Common use of Steering Committee Clause in Contracts

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. The Steering Committee 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 Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 indicated 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. Within twenty (20) calendar days from the Effective Date, the parties will The Parties shall form a Steering Committee consisting of Committee, to which each Party will appoint three (3) people 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 each party (time to time by giving written notice to the other Party due time in advance. The Steering Committee”)Committee shall meet within [...***...] after receipt of a written request by one Party to the other Party. A representative from each party The request shall serve as co-chairpersons 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 may establish one 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 more subcommittees as appropriateby a written resolution signed by all of the representatives. The If the Steering Committee shall meet at least quarterlyis 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 shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution decision reached by mutual agreement of the Product in the Territory, including a review and update chief executive officers of the SalesParties shall be final and binding on the Parties. If, Marketing (i) after good faith efforts, the chief executive officers of the Parties are unable to resolve such matter by mutual agreement, and Distribution Plan at least annually; (bii) discuss actions to xxxxxx the 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 such matter concerns the Product for Cygnus 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 2.1(ii); (e) review Sankyo’s efforts 11.6 hereof with regard to develop and implement strategies any matters other than matters resolved by mutual agreement of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under the chief executive officers in accordance with this 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan2.2.3. Each party may change its The members of the Steering Committee at any are set forth in Appendix 3 attached hereto, which may be updated from time upon written notice, and each party will cause its members of to time to reflect changes in the Steering Committee to act reasonably, as provided 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 indicated 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 CygnusSection 2.2.3.

Appears in 3 contracts

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

Steering Committee. Within twenty (20) calendar days from a reasonable period of time after the Effective Date, the parties will Orphan Medical and Celltech shall form a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that shall have certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to: writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical aspects of standards of care in the Territory, (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 arrangement for distributing Product on a Named Patient Basis. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product in outside the Territory, including a review and update the views of the SalesOrphan 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, Marketing 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 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, Orphan Medical and Distribution Plan Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party. During each Contract Year, the parties shall hold at least annually; four (b4) discuss actions to xxxxxx regular meetings of the attainment Steering Committee. Members of sales objectives; the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (c1) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; the four (d4) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees Steering Committee meetings shall be conducted in-person. Employees of each party who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and consistent with the terms and conditions of this Agreementa facility designated by Celltech. The Steering Committee may take action only by the unanimous written consent co-chairpersons of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Orphan Medical Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth 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. Within twenty (20) calendar days from a reasonable period of time after the Effective Date, the parties will Orphan Medical and Celltech shall form a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that shall have certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to: writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical aspects of standards of care in the Territory, (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 arrangement for distributing Product on a Named Patient Basis. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product in outside the Territory, including a review and update the views of the SalesOrphan 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, Marketing 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 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, Orphan Medical and Distribution Plan Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party. During each Contract Year, the parties shall hold at least annually; four (b4) discuss actions to xxxxxx regular meetings of the attainment Steering Committee. Members of sales objectives; the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (c1) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; the four (d4) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees Steering Committee meetings shall be conducted in-person. Employees of each party who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and consistent with the terms and conditions of this Agreementa facility designated by Celltech. The Steering Committee may take action only by the unanimous written consent co-chairpersons of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Orphan Medical Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth 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. Within twenty The Parties shall establish a steering committee which will be responsible for overseeing the Development Plan, including without limitation (20i) calendar days from the Effective Datemonitoring of progress against the Development Plan, (ii) the parties will form a Steering Committee consisting oversight of three any clinical studies to be performed pursuant to the Development Plan, (3iii) people from each party the review and approval of amendments to the Development Plan, and (the iv) regulatory developments relating to any Product (“Steering Committee”). A representative The Steering Committee will be comprised of two (2) representatives from each party shall serve as coActavis and two (2) representatives from Merrimack. Each Party will have the right to replace any of its representatives by written notice to the other Party. Neither Party may designate a non-chairpersons of the Steering Committeeemployee to be a representative. The Steering Committee may establish 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 more subcommittees as appropriatehis 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 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 amend this Agreement or modify the Parties’ rights and obligations hereunder. The Steering Committee shall will meet at least quarterlyevery [**] months, and shall document their meetings or more or less frequently as reasonably agreed by the Parties. Meetings will occur in written minutesperson, to: (a) review via teleconference or videoconference, or otherwise, as reasonably agreed by the sales, marketing and distribution of Parties. An Actavis representative will act as the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members chairperson of the Steering Committee at any time upon written noticeand 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 each party comments, if any, 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 indicated by all members signing the written minutesbe promptly provided. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar dayscommittee members cannot agree on the minutes, any Steering Committee member may submit it the chairperson will have authority to finalize the Executive Officers of minutes and the parties for resolution. The initial Salesother committee members will have the right to note their specific objections, Marketing and Distribution Plan shall which will be mutually agreed upon by Sankyo and Cygnusincluded in the minutes.

