Common use of Adverse Events and Product Quality Complaints Clause in Contracts

Adverse Events and Product Quality Complaints. The Parties agree to the following provisions regarding adverse events and complaints: (a) LMI shall be responsible to (a) report adverse events involving the Product to the FDA and other regulatory authorities, and (b) respond to quality complaints and medical and technical inquiries, respecting the Product. (b) In the event HSL (i) receives information regarding any adverse event relating to the Product, (ii) receives any complaints relating to the Product, (iii) receives any medical or technical inquiry relating to the Product, or (iv) discovers or is notified of any material defect in the Product, it shall immediately notify LMI, through its agent for global pharmacovigilance, as follows (or to such other address, contact person, telephone number, facsimile number or e mail address as may be specified by LMI): 0-000-000-0000 or 000-000-0000 0-000-000-0000 or 000-000-0000 xxxxxxxxxxxxxx@x0xxxxxx.xxx HSL shall also conduct an investigation in accordance with its normal procedures for complaints, inquiries or discoveries of that nature and promptly report the results of such investigation to LMI. The Parties shall reasonably cooperate with and assist each other in connection with any such matter. In addition, HSL will ensure that all relevant personnel are sufficiently informed and trained on the terms and procedures outlined in this Agreement, including without limitation, the process for the receipt, recordation, exchange, communication and submission of safety data for the Product(s) and all relevant regulations and laws thereto. HSL agrees to document the training activities, including the training material(s) used, and make these documents reasonably accessible to LMI upon request.

Adverse Events and Product Quality Complaints. The Parties agree to the following provisions regarding adverse events and complaints: (a) LMI shall be responsible to (a) report adverse events involving the Product products sold by LMI to the FDA and other regulatory authorities, and (b) respond to quality complaints and medical and technical inquiries, respecting the Productsuch LMI products. (b) In the event HSL CMO (i) receives information regarding any adverse event relating to the Productproducts sold by LMI, (ii) receives any complaints relating to the ProductProducts sold by LMI, (iii) receives any medical or technical inquiry relating to the ProductProducts sold by LMI, or (iv) discovers or is notified of any material defect in the ProductProducts sold by LMI, it shall immediately notify LMI, through its agent for global pharmacovigilance, or (iv) discovers or is notified of any facts, circumstances or occurrences that do or could adversely affect the Product manufactured on LMI’s behalf, as follows (or to such other address, contact person, telephone number, facsimile number or e mail address as may be specified by LMI): 0-000-000-0000 #-###-###-#### or 000-000-0000 0-000-000-0000 ###-###-#### #-###-###-#### or 000-000-0000 xxxxxxxxxxxxxx@x0xxxxxx.xxx HSL ###-###-#### **** To the address, contact person, telephone number, facsimile number or email address that LMI will specify pursuant to a separate written notice after the date of this Agreement. CMO shall also conduct an investigation in accordance with its normal procedures for complaints, inquiries or discoveries of that nature and promptly report the results of such investigation event pursuant to LMIthe requirements set forth in the Quality Agreement. The Parties shall reasonably cooperate with and assist each other in connection with any such matter. In addition, HSL CMO will ensure that all relevant personnel are sufficiently informed and trained on the terms and procedures outlined in this Agreement, including without limitation, the process for the receipt, recordation, exchange, communication and submission of safety data for the Product(s) and all relevant regulations and laws thereto. HSL CMO agrees to document the training activities, including the training material(s) used, and make these documents reasonably accessible to LMI upon request.