PRODUCT REGISTRATION, NECESSARY DOCUMENTS AND LICENSES Sample Clauses

PRODUCT REGISTRATION, NECESSARY DOCUMENTS AND LICENSES. Subject to definitive approval from the FDA and approval from the Regulatory Steering Committee, MiniMed shall be responsible for preparing, filing and maintaining, at all times any governmental, public health, import permits, licenses and approvals required to enable it lawfully to perform Selling Activities and Manufacturing Activities of the Products in the Field in the Territory in accordance with the Plan and the RCD. MiniMed shall be responsible for the preparation of any regulatory filings required in order to conduct clinical trials on Products and shall be the owner and party of record for all such regulatory filings. Specifically, MiniMed will hold both the NDA related to the Device (FDA 510k filing) and the NDA for the use of the Product in the Field. Lilly must review all submissions prior to being submitted to the FDA and the proposed submission will only be considered approved upon written confirmation from Lilly, which confirmation shall not be unreasonably withheld or delayed. Lilly will use reasonable efforts to provide MiniMed with such written confirmation within thirty (30) days (but in no event longer than sixty (60) days) from receipt of MiniMed's proposed submission. MiniMed shall provide Lilly permission to provide FDA with reference access to any MiniMed NDA filed relating to this Agreement. MiniMed shall further provide Lilly with access to all MiniMed's data and work relating to the Product. Such access, however, will exclude use of MiniMed NDA for Products to be used in the Field. The Products shall be registered in MiniMed's name or in the name of its designee. Upon termination or expiration of the Agreement, MiniMed shall forthwith take commercially reasonable efforts to transfer all registrations and regulatory filings of Products to Lilly or Lilly's designee at Lilly's cost. This covenant shall survive termination or expiration of this Agreement.
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Related to PRODUCT REGISTRATION, NECESSARY DOCUMENTS AND LICENSES

  • Governmental Authorization; Third Party Consent No approval, consent, compliance, exemption, authorization, or other action by or notice to, or filing with, any governmental authority or any other person or entity in respect of any requirements of law or otherwise is necessary or required by the Company in connection with the execution, delivery or performance by the Company of this Agreement, except for such approval, consent, compliance, exemption, authorization, or other action which, if not obtained or made, would not reasonably be likely to prevent or materially delay the Company from performing its obligations under this Agreement in all material respects.

  • Authorization; No Breach; Valid and Binding Agreement The execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the Transactions have been duly and validly authorized by all requisite corporate or organizational action, and no other proceedings on the part of the Stockholders or the Company are necessary to authorize the execution, delivery or performance of this Agreement. Except as set forth on Schedule 3.02 of the Disclosure Schedules, the execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the Transactions does not and will not (a) conflict with, constitute a default under, result in a breach or violation of, (i) any provision of the Acquired Companies’ certificate of incorporation, certificate of formation, bylaws, limited liability company agreement or other organizational documents, or (ii) the provision of any Law or Governmental Order applicable to any Acquired Company; (b) require the consent, notice or other action by any Person under, conflict with, result in a violation or breach of, constitute a default or an event that, with or without notice or lapse of time or both, would constitute a default under, result in the acceleration of or create in any party the right to accelerate, terminate, modify or cancel any (i) Material Contract or (ii) any Permit affecting the properties, assets or business of the Acquired Companies; or (c) result in the creation or imposition of any Lien (other than Permitted Liens) upon any properties or assets of any of the Acquired Companies, except with respect to clauses (a)(ii), (b)(ii) and (c) above, to the extent such conflict, default, breach, violation, acceleration, termination, modification, cancellation or Lien would not be material to the Acquired Companies taken as a whole. This Agreement has been duly executed and delivered by the Company and, assuming that this Agreement is a valid and binding obligations of Purchaser and Merger Sub, constitute valid and binding obligations of the Company, enforceable in accordance with their terms, except as enforceability may be limited by bankruptcy Laws, other similar Laws affecting creditors’ rights and general principles of equity affecting the availability of specific performance and other equitable remedies (regardless of whether considered in a proceeding in equity or at law). No consent, approval, Permit, Governmental Order, declaration or filing with, or notice to, any Governmental Authority is required by or with respect to the Acquired Companies in connection with the execution, delivery and performance of this Agreement and the Transactions, except for (x) the filing of the Certificate of Merger with the Secretary of State of Delaware and (y) such consents, approvals, Permits, Governmental Orders, declarations or filings with or notices to, any Governmental Authority, the absence of which would not individually or in the aggregate be material to the Acquired Companies. All corporate actions taken by the Company in connection with this Agreement will be duly authorized on or prior to the Closing.

