Research and Development (i) Advice and assistance in relation to research and development of Party B;
Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X
Virus Management Transfer Agent shall maintain a malware protection program designed to deter malware infections, detect the presence of malware within the Transfer Agent environment.
Staffing Consultant will designate in writing to Authority its representative, and the manner in which it will provide staff support for the project, which must be approved by Authority. Consultant must notify Authority’s Contract Representative of any change in personnel assigned to perform work under this Contract, and the Authority’s Contract Representative has the right to reject the person or persons assigned to fill the position or positions. The Authority’s Contract Representative shall also have the right to require the removal of the Consultant’s previously assigned personnel, including Consultant’s representative, provided sufficient cause for such removal exists. The criteria for requesting removal of an individual will be based on, but not limited to, the following: technical incompetence, inability to meet the position’s qualifications, failure to perform, poor attendance, ethics violation, unsafe work habits, or damage to Authority or other property. Upon notice for removal, Consultant shall replace such personnel with personnel substantially equal in ability and qualifications for the positions and shall submit the proposed replacement personnel qualification and abilities to the Authority, in writing, for approval.
Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.
Product Development Attach all requested documentation and attach additional pages as necessary. For all requirements include efforts of all Sublicensees. If not applicable, please so indicate by N/A.
Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.
Development 3.3 Within twenty (20) Working Days after the Commencement Date and in accordance with paragraphs 3.10 to 3.12 (Amendment and Revision), the Contractor will prepare and deliver to the Authority for approval the full and final Security Plan which will be based on the draft Security Plan set out in Appendix B.
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.
Research Support opioid abatement research that may include, but is not limited to, the following: