Lead Product Candidate definition

Lead Product Candidate means the Product Candidate identified on Exhibit D.
Lead Product Candidate means the compound with [*].
Lead Product Candidate means the investigational drug product identified by the Company Group as “CNM-Au8.”

Examples of Lead Product Candidate in a sentence

  • The Lead Product Candidate of the Company and its Subsidiaries has been developed, tested, manufactured and stored, as applicable, in compliance in all material respects with applicable law including, where applicable, the FDA Act and applicable regulations issued by the FDA, including, as applicable, those requirements relating to the FDA’s, EMA’s and other Governmental Entities current good manufacturing practices and good laboratory practices, and good clinical practices.

  • Verification of an absence requires a written notice from parents or guardians to the homeroom teacher.

  • Neither the Company, nor any of its Subsidiaries nor any of their respective employees or agents, have made an untrue or fraudulent statement to the FDA or any other applicable Governmental Entity, or in any records and documentation prepared or maintained to comply with the applicable laws, with respect to the Lead Product Candidate of the Company, or failed to disclose a material fact required to be disclosed to the FDA or any other similar Governmental Entity.

  • And as the cliché goes, whenever the US sneezes, the world catches a cold.

  • KSI-301: Our Lead Product Candidate Our lead product candidate, KSI-301, is a novel, clinical stage anti-VEGF biological agent that combines inhibition of a known pathway with a potentially superior ocular durability profile compared to currently marketed drugs for wet AMD and DR.

  • To the Company’s Knowledge, the conduct of the Business of the Company and its Subsidiaries does not and would not, if the Lead Product Candidate were sold as of the date of this Agreement, infringe, violate or constitute a misappropriation of any Intellectual Property of any third party.

  • Following the Closing, the Buyer shall, and shall cause its Affiliates (including the Surviving Corporation) and the other members of the Buyer Rights Chain Group to, use Commercially Reasonable Efforts to achieve each of the Developmental Milestones with respect to the Lead Product Candidate and to commercialize the ENB-0040 Product for HPP in each country in which the ENB-0040 Product receivesRegulatory Approval for the treatment of HPP.

  • The Parties will determine which Party will have responsibility for (A) the processing of the Lead Product Candidate which incorporates Vectors and associated Payloads supplied by Bluebird for use in any Clinical Studies [***], and (B) the processing of any other Product Candidates which incorporates Vectors and associated Payloads supplied by Bluebird for any Clinical Studies of such other Product Candidates [***].

  • Our Lead Product Candidate Our lead product candidate, AB101, is human recombinant insulin that has been formulated with a polymer in biodegradable microspheres for use in patients with type 1 and type 2 diabetes who require basal insulin replacement therapy for the control of hyperglycemia.

  • For more information, please visit www.oncotelic.com.About Oncotelic’s Lead Product Candidate, OT-101OT-101, the lead immune-oncology drug candidate of Oncotelic, is a first-in-class RNA therapeutic targeting TGF beta that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings.


More Definitions of Lead Product Candidate

Lead Product Candidate means (i) seladelpar, and (ii) any esters, ethers, salts, free acids, free bases, prodrugs, hydrates, solvates, anhydrides, co-crystals, polymorphs, stereoisomers, enantiomers, chelates, metabolites and other derivatives thereof (whether in crystal or amorphous form).
Lead Product Candidate means: The anti-BCMA product candidate known as bb 2121
Lead Product Candidate means a Product as to which Protiva or its Affiliate is conducting GLP studies after notice to Hal-Bio and that has not been shown to have unacceptable characteristics in such studies at the time of sublicensing.

Related to Lead Product Candidate

  • 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.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • 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)).

  • Licensed Compound means [***].

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

  • 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.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • 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.

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

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

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

  • 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.

  • 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).

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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. [***]

  • 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.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • 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 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 Plan has the meaning set forth in Section 6.2.