Maintenance of Drug Master File Sample Clauses

Maintenance of Drug Master File. (a) During the Designated Period, Supplier shall, at Supplier's expense, (i) maintain DMFs on file with the FDA and with such other Regulatory Authorities as Supplier may determine or as BNP may request from time to time, and comply with the requirements of the Regulatory Authorities with respect thereto; (ii) amend the DMFs to permit BNP to incorporate by reference all data and information in the DMFs which BNP requires in support of its submissions to any of the Regulatory Authorities for Product which utilize the Substance; (iii) timely and fully respond to the [ ] issued by the FDA to Supplier in [ ] and to the items relating to Substance contained in the major amendment letter issued by the FDA to [ ] in [ ], and resolve any deficiencies contained in such letters related to Supplier's facilities and/or the Substance to the satisfaction of the FDA; (iv) use its best efforts to resolve other deficiencies identified by any Regulatory Authority which materially and adversely affect BNP's use of the Substance in Product, including without limitation by using its best efforts to provide such documentation, data and information and making such corrections as the Regulatory Authorities may require (in considering the efforts required of Supplier, it is recognized that Supplier intends to exit from the business of manufacturing paclitaxel bulk drug substance and that such exit may limit the efforts it is able to make, but Supplier shall in any event remain able, during the Designated Period, to provide to the Regulatory Authorities the documentation, data, and information, as to Substance delivered or to be delivered under this Agreement, that it would compile in the ordinary course of business and in accordance with the requirements of the Regulatory Authorities if it were not exiting the business); and (v) cooperate with BNP in connection with BNP's submissions to the Regulatory Authorities for approval of Product.
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Maintenance of Drug Master File. (a) During the Designated Period, Supplier shall, at Supplier's expense, (i) [ ].
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Related to Maintenance of Drug Master File

  • Maintenance of Goods Such Grantor will do all things necessary to maintain, preserve, protect and keep its Inventory and the Equipment in good repair and working and saleable condition, except for damaged or defective goods arising in the ordinary course of such Grantor’s business and except for ordinary wear and tear in respect of the Equipment.

  • Maintenance of Patents, Trademarks, Etc Each Loan Party shall, and shall cause each of its Subsidiaries to, maintain in full force and effect all patents, trademarks, service marks, trade names, copyrights, licenses, franchises, permits and other authorizations necessary for the ownership and operation of its properties and business if the failure so to maintain the same would constitute a Material Adverse Change.

  • Patent Maintenance All annuity and maintenance fees that are necessary in order to keep the Patents in force as of the Effective Date have been paid by Seller, and no payment of annuities or fees, or papers to be filed in patent offices, are required to be made within the three-month period after the Effective Date.

  • Filing, Prosecution and Maintenance of Patents RENOVIS agrees to file, prosecute and maintain in the Territory, upon appropriate consultation with MERCK, the RENOVIS Patent Rights licensed to MERCK under this Agreement; provided, however, with respect to Joint Information and Inventions that are not Improvements to RENOVIS Patent Rights or RENOVIS Technology, MERCK shall have the first right to file patent applications for such Joint Information and Inventions. With respect to RENOVIS Information and Inventions, RENOVIS may elect not to file and if so MERCK shall have the right to file patent applications. In such event, RENOVIS shall execute such documents and perform such acts at RENOVIS’ expense as may be reasonably necessary to effect an assignment of such Patent Rights to MERCK in a timely manner to allow MERCK to continue such prosecution or maintenance. In each case, the filing Party shall give the non-filing Party an opportunity to review the text of the application before filing, shall consult with the non-filing Party with respect thereto, and shall supply the non-filing Party with a copy of the application as filed, together with notice of its filing date and serial number. RENOVIS shall keep MERCK advised of the status of the actual and prospective patent filings and upon the request of MERCK, provide advance copies of any papers related to the filing, prosecution and maintenance of such patent filings. RENOVIS shall promptly give notice to MERCK of the grant, lapse, revocation, surrender, invalidation or abandonment of any Patent Rights licensed to MERCK for which RENOVIS is responsible for the filing, prosecution and maintenance. With respect to all filings hereunder, the filing Party shall be responsible for payment of all costs and expenses related to such filings.

  • Filing Prosecution and Maintenance of Patent Rights 7.1 Patent Filing, Prosecution and Maintenance.

  • Patent Filing Prosecution and Maintenance 7.1 Except as otherwise provided in this Article 7, Licensee agrees to take responsibility for, but to consult with, the PHS in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in the Licensed Patent Rights and shall furnish copies of relevant patent-related documents to PHS.

  • Maintenance of Patents 12 5.5. Prosecution of Patent Application................................................. 12 5.6.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Patent Prosecution and Maintenance 8.1 Pursuant to Section 3.1, LICENSEE shall bear the cost of all patent expenses, past and future, associated with the preparation, filing, prosecution, issuance and maintenance of U.S. Patent applications and U.S. Patents included within the PATENT RIGHTS. Such filings and prosecution shall be by counsel of UNIVERSITY’s choosing and shall be in the name of UNIVERSITY or UNIVERSITY and joint owner if jointly owned. UNIVERSITY shall keep LICENSEE advised as to the prosecution of such applications by forwarding to LICENSEE copies of all official correspondence, (including, but not limited to, applications, office actions, responses, etc.) relating thereto. LICENSEE shall have the first right to request filings, prosecute, and maintain patent applications and patents included within the PATENT RIGHTS, however, all such action instructed by LICENSEE shall be requested of UNIVERSITY and, UNIVERSITY shall (i) have a right to make comments thereto, and (ii) timely instruct its counsel to act in accord with LICENSEE’s instructions. In the event of a disagreement between LICENSEE and UNIVERSITY regarding such prosecution or maintenance, UNIVERSITY shall have the right to make the final decisions for all matters associated with such prosecution and maintenance, however, UNIVERSITY shall be responsible for any and all costs associated with prosecution and maintenance matters in which UNIVERSITY made a final determination pursuant to this section. In order to facilitate LICENSEE’s rights to comment and advise Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. UNIVERSITY, UNIVERSITY will provide, to the extent that it is able, copies of all such official correspondence and any proposed responses by UNIVERSITY at least twenty (20) business days prior to any filing or response deadlines. UNIVERSITY shall diligently prosecute such patent applications included within the Patent Rights and shall seek strong and broad claims under the Patent Rights. UNIVERSITY shall not abandon prosecution or maintenance of any Patent Rights without notifying LICENSEE in a timely manner of UNIVERSITY’s intention and reason therefore and providing LICENSEE with reasonable opportunity to comment upon such abandonment and to assume responsibility for prosecution or maintenance of such Patent Rights.

  • Prosecution and Maintenance of Patents Patent Costs ----------------------------------------------------

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