Appears in 2 contracts

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

Steering Committee. Within twenty a. Each PARTY shall appoint up to two (202) calendar days from representatives to serve as members of the Effective DateSTEERING 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 STEERING COMMITTEE shall 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 form 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 Committee consisting reasonable 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 consent will 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) people years from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons termination of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyAGREEMENT, and shall document their meetings in written minutes, to:whichever is later. (a) review c. Obligations regarding confidential information received by either PARTY under the sales, marketing and distribution provisions of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; SUBSECTION (b) discuss actions above shall not apply to xxxxxx any such information that: i) becomes publicly available without default hereunder by the attainment receiving PARTY; or ii) is lawfully acquired by the receiving PARTY from a source not under any obligation of sales objectivesconfidentiality 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 permission of the disclosing PARTY hereunder; or v) is developed by or on behalf of the receiving PARTY by individuals who have not received confidential information hereunder. d. The obligations of confidentiality set forth herein further shall not apply to any information to the extent that such information: i) is required to be disclosed by order of a court of law, provided that the receiving PARTY provides reasonable prior notice of such required disclosure to the disclosing PARTY; (cii) review current marketing, distribution, sales and pricing strategies, including amount and form is used with the prior written consent 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 disclosing PARTY which consent shall not be unreasonably withheld in applications for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 patents on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights INVENTIONS or in financial information in the Territory;usual conduct of business; or (giii) review Cygnus’ proposed product development as set forth has been approved in Section 5.1(hwriting for publication by both of the PARTIES; or iv) in light is submitted to governmental agencies to facilitate the issuance of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) reviewapprovals for materials and products, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 indicated 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 DEVELOPMENT PLAN hereunder provided that reasonable measures shall be mutually agreed upon taken to assure confidential treatment of such information; or v) is product-related information which is reasonably required to be disclosed by Sankyo and Cygnuseither PARTY in connection with its testing or marketing of "relevant products", in such PARTY's discretion.

Appears in 2 contracts

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

Steering Committee. Within twenty (20) calendar days from Under the Effective DatePrior Agreement, the parties will form have formed a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that has certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to: writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical 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, (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 manufacture of Product. In the event and to the extent that the Steering Committee is unable to 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 a review and update pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the SalesProduct within the Territory, Marketing and Distribution Plan at least annually; (b) discuss actions and, if UCB has exercised its manufacturing option under Section 2.2, on any matter relating to xxxxxx the attainment manufacture 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 sale within the Territory, the views of the UCB 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 have the ultimate decision making authority as to Section 2.1(iisuch matter (as provided in the previous two sentences); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ materially affect the rights or obligations under Section 5.1 this Agreement of such party, Jazz Pharmaceuticals and receive updates from Cygnus UCB shall attempt to resolve the matter in a manner which will minimize the impact on other significant activities relating such rights or obligations of such party, but in default of agreement may be referred by either party to its obligations arbitration under Section 5.115.2. During each Contract Year, including an annual review the parties shall hold at least four (4) regular meetings of Cygnus Intellectual Property Rights the Steering Committee. Members of the Steering Committee may participate in meetings of the Territory; Steering Committee in person or by conference telephone call. At least one (g1) review Cygnus’ proposed product development as set forth in Section 5.1(hof the four (4) in light Steering Committee meetings shall be conducted in-person. Employees of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each each party may change its who are not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Jazz Pharmaceuticals’ designated facility and consistent with the terms and conditions of this Agreementa facility designated by UCB. The Steering Committee may take action only by the unanimous written consent co-chairpersons of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Jazz Pharmaceuticals Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth co-chairpersons.

