Study Protocols Sample Clauses

Study Protocols. 11.1 In the event Celestial and/or BWTP proposes to sponsor or conduct any study of a Medicinal Product, it shall first draft and provide copies of the proposed study protocols for such study including all documents associated with such study protocols, including but not limited to all investigator’s brochures (“Study Protocols”) to GSK for comment and afford GSK a period of [**] Days to review such draft Study Protocols. Copies of the draft Study Protocols shall be provided by secure email or, if that is not possible, by fax. 11.2 Prior to the expiration of this [**] Days period, GSK shall have the right to provide written comments, if any, on the draft Study Protocols to Celestial and BWTP. Celestial and BWTP shall amend the draft Study Protocols to reflect all reasonable comments received from GSK. In the event that GSK determines, in its reasonable judgment, that a proposed study as designed would put any patient in safety risk, GSK may instruct Celestial and BWTP so in its written comments, and Celestial and BWTP must refrain from conducting any such study.
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Study Protocols. The conduct of inhalation exposures will be performed according to the following test guideline concerning repeated dose inhalation toxicity studies: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, No. 413 "Sub-Chronic Inhalation Toxicity: 90-day Study" adopted 07 September 2009. In addition the study was carried out taking into account the following guidelines: - Organization for Economic Cooperation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4: Health Effects, Method 453 "Combined Chronic Toxicity/Carcinogenicity Study in Rodents" adopted 07 Sep 2009. - Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part B.33.: Combined Chronic Toxicity/Carcinogenicity Test - US Environmental Protection Agency (EPA), Health Effects Test Guidelines OPPTS870.4300, Combined Chronic Toxicity/Carcinogenicity, EPA 712-C-98-212, August 1998 In deviation to the guidelines, only females were exposed, because female rats are considered to be slightly more sensitive concerning carcinogenicity after inhalation exposure to dust aerosols (Xxxxxx et al. 2000). e. December 2015. The intention for this extension was to enhance study sensitivity. It is known that a relevant portion of particle induced tumours become detectable first rather late in rats. The study sensitivity to detect lung tumours was further enhanced by an extended lung histopathology as 60 instead of 6 sliced will be studied per lung. Satellite groups were sacrificed after 12 months (chronic group with 10 animals per dose for histopathology) and after 3 months, 12 months, and 24 months (for kinetic/organ burden evaluations). Main exposure groups are used for histopathology examinations (carcinogenicity groups). Groups of 50 animals (of each exposure level) were sacrificed and examined after 24 months of exposure. Additional groups of 50 animals were kept without exposure up to 30 months and animals were sacrificed and examined after 30 months or if the only 25% or less animals were still alive. Animals of each group which died during the exposure or post-exposure period are examined as well.
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Study Protocols. Protocols for the studies are attached hereto as Exhibit A.
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Study Protocols. At the first occurrence of an SAE in a particular clinical trial, the Party reporting the SAE shall make available to the other Party a copy of the relevant Study Protocol. This is to provide a clear understanding of the nature of the exposure to the Product and to allow a meaningful interpretation of the SAE.
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Study Protocols. The services to be conducted under this Project Agreement include advancing the Product through the conduct of the [***] listed below. [***] Note that it is anticipated that support of this program will be expanded by amendment, to include – among other potential activities – [***], and through completion of the NDA supporting activities, when those details and timing are understood. [***] The PDT outlined above may be amended from time to time for the most effective use of resources to develop the Program.
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Study Protocols. Institution shall be responsible (at its own expense) for the design of all preclinical and clinical studies involving Materials to be undertaken in connection with the Project. Institution shall provide Company with advance copies of all protocols for proposed studies involving Materials in order to provide Company a reasonable opportunity to review and comment on the protocol and study design which must be found acceptable by Company. Company shall provide any comments to the protocol within thirty (30) days of receipt and Institution shall consider in good faith any comments made by Company with respect to the protocols and/or study design which must be found acceptable by Company. In addition, Company shall have the right to operate clinical monitoring of the study through its own personnel and at its own expenses, while the Research program is being conducted. Moreover, Institution shall submit to Company, for approval, all case record forms and formularies before starting the study.
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Study Protocols. Endorecherche shall be responsible (at its own expense) for the design of all preclinical and clinical studies involving Acolbifene to be undertaken during the Option Period. Endorecherche shall provide Schering with advance copies of all protocols for proposed studies involving Acolbifene in order to provide Schering a reasonable opportunity to review and comment on the protocol and study design. Schering shall provide any comments to the protocol within thirty (30) days of receipt and Endorecherche shall consider in good faith any comments made by Schering with respect to the protocols and/or study design.
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Related to Study Protocols

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • 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.

  • Review Protocol A narrative description of how the Claims Review was conducted and what was evaluated.

  • Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: minimum 21 days/3 weeksuntil patient's weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • 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.

  • Signaling protocol 4.1.3.1 SS7 Signaling is AT&T-21STATE’s preferred method for signaling. Where MF signaling is currently used, the Parties agree to use their best efforts to convert to SS7. If SS7 services are provided by AT&T-21STATE, they will be provided in accordance with the provisions of the applicable access tariffs. 4.1.3.2 Where MF signaling is currently used, the Parties agree to interconnect their networks using MF or dual tone MF (DTMF) signaling, subject to availability at the End Office Switch or Tandem Switch at which Interconnection occurs. The Parties acknowledge that the use of MF signaling may not be optimal. AT&T-21STATE will not be responsible for correcting any undesirable characteristics, service problems or performance problems that are associated with MF/SS7 inter-working or the signaling protocol required for Interconnection with CLEC employing MF signaling.

  • 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.

  • 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.