IND Enabling Activities definition

IND Enabling Activities means, with respect to a particular Research Product, all Development activities required (including the compilation of data resulting therefrom (including CMC Data) in a form suitable) to support the filing of an effective IND with FDA (e.g., that would not be subject to a clinical hold within thirty (30) days of filing) sufficient to conduct human clinical trials for such Research Product in the United States.
Sample 1Sample 2Sample 3
IND Enabling Activities shall have the meaning set forth in Section 2.1.2.
Sample 1
IND Enabling Activities means, the pre-clinical research and development activities intended to enable the submission of an IND, including a toxicology study that satisfies applicable regulatory requirements, using applicable GLP that meets the standard necessary for submission as part of an IND with the applicable Regulatory Authority.
Sample 1

Examples of IND Enabling Activities in a sentence

  • The parties acknowledge that this Agreement requires GBMT to conduct or have conducted all CUDC-908 IND-Enabling Activities in accordance with U.S. regulatory requirements such that the resulting Data is suitable for filing with the FDA of an IND for CUDC-908 (or CUDC-906, as applicable), as well as all applicable regulatory requirements in China as necessary for the filing with the SFDA of an IND for such Compound.

  • In order to [**], Curis shall provide to GBMT up to an aggregate of U.S. $400,000, [**] CUDC-908 IND-Enabling Activities.

  • Subject to Section 5.2, JW will be solely responsible for, and will bear all the costs and expenses of, Manufacturing and supplying all Product for Development and Commercialization in the Field in the JW Territory, and JW will purchase Vector Supply from TSVT or its designee for use in the IND-Enabling Activities and Phase I Clinical Trial of the Initial Product.

Related to IND Enabling Activities

  • Competing Activities means the same or similar services as Xxxxxx Xxx Ltd is providing to the Restaurant under this Agreement or other activities having a similar purpose.

  • Interfering Activities means (A) recruiting, encouraging, soliciting, or inducing, or in any manner attempting to recruit, encourage, solicit, or induce, any Person employed by, or providing consulting services to, any member of the Company Group to terminate such Person’s employment or services (or in the case of a consultant, materially reducing such services) with the Company Group, (B) hiring, or engaging any individual who was employed by or providing services to the Company Group within the six (6) month period prior to the date of such hiring or engagement, or (C) encouraging, soliciting, or inducing, or in any manner attempting to encourage, solicit, or induce, any Business Relation to cease doing business with or reduce the amount of business conducted with the Company Group, or in any way interfering with the relationship between any such Business Relation and the Company Group.

  • Motorcycling Activities means performing or participating in any capacity in any authorised or recognised Motorcycling Organisation event, meeting or activity;

  • Activities has the meaning specified in Section 7.02(b).

  • Economic activities shall in principle include activities of an industrial, commercial and professional character and activities of craftsmen;

  • Service activities means activities in connection with the provision of personal, continuing services to shareholder accounts in the Shares; provided, however, that if the National Association of Securities Dealers, Inc. (“NASD”) adopts a definition of “service fee” for purposes of Section 2830(b)(9) of the NASD Conduct Rules or any successor provision that differs from the definition of “service activities” hereunder, or if the NASD adopts a related interpretive position intended to define the same concept, the definition of “service activities” in this paragraph shall be automatically amended, without further action of the parties, to conform to the then effective NASD definition. Overhead and other expenses related to “distribution activities” or “service activities,” including telephone and other communications expenses, may be included in the information regarding amounts expended for these activities.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Motorsport Activities means any motorsport activities or Recreational Services which are permitted or approved which Motorsport Australia regulates or administers or otherwise are under the responsibility / control of Motorsport Australia;

  • fishing related activities means any operation in support of, or in preparation for, fishing, including the landing, packaging, processing, transshipping or transporting of fish that have not been previously landed at a port, as well as the provisioning of personnel, fuel, gear and other supplies at sea;

  • High Risk Activities means activities where the use or failure of the Services would reasonably be expected to result in death, serious personal injury, or severe environmental or property damage (such as the creation or operation of weaponry).

  • Motor Sport Activities means any motor sport activities or Recreational Services which are permitted or approved which CAMS regulates or administers by CAMS or otherwise under the responsibility / control of CAMS;

  • Interscholastic Activities means athletic or non-athletic/academic activities where students compete on a school vs. school basis.

  • Commercial Activities means activities conducted on a commercial basis.

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.

  • Intrascholastic Activities means athletic or non-athletic/academic activities where students compete with students from within the same school.

  • Corrupt activities means any corrupt activities as contemplated in the Prevention and Combating of Corrupt Activities Act 2004 (Act no. 12 of 2004)

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • investment services and activities means any of the services and activities listed in Section A of Annex I relating to any of the instruments listed in Section C of Annex I;

  • School activities means any activity sponsored by the school including, but not limited to, classroom work, library activities, physical education classes, official assemblies and other similar gatherings, school athletic contests, band concerts, school plays and other theatrical productions, and in-school lunch periods.

  • Eligible activities or "eligible activity" means 1 or more of the following:

  • licensed activities means things authorised to be done by the licence

  • Contracting activity for DoD also means elements designated by the director of a defense agency which has been delegated contracting authority through its agency charter. DoD contracting activities are listed at PGI 202.101.

  • Restricted Activities means those activities described in Section 10 of this Agreement.

  • Permitted Activities The primary activities of the trust created pursuant to this Agreement which shall be:

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;

  • Agricultural activities means agricultural uses and practices including, but not limited to: Producing, breeding, or increasing agricultural products; rotating and changing agricultural crops; allowing land used for agricultural activities to lie fallow in which it is plowed and tilled but left unseeded; allowing land used for agricultural activities to lie dormant as a result of adverse agricultural market conditions; allowing land used for agricultural activities to lie dormant because the land is enrolled in a local, state, or federal conservation program, or the land is subject to a conservation easement; conducting agricultural operations; maintaining, repairing, and replacing agricultural equipment; maintaining, repairing, and replacing agricultural facilities, provided that the replacement facility is no closer to the shoreline than the original facility; and maintaining agricultural lands under production or cultivation;