Appears in 2 contracts

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

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will 5.3.1. The Parties shall form a Steering Committee consisting to which each Party will delegate [**] executive employees who are familiar with the Project. In the case of three (3Lonza, the executives shall be [**] or their designee(s), provided that such designee(s) people from each party (shall have substantially the “Steering Committee”)same authority and decision making power as the aforementioned executives. A representative from each party In the case of Kolltan, the executives shall serve as co-chairpersons of be at the Steering Committee. The Steering Committee may establish one vice president level or more subcommittees as appropriatehigher. The Steering Committee shall meet at least quarterly, provide strategic guidance for the overall collaboration and have general oversight and review of the activities of each Project Team and shall document their 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. Subject to the mutual written agreement of the Parties and the terms of this Agreement, the Steering Committee shall have the ability to 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 take action inconsistent with the terms of this Agreement or any other written agreement between the Parties. 5.3.2. Once Services have commenced, the Steering Committee shall meet on a [**] basis or as otherwise agreed by the Parties. At least [**] meetings per year shall be conducted in–person and such meetings shall alternate between a site designated by Lonza in the United Kingdom and a site designated by Kolltan in the United States. Each Party shall bear its own travel and 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 Committee at the next meeting. 5.3.3. The Steering Committee will take action by unanimous consent of its members, with each representative having a single vote, or by a written minutesresolution 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 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) review If the salesdispute is predominantly concerned with scientific or technical issues, marketing and distribution 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 Product 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 TerritoryEnglish language within [**] weeks after the second expert has been appointed. The decision of such independent experts shall be in writing and, including a review and update save for manifest error on the face of the Salesdecision, Marketing shall be binding on both Lonza and Distribution Plan 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 is an expert in the particular scientific or technical area at least annually;issue. If the Parties cannot agree as to the third unconflicted independent expert, then such third 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 third expert shall be considered final and binding on the Parties. The reasonable costs of the experts shall be paid by the non-prevailing Party. (b) discuss actions If the dispute is predominantly concerned with an issue other than a scientific or technical issue, then the Parties agree to xxxxxx attempt in good faith to resolve such dispute by mediation administered by the attainment CEDR in London, England. The parties agree that they shall share equally the cost 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) reviewany mediation fees, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon cost of the initial Sales, Marketing and Distribution Planmediator. Each party must bear its own attorneys’ fees and associated costs and expenses. The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within [**] calendar days of either Party referring the dispute to mediation either Party may change pursue its members rights in a court of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, law in good faith and consistent accordance with the terms and conditions Clause 14 of this Agreement. The Steering Committee may take action only by Nothing in this Clause 5.3 shall prevent a Party from exercising any right under this Agreement, including the unanimous written consent right of all members, as indicated 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 Cygnustermination 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. Within twenty (20) calendar days from 4.1 MTC and the Effective Date, the parties will form Participating Cities agree to create and hereby establish a Steering Committee consisting to coordinate the activities of three (3) people the Program and make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from each party (the “Steering Committee”). A MTC, and one designated representative from each of the Participating Cities. Each party with a designated representative shall serve 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 co-chairpersons the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which 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. The Steering Committee may establish one or more subcommittees as appropriatewill be to reach decisions by a unanimous vote. The Steering Committee shall meet endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at least quarterlytwo Steering Committee meetings without reaching consensus, and shall document their meetings in written minutes, to: (a) review at the sales, marketing and distribution conclusion of the Product in second meeting, the Territorydecision will be made by MTC. In addition, if the Steering Committee has been unable to reach consensus on a material matter for 30 days since such matter was brought to the attention of the Steering Committee for any reason, including a review and update of failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions right to xxxxxx decide such matter. MTC shall also have the 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 right to make decisions on those matters that MTC reasonably believes are promoting the Product for Cygnus pursuant not material or to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its make decisions after consulting with one or more members of the Steering Committee at whose Participating City may be disproportionately (or solely) affected by such decisions. In no event shall MTC have the right to make any time upon written notice, of the decisions enumerated in Section 33. 4.5 A party shall convey all communications and each party will cause its members of documents intended for the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreementthrough that party’s designated representative. The Steering Committee may take action only shall convey all communications and documents intended for a party to that party’s designated representative. 4.6 Decisions to be made by Steering Committee shall include, but are not limited to: 4.6.1 Whether Operator is in Default, under Section 18 of the unanimous written consent of all membersProgram Agreement; Agreement; Agreement.‌ 4.6.2 KPI Adjustments, as indicated by all members signing described in Section 2.6.2(a) of the written minutes. If an issue remains unresolved after good faith consideration 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 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 or by MTC in accordance with this Section 4 shall be mutually agreed upon by Sankyo and Cygnusbinding on the Participating Cities.

