ImmunoGen Opt-In Data Package definition

ImmunoGen Opt-In Data Package means with respect to the Licensed Product, a written package containing at least [***] and any of the following information solely to the extent (i) not already provided by ImmunoGen to Jazz under the Early Stage Option Data Package, Late Stage Option Data Package or any Interim Data Package (each as defined in the Collaboration and Option Agreement) and (ii) not included in [***] provided by Jazz to ImmunoGen: (a) the final ICH compliant CSRs of all [***] with the Licensed Product, (b) the [***] of all Licensed Product [***], (c) [***] of all [***] for the Licensed Product, (d) [***] of all [***] on the Licensed Product, (e) all [***] from all [***] with the Licensed Product, including the [***] and [***] for the [***] or [***] in [***] and [***] with [***] in [***] and [***], (f) (i) a list of [***] and [***], (ii) (1) to the extent permitted by the [***] after [***] of [***] to [***] such [***] (which [***]), [***] of [***] and [***] to [***] of [***] in connection with the Licensed Product [***], or (2) to the extent [***] of [***] are [***] by the [***] after such [***], [***] of [***] from [***], and (iii) (1) to the extent permitted by the [***] after [***] of [***] to [***] such [***] (which [***]), [***] of [***] for the Licensed Product [***], or (2) to the extent [***] of [***] are [***] by the [***] after such [***], [***] from [***], (g) copies of the [***] in connection with all [***], (h) [***] that all [***] are [***] (if [***] listed in the [***]) or [***] (if [***] as [***]), (i) a [***] that the [***] is [***] and [***], (j) all [***], (k) a [***] of [***], (l) for [***], (m) if there are any [***] or [***] since [***] or [***], a [***] showing [***] to the [***] or [***] as appropriate, (n) the [***] for the Licensed Product, (o) all [***] regarding the Licensed Product, and (p) a list of any [***] with the Licensed Product with a [***].
Sample 1

Examples of ImmunoGen Opt-In Data Package in a sentence

  • If ImmunoGen has not previously exercised the ImmunoGen Opt-In Right under any Exclusive License Agreement, Jazz shall, and shall cause its Affiliates and Sublicensees to, provide written notice to ImmunoGen within [***] Business Days of [***] for the Licensed Product, which notice shall also include (i) if Jazz [***], access for ImmunoGen to the [***] for such [***] and (ii) an ImmunoGen Opt-In Data Package.

Related to ImmunoGen Opt-In Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compound means [***].

  • 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.

  • GSK has the meaning set forth in the preamble.

  • ISIS means the department’s individualized services information system.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • 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.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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.

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Novartis shall have the meaning set forth in the Preamble.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Merck has the meaning set forth in the preamble.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.