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)).

  • 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. $[ * ].

  • Our Bridging Strategy recognises the challenges faced by students transitioning from Level 4-5 and 5-6.

  • Also, Sebastian Abbot, “Private guards anger U.S., Afghans,” Tulsa World, May 1, 2010.113/ See for instance UNWGM report, paragraph 63.114/ As recognized by Presidential Decree 62 and reiterated by 2011 Bridging Strategy, diplomatic entities are exempt from presidential de crees and associated regulations applicable to the PSCs, and instead remain regulated by rules for diplomatic operations in accordance with the principles of the 1969 Vienna Convention.

  • Bridging Strategy for Implementation of Presidential Decree 62 (Dissolution of Private Security Companies) Bridging Period March 22, 2011 to March 20, 2012, 2011, http://psm.du.edu/media/documents/national_regulations/countries/asia_pacific/afghanistan/afghanistan_ decree_briding_strategy_2011-english.pdf.

  • 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.

  • Our Bridging Strategy (for first implementation 2018-19) which although aimed at our wider student demographic (by supporting all students transitioning from Level 3-4; 4- 5; 5-6), has been devised (where appropriate) with some of our under-represented groups in mind (e.g. Mature students).

  • The AMTC Support Contract (Bridging Strategy) provides the capability to coordinate issues on a wide variety of matters pertaining to Army Targeting, Joint Targeting, Joint Integration and Joint/Army training for Tactical and Operational units; and support all ongoing DOTMLPF integration efforts within the AMTC.

  • Additionally, the AMTC Bridging Strategy will allow rapid establishment of critical Program Oversight of Joint Targeting training/certification that is required to fully employ Joint Fires and Cross-Domain Fires in support of Multi-Domain Operations.

  • A Bridging Strategy and New Rental Model were introduced to attract sought-after brands and reputable companies, stimulate high CAPEX investment by tenants and encourage tenant retention.

Related to Bridging Strategy

  • Leader means each elected or appointed member of an AMA Council, AMA Committee, AMA Advisory Committee, or Task Force, members of the AMA Alliance board, members of the AMA Foundation board, and each candidate for an AMA Council, Section Governing Council or Advisory Committee, and other designated AMA committee and task force members and candidates.

  • 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.

  • spatial development framework means the Mhlontlo 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 portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • 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 series of entities involved in the supply and purchase of materials and goods, from raw materials to final product.

  • 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.

  • Level 1 Support means qualifying and logging all Technical Support Incidents, answering technical inquiries via telephone support and email regarding the Work and performing limited diagnostic services.

  • Level 2 Support means, with the use of technical support specialists: (i) performing Defect isolation, Defect replication and interoperability testing; (ii) performing remote diagnostic services and on-site troubleshooting, if required; (iii) identifying the source of Defects; (iv) developing a reproducible test case for any Defect and documenting the details of such Defect for escalation to Level 3 Support; and (v) developing and implementing Workarounds where reasonably possible.

  • 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:

  • 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, safe houses, false documentation or identification, communications equipment, facilities, weapons, lethal substances, explosives, personnel, transportation, and other physical assets, except medicine or religious materials.

  • thalassemia means a group of inherited disorders characterised by reduced or absent amounts of haemoglobin.

  • Project Management Unit and “PMU” each means the Recipient’s unit responsible for the implementation of its Respective Part of the Project referred to in Section I.A.2 of Schedule 2 to this Agreement.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.