Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.
Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D.
(b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties):
(i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period;
(ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law;
(iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer;
(iv) Depomed shall [***];
(v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);
Information and Services Required of the Owner The Owner shall provide information with reasonable promptness, regarding requirements for and limitations on the Project, including a written program which shall set forth the Owner’s objectives, constraints, and criteria, including schedule, space requirements and relationships, flexibility and expandability, special equipment, systems, sustainability and site requirements.
Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.
Information Technology The following applies to all contracts for information technology commodities and contractual services. “Information technology” is defined in section 287.012(15), F.S., to have the same meaning as provided in section 282.0041, F.S.
Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four
Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.
Procurement of Goods and Services (a) If the HSP is subject to the procurement provisions of the BPSAA, the HSP will abide by all directives and guidelines issued by the Management Board of Cabinet that are applicable to the HSP pursuant to the BPSAA.
(b) If the HSP is not subject to the procurement provisions of the BPSAA, the HSP will have a procurement policy in place that requires the acquisition of supplies, equipment or services valued at over $25,000 through a competitive process that ensures the best value for funds expended. If the HSP acquires supplies, equipment or services with the Funding it will do so through a process that is consistent with this policy.
Xxxxxx and Recall 1. When the Board determines to reduce the number of positions in one or more classifications covered by this agreement because of decreased enrollment of pupils, suspension of schools, territorial changes, lack of work, return to duty of an employee from a leave of absence, or financial reasons, the Board shall follow the procedure set forth in this Section.
2. The Board shall determine in which classification the layoffs should occur and the number of employees to be laid off.
3. The Board shall lay off employees in the affected classification on the basis of reverse seniority in that classification. Seniority shall be defined as the length of continuous service as a regular employee of the Board of Education.
4. The names of laid off employees shall be kept on a recall list by classification until for two years maximum. If the Board determines to fill any position in a classification during this period of time, the Board must offer the position to the most senior employee on the recall list for that classification. The offer of recall shall be made by written notice sent to the employee at his most recent address on record by certified mail. It is the employee's responsibility to keep the Board informed of his up to date address. The employee shall have seven (7) days after the notice is mailed to accept the offer of recall and report to work. If he does not report during such seven-day period, his name shall be eliminated from the recall list and the employment relationship between him and the Board shall cease. If the first employee on the recall list for a classification does not accept the recall, the Board shall offer the position to the next most senior employee from that classification on the recall list by the procedure outlined in this Section, and so on, until the position is filled. Any employee who resigns after receiving the notice provided in Division 4 of this Section, shall be entitled, upon request, to be placed upon the recall list and shall have same recall rights as if laid off.
5. For purposes of this Section, the following classifications will be used.
1. Bus Driver 9. Bus Aide
2. Bus Mechanic 10. Head Cook 3. Building Maintenance 11. Cafeteria Worker
