Additional Study-Necessitated Fees A2 Sample Clauses

Additional Study-Necessitated Fees A2. 5 Další poplatky plynoucí ze studie
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Additional Study-Necessitated Fees A2. 5 Další nutné poplatky související s hodnocením rozsahu dávek
Additional Study-Necessitated Fees A2. 5 Další nutné poplatky související s hodnocením rozsahu dávek A3 MISCELLANEOUS A3 OSTATNÍ 50465-102 Study Budget / Rozpočet studie 50465-102 Treatment/Léčba Follow-Up/Následné sledování Screening Phase/Fáze screeningu Cycle 1/Cyklus 1 Cycle 2/Cyklus 2 Cycle 3/Cyklus 3 Cycle 4/Cyklus 4 Cycle 5/Cyklus 5 Cycle 6/Cyklus 6 Cycle 7+/Cyklus 7+ EOT Day 15 (±3 days)/Den Day 1 End of EOT + 30-35 Treatment/Ko days/EOT + Day 1/Den 1 Day 2/Den 2 (±3 days)/Den 8 15 (±3 dny) (±3 days)/Den 1 (±3 dny) Day 2/Den 2 Day 2/Den 2 Day 2/Den 2 Day 2/Den 2 Day 2/Den 2 Day 1/Den 1 nec léčby 30–35 dní STUDY PROCEDURES/POSTUPY STUDIE CPT CODE/KÓD Rate/Saz Quantity/ CPT ba Množství 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00 1. 00

