Option Data Package 1 definition

Option Data Package 1 means the data and materials generated in the performance of Pfenex’s Development of the Pegaspargase Product as described in Exhibit 1.92.
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Option Data Package 1 means (i) the Franchise Product 3 [*] Data Package; (ii) the then-current draft of the IND to be filed with FDA or EMA for Franchise Product 3 that includes the [*]; (iii) the then-current plan and budget for Development for Franchise Product 3; and (iv) the status of the prosecution of all Licensed Amgen Patents with respect to Franchise Product 3.
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Option Data Package 1 means (i) the Franchise Product 3 [*] Data Package; (ii) the then-current draft of the IND to be filed with FDA or EMA for Franchise Product 3 that includes the [*]; (iii) the then-current plan and budget for Development for Franchise Product 3; and (iv) the status of the prosecution of all Licensed Amgen Patents with respect to Franchise Product 3. Amgen Ref. No. 2015641252 Page 13
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Examples of Option Data Package 1 in a sentence

  • Promptly following completion of the corresponding activities under the Development Plan for the Pegaspargase Product, Pfenex shall provide Jazz with Option Data Package 1 and, if Jazz has not previously delivered to Pfenex an Option Exercise Notice or if Jazz delivered an Option Exercise Notice but the Parties were unable to negotiate and enter into an Option Exercise Agreement pursuant to Section 2.4(d), Option Data Package 2.

  • Amgen shall, [*], prepare and deliver to Novartis Option Data Package 1 (and thereafter during Option Period 1, [*] in Option Data Package 1, [*]).

  • Exhibit 1.92 Components of Option Data Package 1 [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

Related to Option Data Package 1

  • 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.

  • 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:

  • Adjustable Product Data means the Adjustable Product Data as specified in § 1 of the Product and Underlying Data.

  • 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)).

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • 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).

  • 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.

  • Milestone Notice has the meaning set forth in Section 2.4(a).

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • 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.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • 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).

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Program Period means the period of time which the department intends to support the program without requiring the recompetition for funds. The program period is specified within the grant application.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • 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.

  • 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 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.

  • Expiry Date (Data di Scadenza) means the Expiry Date as specified in § 1 of the Product and Underlying Data.