Combination Product Post-POC Development Plan definition

Combination Product Post-POC Development Plan means the development plan and budget attached hereto as Schedule 1.67 as the same may be amended from time to time by the JDC pursuant to Section 2.3.2.
Sample 1
Combination Product Post-POC Development Plan means the development plan and budget attached hereto as S chedule 1.67 as the same may be amended from time to time by the JDC pursuant to Section 2.3.2.
Sample 1

Examples of Combination Product Post-POC Development Plan in a sentence

  • NRS 60-4,172 Subsections (1) - As part of the provisions applicable to the operation of commercial motor vehicles, this section requires notification to the non-resident's commercial driver's license or commercial learner's permit issuing authority of any conviction for violations of state and local laws other than parking infractions, committed in a commercial motor vehicle operated in Nebraska, within 10 days of the date of conviction for the holders of a commercial operator's license.

  • The JDC shall manage, coordinate and oversee the Parties’ activities under the Combination Product POC Development Plan, the Combination Product Post-POC Development Plan, the CMC Plan, the Potentiator Post-POC Development Plan and the Galapagos Territory Development Plan.

  • Nothing in this Section 3.1.6(iii) shall limit or otherwise affect the Non-Funding Discovery Party’s obligation to fund Development Costs under the Combination Product POC Development Plan pursuant to Sections 3.2.8 and 3.2.9 and under the Combination Product Post-POC Development Plan pursuant to Sections 3.3.6 and 3.3.7.

  • If the Combination Product Post-POC Development Plan is so amended, the Parties shall Develop such Back-Up Combination Product under such amended Combination Product Post-POC Development Plan in accordance with Section 3.3 (including Section 3.3.7(v)) and the other applicable terms of this Agreement.

  • Each Party shall be responsible for and shall bear its Post-POC Development Cost Portion of all Development Costs incurred by the Parties and their Affiliates in performing Development activities under (a) the Combination Product Post-POC Development Plan for a Patient Population up to the Post-POC Development Cost Cap for such Patient Population and (b) the Potentiator Post-POC Development Plan up to the Potentiator Post-POC Development Cost Cap.

  • There is a risk that firms trading directly on the market through DMA or SA hide behind market members to conceal market abuse.

  • It was also the only one that included not only subjective measurements but also objective measurements associated with the potential effects it examined.

Related to Combination Product Post-POC Development Plan

  • 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.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

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

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

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

  • 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;

  • 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)).

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

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

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

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Development Program means the implementation of the development plan.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • Therapeutically equivalent drug products means drug products that contain the same active

  • 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.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.