Appears in 2 contracts

Sources: Coordination Agreement, Coordination Agreement

Steering Committee. Within twenty 30 days of the execution of this Agreement, LTX and Ando shall establish a joint steering committee (20) calendar days from the Effective Date"Steering Committee"), the parties will form a Steering Committee consisting of three (3) people from four representatives of LTX and four representatives of Ando. One of each party's representatives shall be appointed Chairman by each party (the “Steering Committee”). A representative from each party in its sole discretion, and such Chairman shall serve as co-chairpersons be charged with formally making any decision of the Steering CommitteeCommittee representing LTX or Ando, as the case may be. The Each Steering Committee member will serve at the pleasure of the party designating such member and may establish one be replaced, with or more subcommittees as appropriatewithout cause, at any time by the designating party, effective upon notice to the other party. The Steering Committee shall meet at least quarterly, be responsible for strategic management decisions concerning the Fusion Division and strategic operating decisions under this Agreement which shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution be reasonably made based upon reasonable allocation of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) resources in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and market conditions of this Agreementfor such business. The Steering Committee may take action only shall also review the organizational structure and management personnel for the Fusion Division. The Steering Committee shall be governed by operating procedures to be mutually agreed to by LTX and Ando which LTX and Ando shall use their best efforts to agree to within 30 days after the unanimous written consent execution of all membersthis Agreement; provided, as indicated by all members signing however, that in the written minutes. If an issue remains unresolved after good faith consideration by event the Steering Committee for thirty (30) calendar dayscannot make a strategic management or operating decision as a result of a "deadlock", any 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 unable 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, the strategic management or operating decision shall not be undertaken by the Fusion Division. The Steering Committee member may submit it shall then meet to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be discuss mutually agreed upon by Sankyo and Cygnusacceptable alternatives.

Appears in 2 contracts

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

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form The Parties shall establish a Joint Steering Committee consisting comprised of three (3) people an equal number of representatives from each party Fresenius Kabi and Cerus (the “Steering Committee”). A representative from each party , which members shall serve as co-chairpersons of initially be the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. individuals identified on Exhibit E. The Steering Committee shall meet at least quarterly, twice per calendar year and shall document their meetings in written minutes, have primary responsibility for providing oversight with respect to: : (ai) review the sales, marketing and distribution execution of the Product 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) [ * ] upon termination or expiration of Cerus’ contractual commitments as described in Section 2.3(b) and (iv) the Territorypreparation of detailed project plans, including a review scope, roles and update of responsibilities, prioritization and timelines with respect to the Sales, Marketing and Distribution Plan at least annually;Funded Projects. (b) discuss actions In addition to xxxxxx the attainment of sales objectives;responsibilities set forth in Section 4.3(a), the Steering Committee shall meet at least twice per calendar year to perform the following tasks: AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (FRESENIUS KABI – CERUS) [ * ] = 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 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) review current marketingIn the event that the Steering Committee is unable to reach a decision on any matter after [ * ] business days, distributionthe decision will be escalated to the Chief Executive officer of Cerus and the designated member of the Management Board of Fresenius Kabi (together, sales and pricing strategiesthe “Business Heads”), including amount and form who will have an additional [ * ] business days to reach a mutually agreeable decision. If the Business Heads are unable in good faith to reach resolution, the Parties shall submit the issue to an independent third party jointly selected by the parties for resolutions. The parties shall jointly bear the costs, if any, of discount and rebate programs;such third party. (d) coordinate activities between Sankyo For the avoidance of doubt, and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant subject to Section 2.1(ii2.2, (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) review Sankyo’s efforts For the avoidance of doubt, and subject to develop Sections 2.2 and implement strategies of institutional6.2, 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) reviewCerus shall be able, and if necessary, amend the schedule set forth in Exhibit C hereto; without Fresenius Kabi consent (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the or Steering Committee at involvement), to implement any time upon written noticeprojects or other process improvements, and each party will cause its members of provided that the Steering Committee to act reasonably, parties shall negotiate in good faith any adjustment to pricing that may result from such projects or process improvements, and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written (ii) Fresenius Kabi shall not unreasonably withhold or delay its consent of all members, as indicated 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, to 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 Cygnusnew products or product design changes.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Cerus Corp)

