Novel Formulation Development Plan definition

Novel Formulation Development Plan means the plan and time schedule for performing the Novel Formulation Development Activities, including, without limitation: (a) a description of the First Stage of the Novel Formulation Development Activities (consisting of the Feasibility Assessment); (b) the Approved Budget corresponding to the portion of the Feasibility Assessment set forth in Section 3.2(a) below; (c) a description of the Second Stage of Novel Formulation Development Activities; and (d) the Approved Budget corresponding to such Second Stage of Novel Formulation Development Activities, as set forth in Exhibit E as amended in writing from time to time in accordance with this Agreement.
Sample 1

Examples of Novel Formulation Development Plan in a sentence

  • For the Novel Formulation development, PARI shall only conduct the development activities, which are set forth in the Novel Formulation Development Plan.

  • ABARIS and PARI shall establish a Project Team, which shall, among other activities, finalize the Test Inhaler Development Plan, Inhaler Development Plan and Novel Formulation Development Plan under the direction of ABARIS.

  • The Parties acknowledge that the Novel Formulation Development Plan sets forth: (a) an Approved Budget for the First Stage of the Novel Formulation Development Activities, which consists of the portion of the Feasibility Assessment set forth in Section 3.2(a) above; and (b) an Approved Budget for the Second Stage of the Novel Formulation Development Activities.

  • If ABARIS provides PARI with a written request to proceed with the Novel Formulation Development Activities, the Project Team shall convene to update the Novel Formulation Specifications and update the Novel Formulation Development Plan with a description of activities and a [*] to the Parties.

  • If PARI is chosen to supply the Novel formulation, PARI shall supply ABARIS with quantities of Drug Product made using the Novel Formulation in accordance with the Novel Formulation Development Plan and according to the appropriate regulatory standards.

  • If, at any time during any period of suspension in this Section, ABARIS requests PARI to proceed with the Novel Formulation Development Activities, the Project Team shall convene to review (and possibly revise) the Novel Formulation Specifications and update the Novel Formulation Development Plan with a description of activities and a time schedule mutually acceptable to the Parties.

Related to Novel Formulation Development Plan

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

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

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

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

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

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

  • 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.

  • 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)).

  • Development Program means the implementation of the development plan.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • 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.

  • 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.

  • 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 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).

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.