Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
Licensed Data means the data licensed by the LME to the Licensee set out in the Order Form and further defined in Schedule 1 (Licensed Data);
Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.
Study Data shall have the meaning set forth in Section 8.1.
Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;
Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.
Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;
Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.
Core Curriculum Content Standards means the New Jersey Student Learning Standards.
Study means the investigation to be conducted in accordance with the Protocol.
Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.
Research Results means any technical result acquired based on the Collaborative Research, including, but not limited to, any invention, idea, design, copyrightable work and know-how which relates to the purpose of the Collaborative Research.
Product Information has the meaning specified in Section 10.12(a).
Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;
Donor profile record means all records about donors or potential donors to a public institution of higher education except the names and reported addresses of the actual donors and the date, amount, and conditions of the actual donation.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.
Template Order Form means the template form in Annex 1 to Framework Schedule 4 (Template Order Form and Template Call Off terms);
Batch Record means the production record pertaining to a Batch.
complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.
Peer-reviewed medical literature means a scientific study published only after having been critically
SKU means stock-keeping unit.
Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.
Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.