Provision Language
ARTICLE 3. MANAGEMENT AND GOVERNANCE
3.1. Joint Steering Committee.
(a) Formation and Authority. Within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to provide input and exchange information concerning the Development, Manufacture, and Regulatory Approval process and Commercialization activities being conducted by SIIL or its Affiliates hereunder with respect to the Product. Neither the JSC nor any subcommittee or alliance manager shall have any power to amend, modify, or waive compliance with this Agreement or increase the obligations of either Party. In conducting themselves on the JSC and the subcommittees, and as alliance managers, and in exercising their rights under this Section 3.1, all representatives of either Party shall consider diligently, reasonably and in good faith all input received from the other Party, and shall use reasonable efforts to reach unanimity, where required, on any decision or advice the JSC offers to either or both Parties.
(b) Members. Within thirty (30) days following the Effective Date, each Party shall initially appoint two (2) representatives to the JSC, each of whom shall have sufficient experience in the subject matter of this Agreement, and shall inform the other Party about the appointments. The JSC may change its size from time to time by mutual written consent of the Parties; provided that the JSC shall at all times consist of an equal number of representatives of each Party. Each Party may replace its JSC representatives at any time upon at least ten (10) days prior notification, in writing or electronically, to the other Party. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Upon prior notification, in writing or electronically, to the JSC, each Party may invite no more than two (2) non-members to participate in the discussions and meetings of the JSC. Such participation shall be subject to the consent of both Parties, such consent not to be unreasonably withheld, conditioned or delayed. The JSC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Visterra or SIIL. The initial chairperson shall be selected by Visterra. The role of the chairperson shall be only to administer the meetings of the JSC in a manner intended to ensure equal participation of each Party, and to ensure the prompt preparation of the minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JSC representatives.
(c) Meetings. The JSC shall meet at least once every six (6) months during the Term unless the Parties mutually agree in writing to a different frequency for such meetings. The JSC shall hold its first meeting within sixty (60) days of the Effective Date. Either Party may also call a special meeting of the JSC (by videoconference or teleconference) by at least ten (10) Business Days prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, and such Party shall provide the JSC no later than five (5) Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision. No later than ten (10) Business Days prior to any meeting of the JSC, the chairperson of the JSC or a designate shall prepare and circulate an agenda for such meeting; provided, however, that either Party may propose additional topics to be included on such agenda, prior to such meeting. The JSC may meet in person, by videoconference or by teleconference. Notwithstanding the foregoing, at least one (1) meeting per Calendar Year shall be in person unless the Parties mutually agree in writing to waive such requirement in lieu of a videoconference or teleconference. In-person JSC meetings shall be held at a mutually agreeable location or alternating each meeting between a location selected by Visterra and by SIIL. Each Party shall bear the expense of its respective JSC members’ participation in JSC meetings. Translators at any meetings related to this Agreement shall be the responsibility of the Party requiring translation. All documents shared by one Party with the other Party will be provided in the form and language in which the document is customarily maintained. Meetings of the JSC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. The chairperson of the JSC or a designate shall be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect, without limitation, material decisions made at such meetings. The JSC chairperson or a designate shall send draft meeting minutes to each member of the JSC for review and approval within twenty (20) days after each JSC meeting. Such minutes shall be deemed approved unless one or more members of the JSC object to the accuracy of such minutes within twenty (20) days of receipt. Any objections shall be resolved by the Parties within ten (10) days thereafter. If no resolution is reached in such ten(10) day period, then the Parties shall record, with the assistance of their legal counsel, the details of the dispute.
(d) JSC Responsibilities. The JSC shall:
(i) perform its designated roll [sic] regarding the Parties’ conduct under the Research and Development Plan and the Development of the Product in the Field in the Licensed Territory by SIIL (provided that the JSC shall not be involved in the day-to-day management of the Development, Manufacture or Commercialization of the Product) as further set forth in this Agreement;
(ii) prepare and approve annual or interim amendments to the Research and Development Plan;
(iii) discuss and endeavor to resolve any disputes arising out of this Agreement;
(iv) review and comment upon the Commercialization Plan presented to the JSC by SIIL in accordance with Section 6.1;
(v) appointment of alliance managers;
(vi) review and discuss the Publication Strategy for the Products;
(vii) review and discuss proposed protocols for clinical trials to be conducted by SIIL in the Licensed Territory; and
(viii) consider and act on such other matters that are specifically delegated to the JSC as specified in this Agreement.
(e) JSC Actions. The JSC shall strive to seek consensus in its actions and decision making process. In the event of a disagreement between the Visterra members and SIIL members of the JSC, either Party may refer the matter to one senior executive of each Party (i.e., the Chief Executive Officer of such Party or an executive of such Party who reports directly to the Chief Executive Officer) for resolution. If such senior executives cannot resolve the matter within five (5) Business Days, then such senior executive of SIIL shall have the final decision making authority on such matter; provided that any final determination made by such senior executive of SIIL shall be consistent with the terms of this Agreement and; further provided that SIIL shall not make any final decision with respect to (i) any amendments to the Research and Development Plan that either (A) delay any activity by either Party provided for in such plan by more than six (6) months or (B) require Visterra to perform additional activities or commit additional resources to the performance of activities under the Research and Development Plan or (ii) the approval of any protocol for a clinical trial proposed by SIIL if Visterra in good faith determines the performance of such clinical trial is reasonably likely to have an adverse effect on the safety or wellbeing of patients.
(f) Termination of the JSC.
