Common use of JSC Responsibilities Clause in Contracts

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Collaboration: (a) reviewing reports and updates provided by Alnylam regarding the Development of Licensed Products under the Initial Development Plan, including material modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1; (b) [***]; (c) approving Extra Early Development Costs in accordance with Section 2.3.1(c); (d) reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively; (f) regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing such other activities as the Parties agree in writing shall be the responsibility of the JSC. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For purposes of clarity, the JSC shall not have the authority to modify the terms of this Agreement.

Appears in 3 contracts

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

JSC Responsibilities. The JSC shall have be responsible for overseeing and managing the following responsibilities collaboration with respect to Cell Therapy Products and Collaboration Products, including, without limitation the Collaborationfollowing functions: (aA) reviewing reports The JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen and updates provided ViaCell locations and be held at such times as are agreed upon by Alnylam regarding the Development of Licensed Products under the Initial Development PlanJSC. At least one JSC meeting per year shall be conducted in person, including material modifications and updates to the Initial Development Plan provided whereas other JSC meetings may be held in person or by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1; (b) video conference or teleconference. The first meeting shall be held at Amgen's facilities within [***];] of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings. (cB) approving Extra Early Development Costs in accordance with Section 2.3.1(c); (d) reviewing reports The JSC shall review and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively; (f) regularly assessing discuss the progress of Alnylam ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in its conduct of appropriate detail to enable the Initial Development Plan and JSC members to meaningfully monitor the progress of MedCo the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto. (C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its conduct sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products. (D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the MedCo Development Planbudget and the reconciliation, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing such other activities as the Parties agree in writing approvals shall be noted in the responsibility minutes of the JSCJSC meeting. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[**]. (E) For Collaboration Products, each Party shall submit to the JSC for review prior to the end of [**] its [**] plans and budgets in draft form covering activities for which it is responsible. [**]”. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For . (F) The JSC shall perform such other functions as appropriate to further the purposes of clarity, the collaboration pursuant to the terms and conditions of this Agreement. [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed with the Commission. The JSC shall not have the authority to require Amgen or ViaCell to undertake or modify any activities for which such Party is responsible under this Agreement. Further, notwithstanding the terms above responsibilities of the JSC, nothing in this Section 2.3 shall erode or detract from each Party's rights and responsibilities for Developing, manufacturing and Commercializing Cell Therapy Products and Collaboration Products pursuant to the Program Plan and as described in this Agreement.

Appears in 3 contracts

Sources: Collaboration Agreement (Viacell Inc), Collaboration Agreement (Viacell Inc), Collaboration Agreement (Viacell Inc)