  • Governmental Authorization; Third Party Consents No approval, consent, compliance, exemption or authorization of any governmental authority or agency, or of any other person or entity, is necessary or required in connection with the execution, delivery or performance by, or enforcement against, the Warrant Holder of this Warrant Agreement or the transactions contemplated hereby.

  • 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.

  • Governmental Authorizations; Private Authorizations; Governmental Filings The Borrower has obtained, maintained and kept in full force and effect all Governmental Authorizations and Private Authorizations which are necessary for it to properly carry out its business, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, and made all material Governmental Filings necessary for the execution and delivery by it of the Facility Documents to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement and the performance by the Borrower of its obligations under this Agreement, the other Facility Documents, and no material Governmental Authorization, Private Authorization or Governmental Filing which has not been obtained or made, is required to be obtained or made by it in connection with the execution and delivery by it of any Facility Document to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement or the performance of its obligations under this Agreement and the other Facility Documents to which it is a party.

  • Necessary Governmental Approvals The parties shall have received all approvals and actions of or by all Governmental Bodies necessary to consummate the transactions contemplated hereby, which are required to be obtained prior to the Closing by applicable Requirements of Laws.

  • APPROVALS OF THIRD PARTIES AND PERMITS AND CONSENTS Pentegra shall use its best efforts to secure all necessary approvals and consents of third parties to the consummation of the transactions contemplated hereby.

  • Authorization; Valid and Binding Agreement The execution, delivery and performance of this Agreement by Buyer and the consummation of the transactions contemplated hereby have been duly and validly authorized by all requisite action on the part of Buyer, and no other proceedings on Buyer's part are necessary to authorize the execution, delivery or performance of this Agreement. Assuming that this Agreement is a valid and binding obligation of Seller and H&H Group, this Agreement constitutes a valid and binding obligation of Buyer, enforceable in accordance with its terms, except as enforceability may be limited by bankruptcy Laws, other similar Laws affecting creditors' rights and general principles of equity affecting the availability of specific performance and other equitable remedies.

  • Corporate and Governmental Authorization; No Contravention The Borrower’s incurrence of Debt hereunder, and the execution, delivery and performance by the Borrower of this Agreement and the Notes, are within the corporate powers of the Borrower, have been duly authorized by all necessary corporate action, require no action by or in respect of, or filing with, any Governmental Authority (except such as has been obtained), do not contravene, or constitute a default under, any provision of applicable law or regulation or of the certificate of incorporation or by-laws of the Borrower or of any agreement, judgment, injunction, order, decree or other instrument binding upon the Borrower or any of its Subsidiaries, or result in the creation or imposition of any Lien on any asset of the Borrower or any of its Subsidiaries.

  • Organization and Governmental Authorization; No Contravention The execution, delivery and performance by each Credit Party of the Operative Documents to which it is a party are within its powers, have been duly authorized by all necessary action pursuant to its Organizational Documents, require no further action by or in respect of, or filing with, any Governmental Authority and do not violate, conflict with or cause a breach or a default under (a) any Law applicable to any Credit Party or any of the Organizational Documents of any Credit Party, or (b) any agreement or instrument binding upon it, except for such violations, conflicts, breaches or defaults as could not, with respect to this clause (b), reasonably be expected to have a Material Adverse Effect.

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