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...
View SourceView Similar (2)
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.
View Source
Certain Product Events 
View SourceView Similar (9)

Related to Certain Product Events

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Particular Methods of Procurement of Goods and Works International Competitive Bidding. Goods and works shall be procured under contracts awarded on the basis of International Competitive Bidding.

  • Particular Methods of Procurement of Goods Works and Services (other than Consultants’ Services)

  • License Types (a) A Team License shall mean a subscription license that provides a limited number of licenses to a set amount of developers for a named Customer. Customer must procure enough active licenses for each individual who has Programmatic Access. A Team License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer. A Team License cannot be used as a floating license. (b) A Project License shall mean a subscription license which covers one named Customer application. The license fees are based on the total number of developers working on a named project, regardless of whether such developers are directly using the Licensed Product. For the purposes of pricing and license administration, a “Project Group” is deemed to be a distinct Customer software team within a Customer’s business unit that works towards a distinct business purpose for the benefit of a single application. Customer is required to identify the name of each such Project Group to Syncfusion; such name must be unambiguous in nature. It is acknowledged and agreed by Customer that each identified Project Group shall exist for a valid business purpose and not just as a means for consolidating software licenses to minimize license fees that are otherwise due. If, in the sole opinion of Syncfusion, multiple Customer teams would each individually meet the above definition of a Project Group, such multiple teams shall not be combined for the purpose of consolidating licenses under a single Project Group. Customer is responsible for providing information about each such Project Group to Syncfusion. By entering into this Agreement, Customer represents that after the effective date, it will not withhold information that Syncfusion requires to properly license each such Project Group, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement. (c) A Division License shall mean a subscription license which will cover one named Division and allow for development work on more than one project within such Division. A Division shall mean a business unit within Customer’s organization that works towards a distinct business purpose. Customer is required to identify the name of such Division to Syncfusion; such name must be unambiguous in nature. License fee determinations will be at the sole discretion of Syncfusion and be based on such factors including, but not limited to, Customer’s Division size, developer count, and the scope of the Division’s business purpose. By entering into this Agreement, Customer acknowledges that it is responsible for providing information about the named Customer Division to Syncfusion sufficient for Syncfusion to price the Division License, and Customer represents that it will not withhold information that Syncfusion requires to properly license each such named Customer division, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement. (d) A Global License shall mean a subscription license for all development for a named Customer, where the license fees are based on the overall size of a named Customer. A Global License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer. (e) A Retail License shall mean a single named user, non-transferable license to use the Licensed Product. Retail Licenses will only made available to Customers in Syncfusion’s sole discretion and only when the number of such End-Users is finite and readily ascertainable. Accordingly, Syncfusion will make a determination as to whether or not the provision of Retail Licenses is appropriate under the circumstances applicable to any given Customer, and Syncfusion reserves the right, in its sole discretion, to refuse to make available Retail Licenses to a Customer and instead require a given Customer to procure a Project License, Division License, or Global License as circumstances dictate. A Retail License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer.

  • Combination Product The term “