Manufacturing Licenses and Governmental Audits Sample Clauses

Manufacturing Licenses and Governmental Audits. ImmunoGen shall obtain and maintain at its sole expense all licenses and registrations appropriate and necessary in connection with any manufacturing activities it agrees to conduct under this Section 4 at its manufacturing facility. To the extent ImmunoGen undertakes any manufacturing obligations under this Xxxxxxx 0, XxxxxxXxx shall notify Centocor of any inspections or audits of ImmunoGen’s facilities conducted by governmental authorities (such as the FDA and equivalent European regulatory authorities) affecting or which could reasonably be expected to affect the manufacture of Licensed Product. All of ImmunoGen’s expenses (including internal costs such as, without limitation, labor costs) associated with such audits or inspections shall be borne by ImmunoGen.
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Related to Manufacturing Licenses and Governmental Audits

  • Compliance; Governmental Authorizations The Seller has complied in all material respects with all applicable Federal, state, local or foreign laws, ordinances, regulations and orders. The Seller has all Federal, state, local and foreign governmental licenses and permits necessary in the conduct of the Subject Business the lack of which would have a material adverse effect on the Buyer's ability to operate the Subject Business after the Closing on substantially the same basis as presently operated, such licenses and permits are in full force and effect, no violations are or have been recorded in respect of any thereof and no proceeding is pending or threatened to revoke or limit any thereof. None of such licenses and permits shall be affected in any material respect by the transactions contemplated hereby.

  • TECHNOLOGY/KNOWLEDGE TRANSFER ACTIVITIES The goal of this task is to develop a plan to make the knowledge gained, experimental results, and lessons learned available to the public and key decision makers. • Prepare an Initial Fact Sheet at start of the project that describes the project. Use the format provided by the CAM. • Prepare a Final Project Fact Sheet at the project’s conclusion that discusses results. Use the format provided by the CAM. • Prepare a Technology/Knowledge Transfer Plan that includes: o An explanation of how the knowledge gained from the project will be made available to the public, including the targeted market sector and potential outreach to end users, utilities, regulatory agencies, and others. o A description of the intended use(s) for and users of the project results. o Published documents, including date, title, and periodical name. o Copies of documents, fact sheets, journal articles, press releases, and other documents prepared for public dissemination. These documents must include the Legal Notice required in the terms and conditions. Indicate where and when the documents were disseminated. o A discussion of policy development. State if project has been or will be cited in government policy publications, or used to inform regulatory bodies. o The number of website downloads or public requests for project results. o Additional areas as determined by the CAM. • Conduct technology transfer activities in accordance with the Technology/Knowledge Transfer Plan. These activities will be reported in the Progress Reports. • When directed by the CAM, develop Presentation Materials for an Energy Commission- sponsored conference/workshop(s) on the project. • When directed by the CAM, participate in annual EPIC symposium(s) sponsored by the California Energy Commission. • Provide at least (6) six High Quality Digital Photographs (minimum resolution of 1300x500 pixels in landscape ratio) of pre and post technology installation at the project sites or related project photographs. • Prepare a Technology/Knowledge Transfer Report on technology transfer activities conducted during the project. • Initial Fact Sheet (draft and final) • Final Project Fact Sheet (draft and final) • Presentation Materials (draft and final) • High Quality Digital Photographs • Technology/Knowledge Transfer Plan (draft and final) • Technology/Knowledge Transfer Report (draft and final)

  • Governmental and Regulatory Approvals Approvals from any Governmental or Regulatory Authority (if any) necessary for consummation of the transactions contemplated hereby shall have been obtained.

  • DEVELOPMENTAL REQUIREMENTS The Personal Development Plan (PDP) for addressing developmental gaps is attached as Annexure B.

  • Other Governmental Approvals Developer may apply for such other permits and approvals as may be required for development of the Project in accordance with this Agreement from other governmental or quasi-governmental agencies having jurisdiction over the Property. The City shall reasonably cooperate with Developer in its endeavors to obtain such permits and approvals.

  • Governmental and Third Party Approvals The Credit Parties shall have received all material governmental, shareholder and third party consents and approvals necessary (or any other material consents as determined in the reasonable discretion of the Administrative Agent) in connection with the transactions contemplated by this Agreement and the other Loan Documents and the other transactions contemplated hereby and all applicable waiting periods shall have expired without any action being taken by any Person that could reasonably be expected to restrain, prevent or impose any material adverse conditions on any of the Credit Parties or such other transactions or that could seek or threaten any of the foregoing, and no law or regulation shall be applicable which in the reasonable judgment of the Administrative Agent could reasonably be expected to have such effect.

  • Necessary Governmental Approvals The parties shall have received all approvals and actions of or by all Governmental Bodies which are necessary to consummate the transactions contemplated hereby, which are either specified in Schedule 5.3(B)(ii) or otherwise required to be obtained prior to the Closing by applicable Requirements of Laws.

  • Required Governmental Approvals All governmental authorizations, consents and approvals necessary for the valid consummation of the transactions contemplated hereby shall have been obtained and shall be in full force and effect. All applicable governmental pre-acquisition filing, information furnishing and waiting period requirements shall have been met or such compliance shall have been waived by the governmental authority having authority to grant such waivers.

  • Requisite Governmental Approvals No Consent of any Governmental Authority is required on the part of Parent, Merger Sub or any of their Affiliates in connection with the (a) execution and delivery of this Agreement by each of Parent and Merger Sub; (b) performance by each of Parent and Merger Sub of their respective covenants and obligations pursuant to this Agreement; or (c) consummation of the Merger, except (i) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware and such filings with Governmental Authorities to satisfy the applicable Laws of states in which the Company and its Subsidiaries are qualified to do business; (ii) such filings and approvals as may be required by any federal or state securities Laws, including compliance with any applicable requirements of the Exchange Act; (iii) compliance with any applicable requirements of the HSR Act and any applicable foreign Antitrust Laws; and (iv) such other Consents the failure of which to obtain would not, individually or in the aggregate, have a Parent Material Adverse Effect.

  • Compliance with Law; Governmental Approvals Each of the Borrower, the other Loan Parties and the other Subsidiaries is in compliance with each Governmental Approval and all other Applicable Laws relating to it except for noncompliances which, and Governmental Approvals the failure to possess which, could not, individually or in the aggregate, reasonably be expected to cause a Default or Event of Default or have a Material Adverse Effect.

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