(i) Disbanding of JSC. The Parties may disband the JSC upon mutual written agreement.
(ii) Withdrawal from JSC. Visterra’s membership in the JSC shall be at its sole discretion, as a matter of right and not obligation, for the sole purpose of participation in governance, decision-making and information exchange with respect to activities within the authority of the JSC. At any time, Visterra shall have the right to withdraw from membership or participation in the JSC upon [**] days’ prior written notice to SIIL. Following Visterra’s withdrawal from membership or participation in the JSC,(A) the JSC shall be disbanded, (B) following disbandment of the JSC, all decisions from and after such date which would have been submitted to the JSC for resolution under the Agreement had the JSC not been disbanded shall instead be submitted for resolution by the Chief Executive Officers of the Parties (or any senior executive reporting directly to either Party’s Chief Executive Officer) and (C) each party shall have the right to continue to receive the information it would otherwise be entitled toreceive under this Agreement.
3.2. Scientific Exchanges. No less than [**], key scientific representatives from each Party (the “Key Scientific Representatives”) shall meet in person, or by videoconference or by teleconference to discuss and exchange scientific findings and concerns relating to the Product. In-person meetings of the Key Scientific Representatives shall be held at a mutually agreeable location or alternating each meeting between a location selected by Visterra and by SIIL. The Parties shall discuss and agree upon an agenda in advance for each meeting of the Key Scientific Representatives and determine the appropriate representatives from each Party to be included in such meeting. Meetings of the Key Scientific Representatives shall be for information-exchanging and collaboration purposes only and the Key Scientific Representatives shall have no decision-making authority. The Key Scientific Representatives shall continue to meet as provided in this Section 3.2 until [**] or until such time as otherwise mutually agreed upon by the Parties.
3.3. Operational Meetings. No less than once per Calendar Quarter, key operational representatives from each Party (the “Key Operational Representatives”) shall meet in person, or by videoconference or by teleconference to discuss key operational matters relating to the Development, Manufacture and Commercialization of the Product in the Visterra Territory and Licensed Territory. In-person meetings of the Key Operational Representatives shall be held at a mutually agreeable location or alternating each meeting between a location selected by Visterra and by SIIL. The Parties shall discuss and agree upon an agenda in advance for each meeting of the Key Operational Representatives and determine the appropriate representatives from each Party to be included in such meeting. Meetings of the Key Operational Representatives shall be for information-exchanging and collaboration purposes only, and the Key Operational Representatives shall have no decision-making authority. The Key Operational Representatives shall continue to meet as provided in this Section 3.3 until [**] or until such time as otherwise mutually agreed upon by the Parties.
ARTICLE 4. PRODUCT DEVELOPMENT
4.1. Research and Development Plan. The initial plan for the research and Development of the Product in the Field in the Licensed Territory, which includes a responsibility matrix allocating responsibility between the Parties, is attached hereto as Exhibit C (such plan, as amended from time to time as provided herein the “Research and Development Plan”). The JSC shall oversee the Development of the Product in the Field in the Licensed Territory according to the Research and Development Plan. The Research and Development Plan shall provide generally for a budget for the internal costs and out-of-pocket expenses to be incurred by Visterra in conducting activities under the Research and Development Plan and agreed upon by the Parties (including any reimbursements to be paid by either Party) and assignment of responsibilities between the Parties for the various activities to be undertaken under the Research and Development Plan, including the following: [**]. During the Term, the JSC shall review the Research and Development Plan at least [**] and comment upon such Research and Development Plan on an ongoing basis as necessary and the Parties will amend such Research Plan to the extent necessary. The then-current Research and Development Plan shall at all times contain at least that level of detail and cover at least the same matters (to the extent applicable) as the initial Research and Development Plan.
4.2. Development Responsibility. Unless specifically set forth in the Research and Development Plan, SIIL shall be solely responsible for the conduct of all Development activities set forth in the Research and Development Plan. Visterra shall provide assistance to SIIL in an advisory role through the JSC and shall conduct those activities for which it is specifically designated as the responsible Party in the Research and Development Plan. At each meeting of the JSC, each Party shall reasonably update the otherParty on the status, progress and results of its Development activities under the Research and Development Plan.
ARTICLE 6. COMMERCIALIZATION
6.1. Overview of Commercialization in the Licensed Territory. SIIL shall be solely responsible for all aspects of the Commercialization of the Product in the Field in the Licensed Territory, in compliance with all applicable Laws in accordance with a commercialization plan to be prepared by SIIL and provided to JSC for its review and comment prior to the First Commercial Sale of the Product in the Licensed Territory (the “Commercialization Plan”). Such Commercialization Plan shall include, to the extent permitted by applicable Law, the activities to be conducted and the overall timelines therefor in preparation for the launch of the Product and after such Product launch in the respective countries and marketing materials, which shall be updated on [**] basis during the [**]-month period prior to the First Commercial Sale of the Product and thereafter on [**] basis by SIIL and provided to the JSC for its review and comment. SIIL shall book sales for the Product in the Licensed Territory and shall be responsible for all order processing, invoicing, collection, distribution, inventory, and returns necessary in connection therewith.
ARTICLE 14. DISPUTE RESOLUTION
14.1. Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner.
14.2. Internal Resolution. With respect to all disputes arising between the Parties under this Agreement, including any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Chief Executive Officers of the Parties (or any senior executive reporting directly to either Party’s Chief Executive Officer) for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. If no resolution is reached, then each Party may seek any legal remedy available to it to the extent permitted under this Agreement.