IND Submission and Manufacturing Update Plan definition

IND Submission and Manufacturing Update Plan means the activities specified in the IND Submission and Manufacturing Update Plan Schedule attached hereto as may be modified by the JSC in accordance with Section 4.5.
Sample 1

Examples of IND Submission and Manufacturing Update Plan in a sentence

  • Should Aduro and JBI agree to perform together Development or Manufacturing of Licensed Immunotherapeutics other than as set forth in the IND Submission and Manufacturing Update Plan (each an “Other Development”), then such Other Development, along with relevant timelines and budgets (and any terms and conditions particular to such Other Development), shall be set forth in a plan for such Other Development that is agreed and executed by the Parties.

  • Additional the driving of piles could affect the stability of adjacent structures and may well be limited in the achievable penetration depth.

  • If either JBI or Aduro discovers any Aduro Know-How or materials that have not been transferred to JBI pursuant to Sections 5.1 and 5.2 above and that is useful or reasonably necessary for the Development and Commercialization of a Licensed Immunotherapeutic, including any which arises pursuant to the activities conducted under the IND Submission and Manufacturing Update Plan, then Aduro shall promptly transfer to JBI, such materials or a copy of such Aduro Know-How.

  • Aduro shall conduct the activities performed under the IND Submission and Manufacturing Update Plan in cooperation with JBI (and excluding any activities to be conducted by JBI as expressly set forth therein).

  • Following completion of the activities specified in each of the IND Submission and Manufacturing Update Plan and Technology Transfer Plan, either Party shall have the right to terminate the JSC by written notice to the other.

  • Notwithstanding the foregoing, except as expressly set forth otherwise in the IND Submission and Manufacturing Update Plan, Aduro shall not sub-contract any of the activities set forth therein to a Third Party without JBI’s prior written consent, which consent shall not be unreasonably withheld, delayed or conditional.

  • I will focus on the interpretation of this plot in the context of the problem.

  • The Parties shall each perform the activities specified in and allocated to it in the IND Submission and Manufacturing Update Plan in the time frames set forth therein.

  • Short texts are harder to interpret than long texts because short texts lack discourse clues and they lack redundancy.

  • The Parties recognize that JBI or its designee as the holder of all Regulatory Approval applications (except as contemplated by the IND Submission and Manufacturing Update Plan) and Regulatory Approvals in the Territory for Licensed Immunotherapeutics may be required to submit information and file reports to Regulatory Authorities on Licensed Immunotherapeutics which are under clinical investigation, proposed for marketing, or marketed in the Territory.

Related to IND Submission and Manufacturing Update Plan

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

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Manufacturing Process means any process for—

  • 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;

  • 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.

  • 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).

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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 [***].

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

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

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.