Institution Representations Sample Clauses
The Institution Representations clause sets out the specific statements or assurances that an institution makes regarding its authority, capacity, and compliance in entering into an agreement. Typically, this clause requires the institution to confirm that it is duly organized, has obtained all necessary approvals, and is not in violation of any laws or other agreements by participating. By including these representations, the clause helps ensure that the institution is legally able to fulfill its obligations, thereby reducing the risk of disputes or unenforceable contracts.
Institution Representations. The Institution represents and certifies to the following:
a) the information set forth in its Application for Site Survey and any other information submitted to PTSF is true and correct.
b) The Institution is licensed as a general acute care hospital by the Pennsylvania Department of Health.
c) The Institution is accredited by The Joint Commission or a recognized state or nationally based accrediting agency for acute care hospitals.
d) The Institution represents that to the best of its ability it meets the “Standards for Trauma Center Accreditation” of the Foundation.
e) This Institution complies with Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the regulations issued under HIPAA and HITECH (collectively, “HIPAA”) governing the use and disclosure of protected health information (“PHI”) by health careproviders, payers and clearinghouses.
f) The Institution operates without restriction by reason of gender, race, color, national origin, age, sexual orientation, handicap and/or disability.
g) For Institutions seeking accreditation for the first time; all information outlined in PTSF Policy AC-130, Process for Becoming an Accredited Trauma Center, is in place as per the policy.
Institution Representations. In connection with Fidelity’s Product and Services, Institution represents:
A. With respect to plans subject to Title I of ERISA, Mutual of America does not and has never acknowledged or represented ERISA fiduciary status in providing its products and services. Such products and services are made available to plan fiduciaries of a plan, without regard to the individualized needs of the plan, its participants, or beneficiaries as a platform from which a plan fiduciary may select or monitor investment alternatives into which plan participants or beneficiaries may direct the investment of assets held in, or contributed to, their individual accounts.
B. It is organized as one of the following types of entities:
i. A bank as defined in section 202 of the Investment Advisers Act of 1940 or similar institution that is regulated and supervised and subject to periodic examination by a State or Federal agency;
ii. An insurance carrier which is qualified under the laws of more than one state to perform the services of managing, acquiring or disposing of assets of a Plan;
iii. A broker-dealer registered under the Securities Exchange Act of 1934 To the extent the Institution (including its affiliates, employees, associated persons, or other agents) provides “investment advice” to Retirement Customers (within the meaning of 29 CFR 2510.3-21(a)), (a) it is acting as a fiduciary under the Fiduciary Rule and is responsible for exercising independent judgment in evaluating any transactions and (b) with respect to the Products and Services and any Fidelity communications with respect thereto, it is capable of evaluating investment risks independently, both in general and with regard to particular transactions and investment strategies.
Institution Representations. INSTITUTION represents that it: (a) shall remain responsible for ensuring compliance with IRB #1’s determinations, with the terms of INSTITUTION’s OHRP-approved FWA, and with all laws governing the Research; and (b) shall immediately report to IRB #1 in writing upon becoming aware of any new or continuing noncompliance with any relevant contract, law or institutional policy governing the Research, including but not limited to human subject protections, conflicts of interest, and research misconduct. INSTITUTION’s obligation to report under 3(b) is in addition to, and in no way replaces, a principal investigator’s duty to report any matters such as unanticipated problems involving risks to subjects and others. INSTITUTION shall make all such reports to the Director of IRB #1.
Institution Representations. Additionally, Institution represents and covenants to Sanofi as follows:
(i) neither it nor any individual employed or engaged by Institution in connection with the Study have ever been and are not currently (a) under investigation for debarment or debarred pursuant to federal, regional, state law, local law or regulation; (b) excluded by government agency from participation in any government sponsored or controlled health care program; or (c) otherwise disqualified or restricted by the any regulatory authority, nor will Institution knowingly utilize any debarred, excluded or disqualified personnel to perform the Study hereunder;
(ii) it will notify Sanofi immediately in the event any investigation or proceeding for debarment, exclusion or disqualification is initiated against Institution or any individual employed or engaged by Institution that is performing the Study hereunder;
(iii) it shall perform the Study in compliance in all material respects with all applicable federal, regional, state and local laws, rules and regulations;
(iv) it has notified Sanofi of all encumbrances integral to the conduct of the Study that could reasonably impact Sanofi’s decision to enter into this Agreement;
(v) it shall use reasonable efforts to perform the Study in accordance with the terms and conditions of this Agreement;
(vi) it is the sole sponsor of the Study;
(vii) it has not and will not receive any financial support or other renumeration from any third party (other than from Sanofi as set forth in this Agreement) in connection with the Study; and
(viii) it shall not knowingly infringe any patent or other proprietary right of any third party in its conduct of the Study or by providing the Study Results pursuant to this Agreement.