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Development, Manufacturing, having Manufactured and Commercialization of Licensed Drug Candidates and Licensed Products pursuant to the Collaboration: (a) reviewing reports review, discuss and updates provided by Alnylam regarding approve the Development of Licensed Products under the Initial Development Plan, including material modifications and updates to the Initial Global Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same including regulatory strategy and approving such any updates and modifications to the Initial Development Plan in accordance with Section 2.2.1or amendments thereto; (b) [***]review and discuss each Ono Territory Development Plan, and all amendments and updates to such Ono Territory Development Plan; (c) approving Extra Early review and discuss each Repare Territory Development Costs in accordance with Section 2.3.1(c)Plan, and all amendments and updates to such Repare Territory Development Plan; (d) reviewing reports and updates provided endeavor to ensure that each Party is appropriately advised as to Development being conducted by MedCo regarding the Development of Licensed Products other Party in the its respective Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to report and monitor progress of Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform and discuss any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectivelyresults thereunder; (f) regularly assessing review protocols for Clinical Studies for the progress of Alnylam in its conduct of the Initial Development Plan Licensed Drug Candidate and the progress of MedCo in its conduct of the MedCo Development PlanLicensed Product, against the respective timelines contained thereinincluding combination therapy; (g) reviewing Alnylam Technology that would be reasonably helpful assist in coordinating scientific interactions and division of responsibilities, when applicable, with respect to MedCo’s Development activities; (h) review and approve Global Commercialization Strategy; (i) review and discuss Ono Territory Commercialization Plan and any updates or amendments thereto, and discuss any results thereunder; (j) review and approve Global Branding Strategy and any updates or amendments thereto, and discuss any results thereunder; (k) serve as the forum for the settlement of disputes or disagreements, including whether or not either Party is making its Commercially Reasonable Efforts in relation to the Development or the Commercialization of Licensed Drug Candidates and Licensed Products; (l) review and approve a proposal from a Party to conduct preclinical and non-clinical studies with respect to Drug Candidates and Licensed Products in other Party’s Territory (which approval shall not be unreasonably withheld ); (m) review, discuss and determine which approve each Global Clinical Study Proposal; (n) review and discuss each Party’s or its Related Party’s long term Development strategy in the respective Territory in a timely manner; (o) review, discuss and oversee the CMC and Manufacture of Licensed Drug Candidates and Licensed Products; (p) overseeing the JSC’s Working Group and ensuring effective participation in each such Alnylam Technology should be transferred Working Group’s operations by any of its members; (q) reviewing the status of Licensed Drug Candidates and Licensed Products, including material Development and Commercialization matters; (r) addressing any other matters referred to MedCothe JSC by the terms of this Agreement; and (hs) performing such other activities as the Parties agree in writing from time to time shall be the responsibility of the JSC. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For purposes the avoidance of claritydoubt, decisions with respect to each of the above matters or any other matter that is identified in this Agreement as being subject to JSC approval, shall not have be subject to the authority to modify processes set forth in Section 8.1.7 (Decision Making), including the terms of escalation and tie-breaking provisions provided herein, except as otherwise expressly set forth in this Agreement.

Appears in 2 contracts

Sources: Research Services, License and Collaboration Agreement (Repare Therapeutics Inc.), Research Services, License and Collaboration Agreement (Repare Therapeutics Inc.)

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Collaborationresponsibilities: (a) reviewing reports reviewing, approving, monitoring and updates provided by Alnylam regarding the overseeing all Palatin Development of Licensed Products under the Initial Development PlanActivities, including material modifications ensuring AMAG’s ability to review and updates comment on all materials, discussions and strategies related to, and to attend, as applicable, (i) clinical studies (including related protocols and final study reports) to be conducted by Palatin pursuant to the Initial Palatin Development Plan provided by Alnylam in accordance Activities, (ii) any meetings or discussions with Section 2.2.1any Regulatory Authorities with respect thereto, providing Alnylam including any pre-NDA meetings and (iii) interactions with feedback regarding same scientific advisors and approving such updates and modifications to the Initial Development Plan in accordance key opinion leaders with Section 2.2.1respect thereto; (b) [***]establishing procedures for maintaining and recording the costs incurred in conducting the Palatin Development Activities, and establish and update as required approved budgets for Palatin Development Activities; (c) approving Extra Early establishing procedures to allow AMAG to audit Palatin’s Third Party vendors with respect to the Palatin Development Costs in accordance with Section 2.3.1(c)Activities; (d) reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively; (f) regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing forming such other activities committees and sub-committees as the Parties agree in writing shall be the responsibility of the JSC. JSC may deem appropriate, provided that such committees and sub-committees may 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 UNDER RULE 24b-2 OF 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. For purposes of clarity, make recommendations to the JSC but may not be delegated JSC decision-making authority; and (e) performing such other activities as the Parties agree in writing shall not have be the authority to modify responsibility of the terms of this AgreementJSC.

Appears in 2 contracts

Sources: License Agreement (Palatin Technologies Inc), License Agreement (Amag Pharmaceuticals Inc.)

