INVESTIGATOR SPONSORED STUDIES Sample Clauses

INVESTIGATOR SPONSORED STUDIES. 14.1 The Company recognises the importance of Investigator Sponsored Studies (“ISSs”) in expanding scientific knowledge related to potential Uses of Company Products. 14.2 The Company may provide support for an ISS, but must not be considered to be the sponsor or to have any partial sponsorship role in the study in accordance with local law. 14.3 See Section 2 of this Policy for further requirements on ISSs. Employees must also refer to the Relevant Procedures (i.e., International Procedures)
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INVESTIGATOR SPONSORED STUDIES. The parties acknowledge that ALZA has agreed to provide funds and/or PRODUCT to ------------------------------ support independent Investigator Sponsored Studies ("ISS") of the PRODUCT. ALZA has used commercially reasonable efforts to identify all such studies, which are identified on a list attached hereto as Exhibit A. Upon MedImmune's request, ALZA shall provide true and complete copies of the ISS agreements, including the exhibits to the agreements and amendments, that cover the studies listed on Exhibit A. On or before September 10, 2001, MedImmune shall review the list and identify those studies it wishes to continue, and upon request and approval by MedImmune, ALZA shall assign the agreements pertaining to those ISS' to MedImmune. The ISS agreements that MedImmune does not request to have assigned to it will be terminated by ALZA. MedImmune specifically agrees that it will accept assignment of the ISS agreement between ALZA and PRN dated January 19, 1999 (the "PRN Agreement") concerning the investigation of PRODUCT in the treatment of Stage III A, III B, Non-Small Cell Lung Cancer (NSCLC) (the "PRN Study"), and the ISS agreement between ALZA and the American College of Radiology, Radiation Therapy Oncology Group, dated July 25, 1998 (the "RTOG Agreement"), also concerning the investigation of PRODUCT in NSCLC (the "RTOG Study"). ALZA shall be responsible for paying and fulfilling all costs and obligations of the PRN Agreement that result from conducting the PRN Study on or before September 30, 2001, including those associated with patient recruitment. MedImmune shall be responsible for paying all costs and obligations of the PRN Agreement that result from conducting the PRN Study on or after October 1, 2001. MedImmune shall also be responsible for paying and fulfilling all costs and obligations of the RTOG Agreement that result from conducting the RTOG Study on or after the date of this Amendment No. 3 and (notwithstanding the provisions of the letter agreement between ALZA and U.S. Bioscience dated July 25, 1998) shall be responsible for paying the milestone for (CONFIDENTIAL TREATMENT REQUESTED) in the RTOG study set forth in Section I(c) of Exhibit B of the RTOG Agreement ("Milestone
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INVESTIGATOR SPONSORED STUDIES. Investigator-sponsored studies of the Collaboration Product with respect to which a Party or its Affiliate or its Sublicensee is providing funding or clinical supplies of Collaboration Product shall be treated as a Clinical Study Conducted by such Party for all purposes (including JDC review and approval, cost allocation and intellectual property). [***].
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INVESTIGATOR SPONSORED STUDIES. 11.1 The Counterparty must recognise the importance of ISSs in expanding scientific knowledge related to potential uses of AstraZeneca products. 11.2 The Counterparty may provide support to an ISS if its activities for AstraZeneca are suitable for an ISS. The Counterparty must not , be considered to be the sponsor or undertake responsibilities which the applicable regulatory authority has designated as responsibilities of the sponsor.
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INVESTIGATOR SPONSORED STUDIES. (a) Before either Party authorizes or facilitates an investigator to conduct an ISS for the Product in the Field that complies with the guidelines established by the JDC pursuant to Section 3.2(a)(iv), such Party shall notify the other Party in writing, which notice shall provide a reasonably detailed description of such ISS and explanation of how it complies with such guidelines. (b) Before either Party authorizes or facilitates an investigator to conduct an ISS for the Product in the Field that does not comply with the guidelines established by the JDC pursuant to Section 3.2(a)(iv), such Party shall provide the other Party with information relating to such ISS and shall provide the other Party a reasonable opportunity to review and comment upon such ISS. Such Party shall give reasonable consideration to the other Party’s comments. The other Party shall have [ * ] after such information is given (or such longer period of time as agreed upon in writing by the Parties), to allege that the conduct of such ISS is substantially likely to create a Material Impact and if such Party disagrees with such allegation, then the Parties shall bring such disagreement to the JDC for resolution. (c) ISSs shall not be included in the Development Plan. (d) A Party authorizing or facilitating an ISS pursuant to this Section 4.7 shall only receive disclosure, access or a license to any Information or Patent arising from such ISS under terms that allow such Party to Control such Information or Patent, such that such Information or Patent shall be included in Allos ISS Technology if such Party is Allos or Mundipharma ISS Technology if such Party is Mundipharma. Such Party shall disclose all such Information and Patents to the other Party promptly following its receipt of disclosure of or access to such Information or Patent.
