Common use of Steering Committee Clause in Contracts

Steering Committee. The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3.

Appears in 3 contracts

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

Steering Committee. The Parties shall Within twenty (20) calendar days from the Effective Date, the parties will form a Steering Committee, to which each Party will appoint Committee consisting of three (3) executive employees, including people from each party (the Project Managers, all of whom “Steering Committee”). A representative from each party shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee serve as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications co-chairpersons of the Steering Committee. The Steering Committee will take action by unanimous consent may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the PartiesProduct in the Territory, with the representatives of BII collectively having including a single vote review and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all update of the representatives. If Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to ▇▇▇▇▇▇ the Steering Committee is unable attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith Section 2.1(ii); (e) review Sankyo’s efforts to resolve such matterdevelop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the decision reached by mutual agreement Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the chief executive officers of the Parties shall be final and binding on the Parties. If, Product; (h) review Sankyo’s obligations under Section 4.1; (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreementreview, and if necessary, amend the schedule set forth in Exhibit C hereto; (iij) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings disputes pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of 7.1; and (k) agree upon the chief executive officers in accordance with this Section 2.2.3initial Sales, Marketing and Distribution Plan. The Each party may change its members of the Steering Committee are set forth in Appendix 3 attached heretoat any time upon written notice, which may be updated from time to time to reflect changes in and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as provided in this Section 2.2.3indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnus.

Appears in 3 contracts

Sources: Sales, Marketing and Distribution Agreement (Cygnus Inc /De/), Sales and Distribution Agreement (Cygnus Inc /De/), Sales, Marketing and Distribution Agreement (Cygnus Inc /De/)

Steering Committee. The Parties Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all Committee made up of whom shall be familiar with the Project. The Steering Committee commercial and technical employees from both companies that shall have general certain decision-making authority, and provide oversight and review for the administration of the activities of the Project Team and this Agreement. Each party shall resolve any issues referred to maintain two (2) members on the Steering Committee by the Project Team. Each Party shall have the right to substitute its with other members of the Steering Committee added as needed from time to time by giving written notice to the other Party due time in advanceneeded. The Steering Committee parties shall meet within [...***...] after receipt each select one of its representatives to serve as a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications co-chairperson of the Steering Committee. The Steering Committee will take action shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by unanimous consent the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the PartiesTerritory, with (c) review clinical developments across territories, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) review the representatives of BII collectively having arrangement for distributing Product on a single vote Named Patient Basis. In the event and to the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If extent that the Steering Committee is unable to reach unanimous consent come to a consensus on a particular matter, then the any matter will be referred relating to the chief executive officers development or manufacture of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the ProcessRegistration, but packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not concern have the BI Facility ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or the management obligations under this Agreement of manufacturing slotssuch party, then the chief executive officer of XENCOR shall make the final decision about how Orphan Medical and Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such disputerights or obligations of such party. During each Contract Year, after good faith consideration the parties shall hold at least four (4) regular meetings of BII’s position, which decision the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be final conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and binding on a facility designated by Celltech. The co-chairpersons of the PartiesSteering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that, in resolving that such matter, XENCOR’s chief executive officer minutes shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated become official until agreed upon by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3both co-chairpersons.

Appears in 3 contracts

Sources: License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc)

Steering Committee. The Parties Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all Committee made up of whom shall be familiar with the Project. The Steering Committee commercial and technical employees from both companies that shall have general certain decision-making authority, and provide oversight and review for the administration of the activities of the Project Team and this Agreement. Each party shall resolve any issues referred to maintain two (2) members on the Steering Committee by the Project Team. Each Party shall have the right to substitute its with other members of the Steering Committee added as needed from time to time by giving written notice to the other Party due time in advanceneeded. The Steering Committee parties shall meet within [...***...] after receipt each select one of its representatives to serve as a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications co-chairperson of the Steering Committee. The Steering Committee will take action shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by unanimous consent the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the PartiesTerritory, with (c) review clinical developments across territories, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) review the representatives of BII collectively having arrangement for distributing Product on a single vote Named Patient Basis. In the event and to the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If extent that the Steering Committee is unable to reach unanimous consent come to a consensus on a particular matter, then the any matter will be referred relating to the chief executive officers development or manufacture of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the ProcessRegistration, but packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not concern have the BI Facility ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or the management obligations under this Agreement of manufacturing slotssuch party, then the chief executive officer of XENCOR shall make the final decision about how Orphan Medical and Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such disputerights or obligations of such party. During each Contract Year, after good faith consideration the parties shall hold at least four (4) regular meetings of BII’s position, which decision the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be final conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and binding on a facility designated by Celltech. The co-chairpersons of the PartiesSteering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that, in resolving that such matter, XENCOR’s chief executive officer minutes shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated become official until agreed upon by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3both co-chairpersons.

Appears in 3 contracts

Sources: License and Distribution Agreement, License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Celltech Group PLC)

Steering Committee. 3.1.1 The Parties shall form a Steering Committee, to which each Party will appoint three ” or “SC” consisting of two (32) executive employees, including the Project Managers, all of whom shall be familiar with the Projectpermanent members representing Coskata and two (2) permanent members representing TPRF. The Steering Committee Parties agree that TPRF shall have general oversight and review the right to elect its representative from within the personnel of its Affiliates. Each member has the right to invite up to two experts in support of the activities and responsibilities of the Project Team SC, provided that: (a) the inviting Party shall provide the other Party with a prior notice of such invitation and shall resolve any issues referred to (b) the Steering Committee by the Project Team. Each other Party shall have the right to substitute its members refuse such invitation in case this expert is not a member of the inviting Party’s personnel and (c) such invited expert shall in no event have the right to vote within the SC and (d) any expert attending a SC meeting who is not a member of any Party’s personnel shall have agreed in writing to the confidentiality provisions of Section 11. 3.1.2 Without prejudice to each Party’s responsibilities and liabilities specified herein, the Steering Committee shall be responsible hereunder for those activities conducted under this Agreement that are attributed to the Steering Committee. Accordingly, the responsibilities of the Steering Committee as needed from time to time by giving written notice shall consist of: (a) the evaluation of progress made in relation to the work to be performed by the Parties under this Agreement, the confirmation of achievement of milestones directed to the implementation of the IJDP and any ADPs and the decision to enter into a given phase of the IJDP and/or ADP; (b) the review, approval and rejection of proposals relating to the IJDP or an ADPs, including review and approval of the Approved Licensing Conditions and the Approved Package; (c) the discussion and recommendation of any amendments to this Agreement (if any) to be executed by the Parties; (d) the resolving of intellectual property matters; (e) the management of the preparation of the commercialization (industrialisation and licensing) of the Propanol Fermentation Technology; (f) all major decisions relating to the joint implementation of this Agreement between the Parties; and (g) any other Party due time in advance. responsibility as agreed by the Steering Committee. 3.1.3 The Steering Committee shall meet for the first time to establish an initial path forward for the implementation of the IJDP as described in Appendix 2 at a mutually agreeable date, but no later than forty-five (45) calendar days after the Effective Date. Details of the form, date, and place of the initial meeting will be as agreed by the Parties within fourteen (14) calendar days of the Effective Date. During the remainder of the term of this Agreement, the Steering Committee will meet every six (6) months, or as may otherwise be mutually agreed upon by the Parties, at times and places mutually agreed upon by the Parties. 3.1.4 The Steering Committee shall only take decisions hereunder on the basis [...***...] after receipt of a written request the votes issued by one all its Parties through its permanent members, meaning that each Party represented by its permanent member(s) shall have the specific right to the [***] made by or on behalf of any other Party. The request shall describe the matter in dispute Party (through its permanent members or otherwise) and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications without such consent, or if so rejected, such proposal, resolution, or directive does not become valid or effective as an act of the Steering Committee. Any such decision [***] shall require that all permanent members are present or otherwise involved in the relevant decision making process. [***] Indicates that text has been omitted which is the subject of a confidential treatment request. The Steering Committee will take action by unanimous consent of the Parties, text has been separately filed with the representatives of BII collectively having a single vote Securities and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3Exchange Commission.

Appears in 2 contracts

Sources: Joint Development Agreement, Joint Development Agreement (Coskata, Inc.)

Steering Committee. The Parties shall form Under the Prior Agreement, the parties have formed a Steering CommitteeCommittee made up of commercial and technical employees from both companies that has certain decision-making authority, to which each Party will appoint three and provide oversight for the administration of this Agreement. Each party shall maintain two (32) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to members on the Steering Committee by the Project Team. Each Party shall have the right to substitute its with other members of the Steering Committee added as needed from time to time by giving written notice to the other Party due time in advanceneeded. The Steering Committee parties shall meet within [...***...] after receipt each select one of its representatives to serve as a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications co-chairperson of the Steering Committee. The Steering Committee will take action shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by unanimous consent the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories to the extent permitted by Jazz Pharmaceuticals’ agreements with Third Parties, with (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, inventory stocks and ordering, and (g) establish a manufacturing sub-committee which shall review matters relating to the representatives manufacture of BII collectively having a single vote Product. In the event and to the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If extent that the Steering Committee is unable to reach unanimous consent come to a consensus on any matter relating to the development (except to the extent that such development involves clinical trials that would occur solely in the Territory) or manufacture of the Product, Registration (including pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Jazz Pharmaceuticals Steering Committee members shall prevail. In the event and to the extent that the Steering [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKET BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Committee is unable to come to a consensus on any matter relating to clinical trial activity that would occur solely in the Territory, Registration (including pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, and, if UCB has exercised its manufacturing option under Section 2.2, on any matter relating to the manufacture of the Product for sale within the Territory, the views of the UCB Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular mattermatter for which there is no consensus of the Steering Committee could, then in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Jazz Pharmaceuticals and UCB shall attempt to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party, but in default of agreement may be referred by either party to arbitration under Section 15.2. During each Contract Year, the chief executive officers parties shall hold at least four (4) regular meetings of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement Steering Committee. Members of the chief executive officers Steering Committee may participate in meetings of the Parties Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be final and binding on the Partiesconducted in-person. If, (i) after good faith efforts, the chief executive officers Employees of each party who are not members of the Parties are unable to resolve such matter Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Jazz Pharmaceuticals’ designated facility and a facility designated by mutual agreementUCB. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, and (ii) such matter concerns with the Product or Jazz Pharmaceuticals Chairperson preparing minutes for the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Partiesfirst Steering Committee meeting; provided, however, that, in resolving that such matter, XENCOR’s chief executive officer minutes shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated become official until agreed upon by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3both co-chairpersons.