Institution Representations. Z áruky, prohlášení a ujednání Warranties and Covenants zdravotnického zařízení
4.2.1 The Institution covenants, warrants Zdravotnické zařízení se zavazují, zaručují a and represents that: prohlašují, že:
4.2.1.1 they have at all times during the má vždy v průběhu klinického hodnocení course of the Study, the appropriate příslušné licence, schválení a osvědčení, jež licenses, approvals and certifications jsou nezbytná pro bezpečné, odpovídající a necessary to safely, adequately and zákonné provedení klinického hodnocení v lawfully perform the Study in souladu s příslušnými právními předpisy, accordance with applicable protokolem, touto smlouvou a správnou Regulations, the Protocol, this klinickou praxí, a nebyla jim oznámena Agreement and good clinical žádná šetření, která by mohla takové practice and have no notice of any licence, schválení nebo osvědčení ohrozit; investigations that would jeopardize such licenses, approvals or certifications; zkoušející je v průběhu klinického hodnocení
4.2.1.2 Investigator is at all times during the vždy kvalifikován svým odborným course of the Study qualified by vzděláním, výcvikem a zkušenostmi k training and experience with provedení klinického hodnocení v rámci appropriate expertise to conduct the jurisdikce, v níž klinické hodnocení probíhá; Study within the jurisdiction where the Study is being conducted;
4.2.1.3 Study Personnel are and at all times during the course of the Study continue to be appropriately trained in ICH GCP, Study procedures and the Protocol; pracovníci klinického hodnocení jsou a v průběhu studie vždy budou řádně zaškoleni v oblasti SKP ICH, úkonech klinického hodnocení a protokolu;
4.2.1.4 sufficient resources and time are available and shall continue to be available to Investigator for timely and proper performance of the Study in accordance with Protocol and this Agreement; zkoušející má a bude mít k dispozici dostatečné zdroje a čas pro včasné a řádné provedení klinického hodnocení v souladu s protokolem a touto smlouvou;
4.2.1.5 all tasks and activities to be performed under this Agreement shall be performed in a timely manner, with all due care and skill and in compliance with Agreement; všechny úkoly a aktivity, které mají být provedeny podle této smlouvy, budou provedeny včas, s náležitou péčí a v souladu s touto smlouvou; 4.
Institution Representations. In connection with Fidelity's Product and Services, Institution represents:
A. It is an independent fiduciary and, with respect to transactions involving its Retirement Customers, it is a fiduciary under ERISA or the Code.
B. It is organized as one of the following types of entities:
i. A bank as defined in section 202 of the Investment Advisers Act of 1940 or similar institution that is regulated and supervised and subject to periodic examination by a State or Federal agency;
ii. An insurance carrier which is qualified under the laws of more than one state to perform the services of managing, acquiring or disposing of assets of a Plan;
iii. A broker-dealer registered under the Securities Exchange Act of 1934
C. To the extent the Institution (including its affiliates, employees, associated persons, or other agents) provides "investment advice" to Retirement Customers (within the meaning of 29 CFR 2510.3-21(a)), (a) it is acting as a fiduciary under the Fiduciary Rule and is responsible for exercising independent judgment in evaluating the transaction and (b) with respect to the Products and Services and any Fidelity communications with respect thereto, it is capable of evaluating investment risks independently, both in general and with regard to particular transactions and investment strategies.