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form xxxxxx Xxxxxx and Investor Parent hereby establish a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party , which shall serve as co-chairpersons consist of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateup to six (6) members, up to three (3) of which shall be designated by xxxxxx Xxxxxx and up to three (3) of which shall be designated by Investor Parent. The Steering Committee shall meet at least quarterlyto discuss and review issues of a commercial, financial and shall document their meetings in written minutes, to: (a) review technical nature concerning the sales, marketing and distribution of the Product in the TerritoryProject, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx work being performed by the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development Consulting Firm as set forth in Section 5.1(h) in light of marketing issues regarding this Agreement and matters with respect to risks, Permits, technical assurance to the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, Consolidated Project Budget and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Project Work Plan. Any material contract proposed to be entered 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 may change its members member of the Steering Committee shall be permitted to conduct at least four site visits per year at reasonable intervals of time and upon reasonable advance notice to the Company; provided, however, that such site visits may be conditioned upon such Steering Committee members executing any time upon written noticeapplicable 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 meet (including remotely) at least on a monthly basis unless otherwise agreed by ioneer Parent and Investor Parent. In addition to any regularly scheduled meetings, and each party will cause its members any member of the Steering Committee to act reasonably, in good faith and consistent with may call a meeting of the terms and conditions of this AgreementSteering Committee on no less than 72 hours’ advance notice. The Steering Committee may take action only 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 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 unanimous written consent of all membersHSR Act no later than June 30, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty 2023.” (30p) calendar days, any Steering Committee member may submit it to the Executive Officers Article V of the parties for resolution. The initial SalesAgreement is hereby amended by adding new Section 5.20, Marketing Section 5.21, Section 5.22 and Distribution Plan Section 5.23, which shall be mutually agreed upon by Sankyo appear in their respective corresponding location immediately following Section 5.19 of the Agreement, and Cygnus.which shall read as follows:

Appears in 1 contract

Sources: Unit Purchase and Subscription Agreement (Ioneer LTD)

Steering Committee. Within twenty (20a) calendar days from Promptly after the Effective Date, the parties will form shall establish a Steering Committee consisting of three (3) people from each party joint committee (the “Steering Committee”). A representative from each party shall serve as co"STEERING COMMITTEE") having oversight responsibility for the day-chairpersons to-day management and performance of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateScreening Program. The Steering Committee shall meet at least quarterlyconsist of six (6) members, three (3) members to be appointed by each of NeoGenesis and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution PlanSPL. Each party may change shall notify the other party of the names and contact information for its members of the Steering Committee at any time upon written noticeCommittee, and each party will cause thereafter may with notice to the other substitute any of its members serving on the Steering Committee. Each member of the Steering Committee to act reasonablywill have one vote and all decisions of the Steering Committee will be by unanimous agreement. The quorum for Steering Committee meetings shall be two, in good faith provided there is at least one member from each of NeoGenesis and consistent with the terms and conditions of this AgreementSPL present. The Steering Committee will render decisions by unanimous vote. *= 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 Screening Program and shall in particular: (i) consider, review and amend the Screening Program from time to time in such manner as may take action only by be appropriate; (ii) monitor progress of the unanimous written consent Screening Program; (iii) report regularly to the management of all members, as indicated by all members signing both parties upon the written minutesprogress of the Screening Program; and (iv) be the initial medium for transfer of information between the parties. If an issue remains unresolved after good faith consideration by SPL shall keep the Steering Committee for 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) calendar days, any days of receipt of such minutes). (d) In the event that the Steering Committee member may submit it is unable to reach agreement, the issue in dispute shall be referred to an "OVERSIGHT COMMITTEE" consisting of the Executive Officers Vice President, Discovery Research of the parties Schering-Plough Research Institute (an Affiliate of SPL) and NeoGenesis' Chief Executive Officer, or their respective designees, for resolution. The initial SalesIf the disagreement is not resolved by the Oversight Committee within thirty (30) days, Marketing then SPL shall have the right to make the final decision on such matter; PROVIDED, that in the event and Distribution Plan to the extent that any dispute concerns whether or not budgeted FTE funding for the Screening Program has been expended in accordance with the provisions of this Agreement such matter shall be mutually agreed upon by Sankyo and Cygnusresolved using the procedure specified in Section 9.1.

