ANDA Sample Clauses

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ANDA. As further described in Section 6.2, Seller will deliver the ANDA to Buyer.
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ANDA. The New Drug Application filed by an Affiliate of Ingenus for the Product, of which Ingenus has the full rights to such ANDA
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ANDA. “ANDA” means Abbreviated New Drug Application.
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ANDA. MOVA shall be responsible for obtaining the approval of ---- the ANDA by the FDA and in so doing shall exercise what it in good faith believes to be reasonable commercial effort to obtain such approval at the earliest possible date.
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ANDA. ▇▇▇▇▇▇ shall be the sponsor and owner of the ANDA for the Product Elite will provide copies of all correspondence with the FDA and required supporting filing (i.e. copies of annual reports etc.) to ▇▇▇▇▇▇ within ten (10) days of filing such documents with the FDA. ▇▇▇▇▇▇, Elite and Tishtec shall be responsible for prosecuting and filing the ANDA. ▇▇▇▇▇▇ shall be responsible for maintaining the ANDA after approval of the ANDA.
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ANDA. Sagent shall file the ANDA using the Product Information from Gland, and shall be responsible for the maintenance of the ANDA.
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ANDA. 7.1 Aurobindo will maintain the product license (including the ANDA) for the Products and insure the GMP manufacture and release under existing approved quality standards.
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ANDA. Harris shall be the sponsor and owner of the A▇▇▇ ▇▇r the Product Elite will provide copies of all correspondence with the FDA and required supporting filing (i.e. copies of annual reports etc.) to Harris within ten (10) days of filing such documents with the FDA. Harris, Elite and Tishtec shall be ▇esponsible for prosecuting and filing the ANDA. Harris shall be responsible for ma▇▇▇▇▇▇ing the ANDA after approval of the ANDA.
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ANDA. DPSI will prosecute the ANDA for the Product and take all actions necessary to obtain full and effective FDA approval as expeditiously as possible for the manufacture, distribution and sale of the Product in the Territory. If DPSI fails or is unable or unwilling to take any action necessary in relation to the preparation, filing, prosecution or maintenance of the ANDA for the Product, then Mylan, either itself or through agents or designees, shall be authorized to take all necessary and reasonable steps in connection with such filings at DPSI’s expense, such expense to be authorized in advance by DPSI, including without limitation, to file or have filed supplements or amendments to the ANDA and to respond to and correspond with the FDA as necessary in connection therewith, and DPSI shall execute such powers of attorney, consents, assignments or other instruments as may be required for Mylan to perform such activities.
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Related to ANDA

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Regulatory Applications (a) Summit and GAFC and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Summit and GAFC shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and stockholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.