Initial POZEN Product definition

Initial POZEN Product means the POZEN Product containing non-enteric coated Esomeprazole and enteric-coated Naproxen that is the subject of NDA #22-511.
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Initial POZEN Product means the POZEN Product containing non-enteric coated Esomeprazole and enteric-coated Naproxen that is the subject of NDA #22-511. 1.37 “Invention” means any invention, discovery or Know-How that is conceived during the Term in the performance of activities undertaken pursuant to this Agreement by employees, agents, or independent contractors of either Party, its Affiliates or Sublicensees and is Controlled by such Party, Affiliates or Sublicensees. 1.38 “Joint Invention” means any Invention that is conceived jointly by one or more employees, agents, or independent contractors of Licensee or its Affiliate(s) and one or more employees, agents, or independent contractors of POZEN or its Affiliate(s). 1.39 “Joint Patent” means a Patent claiming a Joint Invention. 1.40 “JSC” has the meaning set forth in Section 2.1.2 (Joint Steering Committee). 1.41 “Know-How” means any non-public, documented or otherwise recorded or memorialized knowledge, experience, know-how, technology, information, and data, including formulas and formulations, processes, techniques, unpatented inventions, discoveries, ideas, and developments, test procedures, and results, together with all documents and files embodying the foregoing.
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Examples of Initial POZEN Product in a sentence

  • Each Party will comply with all Applicable Laws relating to activities performed or to be performed by such Party (or its Affiliates or contractors) under or in relation to the Commercialization of the Initial POZEN Product in the Territory pursuant to this Agreement.

  • Each Party will consult with the other Party regarding (and provide copies of materials prior to any submission to a Regulatory Authority and materials after receipt from a Regulatory Authority), and keep such other Party reasonably and regularly informed of, the status of the preparation of all Regulatory Materials in the Territory, review of such materials by the relevant Regulatory Authority in the Territory, and Marketing Approvals received for the Initial POZEN Product in the Territory.

  • Except as may be required by Applicable Law, only Licensee will communicate regarding POZEN Products, including the Initial POZEN Product, with any Regulatory Authority in the Territory.

  • The product director designated by Licensee for the Initial POZEN Product will chair the PT (“PT Chair”).

  • Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product.

  • Licensee shall have the sole right at its own expense to (a) seek any Marketing Approval for Products in the Territory, including Marketing Approval for claims not obtained in the initial NDA Approval for the Initial POZEN Product, and (b) prepare or make any filings or submissions to, or otherwise communicate with, any Regulatory Authority in the Territory regarding Products.

  • The PT will coordinate and oversee the Commercialization of the Initial POZEN Product hereunder.

  • Without limiting the foregoing, as owner of the NDA Approval for the Initial POZEN Product, Licensee will be the sole owner of all data exclusivity protection related to the Initial POZEN Product in the Territory as provided by Applicable Law.

  • Licensee will have the right to Develop and Commercialize Products during the Term in the Territory, for so long as Licensee is using Diligent Efforts to Commercialize at least one POZEN Product in accordance with this Section 5.3, it being understood that the Parties intend for Licensee to focus its initial efforts on the Commercialization of the Initial POZEN Product in the Territory.

  • The purposes of the PT will be, with respect to the Initial POZEN Product only, to develop Licensee’s marketing plans for the Initial POZEN Product in the Territory.