TZP-101 definition

TZP-101 means Tranzyme’s proprietary ghrelin agonist known as TZP-101 (ulimorelin), having the chemical structure set forth on Exhibit B, including any salt, ester, solvate, polymorphic form, stereoisomer, metabolite, and pro-drug thereof.

Examples of TZP-101 in a sentence

  • Ejskjaer, N., et al., Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a randomized, placebo- controlled study.

  • Similarly, Chapter 5.0 reports the projected environmental effects of implementing sub-alternatives for military administration, withdrawal land area, and the administration of natural and cultural resource management.

  • Existing breeders should complete all parts of this form to allow us to update our database where required.

  • Wo, J.M., et al., Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting--randomised clinical study subset data.

  • Tranzyme shall, in good faith, consider the advice and comments of Norgine for TZP-101 Specific Claims in the Licensed Territory, but the final decision on such matters shall be Tranzyme’s (which will be exercised in good faith).

  • Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a randomized, placebo-controlled study.

  • XXXXXXXX XXXXXXXX XXXX, XX and AMSTERDAM, NETHERLANDS (Month Day, 2010) — Tranzyme Pharma, a clinical-stage biopharmaceutical company, and Norgine B.V., a European specialty pharmaceutical company, announced today that they have entered into a licensing agreement that provides Norgine with the exclusive rights to develop and commercialize Tranzyme’s novel ghrelin agonist, ulimorelin (TZP-101), in Europe, Xxxxxxxxx, Xxx Xxxxxxx, xxx Xxxxxx Xxxx, Xxxxx Xxxxxx and North Africa.

  • Norgine shall use reasonable efforts to prosecute patent applications forming part of Tranzyme Prosecuted Patents to grant with Valid Claims in the Licensed Territory, with the goal of achieving broad coverage for the composition of matter of, and method of making and using, TZP-101 and Product.

  • Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a rand- omized, placebo-controlled study.

  • If such TZP-101 Divisionals are created after the Effective Date, then such TZP-101 Divisionals shall be deemed Tranzyme Product-Specific Patents.

Related to TZP-101

  • NI 44-101 means National Instrument 44-101 – Short Form Prospectus Distributions;

  • NI 41-101 means National Instrument 41-101 – General Prospectus Requirements;

  • MI 61-101 means Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions;

  • NI 43-101 means National Instrument 43-101 – Standards of Disclosure for Mineral Projects;

  • NI 54-101 means National Instrument 54-101 – Communication with Beneficial Owners of Securities of a Reporting Issuer;

  • NI 58-101 means National Instrument 58-101 Disclosure of Corporate Governance Practices;

  • NI 51-101 means National Instrument 51-101 Standards of Disclosure for Oil and Gas Activities;

  • NP 11-202 means National Policy 11-202 – Process for Prospectus Reviews in Multiple Jurisdictions;

  • MI 11-102 means Multilateral Instrument 11-102 – Passport System;

  • MI 62-104 means Multilateral Instrument 62-104 Take-Over Bids and Issuer Bids;

  • NI 62-104 means National Instrument 62-104 Take-Over Bids and Issuer Bids adopted by the Canadian securities regulatory authorities, as now in effect or as the same may from time to time be amended, re-enacted or replaced;

  • NP 46-201 means National Policy 46-201 – Escrow for Initial Public Offerings.

  • NI 44-102 means National Instrument 44-102 – Shelf Distributions;

  • NI 45-102 means National Instrument 45-102 – Resale of Securities.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

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

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • NI 81-102 means National Instrument 81-102 – Investment Funds.

  • NI 51-102 means National Instrument 51-102 – Continuous Disclosure Obligations;

  • Biosimilar means a biological product that is highly similar to a specific reference biological

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • thalassemia means a group of inherited disorders characterised by reduced or absent amounts of haemoglobin.

  • 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.