Development Overview. Qorvo and Zomedica will work in collaboration to develop (a) Instruments that meet the Specifications as set forth in the applicable Instrument SOW, (b) Cartridges that meet the Specifications as set forth in the applicable Cartridge SOW, and (c) Assays specified by Zomedica for use with the Instruments and Cartridges for the purpose of performing such Assays for use in the Field.
Development Overview. The term “
Development Overview. The Parties desire and intend to transition the Development of Compounds and Products from Principia to Sanofi (the “Transition”), provided that, before the completion of the Transition, Principia will conduct certain early Development activities set forth in Section 3.2 in coordination with Sanofi.
Development Overview. The Parties shall collaborate in the development of Licensed Products up until the completion of Phase I Clinical Trials in the Field globally in accordance with the Global Development Plan and Section 4.3 below. Thereafter, the Parties may continue the development collaboration or conduct development activities in their respective territories separately in accordance with Section 4.4 below.
Development Overview. Nightstar intends to progress the programmes through the necessary pre-clinical, IND/CTA enabling and clinical development phases necessary to achieve regulatory product licensure in the US and EU. The programs are in various stages of pre-clinical development and will require a significant amount of activity to get clinic ready. It is anticipated that a number of IND-enabling activities are ‘pipeline’ activities; synergistic activities applicable to all the programmes, supporting the development through to entry into clinical testing. Given the early stage, the number of programs and the available resources, the programmes will proceed into the clinic in a serial fashion. The order in which the programmes progress will be determined by a multifactorial assessment of the following criteria: • Overall disease severity • Clinical tractability (well defined measureable endpoints accepted by regulatory bodies) • Competitive intensity • IP freedom to operate, potential for blocking IP • Program maturity/Clinic readiness • Probability of technical success • Market potential Each programme will follow approximately equivalent detailed project plans leading up to BLA/MAA for each programme. The project plans incorporate all CMC, non-clinical and clinical activities and are significantly refined by the Company’s experience developing its lead Choroideremia programme. It is assumed that the first programme would enter into a phase I/II study [*] months after the execution of the licence. The second program would follow approximately [*] post the commencement of program 1 and each successive program will begin [*] from the initiation of the previous program. Each program will consist of a pre-clinical, CMC, Phase 1/2, Pivotal and Regulatory Approval phase which is estimated to take [*] from initiation to approval, for programmes with less clear endpoints or more sophisticated mechanisms, proof-of-concept trials are expected to be longer. These timelines are consistent with our lead Choroideremia program. Figure 1 shows an overview of the estimated timeline for development of the X-linked retinitis pigmentosa gene therapy programme. A more detailed development plan will be generated following execution of the license. [*] *For programs with less dear endpoints or more sophisticated mechanisms PoC trials are expected to be longer X-linked Retinitis Pigmentosa Background X-linked retinitis pigmentosa (XLRP) is a severe and early onset form of retinal degeneration, and n...
Development Overview. Janie’s Garden I is an existing 86 unit development with 14 residential buildings consisting of townhomes, duplexes and garden apartments, and located in Sarasota, Sarasota County, Florida. The unit mix includes 15 one bedroom/one bathroom units, 9 two bedroom/one bathroom units, 47 two bedroom/one and one-half bathroom, 9 three bedroom/two bathroom units and 6 four bedroom/two bathroom units. The demographic commitment is Family. Of the 86 units, 20 are market rate units, 66 are Low Income Housing Tax Credit (“LIHTC”) units, of which 26 are public housing units.. The Florida Housing set asides are as follows per the First Amendment to the Extended Low-Income Housing Agreement (“ELIHA”), dated March 18, 2010: 20% (18 Extremely Low Income “XXX” units) at or below 30% Area Median Income (“AMI”) for 50 years. 56% (48 units) at or below 60% AMI for 50 years (000) 000-0000 • (000) 000-0000 • 0000 X. Xxxxxxx Xx., Xxxxx #000, Xxxxx, XX 00000 • xxx.xxxxxxxxxx.xxx
Development Overview. The DA seeks development consent to the subdivision and construction of three (3) residential flat buildings and ancillary works on Lot 1 DP 1226122 (development site).
Development Overview. On a Category 1 Target‑by‑ Category 1 Target basis, Wave will use Commercially Reasonable Efforts to Develop all Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target in accordance with this Agreement, including the applicable Candidate Category 1 Development Plan or Licensed Category 1 Development Plan (each a “Category 1 Development Program”). Notwithstanding the foregoing, the Parties may agree upon certain activities that Takeda will conduct under a Category 1 Development Plan for a Category 1 Development Program. Each Category 1 Development Program will include the [***]. Each Party will conduct all Development of Category 1 Compounds, Category 1 Products, and Companion Diagnostics directed to the applicable Category 1 Target as part of the applicable Category 1 Development Program and in accordance with the applicable Category 1 Development Plan [***].
Development Overview. (a) Promptly following the Effective Date, Aradigm shall use Commercially Reasonable Efforts to perform the POC Study at its sole cost and expense in close consultation with Lung Rx, with the complete final report describing the results of the POC Study to be delivered to Lung Rx within a commercially reasonable period of time.
Development Overview. 10 2.2 Overall Management of Development Efforts.......................10 2.3
