Additional Clinical Studies Clause Samples

Additional Clinical Studies. Licensee is interested in participating in future clinicial studies which TXMD may wish to conduct in order to expand the Initial Indication of the Products. Licensee would commit to contribute both financially and using its technical expertise. The design and cost of any such studies would need to be mutually agreed between the Parties.
View Source
Additional Clinical Studies. Upon ▇▇▇▇▇▇'▇ initiation of any Investigational New Drug Application related to any new indication, dosage form or formulation of the Product, the parties shall meet to discuss such Investigational New Drug Application and the projected expenses involved in conducting a program for a Supplemental New Drug Application to the FDA, including required expenditures for new clinical development programs. If Cephalon is interested in pursuing a collaboration for such new indication, dosage form, or formulation, Cephalon shall notify ▇▇▇▇▇▇ within thirty (30) days of their meeting and the parties shall thereafter negotiate in good faith during the succeeding three (3) month period a sharing of the clinical development expenditures necessary to file a Supplemental New Drug Application, the allocation of marketing responsibilities, as well as a sharing of the revenues related to the sale of drug under such Supplemental New Drug Application. The sharing of such expenditures, responsibilities and revenues shall reflect the parties' good faith determination of the extent to which the percentage of the market for the new indication, dosage form or formulation is in the Field. If the parties are unable to agree on such sharing arrangements, the matter shall be referred to ▇▇▇▇▇▇'▇ Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaid, the matter shall be submitted to alternative dispute resolution in accordance with Section 18.7 hereof. If Cephalon is not interested in pursuing such a collaboration, or if the parties are unable to agree on the terms of such a collaboration within three (3) months following good faith negotiations and the dispute is not submitted to alternative dispute resolution in accordance with Section 18.7, then ▇▇▇▇▇▇ shall have the right to develop and market, either by itself or with other collaboration partners, the new indication, dosage form, or formulation that is the subject of the Supplemental New Drug Application. If ▇▇▇▇▇▇ markets such new indication, dosage form, or formulation in the Territory during the Collaboration Period, the parties further agree to examine in good faith an appropriate methodology, if necessary, to distinguish sales of the new indication, dosage form, or formulation from "Net Sales" of the Product so that neither party is prejudiced hereunder by the sale of such new indication, dosage form, or formulation in the Te...
View Source
Additional Clinical Studies. BMS will provide ASCENT from time to time with reasonable quantities, as determined by ASCENT in its sole discretion, of samples of the Product to be used in making detail calls to Pediatricians in the Territory. Product samples will in all cases be shipped to ASCENT on not less than thirty (30) days' advance written notice and subject to the same shipping schedules as that under which BMS distributes Product samples to its own sales representatives. Product samples will be shipped to an ASCENT central distribution point from which ASCENT will further distribute them to its sales representatives. All costs
View Source

Related to Additional Clinical Studies

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.