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INVESTIGATOR SPONSORED STUDIES. The JDC shall establish and implement a policy regarding publications of investigator-sponsored trials of the Licensed Product in the Field in the Licensed Territory, which shall include the ability of the Parties to comment thereon, including without limitation with respect to study design and endpoints, and to request delays to allow the filing of patent applications on any patentable inventions disclosed therein in a manner consistent with Section 7.
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INVESTIGATOR SPONSORED STUDIES. All investigator-sponsored studies shall be reviewed and approved by the JDC. Neither Party may Conduct, or otherwise support (including providing funding or clinical supplies of Collaboration Product) any investigator-sponsored studies of the Collaboration Products without first obtaining the JDC’s approval. Any such approved activities with respect to investigator-sponsored studies of the Collaboration Products shall be considered Development Activities.
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INVESTIGATOR SPONSORED STUDIES. (a) Before either Party authorizes or facilitates an investigator to conduct an ISS for the Product in the Field, such Party shall notify the other Party in writing, which notice shall provide a reasonably detailed description of such ISS and shall provide the other Party a reasonable opportunity to review and comment upon such ISS. Such Party shall give reasonable consideration to the other Party’s comments. (b) If Mundipharma proposes to authorize or facilitate an investigator to conduct an ISS for the Product in the Field, Allos shall have [***] after the notice required under Section 4.7(a) is given (or such longer period of time as agreed upon in writing by the Parties) to allege that the conduct of such ISS is substantially likely to create a Material Impact and if Mundipharma disagrees with such allegation, then the JPC shall discuss and decide whether such
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INVESTIGATOR SPONSORED STUDIES. In the event that a Party desires to facilitate an Investigator Sponsored Study in the Amgen Territory or in the KKC Territory, and such Investigator Sponsored Study is not already included in the then-current Global Development Plan, then such Party shall [***].
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Related to INVESTIGATOR SPONSORED 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.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Investigator Where a difference arises between the parties relating to the dismissal, discipline or suspension of an employee, or to the interpretation, application, operation or alleged violation of this agreement, including any questions as to whether a matter is arbitrable, during the term of the collective agreement, an arbitrator agreed to by the parties shall, at the request of either party: (a) investigate the difference; (b) define the issue in the difference; and (c) make written recommendations to resolve the difference within five days of the date of receipt of the request and for those five days from that date time does not run in respect of the grievance procedure. The parties agree that this procedure will not be invoked until the grievance procedure has been completed.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • 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.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • 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.

  • 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.

  • 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.

  • Investigatory Interview When the employee under investigation is to be interviewed concerning the alleged conduct which could result in discharge or other discipline, the employee and his or her representative shall be notified in writing, at least forty-eight (48) hours prior to the interview. In the event of an emergency, such reasonable notice as the circumstances permit shall be given. The notice shall state that an official investigation is being conducted and shall state the subject matter of the investigatory interview. a. Prior to being interviewed pursuant to this section, the employee shall be afforded a reasonable opportunity and facilities to contact and consult privately with his or her union representative or union attorney. b. Any interview of an employee under this section shall be conducted at a reasonable time, at a suitable location and, when practicable, on the department’s premises when the employee is on duty. The union representative or union attorney may participate in the interview. c. The interview shall be limited to questions that are directly, narrowly, and specifically related to the employee’s job performance as it relates to the allegation(s) or complaints. The employee shall not be subjected to any offensive language nor be threatened with transfer, dismissal or other disciplinary action. Confidentiality of the interview shall be maintained.

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