Joint Clinical Data definition

Joint Clinical Data means all data (including raw data) and results generated by or on behalf of either Party or at either Party’s direction, or by or on behalf of the Parties together or at their direction, in the course of the Combination Arm(s); provided however, that Joint Clinical Data does not include Sample Testing Results, Collaborator Clinical Data or MSD Clinical Data.
Sample 1Sample 2Sample 3
Joint Clinical Data means all Clinical Data developed jointly by or on behalf of Salix or its Affiliates or Sublicensees and Alfa or its Affiliates or Sublicensees.
Sample 1Sample 2
Joint Clinical Data means all the Clinical Data generated or derived from or in pursuit of each of the UCL ADA SCID Clinical Trial and UCLA ADA SCID Clinical Trial, including the data described in Part D of Schedule 1;
Sample 1Sample 2

Examples of Joint Clinical Data in a sentence

  • Neither Party shall be liable for any use that the other Party may make of the Joint Clinical Data or shared Sample Testing Results, nor for advice or information given in connection therewith.

  • Collaborator shall maintain the Joint Clinical Data and any MSD Clinical Data in its internal database; [***].

  • Collaborator shall ensure that: (i) all patient authorizations and consents required under Applicable Law in connection with the Collaborator Clinical Trial permit such sharing of Joint Clinical Data and any MSD Clinical Data with MSD; and (ii) it complies with Applicable Law in transferring personal data hereunder.

  • Collaborator shall provide to MSD copies of all Joint Clinical Data and any MSD Clinical Data in electronic form or other mutually agreeable alternate form and on the timelines specified in the Data Sharing Schedule or mutually agreed; provided, however, that a complete copy of the Joint Clinical Data and any MSD Clinical Data shall be provided to MSD no later than [***] days following MSD Compound Study Completion or any sooner termination of this Agreement.


More Definitions of Joint Clinical Data

Joint Clinical Data means all Clinical Data developed jointly by or on behalf of AgeX or its Affiliates or Sublicensees, and BioTime or its Affiliates or Sublicensees.
Sample 1

Related to Joint Clinical Data

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 2 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IV Clinical Trial means a Clinical Trial conducted after Regulatory Approval of the applicable Product has been obtained from an appropriate Regulatory Authority as a condition to, or for the maintenance of, any Regulatory Approval, including a trial that would satisfy the requirements of 21 C.F.R. 312.85, as may be amended, or the foreign equivalent thereof.

  • Clinical Studies means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.