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Collaborationresponsibilities: (ai) reviewing reports review, discuss and updates provided comment on the status and progress of completing the activities contemplated by Alnylam regarding Section 2.2 and Section 4.2 and by the Development of Licensed Products under TSA; (ii) review and approve the Initial Development Regulatory Transition Plan, including material any amendments or modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1thereto; (biii) [***]review, discuss and comment on the status and progress of completing the activities set forth in the Regulatory Transition Plan; (civ) approving Extra Early Development Costs review, discuss and comment on the status and progress of completing the activities to be performed by ▇▇▇▇▇ pursuant to the TSA, including the costs and expenses incurred by or on behalf of ▇▇▇▇▇ in accordance connection therewith, and any amendments or modifications thereto; (v) facilitate the exchange of material Regulatory Filings and information regarding material interactions with Regulatory Authorities between the Parties pertaining to Licensed Compounds and Licensed Products inside and outside of the Territory; (vi) facilitate the exchange of information regarding any significant issues concerning any serious adverse event or adverse event and safety issues for each Licensed Product inside and outside of the Territory in compliance with this Agreement and the Pharmacovigilance Agreement; (vii) facilitate the exchange of information contemplated by Section 2.3.1(c3.4(b); (dviii) reviewing reports review, discuss and updates comment on any Publications provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with either Party pursuant to Section 2.2.36.5; (eix) ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform establish and monitor any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties subcommittees or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectivelyworking group; (fx) regularly assessing perform such other duties or functions as are expressly assigned to the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained thereinJSC under this Agreement; (gxi) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development consider and approve the dissolution of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; andthe JSC, when appropriate; (hxii) performing such other activities as the Parties agree in writing shall be provide a forum for dispute resolution for any matters within the responsibility of the JSC. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For purposes ; (xiii) provide a forum for the Parties to discuss coordination of clarityTakeda’s efforts with those of ▇▇▇▇▇’▇ licensee with respect to the Excluded Territory; (xiv) provide a forum through which Takeda can update Keros regarding, and the JSC shall not have Parties can discuss updates and status related to, Takeda’s Development, regulatory and Commercialization Plans and efforts; and (xv) other topics as mutually agreed by the authority to modify the terms of this AgreementParties.

Appears in 1 contract

Sources: Exclusive License Agreement (Keros Therapeutics, Inc.)

JSC Responsibilities. The JSC JSC’s overall responsibility shall have the following responsibilities with respect be to the Collaboration: (a) reviewing reports encourage and updates provided by Alnylam regarding the Development of Licensed Products under the Initial Development Plan, including material modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1; (b) [***]; (c) approving Extra Early Development Costs in accordance with Section 2.3.1(c); (d) reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination facilitate ongoing cooperation between the Parties with respect to Development the activities in contemplated by this Agreement and to perform the Territory for Licensed Products under the MedCo Development Plan (other obligations specifically delegated to the extent the Parties have agreed in writing that Alnylam should perform any such activities)JSC by this Agreement, and regulatory and pharmacovigilance requirements and matters subject to the extent necessary limitations set forth in this Section 4.5(b). The JSC shall also serve as the principal means by which GSK keeps Idenix informed regarding GSK’s development plans, efforts and results with respect to Products as required under this Agreement. (i) Decisions of the JSC shall be made by unanimous vote, with each Party’s representatives on the JSC collectively having one (1) vote. No vote of the JSC may be taken unless at least [**] of each Party’s representatives is present for the Parties to perform their duties or exercise their rights hereunder and for JSC vote. Notwithstanding the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authoritiesforegoing, respectively; (f) regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing such other activities as the Parties agree in writing shall be to the responsibility following limitations with respect to the authority of the JSC. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For purposes of clarity: (ii) The JSC’s role with respect to Products shall be solely informational and advisory, and the JSC shall not have any decision-making authority, or any power to direct GSK’s Development efforts or amend this Agreement. If, GSK determines in good faith that material changes to the Development Plan are advisable, GSK shall promptly inform Idenix thereof and, at Idenix’s written request, the Parties shall promptly convene a JSC meeting to discuss the nature of such changes and the rationale therefor. In addition, if GSK determines, that a material delay in the performance of the Development Plan is reasonably likely, GSK shall promptly inform Idenix thereof and, at Idenix’s written request, the Parties shall promptly convene a JSC meeting to discuss the cause(s) of such delay, the estimated duration of the delay and the possibility of avoiding or mitigating such delay. Notwithstanding the foregoing GSK may not, without the prior written consent of Idenix, not to be unreasonably withheld, make a change to the Development Plan that would remove or significantly delay any Development milestone provided in Section 5.2(a) below, not including any delays caused by Regulatory Authorities. However, in the event of a fundamental difference of opinion between the Parties regarding the Development path for Products, Idenix or GSK shall have the right to refer such matter to the Chief Executive Officer of Idenix and the SVP Medicines Development Center, Infectious Diseases at GSK for further discussion for a period of [**] (unless extended by mutual agreement of such officers). Such officers shall discuss such matter in good faith and attempt to reach resolution. In the event the Parties still cannot agree on a matter after such escalation to such officers, GSK shall have the ultimate decision-making authority with respect to any such Development matter subject to the limitations on such authority provided in Section 14.8(a). For the avoidance of doubt, GSK shall have sole authority to modify manufacture the terms of this AgreementProducts.

