Reading System Development and Preparation Sample Clauses

Reading System Development and Preparation. BIOCLINICA will develop a custom application to execute the independent read. The development of this application will include the following: • Creation of a client user requirement document • Creation of a functional user requirement document • Full unit testingProgram documentationTest script development and execution of test planValidation reportUser acceptance testingValidation and testing to ensure the system conforms to regulatory requirements and documentation of all programming and testing BIOCLINICA will work in collaboration with ALCHEMIA to design this application. BIOCLINICA requires that the client user requirement document be finalized at least sixteen (16) weeks prior to the first reading session. Upon written approval of the client user requirement document by ALCHEMIA, BIOCLINICA will begin the actual programming of the application. In order to allow a sufficient amount of time to prepare the image data, BIOCLINICA requires that all data to be included in a given read session be resident at BIOCLINICA at least fifteen (15) business days prior to the read session. In the event that data is received after the fifteen (15) day cut-off, BIOCLINICA will make best efforts to include the data within the given read session. However, depending on when the data is received and/or discrepancies are found, BIOCLINICA cannot guarantee that the data will be included within the read session. In the event of incomplete or missing scans of patients, BIOCLINICA must notify ALCHEMIA and seek ALCHEMIA’s consent before proceeding with such reads. BIOCLINICA will conduct a review session prior to the first independent read. Representatives from BIOCLINICA’s Project Management, Clinical Operations and Technical Services departments will attend and participate in this session. Representatives from the CRO will also be entitled to attend. The review session is conducted in part for the purpose of familiarizing both ALCHEMIA personnel and/or its designated representatives and the reader(s) with the reading application as well as the independent read design. During this meeting, ALCHEMIA personnel and the independent reader(s) will review the operation of the BioRead™ application including the interrelationship between questions, sessions, and image display utilizing non-study subjects with relevant image sets. BIOCLINICA will develop a reader manual to be used for this study. This manual will include information on the use of the reading application,...
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Related to Reading System Development and Preparation

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

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  • Joint Preparation The preparation of this Agreement has been a joint effort of the parties and the resulting documents shall not, solely as a matter of judicial construction, be construed more severely against one of the parties than the other.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

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  • Development of the Project The Board of Managers shall take such actions as shall be required to cause either the Company or the Management Company (as defined in Section 9(b) below) to perform and complete the construction and other development work as contemplated and/or required under the NVR Purchase and Sale Agreements, or any other construction company selected by the Board of Managers (the “Development Work”), substantially in accordance with the Project Plan, at a cost to the Company not exceeding the total cost set forth in the Budget, in a manner consistent with this Agreement and all applicable laws, ordinances, rules, regulations or requirements (including, without limitation, those with respect to discrimination) of governmental authorities, and in compliance with any covenants, conditions or restrictions affecting all or any portion of the Property.

  • Site Preparation Contractor shall be responsible for carrying out Stage 2 Site preparation Work as defined in Basis of Design, including:

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development Plan As defined in Section 3.2(a).

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

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