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

  • Third-Party Agreements and Rights The Executive hereby confirms that the Executive is not bound by the terms of any agreement with any previous employer or other party which restricts in any way the Executive’s use or disclosure of information or the Executive’s engagement in any business. The Executive represents to the Company that the Executive’s execution of this Agreement, the Executive’s employment with the Company and the performance of the Executive’s proposed duties for the Company will not violate any obligations the Executive may have to any such previous employer or other party. In the Executive’s work for the Company, the Executive will not disclose or make use of any information in violation of any agreements with or rights of any such previous employer or other party, and the Executive will not bring to the premises of the Company any copies or other tangible embodiments of non-public information belonging to or obtained from any such previous employment or other party.

  • 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.

  • Know-How Necessary for the Business The Intellectual Property Rights are all those necessary for the operation of the Company’s businesses as it is currently conducted or as represented, in writing, to the Purchasers to be conducted. The Company is the owner of all right, title, and interest in and to each of the Intellectual Property Rights, free and clear of all liens, security interests, charges, encumbrances, equities, and other adverse claims, and has the right to use all of the Intellectual Property Rights. To the Company’s knowledge, no employee of the Company has entered into any contract that restricts or limits in any way the scope or type of work in which the employee may be engaged or requires the employee to transfer, assign, or disclose information concerning his work to anyone other than of the Company.

  • 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.

  • Necessary Filings 3 2.2. No Liens.........................................................3 2.3.

  • Permits and Licenses The Contractor shall observe and comply with all laws, rules, and regulations affecting services under this Agreement. The Contractor shall procure and keep in full force and effect during the term of this Agreement all permits and licenses necessary to accomplish the Work contemplated in this Agreement.

  • Possession of Licenses and Permits The Company and its subsidiaries possess such permits, licenses, approvals, consents and other authorizations (collectively, "Governmental Licenses") issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business now operated by them; the Company and its subsidiaries are in compliance with the terms and conditions of all such Governmental Licenses, except where the failure so to comply would not, singly or in the aggregate, have a Material Adverse Effect; all of the Governmental Licenses are valid and in full force and effect, except when the invalidity of such Governmental Licenses or the failure of such Governmental Licenses to be in full force and effect would not have a Material Adverse Effect; and neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such Governmental Licenses which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would result in a Material Adverse Effect.

  • Trademarks, Franchises, and Licenses The Borrower and its Subsidiaries own, possess, or have the right to use all necessary patents, licenses, franchises, trademarks, trade names, trade styles, copyrights, trade secrets, know how, and confidential commercial and proprietary information to conduct their businesses as now conducted, without known conflict with any patent, license, franchise, trademark, trade name, trade style, copyright or other proprietary right of any other Person.

  • No Violation; Necessary Approvals Neither the execution and delivery of this Agreement by the Company, nor the consummation or performance by the Company of any of the transactions contemplated hereby, will: (a) with or without notice or lapse of time, constitute, create or result in a breach or violation of, default under, loss of benefit or right under or acceleration of performance of any obligation required under any Law, Order, contract or Permit to which the Company is a party or by which it is bound or any of its assets are subject, or any provision of the Company’s organizational documents as in effect on the Closing Date, (b) result in the imposition of any lien, claim or encumbrance upon any assets owned by the Company; (c) require any Consent under any contract or organizational document to which the Company is a party or by which it is bound; or (d) require any Permit under any Law or Order other than (i) required filings, if any, with the SEC and (ii) notifications or other filings with state or federal regulatory agencies after the Closing that are necessary or convenient and do not require approval of the agency as a condition to the validity of the transactions contemplated hereunder; or (e) trigger any rights of first refusal, preferential purchase or similar rights with respect to any of the Shares.

  • Third Party Agreements To use our Services you may need to enter into agreements with other service providers which we call “Third Party Service Providers”. For example, if you use our Services via our mobile app, you may need to enter into an agreement with your mobile device manufacturer and network operator. You agree to comply with the terms of the agreements you enter into with Third Party Service Providers and which are related to your use of our Services.

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