Appears in 2 contracts

Sources: License and Distribution Agreement (Jazz Pharmaceuticals Inc), License and Distribution Agreement (Jazz Pharmaceuticals Inc)

Steering Committee. 5.3.1. The Parties shall form a Steering Committee, Committee to which each Party will appoint three (3) delegate [**] executive employees, including the Project Managers, all of whom shall be employees who are familiar with the Project. In the case of Lonza, the executives shall be [**] or their designee(s), provided that such designee(s) shall have substantially the same authority and decision making power as the aforementioned executives. In the case of Kolltan, the executives shall be at the vice president level or higher. The Steering Committee shall provide strategic guidance for the overall collaboration and have general oversight and review of the activities of the each Project Team and shall resolve be responsible for resolving any issues referred to the Steering Committee by the Parties. For clarification, while each Project will have its own Project Team, the Steering Committee will have oversight and governance over all Projects. Each Party Subject to the mutual written agreement of the Parties and the terms of this Agreement, the Steering Committee shall have the right ability to substitute its members make any necessary adjustments to the governance structure of the collaboration, including the Project Teams, propose amendments to the definition of each Party’s deliverables under the Agreement, as well as review key performance indicators previously agreed to by the Parties, provided, however, in no event shall the Steering Committee as needed from time to time by giving take action inconsistent with the terms of this Agreement or any other written notice to agreement between the other Party due time in advanceParties. 5.3.2. The Once Services have commenced, the Steering Committee shall meet within on a [...**] basis or as otherwise agreed by the Parties. At least [*...*] after receipt of meetings per year shall be conducted in–person and such meetings shall alternate between a written request site designated by one Party to Lonza in the other Party. The request shall describe United Kingdom and a site designated by Kolltan in the matter in dispute and the solution which the requesting Party proposes to be decidedUnited States. Each Party shall bear its own costs associated with meetings travel and communications accommodation costs. Minutes of each meeting shall be taken on a rotational basis between Lonza and Kolltan and shall be distributed for approval by the Steering CommitteeCommittee at the next meeting. 5.3.3. The Steering Committee will take action by unanimous consent of the Partiesits members, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively each representative having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to a personal meeting (which shall be face-to-face if requested by either Party) between Lonza’s Head of the chief executive officers Custom Manufacturing division or his/her designee and the Chief Executive Officer of Kolltan or his/her designee, who in each case may not be a member of the Steering Committee and both of whom shall act in good faith and discuss the issue to seek a resolution acceptable to both Parties and if resolved the resolution shall be binding and final, provided, however, in no event shall such resolution be inconsistent with the terms of this Agreement or any other agreement between the Parties. In each case, any designee(s) appointed by the Parties must have the authority and decision making power granted by the aforementioned executives to bind the respective Parties to the resolution(s) that may result from such a meeting. The meeting shall take place within [**] calendar days of the relevant referral, or as otherwise mutually agreed. In case such persons cannot agree within a further [**] calendar days after such meeting, then the following shall apply: (a) If the dispute is predominantly concerned with scientific or technical issues, then the entire dispute shall be referred to independent experts on whom the Parties agree as set forth hereinafter. Each Party is entitled to propose one (1) unconflicted independent expert, subject to the consent of the other Party, and the other Party shall not unreasonably withhold its consent to the appointment of such expert. The Parties will make available the same set of documents to both experts and both experts shall provide their expert opinion in the English language within [**] weeks after the second expert has been appointed. The decision of such independent experts shall be in writing and, save for manifest error on the face of the decision, shall be binding on both Lonza and Kolltan. If the two (2) experts come to dissenting opinions and are unable to solve the dispute among themselves, a third unconflicted independent expert shall be appointed jointly by the Parties, who will use good faith efforts is an expert in the particular scientific or technical area at issue. If the Parties cannot agree as to resolve the third unconflicted independent expert, then such matterthird expert shall be appointed by the CEDR (Centre for Effective Dispute Resolution) in London, England and such decision by the CEDR shall be binding. Such third expert shall have access to the written opinions of the two other experts as well as to all documents that were made available to the two experts. The third expert shall then approve one of the two opinions of the first two experts, and such opinion approved by the decision reached by mutual agreement of the chief executive officers of the Parties third expert shall be considered final and binding on the Parties. IfThe reasonable costs of the experts shall be paid by the non-prevailing Party. (b) If the dispute is predominantly concerned with an issue other than a scientific or technical issue, (i) after then the Parties agree to attempt in good faith efforts, the chief executive officers of the Parties are unable to resolve such matter dispute by mutual agreementmediation administered by the CEDR in London, England. The parties agree that they shall share equally the cost of any mediation fees, and (ii) such matter concerns the Product or cost of the Process, but does not concern the BI Facility or the management mediator. Each party must bear its own attorneys’ fees and associated costs and expenses. The place of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision any mediation shall be final and binding on London, England. If efforts at mediation are unsuccessful within [**] calendar days of either Party referring the Parties; provided, however, that, dispute to mediation either Party may pursue its rights in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by a court of law in accordance with Clause 14 of this Agreement. In no event will the Steering Committee, or the executive officers of the Parties Nothing in resolving this Clause 5.3 shall prevent a Party from exercising any Steering Committee matter, have any authority to amend or modify right under this Agreement; any such amendment or modification , including the right of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3termination under Clause 11 below.

Appears in 2 contracts

Sources: Development and Manufacturing Services Agreement (Kolltan Pharmaceuticals Inc), Development and Manufacturing Services Agreement (Kolltan Pharmaceuticals Inc)

Steering Committee. The Parties shall form 4.1 MTC and the Participating Cities agree to create and hereby establish a Steering CommitteeCommittee to coordinate the activities of the Program and make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from MTC, and one designated representative from each of the Participating Cities. Each party with a designated representative shall have the right to change its designated representative upon five (5) days written notice to the other parties. Each party with a designated representative may appoint an alternate representative that will have full voting rights as the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which each Party may be called at any reasonable time by any designated representative. A Steering Committee meeting or teleconference cannot be held unless a majority of the designated representatives, or alternates in their absence, are present or available by telephone. Designated representatives and any staff of a party may attend meetings in person or by teleconference. An absent designated representative may vote by giving a written proxy to another designated representative. 4.4 The goal of the Steering Committee will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Projectto reach decisions by a unanimous vote. The Steering Committee shall have general oversight and review endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at two Steering Committee meetings without reaching consensus, at the conclusion of the activities of second meeting, the Project Team and shall resolve any issues referred to decision will be made by MTC. In addition, if the Steering Committee by has been unable to reach consensus on a material matter for 30 days since such matter was brought to the Project Team. Each Party attention of the Steering Committee for any reason, including failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the right to substitute its decide such matter. MTC shall also have the right to make decisions on those matters that MTC reasonably believes are not material or to make decisions after consulting with one or more members of the Steering Committee as needed from time whose Participating City may be disproportionately (or solely) affected by such decisions. In no event shall MTC have the right to time by giving written notice to make any of the other Party due time decisions enumerated in advanceSection 33. 4.5 A party shall convey all communications and documents intended for the Steering Committee through that party’s designated representative. The Steering Committee shall meet within [...***...] after receipt of convey all communications and documents intended for a written request by one Party party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes that party’s designated representative. 4.6 Decisions to be decided. Each Party made by Steering Committee shall bear its own costs associated with meetings and communications include, but are not limited to: 4.6.1 Whether Operator is in Default, under Section 18 of the Steering Committee. The Steering Committee will take action by unanimous consent Program Agreement; Agreement; Agreement.‌ 4.6.2 KPI Adjustments, as described in Section 2.6.2(a) of the PartiesProgram 4.6.3 Title Sponsorship approval, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all as described in Section 7.1 of the representatives. If Program 4.7 All decisions made by the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached or by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers MTC in accordance with this Section 2.2.3. The members of 4 shall be binding on the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3Participating Cities.

Appears in 2 contracts

Sources: Coordination Agreement, Coordination Agreement

Steering Committee. The Parties Within 30 days of the execution of this Agreement, LTX and Ando shall form establish a joint steering committee (the "Steering Committee"), to which consisting of four representatives of LTX and four representatives of Ando. One of each Party will appoint three (3) executive employees, including the Project Managers, all of whom party's representatives shall be familiar appointed Chairman by each party in its sole discretion, and such Chairman shall be charged with formally making any decision of the ProjectSteering Committee representing LTX or Ando, as the case may be. Each Steering Committee member will serve at the pleasure of the party designating such member and may be replaced, with or without cause, at any time by the designating party, effective upon notice to the other party. The Steering Committee shall have general oversight be responsible for strategic management decisions concerning the Fusion Division and review strategic operating decisions under this Agreement which shall be reasonably made based upon reasonable allocation of the activities resources in light of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advancemarket conditions for such business. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to also review the other Party. The request shall describe organizational structure and management personnel for the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering CommitteeFusion Division. The Steering Committee will take action shall be governed by unanimous consent of the Parties, with the representatives of BII collectively having a single vote operating procedures to be mutually agreed to by LTX and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will Ando which LTX and Ando shall use good faith their best efforts to resolve such matter, and agree to within 30 days after the decision reached by mutual agreement execution of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Partiesthis Agreement; provided, however, that, that in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no the event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee cannot make a strategic management or operating decision as a result of a "deadlock", LTX and Ando agree that the matter shall be provided to each party's respective President, and such Presidents shall attempt, in good faith, to resolve the matter. In the event the Presidents are set forth in Appendix 3 attached heretounable or unwilling to resolve such matter within * Confidential treatment requested as to certain portions thereof. The confidential portion has been omitted and filed separately with the Commission. a reasonable time period, which may the strategic management or operating decision shall not be updated from time to time to reflect changes in undertaken by the Fusion Division. The Steering Committee as provided in this Section 2.2.3shall then meet to discuss mutually acceptable alternatives.

Appears in 2 contracts

Sources: Fusion Agreement (LTX Corp), Fusion Agreement (LTX Corp)

Steering Committee. The Parties shall form establish a steering committee which will be responsible for overseeing the Development Plan, including without limitation (i) the monitoring of progress against the Development Plan, (ii) the oversight of any clinical studies to be performed pursuant to the Development Plan, (iii) the review and approval of amendments to the Development Plan, and (iv) regulatory developments relating to any Product (“Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project”). The Steering Committee shall will be comprised of two (2) representatives from Actavis and two (2) representatives from Merrimack. Each Party will have general oversight and review the right to replace any of its representatives by written notice to the activities of the Project Team and shall resolve any issues referred other Party. Neither Party may designate a non-employee to be a representative. The Steering Committee will make decisions by unanimous consent with each Party having one vote. In making decisions, the Steering Committee will consider the interests of both Parties and will act in good faith in the interest of the Development Plan and the Product. In the event the Parties fail to agree upon any matter before the Steering Committee, such matter would be escalated to Actavis’ President of Global Generics (or his designee) and Merrimack’s President, Merrimack Healthcare Solutions (or his designee) for resolution by mutual agreement; provided that, if such matter is an intellectual property matter related to whether the Project Team. Each Finished Product or the process by which it is to be made would infringe the rights of a Third Party or a regulatory matter related to the Finished Product or any Additional Product (excluding the Bulk Product contained therein) and such officers are not able to resolve the matter within [**] days after such escalation, Actavis shall have final decision making authority with respect to such matter; provided such determination does not adversely affect Merrimack’s manufacture of the Bulk Product; and provided further that neither the Steering Committee nor such officers shall have the right to substitute its members of amend this Agreement or modify the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute Parties’ rights and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committeeobligations hereunder. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single votemeet every [**] months, or more or less frequently as reasonably agreed by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. IfMeetings will occur in person, (i) after good faith effortsvia teleconference or videoconference, the chief executive officers of the Parties are unable to resolve such matter or otherwise, as reasonably agreed by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event An Actavis representative will act as the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members chairperson of the Steering Committee are set forth in Appendix 3 attached heretoand will be responsible for taking minutes of each meeting. Such minutes will be circulated to the entire committee within [**] business days after each committee meeting, and comments, if any, will be promptly provided. If the committee members cannot agree on the minutes, the chairperson will have authority to finalize the minutes and the other committee members will have the right to note their specific objections, which may will be updated from time to time to reflect changes included in the Steering Committee as provided in this Section 2.2.3minutes.