Appears in 1 contract

Sources: Confidentiality Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. 23.1 Within twenty thirty (2030) calendar days from following the Effective Date, Date the parties will form a Steering Committee consisting of three (3) people from each party (shall establish the Steering Committee”). A representative from each party shall serve as co-chairpersons . 23.2 The membership of the Steering Committee shall be comprised of two representatives of each party. 23.3 Each party may, from time to time, replace those members appointed by it to the Steering Committee at will and upon notice to the other party. 23.4 Each party shall ensure that the 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 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 establish one be agreed by 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 matters which this agreement requires to be resolved or more subcommittees as appropriate. managed by the Steering Committee. 23.7 The Steering Committee shall meet at least quarterlywhere and when it determines, and shall document their meetings in written minutes, toprovided that: (a) review the sales, marketing and distribution each of the Product in the Territory, including its meetings shall be at a review and update of the Sales, Marketing and Distribution Plan at least annuallylocation reasonably accessible to all its members; (b) discuss actions its members shall be entitled to xxxxxx the attainment of sales objectivesattend its meetings by telephone and that suitable telephone facilities are present at its meetings to enable this; (c) review current marketingit shall meet no less than once every six (6) months, distributionthe first meeting to be within six (6) months of the Effective Date, sales and pricing strategies, including amount and form of discount and rebate programs;otherwise within a reasonable time to determine any matter referred to it; and (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant it shall meet on no less than two (2) weeks' notice to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change 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 shall discharge its functions set out in clause 23.6 in such manner as it reasonably sees fit. All decisions shall be made by vote of the Steering Committee members, 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 any time upon written notice, least one representative of each of Protherics and each party will cause its members the Licensee. 23.10 All decisions 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 indicated 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 shall be notified 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.Alliance Managers within five (5)

Appears in 1 contract

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

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will The Parties shall form a Steering Committee consisting of three to which each Party will delegate two (32) people from each party (executive employees, who are familiar with the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering CommitteeProject. The Steering Committee may establish one or more subcommittees as appropriateshall have general oversight and review of the activities of the Project Team and shall be responsible for resolving any issues referred to the Steering Committee by the Parties. The Steering Committee shall meet at least in person or via teleconferences within [***] after a written request by either Party to the other Party, or sooner, if required, and calendar quarterly, and shall document their meetings in written minutes, to: (a) review if possible towards the sales, marketing and distribution end of a stage of the Product Project. The request shall describe the matter in dispute and the Territorysolution which the requesting Party proposes to be decided. The Steering Committee will take action by unanimous consent of its members, including with each representative having a review and update single vote, or by a written resolution signed by all of the Salesrepresentatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, Marketing then the matter will be referred to a personal face-to-face meeting between Lonza's [***] and Distribution Plan at least annually; (b) the [***] of Micromet, who in each case may not be a member of the Steering Committee and both of whom shall act in good faith and discuss actions the issue to xxxxxx seek a resolution amicably acceptable to both Parties and if resolved the attainment resolution shall be binding and final. The meeting shall take place within [***] of sales objectives; (c) review current marketingthe relevant referral. In case such persons cannot agree within further [***] after such face-to-face meeting, 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 then the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1;following shall apply: (i) reviewIf the dispute is predominantly concerned with scientific or technical issues then the entire dispute shall be referred to independent experts on who the Parties agree as set forth hereinafter: Each Party is entitled to propose one (1) independent expert 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 English language within [***] after the second expert has been appointed. If the two (2) experts come to dissenting opinions and are unable to solve the dispute among themselves, a third expert shall be appointed either jointly by the Parties or by the President of the German Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie, BPI), if the Parties cannot agree, who is an expert in the particular scientific or technical area at issue and who shall act as an expert and not an arbitrator. Such third expert shall have access to the written opinions of the two other experts as well as to all documents which were made available to the two experts. The third expert shall then approve either one of the two opinions of the first two experts, and such opinion approved by the third expert shall be considered final and binding on the Parties except if necessarythere has been a manifest error on the face of the decision whereupon the Parties may revert to their respective remedies under Clause 16 below. The reasonable costs of the experts shall be paid or refunded, amend as the schedule set forth case may be, by the non-prevailing Party. *** Certain confidential information contained in Exhibit C hereto;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 amended. (jii) resolve any disputes pursuant to Section 7.1; and (k) agree upon If the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent dispute is predominantly concerned with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated 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 other than scientific or technical then 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 Cygnusresolved in accordance with Clause 16 below.

