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.
IND Enabling Activities shall have the meaning set forth in Section 2.1.2.
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.

Examples of IND Enabling Activities in a sentence

  • The principle objective of the activities under the Research Plan is for Morphic to generate and Develop Research Products Directed to each Research Target, including performing IND Enabling Activities for at least [***] Research CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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) encouraging, soliciting, or inducing, or in any manner attempting to 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 any individual who was employed by the Company Group within the six (6) month period prior to the date of such hiring; 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 any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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 uses such as the operation of nuclear facilities, air traffic control, or life support systems, where the use or failure of the Services could lead to death, personal injury, or environmental damage.

  • 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.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • 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 and includes the following:

  • 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;