Appears in 2 contracts

Sources: Development, License and Supply Agreement, Development, License and Supply Agreement (Merrimack Pharmaceuticals Inc)

Steering Committee. a. Each PARTY shall appoint up to two (2) representatives to serve as members of the STEERING COMMITTEE to direct the overall course of activities under this AGREEMENT. Decisions of the STEERING COMMITTEE shall require a unanimous vote. Chairmanship of the STEERING COMMITTEE shall rotate, beginning with a P&G representative, for twelve- (12) month periods. b. Subject to the oversight and approval of the PARTIES, the STEERING COMMITTEE shall be responsible for the following: (i) Overall direction of the DEVELOPMENT PLAN and each individual project thereof, including safety testing, staffing and other requirements for the DEVELOPMENT PLAN; (ii) Monitoring, updating and modifying, if necessary, the overall DEVELOPMENT PLAN; (iii) Scheduling and conducting biannual reviews, or such more frequent reviews as the STEERING COMMITTEE determines necessary; (iv) Recommending to the PARTIES the licensing of technology and/or intellectual property, if any, from third parties to enhance the DEVELOPMENT PLAN projects as needed; (v) Preparation and approval of the Success Criteria, consistent with the terms of this AGREEMENT; and (vi) Reviewing INVENTIONS made pursuant to this AGREEMENT with patent counsel, facilitating patent filings by the appropriate PARTY, and tracking of patent activities. c. Each PARTY shall notify the other within thirty (30) days after the EFFECTIVE DATE of the names of its STEERING COMMITTEE members. The Parties STEERING COMMITTEE shall form have no authority to modify or amend the terms of this AGREEMENT. Any dispute or issue that cannot be resolved by the STEERING COMMITTEE shall be referred to senior management of the PARTIES to be resolved by them, if possible. For purposes of this SECTION, "senior management" for P&G shall be Vice President, Research & Development, Global Beauty Care and President, Global Cosmetics & Skin Care and for GCI shall be Vice President, Research and Vice President, Enzyme Cleaning Products 12. CONFIDENTIALITY a. Disclosure of confidential and proprietary information hereunder by either PARTY to the other will be made in writing or other tangible form, or confirmed in writing within thirty (30) days of disclosure if made in nontangible form, will be clearly marked confidential and will include any confidential information provided to GCI, or P&G under the Non-Disclosure Agreement dated February 3, 2000. b. Such confidential information will be safeguarded by the receiving PARTY. The receiving PARTY shall protect the disclosing PARTY's confidential information against unauthorized disclosure using the same degree of care, but no less than a Steering Committeereasonable degree of care, as the receiving PARTY uses to protect its own confidential information of a like nature. Such confidential information will be used by the receiving PARTY only for the purpose of this AGREEMENT and will not be otherwise utilized or disclosed to third parties without first having obtained written consent of the disclosing PARTY, which each Party consent will appoint not be unreasonably withheld. Disclosing PARTY's confidential information will be made available only to such receiving PARTY's employees and AFFILIATES who have a need to know such information. Subject to the provisions of this SECTION these obligations of confidentiality will apply until the expiration of exclusivity or three (3) executive employeesyears from the termination of the AGREEMENT, including whichever is later. c. Obligations regarding confidential information received by either PARTY under the Project Managers, all provisions of whom SUBSECTION (b) above shall be familiar not apply to any such information that: i) becomes publicly available without default hereunder by the receiving PARTY; or ii) is lawfully acquired by the receiving PARTY from a source not under any obligation of confidentiality to the disclosing PARTY regarding disclosure of such information; or iii) is in the possession of the receiving PARTY in written or other recorded form at the time of its disclosure hereunder; or iv) is nonconfidentially disclosed to any third party by or with the Project. The Steering Committee shall have general oversight and review permission of the activities disclosing PARTY hereunder; or v) is developed by or on behalf of the Project Team and receiving PARTY by individuals who have not received confidential information hereunder. d. The obligations of confidentiality set forth herein further shall resolve not apply to any issues referred information to the Steering Committee extent that such information: i) is required to be disclosed by order of a court of law, provided that the Project Team. Each Party shall have the right to substitute its members receiving PARTY provides reasonable prior notice of the Steering Committee as needed from time to time by giving written notice such required disclosure to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a disclosing PARTY; ii) is used with the prior written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Partiesdisclosing PARTY which consent shall not be unreasonably withheld in applications for patents on INVENTIONS or in financial information in the usual conduct of business; or iii) has been approved in writing for publication by both of the PARTIES; or iv) is submitted to governmental agencies to facilitate the issuance of marketing approvals for materials and products, consistent with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties DEVELOPMENT PLAN hereunder provided that reasonable measures shall be final and binding on the Parties. If, (itaken to assure confidential treatment of such information; or v) after good faith efforts, the chief executive officers is product-related information which is reasonably required to be disclosed by either PARTY in connection with its testing or marketing of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that"relevant products", in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3PARTY's discretion.

Appears in 2 contracts

Sources: Commercialization Agreement (Genencor International Inc), Commercialization Agreement (Genencor International Inc)

Steering Committee. The In accordance with the terms and conditions set forth below, the commercial development of Licensed Products in the Field ("Development Work") will be conducted by or on behalf of the Parties pursuant to the mutually agreed development plan to be attached hereto as Exhibit A (the --------- "Development Plan"). Within ten (10) days after the Effective Date, each of the Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including persons to serve as its representatives on a joint steering committee (the Project Managers, all of whom shall be familiar with the Project. The "Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project TeamCommittee"). Each Party shall have the right to substitute change any or all of its members of representatives on the Steering Committee as needed from time to time by giving upon written notice to the other Party. The Steering Committee shall: (a) Establish the Development Plan, including without limitation milestones, go/no-go criteria, timelines and responsibilities, and ensure that each Party due time completes its respective work in advancecompliance with the Development Plan; (b) Monitor and make recommendations regarding the performance of the Development Plan and the conduct of the Development Work; (c) Propose modifications to the Development Plan; (d) Establish regulatory strategies; (e) Determine how Improvements should be incorporated into the Development Plan; (f) Determine whether to recommend that an Improvement be incorporated or that a New Product be developed, and if so whether such incorporation or development should occur in lieu of or in addition to the then-current activities with respect to existing Licensed Product(s); and (g) Review any and all proposed publications or communications relating to the Development Plan, and activities relating to an Improvement or a New Product, if applicable, and the results therefrom and any and all proposed filings of patent applications in connection therewith. The Steering Committee shall meet within [...***...] after receipt of a written request not less frequently than once per calendar quarter during the Development Period, on such dates and at such times as agreed to by the Parties. All decisions made or actions taken by the Steering Committee shall be made unanimously, with each Party entitled to one Party to the other Party(1) vote. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications A quorum of the Steering CommitteeCommittee shall consist of two members, provided that at least one member appointed by each Party is present. The Steering Committee will take action by unanimous consent Members of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on may attend a particular matter, then the matter will be referred to the chief executive officers meeting of the PartiesSteering Committee either in person or by telephone conference call, who will use good faith efforts to resolve such matterbut not by proxy. In the event of a deadlock vote regarding a matter before the Steering Committee, and the decision reached by mutual agreement of the chief executive officers Responsible Executives of the Parties shall be final and binding on meet to resolve the Partiesmatter. If, (i) after good faith efforts, If resolution of the chief executive officers matter is not achieved by the Responsible Executives of the Parties are unable within thirty (30) days of the deadlock vote, TGC shall have the right to resolve such matter by mutual agreement, and (ii) such matter concerns deadlock until the Product or start of the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Partiesfirst Phase II Clinical Trial; provided, however, thatthat Medeva shall have the right to resolve any deadlock with respect to the design and location of Phase II Clinical Trials and the determination of which Party shall be responsible to conduct such trials. Thereafter, in resolving such matter, XENCOR’s chief executive officer Medeva shall not have the right to resolve any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3deadlock.

Appears in 1 contract

Sources: License and Collaboration Agreement (Targeted Genetics Corp /Wa/)

Steering Committee. (a) The Parties shall form establish a Joint Steering Committee comprised of an equal number of representatives from Fresenius Kabi and Cerus (the “Steering Committee”), to which each Party will appoint three (3) executive employees, including members shall initially be the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. individuals identified on Exhibit E. The Steering Committee shall meet within [...***...at least twice per calendar year and shall have primary responsibility for providing oversight with respect to: (i) execution of the Business Continuity Plan; (ii) the overall stability and long-term viability of the Facility for purposes of enabling Cerus to evaluate its rights and obligations under [ * ]; (iii) [ * ] after receipt upon termination or expiration of a written request by one Party Cerus’ contractual commitments as described in Section 2.3(b) and (iv) the preparation of detailed project plans, including scope, roles and responsibilities, prioritization and timelines with respect to the other Party. The request shall describe Funded Projects. (b) In addition to the matter responsibilities set forth in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of Section 4.3(a), the Steering Committee. The Steering Committee will take action by unanimous consent of shall meet at least twice per calendar year to perform the Partiesfollowing tasks: AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (FRESENIUS KABI – CERUS) [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, with MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (i) Review and prioritize cost reduction initiatives, at which time, Cerus and Fresenius Kabi shall identify projects for implementation (if any), and estimate and allocate related costs (including, but not limited to, engineering time, operating and capital expenses), and risks and benefits. (ii) Review and prioritize New Products and product improvements, and anticipated changes. (c) In the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If event that the Steering Committee is unable to reach unanimous consent a decision on a particular matterany matter after [ * ] business days, then the matter decision will be referred escalated to the chief executive officers Chief Executive officer of Cerus and the designated member of the PartiesManagement Board of Fresenius Kabi (together, the “Business Heads”), who will use have an additional [ * ] business days to reach a mutually agreeable decision. If the Business Heads are unable in good faith efforts to resolve such matterreach resolution, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on submit the Partiesissue to an independent third party jointly selected by the parties for resolutions. IfThe parties shall jointly bear the costs, if any, of such third party. (id) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant and subject to Section 11.6 hereof with regard 2.2, (i) Fresenius Kabi shall be able, without Cerus’ consent (or Steering Committee involvement), to implement any projects or other process improvements that do not affect product specifications or registrations, provided that such projects or process improvements do not result in an increase in pricing, and (ii) Cerus shall not unreasonably withhold or delay its consent to initiate any projects or other process improvements that affect product registrations, provided that such projects or process improvements shall not be implemented without Cerus’ consent and approval until any required Regulatory Approvals are obtained. (e) For the avoidance of doubt, and subject to Sections 2.2 and 6.2, (i) Cerus shall be able, without Fresenius Kabi consent (or Steering Committee involvement), to implement any projects or other process improvements, provided that the parties shall negotiate in good faith any adjustment to pricing that may result from such projects or process improvements, and (ii) Fresenius Kabi shall not unreasonably withhold or delay its consent to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3new products or product design changes.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Cerus Corp)

Steering Committee. The Parties shall form 4.1 MTC and the Participating Cities agree to create and hereby establish a Steering CommitteeCommittee to coordinate the activities of the Program and make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from MTC, and one designated representative from each of the Participating Cities. Each party with a designated representative shall have the right to change its designated representative upon five (5) days written notice to the other parties. Each party with a designated representative may appoint an alternate representative that will have full voting rights as the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which each Party may be called at any reasonable time by any designated representative. A Steering Committee meeting or teleconference cannot be held unless a majority of the designated representatives, or alternates in their absence, are present or available by telephone. Designated representatives and any staff of a party may attend meetings in person or by teleconference. An absent designated representative may vote by giving a written proxy to another designated representative. 4.4 The goal of the Steering Committee will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Projectto reach decisions by a unanimous vote. The Steering Committee shall have general oversight and review endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at two Steering Committee meetings without reaching consensus, at the conclusion of the activities of second meeting, the Project Team and shall resolve any issues referred to decision will be made by MTC. In addition, if the Steering Committee by has been unable to reach consensus on a material matter for 30 days since such matter was brought to the Project Team. Each Party attention of the Steering Committee for any reason, including failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the right to substitute its decide such matter. MTC shall also have the right to make decisions on those matters that MTC reasonably believes are not material or to make decisions after consulting with one or more members of the Steering Committee as needed from time to time whose Participating City may be disproportionately (or solely) affected by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreementdecisions. In no event will shall MTC have the Steering Committee, or the executive officers right to make any of the Parties decisions enumerated in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section 33. 4.5 A party shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of convey all communications and documents intended for the Steering Committee through that party’s designated representative. The Steering 4.6 Decisions to be made by Steering Committee shall include, but are set forth not limited to: 4.6.1 Whether Operator is in Appendix 3 attached heretoDefault, which may be updated from time to time to reflect changes under Section 18 of the Program 4.6.2 KPI Adjustments, as described in Section 2.6.2(a) of the Program 4.6.3 Title Sponsorship approval, as described in Section 7.1 of the Program 4.7 All decisions made by the Steering Committee as provided or by MTC in this Section 2.2.3.accordance

