Institutional Details Sample Clauses

Institutional Details. The Food and Drug Administration (FDA) in the US and the Eu- ropean Medicines Agency (EMA) in the EU (or national medicinal agencies) are responsible for granting market authorization (MA) for drugs.25 When applying to the EMA a firm can choose to apply via the community authorization procedure (CAP), where a single application can be used for authorization in multiple jurisdictions, or it can choose to obtain market authorization from a national agency directly and obtain authorization for that member state only. Alternatively, if the drug is already approved in one member state, the firm can apply for the mutual recognition procedure (MRP) to gain marketing approval in other member states. Finally, if no national mar- ket authorization exists, the firm can also use the decentralized procedure (DCP), which allows for submission of the application in select multiple member states, and where one country is designated as a reference member state. All in all, there are three different procedures (CAP, MRP and DCP) for gaining marketing authorization with the EMA or via 27 national medical agencies.‌ In the first instance, original drugs are protected from direct competition from generics via patents, which are granted for 20 years and confer monopoly rights to the originators. In the US, the originator lists the relevant patents with the FDA when filing for a New Drug Application (NDA), while in the EU a similar ‘full application’ is filed with the EMA but without any patent linkage. The drug approval process for new drugs lasts several years, involving multiple phases of clinical trials establishing safety and efficacy. However, since these cut the effective exclusive market life of the patented drug significantly, both the US and EU provide non-patent exclusivity to the originator to compensate for these delays. In the US, a market exclusivity period for the originator was introduced as part of the Xxxxx-Xxxxxx Act, where the originator is protected from generic competition via the ‘data exclusivity’ period – a period during which a generic firm cannot rely on the original drug’s safety and efficacy to file its own application. As per the provisions of the Act, a generic can forego clinical trials, citing safety and efficacy already established by the originator’s reference drug, and file instead for bio-equivalence under the abbreviated new drugs application (ANDA) procedure, but not during the data exclusivity period. Testing and establishing bio-equivale...
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Institutional Details. Full Legal Name of Institution National University of Ireland, Galway (NUI Galway) Address University Road, Galway, Ireland Erasmus ID code IRLGALWAY01 EUC Number 28471-IC-1-2007-1-IE-ERASMUS-EUCX-1 Institution website xxx.xxxxxxxxx.xx Erasmus website xxx.xxxxxxxxx.xx/xxxxxxx Course catalogue xxx.xxxxxxxxx.xx/xxxxxxx/xxxxxxxx/xxxxxxx.xxxx
Institutional Details 

Related to Institutional Details

  • Institutional Arrangements 1. The AIA Council, as established by the AEM under the AIA Agreement, shall be responsible for the implementation of this Agreement.

  • Institutional and Controls The controls and requirements listed in the Department approved Site Management Plan ("SMP") including any and all Department approved amendments to the SMP are incorporated into and made part of this Environmental Easement. These controls and requirements apply to the use of the Controlled Property, run with the land, are binding on the Grantor and the Grantor's successors and assigns, and are enforceable in law or equity against any owner of the Controlled Property, any lessees and any person using the Controlled Property.

  • Institution and Investigator acknowledge that SPONSOR has no obligation to indemnify or be responsible for any loss, claim, cost (including reasonable attorney fees) or demand if and to the extent such losses, claims or demands arise from any injuries or damages resulting from Institution’s, Investigator’s or the Study Personnel’s negligence, breach of this Agreement, failure to adhere to the Protocol, failure to obtain signed informed consent forms, failure to follow Applicable Law, misuse of the Study Drug, unauthorized warranties, or willful misconduct. This indemnification obligation is without prejudice to the precedence of insurance coverage from compulsory clinical trial insurance. 12.3. Zdravotnické zařízení a zkoušející berou na vědomí, že ZADAVATEL nevyplatí žádné odškodnění ani není odpovědný za žádné ztráty, náklady, spory (včetně přiměřených nákladů na právní pomoc) či nároky v souvislosti s újmou či škodou, ke kterým došlo v důsledku nedbalosti na straně zdravotnického zařízení, zkoušejícího a/nebo členů týmu provádějícího klinické hodnocení a/nebo v důsledku toho, že zdravotnické zařízení, zkoušející a/nebo některý člen týmu provádějícího klinické hodnocení porušili ustanovení této smlouvy, porušili ustanovení protokolu, nenechali subjekt hodnocení podepsat informovaný souhlas, porušili ustanovení platných zákonů, chybným způsobem použili studijní léčivo ZADAVATELe, způsobili škodu úmyslným zaviněním a/nebo poskytli neoprávněné záruky. Touto povinností odškodnění není dotčeno přednostní pojistné krytí z povinného pojištění klinického hodnocení.