Appears in 1 contract

Sources: Development and Supply Agreement (Micromet, Inc.)

Steering Committee. Within twenty (20a) calendar days from The Research Program and the Effective Date, Development Program shall be conducted under the parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons overall direction of the Steering CommitteeCommittee comprised of four (4) members, with two (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 be the same committee as the Steering Committee established by the Collaboration Agreement. All actions of the Steering Committee with respect to the activities contemplated by this Agreement shall be governed by the terms of this Agreement. The initial members of the Steering Committee shall be: (a) for Ligand, D. Rxxxxxxx xxx A. Negro-Vilar, and (b) for Lilly, J. Hxxxxx xxx J. Cxxx. *** Either party may establish change its representative on the Steering Committee at any time by prior written notice to the other party. The party hosting the meeting of the Steering Committee shall prepare and deliver to the other party one or more subcommittees as appropriateweek 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 form 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 at least quarterlyonce in each Calendar Quarter, at such times and shall document their meetings in written minutesplaces as are agreed to by Ligand and Lilly, to: (a) review alternating between San Diego and Indianapolis, or such other locations as the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written noticeshall agree. Meetings of the Steering Committee may be 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 will cause its as the members of the Steering Committee may from time to act reasonablytime agree, in good faith and consistent but only members of the Steering Committee 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 terms provisions of this Agreement relating to the scheduling and conditions conduct of the meetings of all committees established pursuant to this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated 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 dispute regarding any Steering Committee member may submit it such amendment or waiver shall not be subject to the Executive Officers dispute resolution provisions of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and CygnusSection 2.6.

Appears in 1 contract

Sources: Development and License Agreement (Ligand Pharmaceuticals Inc)

Steering Committee. 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 twenty ten (2010) calendar days from after the Effective Date, each of the parties will form a Steering Committee consisting of Parties shall appoint three (3) people from each party persons to serve as its representatives on a joint steering committee (the "Steering Committee"). A representative from each party Each Party shall serve as co-chairpersons have the right to change any or all of its representatives on the Steering CommitteeCommittee upon written notice to the other Party. The Steering Committee may establish one shall: (a) Establish the Development Plan, including without limitation milestones, go/no-go criteria, timelines and responsibilities, and ensure that each Party completes its respective work in compliance 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 more subcommittees as appropriatethat 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 not less frequently than once per calendar quarter during the Development Period, on such dates and at least quarterlysuch times as agreed to by the Parties. All decisions made or actions taken by the Steering Committee shall be made unanimously, and shall document their meetings in written minutes, to: with each Party entitled to one (a1) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planvote. Each party may change its members A quorum of the Steering Committee shall consist of two members, provided that at any time upon written notice, and least one member appointed by each party will cause its members Party is present. Members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions may attend a meeting of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for either in person or by telephone conference call, but not by proxy. In the event of a deadlock vote regarding a matter before the Steering Committee, the Responsible Executives of the Parties shall meet to resolve the matter. If resolution of the matter is not achieved by the Responsible Executives of the Parties within thirty (30) calendar daysdays of the deadlock vote, TGC shall have the right to resolve such deadlock until the start of the first Phase II Clinical Trial; provided, however, that Medeva shall have the right to resolve any Steering Committee member may submit it deadlock with respect to the Executive Officers design and location of Phase II Clinical Trials and the parties for resolution. The initial Sales, Marketing and Distribution Plan determination of which Party shall be mutually agreed upon by Sankyo and Cygnusresponsible to conduct such trials. Thereafter, Medeva shall have the right to resolve any deadlock.