Appears in 1 contract

Sources: Coordination Agreement

Steering Committee. The 18.1. In order to permanently favor dialogue and to permit each of the Parties shall form to satisfy the obligations stipulated in the agreement, the Parties have decided that a steering committee (the “Steering Committee”) will be set up as soon as the agreement is signed, whose task it will be to: a) draft a quarterly report on the implementation of the agreement. b) amicably resolve any dispute which may arise among the Parties regarding the validity, interpretation or execution of the agreement c) handle in the interest of both parties the consequences of any force majeure event on the execution of the agreement d) propose to which each Party will appoint three (3the Mediation Board any proposed amendment to the terms and conditions of this agreement e) executive employeesagree upon the annual change in costs as discussed in Article 12. f) manage the evolution of toll prices, including both for their impact on the Project Managerspurchase of raw materials and on the toll drying services rendered. In this respect, all the Steering Committee shall act as the first level of whom shall be familiar with recourse for the Projectresolution of problems arising from the execution of the agreement. The Steering Committee shall have general oversight and review be comprised of 2 members, designated by each of the activities Parties. Each Party may be accompanied, for consultation purposes, by associates of their choice, subject to approval by the Project Team and other Party. This Steering Committee will be obligated to meet at least once a quarter and, in any case shall resolve any issues referred to meet whenever one or the other of its members considers it necessary in light of its abovementioned mission. No meeting of the Steering Committee by shall be held without at least one member of the Project TeamCommittee representing each of the two Parties being present. Each The decisions of the Steering Committee shall be made unanimously, with each Party having one vote. The decisions of the Steering Committee shall have apply immediately; the right Parties expressly commit to substitute its this, subject to the dispositions given below. Failing agreement within the Steering Committee, the members of the Steering Committee as needed from time Committee, after a second meeting to time by giving written notice consider the subject matter, shall declare the Steering Committee’s failure to the other Party due time fulfill its mission. The mediation procedure discussed in advanceArticle 19 below will then be invoked. 18.2. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party may create an operational technical committee whose members it will designate, so as to the other Party. The request shall describe the matter handle in dispute an operational manner any issues related to delivery schedules, quality, Contract Specifications and the solution which the requesting Party proposes to be decidedtreatment of Whey compliances. 18.3. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the PartiesOnce a year, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then shall meet with the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time operational technical committee to time to reflect changes in draft a report on the Steering Committee as provided in this Section 2.2.3implementation of the agreement.

Appears in 1 contract

Sources: Whey Supply Agreement (Synutra International, Inc.)

Steering Committee. The Parties shall form ▇▇▇▇▇▇ ▇▇▇▇▇▇ and Investor Parent hereby establish a Steering Committee (the “Steering Committee”), which shall consist of up to which each Party will appoint six (6) members, up to three (3) executive employees, including the Project Managers, all of whom which shall be familiar with the Project. The Steering Committee designated by ▇▇▇▇▇▇ ▇▇▇▇▇▇ and up to three (3) of which shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee be designated by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advanceInvestor Parent. The Steering Committee shall meet within [...***...] after receipt to discuss and review issues of a written request commercial, financial and technical nature concerning the Project, including the work being performed by one Party the Consulting Firm as set forth in this Agreement and matters with respect to risks, Permits, technical assurance to the other Party. The request shall describe the matter in dispute Consolidated Project Budget and the solution which the requesting Party proposes Project Work Plan. Any material contract proposed to be decidedentered into or amended by the Company or any of its Subsidiaries or otherwise relevant to the Project and any proposed material changes to the Project, the Mine Plan of Operations submitted to the BLM on July 15, 2022, the Consolidated Project Budget, the Project Work Plan, or the Project schedule, construction and execution plans will be discussed in the Steering Committee and ioneer Parent shall consider in good faith any matters related thereto and comments thereon raised by Investor Parent and representatives of Investor Parent. Each Party shall bear its own costs associated with meetings and communications member of the Steering Committee. The Steering Committee will take action by unanimous consent shall be permitted to conduct at least four site visits per year at reasonable intervals of the Parties, with the representatives of BII collectively having a single vote time and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred upon reasonable advance notice to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the PartiesCompany; provided, however, that, in resolving that such matter, XENCOR’s chief executive officer site visits may be conditioned upon such Steering Committee members executing any applicable liability waivers or other documents reasonably requested by the Company and complying with all applicable policies and procedures of the Company with respect to site visitors. The Steering Committee shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated meet (including remotely) at least on a monthly basis unless otherwise agreed by this Agreementioneer Parent and Investor Parent. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard addition to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members regularly scheduled meetings, any member of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in call a meeting of the Steering Committee on no less than 72 hours’ advance notice. The Steering Committee shall be disbanded upon the Closing.” (o) The first sentence of Section 5.17 of the Agreement is hereby amended and restated in its entirety as provided follows: “Investor shall file or cause to be filed with the United States Federal Trade Commission (“FTC”) and the Antitrust Division of the United States Department of Justice (“DOJ”) a Notification and Report Form relating to this Agreement and the transactions contemplated by this Agreement as required by the HSR Act no later than June 30, 2023.” (p) Article V of the Agreement is hereby amended by adding new Section 5.20, Section 5.21, Section 5.22 and Section 5.23, which shall appear in this their respective corresponding location immediately following Section 2.2.3.5.19 of the Agreement, and which shall read as follows:

Appears in 1 contract

Sources: Unit Purchase and Subscription Agreement (Ioneer LTD)

Steering Committee. The Parties shall form have formed a Steering Committee, to in which each Party will appoint three has appointed [*] executive employees as such Party’s members of the Steering Committee (3) executive employees, including the Project Managers“Members”), all of whom shall be familiar with and have responsibility for oversight of the Projectactivities under this Agreement. Each Party may with written notice to the other Party, change one or more of its Members appointed to the Steering Committee. The Steering Committee shall have general oversight and review of the activities of the Project Team and results under this Agreement and shall be the initial forum for seeking to resolve any issues referred to the Steering Committee by the Project Teameither Party or both. Each Party shall have the right to substitute its members of Specifically, but without limitation, the Steering Committee shall seek in good faith to resolve any disputes or issues regarding the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as needed from time to time by giving written notice to the other Party due time in advanceamended. Commercial Supply Agreement, BI/ VERSARTIS Execution Version manufacturing schedule or manufacturing processes for Drug Substance and/or Drug Product. The Steering Committee shall meet meet, in person or via teleconference or video-conference, on a reasonably regular basis, as planned and agreed by the Steering Committee Members, and in any event within [...***...] calendar days after receipt of a written request for such a meeting by one Party to the other Party. The request shall describe the matters or issues to be discussed, including any matter in dispute dispute, and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of may invite other employees to attend the Steering CommitteeCommittee meeting from particular departments/areas of expertise as may be necessary to discuss the agenda topics, or matters or issues in dispute. The Any action or decision by the Steering Committee will take action shall be taken by unanimous consent of the PartiesSteering Committee, with the representatives Members of BII collectively having a single vote and the representatives of XENCOR each Party collectively having a single vote, or by a written resolution signed by all of the representativesMembers. If the Steering Committee is unable to reach unanimous consent on a particular mattermatter or issue being discussed by the Steering Committee, then the matter or issues will be referred by each Party to the chief executive officers a responsible member of the Partiessenior management to be designated by each Party, who will use good faith efforts to resolve such matter, and the decision reached matter or issue. If such matter is not resolved by mutual agreement of the chief executive officers of the Parties officers, then arbitration shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant used according to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.314.8. The members Members of the Steering Committee of the Parties are set forth in Appendix 3 6 attached hereto, which may be updated amended from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3any changes.

Appears in 1 contract

Sources: Commercial Supply Agreement (Versartis, Inc.)

Steering Committee. 5.1 The Parties shall form Steering Committee oversees the Development and Commercialising of the Licensed Product in the Territory and the success of the collaboration between AEZS and CH, and provides a forum for communication and consultation between the Parties. The tasks of the Steering CommitteeCommittee include: (i) regularly informing CH about the status of and consulting with CH in relation to progress with the PCT and related activities, and keeping CH (a) informed about all commercial activities in other territories outside of the Territory about which AEZS has information, and (b) fully appraised of any ongoing development of the Licensed Product or any therapeutic product containing the same active ingredient as the Licensed Product; in each case provided that this information can be shared by AEZS with CH without infringing any confidentiality obligation in existence as at the Effective Date. Where AEZS is under a confidentiality obligation as at the Effective Date which would prevent it sharing the relevant information with CH it will seek consent from the relevant third party to share such information with CH (it being acknowledged that whilst AEZS will use all reasonable endeavours to persuade the relevant third party to give such consent, this cannot be guaranteed); (ii) regularly providing AEZS with information and an overview of the Commercialisation of the Licensed Product in the Territory including the status of pricing and reimbursement negotiations and approvals on a country and country basis; (iii) regularly exchanging a copy (in electronic format, where possible) of all promotional materials, including sales representative training materials, sales literature and brochures, used by AEZS or by or on behalf of CH to promote the Licensed Product; (iv) reporting on progress against the Business Plan; (v) reviewing time frames for the completion of the PCT and for submission of applications for and status of Regulatory Approvals etc.; and (vi) coordinating patents and other IPR applications regarding Joint Inventions and/or improvements. 5.2 The Steering Committee may establish sub-committees, which, e. g., are responsible for Commercialisation and for co-ordination of Regulatory activities (each of which would be chaired by CH), and for the Development, for IPR and/or for the supply of Licensed Product (each Party will appoint of which would be chaired by AEZS). 5.3 The Steering Committee consists of an equal number (up to three (3) executive employees, including the Project Managers, all per Party) of whom shall be familiar with the Projectrepresentatives of AEZS and representatives of CH. The representatives in the Steering Committee are to have the necessary experience, expertise and seniority in order to address all strategic questions, which the Steering Committee is to deal in accordance with Section 5.1. Each Party may invite guests to the meetings, in order to discuss special technical or commercial topics. A chairman for each meeting of the Steering Committee shall have general oversight be appointed on an alternate basis, whereby AEZS designates the chairman for the first meeting, the chairman for the second meeting shall be designated by CH, and review chairman for each subsequent meeting shall alternate between the Parties. A secretary of the activities of the Project Team and shall resolve any issues referred to the Steering Committee shall be appointed on an alternate basis, whereby CH designates the secretary for the first meeting, the secretary for the second meeting shall be designated by AEZS, and the Project Teamsecretary for each subsequent meeting shall alternate between the Parties. The secretary is responsible for scheduling the quarterly meetings, the distribution of documents before the meetings and the minutes of the meetings. Each Party shall have the right to substitute call for an extraordinary meeting. The Party, on whose request the extraordinary meeting is being held, will send relevant information and an agenda for such meeting to the other Party and to each member of the Steering Committee. 5.4 The Steering Committee meets for the first time as soon as reasonable after the Effective Date (but not later than January 2021) and afterwards as needed, in order to fulfil its members tasks, however, at least calendar-quarterly. The meetings of the Steering Committee as needed from time to time may take place by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decidedteleconference, videoconference or face-to-face, whereby at least two (2) meetings per year ideally should take place face-to-face. Each Party shall bear may call for an extraordinary meeting of the Steering Committee up to two (2) times per calendar year with fifteen (15) days advance notice. The meeting place alternates between the company seats of the Parties, unless they agree otherwise. Each Party bears its own costs associated cost in connection with meetings and communications the work of the Steering Committee. The . 5.5 All decisions of the Steering Committee will take action by unanimous consent are to be made in good faith and in the best interest of the PartiesAgreement, with shall be reflected in the representatives minutes of BII collectively having a single vote the relevant meeting and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of Parties shall use their reasonable efforts to take decisions unanimously. In the representatives. If event that the Steering Committee is unable to reach unanimous consent agree on a particular matter, then the any matter will be referred to the chief executive officers of the Parties, who will use after good faith efforts attempts to resolve such matterdisagreement in a commercially reasonable fashion, then either Party may refer the disagreement to a personal face-to-face meeting between the Chief Executive Officer of AEZS (or another appropriate representative of AEZS) and the decision reached by mutual agreement Chief Executive Officer of CH (or another appropriate representative of CH) which meeting shall take place within fourteen (14) days of the chief executive officers date of the Parties shall be final and binding on the Partiesrelevant referral. IfIf these persons are not able to resolve such disagreement in a mutually acceptable manner within a further fourteen (14) days after such face-to-face meeting, then: (i) after good faith effortsfor or in respect of any decisions which relate to the IPR or the Development of the Licensed Product (including conducting the PCT) or matters outside of the Territory, the chief executive officers vote of AEZS with appropriate consideration of the Parties are unable to resolve such matter by mutual agreement, interests of CH shall be decisive; and (ii) such matter concerns for decisions on all other matters (including for or in respect of the Commercialisation and/or the Regulatory Approval procedures in respect of the Licensed Product or in the ProcessTerritory), but does not concern the BI Facility or the management vote of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith CH with appropriate consideration of BII’s position, which decision the interests of AEZS shall be final and binding on decisive. The decisive vote of AEZS or CH (as the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall case may be) may not have lead to a financial burden of CH or AEZS respectively or amend or conflict with any authority of the express terms of or override the rights of the Parties pursuant to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers It is acknowledged that any decision of the Parties in resolving JSC (including any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification decisive vote of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings CH pursuant to Section 11.6 hereof with regard this Section) in relation to any matters other than matters resolved by mutual agreement a change of the chief executive officers in accordance with this Business Plan shall not be deemed to reduce CH’s obligations under Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.314.1.

