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New Studies Sample Clauses

New StudiesIn case of new studies launched by the Lead Company in order to fulfil the requirements of REACH annexes 7 and 8 the costs to be shared are equal to the real costs paid plus the relevant Administrative Expenses. A rebate of 50% will then be applied to the cost of the new studies for the restricted use for REACH purposes only (no transfer of the actual study report and study data). If rights to use such new studies are to be granted to third parties to be used for another purpose, a bilateral agreement shall be developed with the Lead Company on behalf of all co-owners of the new studies, with any compensation obtained from a third party to be shared equally between the co-owners. In the event that new studies must be commissioned at the request of the European Chemicals Agency (ECHA) for REACH annexes 9 and 10 the costs will be shared equally between all registrants (ie Consortium and SIEF members). All calculated values must be documented.
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New Studies. (a) As promptly as practicable following the execution of this Amendment, the Parties agree to update the U.S. Development Plan to reflect *** of the ***, in a manner that is consistent with *** in the ***. AstraZeneca will pay POZEN for its costs for *** in accordance with Section 3.3.3 of the Agreement (Expenses); provided, however, that in no event will *** for the *** in the ***. The Parties will ***. The Parties will use Diligent Efforts to *** and to *** in the *** for the *** within the ***. (b) To the extent that *** in the ***, the GPT will agree upon *** of the *** provided, however, that *** for the *** in the ***, if any, may include, but would not be limited to, *** and a *** of the *** of the ***. If the *** in the *** as an ***. AstraZeneca will conduct *** for the *** taking into account *** to the *** of the ***. Assessments *** for this purpose will include ***. Representatives from POZEN will participate *** to the ***. AstraZeneca will be obligated to *** if the ***. In the event that AstraZeneca’s and POZEN’s representatives on the GPT *** of a *** will be *** of the *** to be *** of the ***. AstraZeneca will conduct ***, but in any event will ***. (c) of the *** but if ***. *** of the ***. Promptly after execution of this Amendment by both Parties, the Parties will *** for the *** and will *** after the *** of the ***. The expenses *** in the ***. (d) AstraZeneca will ***, at AstraZeneca’s expense, *** with the *** of the *** in the *** of the *** in the ***. *** Portion for which confidential treatment requested.
New StudiesIf either Party (the “Proposing Party”) intends to conduct additional Development activities with respect to the Licensed Product for use in the Territory (in the case of Teijin) or outside the Territory (in the case of Nativis, solely to the extent that such Development would, in the opinion of Nativis, impact the Licensed Product in the Field in the Territory) beyond what is provided for in Sections 4.2 and 4.3 (i.e., studies or other Development related to modification any component of the Licensed Product other than the Controller), in all cases the “New Studies”, then the Proposing Party will provide the other Party (the “Non- Proposing Party”) with a written detailed plan and Budget for such New Studies (the “Development Proposal”). Within thirty (30) days of receipt of any such Development Proposal, the JSC will meet to review the Development Proposal and permit the Non-Proposing Party the opportunity to ask questions and request additional information from the Proposing Party related to the New Studies, including whether such New Studies are reasonably likely to have a material and adverse effect on the Development or Commercialization of the Licensed Product in the Non- Proposing Party’s territory. In the event that the Parties agree to jointly conduct the work set forth in the Development Proposal (the “Joint Development Work”), the costs of such Joint Development Work (the “Joint Work Costs”) will be shared by the Parties as set forth below in Section 4.6(b)(i). If the Non-Proposing Party decides not to jointly conduct the work set forth in the Development Proposal with the Proposing Party, subject to Section 3.5(b), the Proposing Party may conduct such work in its respective territory solely (the “Independent Development Work”) and the Development Costs of such Independent Development Work (the “Independent Work Costs”) will be subject to Section 4.6(b)(ii) below.
New StudiesIn the event MabCure conducts a clinical study at the request of NewCo, NewCo shall reimburse MabCure for the cost of such clinical study. Such arrangement shall be the subject of a separate agreement between the parties.

Related to New 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.

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

  • 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 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.

  • 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.

  • 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.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

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