IND Preparation definition

IND Preparation means all drug development activities in support of a Lead Candidate or Product Candidate up to the filing of the IND for the Phase I Clinical Trial, including, but not limited to, assay development, sample analysis, preclinical toxicology, preclinical pharmacokinetics and toxicokinetics, pharmacological assessment (if applicable), cell line development and protein chemistry sciences, formulation development, clinical trial protocol development, IND drafting and data compilation, and manufacturing preclinical and clinical supplies.

Examples of IND Preparation in a sentence

  • Without limiting the foregoing, Regeneron will use Commercially Reasonable Efforts to identify Lead Candidates and complete IND Preparation for Lead Candidates in a timely manner during the term of the Discovery Program.

  • The JRC will also prioritize the Antibodies, including MTCs, to be further pursued as Lead Candidates, and Regeneron will commence IND Preparation activities only for those Antibodies, including MTCs, that meet the applicable criteria set forth in Schedule 4.

  • The sole-developing Party shall propose to the JRC the Solely Developed Immunoconjugate for inclusion in the Discovery Program when the Solely Developed Immunoconjugate has completed IND Preparation (unless the naked Antibody directed against the same Target as the Solely Developed Immunoconjugate is an IFM), and shall do so by submitting to the JRC a copy of the IND filing following the IND filing date.

  • The objective of the Parties during the Discovery Program is for Regeneron to discover, identify and/or validate Targets from which to select Program Targets, generate Antibodies, including MTCs, against such Program Targets (including Program Targets that are Sanofi Targets) from which to select Lead Candidates, and develop them through IND Preparation to offer to Sanofi for joint development and commercialization under the terms set forth herein and in the License and Collaboration Agreement.

  • Some analysts have been somewhat critical of ASEAN’s lame response to the second Mischief Reef incident.

  • For each Lead Candidate, the Antibody Discovery Plan will include activities and a planned timeline for IND Preparation.

  • For each Lead Candidate, the Discovery Plan will include activities and a planned timeline for IND Preparation.

  • Both the GSEs and FHA have raised their fees after the financial crisis, yet at different levels and different dates.

  • O'Reilly, "IND Preparation and Maintenance," Duke Translational Medicine Institute, available at <http://tracs.unc.edu/docs/regulatory/IND_Presentation- IND_Preparation_and_Maintenance-Best_Practices.ppt> (last visited June 20, 2013);E.

Related to IND Preparation

  • Preparation Each Approved Service Order will be in substantially the form specified in Exhibit A. Subject to the terms and conditions of this Master Agreement, the Consultant and the City will negotiate the specific requirements of each Approved Service Order.

  • Site preparation means those activities associated with the removal of slash in preparing a site for planting and shall include scarification and/or slash burning.

  • Trial preparation record means any record that contains information that is specifically compiled in reasonable anticipation of, or in defense of, a civil or criminal action or proceeding, including the independent thought processes and personal trial preparation of an attorney.

  • Coal preparation plant means a facility where coal is crushed, screened, sized, cleaned, dried, or otherwise prepared and loaded for transit to a consuming facility. “Coal preparation plant associated areas” means the coal preparation plant yards, immediate access roads, coal refuse piles, and coal storage piles and facilities. “Coal preparation plant water circuit means all pipes, channels, basins, tanks, and all other structures and equipment that convey, contain, treat, or process any water that is used in coal preparation processes within a coal preparation plant.

  • Program Preparation Advance (renamed as such pursuant to subparagraph 8 (c) above) is modified to read “Preparation Advance” and its definition is modified to read as follows:

  • Project Preparation Advance is modified to read “Preparation Advance” and its definition is modified to read as follows:

  • Negotiation means a transfer of possession, whether voluntary or involuntary, of an instrument by a person other than the issuer to a person who thereby becomes its holder.

  • ‘Preparation Advance’ means the advance referred to in the Financing Agreement and repayable in accordance with Section 2.07.”

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Prosthesis means an artificial substitute for a missing body part.

  • Written application or "written election" means a written instrument, required by statute or the

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • Prosthetic device means a replacement, corrective, or supportive device, other than contact lenses and dental prosthesis, dispensed pursuant to a prescription, including repair or replacement parts for that device, worn on or in the body to do 1 or more of the following:

  • 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;

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Licensed Process means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.

  • Agreed Process means any process agreed between the parties in respect of a Dispute other than the Dispute Resolution Procedure, as may be amended between the parties.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Due Diligence At any time prior to the Closing Date, the Underwriters have the right to inspect the Asset Files and the related loan origination procedures and to confirm the existence of the related manufactured homes or mortgaged properties to ensure conformity with the Final Prospectus and the Prospectus Supplement.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Participating Prosthetic Provider means a Prosthetic Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Involved means having a license censured, suspended, revoked, canceled, terminated; or, being assessed a fine, a cease and desist order, a prohibition order, a compliance order, placed on probation, sanctioned or surrendering a license to resolve an administrative action. “Involved” also means being named as a party to an administrative or arbitration proceeding, which is related to a professional or occupational license or registration. “Involved” also means having a license application denied or the act of withdrawing an application to avoid a denial. You may EXCLUDE terminations due solely to noncompliance with continuing education requirements or failure to pay a renewal fee.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • Sales Report means a report in substantially the form set forth in Exhibit B “Royalty Report Form”.