Appears in 1 contract

Sources: License Agreement (Aeterna Zentaris Inc.)

Steering Committee. The Parties 23.1 Within thirty (30) days following the Effective Date the parties shall form a establish the Steering Committee, to which each Party will appoint three (3) executive employees, including . 23.2 The membership of the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review be comprised of the activities two representatives of the Project Team and shall resolve any issues referred each party. 23.3 Each party may, from time to time, replace those members appointed by it to the Steering Committee by at will and upon notice to the Project Team. other party. 23.4 Each Party party shall have ensure that the right to substitute its members of the Steering Committee appointed by it, and present on the Steering Committee, are at all times suitably skilled, willing, available and qualified to undertake their roles as needed members thereof, as such roles may change over time, and shall remove from the Steering Committee, and promptly replace, any of them who is not, or otherwise provide them with such training or other assistance as may be required such that they are so skilled, willing, available and qualified as soon as reasonably practicable. 23.5 Notwithstanding clause 23.4, if the members of the Steering Committee reasonably object to the inclusion in the membership of the Steering Committee of any person, they may remove him with immediate effect if a majority of the members decide that he/she should be removed. 23.6 The Steering Committee shall be responsible for overseeing the general working relationships under this agreement and the performance of the Process, Manufacturing and Supply Committee. In particular, the responsibilities of the Steering Committee shall include: (a) Resolving disputes arising from: (i) the Process, Manufacturing and Supply Committee; and (ii) matters which are specifically expressed in the MSA to be subject to resolution by the Steering Committee; (b) Appointing additional committees and/or working groups from time to time as may be agreed by giving written notice the Steering Committee as necessary to facilitate the working of this agreement; (c) Maintaining a good working relationship between the parties and providing guidance to the Alliance Managers on their respective roles and actions under this agreement; and (d) Any other Party due time in advance. matters which this agreement requires to be resolved or managed by the Steering Committee. 23.7 The Steering Committee shall meet within [...***...] after receipt where and when it determines, provided that: (a) each of its meetings shall be at a written request location reasonably accessible to all its members; (b) its members shall be entitled to attend its meetings by one Party telephone and that suitable telephone facilities are present at its meetings to enable this; (c) it shall meet no less than once every six (6) months, the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes first meeting to be decided. Each Party shall bear its own costs associated with meetings and communications within six (6) months of the Steering Committee. Effective Date, and otherwise within a reasonable time to determine any matter referred to it; and (d) it shall meet on no less than two (2) weeks' notice to all its members sent to each member in such manner as he/she may have reasonably specified or otherwise by fax or first class post (and for these purposes the provisions of clause 22.3 shall apply mutadis mutandis). 23.8 The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representativesshall discharge its functions set out in clause 23.6 in such manner as it reasonably sees fit. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties All decisions shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter made by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members vote of the Steering Committee are set forth in Appendix 3 attached heretomembers, which may be updated from time to time to reflect changes in if quorate, with each of Protherics and the Licensee having one vote. The Licensee shall have a casting vote. 23.9 The Steering Committee shall determine its own quorum, provided that this shall always include at least one representative of each of Protherics and the Licensee. 23.10 All decisions of the Steering Committee as provided in this Section 2.2.3.shall be notified to the Alliance Managers within five (5)

Appears in 1 contract

Sources: Patent and Know How Licence Agreement (Protherics PLC)

Steering Committee. The (a) Within thirty (30) days after the date of this Agreement, the Parties shall form a Steering Committee, to which Committee consisting of an equal number of representatives of each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the ProjectParty. The Steering Committee shall have general oversight authority over the strategic direction and review overall management of the activities of the Project Team Product Development Plan and shall resolve any issues referred operate and have the further authority described in this Section 4.2. (b) ACTII and Amylin shall each appoint three (3) representatives as their representatives to serve on the Steering Committee by the Project TeamCommittee. Each A Party shall have the right to substitute may change its members of the Steering Committee as needed representatives from time to time by giving written notice to the other Party due time in advance. Party. (c) The Steering Committee shall generally meet within [...***...] after receipt at such times as it may decide and at least once per calendar quarter. The location of Steering Committee meetings shall alternate between ACTII's offices and Amylin's offices unless otherwise agreed by the Parties, with the first meeting being held at Amylin's office. Minutes of a written request meeting setting forth decisions of the Steering Committee shall be prepared by one the Party hosting the meeting. Minutes will become official when agreed to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications by all members of the Steering Committee. The Each Party will bear all expenses associated with attendance of its representatives at meetings. If the Steering Committee will take action members all agree, a meeting may be held by telephone. * CONFIDENTIAL TREATMENT REQUESTED (d) Decisions of the Steering Committee shall be made by unanimous consent of the Partiesvote, with the representatives of BII collectively each member having a single vote and the representatives of XENCOR collectively having a single one vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach a unanimous consent vote on a particular matterany issue, then the matter will issue shall be referred to the chief executive officers President of the Parties, who will use good faith efforts to resolve such matterACTII (or successor position), and the decision reached by mutual agreement Vice President of Corporate Development of Amylin (or successor position) for resolution. These individuals shall, as soon as practicable, attempt in good faith to decide the chief executive officers of issue. If the Parties issue is not decided within fifteen (15) days after it has been referred to such individuals, it shall be final and binding on the Parties. Ifreferred to Amylin's Chief Executive Officer (or successor position), (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR who shall make the final decision about how regarding such issue. (e) Within fifteen (15) days after the receipt of the proposed Product Development Plan or any amendments thereto from the Project Working Team or any appeals of decisions of the Project Working Team, the Steering Committee shall meet to resolve consider approval of such disputeplan or amendments, after good faith consideration or appeal of BII’s positionsuch decision, which decision as applicable. The Steering Committee shall be final periodically review the Product Development Plan from a strategic perspective, the status of efforts to implement it and binding on to make any changes to it that it deems necessary to accomplish the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by purpose of this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any The Steering Committee matter, have shall also settle any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For disputes among the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3Project Working Team.

Appears in 1 contract

Sources: Development and License Agreement (Amylin Pharmaceuticals Inc)

Steering Committee. Columbia shall make all decisions with respect to the strategy for the marketing and promotion of the Products. However, other issues may arise under the terms of this Amended and Restated Sales Force Work Order or between the parties while operating under this Amended and Restated Sales Force Work Order which are appropriate for consultation between the parties to ensure maximum productivity of the Innovex Sales Force, including, but not limited to, the establishment of work rules or the response to greater than expected Innovex Sales Force turnover or lower than expected Innovex Sales Force performance, and other changing market conditions. The Parties shall form parties shall, therefore, establish a Steering Committee, chaired by Columbia and consisting of up to which each Party will appoint three (3) executive employeesmembers from each party. The chairperson’s duties shall include site selection, including logistics, agenda and facilitation; provided however, that an Innovex Committee member may submit agenda items to the Project Managers, all of whom Chair and such items shall be familiar with included in the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications next regular meeting of the Steering Committee. The Steering Committee will take action by unanimous consent of the Partiesinitial Innovex members are ▇▇▇▇ ▇▇▇▇, with the representatives of BII collectively having a single vote ▇▇▇▇▇ ▇▇▇▇▇▇▇, and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter▇▇ ▇▇▇▇▇▇▇, and the decision reached by mutual agreement initial Columbia members are ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ (chair), ▇▇▇ ▇▇▇▇▇▇, and ▇▇▇▇ ▇▇▇▇▇▇. A member of the chief executive officers Committee may be removed and replaced at any time, with or without cause, and replaced by the party that appointed such member. The Committee shall meet at least monthly, or otherwise at the call of the Parties shall be final chairperson to review, coordinate, and binding on discuss issues regarding the PartiesProject. If, (i) after good faith effortsIn addition, the chief executive officers of the Parties are unable Committee shall review and attempt to resolve such matter by mutual agreement, issues pertaining to this Amended and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3Restated Sales Force Work Order. The members of the Steering Committee are set forth in Appendix 3 attached heretowill use reasonable efforts to reach consensus on all decisions. For decisions concerning the day-to-day operations of the Re-Aligned Sales Force (such as discretionary spending for promotional expense monies, incentive compensation payments, revision of Sales Force responsibilities), for which may be updated from time to time to reflect changes in the Steering Committee cannot reach consensus, the chair shall cast the deciding vote. Notwithstanding anything else to the contrary, the Steering Committee shall have no authority to alter the basic economic terms of this Amended and Restated Work Order, including the pricing terms, the number of members of the Innovex Sales Force, and the Project End Date. In Witness Whereof, Columbia and Innovex have each caused this Amended and Restated Sales Force Work Order #8795 to be duly executed on their behalf by their authorized representatives and made effective as provided of Effective Date of Work Order appearing above. COLUMBIA LABORATORIES, INC. INNOVEX, INC. /S/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ /S/ ▇▇▇▇▇▇▇ ▇ ▇▇▇▇ By: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ By: ▇▇▇▇▇▇▇ ▇ ▇▇▇▇ Title: President & CEO Title: President Date: January 26, 2004 Date: January 26, 2004 Salary, including payroll taxes, for Innovex Sales Representatives, Innovex Field Coordinators and the Innovex National Field Coordinator. Incentive compensation for Innovex Field Coordinators, compensation for the Innovex National Field Coordinator. X Incentive compensation (bonus) for Innovex Sales Representatives, plus [***] X Benefits package, including (401k), medical, dental, Rx, vacation, holidays X Auto Costs in this Section 2.2.3Territory, including monthly allowance, mileage reimbursement, parking and tolls. X Basic Business Expenses in Territory, including phone, paper supplies, postage and voice mail. X Business Cards & Detail Bags for Innovex Sales Force members X Call Reporting; SFA X Computers for Innovex Sales Representatives, including software, helpdesk support, data/replication lines X Computers for FCs, NFC, including software, helpdesk support, data/replication lines X Infrastructure support (operations, HR, finance, legal) X Liability Insurance: employment, workers comp, E & O, CGL, auto X Recruitment and re-recruitment, includes drug screens, background and motor vehicle checks X Meetings: Columbia national, regional and district meetings; product launches X Access Money, Lunch and Learn and Speaker Programs X Promotional Program and Promotional Materials (sales aids) X Promotional marketing expenses, including sales data X Training program, materials and facilities; initial and follow-up X Travel Expenses (air, hotel, meals, T&E) for Innovex Sales Representatives, Innovex Field Coordinators, and the Innovex National Field Coordinator * Interviewing * Territory travel for field management purposes X This Request for Additional Innovex Sales Representative is issued pursuant to the Master Sales Services Agreement between Columbia and Innovex LP, dated as of July 31, 2002, and Amended and Restated Sales Force Work Order #8795, dated as of January 16, 2004. PART 1 To be completed by Columbia Attach any relevant, helpful information PART 2 To Be Completed by Innovex Innovex shall respond within ten (10) business days after receipt of the Additional Innovex Sales Representatives Request.

