Certain Product Events Clause Samples
The 'Certain Product Events' clause defines specific occurrences or changes related to a product that may trigger particular rights, obligations, or consequences under an agreement. Typically, this clause outlines events such as product recalls, regulatory actions, significant modifications, or discontinuation, and details the procedures or responses required from the parties when such events occur. Its core practical function is to ensure that both parties are prepared to address significant product-related developments, thereby allocating risk and clarifying responsibilities in the event of unforeseen product issues.
Certain Product Events. (a) The Parties shall establish a joint product incident review team to consider any proposed Remedial Action with respect to Product in the Licensed Territory. If either Party is aware of a defect, incident or other information in respect of Product that they believe may lead to a Remedial Action, then it shall promptly inform the other Party’s primary contact on the Product incident review team. Upon such notice, the Product incident review team shall promptly meet to consider the appropriate action. Each Party shall cooperate fully with the other with respect to the consideration of any such matter. If the Product incident review team cannot agree upon how to proceed, such matter shall be escalated to the head of quality for each Party (or his or her designee) for determination. In the event of a deadlock on such matter, GSK will have the right to make the decision; except that, after such deadlock, GSK shall commence the proposed Remedial Action in the Licensed Territory upon Impax’s request, notwithstanding such deadlock, if Impax reasonably believes that the proposed Remedial Action is appropriate due to Impax’s nonconformance with cGMP requirements. Notwithstanding any provision in this Supply Agreement to the contrary, including this Section 6.7, GSK shall not be required to commence any Remedial Action (including, without limitation, Remedial Action requested by Impax), that would violate applicable Laws in any jurisdiction in the Licensed Territory. The conduct of any Remedial Action will be handled in accordance with the Quality Agreement. For the avoidance of doubt, none of the Alliance Managers, Joint Steering Committee or Joint Patents Committee shall have any responsibility for decisions in respect of a Remedial Action. Without limiting the generality of the foregoing, with respect to Remedial Action, each Party shall:
(i) Inform the other Party immediately of any defect found, subsequent to release, which may be grounds to initiate a Remedial Action;
(ii) Maintain a procedure to cover Remedial Action, including contact arrangements for hours falling outside the typical Business Day;
(iii) Provide all support reasonably necessary to support any investigation and subsequent actions in connection with Remedial Action; and
(iv) Maintain component traceability records of Products for the periods required by the Quality Agreement, cGMPs or Laws, enabling traceability at the Product batch number level to customers of the Products supplied by Impax...
Certain Product Events. In the event Purchaser shall be required by a Governmental Authority to initiate a recall (or Purchaser voluntarily initiates a recall), withdrawal or field correction of, field alert report or comparable report with respect to, any Finished Product manufactured using API supplied by FIS pursuant to this Agreement, Purchaser shall notify FIS within 48 hours. Purchaser shall be responsible for the costs of all recalls of Finished Products and initiated by Purchaser or any Affiliate or licensee thereof; provided that, notwithstanding the foregoing, FIS shall reimburse Purchaser for all reasonable costs and expenses incurred by Purchaser in procuring or complying with the requirements of any recall of Finished Products that is attributable to FIS’s failure to manufacture, test, package, store, label, release or deliver any API in accordance with the Specifications, Laws, or cGMPs. FIS shall, at Purchaser’s sole option, either (a) replace the API which is the subject of such recall at no additional cost to the Purchaser as soon as reasonably practicable, or (b) reimburse Purchaser for the amount paid by Purchaser to purchase and ship the API which is the subject of such recall.
Certain Product Events