Common use of Formation; Purpose Clause in Contracts

Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint coordination committee (the “Joint Coordination Committee” or “JCC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JCC shall be to: (i) review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of Licensed Products in the Hansoh Territory, including planning and executing of any Clinical Trials, regulatory filings and/or registration in the Territory; (ii) review, discuss and approve (subject to Section 3.3) the inclusion of Additional Indications within the Field for the Development and Commercialization of Licensed Products in the Hansoh Territory, including approval of the relevant Development Plan for such Indications; (iii) review, discuss and approve (subject to Section 3.3) any proposed amendments or revisions to the Development Plan, including those with respect to clinical Development activities set forth in Section 4.3, and to review, discuss and approve (subject to Section 3.3) the conduct of any Development activities by Hansoh; (iv) review and discuss (but not approve) any Global Clinical Trial Plan and any proposed amendments or revisions thereto; (v) review and discuss (but not approve) any Local Clinical Trial Plan and any proposed amendments or revisions thereto; (vi) oversee the initial transfer of the Keros Technology and Development activities related to the Licensed Products from Keros to Hansoh in accordance with the terms of this Agreement; (vii) review and coordinate the Manufacture of Licensed Products and the transfer thereof by Keros to Hansoh; (viii) coordinate the schedule for reporting safety data related to Licensed Products in the Hansoh Territory and any other expected and unrelated serious adverse events and adverse events related to Licensed Products; (ix) facilitate the exchange of Data pursuant to Section 4.7; (x) review, coordinate, and discuss the conduct of any combination studies involving Licensed Products in the Hansoh Territory; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.

Appears in 1 contract

Sources: License Agreement (Keros Therapeutics, Inc.)

Formation; Purpose. Within [***] after the Effective Date, the Parties shall will establish a joint coordination steering committee (the “Joint Coordination Committee” or “JCCJSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JCC shall JSC will be to: (i) reviewreview and discuss ArriVent’s, discuss its Affiliates’ and coordinate the overall strategy for the Development, Manufacturing, Sublicensees’ Exploitation of Licensed Compounds and Commercialization of Licensed Products in the Hansoh Field in the ArriVent Territory, including planning regulatory activities directed to obtaining an IND and executing of any Clinical Trials, regulatory filings and/or registration other Regulatory Approvals relating to Licensed Products in the ArriVent Territory; (ii) review, discuss and approve (subject to Section 3.3) the inclusion of Additional Indications within the Field for the Development Plan and Commercialization of Licensed Products in the Hansoh Territory, including approval of the relevant Development Plan for such Indicationsany amendments thereto; (iii) review, discuss and approve determine whether to include any modified versions of MRG007 (subject i.e., an alternative Antibody or linker-payload) under this Agreement for ArriVent’s Exploitation in the ArriVent Territory (any such modified version, a “Backup Compound”) following a determination by the Parties to Section 3.3) any proposed amendments or revisions to the terminate Development Plan, including those with respect to clinical Development activities set forth in Section 4.3, and to review, discuss and approve (subject to Section 3.3) the conduct of any Development activities by HansohMRG007; (iv) review coordinate the sharing and discuss transfer (but not approveincluding the frequency thereof) any Global Clinical Trial Plan of information and any proposed amendments or revisions theretomaterials, including Licensed Know-How and ArriVent Know-How, between the Parties; (v) review and discuss (but not approve) any Local the feasibility of pursuing a Global Trial and, if applicable, review and discuss the development plan for such Global Trial and the development plan of all on-going and potential future Clinical Trial Plan and any proposed amendments or revisions theretoTrials; (vi) oversee the initial transfer of the Keros Technology review, discuss and Development activities related to the Licensed Products from Keros to Hansoh determine whether a Third Party Patent is necessary in accordance with the terms of this AgreementSection 8.5(e) (Third Party Intellectual Property); (vii) establish a process for the submission, review and coordinate the Manufacture approval of Licensed Products and the transfer thereof by Keros to Hansoh;publications in accordance with Section 12.4 (Technical Publication); and (viii) coordinate the schedule for reporting safety data related to Licensed Products in the Hansoh Territory and any other expected and unrelated serious adverse events and adverse events related to Licensed Products; (ix) facilitate the exchange of Data pursuant to Section 4.7; (x) review, coordinate, and discuss the conduct of any combination studies involving Licensed Products in the Hansoh Territory; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.

Appears in 1 contract

Sources: Exclusive License Agreement (ArriVent BioPharma, Inc.)

Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint coordination steering committee (the “Joint Coordination Steering Committee” or “JCCJSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JCC JSC shall be tobe: (i) to review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of Licensed Products in the Hansoh Field in the 3D Medicines Territory, including planning and executing of any Clinical Trials, related regulatory filings and/or registration in the Territoryactivities; (ii) to review, discuss and approve (subject to Section 3.3) the inclusion of Additional Indications within the Field for the Development and Commercialization of Licensed Products in the Hansoh Territory, including approval of the relevant Development Plan for such Indications; (iii) review, discuss and approve (subject to Section 3.3) any proposed amendments or revisions to the Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.3, and to review, discuss and approve (subject to Section 3.3) the conduct of any Development activities by Hansoh4.3(b); (iviii) to review and discuss (but not approveapprove (except as otherwise expressly provided for in Section 3.2(d))) any Global Clinical Trial the Commercialization Plan and any proposed amendments or revisions thereto; (v) to such plan, and review and discuss (but not approveapprove (except as otherwise expressly provided for in Section 3.2(d))) any Local Clinical Trial Plan and any proposed amendments or revisions thereto; (vi) oversee the initial transfer Commercialization of the Keros Technology and Development activities related to the Licensed Products from Keros to Hansoh in accordance with the terms of this Agreement; (vii) review and coordinate the Manufacture of Licensed Products and the transfer thereof by Keros to Hansoh; (viii) coordinate the schedule for reporting safety data related to Licensed Products in the Hansoh Field in the 3D Medicines Territory and (including any other expected and unrelated serious adverse events and adverse events related pricing strategy with respect to Licensed Products); (ixiv) facilitate to coordinate the exchange Commercialization of Data pursuant to Section 4.7; (x) review, coordinate, and discuss the conduct of any combination studies involving Licensed Products in the Hansoh 3D Medicines Territory and Aravive Territory to ensure consistent global marketing of Licensed Products in the Field (provided, that 3D Medicines will have responsibility, subject to the oversite of the JSC, for determining and establishing the price of a Licensed Product for each Region in the 3D Medicines Territory; provided that, to the extent permitted under Applicable Law, pricing shall optimize the economic value of a Licensed Product in such Region and be consistent with the global commercialization strategy and global brand plan for the Licensed Product. For clarity, Aravive will have sole authority for determining and establishing the price of Licensed Products in the Aravive Territory); and (xiv) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.

Appears in 1 contract

Sources: Collaboration and License Agreement (Aravive, Inc.)