Phase 2 Activities definition

Phase 2 Activities means the Initial Trials and any associated Development activities set forth in the Clinical Development Plan.
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Phase 2 Activities means the CD Phase 2 Clinical Trial and any related Development activities set forth in the Clinical Development Plan.
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Phase 2 Activities has the meaning set forth in Section 3.1.1(f).
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Examples of Phase 2 Activities in a sentence

  • Xxxxxxx shall have day-to-day operational control over the conduct of the Phase 2 Activities.

  • Haz-Mat Abatement and Demolition Phase 2 Activities on June 1, 2017.

  • The JSC shall also discuss whether any amendments to the Phase 2 Activities in the Clinical Development Plan should be made due to the results from the Phase 1 Activities and/or to address Material Safety Issues raised by either Party, and any such amendments shall be approved by the JSC in accordance with Section 3.2.2.

  • The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. Xxxxxxx shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the Clinical Development Plan (including the timeline set forth therein).

  • Xxxxxxx shall be solely responsible for conducting the Phase 2 Activities.

  • In addition to its rights under Section 3.6.1(g), each Party shall have the right to conduct an audit of the manufacturing sites where any Collaboration CMC Activities for the Phase 1 Activities and Phase 2 Activities are conducted by the other Party (the “Manufacturing Party”) or its Third Party Subcontractors, and subject to the terms of any agreement between the Manufacturing Party and the applicable Third Party Subcontractors.

  • If the CMC Development Plan allocates responsibility for Manufacture and supply of Compound API or Drug Product for any Phase 2 Activities to Protagonist, the Parties shall negotiate in good faith and attempt to agree within [ * ] after the Effective Date upon a supply agreement for such supplies by Protagonist to Xxxxxxx at cost with no markup (the “Clinical Supply Agreement”) and a related quality agreement.

  • Achievements, Evolving Requirements and Roadmap for Phase 2 Activities, September 19, 2014.

  • Notwithstanding the foregoing, any Third Party Subcontractor to be used by the Conducting Party to perform any Collaboration CMC Activities for the Phase 1 Activities and Phase 2 Activities must be approved in advance by the other Party, which approval shall not be unreasonably withheld.

  • Following Xxxxxxx’x receipt of a complete Phase 1 Data Package pursuant to Section 3.3.2, the JSC shall meet to discuss such Phase 1 Data Package and determine whether the results from the Phase 1 Activities support continuation of preparation and conduct of the CD Phase 2 Clinical Trial and related Phase 2 Activities.


More Definitions of Phase 2 Activities

Phase 2 Activities means (a) with respect to the Initial Product, the CD Phase 2 Clinical Trial and any other Phase 2 Clinical Trial, and any related Development activities, set forth in the Clinical Development Plan, and
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Related to Phase 2 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;

  • 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;

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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.

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

  • Funded Activities means the activities set out in the Grant Offer Letter and Annex 2 of these Conditions; General Data Protection Regulation and GDPR means the General Data Protection Regulation (EU) 2016/679; Grant means the sum or sums that DWP will pay to the Grant Recipient in accordance with clause 4 and subject to the provisions set out at clause 22.

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

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

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • 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.

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

  • Commercial Activities means activities conducted on a commercial basis.

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

  • Covered Activities means those land uses and conservation and other activities described in Chapter 2.3 of the HCP/NCCP to be carried out by the Conservancy or its agents that may result in Authorized Take of Covered Species during the term of the HCP/NCCP, and that are otherwise lawful.

  • 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.

  • 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;

  • Commercial cannabis activity means the production, cultivation,

  • Construction Activities means the disturbance of soils associated with clearing, grading, excavation activities or other construction-related activities.

  • 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.

  • 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;

  • 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.

  • Development Area means that area to which a development plan is applicable.

  • Principal activities means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Development Program means the implementation of the development plan.