Bridging Strategy definition

Bridging Strategy means the decision by Astellas to file an MAA in the Astellas Territory by submitting the data from the Phase III clinical trial of FG or its Affiliate or Sublicensee.
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Bridging Strategy means a development strategy for a new drug application that utilizes the Laxdale Approved Registration Dossier (as after defined) and the Laxdale Know-How, and if needed, in which only a bridging study is conducted to extrapolate the efficacy data and/or safety data in the Laxdale Approved Registration Dossier to the Territory;
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Bridging Strategy means the strategy for submission of a New Drug Application to the Regulatory Authority in Japan that involves use of results from Clinical Studies conducted outside Japan as indicated in ICH-E5.
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Examples of Bridging Strategy in a sentence

  • Natural Cu0 Cu2+Cu+ Inorganic Cu Complexes Organic Cu Complexes Cu (II)Minerals Cu (I)Minerals Figure 1 – Environmental Fate Bridging Strategy for Cu Minerals and Comple xes Copper can exist in various oxidation states as inorganic complexes, organic complexes and minerals; Figure 1 distinguishes these mineral states with Roman numerals (e.g., Cu(I) and Cu(II)).

  • Results indicated the APPF was not on track to meet the requirements of the Bridging Strategy.

  • AR, Tab 15, Bridging Strategy for Implementation of Presidential Decree 62, at 1, 3.

  • Upon the first [ * ] for the [ * ]; provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ]2.

  • Final Report to the 6-Month Assessment to the Bridging Strategy for Implementation of Presidential Decree 62 (Dissolution of Private Security Companies), Bridging Period March 22, 2011 to March 20, 2012.To date, the APPF reported it had signed 18 contracts to provide guard services for development activities.

  • Either notify FG of its intent to employ the Bridging Strategy, if applicable, or Initiate Phase III clinical trials within[ * ] of the later of (i) FG’s, or its Sublicensee’s Initiation of a Phase III clinical trial and (ii) Astellas’ Completion of its Phase II clinical trial(s).

  • Guided by those principles, our strategic and financial planning comprises three core elements: a Bridging Strategy to set our course for the next 12 to 18 months; scenario planning to map out the major risks we may face and model their likely impacts; and the development of a range of potential mitigation actions we may need to introduce as a response to the risks, and opportunities, we will face ahead.

  • Upon the first [ * ] in the Astellas Territory for the [ * ]; provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ].3.

  • Upon[ * ] or in the event that Astellas chooses to utilize the Bridging Strategy, the payment shall be made concurrent with the payment required in paragraph 4 of this Section 6.1.1 below.

  • Upon the first [ * ] in the Astellas Territory for the [ * ]; provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ].4.


More Definitions of Bridging Strategy

Bridging Strategy means the decision by Astellas to file an MAA in the Astellas Territory by submitting the data from the Phase III clinical trial of FG or its Affiliate or Sublicensee. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Related to Bridging Strategy

  • Leader means the person vested from time to time (in accordance with law and the applicable constitutional arrangements) with the political leadership, for the purposes of this Agreement, of each of the London Local Authorities listed in Part 1 of Schedule 1

  • Strategy means the Department of Education International Risk Management Strategy for Homestays and Short Term Cultural Exchanges developed and implemented under section 171 of the Working With Children (Risk Management and Screening) Act 2000 as in force at any given time.

  • Conference bridging service means an ancillary service that links two or more participants of an audio or video conference call and may include the provision of a telephone number. Conference bridging service does not include the telecommunications services used to reach the conference bridge.

  • Supply Chain Management All aspects of supply chain management, from the initial sourcing phase through customer delivery (e.g., procurement, sourcing management, inventory management, catalog management, ordering/purchasing, invoice tracking, storefront/shopping cart, warehouse management, returns management, logistics/transportation).

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Financial Support means any loans, guarantees, Security or other financial assistance (whether actual or contingent).

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Design Criteria Professional means a firm who holds a current certificate of registration under Chapter 481 of the Florida Statutes, to practice architecture or landscape architecture, or a firm who holds a current certificate as a registered engineer under Chapter 471 of the Florida Statutes, to practice engineering, and who is employed by or under contract to the District to provide professional architect services, landscape architect services, or engineering services in connection with the preparation of the Design Criteria Package.

  • Project Management The individuals appointed by each Party cf. clause 4.1 in the Agreement.

  • Supply Chain means the individuals and organisations who will be responsible for any of the design and/or construction of the Works as set out in the Schedule of Supply Chain Members;

  • Cannabis retailer means any licensed person or entity that purchases or otherwise obtains usable cannabis from cannabis cultivators and cannabis items from cannabis manufacturers or cannabis wholesalers, and sells these to consumers from a retail store, and may use a cannabis delivery service or a certified cannabis handler for the off-premises delivery of cannabis items and related supplies to consumers. A cannabis retailer shall also accept consumer purchases to be fulfilled from its retail store that are presented by a cannabis delivery service which will be delivered by the cannabis delivery service to that consumer.

  • Outsourcing facility means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law, including the Federal Food, Drug, and Cosmetic Act.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • R2000 Strategy means an initiative by the Government of Kenya to improve the maintenance of the country’s Road Network by giving priority to maintenance through network approach, using appropriate technology, labour-based methods, local resources and increased usage of small-scale entrepreneurs.

  • Lodging establishment means any of the following:

  • Cannabis processing facility means a person that:

  • Family support services means providing opportunities for

  • Technical Support means the technical assistance for attempting resolution of a reported Case through error correction, patches, hot fixes, workarounds, replacement deliveries, or any other type of Product corrections or modifications.

  • Alternative program means a non-disciplinary monitoring or practice remediation process approved by a physical therapy licensing board. This includes, but is not limited to, substance abuse issues.

  • Technical Support Services means the technical support and maintenance Services provided by us according to our then-current technical support policy and procedure listed at xxxxxxxxxxxxx.xxx (“Technical Support Policy”) when the Services are purchased.

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste

  • Material support and resources means currency or monetary instruments or financial securities, financial services, lodging, training, expert advice or assistance, safehouses, false documentation or identification, communications equipment, facilities, weapons, lethal substances, explosives, personnel, transportation, and other physical assets, except medicine or religious materials.”

  • Project Management Unit or “PMU” means the Recipient’s management and Implementation unit referred to in Section I.A.2 of Schedule 2 to this Agreement.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;