New Clinical Trials and Other Studies Sample Clauses

New Clinical Trials and Other Studies. If (i) a Party (the “Proposing Party”) wishes (A) to Develop Licensed Products in a country for which it is the Development Lead Party for any Indication in the Field other than the Indication for which such Licensed [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Products are being Developed pursuant to the License Development Plan, (B) to Develop a dosage form or formulation of Licensed Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the License Development Plan, or (C) to conduct any other Clinical Trial of a Licensed Products in the Field in a country for which the Proposing Party is the Development Lead Party that is not at such time [***] or is not otherwise set forth in the License Development Plan, including any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a License Development Plan, an “Additional Study”), then the Proposing Party may so notify the other Party and present the proposed design and projected costs of such Additional Study to the JRDC, and the following shall apply:
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New Clinical Trials and Other Studies. If, following the Celgene Lead Effective Date, Celgene wishes (i) to conduct a Clinical Trial or other study of Co-Co Products for ROW Administration or for U.S. Administration, (ii) to Develop Co-Co Products in a country in the Territory for any Co-Co Indication in the Field other than a Co-Co Indication for which such Co-Co Products are being Developed pursuant to the Celgene Co-Co Development Plan, (iii) to Develop a dosage form or formulation of Co-Co Products in a country in the Territory other than that being studied in the Celgene Co-Co Development Plan, or (iv) to conduct any other Clinical Trial of a Co-Co Product in the Field in a country for in the Territory, including any Clinical Trial that the JSC determines is a Core Dossier Study after the Celgene Lead Effective Date, or any Clinical Trial or study that is not otherwise set forth in the Celgene Co-Co Development Plan, or any Clinical Trial that Celgene believes may have utility to support Regulatory Approval on a global basis (each such study not already included in a Celgene Co-Co Development Plan, a “Celgene Co-Co Additional Study”), then (A) Celgene shall first provide the proposed trial design and protocol for such Celgene Co-Co Additional Study to the JSC for review and approval as to the clinical and regulatory aspects of such Celgene Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Celgene Co-Co Additional Study design and protocol, and (B) following such review by the JSC, provide the final proposed design and projected costs of such Celgene Co-Co Additional Study to the JSC.
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New Clinical Trials and Other Studies. If, following the Jounce Lead Effective Date, a Party (the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study of Co-Co Products for ROW Administration (where the Proposing Party is Celgene), or for U.S. Administration (where the Proposing Party is Jounce), (ii) to Develop Co-Co Products in a country for which it is the Development Lead Party for any Co-Co Indication in the Field other than a Co-Co Indication for which such Co-Co Products are being Developed pursuant to the Jounce Co-Co Development Plan, (iii) to Develop a dosage form or formulation of Co-Co Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Jounce Co-Co Development Plan, or (iv) to conduct any other Clinical Trial of a Co-Co Product in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial that the JSC determines is a Core Dossier Study after the Jounce Lead Effective Date, or any Clinical Trial or study that is not otherwise set forth in the Jounce Co-Co Development Plan, or any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis (each such study not already included in a Jounce Co-Co Development Plan, a “Jounce Co-Co Additional Study”), then (A) the Proposing Party shall first provide the proposed trial design and protocol for such Jounce Co-Co Additional Study to the JSC for review and approval as to the clinical and regulatory aspects of such Jounce Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol, and (B) following such review by the JSC, provide the final proposed design and projected costs of such Jounce Co-Co Additional Study to the JSC.
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New Clinical Trials and Other Studies. If, following the PD-1 Effective Date, a Party (the “Proposing Party”) wishes to conduct a Clinical Trial or other study for Monotherapy Products in the Territory not already included in a Development Plan (an “Additional Study”), then solely in the case of Development of Monotherapy Products: (A) the Proposing Party shall first provide the proposed trial design and protocol for such Additional Study to the other Party (the “Non-Proposing Party”) for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the Non-Proposing Party into such Additional Study design and protocol, and (B) following such review, provide the final proposed design and projected costs of such Additional Study to the Non-Proposing Party; it being understood and agreed that (1) in the case of any Additional Studies involving a Collaboration Combination Product, the terms and conditions for such Additional Study under Section 2.3 of the applicable Co-Development & Co-Commercialization Agreement shall supersede the following provisions in this Section 2.3.3, and (2) in the case of any Monotherapy Product, then the Parties agree that neither Party shall be entitled to participate in or have any access to any of the efficacy data arising under such Additional Study (and, for the avoidance of doubt, the Parties understand and agree that neither Party shall be required to submit any proposed trial design, protocol or otherwise for any such Additional Study to the other Party), provided that each party shall have a right to access such data for safety reporting to applicable Regulatory Authorities. Subject to the preceding sentence, the following shall apply for Additional Studies hereunder:
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Related to New Clinical Trials and Other 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package 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 EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package 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 Disclosure Package and 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, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, 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, the Time of Sale Disclosure Package 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 studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • 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.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

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