Dynavax Program definition

Dynavax Program means Dynavax’s Research and Development of Compounds through to either the [ * ] or completion of a [ * ] or Proof of Concept Study, as applicable. For clarity, there will be a maximum of [ * ] potential Dynavax Programs under this Agreement, which shall be the TLR 7/9 Program [ * ], each of which is subject to the relevant diligence provisions and milestones as if separate programs hereunder) and up to two (2) additional Dynavax Programs as identified pursuant to Section 2.5.
Sample 1Sample 2Sample 3

Examples of Dynavax Program in a sentence

  • Within [ * ] after the identification of a Dynavax Program under Section 2.5, the JSC shall establish Phase I Ready Criteria for such Dynavax Program, which shall be substantially similar to the example of Phase I Ready Criteria set forth in Exhibit C.

  • For the avoidance of doubt, this Section 2.10 shall not apply to any materials and/or Compounds supplied to GSK by Dynavax in accordance with Section 4.3 pursuant to the exercise by GSK of its Option for a Dynavax Program.

  • If a Third Party asserts that a Patent or other right owned by it is infringed by the manufacture, use, sale or importation of any Compound in a Dynavax Program as to which GSK has not exercised its Option, or any Compound within a Dynavax Development Program, Dynavax shall have the primary right but not the obligation to defend against any such assertions at its cost and expense.

  • For clarity, nothing in this Section 7.1 shall limit Dynavax’s rights to Develop or commercialize on its own or with or for a Third Party Compounds and Dynavax Products within a Dynavax Development Program, if such Program results from termination or expiration of the Option Deadline Period, including any Option Deadline Extension Period (as may be extended), for an Option without exercise by GSK, the JSC’s or GSK’s decision to terminate a Dynavax Program, or the termination of a GSK Development Program.

  • On a Dynavax Program-by-Dynavax Program basis, the Parties shall discuss and consider in good faith [ * ], prior to GSK’s exercise of an Option with respect to such Dynavax Program in order to [ * ].

  • Prior to exercise of an Option for a Dynavax Program, if the Chief Patent Counsel are unable to determine a resolution in a timely manner: (a) with respect to [ * ] related to such Program, then the decision of the chief patent counsel [ * ] shall be binding upon the Parties without further review, and (b) with respect to [ * ] related to such Program, then the decision of the chief patent counsel of [ * ] shall be binding upon the Parties without further review.

  • The Party engaging a subcontractor under a Dynavax Program shall be solely responsible for all costs associated with obtaining such exclusive Control and rights to such intellectual property.

  • The objective of each Dynavax Program is to discover and Develop [ * ] and, if applicable under [ * ], Compounds satisfying the Proof of Concept Criteria or [ * ] Criteria, as applicable.

  • After exercising an Option with respect to a particular Dynavax Program, GSK may, at its sole discretion and without any penalty or liability (other than the transfer of any data, regulatory filings and other Information and grant of rights contemplated under this Section 5.3.2), terminate its Development or commercialization of all the Compounds or GSK Products within such Program upon written notice to Dynavax.

  • Upon [ * ] with respect to a Dynavax Program, Dynavax shall [ * ] as soon as reasonably practicable of all regulatory filings for the resulting GSK Development Compounds (including Back-up Compounds), including all relevant INDs, and provide GSK with copies of such INDs and other regulatory filings and all pre-clinical and clinical data and results (including pharmacology, toxicology, formulation, and stability studies).

Related to Dynavax Program

  • Development Program means the implementation of the development plan.

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

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

  • Pfizer shall have the meaning set forth in the preamble.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • GSK will have the meaning set forth in the Preamble.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Merck has the meaning set forth in the preamble.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

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

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

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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)).

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • DS Electric generation service that is provided at retail pursuant to the Applicable Legal Authorities under the Company’s retail electric tariffs and under any other agreements or arrangements between the Company and Customers, to any Customer that is not being served by an EGS. Default Allocation Assessment – shall have the meaning ascribed to it under the PJM Agreements. Delivery Period – The delivery period specified in an Appendix C Transaction Confirmation. Delivery Point – Means the applicable zone of the Company as designated by PJM. DS Customer(s) – Retail customers who are provided Default Service pursuant to the terms of this Agreement, the Applicable Legal Authorities and the Company’s retail tariffs.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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.

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • 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:

  • 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.

  • Pilot program means a program using a representative sample of residential and small commercial customers to assist in developing and offering customer choice of electricity supply for all residential and commercial customers.

  • 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).