IND shall definition

IND shall mean an Investigational New Drug Application filed with the FDA and any foreign counterparts thereof.
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IND shall mean an Investigational New Drug Application, as defined in the United States Code of Federal Regulations (21 CFR).
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Examples of IND shall in a sentence

  • Such transfers and disclosures shall be made (x) in any manner or form reasonably requested by Kolltan (provided, however, that any data generated since the filing of the Existing IND shall be transferred in the form in which such data exists as of the Effective Date) and (y) at MedImmune’s expense.

  • If the IND is not transferred to Allos within one (1) month after the Effective Date and such failure is not due to a delay by the FDA directly or indirectly caused by Licensor or Allos, such failure to timely transfer the IND shall be deemed a material breach of this Agreement, pursuant to which Allos may terminate this Agreement by providing written notice to Licensor as provided in Article 9.4(a).

  • The term "IND" shall mean an application for investigation of a new drug that has been submitted to the FDA pursuant to the Federal Food Drug and Cosmetic Act, as amended [Title 21, United States Code] and the regulations promulgated thereunder, or an equivalent application to another Regulatory Authority.

  • Any product which contains an Option Compound that is the subject of an Option IND shall herein be referred to as an “Option Product”.

  • Ciba agrees to make the following payments to Neurocrine upon the occurrence of each milestone specified below for the first Collaboration Product which meets such milestone: MILESTONES PAYMENT ---------- ------- [ * ] TOTAL OF 1-6: It is understood that an IND shall be considered "filed" when accepted by the FDA or its equivalent in another country.

  • IND" shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the United States, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto, including EMA, prior to beginning clinical trials in humans in that country or in that group of countries.

  • With respect to any of the Products in the United States, (i) no Governmental Authority shall have permanently prohibited the further clinical use or terminated the IND (including under 21 CFR 312.44 on grounds of safety) and (ii) no IND shall have been definitively converted to “inactive status” under 21 CFR 312.45 as a result of a clinical hold imposed by the FDA on grounds of safety.

  • Cidara shall have the right to retain a copy of any Transferred IND, provided that, upon assignment and transfer to Xxxxxxx of a Transferred IND, such Transferred IND shall become the Confidential Information of Xxxxxxx.

  • The MB/Rich Agreement shall provide that the consideration to be paid by MB to Rich for the use of the IND shall be 15,000,000 shares of MB common stock and $100,000, of which 5,000,000 shares will be distributed to the shareholders of Rich.

  • For the avoidance of doubt, the transfer of such IND shall not be effective to transfer to Hyseq the ownership of or the right to practice any Amgen Material and Manufacturing Information.

Related to IND shall

  • shall mean the Pension Benefit Guaranty Corporation.

  • will shall be interpreted to express a command;

  • Diligent Efforts means, with respect to a Party’s obligations hereunder, the carrying out of obligations or tasks in a sustained manner consistent with the efforts a Party devotes to a research, development or marketing project for a pharmaceutical product or products of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, which efforts shall in any event be no less than those which would be considered reasonable in the pharmaceutical or biotechnology industries.

  • GSK has the meaning set forth in the preamble.

  • Development Phase means the period before a vehicle type is type approved.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Novartis shall have the meaning set forth in the Preamble.

  • BLS means Basic Life Support.

  • Product Terms means the document that provides information about Products available under this Agreement. The Product Terms document is published on the Licensing Site and is updated from time to time.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Reasonable Efforts means, with respect to any action required to be made, attempted, or taken by an Interconnection Party or by a Construction Party under Tariff, Part IV or Tariff, Part VI, an Interconnection Service Agreement, or a Construction Service Agreement, such efforts as are timely and consistent with Good Utility Practice and with efforts that such party would undertake for the protection of its own interests. Regional Entity:

  • of a Person shall mean: (i) any other Person directly, or indirectly through one or more intermediaries, controlling, controlled by or under common control with such Person; (ii) any officer, director, partner, employer, or direct or indirect beneficial owner of any 10% or greater equity or voting interest of such Person; or (iii) any other Person for which a Person described in clause (ii) acts in any such capacity.

  • ISIS means the department’s individualized services information system.

  • Best Efforts the efforts that a prudent Person desirous of achieving a result would use in similar circumstances to ensure that such result is achieved as expeditiously as possible.

  • Project Term the period from the Operation Commencement Date to the Expiry Date or the Termination Date, whichever occurs first, which is further described in Clause 3;

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Maintenance Term means, initially, the Maintenance Term identified in the Order. Upon expiration of the initial Maintenance Term, the Maintenance Term shall automatically renew for additional one (1) year periods unless terminated earlier by either party, at its option, by written notice at least sixty (60) days prior to the end of the then-current Maintenance Term. The Maintenance Term shall immediately terminate upon the termination, expiration, or cancellation of this Agreement for any reason.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • promptly as used in paragraph 3(a) shall mean as soon as practicable but in no event later than ten business days from the Intermediary’s receipt of the request for information from the Fund or its designee. DWS XXXXXXX DISTRIBUTORS, INC. By: __________________________ Name: Xxxxxxx Xxxxxxx Title: Chief Executive Officer FIRM: ________________________ By: __________________________ Name: ________________________ Title: _________________________ Date: _________________________

  • Contract Manager means the DNR staff person who processes this contract, makes payments, provides and facilitates dispute resolution, provides technical advice to the Compliance Forester, and is the first point of contact for questions relating to this contract or interpretation of Work. The Contract Manager may perform the duties of the Compliance Forester.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • GTC means General Terms & Conditions of Contract.