Clinical Trial Agreements Sample Clauses

Clinical Trial Agreements. For sites who have participated in the previous study these agreements will be used as the basis for the new study agreement, decreasing the need for negotiation, which will facilitate the execution process. If new sites will be initiated these agreements will serve as a template for the new agreements. Activities include: • Create all clinical study agreements templates and patient budget template with the Sponsor • When possible, set up pre-approved alternative language and budget parameters in anticipation of negotiation • Negotiate all clinical study agreements that satisfy Sponsor requirements on behalf of the Sponsor • Incorporate changes using pre-approved alternative parameters and if changes are outside parameters, secure approval by the Sponsor • Obtain signatures from investigators, institutions, facilities, on all clinical study agreements as needed • Collect IRS Form W9 and payment information forms from sites • Track documentation and communication with the sites, Omnicare CR Project Management and the Sponsor.
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Clinical Trial Agreements. (a) [***] effective [***] between OGX, [***] and [***] with respect to [***].
Sample 1
Clinical Trial Agreements. Unless otherwise agreed to in the Work Order, the Clinical Trial Agreement will be Syneos Health’s standard template, which will be provided to Sponsor for review. If there are material changes to such template suggested by Investigators that have a direct impact on Sponsor’s rights, Sponsor will provide timely feedback in connection with the drafting and negotiation of such Clinical Trial Agreement. Syneos Health is not responsible for any undue delay attributable to Sponsor’s failure to provide timely approvals or responses. If requested by an Investigator, Sponsor will provide a written indemnification directly to the Investigator. Sponsor acknowledges that Syneos Health shall have no indemnification obligation to any Investigator relative to the applicable Study Product or Protocol.
Sample 1
Clinical Trial Agreements. If SynteractHCR will be negotiating the clinical trial agreement (“CTA”) and Study budget with the clinical investigational sites (“Sites”) on behalf of Sponsor, Sponsor will provide written approval on the Study specific CTA and budget templates to SynteractHCR for use during such negotiations. Sponsor shall provide to SynteractHCR Sponsor’s negotiating parameters for CTA terms, subject budget amount, start-up and pass-through costs as the basis for negotiation with the Sites. Any modification outside of such written parameters shall require approval of Sponsor. In no event will a Site be construed to be an employee, subcontractor, agent, consultant, or representative of SynteractHCR, or be deemed to be a Subcontractor (as defined in Section 3.3).
Sample 1
Clinical Trial Agreements. In connection with Registration Studies or Other Clinical Studies sponsored by Pharmion, Pharmion will use Commercially Reasonable Efforts to ensure that all clinical trial agreements with third parties, including principal investigators and CROs, will be assignable to XXX and that such agreements may be terminated, on no more than 90 days' notice by the payment of no more than the costs incurred by the third party through the date of termination.
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Clinical Trial Agreements. Pfizer shall be responsible for the negotiation and administration of all clinical trial agreements with Third Party clinical trial sites or investigators.
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Clinical Trial Agreements. Listed below is the identity of each and every one of the clinical trial agreements or clinical trials which Sclavo has sponsored, conducted, funded or provided TA-1 material for, in the past or now has with respect to the Licensed Products: A Randomized Controlled Trial of Thymosin-Alpha 1, Versus Interferon Alpha Treatment in Patients with Hepatitis B and Antigen Antibody and Hepatitis B, Virus DNA - Positive Chronic Hepatitis B All obligations to be performed by Sclavo pursuant to said clinical trial agreements have been performed and completed, excepting only as otherwise set forth on Exhibit A-1 attached hereto. All obligations of the other parties to said clinical trial agreements have been performed and completed, excepting only as otherwise set forth on Exhibit A-1 attached hereto.
Sample 1
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Clinical Trial Agreements. INEX and Hana hereby acknowledge and agree that:
Sample 1
Clinical Trial Agreements. The Parties wish to reflect the transfer to Licensee of pre-clinical, clinical, manufacturing and regulatory activities which were being performed by Licensor and/or Licensee with respect to current clinical trials relating to DME, Uveitis and ARMD (the "Clinical Activities"). As agreed upon by the Parties, prior to Licensor's withdrawal of its IND covering such Clinical Activities, Licensee has provided: (a) notice of assignment and assumption to third parties under the third party contracts related to the Clinical Activities listed on Exhibit 36.1A (the "Clinical Agreements"); and (b) a notice of termination (as executed by Licensor) to third parties under third party clinical trial agreements listed on Exhibit 36.1B ("Trial Agreements"). Consequently, Licensor hereby transfers and assigns to Licensee, and Licensee hereby assumes, (i) all Clinical Agreements; (ii) all outstanding bills for Clinical Activities provided by Licensor to Licensee as of June 18, 2003; (iii) all payment obligations arising on or after June 18, 2003 under the Clinical Agreements; and (iv) all payments obligations for services required under the Trial Agreements through the date of termination of such Trial Agreements. However, notwithstanding any payments by Licensee with respect to any Clinical or Trial Agreement, Licensor shall be responsible for any material breach or failure by Licensor in the performance of any such agreement prior to the assumption by Licensee, or the termination, of such agreement, except for (x) the payment obligations assumed by Licensee pursuant to this Section 36.1; or (y) breaches of a Clinical or Trial Agreement resulting from a delay by Licensee in providing notice of termination or assignment and assumption to third parties pursuant to subsections (a) or (b) above.
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Related to Clinical Trial Agreements

  • 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.

  • 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.

  • 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:

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • License Agreements (a) Each Borrower and Guarantor shall (i) promptly and faithfully observe and perform all of the material terms, covenants, conditions and provisions of the material License Agreements to which it is a party to be observed and performed by it, at the times set forth therein, if any, (ii) not do, permit, suffer or refrain from doing anything that could reasonably be expected to result in a default under or breach of any of the terms of any material License Agreement, (iii) not cancel, surrender, modify, amend, waive or release any material License Agreement in any material respect or any term, provision or right of the licensee thereunder in any material respect, or consent to or permit to occur any of the foregoing; except, that, subject to Section 9.19(b) below, such Borrower or Guarantor may cancel, surrender or release any material License Agreement in the ordinary course of the business of such Borrower or Guarantor; provided, that, such Borrower or Guarantor (as the case may be) shall give Agent not less than thirty (30) days prior written notice of its intention to so cancel, surrender and release any such material License Agreement, (iv) give Agent prompt written notice of any material License Agreement entered into by such Borrower or Guarantor after the date hereof, together with a true, correct and complete copy thereof and such other information with respect thereto as Agent may request, (v) give Agent prompt written notice of any material breach of any obligation, or any default, by any party under any material License Agreement, and deliver to Agent (promptly upon the receipt thereof by such Borrower or Guarantor in the case of a notice to such Borrower or Guarantor and concurrently with the sending thereof in the case of a notice from such Borrower or Guarantor) a copy of each notice of default and every other notice and other communication received or delivered by such Borrower or Guarantor in connection with any material License Agreement which relates to the right of such Borrower or Guarantor to continue to use the property subject to such License Agreement, and (vi) furnish to Agent, promptly upon the request of Agent, such information and evidence as Agent may reasonably require from time to time concerning the observance, performance and compliance by such Borrower or Guarantor or the other party or parties thereto with the material terms, covenants or provisions of any material License Agreement.

  • 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.).

  • 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.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

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