IND-Enabling Toxicology Studies Sample Clauses

IND-Enabling Toxicology Studies. (i) For each Development Candidate under a Collaboration Program that is not an ALS Collaboration Program, the applicable Neurology JDC will agree upon a high level pre-clinical toxicology strategy no later than [***] days following its receipt of the applicable Development Candidate Data Package. Isis will conduct the IND-Enabling Toxicology Studies under such strategy to the extent consistent with the activities set forth on SCHEDULE 1.10.2(C); provided, however, if the initial strategy or applicable Initial Development Plan requires IND-Enabling Toxicology Studies that are in addition to or different from the activities set forth on SCHEDULE 1.10.2(C), then Biogen Idec will pay Isis the costs of such additional or different activities to the extent such costs exceed [***]% of the costs of the activities set forth on SCHEDULE 1.10.2(C). Such additional costs will be Biogen Idec-Approved Costs and will be handled in accordance with the process described in Section 1.14.
Sample 1
AutoNDA by SimpleDocs
IND-Enabling Toxicology Studies. For each Collaboration Program, the JSC will agree upon a high level preclinical toxicology strategy (including the contract research organization (CRO) to be used to conduct the IND-Enabling Toxicology Studies) for each Development Candidate no later than [***] days following designation of the Development Candidate under such Collaboration Program. In addition, the JSC will approve any study protocols for the IND-Enabling Toxicology Studies at least [***] prior to the anticipated commencement of such IND-Enabling Toxicology Studies. If the JSC does not agree on such high level preclinical toxicology strategy or study protocols for a particular Collaboration Program within the applicable time period as set forth above in this Section 1.5, then Biogen will have final decision-making authority with respect thereto; provided, that, solely with respect to the categories of IND-Enabling Toxicology Studies listed on Schedule 1.5, Biogen will not use a [***] to conduct any such IND-Enabling Toxicology Study that is not [***] listed on Schedule 1.5 with respect to the applicable category of IND-Enabling Toxicology Studies, [***]
Sample 1
IND-Enabling Toxicology Studies. (i) For each Development Candidate under a Collaboration Program that is not an ALS Collaboration Program or a Biogen Conducted Non-ALS Collaboration Program, the applicable Neurology JDC will agree upon a high level pre-clinical toxicology strategy no later than [***] days following its receipt of the applicable Development Candidate Data Package. Ionis will conduct the IND-Enabling Toxicology Studies under such strategy to the extent consistent with the activities set forth on Schedule 1.10.2(c); provided, however, if the initial strategy or applicable Initial Development Plan requires IND-Enabling Toxicology Studies that are in addition to or different from the activities set forth on Schedule 1.10.2(c), then Biogen will pay Ionis the costs of such additional or different activities to the extent such costs exceed [***]% of the costs of the activities set forth on Schedule 1.10.2(c). Such additional costs will be Biogen-Approved Costs and will be handled in accordance with the process described in Section 1.14.1. (ii) For each ALS Collaboration Program and each Biogen Conducted Non-ALS Collaboration Program, the applicable Neurology JDC will agree upon a high level pre-clinical toxicology strategy no later than [***] days following its receipt of the applicable Development Candidate Data Package. In addition, the applicable Neurology JDC will approve any study protocols for the IND-Enabling Toxicology Studies at least [***] months prior to the anticipated commencement of such IND-Enabling Toxicology Studies. If the Neurology JDC is unable to agree on such high level pre-clinical toxicology strategy or study protocols for a particular ALS Collaboration Program or Biogen Conducted Non-ALS Collaboration Program within the applicable time period as set forth above in this Section 1.10.2(c)(ii), the matter will be referred to the CSC for resolution. If the CSC cannot agree on such a high level pre-clinical toxicology strategy within [***] days after the matter is so referred, or on any such study protocol within [***] days after the matter is so referred, as applicable, then Biogen will have final decision-making authority with respect thereto for IND-Enabling Toxicology Studies conducted by Biogen. Solely with respect to the first ALS Collaboration Program to have a Development Candidate, Ionis will conduct the IND-Enabling Toxicology Studies utilizing the same mechanics as set forth in Section 1.10.2(c)(i), and upon Initiation of such IND-Enabling Toxicolo...
Sample 1
IND-Enabling Toxicology Studies. [***]. For the first Ionis Development Candidate for a given Target, [***] will decide which Party will conduct IND-Enabling Toxicology Studies in accordance with Section 3.1.6 (Roche Performing IND-Enabling Toxicology Studies for First Ionis Development Candidate), and will either (a) [***], or (b) [***]. In case of (a) above, [***].
Sample 1
IND-Enabling Toxicology Studies. For each Development Candidate, at least [***] before an IND is filed by or on behalf of Novartis with respect to such Development Candidate or earlier if available and upon Ionis’ reasonable request, Novartis will provide Ionis with a Draft Report from an IND-Enabling Toxicology Study for such Development Candidate for Ionis to review. Upon Ionis’ reasonable request, the JSC (or, if the JSC has been discontinued, the Parties) will promptly convene a meeting to discuss [***] any comments or concerns raised by Xxxxx with respect to such Draft Report, which meeting will be convened prior to Novartis filing an IND for such Development Candidate.
Sample 1
IND-Enabling Toxicology Studies 
Sample 1

Related to IND-Enabling Toxicology 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.

  • 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 submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, 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 in all material respects and fairly present the data derived from such studies and trials; 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 reasonably 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 written 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.

  • 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.

  • 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 and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the regulatory milestone events (“Regulatory Milestone Events”) set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-1, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Development Milestones Subject to the terms and conditions of this Agreement, no later than [**] following the first occurrence of each event described below (each, a “Development Milestone”), on Product-by-Product basis Moderna shall pay Carisma the non-refundable and non-creditable amounts set forth below for each Product to achieve such event (each, a “Development Milestone Payment”): ​ Development MilestoneDevelopment Milestone Payment (in US$ millions) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] ​ Moderna shall provide written notice to Carisma of the achievement of each Development Milestone within [**] after such achievement. If a Development Milestone for a Product is achieved without the preceding Development Milestone(s) having been achieved for such Product, then the Development Milestone Payment for such preceding Development Milestone(s) shall be paid by Moderna to Carisma together with ​ ​ the Development Milestone Payment for the Development Milestone that was achieved. For example, if the [**] Development Milestone [**] in the table above is achieved for a Product but the [**] Development Milestone [**] in the table above had not been achieved for such Product, then Moderna would pay the Development Milestone Payment for both such [**] Development Milestone and [**] Development Milestone upon achievement of the [**] Development Milestone. Each of the Development Milestone Payments set forth above shall be payable one time only per Product. If Moderna or its Affiliates or Sublicensees Develops a Product that has achieved at least one Development Milestone and subsequently discontinues Development of such Product and Develops a different Product incorporating or directed to the same combination of Collaboration Targets (whether one Collaboration Target or multiple Collaboration Targets), then Moderna shall be required to pay Development Milestone Payments for such different Product only for Development Milestones that had not been achieved by such discontinued Product.

  • Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

Time is Money Join Law Insider Premium to draft better contracts faster.