Zahájení studie Sample Clauses

Zahájení studie. (a) The Institution shall not, and shall not permit the Physician to, commence recruitment of potential Study Subjects to participate in the Study unless and until the Physician (i) is notified by Biogen Idec or its agents in writing that all approvals, authorizations and documentation necessary to conduct the Study have been obtained; and (ii) has signed the Protocol and thereby agreed to conduct the Study in accordance with the terms and the conditions of the Protocol. Further, the Physician shall not conduct research covered under this Agreement unless and until the Study Subject has confirmed, in writing, receipt and review and execution of, an informed consent form for the Study, which form shall have been previously approved by Biogen Idec and provided to the Physician. (a) Zdravotnické zařízení nezahájí ani nedovolí lékaři zahájit xxxxx potenciálních subjektů hodnocení pro účast ve studii, dokud lékař (i) nebude společností Biogen Idec nebo jejími zástupci písemně informován, že byly získány všechny souhlasy, povolení a dokumentace potřebná k provádění studie; a (ii) nepodepsal protokol a nepřistoupil tak na provádění studie v souladu s podmínkami protokolu. Xxxxx xxxx nebude provádět výzkum podle této smlouvy, pokud a dokud subjekt hodnocení písemně nepotvrdí převzetí, prostudování a podepsání formuláře informovaného souhlasu pro studii s xxx, že formulář informovaného souhlasu byl předem schválen společností Biogen Idec a poskytnut lékaři. (b) The Institution shall appoint the Physician and the personnel (the “Staff”), necessary to support the conduct of the Study. The Physician declares that he has the relevant qualifications to perform his obligations under this Agreement and that he shall at all times comply with the terms and obligations of this Agreement. The Physician shall ensure that Staff have the relevant qualifications to perform their obligations under this Agreement and that they shall at all times comply with the terms and obligations of this Agreement. The Physician represents and warrants that he has or will obtain from all Staff, himself, agreements that impose on such Staff confidentiality obligations at least as restrictive as those applicable to Institution or Physician, and the Institution represents and warrants that the Institution has or will obtain from all Staff, including the Physician, agreements that impose on such Staff assignment of invention obligations that effectively vest in the Institution any rights the Staff m...
Sample 1
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Zahájení studie. (a) Zdravotnické zařízení a lékař nezahájí nábor potenciálních subjektů studie pro účast ve studii, dokud zdravotnické zařízení a lékař (i) nebudou společností Biogen nebo jejími zástupci písemně informováni, že byly získány všechny souhlasy, povolení a dokumentace potřebné k provádění studie; a dokud lékař (ii) nepodepíše protokol a neodsouhlasí, že bude studii provádět v souladu s podmínkami protokolu. Zdravotnické zařízení a lékař dále nebudou provádět výzkum podle této smlouvy, pokud a dokud subjekt studie písemně nepotvrdí převzetí, prostudování a podepsání formuláře informovaného souhlasu pro studii s tím, že formulář informovaného souhlasu byl předem schválen společností Biogen a poskytnut lékaři.
Sample 1
Zahájení studie. Poskytovatel nezahájí a nedovolí Hlavnímu zkoušejícímu zahájit nábor potenciálních subjektů pro účast ve Studii, dokud Hlavní zkoušející (i) neobdrží písemné oznámení od společnosti X4 nebo CRO, že byla získána veškerá povolení, oprávnění a dokumentace nezbytná k provedení Multicentrického hodnocení; (ii) nepodepíše Protokol, čímž se zaváže plnit všechny povinnosti v něm uvedené; a (iii) nepodepíše Prohlášení Hlavního zkoušejícího (připojené k této Smlouvě jako Příloha B). Hlavní zkoušející nesmí provádět Studii, podávat Hodnocený přípravek nebo jiné Studijní léčivo (jak je definováno níže) žádnému subjektu Studie ani provádět žádné postupy nebo hodnocení související se Studií u subjektu Studie, pokud a dokud konkrétní subjekt Studie písemně nepotvrdí,
Sample 1
Zahájení studie. (a) The Provider shall not, and shall not permit the Investigator to, commence recruitment of potential Study Subjects to participate in the Study unless and until the Investigator (i) is notified by Biogen Idec or its agents in writing that all approvals, authorizations and documentation necessary to conduct the Study have been obtained; and
Sample 1
Zahájení studie. Léčba Subjektů Studie nebude zahájena, dokud nebudou obdržena veškerá schválení etických komisí, souhlas SÚKL a jakákoliv xxxx svolení potřebná k zahájení Studie.
Sample 1

Related to Zahájení studie

  • 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.

  • 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.

  • Commercialization BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreement, for a period not to exceed [***] from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons.

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