Institution Representations. As of the Effective Date and throughout the Term of this Agreement, the Institution represents, warrants, and agrees that:
5.2.1 Each Collaborating Personnel serving as an Investigator possesses appropriate professional qualifications to conduct Research, possesses the necessary and appropriate professional qualifications in accordance with the terms of this Agreement, and will:
(a) possess a valid and unrestricted license to practice medicine pursuant to the laws of the state in which they reside or practice, or other academic or other suitable degree as reasonably necessary to conduct an ALCMI Research Project, for example, a Ph.D.;
(b) possess valid state and federal narcotics numbers, if a licensed physician engaged in the practice of medicine;
(c) hold a Human Subject Protection Certification as required by the NIH; and
(d) attest that they have not, at any time, been convicted of any state or federal crime that would constitute a bar to employment by the Institution or termination from the Institution’s medical staff.
5.2.2 This Agreement has been authorized by all requisite officials of the Institution and the Institution has the full legal right, interest, power and authority to enter into this Agreement and to perform its legal obligations hereunder;
5.2.3 The execution and delivery of this Agreement and the performance of the Institution’s respective obligations hereunder do not conflict with or violate any legal authority or obligation or with any contractual obligation of the Institution, its Collaborating Personnel, or, to the best knowledge of the Institution, any Collaborating Personnel who become affiliated with or employed by the Institution subsequent to the Effective Date of this Agreement;
5.2.4 Neither the Institution nor any of its Collaborating Personnel, or agents or subcontractors that are involved in an ALCMI Research Project is: (1) excluded from participation in a Federal Health Care Program (as defined in 42 U.S.C. § 1320a-7b(f)) by the U.S. Department of Health and Human Services or any state government agency; (2) debarred from any federal or state procurement or nonprocurement program by a federal or state government agency; or (3) designated a Specially Designated National or Blocked Person by the Office of Foreign Asset Control of the U.S. Department of Treasury;
5.2.5 The Institution has not been, at any time suspended, temporary excluded, or debarred from any federal program.
5.2.6 The Institution will promptly notify AL...
Institution Representations. Institution represents that it holds all necessary permissions, authorizations licenses and certifications necessary and that it is fully capable of providing the services described in Section 7 and in Appendix A of this Agreement. Institution represents that it and all its employees, investigators agents and subcontractors hold all necessary expertise and knowledge to perform all of their obligations under this Agreement.
Institution Representations. (i) The Institution hereby represents and warrants to BioNumerik that it has the right to grant licenses to BioNumerik on an exclusive basis in accordance with the terms and conditions of this Agreement.
(ii) The Institution further represents and warrants to BioNumerik that: (A) it has not licensed any rights to the New Inventions and Discoveries or Know-How to any party other than BioNumerik; and (B) there are no liens, mortgages, pledges, claims, charges or other encumbrances that are applicable to the New Inventions and Discoveries or other rights licensed hereunder. [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(iii) The Institution hereby agrees to take any and all actions as may be reasonably requested by BioNumerik to further evidence BioNumerik's license rights granted hereunder.
(iv) The Institution warrants that it has the authority to acquire and convey title to its interest in the New Inventions and Discoveries with the exception of certain rights that may possibly be retained by the United States government. The Institution does not warrant the validity of any patents or that practice under such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 8, BIONUMERIK AGREES (AND ANY AFFILIATES OR SUBLICENSEES WHO OBTAIN RIGHTS HEREUNDER SHALL AGREE) THAT THE NEW INVENTIONS AND DISCOVERIES AND KNOW-HOW ARE PROVIDED "AS IS", AND THAT THE INSTITUTION MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF PRODUCTS) INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 8, THE INSTITUTION DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCTS) LICENSED UNDER THIS AGREEMENT, INCLUDING BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT AND EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 8, THE INSTITUTION ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF THE INSTITUTION AND THE FACULTY, EMPLOYEES OR STUDENTS OF THE INSTITUTION THAT ARE INVENTORS OF ANY OF THE NEW INVENTIONS AND DISCOVERIES OR KNOW-HOW (COLLECTIVELY, THE "INVENTORS") FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS' AND EXPERTS' FEES, AND COURT COSTS (EVEN IF THE INSTITUTI...