Workplans. Facilities located out- side the United States must operate in accordance with a workplan. The workplan must be signed by a rep- resentative of the heat treatment fa- cilities located outside the United States, the national plant protection organization of the country of origin (NPPO), and APHIS. The workplan must contain requirements for equip- ment, temperature, water quality, cir- culation, and other measures to ensure that heat treatments are administered properly. Workplans for facilities out- side the United States must include trust fund agreement information re- xxxxxxx payment of the salaries and ex- penses of APHIS employees on site. Workplans must allow officials of the NPPO and APHIS to inspect the facil- ity to monitor compliance with APHIS regulations.
Workplans. (a) An overall Workplan for the R&D Program is attached hereto as Exhibit A, which Workplan also includes a detailed Workplan for at least the first twelve (12) months of the R&D Program. At the end of each Calendar Quarter, a detailed Workplan for the next twelve (12) months shall be prepared by SEMBIOSYS and MARTEK and approved in writing by MARTEK, no later than ten (10) days after the end of such Calendar Quarter. The detailed Workplans for each twelve (12) month period shall set forth specific research and development objectives, milestones and resource allocation requirements and shall be designed to facilitate the earliest practical achievement of the objectives of the R&D Program. Each Workplan, including the overall Workplan and the detailed twelve-month Workplan, shall be in writing and shall set forth with reasonable specificity tasks for the period covered by the Workplan. The RSC may make adjustments in the Workplan as it may determine, subject to MARTEK’s written approval.
Workplans. The Parties shall undertake each Product Development Program in accordance with a Workplan for such Product Development Program. The Initial PDP Workplan has been agreed by the Parties as of the Restatement Date, except that (i) the Preliminary Success Criteria shall be agreed by the Parties within ninety (90) days after the Restatement Date or, if the Parties are unable to agree within such 90-day period, each Party shall notify the other Party, in writing, of [**] Preliminary Success Criteria, and (ii) the [**] criteria for the Initial Product Development Program, including the design and protocols for conducting studies suitable to demonstrate [**], shall be agreed to by the Parties within [**]; provided that if the Parties are unable to agree upon the [**] criteria within such [**] period, then either Party may refer the matter for resolution pursuant to the procedures set forth in the second and third sentences of Section 2.2(e). The first dosing of a participant in the first such Phase II(a) Study or Phase II(b) Study shall not be undertaken by or on behalf of either Party until after the [**] criteria have been determined and documented for such Product Development Program. Notwithstanding anything to the contrary in a Workplan, Medtronic shall not have any liability for any failure to develop any improvement to or next generation of a Medtronic Device. The Workplan, the license royalty rates and the minimum duration of the Royalty Term for each Additional Product Development Program shall be agreed by the Parties in connection with the Parties’ agreement to initiate such Additional Product Development Program. Each Workplan shall address, in reasonable detail, the roles and responsibilities of each Party with respect to the Discovery and Development of Licensed Product(s) covered by such Product Development Program, including each Party’s roles and responsibilities with respect to (x) clinical study activities, such as filing INDs with Regulatory Authorities, the selection of centers, negotiation and execution of clinical agreements, training, monitoring, data collection, notice of adverse events and other regulatory requirements, and (y) other activities as necessary to effect the Discovery and Development of Licensed Products under such Collaboration Program. Such Workplan shall further (A) set forth the Target Indication(s) for the corresponding Product Development Program, (B) include budgets for the Parties’ Discovery and Development activitie...
Workplans. From time to time during the term of this Agreement, the parties may decide to amend, expand or supplement the Workplan for the performance of Services under this Agreement via written amendment. To the extent the terms in a Workplan shall at any time conflict with the terms of this Agreement, the terms of this Agreement shall control, unless specifically stated otherwise in the Workplan.
Workplans. The [**] Development Program Workplan negotiated by the Parties prior to the Proceed-to-PDP Determination shall specify that [**]; provided that Medtronic will lead, and Alnylam will cooperate with Medtronic with respect to all Product Development Program activities (i) relating directly to the design, configuration, assembly, filling or re-filling of Devices, [**] Product Development Program [**]y. Alnylam shall be responsible for [**] to the designated Development Candidate in the course of the [**] Development Program activities assigned to it pursuant to the [**] Development Program Workplan (including the [**]; provided that, if a [**] is achieved is designed with the intention that [**] may be determined based on an [**], then Alnylam shall [**]and Medtronic shall be responsible for all subsequent costs of such clinical study[**] and Medtronic shall [**] [**] Development Program [**]. Following the achievement of [**], the Parties shall, subject to any early termination of the Initial Product Development Program, adopt additional Workplan(s) to cover further Development of the designated Development Candidate and of applicable Devices (each such additional Workplan, a "[**] Development Program Workplan" and the portions of the Initial Product Development Program covered by each such additional Workplan, collectively, the "[**] Development Program"). Medtronic shall be responsible for [**]Development Program. Each [**] Development Program Workplan shall specify as appropriate, in all requisite detail, [**] in connection with any activities to be performed by Alnylam pursuant to [**] Development Program Workplan. In connection with such activities, Medtronic shall [**] through the Supply Agreement as described in Section 2.8, (y) [**] in accordance with the [**] Development Program Workplan, and (z) the [**] internal resources used by Alnylam in accordance with the [**] Development Program Workplan. Notwithstanding the foregoing, Medtronic shall [**] Alnylam's JRDC Representatives performing JRDC responsibilities or by Alnylam employees or agents for activities not assigned to Alnylam in the [**] Development Program Workplan [**] in accordance with Section 2.3(b)).
Workplans. (a) An overall Workplan for the R&D Program is attached hereto as Exhibit A, which Workplan also includes a detailed Workplan for at least the first twelve (12) months of the R&D Program. At the end of each Calendar Quarter, a detailed Workplan for the next twelve (12) months shall be prepared by SEMBIOSYS and MARTEK and approved in writing by MARTEK, no later than ten (10) days after the end of such Calendar Quarter. The detailed *The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission Workplans for each twelve (12) month period shall set forth specific research and development objectives, milestones and resource allocation requirements and shall be designed to facilitate the earliest practical achievement of the objectives of the R&D Program. Each Workplan, including the overall Workplan and the detailed twelve-month Workplan, shall be in writing and shall set forth with reasonable specificity tasks for the period covered by the Workplan. The RSC may make adjustments in the Workplan as it may determine, subject to MARTEK’s written approval.
Workplans. 1. The Parties will conclude one or several WPs as the case may be. WPs shall be signed by duly authorized representatives of the Parties.
Workplans. CDC shall submit, in form and substance satisfactory to USAID, annual country and program-specific work plans. A proposed format for the work plan is included in Attachment 1. The workplans shall:
Workplans. 5.1. The Forum shall adopt a Workplan, which shall be supplemented by individual Workplans of the Parties.
Workplans. Facilities located out- side the United States must operate in accordance with a workplan. The Animal and Plant Health Inspection Service, USDA § 305.9 workplan must be signed by a rep- resentative of the heat treatment fa- cilities located outside the United States, the national plant protection organization of the country of origin (NPPO), and APHIS. The workplan must contain requirements for equip- ment, temperature, water quality, cir- culation, and other measures to ensure that heat treatments are administered properly. Workplans for facilities out- side the United States must include trust fund agreement information re- xxxxxxx payment of the salaries and ex- penses of APHIS employees on site. Workplans must allow officials of the NPPO and APHIS to inspect the facil- ity to monitor compliance with APHIS regulations.
