IBD Indication definition

IBD Indication means any chronic intestinal disease that is characterized by inflammation of the bowel, including ulcerative colitis (UC) and Crohn’s disease (CD), celiac disease and immune checkpoint inhibitor (ICI) induced colitis.
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IBD Indication means the prevention, treatment or control of Crohn’s Disease and/or ulcerative colitis in humans and/or animals.
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Examples of IBD Indication in a sentence

  • By way of illustration and without limitation, if a Product Candidate targeting CCR9 in an IBD Indication has achieved [***] for filing but is not granted [***], and if a subsequent Product Candidate targeting CCR9 for an IBD Indication achieves [***], such milestone will be deemed to have already been paid.

  • In the event Celltech intends to assign its rights to co-promote Collaboration Products in the IBD Indication, Celltech shall provide Pharmacia with the opportunity to negotiate terms under which Pharmacia would assume Celltech’s obligations pursuant to Section 5.13.

  • In the event that such service providers are unable to provide the Parties with accurate information, the Parties may mutually agree to consider other methods for allocating Net Sales between RA Indication, IBD Indication and Other Indications, which may include, but need not be limited to, type of doctor writing a script, dispensing location, and other relevant facts.

  • The Clinical Development Plan shall contain key Development activities (other than CMC Development Activities) necessary to complete Development of the Initial Product for an IBD Indication through the end of Phase 3, and may also include Development activities with respect to other Compounds and Products mutually agreed upon by the Parties.

  • For each Licensed Product targeting CCR9 for Indications other than the IBD Indication (“Non-IBD Indications”), GSK shall pay to ChemoCentryx a royalty on annual Non- *** Certain information on this page has been omitted and filed separately with the Commission.

  • For each Licensed Product targeting CCR9 for Indications other than the IBD Indication (“Non-IBD Indications”), GSK shall pay to ChemoCentryx a royalty on annual Non-IBD Net Sales (as defined below) as specified below for annual Net Sales tiers achieved in the U.S. or the Rest of World (ROW), determined separately, in accordance with this Section 6.6.2, at the percentage rate set forth below, [***], as provided in the following schedule.

  • The Product Contribution shall be calculated for both the RA Indication and the IBD Indication for each Major Territory, all in accordance with Exhibit A.

  • To the extent practicable, Celltech shall have the right to have a representative participate in all material meetings and telephone discussions between representatives of Pharmacia and the Regulatory Authorities relating to the Development and Commercialization of Collaboration Products in the RA Indication, IBD Indication or Celltech Other Indication.

  • Like briefly mentioned in the introduction of this section, these systems provide one or more of two services, namely room heating and tap- water heating.

  • To the extent relevant to the Development or Commercialization of a Collaboration Product in the IBD Indication or Celltech Other Indication, Pharmacia shall promptly provide to Celltech copies of any documents or other correspondence received from Regulatory Authorities pertaining to the use of a Collaboration Product outside of the IBD Indication or Celltech Other Indication.

Related to IBD Indication

  • Second Indication means [***].

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Additional Indication means any indication other than the Initial Indication.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

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

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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 II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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).

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.