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 Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
Performance Review Where a performance review of an employee’s performance is carried out, the employee shall be given sufficient opportunity after the interview to read and review the performance review. Provision shall be made on the performance review form for an employee to sign it. The form shall provide for the employee’s signature in two (2) places, one (1) indicating that the employee has read and accepts the performance review, and the other indicating that the employee disagrees with the performance review. The employee shall sign in only one (1) of the places provided. No employee may initiate a grievance regarding the contents of a performance review unless the signature indicates disagreement. An employee shall, upon request, receive a copy of this performance review at the time of signing. An employee’s performance review shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure of this Agreement. The employee may respond, in writing, to the performance review. Such response will be attached to the performance review.
Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.
Development Milestone Payments (i) In addition to the Closing Date Merger Consideration (less the Remaining Option Consideration and Rights Proceeds Amount, if any) and any Net TNF Sales Payments (as defined below), upon the attainment of the development ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. milestones set forth below (each, a “Development Milestone”), Parent shall, or shall cause the Surviving Corporation to, [**] after the occurrence of each Development Milestone, deliver to the Paying Agent (for further payment to the holders of Stock Certificates and Stock Agreements outstanding immediately prior to the Effective Time), via wire transfer of immediately available funds, the respective amounts set forth below minus, in each case, the applicable Contingent Consideration Distribution Fee associated therewith and any amount designated by the Stockholders’ Representatives to be placed in the Administrative Expense Account (each, a “Development Milestone Payment” and collectively, the “Development Milestone Payments”):
(A) Upon FDA approval of Reslizumab for the treatment of eosinophilic esophagitis, a cash payment of [**];
(B) Upon marketing authorization of Reslizumab for the treatment of eosinophilic esophagitis being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**];
(C) If Res 5-0010 Asthma Study Completion has not occurred on or prior to the Closing Date, then upon the occurrence of the Res 5-0010 Asthma Study Completion, a cash payment of $50,000,000 (fifty million dollars) (the “Res 5-0010 Asthma Payment”);
(D) Upon FDA approval of Reslizumab for any asthma indication, a cash payment of [**];
(E) Upon marketing authorization of Reslizumab for the treatment of any asthma indication being granted by the European Commission in accordance with Regulation (EC) No. 726/2004, a cash payment of [**]; and
(F) Upon FDA approval of an Oral Anti-TNF Product, a cash payment of [**].
Project Review A. Programmatic Allowances
1. If FEMA determines that the entire scope of an Undertaking conforms to one or more allowances in Appendix B of this Agreement, with determinations for Tier II Allowances being made by SOI-qualified staff, FEMA shall complete the Section 106 review process by documenting this determination in the project file, without SHPO review or notification.
2. If the Undertaking involves a National Historic Landmark (NHL), FEMA shall notify the SHPO, participating Tribe(s), and the NPS NHL Program Manager of the NPS Midwest Regional Office that the Undertaking conforms to one or more allowances. FEMA shall provide information about the proposed scope of work for the Undertaking and the allowance(s) enabling FEMA’s determination.
3. If FEMA determines any portion of an Undertaking’s scope of work does not conform to one or more allowances listed in Appendix B, FEMA shall conduct expedited or standard Section 106 review, as appropriate, for the entire Undertaking in accordance with Stipulation II.B, Expedited Review for Emergency Undertakings, or Stipulation II.C, Standard Project Review.
4. Allowances may be revised and new allowances may be added to this Agreement in accordance with Stipulation IV.A.3, Amendments.
B. Expedited Review for Emergency Undertakings
Project/Milestones Taxpayer provides refrigerated warehousing and logistic distribution services to clients throughout the United States. In consideration for the Credit, Taxpayer agrees to invest in a new refrigeration and distribution facility in the XxXxxxxxx Park area of Sacramento, California, and hire full-time employees (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit A (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full-time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by Taxpayer for the entire taxable year shall be annualized. In addition, the salary of any full-time employee hired to fill a vacated position in which a full-time employee was employed during Taxpayer’s Base Year shall be disregarded.
Annual Performance Review The Employee’s performance of his duties under this Agreement shall be reviewed by the Board of Directors or a committee of the Board of Directors at least annually and finalized within thirty (30) days of the receipt of the annual audited financial statements. The Board of Directors or a committee of the Board of Directors shall additionally review the base salary, bonus and benefits provided to the Employee under this Agreement and may, in their discretion, adjust the same, as outlined in Addendum B of this Agreement, provided, however, that Employee’s annual base salary shall not be less than the base salary set forth in Section 4(A) hereof.
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 Concession Area, including its abandonment.
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.
