Combined Therapy IND definition

Combined Therapy IND shall have the meaning set forth in Section 2.1(b).
Combined Therapy IND has the meaning set forth in Section 2.1(f). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Combined Therapy IND. Defined Term Section Alliance Manager 2.6 Breaching Party 12.2(a) CDA 9.1 Tyrosine Kinase Inhibitor Trial 5.4(d) Co-Chair 2.3(a) Cure Period 12.2(a) Dispute 13.3(a) Exclusive Discussion Period 5.4(d) GAAP 4.1(a)

Examples of Combined Therapy IND in a sentence

  • Appendix E was prepared in September 2014 and since then details of the proposal have been further refined.

  • The Recipient shall be the sole holder of all legal interests in the Combined Therapy IND; provided, however, that the Recipient may not grant any Third Party any Right of Cross-Reference with respect to any portion of the Combined Therapy IND pertaining to BMS’s Single Agent Compound for use as monotherapy or for use in combination with any molecules, agents, antibodies or compounds other than the Recipient Study Drug.

  • The Parties shall discuss the approach for obtaining for BioXcel a Right of Cross-Reference to the CPI Compound as necessary to allow the Combined Therapy Trials to be conducted under the Combined Therapy IND.

  • Ipsen and Exelixis have agreed to the division of responsibilities for the Initial Trials, including but not limited to BMS’ right to be the Conducting Party and holder of the Combined Therapy IND for the RCC and HCC studies, as identified in Exhibit A to the Agreement.

  • Each Party shall provide a Right of Cross-Reference to its existing respective IND(s) as necessary to allow the Combined Therapy Study to be conducted under the respective INDs or if required by Regulatory Authorities, the Combined Therapy IND.

  • The Recipient shall be the sole holder of all legal interests in the Combined Therapy IND; provided, however, that the Recipient may not grant any Third Party any Right of Cross-Reference with respect to any portion of the Combined Therapy IND pertaining to BMS’s Single Agent Study Drug for use as monotherapy or for use in combination with any molecules, agents, antibodies or compounds other than the Recipient Study Drug.

  • Unless otherwise required by a Regulatory Authority, each Independent Combined Therapy Trial shall be conducted under either an existing IND or a Combined Therapy IND.

  • HUD and the Recipient entered into a Grant Agreement dated 10/1/2019, having Grant No. FL0121L4H101810 (the Grant Agreement).

  • Ipsen and Exelixis have agreed to the division of responsibilities for the Initial Trials, including but not limited to Roche’s right to be the Conducting Party and holder of the IND, or Combined Therapy IND as necessary, as identified in Exhibit A to the Agreement.

  • Each Party shall provide to the other Party a Right of Cross-Reference to its existing respective IND for its respective Single Agent Compound(s) as necessary to allow a Combined Therapy Trial to be conducted under the Combined Therapy IND.

Related to Combined Therapy IND

  • Step therapy means a program for Insureds who take Prescription Drugs for an ongoing medical condition, such as arthritis, asthma or high blood pressure, which ensures the Insured receives the most appropriate and cost-effective drug therapy for their condition. The Step Therapy program requires that before benefits are payable for a high cost Covered Drug that may have initially been prescribed, the Insured try a lower cost first-step Covered Drug. If the prescribing Physician has documented with SHL why the Insured’s condition cannot be stabilized with the first-step Covered Drug, SHL will review a request for Prior Authorization to move the Insured to a second-step drug, and so on, until it is determined by SHL that the prescribed Covered Drug is Medically Necessary and eligible for benefit payment.

  • 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.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy 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.

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Therapy means the administration of drugs or chemicals to remove toxic concentrations of metals from the body.

  • Radiation therapy simulation system means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

  • 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.

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • Background radiation means radiation from cosmic sources; naturally occurring radioactive materials, including radon (except as a decay product of source or special nuclear material); and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. “Background radiation” does not include sources of radiation from radioactive materials regulated by the agency.

  • Diagnostic mammography means a method of screening that

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Psychotherapy notes means notes recorded (in any medium) by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family counseling session and that are separated from the rest of the of the individual’s medical record. Psychotherapy notes excludes medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date. 45 C.F.R. § 164.501.

  • Non-Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who does not have 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.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Stray radiation means the sum of leakage and scattered radiation.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Total tetrahydrocannabinol means the same as that term is defined in § 3.2-4112.

  • Radiation therapist means a person, other than a Licensed Practitioner or Nuclear Medicine Technologist, who applies radiation to humans for therapeutic purposes under the supervision of a Licensed Practitioner;

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;