Encap Regulatory Obligations Sample Clauses

Encap Regulatory Obligations. Encap shall be responsible for and shall conduct all activities necessary for (i) maintaining approved regulatory status for commercial production and testing facilities including U.S. FDA and its equivalent in the Territory and other customary standards and paying all regulatory and license fees for its facilities, conducting Product support such as periodic audits, annual Product reviews, sample storage, batch documentation, audit reports, appropriate vendor qualification and other applicable regulatory requirements to supply Product to the Territory during the Term and following FDA approval of the Product; (ii) serving as the importer of record and import the API on Customer’s behalf and at Customer’s expense, including obtaining all permits and licenses required to import of raw materials and components, including API, and co-operating with Customer on the export of API for the development, manufacture, and delivery of pilot batches, pivotal batches, validation, and commercial batches of the Product, along with associated costs for the import permits or licenses; (iii) being prepared for an FDA pre-approval inspection within [***] working days of Application submission; and (iv) diligently sharing with Customer all regulatory communication pertaining to Product supply and quality. “Submission” shall be deemed to have occurred on the date that the Application is delivered to the FDA by Customer or its agent.
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Related to Encap Regulatory Obligations

  • Statutory Obligations Nothing in this Agreement shall be construed to modify, eliminate or detract from the statutory responsibilities and obligations of the Employer except that the exercise of its rights in the furtherance of such statutory obligations shall not be in conflict with the provisions of this Agreement.

  • 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.

  • Third Party Obligations 3.1. The THIRD PARTY shall:-

  • 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.

  • Customer Obligations Customer shall:

  • Primary Obligations This Guaranty is a primary and original obligation of Guarantor, is not merely the creation of a surety relationship, and is an absolute, unconditional, and continuing guaranty of payment and performance which shall remain in full force and effect without respect to future changes in conditions. Guarantor hereby agrees that it is directly, jointly and severally with any other guarantor of the Guarantied Obligations, liable to Agent, for the benefit of the Lender Group and the Bank Product Providers, that the obligations of Guarantor hereunder are independent of the obligations of Borrower or any other guarantor, and that a separate action may be brought against Guarantor, whether such action is brought against Borrower or any other guarantor or whether Borrower or any other guarantor is joined in such action. Guarantor hereby agrees that its liability hereunder shall be immediate and shall not be contingent upon the exercise or enforcement by any member of the Lender Group or any Bank Product Provider of whatever remedies they may have against Borrower or any other guarantor, or the enforcement of any lien or realization upon any security by any member of the Lender Group or any Bank Product Provider. Guarantor hereby agrees that any release which may be given by Agent to Borrower or any other guarantor, or with respect to any property or asset subject to a Lien, shall not release Guarantor. Guarantor consents and agrees that no member of the Lender Group nor any Bank Product Provider shall be under any obligation to marshal any property or assets of Borrower or any other guarantor in favor of Guarantor, or against or in payment of any or all of the Guarantied Obligations.

  • Delivery Obligations 9.1 The Grant Recipient must in relation to each Named Project:

  • Licensee Obligations 3.1 The Licensee is responsible for the installation, operation and maintenance of telecommunication lines, equipment, software and other arrangements necessary for the Licensee to receive the Licensed Data from the LME.

  • Warranty Obligations (a) Project Co represents, warrants and covenants that:

  • 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.

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