Existing Regulatory Materials definition

Existing Regulatory Materials is defined in Section 7.2.1 (Existing Regulatory Materials).
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Existing Regulatory Materials has the meaning set forth in Section 5.2.1.
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Existing Regulatory Materials means Bevacizumab Existing Regulatory Materials and Rituximab Existing Regulatory Materials, as applicable.
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Examples of Existing Regulatory Materials in a sentence

  • In the case of an estate or trust, an allocation of a deduction pursuant to rules described in §1.652(b)–3(b) (and§1.641(c)–1(h) in the case of an ESBT) is also a reasonable method.(2) Recoveries of properly allocable deductions—(i) General rule.

  • Thereafter Celgene (or its designee) shall have the sole right, in its discretion, to file, maintain and hold title to, all Existing Regulatory Materials.

  • In all cases, Seagen and its designees will have access to all data contained or referenced in all such Regulatory Materials described in Section 7.2.1 (Existing Regulatory Materials) or Section 7.2.2 (New Regulatory Materials), and Nurix will ensure that Seagen and its designees are afforded such access by fulfilling its obligations thereunder.

  • From and after such assignment and transfer, Seagen (or its designee) will have the sole right, in its sole discretion, to file, maintain and hold title to all such Existing Regulatory Materials.

  • Advertisers/advertising agencies receive incentive discount based on advertiser’s budget increase in AXN channel in 2022 (if any) compared to the previous year according to the table below.

  • From and after such assignment and transfer, Gilead (or its designee) shall have the sole right, in its sole discretion, to file, maintain, and hold title to all Existing Regulatory Materials.

  • Other than the Existing Regulatory Materials, neither Leap nor any of its Affiliates has, as of the Effective Date, obtained, or filed, any INDs, CTAs or any other form of regulatory application with Regulatory Approvals for approval of Clinical Trials, marketing or other purpose, for the Licensed Antibody or any Licensed Product.

  • From and after such assignment and transfer, Licensee (or its designee) will have the sole right, in its sole discretion, and the responsibility, to file, maintain and hold title to all such Existing Regulatory Materials.

  • Prior to the transfer of any Regulatory Materials for the Licensed Compound held or filed by or on behalf of BeiGene or its Affiliates prior to the Execution Date (the “Existing Regulatory Materials”) in accordance with the Regulatory Transition Plan, all Existing Regulatory Materials shall be owned by and held in the name of BeiGene or its designee and BeiGene (or its designee) shall, subject to Section 4.1, have the sole right to file, maintain, and hold title to such Existing Regulatory Materials.

  • The cost of translating the Rituximab Existing Regulatory Materials into English shall be borne [***], which shall include any costs and expense incurred by Innovent prior to the Effective Date directly in connection with such translation, to the extent reasonably documented.


More Definitions of Existing Regulatory Materials

Existing Regulatory Materials is defined in Section 4.2 (Regulatory Materials).
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Existing Regulatory Materials means the Regulatory Materials held by or on behalf of BeiGene or any of its Affiliates as of the Execution Date related to a Licensed Compound, Licensed Product or Licensed Diagnostic Product in the Field in the Celgene Territory.
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Related to Existing Regulatory Materials

  • 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.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

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

  • Promotional Materials means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.

  • Program Know-How means all Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of either Party or its Affiliates or sublicensees in connection with the work conducted under or in connection with this Agreement.

  • Product Know-How means all the know how, trade secrets, expertise, inventions, discoveries, technical information and other unpatented information related solely and specifically to the Product, that is owned or controlled by Seller or its Affiliates and used in the Territory, including, but not limited to, all information presently used by the Seller to make, have made, use or sell the Product.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • 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.

  • Training Materials means any and all materials, documentation, notebooks, forms, diagrams, manuals and other written materials and tangible objects, describing how to maintain the Facilities, including any corrections, improvements and enhancements thereto to the Bloom Systems which are delivered by Operator to Owner, but excluding any data and reports delivered to Owner.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • 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.

  • SAP Materials means any software, programs, tools, systems, data, or other materials made available by SAP or any other member of the SAP Group to Partner or to an End User (either directly or indirectly via Partner) prior to or in the course of the performance under any part of this Agreement including, but not limited to, the other SAP Products.

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Promotional Material means any communication that relates to the Company or its services made to or directed at, or that relates in any way to the solicitation of a Prospective Customer or a transaction in an Existing Customer’s trading account. Promotional Material includes, but is not limited to, published written texts, training materials, advertisements, market analysis, research reports, correspondence to Existing Customers or Prospective Customers, newsletters and generally anything written that assists in the solicitation process.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

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