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
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Institutional Details 
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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. 2. The ASEAN Coordinating Committee on Investment (CCI) as established by the AIA Council and comprising senior officials responsible for investment and other senior officials from relevant government agencies, shall assist the AIA Council in the performance of its functions. The CCI shall report to the AIA Council through the Senior Economic Officials Meeting (SEOM). The ASEAN Secretariat shall be the secretariat for the AIA Council and the CCI. 3. The functions of the AIA Council shall be to: (a) provide policy guidance on global and regional investment matters concerning promotion, facilitation, protection, and liberalisation; (b) oversee, coordinate and review the implementation of this Agreement; (c) update the AEM on the implementation and operation of this Agreement; (d) consider and recommend to the AEM any amendments to this Agreement; (e) Update and endorse the Reservation Lists of this Agreement; (f) facilitate the avoidance and settlement of disputes arising from this Agreement; (g) supervise and coordinate the work of the CCI; (h) adopt any necessary decisions; and (i) carry out any other functions as the AEM may agree.

  • Institutional and Retail Sales You authorize the Manager to sell to institutions and retail purchasers such Securities purchased by you pursuant to the Underwriting Agreement as the Manager will determine. The Selling Concession on any such sales will be credited to the accounts of the Underwriters as the Manager will determine.

  • EEA Financial Institution No Loan Party is an EEA Financial Institution.

  • 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.

  • Authority of Representatives In all dealings hereunder, the Representatives of the Underwriters of the Designated Securities shall act on behalf of each of such Underwriters, and the parties hereto shall be entitled to act and rely upon any statement, request, notice or agreement on behalf of any Underwriter made or given by such Representatives jointly or by such of the Representatives, if any, as may be designated for such purpose in the Pricing Agreement.

  • EEA Financial Institutions No Loan Party is an EEA Financial Institution.

  • 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.

  • Affected Financial Institution No Loan Party is an Affected Financial Institution.

  • 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 as to its agents, Subcontractors, officers, distributors, resellers or employees regarding the obligations arising under this clause to insure such confidentiality.

  • Information about European Union Funds The procurement is related to a project and/or programme financed by European Union funds: No

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