Optioned Lead Program definition

Optioned Lead Program means any Lead Program as to which Novartis has exercised its Option.
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Examples of Optioned Lead Program in a sentence

  • Milestone payments shall be payable only once with respect to a particular Optioned Lead Program, even though the Optioned Lead Program, Optioned Lead Program Compound, Derivative Compound or Drug Product may be subsequently developed for indications other than those for which Regulatory Approval was initially sought.

  • Each Party shall notify the other promptly of any possible infringements, imitations or unauthorized possession, knowledge or use of the Intellectual Property embodied in any of the Optioned Lead Programs, Collaboration Intellectual Property, or Licensed Intellectual Property related to the manufacture or use of the Optioned Lead Program, Optioned Lead Program Compounds or Licensed Drug Product by Third Parties in any country, of which such Party becomes aware.

  • During the term of this License Agreement, Novartis shall deliver to Infinity a written notice of the occurrence of each of the events described in Section 4.1(b) with respect to each Optioned Lead Program within [**] days after such occurrence.

  • Novartis, its Affiliates and sublicensees shall have sole and worldwide rights, even as to Infinity, to develop, commercialize, manufacture, promote, sell, and distribute each Optioned Lead Program, Optioned Lead Program Compound or Licensed Drug Product in the Field.

  • This License Agreement is made subject to any restrictions concerning the export of Optioned Lead Program Compounds, Derivative Compounds, Drug Products, Infinity Background Intellectual Property, Licensed Intellectual Property or Collaboration Intellectual Property from the United States that may be imposed upon or related to either Party from time to time by the Government of the United States.

  • For the avoidance of doubt, the licenses granted to Novartis in this Section 2.1 shall be effective with respect to any other lead program that Novartis may pursue using the Optioned Lead Program, Optioned Lead Program Compounds or Licensed Drug Product.

  • Infinity shall not develop, make, have made, use, market and sell, itself or through a Third Party licensee, for use within the Field, any other Lead Program involving the Optioned Lead Program Compounds and/or Licensed Drug Product.

  • Novartis shall make the following royalty payments to Infinity on total annual Net Sales of each Drug Product incorporating an Optioned Lead Program Compound or Derivative Compound, for which there is a Live Claim covering such Optioned Lead Program, or the related Optioned Lead Program Compounds, Derivative Compounds or Drug Products, or their uses or manufacture thereof on a country-by-country and Drug Product-by-Drug Product basis.

  • With respect to licenses of non-Patented Intellectual Property included in Infinity Background Intellectual Property, Licensed Technology or in Collaboration Intellectual Property, such licenses shall be perpetual and fully-paid with respect to such Optioned Lead Program, and the related Optioned Lead Program Compounds and Licensed Drug Products.

  • Subsequent to the date on which Novartis exercises its Option with respect to a particular Optioned Lead Program, Novartis or its Affiliates shall take responsibility and pay for the preparation, filing, prosecution and maintenance of any and all Patents covering such Optioned Lead Program, Optioned Lead Program Compound or Licensed Drug Product, and for any uses, formulations, manufacture and other process inventions with respect thereto made by or on behalf of Novartis or its Affiliates.

Related to Optioned Lead Program

  • Development Program means the implementation of the development plan.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Collaboration Term has the meaning set forth in Section 2.2.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Research Program has the meaning set forth in Section 2.1.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • Covered Program means an education program or activity over which the College exercised substantial control over both the Respondent and the context in which the sexual harassment occurred.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Prospective Student means an Applicant for admission to an Educational Institution.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Program change means any elimination, curtailment or reorganization of a curriculum offering, program or school operation or a reorganization or closing of a school or consolidation of two or more individual schools or school districts that is unrelated to financial exigency.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.