Development and Validation Sample Clauses

Development and Validation. The fourth stage of development will cover all of the activities needed for the development and approval of a CDx assay in the USA, Canada, EU and Australia. This stage will include all Design Verification and Clinical Validation Studies Stage 5 CDx Approval and Product Implementation Product Implementation into the US will follow approval of the PMA approval and agreement on the device labelling with CDRH For the EU development data used to support the US PMA application will be used to generate a technical file in compliance with the Essential Requirements Checklist. The MHRA shall be notified of the new product under the self-certification scheme. Appropriate labeling and translations will be prepared as necessary for EU countries accepting the CE Xxxx. For Canada it is also assumed that data used to support the US PMA application will be used to complete the necessary requirements as established by Health Canada for successful submission and approval. Product Implementation will follow and establish the product in the Canadian market with appropriate labelling and translations as necessary. For Australia it is also assumed that data used to support the US PMA application will be used to complete the necessary requirements as established by the Australian Therapeutic Goods Administration (TGA) for successful submission and approval. Product Implementation will follow.
Sample 1
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Development and Validation. Name Description Estimated Cost (US$) GMP Raw materials Primers & Probes for the development and manufacture of PDGFRα tests. Estimate includes HPLC and Mass determination for each oligonucleotide [***] Positive control oligonucleotides Long oligonucleotides for the generation of positive controls [***] Sample Costs Procurement of sample will be required to support development. The cost of sample procurement varies depending on the disease tissue of interest. [***] Engineering of Cell Lines In the absence of clinical samples, it may be necessary to engineer cell line that to act as a surrogate. Cell line engineering would be carried out by a third party supplier. [***] Cell Line Control Materials FFPE Cell lines may be used as a model for Clinical materials. This will require cell line embedded in paraffin. The manufacture of the cell line blocks will be carried out by a third party specialist standards and controls supplier. [***] Clinical Test Site Monitoring During the course of the Phase 1 trial, monitoring of sites carrying out clinical testing will be conducted. The number of visits will be dependent on recruitment rate and site performance. The estimated cost per visit is approximately [***] per visit, and the Parties currently estimate approximately [***] visits. For clarity, the estimated cost per visit includes any travel and accommodation costs incurred during each such visit. [***] Confidential and Proprietary Information of Blueprint and QIAGEN *** Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 230.406 Name Description Estimated Cost (US$) Travel & Accommodation During the course of the program face-to-face Joint Project Team and Joint Steering Committee meetings will take place. The frequency of these meetings will be mutually agreed between QIAGEN and Blueprint in accordance with the MCA. [***] Canada Registration Product implementation together with IVD registration activities and submission fees for Health Canada (Assumes no additional data generation) [***] IP Analyze third party rights for freedom-to-operate of the assay. Does not include licensing fees. – covered under IUO development [***] Total Estimated Pass-Through Costs for CDx Development and Validation [***] Total Estimated Pass-Through Costs for IUO Assay Development and CDx Development and Validation: $[***]
Sample 1
Development and Validation. Upon approval of a LLRC design proposal or container modification proposal, the contractor shall build a prototype and validate the design. A Government representative will witness validation. Validation report and technical data shall be IAW the approved design proposal and CDRL A044.
Sample 1

Related to Development and Validation

  • 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 of the Project 4.1 TSP's obligations in development of the Project: Subject to the terms and conditions of this Agreement, the TSP at its own cost and expense shall observe, comply with, perform, undertake and be responsible:

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Development 3.3 Within twenty (20) Working Days after the Commencement Date and in accordance with paragraphs 3.10 to 3.12 (Amendment and Revision), the Contractor will prepare and deliver to the Authority for approval the full and final Security Plan which will be based on the draft Security Plan set out in Appendix B.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

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

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Formation and Composition The Parties to this agreement will maintain a Joint Administration and Dispute Resolution Committee (JADRC) consisting of five (5) representatives of the employers and five (5) representatives of the Provincial Bargaining Council.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

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