Appears in 1 contract

Sources: License Agreement (Idenix Pharmaceuticals Inc)

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Collaborationwill be responsible for: (a) reviewing reports and updates provided by Alnylam regarding overseeing the Development implementation of Licensed Products under the Initial Development Research Plan, including material modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1; (b) considering the results of Celera Validation; (c) considering the results of SGI Validation and selecting Collaboration Products from Designated Antibodies and ADC Products; (d) allocating responsibility for Research Plan activities between the Parties, taking into consideration their relevant expertise and available resources; (e) monitoring and reviewing the progress of the Research Plan and the results thereof; (f) recommending to the Parties any modifications to the Research Plan; *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (g) facilitating an effective exchange of information between the Parties regarding the Research Plan and any Development and Commercialization Plan(s); (h) determining whether a Designated Antigen will be a source of Collaboration Products; (i) approving the Annual Budget; (j) evaluating the impact of Third Party Obligations on the development and Commercialization of any Collaboration Product and rejecting or accepting such Collaboration Product in view of such Third Party Obligations; (k) developing a [***]; (cl) approving Extra Early Development Costs in accordance with Section 2.3.1(c); (d) reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3; (e) ensuring coordination between the Parties with respect to Development activities in the Territory allocating responsibility for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively; (f) regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein; (g) reviewing Alnylam Technology that would be reasonably helpful to MedCo’s Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and (h) performing such other activities as the Parties agree in writing shall be the responsibility of the JSC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “each [***]”. 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. For ; (m) monitoring and reviewing the progress of the Development and Commercialization Plans and the results thereof; (n) recommending to the Parties any modifications to Development and Commercialization Plans; (o) approving the Collaboration Accounting Policies and any subsequent changes thereto; (p) approving termination of any Development and Commercialization Plan or abandonment of any Collaboration Product, and determining whether a particular Designated Antibody or ADC Product will not be a Collaboration Product; (q) overseeing the Commercialization activities of the Collaboration Program; (r) recommending the [***]; (s) reviewing for approval or rejection a request by a Party to grant a license to a Third Party under any Collaboration Technology or Collaboration Patent Rights; and (t) consistent with and subject to Article 9 and Article 10 of this Agreement, overseeing intellectual property matters arising under the Collaboration Program, including, without limitation: (i) assigning responsibility for the preparation, filing, prosecution and maintenance of Joint Collaboration Patent Rights; (ii) reviewing all invention disclosures arising under or relating to the Collaboration Program for the purposes of claritymaking patent application filing recommendations to the Parties and for determining proper inventorship and ownership of such inventions; (iii) establishing policies for the filing of foreign patent applications arising from the Collaboration Program; (iv) creating and approving, as necessary, a budget for management of intellectual property related costs to be shared by the Parties pursuant to this Agreement; (v) determining which Collaboration Products should be marked with which Patent Right numbers; and (vi) addressing any other intellectual property issues referred to the JSC shall not have the authority pursuant to modify the terms of this Agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Seattle Genetics Inc /Wa)