Appears in 1 contract

Sources: Sales Contracts (Columbia Laboratories Inc)

Steering Committee. (a) The Parties shall form establish and maintain throughout the term of this Agreement a committee (the “Steering Committee, ”) to which each Party will appoint three (3) executive employees, including oversee the Project Managers, all implementation and operation of whom shall be familiar with the Projectthis Agreement. The Steering Committee shall have general oversight and review consist of the activities of the Project Team and four people. Seller shall resolve any issues referred be entitled to the Steering Committee by the Project Team. Each Party shall have the right to substitute its appoint two members of the Steering Committee as needed from time and Buyer shall be entitled to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications appoint two members of the Steering Committee. The Steering Committee will take action by unanimous consent initial members of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matterappointed by Seller shall be the Managing Director of Europe, then Africa and The Middle East and the matter will be referred to the chief executive officers Director of the Parties, who will use good faith efforts to resolve such matterU.S. Sales of Seller, and the decision reached by mutual agreement initial members of the chief executive officers Steering Committee appointed by Buyer shall be the Category Manager — Proppants and the Vice President of Production Enhancement of Buyer. Seller shall be entitled to remove and replace at any time one or more of the Parties members of the Steering Committee appointed by Seller and Buyer shall be final entitled to remove and binding on the Parties. If, (i) after good faith efforts, the chief executive officers replace at any time one or more of the Parties members of the Steering Committee appointed by Buyer. (b) The Steering Committee shall oversee the implementation and operation of this Agreement with the purpose of ensuring that each Party’s relevant interests, as summarized in the Recitals to this Agreement, have and are unable to resolve such matter by mutual agreement, and (ii) such matter concerns being addressed in a satisfactory manner consistent with the Product or broad principles of cooperation underlying the Process, but does not concern the BI Facility or the management execution of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will If and to the extent the Steering CommitteeCommittee determines that such relevant interests are not being addressed in a fully satisfactory manner as contemplated herein, or then they will attempt to agree on what action, if any, is required in view of their joint determination. Without limiting the executive officers of foregoing, the Parties in resolving any Steering Committee matter, have any authority shall meet to amend or modify discuss: A. Product purchase prices under this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8 B. Product lead times C. Payment issues (past due, credit holds, etc) D. Discuss pertinent end customer information 1. Input from end customers relating to the Products 2. Discuss end customer service issues and opportunities E. Marketing & sales information F. Evaluate and discuss market status and strategy G. Delivery performance H. Foreign Corrupt Practices Act and OFAC Compliance issues For the avoidance of doubt, nothing in this Section shall prevent any each Party from seeking arbitration proceedings pursuant will retain independent pricing authority and will determine on its own the pricing for its sales of Products to Section 11.6 hereof with regard to any matters other than matters resolved third parties. (c) Unless otherwise agreed by mutual agreement the Parties, through their representatives on the Steering Committee, until the first anniversary of the chief executive officers in accordance with this Section 2.2.3. The members of Effective Date, the Steering Committee are set forth in Appendix 3 attached heretoshall meet monthly at a mutually agreed date and location to review the Parties’ performance under this Agreement. Following the first anniversary of the Effective Date, which may be updated from time to time to reflect changes in the Steering Committee shall meet as provided agreed upon by the Parties, through their representatives on the Steering Committee, but in this Section 2.2.3no event shall the Steering Committee meet less than quarterly.

Appears in 1 contract

Sources: Proppant Supply Agreement (Carbo Ceramics Inc)

Steering Committee. 2.6.1 A Steering Committee composed of two representatives who are employees of each Party (beginning with [*] and [*] from Firmenich and [*] and [*] from Amyris, any of whom can be substituted at any time in the sole discretion of their respective employer, Firmenich or Amyris) will meet quarterly until the Termination Date of the last Commercialization Program or as otherwise mutually agreed by the Parties. Additional employees of either Party may attend and participate in discussions at Steering Committee meetings with the prior approval of the other Party. The Parties shall form a role of the Steering Committee will extend through the Supply Agreement and accordingly will be to set the overall strategy and business direction of each of the Projects. The Steering Committee's role, in addition, will be to which ▇▇▇▇▇▇ a spirit of collaboration between the Parties and oversee and coordinate each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the ProjectParty's activities to optimize capital efficiency. The Steering Committee shall have general oversight will be responsible for review and approval, subject to the terms of section 2.6.3 below, of selection of Commercial Strains, Ingredients, Work Plans (and any change to it requiring an increase in the then current Budget for that Project), Target Cost, Target Cost Model, Budgets, Regulatory Plan, Start Up Plan, the Collaboration portfolio of Projects, whether and how to transform an Intermediate into an Ingredient in accordance with section 3.11, commercialization strategy (marketing and distribution) and manufacturing strategy for the Intermediates and Ingredients (including capital expenditure, manufacturing location and proposed manufacturer for the Intermediates and Ingredients, as the case may be), as well as conferring with the Technical Committee on resourcing. The Steering Committee will also be responsible for final approval of resourcing and for resolving any disputes of the Technical Committee where there is a deadlock. Firmenich (and, at Firmenich's request, Amyris) will nominate new Projects and present the business case for proceeding with such Projects to the Steering Committee. In addition, the Steering Committee will review the anticipated Ingredient Price, and Firmenich Production and Commercialization Costs at least quarterly and review of the activities of Maximum Annual Production Cap and recommend changes as necessary. The Steering Committee will perform such other duties and functions as may be assigned to the Project Team and shall resolve any issues referred Steering Committee in this Agreement or later assigned to the Steering Committee by written agreement of the Project TeamParties. Each The Steering Committee chairman shall initially be [*], and the chairmanship will rotate between the Parties annually with a new chairman to assume such position after each one year term of office. 2.6.2 All decisions by the Steering Committee will be made by consensus, with one vote cast by each Party (subject to the following). A quorum of one representative from each Party will be required for every meeting. The chairperson of the Steering Committee is responsible for preparing and circulating draft minutes after each meeting for approval at the next meeting. The Steering Committee will, at that meeting, resolve any areas of disagreement or ambiguity if they are unable to fully concur with the draft minutes. The chairperson will within ten (10) days circulate the revised minutes for approval, and if the Steering Committee still fail to agree, the Steering Committee will meet by teleconference or otherwise within the following five (5) days, with the process repeated until the Steering Committee agrees on the final written minutes, which shall have the right to substitute its be signed or acknowledged by all members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3.

Appears in 1 contract

Sources: Collaboration Agreement (Amyris, Inc.)

Steering Committee. The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project. 6.1 The Steering Committee shall have general oversight and review of the activities be composed of the Project Co-ordinator, his Deputy, the Administrative Manager and all Work Package Leaders. 6.2 Each Work Package Leader and each member of the Management Team and shall resolve any issues referred to the have one vote. 6.3 The Steering Committee shall be chaired by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advanceCo-ordinator or his Deputy. The Steering Committee shall meet within [...***...] after receipt of as often as deemed necessary by its members and typically four (4) times a year. 6.4 All meetings shall be convened by the Co-ordinator (Administrative Manager), who shall give at least fourteen (14) calendar days prior written request notice and who shall include the agenda in the notice. Shorter notice may be given subject to prior approval thereof by one Party all Steering Committee members and items may be added to the other Partyagenda during the meeting if so agreed by all Steering Committee members present at the meeting. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications Minutes of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members meetings of the Steering Committee are set forth shall be transmitted within seven (7) calendar days by the Co-ordinator to all Steering Committee members. They shall be considered as accepted if within fourteen (14) calendar days from receipt no member has objected in Appendix 3 attached hereto, which may writing to the chairperson. 6.5 Decisions shall be updated from time to time to reflect changes in taken by a majority of two-thirds of the votes of the Steering Committee as members present and voting it being understood that the Steering Committee shall endeavour to reach consensus on its decisions wherever possible. Any decision by a two-thirds majority vote shall be subject to two-thirds of the Steering Committee members being present or represented and voting. In case this quorum is not reached, another extraordinary Steering Board meeting may be convened within thirty (30) calendar days where the decision may be re-submitted to a vote. 6.6 Decisions may be taken, without a meeting, by e-mail, provided that prior written notice of the matter to be decided upon has been given to all Steering Committee members and that all Steering Committee members have given their written approval of the proposal to vote by e-mail; and that the decision so taken is approved by the Steering Committee members that would have been required to take that decision at a meeting where all entitled to vote would have been present or represented and voting. 6.7 The Steering Committee, with due respect to the Grant Agreement including Annex 1 (Description of Work) thereto, shall in this Section 2.2.3.particular: (a) ensure the implementation of decisions taken by the Governing Board; (b) monitor the progress of the work and review Project Deliverables; (c) assist the Co-ordinator in ensuring compliance by the Parties of their obligations under the Grant Agreement; (d) take executive decisions on administrative and scientific issues, (e) adopt or amend the Project Management Plan;

Appears in 1 contract

Sources: Consortium Agreement

Steering Committee. The Parties shall form a Steering Committee, to which each Party will appoint three (3a) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review Within *_____* of the activities of Effective Date, the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of Parties will establish the Steering Committee. The Steering Committee will take action be composed of *_____*. Such representatives will include individuals with expertise and responsibilities in areas such as preclinical development, clinical development, process sciences, manufacturing, marketing or regulatory affairs. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. The Steering Committee will meet (in person, telephonically, or via videoconference) at least once each calendar quarter, or more frequently, as agreed to by unanimous consent the Steering Committee. (b) The Steering Committee shall: (i) coordinate development of the PartiesLicensed Product in the United States and in the Licensed Territory, with in the representatives Field, as envisaged in the Collaboration Agreement, including the coordination of BII collectively having a single vote activities and exchange of information regarding ongoing and new clinical studies, regulatory strategy and commercial development (including pricing and product positioning issues) and the representatives establishment of XENCOR collectively having the relevant timelines; (ii) coordinate the expedited development of Licensed Product to obtain *_____* Regulatory Approval in the United States as set forth in Article 4; (iii) discuss the need, desirability of, structure and/or allocation of costs of any clinical studies or other development efforts relating to the Licensed Product to be carried out in the United States and/or the Licensed Territory; (iv) discuss actions planned by either Party in respect of the Licensed Product where such actions could reasonably be expected to have a single votematerial impact on the Licensed Product in the other Party's territory; and (v) discuss collaboration in the development of the Licensed Product for indications other than the Initial Indication. (c) The general principles relating to clinical studies (other than those studies required by the FDA for Regulatory Approval in the United States for the Initial Indication, the results of which will be made available by IDEC to SCHERING without charge) shall be as follows: (i) Where the Parties agree, prior to commencement of such a study, that the results of such study are to be used for regulatory or commercial purposes in both the United States and the Licensed Territory the costs of the study shall be shared by the Parties and the cost allocation, structure, timelines and other details of the study shall be agreed between the Parties in good faith taking account of the relative importance and value to each Party of the study in question. (ii) Where a study is required by a written resolution signed by all regulatory authority in the Licensed Territory the costs of the representatives. If the Steering Committee is unable to reach unanimous consent on such a particular matter, then the matter will study shall be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matterborne, and the decision reached by mutual agreement of the chief executive officers of the Parties its organization and structure shall be final determined, solely by SCHERING. Where a study is required by the FDA the costs of such a study shall be borne, and binding on the Partiesits organization and structure shall be determined, solely by IDEC. If, (i) after good faith effortshowever, any regulatory authority in the chief executive officers Licensed Territory subsequently requires the results of IDEC's FDA- ---------- *_____* Indicates that material has been omitted and confidential treatment has been requested therefor. All such omitted material has been filed separately with Secretary of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns Commission in the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings Company's Application Requesting Confidential Treatment pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement Rule 24b-2 under the Securities Exchange Act of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto1934, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.3amended.

