NDA and NDC Sample Clauses

NDA and NDC. BexR shall assist Napo with transfer of the Product New Drug Application (“NDA”) from Valeant Pharmaceuticals International, Inc., as successor to Salix Pharmaceuticals, Inc. (“Valeant”) and shall coordinate with Napo to obtain a new National Drug Code (“NDC”) for the Product, including assistance with interactions with the FDA regarding the foregoing, and thereafter, assist Napo with the maintenance of the NDA in the U.S. as defined in Exhibit B.
AutoNDA by SimpleDocs

Related to NDA and NDC

  • Export Administration Each party agrees to comply with all export laws and regulations of the United States (“Export Laws”) to assure that no software deliverable, item, service, technical data or any direct product thereof arising out of or related to this Agreement is exported directly or indirectly (as a physical export or a deemed export) in violation of Export Laws.

  • Export Control This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.

  • Procurement of Goods and Works Except as ADB may otherwise agree, Goods and Works shall only be procured on the basis of the methods of procurement set forth below:

  • Export Control Regulations Buyer understands that Seller and the Goods are subject to the United States Export Administration Act, the Trading with the Enemy Act, the International Traffic in Arms Regulations (in the case of Goods that are considered defense articles), and other laws and regulations of the United States of America (collectively, the “Regulations”), which Regulations are enforced, inter alia, by the United States Departments of Commerce, State and Treasury. The Regulations, in part, prohibit export or diversion of the Goods to certain countries. Xxxxx agrees to abide by all Regulations, including those concerning the resale and disposition of the Goods. Buyer warrants that it will not sell, transfer or support, directly or indirectly, or assist in any sale or transfer of any products or product technology in countries or to users concerning which such sale, transfer or support is not permitted under applicable Regulations. Buyer shall defend, hold harmless and indemnify Seller for any damages resulting to Seller from a breach of this paragraph by Xxxxx.

  • Export Control Laws LICENSEE shall observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data to foreign countries, including, without limitation, the International Traffic in Arms Regulations and the Export Administration Regulations.

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • QUALITY OF GOODS 5.1 Voip Unlimited warrants that on delivery, the Goods shall: (a) conform in all material respects with the Goods Specification; (b) be free from material defects in design, material and workmanship; (c) be of satisfactory quality (within the meaning of the Sale of Goods Act 1979); and (d) be fit for any purpose held out by Voip Unlimited. 5.2 Subject to clause 5.3, if: (a) the Customer gives notice in writing within a reasonable time of discovery that some or all of the Goods do not comply with the warranty set out in clause 5.1; (b) Voip Unlimited is given a reasonable opportunity of examining such Goods; and (c) the Customer (if asked to do so by Voip Unlimited) returns such Goods to Voip Unlimited's place of business at Voip Unlimited's cost, Voip Unlimited shall, at its option, repair or replace the defective Goods, or refund the price of the defective Goods in full. 5.3 Voip Unlimited shall not be liable for the Goods' failure to comply with the warranty in clause 5.1 if: (a) the Customer makes any further use of such Goods after giving a notice in accordance with clause 5.2; (b) the defect arises because the Customer failed to follow Voip Unlimited's oral or written instructions as to the storage, installation, commissioning, use or maintenance of the Goods or (if there are none) good trade practice; (c) the defect arises as a result of Voip Unlimited following any drawing, design or Goods Specification supplied by the Customer; (d) the Customer alters or repairs such Goods without the written consent of Voip Unlimited; (e) the defect arises as a result of fair wear and tear, wilful damage, negligence, or abnormal working conditions; (f) the Goods differ from the Goods Specification as a result of changes made to ensure they comply with applicable statutory or regulatory standards. 5.4 Except as provided in this clause 5, Voip Unlimited shall have no liability to the Customer in respect of the Goods' failure to comply with the warranty set out in clause 5.1. 5.5 The terms of these Conditions shall apply to any repaired or replacement Goods supplied by Voip Unlimited under clause 5.2.

  • LEAVE FOR REGULATORY BUSINESS AS PER THE TEACHERS’ ACT 1. Upon written request to the Superintendent or designate from the Ministry of Education, an employee who is appointed or elected to the BC Teachers’ Council or appointed to the Disciplinary or Professional Conduct Board shall be entitled to a leave of absence with pay and shall be deemed to be in the full employ of the board as defined in Article G.6.1. 2. Upon written request to the superintendent or designate from the Ministry of Education, a teacher teaching on call (TTOC) who is appointed or elected to the BC Teachers’ Council or appointed to the Disciplinary and Professional Conduct Board shall be considered on leave and shall be deemed to be in the full employ of the Board as defined in Article A.10.1 above. TTOCs shall be paid in accordance with the collective agreement. 3. Leave pursuant to Article A.10.1 and A.10.2 above shall not count toward any limits on the number of days and/or teachers on leave in the provisions in Article G.6.

  • Export Control Compliance User acknowledges that Center is an open laboratory for fundamental research that has many foreign persons as its employees and students. User understands and agrees that under no circumstances will User bring export control-listed items, or unpublished software source code or technical information in the form of defense articles or technical data regulated by the International Traffic in Arms Regulations (ITAR), to Center. Use of Center or facilities for activity subject to the ITAR, including the development, assembly or fabrication of defense articles identified on the US Munitions List, is prohibited.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!