Alder Cancer Territory definition

Alder Cancer Territory means (i) all countries of the world, in the case where BMS has not exercised the Option and (ii) in the case where BMS has exercised the Option, the U.S. plus any other country as to which BMS’ rights with respect to the Cancer Product have reverted to Alder pursuant to Section 11.1(c)(iii), or as to which the Agreement has been terminated, in accordance with Article 13.
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Examples of Alder Cancer Territory in a sentence

  • In addition, BMS shall [***] provide reasonable consultation and assistance for the purpose of transferring to Alder all such BMS Know-How, to the extent reasonably necessary or useful for Alder to Develop, manufacture and Commercialize Cancer Product for the Cancer Field in the Alder Cancer Territory.

  • This is without considering that fuel economy technology is only one of the many different improvements that increase a vehicle’s MSRP, such as safety technology, convenience items and design changes which are all equal or higher drivers to increased vehicle costs.

  • In addition, with respect to a claim, suit or action brought by BMS pursuant to Section 9.4(b)(i) with respect to any Infringement in the Cancer Field of a Core Patent in a country the Alder Cancer Territory, BMS shall not settle such claim, suit or action without the prior written consent of Alder.

  • Alder will be solely responsible for all pricing and reimbursement approval proceedings relating to the Co-Developed Product in the Alder Cancer Territory.

  • Until and unless BMS exercises the Option, Alder shall, in accordance with the terms and conditions of this Agreement, be responsible for any Development and Commercialization of Cancer Product in the Cancer Field in the Alder Cancer Territory.

  • Alder shall have the right to develop and commercialize each Selected Cancer Backup Compound solely as a Cancer Product in the Cancer Field in the Alder Cancer Territory, and BMS shall not have the right to develop and/or commercialize pharmaceutical products comprising such [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

  • To the extent that Licensed Product is determined by the JEC to be used for the treatment of indications in the Cancer Field in a Major Market country in the Alder Cancer Territory (i.e., a country where BMS is not granted commercialization rights for the Cancer Field) at a level [***], BMS shall pay to Alder [***].

  • To the extent that Cancer Product is determined by the JEC to be used for the treatment of indications in the Licensed Field in a Major Market country in the Alder Cancer Territory at a level [***], Alder shall pay to BMS [***].

  • BMS shall xxxxx Xxxxx [***] and [***] in order to allow Alder (i) perform any activities [***] or (ii) support [***] Cancer Products in the Cancer Field in the Alder Cancer Territory and interactions with [***] in connection with [***] of Cancer Products in the Cancer Field in the Alder Cancer Territory.

  • In the case where BMS does not exercise the Option, (i) Alder shall be solely responsible for creating all packaging and promotional materials for the Cancer Product in the Cancer Field in the Alder Cancer Territory and (ii) AlderHoldings shall own all right, title and interest in and to any and all such promotional materials, including all applicable copyrights, trademarks, program names and domain names; subject in each case of clause (i) and (ii) to the other provisions of Article 10.

Related to Alder Cancer Territory

  • 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 I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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.

  • 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).

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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 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.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity 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 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.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Compound means [***].

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • 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;

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.