New Formulation definition
Examples of New Formulation in a sentence
How shall mean all Know-How that is included within Ipsen New Formulation Technology.
Notwithstanding the foregoing provisions of this definition, the term “Licensee Know-How” shall not include Ipsen Licensed Know-How, Ipsen New Formulation Know-How and Joint Know-How.
AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Formulation containing other compounds in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.
From time to time during the term of this Agreement or upon the reasonable request of Radius, Ipsen shall supply Radius with reasonable quantities of compounds generated or formulated by Ipsen in the course of performing its research tasks and activities under the Work Plan for purposes of enabling Radius to test such compounds and the formulation thereof and for purposes of allowing Radius to assess the extent to which such compounds meet the specifications for a New Formulation Licensed Product.
The supply of New Formulation Licensed Product by Ipsen to Radius for use in phase II clinical trials will be managed under the terms agreed in Appendix D of the License Agreement dated September 27 2005 “Clinical Supply and Technical Transfer Agreement BIM 44058 injection clinical supplies and technology transfer” (hereinafter the “Clinical Supply Agreement”).
In the event that Licensee develops a new formulation or dosage form of a License Product that requires clinical studies for regulatory approval or [*] (a “New Formulation or Use”), Licensee shall pay royalties to GenuPro on such New Formulation or Use at the same rate as set forth in Section 5.03 hereof, provided that the amount of royalties otherwise due under this Section 5.08(c) will not be paid until Licensee [*].
Under the Clinical Supply Agreement, Ipsen will manufacture or have manufactured and tested the bulk product and devices applicable to the New Formulation Licensed Product for phase II clinical trials, and will provide the analytical control data, with suitable documentation from contract manufacturing company, and Radius will complete final clinical packaging/labeling, and final Quality Assurance release of the clinical supplies of New Formulation Licensed Product for phase II clinical trials.
All terms of such Clinical Supply Agreement apply to the supply by Ipsen to Radius of New Formulation Licensed Product for phase II clinical trials to the exception of the Technical Specifications, Manufacturing and Analytical Procedure and Safety Agreement and the price for the clinical supplies and work associated and quantities of clinical batches.
Licensor and Licensee shall, as soon as practicable after the Effective Date, confer to agree upon reasonable milestones towards the development of a New Formulation in line with these registration timeframes.
Licensee hereby grants to AbbVie a right of first negotiation to obtain the sole rights to commercialize any New Formulation which is not a New Lopinavir/Ritonavir Formulation under the two options described in Section 5.1(a).