IND/IMPD definition

IND/IMPD means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, (b) the Investigational Medicinal Product Dossier in the European Territory, or (c) the equivalent application to the applicable Competent Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
Sample 1

Examples of IND/IMPD in a sentence

  • Until the Technology Transfer as set forth in Section 6.1.2, Sorrento shall have Manufactured and supplied to Servier the mutually agreed upon quantity of pre-clinical samples of the Initial Product for the IND/IMPD submissions as set forth in Section 6.2.1, for Development pursuant to this Agreement.

  • The Sponsor will notify the site/investigator if the NDA/MAA is approved or if the IND/IMPD is discontinued.

  • For each Collaboration Product, SGEN shall file an IND/IMPD no later than [***] years after the [***] for such Collaboration Product.

  • In consideration for the rights granted under this Agreement, Servier shall pay Sorrento a one-time, non-refundable and non-creditable lump sum payment of: (a) Twenty-Five Million Euros (EUR 25,000,000€), within ten (10) days of the Effective Date and receipt of the corresponding invoice from Sorrento and (b) * (EUR *€) within ten (10) days of the first IND/IMPD submission by Servier, if any, and receipt of the corresponding invoice from Sorrento.

  • Those data can already become part of the IND/IMPD submissions for advanced therapies in four to seven years.

  • In particular, no later than *, Sorrento shall provide to Servier the IMPD/IND quality part of the CMC documentation as needed for Servier to file the IND/IMPD for the Initial Product.

  • CONFIDENTIAL TREATMENT REQUESTED shall take all actions necessary to permit the IND Beneficiary to cross-reference such IND/IMPD (in its entirety) in its own Regulatory Materials (including any IND) for a product (including any Collaboration Product) that includes the same Building Block as the Reference Product.

  • A detailed discussion of moving oligonucleotide therapeutics from discovery to clinical trials will include a description of strategies for early clinical development, including GMP synthesis, analytical controls and specifications; nonclinical, CMC, manufacturing and scale-up and the regulatory framework for preparation of IND-IMPD dossiers.

  • Susan Srivatsa, Ph.D., President, ElixinPharma, USADmitry Samarsky, Ph.D., Chief Scientific Officer, Silence Therapeutics, USAMimoun Ayoub, Ph.D., Director, Global Tides, Lipids and Carbohydrates & Injectables, CordenPharma International, Switzerland PRE-CONFERENCE WORKSHOPS Tuesday, February 21, 2017 • 8:00am-12:00pm Workshop #1: ROADMAP TO A SUCCESSFUL IND/IMPD SUBMISSION FOR OLIGONUCLEOTIDE THERAPEUTICS – DEFINING AND MANAGING CMC ACTIVITIESWorkshop Leaders:G.

  • Since all PACE members are also members of national parliaments, these parliaments should strengthen codes of conduct, oversight and disclosure requirements for their own members while serving in PACE.

Related to IND/IMPD

  • aerodrome means a defined area on land or water (including any buildings, installations and equipment) intended to be used either wholly or in part for the arrival, departure and surface movement of aircraft;

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.

  • IPPF means the indigenous peoples planning framework for the Investment Program, including any update thereto, agreed between the Borrower and ADB and incorporated by reference in the FFA;

  • Tetrahydrocannabinol means the natural or synthetic equivalents of the substances contained in the plant, or in the resinous extractives of, Cannabis sativa, or any synthetic substances, compounds, salts, or derivatives of the plant or chemicals and their isomers with similar chemical structure and pharmacological activity.

  • Mining Xxx 0000 means (unless the context otherwise requires) the Mining Xxx 0000 and the amendments thereto and the regulations made thereunder as in force on 31st December, 1981;

  • Embryo/fetus means the developing human organism from conception until the time of birth.

  • Sadomasochistic abuse means actual or explicitly simulated flagellation or torture by or upon a person who is nude or clad in undergarments, a mask or bizarre costume, or the condition of being fettered, bound or otherwise physically restrained on the part of one so clothed.

  • snippet means with respect to any Material Contract, a consent and agreement in favor of the Term Loan Collateral Agent (for the benefit of the Secured Parties) in substantially the form attached hereto as Exhibit F or otherwise in form and substance reasonably satisfactory to the Term Loan Collateral Agent and the Administrative Agent.","hash":"b253905eac2329f4ce5deee359573d97","id":7},{"snippetLinks":[{"key":"the-consent","type":"clause","offset":[6,17]},{"key":"dated-as-of","type":"definition","offset": [32,43]},{"key":"march","type":"clause","offset":[44,49]},{"key":"the-bank","type":"clause","offset":[72,80]},{"key":"sumitomo","type":"definition","offset":[87,95]},{"key":"heavy","type":"clause","offset":[96,101]},{"key":"industries","type":"clause","offset":[102,112]},{"key":"ltd","type":"clause","offset":[114,117]},{"key":"solely-for-purposes-of- section","type":"clause","offset":[120,150]},{"key":"borrower-and","type":"clause","offset":[173,185]},{"key":"certain","type":"clause","offset":[186,193]},{"key":"subsidiaries","type":"clause","offset":[208,220]}],"samples":[{"uri":"/contracts/8I1kKDYnIWF#consent-and-agreement","label":"Loan and Security Agreement (Axcelis Technologies Inc)","score":21},{"uri":"/contracts/ef30eXHgcuS#consent-and-agreement","label":"Loan and Security Agreement (Axcelis Technologies Inc)","score":21},{"uri":"/contracts/dwF8yXcI2kh#consent-and-agreement","label":"Loan and Security Agreement (Axcelis Technologies Inc)","score":21}],"size":6,"snippet":"means the Consent and Agreement dated as of March 30, 2009 by and among the Bank, SEN, Sumitomo Heavy Industries, Ltd. (solely for purposes of Section 2(b) thereunder), the Borrower and certain of Borrower’s Subsidiaries named therein.","hash":"e15b2264efd3078b83ce802817c2631f","id":8},{"snippetLinks":[{"key":"a-consent","type":"clause","offset":[6,15]},

  • HCD means the California Department of Housing and Community Development.

  • Panchayat means an institution (by whatever name called) of self-government constituted under article 243B, for the rural areas;

  • Total tetrahydrocannabinol means the sum of the percentage by weight of tetrahydrocannabinolic acid multiplied by eight hundred seventy-seven thousandths plus the percentage of weight of tetrahydrocannabinol.

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • COVID-19 means SARS-CoV-2 or COVID-19, and any evolutions thereof or related or associated epidemics, pandemic or disease outbreaks.

  • Catechumen means a member of the catechumenate of a Catholic Church. This will normally be evidenced by a certificate of reception into the order of catechumens.

  • Drug outlet means a pharmacy, nursing home, shelter home, convalescent home, extended care facility, drug abuse treatment center, penal institution, hospital, family planning clinic, student health center, retail store, wholesaler, manufacturer, mail-order vendor or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Commercial cannabis activity means the production, cultivation,

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Pharmaceutical care means the provision of drug therapy and

  • Cannabidiol means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • API means the American Petroleum Institute.

  • Holocene means the most recent epoch of the Quaternary period, extending from the end of the Pleistocene Epoch to the present.