Active Development definition
Active Development means that at any given time Licensee, Sublicensee, or delegated party shall be diligently engaging in one or more of the following Development activities for the lead. Licensed Product it has selected to Develop: formulation development, study/protocol design activity, awaiting protocol approval from the applicable institutional review board or FDA, patient recruitment, patient treatment, data analysis, report writing for any clinical trial, regulatory file(s) being drafted or pending, pricing or marketing approvals pending, manufacturing investment work, synthetic process development, drug synthesis, packaging development, manufacturing scale-up and validation, preclinical or in vitro characterization and go/no go decision awaited from a formal research and development committee within Licensee to initiate any of the preceding activities
Active Development means, with respect to any Compound, that Tanabe is using at least such level of effort, in accordance with Tanabe's business, legal, medical and scientific judgement and Tanabe's normal practices and procedures, to continue the development of such Compound through preclinical and clinical studies and other registration directed activities as Tanabe spends on its own products in pre-clinical and clinical study with similar technical and commercial potential.
Active Development of a product (and as to the point in time when this definition is referenced in this Agreement for such product), means that the product has by that time achieved the milestone in clause (a) below and has progressed through the further development stages in compliance with the time frames set forth below:
Examples of Active Development in a sentence
Both of Borrower’s drug candidates INBRX-106 and INBRX-109 are no longer under Active Development.
More Definitions of Active Development
Active Development means substantial use of the Project Technology (defined in Section 9.2) in an active or ongoing scientific research or development project reasonably calculated to yield results or awaiting approval by the U.S. Food and Drug Administration (“FDA”) or any foreign equivalent to market a Product for sale for use in humans. Active Development will have ceased if you or, if applicable, your licensee or transferee, (i) discontinues all clinical development and/or commercial development of Product; and (ii) has not obtained financing to fund such activities, in the event of either (i) or (ii), for a period of one hundred eighty (180) days or longer.
Active Development means where construction is ongoing on a property in relation to an application for a Plan of Subdivision or a Site Plan application that has been approved by the City;
Active Development means the ongoing expenditure of reasonable resources (including under the Sponsored Research Agreement) toward the commercialization of a Licensed Product in one or more of the following activities: marker validation, assay development, preparation or performance of clinical studies, data analysis, test manufacturing, preparation for or pursuit of regulatory approvals or payor coverage, preparing or offering to sell. For purposes of clarification, any of the foregoing activities for a Licensed Product constitutes Active Development of all markers remaining under Active Development for all Licensed Product for the same cancer, precancer, disease or condition. The Parties acknowledge that (i) a marker may be under Active Development for multiple Licensed Products (including Licensed Products for the same cancer, precancer, disease or condition), (ii) a marker would be considered to remain under Active Development during reasonable pauses between development activities, provided that such pause lasts no longer than six months and ESDC maintains the good faith intention to continue development of such marker for a Licensed Product, (iii) discontinuation of Active Development with respect to a marker for one Licensed Product does not constitute discontinuation of Active Development with respect to a marker for any other Licensed Product, and (iv) activities performed by a diagnostic reference laboratory that is not an Affiliate of ESDC under a sublicense do not constitute Active Development.
Active Development means, with respect to a Licensed Product, that Prevail or any of its Affiliates or sublicensees are engaging in one or more of the following activities for such Licensed Product: [***].
Active Development means that at any given time Novartis or an Affiliate, Sublicensee or Permitted Third Party Service Provider shall be diligently engaging in one or more of the following Development activities for a given Licensed Product: [***]. Anything contained in this Agreement to the contrary notwithstanding, the obligations under this Section 3.3(b) shall cease upon achievement of the [***] of a [***] by the applicable [***] for any Licensed Product.
Active Development means that Pulmatrix, Sublicensee, or delegated Affiliate shall use Commercially Reasonable Efforts (as defined below) in engaging in, or retaining a third- party to engage in, one or more of the following Development activities for the lead Licensed Product it has selected to Develop: formulation development, study/protocol design activity, awaiting protocol approval from the applicable institutional review board or FDA, patient recruitment, patient treatment, data analysis, report writing for any clinical trial, regulatory file(s) being drafted or pending, pricing or marketing approvals pending, manufacturing investment work, synthetic process development, drug synthesis, packaging development, manufacturing scale-up and validation, preclinical or in vitro characterization and pursuing a go/no go decision awaited from the appropriate decision-maker(s) within Pulmatrix to initiate any of the preceding activities.
Active Development shall have the meaning provided in the UPenn Agreement.