  • Authority of Representative The Representative shall have the power, on behalf of each Holder, to pursue such remedies as may be available by law and pursuant to this Revenue Sharing Agreement, for the purpose of maximizing the return to the Holders as a group, and to settle the claims of each Holder on such terms as the Representative may determine in its sole and unlimited discretion, subject to the other provisions of this Revenue Sharing Agreement. The Representative may pursue such remedies notwithstanding that the Representative does not have physical possession of the Notes and without naming the Holders as parties.

  • Institution For the purposes of these Terms and Conditions, the “Institution” means the institution purchasing goods and services for which a Purchase Order has been lawfully issued to the Vendor.

  • International Organization Any international organization or wholly owned agency or instrumentality thereof. This category includes any intergovernmental organization (including a supranational organization) (1) that is comprised primarily of non-U.S. governments; (2) that has in effect a headquarters agreement with Singapore; and (3) the income of which does not inure to the benefit of private persons.

  • Institutional Certification Certification by the Submitting Institution that delineates, among other items, the appropriate research uses of the data and the uses that are specifically excluded by the relevant informed consent documents. Further information may be found here.

  • International or National Shopping Goods estimated to cost less than $30,000 equivalent per contract may be procured under contracts awarded on the basis of international or national shopping procedures in accordance with the provisions of paragraphs 3.5 and 3.6 of the Guidelines.

  • COMMISSIONER OR AUTHORIZED USER Contractor warrants, covenants and represents that any confidential information obtained by Contractor, its agents, Subcontractors, officers, distributors, resellers or employees in the course of performing its obligations, including without limitation, security procedures, business operations information, or commercial proprietary information in the possession of the State or any Authorized User hereunder or received from another third party, will not be divulged to any third parties without the written consent of the Commissioner or Authorized User. Contractor shall not be required to keep confidential any such material that is publicly available through no fault of Contractor, independently developed by Contractor without reliance on confidential information of the Authorized User, or otherwise obtained under the Freedom of Information Law or other applicable New York State laws and regulations. This warranty shall survive termination of this Contract. Contractor further agrees to take commercially reasonable steps to inform its agents, Subcontractors, officers, distributors, resellers or employees of the obligations arising under this clause to ensure such confidentiality.

  • Vendor Certification of Criminal History Texas Education Code Chapter 22 8 Texas Education Code Chapter 22 requires entities that contract with school districts to provide services to obtain criminal history record information regarding covered employees. Contractors must certify to the district that they have complied. Covered employees with disqualifying criminal histories are prohibited from serving at a school district pursuant to this law. DEFINITIONS Covered employees: Employees of a contractor or subcontractor who have or will have continuing duties related to the service to be performed at the District and have or will have direct contact with students. The District will be the final arbiter of what constitutes direct contact with students. Disqualifying criminal history: Any conviction or other criminal history information designated by the District, or one of the following offenses, if at the time of the offense, the victim was under 18 or enrolled in a public school: (a) a felony offense under Title 5, Texas Penal Code; (b) an offense for which a defendant is required to register as a sex offender under Chapter 62, Texas Code of Criminal Procedure; or (c) an equivalent offense under federal law or the laws of another state. Vendor certifies: NONE (Section A): None of the employees of Vendor and any subcontractors are covered employees, as defined above. If this box is checked, I further certify that Contractor has taken precautions or imposed conditions to ensure that the employees of Vendor and any subcontractor will not become covered employees. Contractor will maintain these precautions or conditions throughout the time the contracted services are provided under this procurement. OR SOME (Section B): Some or all of the employees of Vendor and any subcontractor are covered employees. If this box is checked, I further certify that: (1) Vendor has obtained all required criminal history record information regarding its covered employees. None of the covered employees has a disqualifying criminal history; (2) If Vendor receives information that a covered employee subsequently has a reported criminal history, Vendor will immediately remove the covered employee from contract duties and notify the purchasing entity in writing within 3 business days; (3) Upon request, Vendor will provide the purchasing entity with the name and any other requested information of covered employees so that the purchasing entity may obtain criminal history record information on the covered employees; (4) If the purchasing entity objects to the assignment of a covered employee on the basis of the covered employee's criminal history record information, Xxxxxx agrees to discontinue using that covered employee to provide services at the purchasing entity. Which option does Vendor certify? None Certification Regarding "Choice of Law" Terms with TIPS Members Vendor agrees that if any "Choice of Law" provision is included in any sales agreement/contract between Vendor and a TIPS Member, that clause must provide that the "Choice of Law" applicable to the sales agreement/contract between Vendor and TIPS Member shall be the state where the TIPS Member operates unless the TIPS Member expressly agrees otherwise. Any TIPS Sale Supplemental Agreement containing a "Choice of Law" clause that conflicts with these terms is rendered void and unenforceable. If Vendor disagrees, after this solicitation legally closes and TIPS begins evaluating Vendor's file, TIPS will provide Vendor with a draft Word Document version of the Vendor Agreement and will be instructed to include all requested negotiations as redline edits for TIPS consideration. Does Vendor agree? Yes

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