Program Design The County Human Resources Department will operate a Catastrophic Leave Bank which is designed to assist any County employee who has exhausted all paid accruals due to a serious or catastrophic illness, injury, or condition of the employee or family member. The program establishes and maintains a Countywide bank wherein any employee who wishes to contribute may authorize that a portion of his/her accrued vacation, compensatory time, holiday compensatory time or floating holiday be deducted from those account(s) and credited to the Catastrophic Leave Bank. Employees may donate hours either to a specific eligible employee or to the bank. Upon approval, credits from the Catastrophic Leave Bank may be transferred to a requesting employee's sick leave account so that employee may remain in paid status for a longer period of time, thus partially ameliorating the financial impact of the illness, injury, or condition. Catastrophic illness or injury is defined as a critical medical condition, a long-term major physical impairment or disability which manifests itself during employment.
Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.
Project Design Applicants must design a project that provides access to health services to enable eligible women and men experiencing health needs to secure and maintain safe and accessible quality screening and diagnostic services, comprehensive family planning, and/ or other women’s health services. A. Applicants are encouraged to emphasize the following components in the design of their projects. Projects must: 1. Use a collaborative approach to maximize existing community resources and avoid duplication of effort; 2. Enhance systems and local processes to make it easier for people to transition to, from, and between services; 3. Address barriers to ensure services are accessible to people regardless of setting or location; and 4. Promote improvement and positively impact health and well-being through coordinated service delivery. B. To be effective, services and activities provided or made available as part of the Proposed Project should have policies and procedures in place and include with the application as an attachment that: 1. Delineate the timely provision of services; 2. Deem Client eligibility and service provision as soon as possible and no later than 30 calendar days from initial request; 3. Require staff to assess and prioritize Client needs; 4. Implement with model fidelity to an evidence-based program or based upon best available research; 5. Plan in partnership with the person and are inclusive; 6. Provide in an environment that is most appropriate and based on a person’s preference including reasonable clinic/reception wait times that are not a barrier to care; 7. Provide referral sources for Clients that cannot be served or receive a specific service; 8. Are culturally and linguistically sensitive; 9. Tailor services to a person’s unique strengths and needs; 10. Manage funds to ensure established Clients continuity of care throughout budget year; 11. Continue to provide services to established Clients after allocated funds are expended; 12. Have processes to identify and eliminate possible barriers to care; 13. Do not deny services due to inability to pay; 14. Have appropriate key personnel and required staff to meet the medical and health needs of Clients; 15. Bill services appropriately and timely through TMHP; 16. Effectively communicate and document information related to health care needs with next steps available to Client; 17. Establish outreach and education plan for the community; and 18. Outline successful delivery of direct clinical services to Clients By submitting an Application under this RFA, the Applicant certifies that Applicant has or will have at time of grant award services, policies, or procedures that conform with the requirements in this section as applicable. HHSC, in its sole discretion, may request to review relevant documentation during the project period as necessary to ensure program fidelity.
Commercialization Plan At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
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 Efforts 4.2.1 Hana shall use Commercially Reasonable Efforts to Develop each Product in the Territory (including carrying out its responsibilities under the Development Plan) to: (a) conduct or cause to be conducted the necessary and appropriate clinical trials as necessary to obtain and maintain Regulatory Approvals for each Product; and (b) prepare, file and prosecute or cause to be prepared, filed and prosecuted the Regulatory Submission for each Product. 4.2.2 Hana will provide INEX with written reports to keep INEX fully informed of the progress of the Development of each Product as follows: (a) at the close of each Calendar Quarter during the first twenty-four (24) months following the Effective Date of the Definitive Agreements; and (b) on or before June 31 and December 31 of each and every calendar year thereafter.
Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time
