Technical Proposal The technical proposal may be presented in free format. It shall not exceed ten pages, not counting the CVs. It shall respect the following page limit and structure: • Technical methodology (max. 7 pages) • Quality management (max. 1 page) • Project management (max. 1 page) • Resource management (proposal (max. 1 page) + CVs of experts)
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Marketing Plan The MCP shall submit an annual marketing plan to ODM that includes all planned activities for promoting membership in or increasing awareness of the MCP. The marketing plan submission shall include an attestation by the MCP that the plan is accurate is not intended to mislead, confuse or defraud the eligible individuals or ODM.
Technical Proposals Technical proposal information will be streamlined, e.g., the Government anticipates written proposals consisting of thirty (30) pages or less stating compliance or exception to requirements, risks, assumptions and conflict of interest issues. Proposals shall not merely restate PWS/SOO requirements. Written technical proposals shall normally address: * Technical Approach and descriptive narrative of the contractor's understanding of the requested effort * PWS in response to a SOO * Integrated Master Plan (if applicable) * Integrated Master Schedule (if applicable) * Key Personnel Assigned * Quantities/Hours of Personnel by Labor Categories and narrative justification (if applicable) * Other Direct Costs (ODCs) (materials and supplies, travel, training, etc.(quantities and types only)) * Period of Performance * Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) * Security (including clearance level) * Teaming Arrangement (including subcontracting; identify new ACAs) * Small Business Plan (if a large business) * Other Pertinent Data, such as assumptions made.
Cost Proposal After the Approved Working Drawings are approved by Landlord and Tenant, and the Contractor and subcontractors have been selected pursuant to Section 4.1 above, Landlord shall provide Tenant with a cost proposal in accordance with the Approved Working Drawings setting forth the reconciled bids and copies of all sub-bids, which cost proposal shall include, as nearly as possible, the cost of all Tenant Improvement Allowance Items to be incurred in connection with the construction of the Tenant Improvements (the "COST PROPOSAL"). The Cost Proposal shall reflect bids that will be priced by Contractor on an individual item-by-item or trade-by-trade basis. Landlord and Tenant shall work together in good faith in an attempt to agree upon a mutually acceptable Cost Proposal as soon as reasonably possible. Notwithstanding the foregoing, portions of the cost of the Tenant Improvements may be delivered to Tenant as such portions of the Tenant Improvements are priced by Contractor (on an individual item-by-item or trade-by-trade basis), even before the Approved Working Drawings are completed (the "PARTIAL COST PROPOSAL") for purposes of facilitating the early purchase of items and construction of the same. Tenant shall approve and deliver the Cost Proposal to Landlord within seven (7) business days of the receipt of the same, or, as to a Partial Cost Proposal within five (5) business days of receipt of the same, and upon receipt of the same by Landlord, Landlord shall be released by Tenant to purchase the items set forth in the Cost Proposal or Partial Cost Proposal, as the case may be, and to commence the construction relating to such items. If Tenant disapproves the Cost Proposal or Partial Cost Proposal, Tenant shall provide Landlord with a reasonably sufficient explanation, and in such event, Landlord and Tenant shall use good faith, diligent efforts to work with each other and Contractor to address Tenant's reasons for disapproving the Cost Proposal or Partial Cost Proposal, whichever is the case and a new Cost Proposal (or Partial Cost Proposal, as applicable) shall be prepared and the process described in this Section 4.2 shall be repeated. The date by which Tenant must approve and deliver the Cost Proposal or the last Partial Cost Proposal to Landlord, as the case may be, shall be known hereafter as the "COST PROPOSAL DELIVERY DATE". The total of all Partial Cost Proposals, if any, shall be known as the Cost Proposal.
Proposed Goods and Services Proposed Goods and Services docx Please upload one or more documents or sheets describing your offerings, line cards, catalogs, links to offerings OR li st links to your offerings that illustrate the catalog of proposed lines of goods and or services you carry and offer unde r this proposal. I does not have to be exhaustive but should, at a minimum tell us what you are offering. It could be as simple as a sheet with your link to your online catalog of goods and services. Resellers/Dealers - COMPLETE AND UPLOAD ONLY IF YOU HAVE RESELLER OF YOUR GOODS OR SERVICES PROPOSED No response If the PROPOSING vendor has resellers that will be selling for the vendor UNDER this contract, the vendor must downl oad the Resellers/Dealers spreadsheet from the attachment tab, fill in the requested information and upload the compl eted spreadsheet. DO NOT UPLOAD encrypted or password protected files. HUB Subcontracting Plan Form OPTIONAL No response Completion of the HUB Subcontracting Plan Form is OPTIONAL. THE FORM INFORMATION HAS NO EFFECT ON YO UR EVALUATION SCORE. IT IS INFORMATIONAL ONLY. Some Texas State agencies and Universities require it be a p art of the file when determining if they can use a TIPS contract. If you choose to complete one, it is not project specific but the general plan the vendor would use. Complete it as best you can. Vendor can download the HUB Subcontracting Plan Form from the "Attachments" tab and upload their HUB Subcontra cting Plan Form. D/M/WBE Certification OPTIONAL No response D/M/WBE Certification documentation may be scanned and uploaded if you desire to claim your status as one of the i dentified enterprises. (Disadvantaged Business Enterprise, Minority Business Enterprise and/or Woman Business Ent erprise) If vendor has more than one certification scan into one document. (PDF Format ONLY) DO NOT UPLOAD encrypted or password protected files. HUB Certification OPTIONAL No response HUB Certification documentation may be scanned and uploaded if you desire to document you status as a HUB compa ny. (Historically Underutilized Business) (PDF Format ONLY) DO NOT UPLOAD encrypted or password protected files. Warranty No response Warranty information (if applicable) must be scanned and uploaded. (PDF Format ONLY) DO NOT UPLOAD encrypted or password protected files. Supplementary No response Supplementary information may be scanned and uploaded. (Company information, brochures, catalogs, etc.) (PDF Fo rmat ONLY) DO NOT UPLOAD encrypted or password protected files. All Other Certificates No response All Other Certificates (if applicable) must be scanned and uploaded. If vendor has more than one other certification sc an into one document. (PDF Format ONLY) DO NOT UPLOAD encrypted or password protected files.
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.
Additional proposals If the Company at any time during the continuance of this Agreement desires to modify expand or otherwise vary its activities carried on pursuant to this Agreement beyond those specified in any approved proposal, it shall give notice of such desire to the Minister and within 2 months after giving such notice shall submit to the Minister detailed proposals in respect of such modifications expansions or variations and such other matters as the Minister may require. The provisions of clause 4 and 5 (including (for the avoidance of doubt) clause 5(9)) shall apply, the necessary changes being made, to proposals submitted pursuant to this clause.
Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.
