Additional Collaboration Indications definition

Additional Collaboration Indications means the Follow-On Indications for which the Parties mutually agree in writing that the costs and expenses thereof are Allowable Development Expenses pursuant to Section 4.1(b) of this Agreement.
Sample 1

Examples of Additional Collaboration Indications in a sentence

  • Such updates may include Additional Collaboration Indications approved for Development in accordance with this Agreement.

  • The Development of Product for the Additional Required Indication and Additional Collaboration Indications and associated Allowable Development Expenses in the Field in the Territory shall be governed by this Agreement and by development plans (“Development Plans”).

  • Notwithstanding anything to the contrary in this Agreement, unless otherwise agreed to by the Parties in writing and other than costs and expenses related to REMS and patient registries, in no event shall either Party be responsible (or obligated to pay or reimburse) [***], for any Development, CMC, Manufacturing, or non-Commercialization costs or expenses incurred or accrued by MAP for the Development of the Additional Required Indication and any other Additional Collaboration Indications.

  • Unless the Parties otherwise agree, Development of Product for each Additional Collaboration Indication shall be [***] such that enrollment of patients in a Clinical Trial for Product for [***], and enrollment of patients in a Clinical Trial for Product for any further Additional Collaboration Indications [***] for the [***].

  • When utilizing retail stores, the waiver agency must assure the item purchased meets the service standards.

Related to Additional Collaboration Indications

  • 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 Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Additional Indication means any indication other than the Initial Indication.

  • 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)).

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.

  • 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.

  • 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 [***].

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

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

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

  • Collaboration IP means Collaboration Know-How and Collaboration Patents.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

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

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

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Internal Collaboration means collaborative arrangements within a group of companies or within various strategic business. units/subsidiaries/operating divisions in order to gain a strategic position whilst sharing resources, profits and losses as well as risks