REGULATORY / PRODUCT LIABILITY Sample Clauses

REGULATORY / PRODUCT LIABILITY. 22.1 All of the Relevant Products are and have been developed, manufactured, tested, packaged, labelled, held, stored, distributed, marketed, imported, exported, and sold, in all material respects in accordance with (i) the requirements, specifications and standards contained in the relevant Product Registration and (ii) all Applicable Laws.
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REGULATORY / PRODUCT LIABILITY. For the purposes of this Clause 11.1, Relevant Period shall mean the period commencing 4 years before the Closing Date and ending on the Closing Date.

Related to REGULATORY / PRODUCT LIABILITY

  • Product Warranty; Product Liability (a) Except as set forth on Company Disclosure Schedule 4.23, the products produced, sold or delivered by the Company in conducting the Business have been in all material respects in conformity with all product specifications and all applicable Laws. To the Company’s Knowledge, the Company has no material Liability for damages in connection therewith or any other customer or product obligations not reserved against on the Balance Sheet.

  • Product Liability and Recalls (a) Except a disclosed in Section 3.27 of the Disclosure Schedule or the Company SEC Documents to the Best Knowledge of the Company, there is no claim, or the basis of any claim, against the Company or any of this subsidiaries for injury to person or property of employees or any third parties suffered as a result of the sale of any product or performance of any service by the Company or any of its subsidiaries, including claims arising out of any alleged defective nature of its products or services, which could reasonably be expected to have a Material Adverse Effect on the Company.

  • Product Liability The Company has no Liability (and there is no basis for any present or future action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand against any of them giving rise to any Liability) arising out of any injury to individuals or property as a result of the ownership, possession, or use of any product manufactured, sold, leased, or delivered by the Company.

  • Product Warranty and Product Liability Schedule 5.17 of the Disclosure Schedule contains a true, correct and complete copy of Company’s standard warranty or warranties for sales of Products (as defined below) and, except as stated therein, there are no warranties, commitments or obligations with respect to the return, repair or replacement of Products. Schedule 5.17 of the Disclosure Schedule contains a description of all product liability claims and similar claims, actions, litigation and other proceedings relating to Products which are presently pending or which to Company’s knowledge are threatened, or which have been asserted or commenced against Company within the last two (2) years, in which a party thereto either requests injunctive relief (whether temporary or permanent) or alleges damages in excess of $100,000.00 (whether or not covered by insurance). To the best of the Company’s knowledge, there are no defects in design, construction or manufacture of Products which would adversely affect performance or create an unusual risk of injury to persons or property. Except as set forth on Schedule 5.17, none of the Products has been the subject of any replacement, field fix, retrofit, modification or recall campaign other than in the ordinary course of business. The Products have been designed and manufactured so as to meet and comply with all governmental standards and specifications currently in effect, and have received all governmental approvals necessary to allow their sale and use. As used herein, the term “Products” means any and all products currently or at any time previously manufactured, distributed or sold by Company, or by any predecessor of Company under any brand name or xxxx under which products are or have been manufactured over the last three (3) years, distributed or sold by Company, in or through the Business. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

  • Product Liabilities There are no product recalls, trade disputes, product liabilities or product tampering claims now pending, threatened against or made by or affecting the Company or any of its directors, officers or employees or the businesses, assets or rights of the Company.

  • Product Liability Claims Notwithstanding the provisions of Section 9.2, any Losses arising out of any Third Party claim, suit, action, proceeding, liability or obligation involving any actual or alleged death or bodily injury arising out of or resulting from the development, manufacture or Commercialization of any Fibrocell Products or Improved Products for use or sale in the Field, to the extent that such Losses exceed the amount (if any) covered by the applicable Party’s product liability insurance (“Excess Product Liability Costs”), shall be paid by [*****], except to the extent such Losses arise out of any Third-Party Claim based on the gross negligence or willful misconduct of a Party, its Affiliates, or its Affiliates’ sublicensees, or any of the respective officers, directors, employees and agents of each of the foregoing entities, in the performance of obligations or exercise of rights under this Agreement.

  • Third Party Patents If any Third Party claims that a patent it owns or controls claims any aspect of a Licensed Product or its manufacture, use or sale, the Party with notice of such claim shall notify the other Party promptly, and the Parties shall as soon as practicable thereafter discuss in good faith regarding the best response.

  • Third Party Patent Rights If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party and having one or more claims that Cover the Compound or Product, or the use, sale, offer for sale or importation of the Compound or Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 7.6, in which case the provisions of Section 7.6 shall govern), such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Provention shall have the exclusive right, but not the obligation, to bring, at its own expense and in its sole control, such action in the Territory. If Provention does not bring such an action in the Territory, within ninety (90) days of notification thereof pursuant to this Section 7.7(a) (or earlier, if required by the nature of the proceeding), MacroGenics shall have the right, but not the obligation, to bring, at MacroGenics’ own expense, such action. The Party not bringing an action under this Section 7.7(a) shall be entitled to separate representation in such proceeding by counsel of its own choice and at its own expense, and shall cooperate fully with the Party bringing such action. Any awards or amounts received in bringing any such action shall be first allocated to reimburse the initiating Party’s expenses in such action, and any remaining amounts shall be allocated between the Parties as provided in Section 7.5(e).

  • Infringement of Third Party Patents (a) If a third party asserts that a patent or other proprietary right owned by it is infringed by the manufacture, use, importation, offer for sale or sale of a Licensed Product in the Field and in the Territory and such alleged infringement arises in whole or in part from Alcon's use of the Pharmacyclics Technology (a "Claim"), the Party against whom such a Claim was asserted shall immediately provide the other Party notice of such Claim and the related facts in reasonable detail. Unless it is mutually agreed that the Parties should proceed jointly in defending such an action, the Party sued shall defend such action. The other Party shall cooperate in connection therewith and shall have the right to be represented separately by counsel of its own choice, at its own expense. The entity (whether Pharmacyclics or Alcon) that controls the defense of such a Claim with respect to the Licensed Product in the Field and in the Territory shall also have the right to control settlement of such Claim; provided, however, that no settlement shall be entered into without the consent of the other Party. To the extent that any of the costs set forth in clauses (i), (ii) or (iii) of this sentence are attributable to infringement arising from Alcon's use of the Pharmacyclics Technology, Alcon shall have the right to deduct from and offset against royalties otherwise payable to Pharmacyclics under Section 4.4(a), the following: (i) all litigation costs related to such Claim; (ii) any money damages paid by Alcon or its Affiliates pursuant to any judgment or settlement resulting from such Claim; and (iii) any royalty that Alcon and/or its Affiliates and sublicensees are required to pay to a third party in settlement of such Claim in order to continue to exercise Alcon's license rights as set forth in this Agreement. Notwithstanding the foregoing, in no event shall royalties owed Pharmacyclics under Section 4.4(a) be reduced by more than (*) in any given royalty period.

  • Product The term “

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