Other Formulation definition

Other Formulation means (i) any formulation [ * ] other than the Current Product and the Current Pediatric Product, or (ii) any [ * ] is [ * ] to or [ * ] a [ * ] (which is the [ * ] that is [ * ] is administered in [ * ]. Other Formulations shall include without limitation [ * ] of the [ * ] formulation [ * ].
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Other Formulation means any and all formulations of Collaboration Compound(s) other than the Initial Formulation.
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Other Formulation means a formulation of a Licensed Product other than an Oral Formulation, Injectable Formulation, Inhaled Formulation or Topical Formulation.
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Examples of Other Formulation in a sentence

  • In the event that either Party proposes to Develop in the Shared Territory (a) a Collaboration Product for the Second Indication or Other Indication, within the Field (a “Label Expansion”) or (b) an Other Formulation for an indication within the Field, such Party shall make a written proposal to the JDC for the Development thereof, including a proposed work plan, budget and timeline (the “JDC Proposal Notice”).

  • If, within [ * ] after any such written notice from Gilead, GSK requests to negotiate the terms pursuant to which the definition of Licensed Product would be expanded to include such Other Formulation and/or the definition of Licensed Indication would be expanded to include such Other Indication (as applicable), the Parties shall negotiate such terms as set forth in Section 3.5(c).

  • GSK shall not develop any Other Formulation or conduct any clinical trials of any Licensed Product for any Other Indication without the prior approval of the Joint Committee.

  • In accordance with Section 3.5(c), prior to any Other Formulation becoming a Licensed Product hereunder, the Parties shall execute a written agreement relating to its supply as further described in such Section.

  • If the Joint Committee is unable to reach consensus to approve GSK's development of any such Other Formulation as a Licensed Product or Other Indication as a Licensed Indication, then GSK shall not conduct such development; [ * ] .

  • GSK shall not file any IND or Marketing Authorization Application for (i) any Other Formulation that is not a Licensed Product for any indication, or (ii) any Licensed Product for an indication that is not a Licensed Indication.

  • Subject to the procedures set forth in this Section 3.5 to permit GSK to expand the licenses granted to it pursuant to Sections 7.1 and 7.3 to include Other Formulations and Other Indications, Gilead may at any time in its sole discretion (i) develop anywhere in the world, and Commercialize in the Gilead Territory, an Other Formulation for any indication, or (ii) develop anywhere in the world (subject to Section 3.8) and Commercialize in the Gilead Territory a Licensed Product for an Other Indication.

  • If Anthera elects to develop a Licensed Product in an Other Formulation, Anthera will make milestone payments related to the development and commercialization of such Licensed Product, which milestone payments will be [***].

  • If Gilead [ * ] for (i) an Other Formulation for any indication, or (ii) a Licensed Product for an Other Indication, then Gilead shall so notify GSK.

  • Gilead shall notify GSK when it [ * ] of (i) an Other Formulation for any indication, or (ii) a Licensed Product for an Other Indication.


More Definitions of Other Formulation

Other Formulation means a formulation of a Licensed Product other than an Oral Formulation, Injectable Formulation, Inhaled Formulation or Topical Formulation. 1.46 “Person” means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority, or any other entity or organization. 1.47 “Phase 1 Clinical Trial” means the first lawful study in humans, conducted in accordance with 21 C.F.R. § 312.21(a) (or the equivalent laws and regulations in jurisdictions outside the United States), of the safety, metabolism and pharmacologic actions of a pharmaceutical or biologic product. 1.48 “Phase 3 Clinical Trial” means a clinical trial conducted in accordance with 21 C.F.R. § 312.21(b) (or the equivalent laws and regulations in jurisdictions outside the United States), of appropriate size and designed to evaluate the effectiveness of the product for a particular indication and to determine the common short-term side effects and risks associated with the product. 1.49 “PLA2” means any member of the phospholipase A2 family including the known forms of all species and any new forms of the enzyme that share the structural and enzymatic properties of this class.
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