Product Event definition

Product Event shall have the meaning provided in Section 6.7 of this Agreement.

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Product Event shall have the meaning set forth in Section 3.22.

Product Event means a recall, withdrawal, retrieval, replacement, post-sale warning, field notification, “dear doctor” letter or other adverse event report or notification in respect of any of the Products.

Examples of Product Event in a sentence

In any event, Prometheus will be responsible for leading all Product Event investigations and for all associated communications with Governmental Authorities.
In the event Prometheus deems it necessary or is otherwise required by a Governmental Authority to initiate a recall, withdrawal or field correction of, field alert report or comparable report with respect to any Product manufactured by GSK pursuant to this Agreement (in each instance, a "Product Event"), Prometheus shall notify GSK and GSK shall fully cooperate with Prometheus to address, as appropriate, such Product Event.
To the Seller’s Knowledge, there are no facts or circumstances reasonably likely to cause (i) a Product Event, (ii) a safety communication, or (iii) a termination, seizure, or suspension of marketing of any Product.
Subject to Clause 28 (Indemnities) and Clause 29 (Liability), the remedy set forth in this Clause 20.3 shall be the Purchaser’s sole and complete remedy under this Agreement with respect to any Product Event.
In all such cases, Licensee shall closely coordinate with Licensor with respect to any actions Licensee or Licensor might take or permit, and in respect to all public statements either party might make regarding the Product Event or Third Party Action.

More Definitions of Product Event

Product Event has the meaning given in Clause 20.2. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.

Product Event will have the meaning set forth in the Section 6.2(c)(i).

Product Event has the meaning given in Clause 21.2.

Product Event has the meaning given in Clause 20.2. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Product Event means any serious adverse event that (i) is determined by an independent safety review committee overseeing the safety of the relevant clinical study to be directly related to the Key Product, IDX-21459 or Samatasvir (not predominantly related to any compound with which such product is co-administered) and to have (a) resulted in death, (b) been life-threatening, (c) required inpatient hospitalization or a significant prolongation of existing hospitalization, (d) resulted in persistent or significant disability or incapacity, (e) resulted in a congenital anomaly or birth defect or (f) required significant intervention to prevent permanent impairment or damage; and (ii) (x) results in the FDA or a comparable foreign regulatory authority, agency, commission, body or governmental entity placing a clinical hold on the development program of the Key Product, IDX-21459 or Samatasvir or (y) is likely to result in a significant delay to the development timeline of the Key Product, IDX-21459 or Samatasvir as of the date of this Agreement. As used in this Agreement, “Key Product” means IDX-21437.

Product Event has the meaning set forth in Section 2.23(d). “Purchase Price Decrease” has the meaning set forth in Section 1.3(e)(ii). “Purchase Price Increase” has the meaning set forth in Section 1.3(e)(i). “Receivables” means all accounts receivable, trade receivables, notes receivable and other receivables of the Company and/or any of its Subsidiaries, including, but not limited to, all proceeds, credits due, and rebates receivable. “Registered Intellectual Property Rights” has the meaning set forth in Section 2.11(a). “Regulatory Laws” shall mean the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; the Federal Alcohol ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇ ▇.▇.▇. §▇▇▇ et seq.; the Federal Trade Commission Act, 15 U.S.C. §41 et seq.; the Organic Foods Production Act, 7 U.S.C. §6501-6524, the implementing regulations under the aforementioned statutes, and all other applicable Laws relating to the development, testing, manufacturing, importation, distribution, labeling, advertising, or promotion of any Product. “Related Persons” has the meaning set forth in Section 2.20(a). “Release” and/or “Releases” means any unauthorized release, deposit, discharge, emission, leaking, spilling, seeping, migrating, injecting, pumping, pouring, emptying, escaping, dumping, disposing or other movement into or upon any land or water or air, or otherwise entering into the indoor or outdoor environment (including the placing, discarding, or abandonment of any barrel, container, or other receptacle containing any Hazardous Substances or other material regulated under Environmental and Safety Laws). “Remediation” means (a) any remedial action, remedy, response, or removal action as those terms are defined in 42 U.S.C. § 9601 and/or the General Law on the Prevention and Integral Management of Wastes, (b) any corrective action as that term has been construed pursuant to 42 U.S.C. § 6924, and (c) any measures or actions required or undertaken to investigate, assess, evaluate, monitor, or otherwise delineate the presence or Release of any Hazardous Substance in or into the environment or to prevent, clean up, or minimize a Release or threatened Release of Hazardous Substances. “Released Persons” has the meaning set forth in Section 5.3. “Sanctioned Person” means at any time any Person: (a) listed on any Sanctions-related list of designated or blocked Persons; (b) the government of, resident in, or organized under the Laws of a country, jurisdiction or territory that is the subject of comprehensi...

Product Event shall have the meaning set forth in Section 4.4(c) of this Termination Agreement.