Appears in 1 contract

Sources: Collaboration & License Agreement (Idec Pharmaceuticals Corp / De)

Steering Committee. The Parties (a) Promptly after the Effective Date, the parties shall form establish a Steering Committee, to which each Party will appoint three joint committee (3the "STEERING COMMITTEE") executive employees, including having oversight responsibility for the Project Managers, all day-to-day management and performance of whom shall be familiar with the ProjectScreening Program. The Steering Committee shall have general oversight consist of six (6) members, three (3) members to be appointed by each of NeoGenesis and review SPL. Each party shall notify the other party of the activities of the Project Team names and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute contact information for its members of the Steering Committee as needed from time to time by giving written Committee, and thereafter may with notice to the other Party due time in advance. The substitute any of its members serving on the Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decidedCommittee. Each Party shall bear its own costs associated with meetings and communications member of the Steering CommitteeCommittee will have one vote and all decisions of the Steering Committee will be by [*]. The quorum for Steering Committee meetings shall be two, provided there is at least one member from each of NeoGenesis and SPL present. The Steering Committee will take action render decisions by unanimous consent [*]. * = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. (b) The Steering Committee shall be responsible for the management and conduct of the PartiesScreening Program and shall in particular: (i) consider, with review and amend the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all Screening Program from time to time in such manner as may be appropriate; (ii) monitor progress of the representativesScreening Program; (iii) report regularly to the management of both parties upon the progress of the Screening Program; and (iv) be the initial medium for transfer of information between the parties. If SPL shall keep the Steering Committee reasonably informed of the status of SPL's activties with respect to the discovery and development of Licensed Products against each Target. (c) During the term of the Screening Program, the Steering Committee shall hold meetings as mutually agreed by the parties (but in no event less quarterly) to review the Screening Program. The first meeting of the Steering Committee shall be held within forty-five (45) days of the Effective Date and shall be held in Cambridge, MA. Thereafter, meetings may be held by telephone or video conference if requested by either party in writing to the other, PROVIDED THAT the parties shall meet in person at least four (4) times per year during the term of the Screening Program. Minutes of all meetings setting forth decisions of the Steering Committee relative to the Screening Program shall be prepared by the host party and circulated to both parties within fifteen (15) days after each meeting, but minutes shall not become official until approved and countersigned by both parties (which approval the parties shall use reasonable efforts to give within thirty (30) days of receipt of such minutes). (d) In the event that the Steering Committee is unable to reach unanimous consent on a particular matteragreement, then the matter will issue in dispute shall be referred to the chief executive officers an "OVERSIGHT COMMITTEE" consisting of the PartiesExecutive Vice President, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement Discovery Research of the chief executive officers Schering-Plough Research Institute (an Affiliate of SPL) and NeoGenesis' Chief Executive Officer, or their respective designees, for resolution. If the Parties shall be final and binding on disagreement is not resolved by the Parties. If, Oversight Committee within thirty (i30) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slotsdays, then SPL shall have the chief executive officer of XENCOR shall right to make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter; PROVIDED, XENCOR’s chief executive officer shall that in the event and to the extent that any dispute concerns whether or not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will budgeted FTE funding for the Steering Committee, or Screening Program has been expended in accordance with the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification provisions of this Agreement must such matter shall be resolved using the procedure specified in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in the Steering Committee as provided in this Section 2.2.39.1.

Appears in 1 contract

Sources: Screening and Analysis Services Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications 2.1 General Responsibilities of the Steering Committee. A four-person steering committee, consisting initially of Paul ▇▇▇▇▇ ▇▇▇ Kenn▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ MSS and [ * ] for the University (the "Steering Committee"), will make joint decisions and provide high level management with respect to the Project. [ * ] will also serve on the Steering Committee as a representative of the employees, faculty, consultants and staff working on the Project. Each person on the Steering Committee will have one vote. Each party may nominate alternative or replacement members to serve on the Steering Committee with the consent of the other party, which consent will not be unreasonably withheld. The Steering Committee will take action by unanimous consent meet on a regular basis as the committee members may determine to be necessary. Written minutes of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all meetings of the representativesSteering Committee will be kept and will be promptly circulated after each meeting to the committee members for approval. The Project will consist of an initial phase and any follow-on phases that the Steering Committee may determine to pursue. During the initial phase, the parties will, in accordance with their respective responsibilities set forth in Section 3 below, file and prosecute U.S. and international patents covering the Initial Eye Disease Test and any other Innovations that the Steering Committee may determine, conduct clinical studies to generate appropriate clinical data and, if such data demonstrates strong clinical utility of potential Products, identify and engage an appropriate Third Party. If the Steering Committee determines that the clinical data is unable not strong enough to reach unanimous consent on seek a particular matterThird Party, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached heretowill determine the next step(s) that should be taken. After completion of the initial phase of the Project, the Steering Committee will review and make decisions as to the next step(s) that should be taken, which may be updated from time to time to reflect changes in include additional research and/or development and testing of Products, seeking of additional Third Parties, direct sales, or termination of the Steering Committee as provided in this Section 2.2.3Project.

Appears in 1 contract

Sources: Development and Commercialization Project Agreement (Medical Science Systems Inc)

Steering Committee. The Parties 3.2.1 Within twenty (20) business days after the Effective Date, the parties shall form establish a Steering Committee ("Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team"). Each Party shall have appoint two (2) of its executives or managers to serve as its representatives on the right to substitute its members Steering Committee. The total number of representatives on a Steering Committee may be changed by mutual agreement of the Parties; provided that there will at all times be an equal number of representatives of each of GPCR and EXICURE on the Steering Committee. In accordance with the provisions and objectives of this Agreement, the Steering Committee as needed from time to time by giving written notice to shall: (i) review progress of Development and discuss future Development activities. (ii) review and recommend patent strategy, including prosecution, protection, and enforcement, of patent on GPCR Technology. (iii) advise on any patent or other Intellectual Property issues that may arise concerning or affecting the other Party due time in advance. Development or Commercialization of the Product. 3.2.2 The Steering Committee shall meet within [...***...] after receipt of a written request by one Party as needed but not less than once each quarter during the Term. EXICURE shall prepare updates on Development activities and present such updates to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications of the Steering Committee. The Steering Committee meetings shall be held at times and places or in such form, such as by telephone or video conference, as the Steering Committee determines, unless otherwise agreed in writing by the Parties. 3.2.3 Decisions of the Steering Committee will take action be by unanimous consent vote of the Partiesnominated representatives or their substitutes, with the each parties' representatives of BII collectively having a single one (1) vote and the representatives of XENCOR collectively having a single vote, or which may be exercised by a written resolution signed by all of party's sole attendee at a meeting if the representativesparty's other representative cannot attend. If In the event that the Steering Committee is unable to reach unanimous consent agree on a particular mattermatter or proposal submitted by either party, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties or proposal shall be final considered in Dispute Resolution. 3.2.4 The Steering Committee will have only the powers expressly delegated to them and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not will have any no authority to require BII (a) amend, modify, or its Affiliated Companies waive compliance with this Agreement; (b) act on behalf of either Party in relation to incur additional expenses any third party; or obligations not contemplated by (c) decide any issues in a manner that would conflict with the express terms of this Agreement. In Each Party will retain the rights, powers, and discretion granted to it under this Agreement, and no event will the Steering Committeesuch rights, powers, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority discretion will be delegated to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which may be updated from time to time to reflect changes vested in the Steering Committee as unless such delegation or vesting of rights is expressly provided for in this Section 2.2.3Agreement or the Parties otherwise expressly agree in writing.

Appears in 1 contract

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

Steering Committee. The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including the Project Managers, all of whom shall be familiar with the Project. The Steering Committee shall have general oversight and review of the activities of the Project Team and shall resolve any issues referred to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings and communications 2.1 General Responsibilities of the Steering Committee. A four-person steering committee, consisting initially of Paul ▇▇▇▇▇ ▇▇▇ Kenn▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ MSS and [ * ] for the University (the "Steering Committee"), will make joint decisions and provide high level management with respect to the Project. [ * ] will also serve on the Steering Committee as a representative of the employees, faculty, consultants and staff working on the Project. Each person on the Steering Committee will have one vote. Each party may nominate alternative or replacement members to serve on the Steering Committee with the consent of the other party, which consent will not be unreasonably withheld. The Steering Committee will take action by unanimous consent meet on a regular basis as the committee members may determine to be necessary. Written minutes of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all meetings of the representativesSteering Committee will be kept and will be promptly circulated after each meeting to the committee members for approval. The Project will consist of an initial phase and any follow-on phases that the Steering Committee may determine to pursue. During the initial phase, the parties will, in accordance with their respective responsibilities set forth in Section 3 below, file and prosecute U.S. and international patents covering the Initial Osteoporosis Test and any other Innovations that the Steering Committee may determine, conduct clinical studies to generate appropriate clinical data and, if such data demonstrates strong clinical utility of potential Products, identify and engage an appropriate Third Party. If the Steering Committee determines that the clinical data is unable not strong enough to reach unanimous consent on seek a particular matterThird Party, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached heretowill determine the next step(s) that should be taken. After completion of the initial phase of the Project, the Steering Committee will review and make decisions as to the next step(s) that should be taken, which may be updated from time to time to reflect changes in include additional research and/or development and testing of Products, seeking of additional Third Parties, direct sales, or termination of the Steering Committee as provided in this Section 2.2.3Project.

