Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement, and subject to Section 2.1.5: (i) coordinate the Parties’ activities under this Agreement; (ii) discuss the overall strategy for the development and regulatory approval of the Products in the Field throughout the Territory; (iii) facilitate communications and discussion between the Parties with respect to the development, manufacture and commercialization of Products; (iv) discuss and approve each Development Plan and any proposed amendments or revisions thereto, including timeframes for the Development activities to be carried out thereunder, on an annual basis or as otherwise agreed upon by the Parties; (v) oversee the implementation of each Development Plan for each Product and review and serve as an information-sharing forum for Development and Commercialization for each Product, including discussion of the results of the activities being carried out thereunder; (vi) define and coordinate regulatory strategy for each Product; (vii) establish subcommittees, as appropriate, as described more fully in Section 2.1.3(d) below; (viii) direct and oversee any subcommittee; (ix) discuss estimated sales forecasts for Products; (x) establishing a process for reviewing and commenting on Promotional Materials and training materials and programs for each Product for the Territory; (xi) designate policies for the Parties’ reporting and recording of Development Costs and other financial terms set forth in this Agreement; (xii) resolve disputed matters that may arise at the subcommittees; and (xiii) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or that are otherwise agreed by the Parties in writing.
Appears in 1 contract
Samples: Collaboration and License Agreement (Aerie Pharmaceuticals Inc)
Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement, and subject to Section 2.1.5will:
(ia) coordinate review, discuss, and approve any amendments to the Parties’ activities under this AgreementWorkplans that may be necessary or desired, and prepare, discuss, and approve any Additional Workplans, in accordance with Section 4.4; provided that, unless ProQR otherwise consents, each amendment to a Workplan and Additional Workplan shall only include obligations for ProQR that are substantially similar in nature and extent to those included in the Initial Workplan;
(ii) discuss the overall strategy for the development and regulatory approval of the Products in the Field throughout the Territory;
(iii) facilitate communications and discussion between the Parties with respect to the development, manufacture and commercialization of Products;
(iv) discuss and approve each Development Plan and any proposed amendments or revisions thereto, including timeframes for the Development activities to be carried out thereunder, on an annual basis or as otherwise agreed upon by the Parties;
(vb) oversee the implementation of each Development Plan the Workplans, including the activities, timing and deliverables thereunder, and coordination of such activities and timing across Research Programs;
(c) assess new Targets of interest and approve (in the case of Additional Projects and Replacement Projects), and refine as necessary (for all Projects), the Critical Success Factors for each Product Project, and review determine whether the applicable Critical Success Factors have been satisfied;
(d) determine whether a Project with respect to a Project Target should be discontinued;
(e) without limiting Lxxxx’x rights pursuant to Section 3.5 to select a Replacement Target, and serve as an informationsubject to Lxxxx’x decision-sharing making authority in Section 2.9, discuss Lxxxx’x selection of Replacement Targets;
(f) discuss the progress of the Research Program and Projects generally, and the validation and development of Compounds Directed To the Project Targets;
(g) [***];
(h) provide a forum for Development the Parties to share and Commercialization for each Productdiscuss information relating to the research and validation of Compounds Directed To the Project Targets, including discussion of the results of the activities being carried out thereunderunder the Workplans;
(vii) define and coordinate regulatory strategy for each Productaddress issues arising in the performance of the Workplans;
(viij) establish subcommitteesWorking Groups, as appropriate, as described more fully in Section 2.1.3(d) below;
(viii) and direct and oversee any subcommittee;
(ix) discuss estimated sales forecasts for Products;
(x) establishing a process for reviewing operating Working Groups on all significant issues, and commenting on Promotional Materials and training materials and programs for each Product for the Territory;
(xi) designate policies for the Parties’ reporting and recording of Development Costs and other financial terms set forth in this Agreement;
(xii) resolve disputed matters that may arise at the subcommitteesWorking Groups;
(k) facilitate the exchange of Know-How or any materials as required hereunder (including pursuant to Section 4.9);
(l) determine [***], as further described in Section 7.1.4;
(m) oversee winding down of the Research Program or a Project with respect to discontinued Project Targets; and
(xiiin) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or that are as otherwise agreed by the Parties in writing.
Appears in 1 contract
Samples: Research and Collaboration Agreement (ProQR Therapeutics N.V.)
Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement, and subject to Section 2.1.5will:
(ia) coordinate prepare, discuss, and approve initial Research Plans for each Program and prepare, review, discuss, and approve any amendments that may be necessary or desired to the Parties’ activities under this AgreementResearch Plans;
(ii) discuss the overall strategy for the development and regulatory approval of the Products in the Field throughout the Territory;
(iii) facilitate communications and discussion between the Parties with respect to the development, manufacture and commercialization of Products;
(iv) discuss and approve each Development Plan and any proposed amendments or revisions thereto, including timeframes for the Development activities to be carried out thereunder, on an annual basis or as otherwise agreed upon by the Parties;
(vb) oversee the implementation of each Development Plan for each Product the Research Plans, including the activities, timing and review deliverables thereunder, and serve as an informationcoordination of such activities and timing across Research Programs;
(c) discuss the progress of the Research, Pre-sharing Clinical Development, and the Programs generally, the validation and development of the Collaboration Targets and the selection, validation and development of the Licensed Products;
(d) provide a forum for the Parties to share and discuss information relating to the (i) Research and validation of the Collaboration Targets (including Replacement Targets), (ii) Research and Pre-Clinical Development and Commercialization for each Productof the Licensed Products, including discussion of the results of the activities being carried out thereunderunder the Research Plans, (iii) manufacturing and CMC development activities being carried out under the Supply Agreements, and (iv) Clinical Development of any Co-Funded Product under this Agreement pursuant to 5.3;
(vie) define and coordinate regulatory strategy for each Productaddress issues arising in the performance of the Research Plans;
(vii) establish subcommittees, as appropriate, as described more fully in Section 2.1.3(d) below;
(viiif) direct and oversee any subcommittee;
(ix) discuss estimated sales forecasts for Products;
(x) establishing a process for reviewing operating Working Groups on all significant issues, and commenting on Promotional Materials and training materials and programs for each Product for the Territory;
(xi) designate policies for the Parties’ reporting and recording of Development Costs and other financial terms set forth in this Agreement;
(xii) resolve disputed matters that may arise at the subcommitteesWorking Groups; WEIL:\97737446\1\59474.0121 EXECUTION VERSION
(g) facilitate the exchange of Know-How or materials (pursuant to Section 4.10, Section 4.11 or Section 5.1, as applicable) as required hereunder;
(h) following Precision’s delivery of a Co-Funding Option Interest Notice in accordance with Section 5.3.1, facilitate Lilly’s provision of information to Precision in response to questions from Precision relating to the Lilly Clinical Development Plan and facilitate Lilly’s provision to Precision of written copies of any updates or amendments to the Lilly Clinical Development Plan; and
(xiiii) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or that are as otherwise agreed by the Parties in writing.
Appears in 1 contract
Samples: Development and License Agreement (Precision Biosciences Inc)
Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement, and subject to Section 2.1.5will:
(ia) coordinate review, discuss, and approve any amendments to the Parties’ activities under this AgreementWorkplans that may be necessary or desired, and prepare, discuss, and approve any Additional Workplans, in accordance with Section 4.4; provided that, unless ProQR otherwise consents, each amendment to a Workplan and Additional Workplan shall only include obligations for ProQR that are substantially similar in nature and extent to those included in the Initial Workplan;
(ii) discuss the overall strategy for the development and regulatory approval of the Products in the Field throughout the Territory;
(iii) facilitate communications and discussion between the Parties with respect to the development, manufacture and commercialization of Products;
(iv) discuss and approve each Development Plan and any proposed amendments or revisions thereto, including timeframes for the Development activities to be carried out thereunder, on an annual basis or as otherwise agreed upon by the Parties;
(vb) oversee the implementation of each Development Plan the Workplans, including the activities, timing and deliverables thereunder, and coordination of such activities and timing across Research Programs;
(c) approve (in the case of Additional Projects and Replacement Projects), and refine as necessary (for all Projects), the Critical Success Factors for each Product Project, and review determine whether the applicable Critical Success Factors have been satisfied;
(d) determine whether a Project with respect to a Project Target should be discontinued;
(e) without limiting Lilly’s rights pursuant to Section 3.5 to select a Replacement Target, and serve as an informationsubject to Lilly’s decision-sharing making authority in Section 2.9, discuss Lilly’s selection of Replacement Targets;
(f) discuss the progress of the Research Program and Projects generally, and the validation and development of Compounds Directed To the Project Targets;
(g) [***];
(h) provide a forum for Development the Parties to share and Commercialization for each Productdiscuss information relating to the research and validation of Compounds Directed To the Project Targets, including discussion of the results of the activities being carried out thereunderunder the Workplans;
(vii) define and coordinate regulatory strategy for each Productaddress issues arising in the performance of the Workplans;
(viij) establish subcommitteesWorking Groups, as appropriate, as described more fully in Section 2.1.3(d) below;
(viii) and direct and oversee any subcommittee;
(ix) discuss estimated sales forecasts for Products;
(x) establishing a process for reviewing operating Working Groups on all significant issues, and commenting on Promotional Materials and training materials and programs for each Product for the Territory;
(xi) designate policies for the Parties’ reporting and recording of Development Costs and other financial terms set forth in this Agreement;
(xii) resolve disputed matters that may arise at the subcommitteesWorking Groups;
(k) facilitate the exchange of Know-How or any materials as required hereunder (including pursuant to Section 4.9);
(l) oversee winding down of the Research Program or a Project with respect to discontinued Project Targets; and
(xiiim) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or that are as otherwise agreed by the Parties in writing.
Appears in 1 contract
Samples: Research and Collaboration Agreement (ProQR Therapeutics N.V.)