Related to Additional Study-Necessitated Fees A2

  • Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

  • 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 Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • Development Fees 1. To assist the City in meeting expenses resulting from ongoing development, Owner shall pay development fees as follows, as set forth in the Tables below. These amounts are those in effect upon the execution of this Agreement and are subject to the annual Adjustment Factor, as defined herein, implemented each subsequent year on July 1, beginning July 1, 2023. Table A DEVELOPMENT FEES AMOUNT DEVELOPMENT FEES AMOUNT DEVELOPMENT FEES AMOUNT 2. All Table A and Table B Development Fees shall be collected at the time of obtaining a building permit and placed in separate interest bearing accounts established for each of the designated categories (i.e. Police, Fire, Recreation, Public Works and Community Facilities). The City may expend the development funds for any purposes designed to provide 3. Notwithstanding any provision to the contrary contained within this Agreement, the Development Fees are being paid in lieu of any other impact fees, development fees or any other similar fees presently existing or adopted by the City at any time hereafter during the term of this Agreement; provided, however, the Owner and/or Developer(s) shall be subject to the payment of any and all present or future permitting fees enacted by the City that are of City-wide application and that relate to processing applications, development permits, building permits, review of plans, or inspections (but no other capital improvement related impact, development or other extractions). 4. Except as set forth in this Agreement, nothing herein shall be construed as relieving the Owner, Developer, a Secondary Developer, a Builder, or their successors, and assigns, from payment of any such fees or charges as may be assessed by entities other than the City. It is the intent of the parties that the fees and obligations contemplated by this Agreement are the only obligations which will be imposed upon the Property however, the provisions of this paragraph shall not preclude the City or another governmental authority from imposing a fee for services or improvements contemplated under this Agreement which are imposed on a consistent basis throughout the area regulated by such governmental authority imposing such obligations. The City or other governing body shall not be precluded by this Agreement from charging fees for delivery of services to citizens or residents (i.e., an EMS response fee or the like), nor from charging fees statutorily authorized in the future (i.e., a real estate transfer fee or the like) which are not collected as a prerequisite to approval of a plat, plan, or construction. The City shall, at Owner/Developer’s request, together with Owner/Developer, challenge any developer fee, impact fee or other obligation imposed by other governmental authorities to the extent that such fees or obligations are not specifically permitted to be imposed pursuant to the terms of this Agreement. 5. The parties hereto recognize that Jasper County may, now or in the future, impose certain development impact fees upon the Property. The intent hereof is that the Owner shall not be charged in both jurisdictions for the same impact fee (development fee) categories, however, should a dispute arise as to whether Owner/Developer shall pay fees to the County or to the City, the Owner/Developer shall be responsible for settling such dispute with each party. The City shall not offset any development fee contained herein against such fees payable to Jasper County. The same principle shall apply regarding all applicable Development Fee categories hereunder, and any such future agreement shall not be deemed a material amendment or breach hereof. If the City becomes involved in litigation or challenge at the request of the Owner/Developer and/or the City becomes a party to ligitation or challenge at the request of the Owner/Developer, the Owner/Developer shall reimburse the City for all costs associated with such challenge and may be required to make a deposit of such in advance with the City. 6. Any Development Fees paid and/or credits for Development Fees with respect to property conveyed, services performed and/or money paid as provided in this Agreement may be assigned by the Owner and/or Developer(s) owning such credits and all such credits shall remain valid until utilized. The City shall recognize all such written assignments of such rights as long as the City has been given an opportunity to review such assignments for accuracy prior to such assignment and shall credit same against any Development Fees which are owed pursuant to this Agreement. 7. For those units that may qualify for Attainable Housing Reductions, the Owner, or authorized agent, shall pay the Table A City Development Fees upon the issuance of a building permit. At the time a Certificate of Occupancy is granted, the Owner, or authorized agent, will provide to the City a copy of the sales contract. If the base sales price meets the criteria for Attainable Housing as defined herein, then the Owner, or authorized agent, is eligible for reduced Development Fees Upon submittal of a closing statement showing a qualifying base sales price, the City shall calculate the credit amount based upon the reduced amounts identified in Table A- 1. The reduced amount from the year shown on the closing statement shall apply. Owner, or authorized agent, may receive a refund for fees paid in excess or held as a credit for payment for future units. If Owner, or authorized agent, does not submit a request for refund within six (6) months of the closing, that Owner, or authorized agent, will no longer be eligible for the reduced Development Fees. Table B and Table C shall not qualify for Attainable Housing Reductions. 8. The Development Fees set forth in the Fee Chart are based upon 2022 figures. The Development Fee amounts shall be increased annually according to the Adjustment Factor. 9. The City, County, or other governmental entity, may establish, solely or in conjunction with each other, a Tax Increment, fee in lieu of tax (FILOT), Multi-County Business Park, or any other special tax district or financing vehicle authorized by applicable provisions of the Code of Laws of South Carolina (1976), as amended, which does not impose additional ad valorem taxes or assessments against the Project. The establishment by the City, County, or other governmental entity, solely or in conjunction with each other, of a special tax district or financing vehicle authorized by applicable provisions of the Code of Laws of South Carolina (1976), as amended, which increases the assessments within the Property solely, shall require the consent of the Owner or Secondary Developer unless such increase is otherwise expressly permitted pursuant to the terms of this Agreement. It is acknowledged that at the written election of Owner, a Municipal Improvement District may be implemented with the consent of the City for the Project as set forth in this Agreement. 10. Owner agrees to pay the actual costs and reasonable, actual expenses of the City’s consultants and professionals incurred in negotiating, processing and evaluating the Development Agreement, as amended hereby, the PDD, and any other related documents (i.e. Assignments and Estoppel letters) as contemplated and provided for in this Agreement. City will provide sufficient documentation of these charges. Owner shall pay such fees within sixty (60) days of the delivery by City of the invoice(s).

  • Development Costs Licensee shall be responsible for all of its costs and expenses in connection with the Development of, and obtaining and maintaining Regulatory Approvals for, the Licensed Products in the Field in the Territory.

  • Benchmarking 19.1 The Parties shall comply with the provisions of Framework Schedule 12 (Continuous Improvement and Benchmarking) in relation to the benchmarking of any or all of the Goods and/or Services.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Development Fee A fee for the packaging of a Property or Mortgage, including the negotiation and approval of plans, and any assistance in obtaining zoning and necessary variances and financing for a specific Property, either initially or at a later date.

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