Appears in 1 contract

Sources: Development and Commercialization Project Agreement (Medical Science Systems Inc)

Steering Committee. (a) The Parties shall form a Steering Committee, to which each Party will appoint three (3) executive employees, including Research Program and the Project Managers, all of whom Development Program shall be familiar conducted under the overall direction of the Steering Committee comprised of four (4) members, with the Projecttwo (2) appointed by Ligand and two (2) appointed by Lilly. The Steering *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 12 Committee established by this Agreement shall have general oversight and review of be the activities of the Project Team and shall resolve any issues referred to same committee as the Steering Committee established by the Project TeamCollaboration Agreement. Each Party All actions of the Steering Committee with respect to the activities contemplated by this Agreement shall have be governed by the right to substitute its terms of this Agreement. The initial members of the Steering Committee as needed from time to shall be: (a) for Ligand, D. R▇▇▇▇▇▇▇ ▇▇▇ A. Negro-Vilar, and (b) for Lilly, J. H▇▇▇▇▇ ▇▇▇ J. C▇▇▇. *** Either party may change its representative on the Steering Committee at any time by giving prior written notice to the other Party due time party. The party hosting the meeting of the Steering Committee shall prepare and deliver to the other party one week prior to the meeting the agenda for the meeting. The party hosting the meeting of the Steering Committee shall prepare and deliver to the other party within ten (10) days after the date of such meeting, minutes of the meeting that set forth all decisions of the Steering Committee relating to the Research Program and the Development Program in advanceform and content reasonably acceptable to the other party. Minutes shall be deemed approved unless any member of the Steering Committee objects to the accuracy of such minutes in writing to the other party within ten (10) business days of receipt. If a party objects to the minutes and the objection is not resolved, the objection will be deemed a dispute and resolved pursuant to Section 2.6. (b) The purpose of the Steering Committee shall be to make key strategy, policy and resource decisions regarding the Research Program and the Development Program and to carry out its other responsibilities described in this Agreement. The Steering Committee shall meet within [...***...] after receipt of a written request at least once in each Calendar Quarter, at such times and places as are agreed to by one Party to the other Party. The request shall describe the matter in dispute Ligand and the solution which the requesting Party proposes to be decided. Each Party shall bear its own costs associated with meetings Lilly, alternating between San Diego and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single voteIndianapolis, or by a written resolution signed by all of such other locations as the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth in Appendix 3 attached hereto, which shall agree. Meetings of the Steering Committee may be updated attended by such other directors, officers and employees of each party as such party deems necessary, and by such consultants and non-employee agents of each party as the members of the Steering Committee may from time to time to reflect changes in agree, but only members of the Steering Committee as provided in shall have the right to vote at such meetings. The Steering Committee, by unanimous consent, shall have the authority to amend or waive compliance with the provisions of this Agreement relating to the scheduling and conduct of the meetings of all committees established pursuant to this Agreement. Any dispute regarding any such amendment or waiver shall not be subject to the dispute resolution provisions of Section 2.2.32.6.

Appears in 1 contract

Sources: Development and License Agreement (Ligand Pharmaceuticals Inc)

Steering Committee. 6.1 For the purpose of proper facilitation of CBM Operations under the provisions of this Contract, there shall be a committee, to be called, the Steering Committee. 6.2 Government shall nominate two (2) members representing Government in the Steering Committee, whereas, each Company constituting Contractor shall nominate one member each to represent it in the Steering Committee. In case, Contractor constitute a single Company, that Company shall nominate two (2) members representing it. The Parties shall form a nominate the members to the Steering Committee within thirty (30) days of the Effective Date. 6.3 Each Party may nominate alternate members with full authority to act in the absence and on behalf of the members nominated under Article 6.2 and may, at any time, nominate another member or alternate member to replace any member nominated earlier by notice to other Parties. 6.4 The representative of the Government shall be designated as the Chairman of the Steering Committee and the alternative representative to the Chairman shall be designated as the Deputy Chairman. One of the members of the Operator in this Steering Committee shall be designated as the Secretary of the committee by the Government. 6.5 All approvals to matters, except those specified in Article 6.9 be taken by the Steering Committee by majority vote of the members attending the meeting as well as the vote of the members received when not attending the meeting. 6.6 The Steering Committee shall review and advise on the following matters:- (a) proposals for surrender or relinquishment of any part of the Contract Area by the Contractor; (b) Annual Work Programme and Budget for Phase-I and Phase-II operations; (c) Budget for Development Operations and Production Operations, and any modification or revisions there to over 20%; (d) any matter required by the terms of this Contract to be submitted to it for review or advice; (e) any other matter which the Contractor decide to submit for review or advice including matters concerning inter-Party relationships; and (f) any other matter, which Government refers to the Steering Committee for its consideration and reasoned advice. 6.7 The following matters shall be submitted to the Steering Committee for approval or making recommendation to the Government, where applicable as per the provisions of the Contract: (a) Annual Work Programme for Development and Production Operations and any modifications or revisions thereto; (b) Approvals to Development Plan(s); (c) Inclusion of an area extending outside the Contract Area in the Development Area pursuant to Article 11.2; (d) Subject to Article 7.2, any change of operatorship; (e) Retention of more than 80% of the Contract Area at the end of Phase II; (f) Subject to Article 25.8, any proposed mortgage, charge or encumbrance on CBM assets, CBM reserves or production of CBM; (g) Matters related to assignment or transfer of Participating Interest(s) etc; (h) Appointment of auditors including scope of work, approval and adoption of accounts; (i) Any matter required by the terms of this Contract to be submitted for the approval of the Steering Committee; and (j) Any matter which the Contractor decide to submit to it. 6.8 In the event that the votes cast in favour are equal to the votes cast against, the Chairman will have an additional vote, called casting vote, to remove the deadlock. 6.9 Matters which each Party will appoint three require unanimous approval of the members of the Steering Committee : 1. Approval to development plan(s); 2. Approval to Annual Work Programme(s) as provided in Article 6.7; 3. Production and Reservoir management related issues; 4. Approval and adoption of annual accounts; and 5. A proposal for determination of “Producible Areas” for the purpose of relinquishment as per the Article 4.5 of the Contract. 6.9.1 In case, unanimity is not reached in the decision process within a reasonable period as may be required under the circumstances, but not exceeding one hundred and eighty (3180) executive employeesdays, including unless provided otherwise in the Project ManagersContract, all of whom the matter shall be familiar with referred to the ProjectGovernment and its decision shall prevail and shall be binding on all Parties. 6.10 The Steering Committee shall not take any decision without obtaining approval of the Government where such approval is required under this Contract or any applicable law (including rules and regulations) of India. The Steering Committee shall have general oversight obtain such approval/ decision and review of convey the activities of the Project Team and shall resolve any issues referred same to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. Contractor with utmost expedition. 6.11 The Steering Committee shall meet within [...***...] after receipt at least once in every six (6) months or more frequently at the request of any member. The Secretary, with the approval of the Chairman, shall convene each meeting by notifying the members twenty eight (28) days prior to such a written request meeting (or a shorter period of notice if the members unanimously so agree) of the time and place of such meeting and the purpose thereof and shall include in such notice a provisional agenda for such meeting. The Chairman shall be responsible for processing of the final agenda for such meeting and the agenda shall include all items of business requested by one Party the members for inclusion, provided such requests are received by the Secretary at least ten (10) days prior to the other Partydate fixed for the meeting. The request Secretary shall describe forward the matter agenda to the members at least nine (9) days prior to the date fixed for the meeting. Matters not included in dispute and the solution which agenda may be taken up at the requesting Party proposes to meeting by any member with the unanimous consent of all the members whether present or not present at the meeting. 6.12 The Chairman or Deputy Chairman, as may be decided. Each Party the case, shall bear its own costs associated with preside over the meetings and communications of the Steering Committee. , and, in their absence, any other member representing Government and present shall preside over the meetings. 6.13 The Secretary to the Steering Committee will take action by unanimous consent be responsible, inter alia, for preparation of the Parties, with minutes of every meeting in the representatives English language and circulate to every member of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, or by a written resolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers with two copies of the Parties, who will use good faith efforts to resolve such matter, and minutes not later than fourteen (14) days after the decision reached by mutual agreement date of the chief executive officers meeting with the approval of the Parties Chairman. 6.14 The meetings of the Steering Committee shall be final and binding on held in India, unless otherwise mutually agreed by the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee. 6.15 Any member shall be entitled, if either he or his alternate is unable to attend a meeting to cast his vote, by telex or facsimile transmission received by the Chairman prior to the date on which the vote is taken in the course of the meeting. Such vote shall have the same effect as if that member had been present and so voted at the meeting. 6.16 A member of the Steering Committee are set forth who is unable to attend a meeting may give prior written notice to all other members and appoint a member representing another Party who consents to such appointment as its proxy to attend a meeting and to exercise the appointing member’s right to vote at that meeting whether as directed by the appointing member or otherwise. A member appointed as a proxy and attending a meeting shall be present in Appendix 3 attached hereto, which may two separate capacities and vote accordingly. 6.17 There shall be updated from time a quorum of the Steering Committee for holding a meeting and making decisions with each Party to time to reflect changes the Contract represented by at least one of its nominated members in the Steering Committee either present in person or represented as provided in this Section 2.2.3.per Article

Appears in 1 contract

Sources: Exploration and Production Agreement

Steering Committee. In order to monitor, coordinate and facilitate implementation of the terms and conditions of this Agreement, Verso and NewPage shall establish a “Steering Committee” consisting of at least one executive officer from each of Verso and NewPage and whereby each of Verso and NewPage is equally represented (provided that the chairman of the Steering Committee shall in all cases be deemed a representative of both Verso and NewPage for purposes of determining equal representation on the Steering Committee). The Parties initial Steering Committee representatives shall form a be ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, who shall also serve as the initial chairman of the Steering Committee, to which each Party will appoint three (3) executive employees▇▇▇ Wilhlelm, including the Project Managersdivisional financial representative of Verso, all and ▇▇▇▇▇▇ ▇. Ashbumer, the divisional financial representative of whom shall be familiar with the ProjectNewPage. The Steering Committee representatives shall have general oversight meet at least quarterly (or more frequently if needed or reasonably requested by a representative) during the Term to determine the Shared Services to be provided and review of the activities of the Project Team and shall resolve any issues referred payments to be made pursuant to this Agreement. Such determination with respect to the Steering Committee by the Project Team. Each Party shall have the right to substitute its members of the Steering Committee as needed from time to time by giving written notice to the other Party due time in advance. The Steering Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. The request shall describe the matter in dispute and the solution which the requesting Party proposes Shared Services to be decided. Each Party provided shall bear its own costs associated with meetings include the scope, manner, level and communications of the Steering Committee. The Steering Committee will take action by unanimous consent of the Parties, with the representatives of BII collectively having a single vote and the representatives of XENCOR collectively having a single vote, place or by a written resolution signed by all of the representativesplaces where such Shared Services shall be provided. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to the chief executive officers of the Parties, who will use good faith efforts to resolve such matter, and the decision reached by mutual agreement of the chief executive officers of the Parties shall be final and binding on the Parties. If, (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and (ii) such matter concerns the Product or the Process, but does not concern the BI Facility or the management of manufacturing slots, then the chief executive officer of XENCOR shall make the final decision about how to resolve such dispute, after good faith consideration of BII’s position, which decision shall be final and binding on the Parties; provided, however, that, in resolving such matter, XENCOR’s chief executive officer shall not have any authority to require BII or its Affiliated Companies to incur additional expenses or obligations not contemplated by this Agreement. In no event will the Steering Committee, or the executive officers of the Parties in resolving any Steering Committee matter, have any authority to amend or modify this Agreement; any such amendment or modification of this Agreement must be in accordance with Section 11.8. For the avoidance of doubt, nothing in this Section shall prevent any Party from seeking arbitration proceedings pursuant to Section 11.6 hereof with regard to any matters other than matters resolved by mutual agreement of the chief executive officers in accordance with this Section 2.2.3. The members of the Steering Committee are set forth unable (whether by majority vote or in Appendix 3 attached hereto, which may be updated from time to time to reflect changes in such other manner as the members of the Steering Committee decide) to determine whether a Shared Service is to be provided, or the scope, manner, level and place or places at which such Shared Service shall be provided, such Shared Service shall not be provided until such time as provided the members of the Steering Committee determine the relevant matters. The Steering Committee representative(s) for NewPage or Verso, as the case may be, shall stay reasonably apprised of the activities of the employees, agents and contractors of NewPage or Verso, as the case may be, who are providing or receiving the Shared Services in this Section 2.2.3order to maximize efficiency in the provision and receipt of the Shared Services.

Appears in 1 contract

Sources: Shared Services Agreement (Verso Paper Holdings LLC)