; COMPLAINTS