Lead Development Party definition

Lead Development Party has the meaning set forth in Section 3.2.
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Lead Development Party means that Party for which a Joint Development Compound falls within that Party's Indications or that Party selected pursuant to Section 3.2.1 to develop a Joint Development Compound.
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Lead Development Party has the meaning set forth in Section 5.1.
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Examples of Lead Development Party in a sentence

  • The JSC shall select the lead development party (“Lead Development Party”) for each Clinical Trial of a Collaboration Product, provided that Trubion shall be the initial Lead Development Party for all Clinical Trials and Non-Clinical Studies of TRU-016 that are on-going as of the Signing Date.

  • The Lead Development Party shall not have the right to change the Development Plan or to make changes to the Clinical Trial protocol or the statistical analysis plan or make changes that affect study design or Clinical Trial strategy (any of the foregoing actions falling under the authority of the JDC or JSC, as applicable).

  • The Lead Development Party shall use Diligent Efforts to prepare a final version of the Initial Development Plan, including a final study protocol, and submit it to the JRDC for final review approximately [ * ] in advance of the anticipated IND submission date.

  • With respect to a Unilateral Phase III Plan for a Unilateral Product in an Indication for a Royalty Region, the applicable Participating Phase III Party shall be the Lead Development Party and Lead Regulatory Party with respect to the Development activities under such Unilateral Phase III Plan (including with respect to the preparation and filing of all Drug Approval Applications for such Unilateral Product in such Indication in such Royalty Region).

  • Upon request of KHK, following the conclusion of the Profit Sharing Period, UGNX shall use Commercially Reasonable Efforts to assist KHK at KHK’s cost in connection with any meetings with, or requests from, Regulatory Authorities with respect to Licensed Products in the Field in any country of the world where KHK is the Lead Development Party.

  • The JRDC shall promptly meet, discuss such final version and provide feedback to the Lead Development Party.

  • The Participating Pre-Phase IIb Party shall be the Lead Development Party and the Lead Regulatory Party for such Unilateral Pre-Phase IIb Development.

  • The Participating Exploratory Party shall be the Lead Development Party and Lead Regulatory Party for its Unilateral Exploratory Development.

  • For Joint Exploratory Development involving a Development Candidate that is a NextGen Targeted AIM that commences after the Initial Studies Period, the JRDI shall appoint the Party that will be the Lead Development Party and Lead Regulatory Party.

  • The Participating Phase IIb Party for particular Unilateral Phase IIb Development shall be the Lead Development Party and the Lead Regulatory Party for such Unilateral Phase IIb Development.


More Definitions of Lead Development Party

Lead Development Party or “LDP” means, with respect to each particular stage of Development of a Development Candidate or Product Candidate in the applicable Development Region or Commercialization Territory, as the case may be, the Party designated as the lead Development Party therefor pursuant to Section 4.3(e), 4.4(d), 5.5(a)(vii), 5.5(b)(iii), 5.5(d)(iv), 5.6(a)(iv), 5.6(b)(ii), or 5.6(d)(iv).
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Lead Development Party means the Party responsible hereunder ---------------------- for the Development of a Collaboration Product, and the execution of the Development Plan related thereto, as further described in Section 4.03 hereof.
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Lead Development Party means, with respect to the Development of a Product for a particular Indication for a country or with respect to a particular Clinical Trial, the Party responsible for taking the lead on Development (other than regulatory) activities either pursuant to Article 3 or as otherwise specified in the applicable Global Development Plan and Budget or Annual Development Plan and Budget.
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Lead Development Party has the meaning assigned in Section 4.1(a)(i).
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Lead Development Party means Nuvelo unless: (a) otherwise agreed by the Parties in writing in their sole discretions on a country-by-country basis or worldwide; or (b) Nuvelo opts-out, in which case such term means Kirin and Kirin will retain the right to lead even if Nuvelo opts back in. Kirin shall not owe any payment for or in connection with conversion to Lead Development Party status resulting from Nuvelo’s opt-out in accordance with clause (b) above.
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Lead Development Party or "LDP" means the Party responsible hereunder for ------------------------ ----- the Development of a Collaboration Compound for a particular Indication at the relevant stage of Development, and shall be the Party carrying out or having carried out the Development Plan related thereto, as further described in Section 4.03 hereof.
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Related to Lead Development Party

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Development Phase means the period before a vehicle type is type approved.

  • Development Committee shall have the meaning set forth in Section 3.4.1.

  • Development Program means the implementation of the development plan.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Land development means the erection of buildings or structures on land, or the change of use of land, including township establishment, the subdivision or consolidation of land or any deviation from the land use or uses permitted in terms of an applicable land use scheme;

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Period means the period from the date of this Agreement until the Appointed Date;