Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Local Government for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential subcontractor or supplier will be notified by the Local Government of the Local Government’s obligations under this Agreement and the Acts and Regulations relative to Nondiscrimination on the grounds of race, color, or national origin.
Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final.
b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.
Elements Unsatisfactory Needs Improvement Proficient Exemplary IV-A-1. Reflective Practice Demonstrates limited reflection on practice and/or use of insights gained to improve practice. May reflect on the effectiveness of lessons/ units and interactions with students but not with colleagues and/or rarely uses insights to improve practice. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues, and uses insights gained to improve practice and student learning. Regularly reflects on the effectiveness of lessons, units, and interactions with students, both individually and with colleagues; and uses and shares with colleagues, insights gained to improve practice and student learning. Is able to model this element.
Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.
a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract.
b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.
Solicitations for Subcontracts, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Engineer for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the Engineer of the Engineer's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin.
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).
DISTRIBUTION OF CONTRACTOR PRICE LIST AND CONTRACT APPENDICES Contractor shall provide Authorized Users with electronic copies of the Contract, including price lists and Appendices, upon request. Contract Updates will be handled as provided in Appendix C – Contract Modification Procedures.
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 [**].
