Product Regulatory Obligations Sample Clauses

Product Regulatory Obligations. All liabilities, obligations and responsibilities undertaken by Horizon pursuant to Section 5.4.
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Product Regulatory Obligations. (a) Handling of Inventory and Finished Product. Purchaser shall hold, store, manufacture, package and test any Inventory consisting of Product lots (including but not limited to its raw materials, excipients, and components) bearing a trade name or trademark used by Seller prior to the Closing Date and which trade name or trademark is not transferred to Purchaser hereunder or pursuant to the Asset Purchase Agreement (any such Product lot, together with any Product lot from which Products were sold by Seller prior to the Closing Date are referred to herein as "Pre-Closing Product Lots") in accordance with (i) current Good Manufacturing Practices, (ii) the Product application or license, (iii) applicable analytical procedures, material specifications, master batch records, stability protocols, analytical methods and packaging instructions and (iv) all other applicable Laws.

Related to Product Regulatory Obligations

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Supply Obligations Upon Licensor’s request, AbbVie shall either (a) to the extent allowable under such agreements, assign to Licensee or its Affiliates the portion of AbbVie’s agreement(s) with its Third Party manufacturing provider related to the Terminated Antibodies, Terminated Products and placebo used in connection therewith, or alternatively, use Commercially Reasonable Efforts to facilitate Licensor’s entering into a direct supply agreement with such Third Party manufacturing provider of the Terminated Antibodies, Terminated Products and placebo used in connection therewith on comparable terms to those between AbbVie and such Third Party manufacturing provider (in each case assuming AbbVie is then obtaining supply of Terminated Antibodies, Terminated Products or placebo used in connection therewith from a Third Party manufacturing provider) and (b) to the extent AbbVie or its Affiliate is producing its own supply of the Terminated Product, Terminated Antibody or placebo, use Commercially Reasonable Efforts to supply to Licensor the Terminated Antibodies and/or Terminated Products and placebo as requested by Licensor, to the extent reasonably necessary for Licensor’s continued Development and Commercialization of such Terminated Antibodies and/or Terminated Products, until the date on which Licensor notifies AbbVie in writing that Licensor has secured an alternative manufacturer for the Terminated Antibodies and/or Terminated Products, but in no event more for than [***] after the effective date of any expiration or termination of this Agreement. In the case of (b), Licensor shall pay to AbbVie a transfer price for the materials supplied equal to the Manufacturing Cost thereof. Without limiting the foregoing, in either case Licensor shall additionally have the right to immediately have AbbVie commence the transfer of the Manufacturing Process to Licensor or its designee, with such transfer to be carried out in accordance with the terms of Section 3.5.3, applied mutatis mutandis. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Third Party Obligations Executive acknowledges that the Company from time to time may have agreements with other persons or entities which impose obligations or restrictions on the Company regarding development-related work made during the course of work thereunder or regarding the confidential nature of such work. Executive agrees to be bound by all such obligations and restrictions and to take all action necessary to discharge the obligations of the Company.

  • Licensee Obligations Licensee shall monitor and censor all Content on the websites associated with the Licensed Domain Names, including without limitation Content posted by end users. Licensor shall also have the right to monitor and censor Content of the websites associated with Licensed Domain Names. Licensee shall remove any offending Content, including, but not limited to, any illegal materials, pornographic, obscene or sexually explicit materials, materials of a violent nature, or politically sensitive materials, from such websites as soon as possible after it becomes aware of such offending Content but in no event later than the timeframe prescribed by the Governmental Authority after receipt of oral or written notice from Licensor or such Governmental Authority. Licensee’s failure to comply with this Section 3.3(a) shall be deemed a material breach of this Agreement. Without limiting the foregoing obligations, Licensee acknowledges that Licensor shall have the right to remove such offending Content from the websites associated with Licensed Domain Names.

  • Product Claims You and the end-user must acknowledge that You, not Apple, are responsible for addressing any claims of the end-user or any third party relating to the Licensed Application or the end-user’s possession and/or use of that Licensed Application, including, but not limited to: (i) product liability claims; (ii) any claim that the Licensed Application fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. The XXXX may not limit Your liability to the end-user beyond what is permitted by applicable law.

  • Royalty Obligations Part 2.7(e) of the Disclosure Schedule contains a complete and accurate list and summary of all royalties, fees, commissions, and other amounts payable by the Seller to any Person (other than sales commissions paid to employees according to the Seller’s standard commissions plan) upon or for the sale, or distribution of any Seller Product or the use of any Seller IP.

  • Product The term “

  • 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.

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