Appears in 1 contract

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

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. 6.1 The Steering Committee may establish shall 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 shall have one vote. 6.3 The Steering Committee shall be chaired by the Project Co-ordinator or more subcommittees as appropriatehis Deputy. The Steering Committee shall meet 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 quarterlyfourteen (14) calendar days prior written notice and who shall include the agenda in the notice. Shorter notice may be given subject to prior approval thereof by all Steering Committee members and items may be added to the agenda during the meeting if so agreed by all Steering Committee members present at the meeting. Minutes of the meetings of the Steering Committee 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 writing to the chairperson. 6.5 Decisions shall be taken by a majority of two-thirds of the votes of the Steering Committee 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 document their meetings in written minutes, toparticular: (a) review ensure the sales, marketing and distribution implementation of decisions taken by the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annuallyGoverning Board; (b) discuss actions to xxxxxx monitor the attainment progress of sales objectivesthe work and review Project Deliverables; (c) review current marketing, distribution, sales and pricing strategies, including amount and form assist the Co-ordinator in ensuring compliance by the Parties of discount and rebate programstheir obligations under the Grant Agreement; (d) coordinate activities between Sankyo take executive decisions on administrative and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii);scientific issues, (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, adopt or amend the schedule set forth in Exhibit C heretoProject Management Plan; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 indicated 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 1 contract

Sources: Consortium Agreement

Steering Committee. Within twenty 2.6.1 A Steering Committee composed of two representatives who are employees of each Party (20beginning 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) calendar days from will meet quarterly until the Effective DateTermination 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 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 xxxxxx a spirit of collaboration between the Parties and oversee and coordinate each Party's activities to optimize capital efficiency. The Steering Committee 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 parties will form a 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 consisting will also be responsible for final approval of three resourcing and for resolving any disputes of the Technical Committee where there is a deadlock. Firmenich (3and, at Firmenich's request, Amyris) people from each party (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 the 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 Steering Committee in this Agreement or later assigned to the Steering Committee by written agreement of the Parties. 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 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 serve as co-chairpersons be signed or acknowledged by all members of the Steering Committee. The Steering Committee 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 Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 indicated 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 1 contract

Sources: Collaboration Agreement (Amyris, Inc.)

Steering Committee. Within twenty (20a) calendar days from Promptly after the Effective Date, the parties will form shall establish a Steering Committee consisting of three (3) people from each party joint committee (the “Steering Committee”). A representative from each party shall serve as co"STEERING COMMITTEE") having oversight responsibility for the day-chairpersons to-day management and performance of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateScreening Program. The Steering Committee shall meet at least quarterlyconsist of six (6) members, three (3) members to be appointed by each of NeoGenesis and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution PlanSchering. Each party may change shall notify the other party of the names and contact information for its members of the Steering Committee at any time upon written noticeCommittee, and each party will cause thereafter may with notice to the other substitute any of its members * = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. serving on the Steering Committee. Each member of the Steering Committee to act reasonablywill have one vote and all decisions of the Steering Committee will be [*]. The quorum for Steering Committee meetings shall be two, in good faith provided there is at least one member from each of NeoGenesis and consistent with the terms and conditions of this AgreementSchering present. The Steering Committee will render decisions by [*]. (b) The Steering Committee shall be responsible for the management and conduct of the Screening Program and shall in particular: (i) consider, review and amend the Screening Program from time to time in such manner as may take action only by be appropriate; (ii) monitor progress of the unanimous written consent Screening Program; (iii) report regularly to the management of all members, as indicated by all members signing both parties upon the written minutesprogress of the Screening Program; and (iv) be the initial medium for transfer of information between the parties. If an issue remains unresolved after good faith consideration by Schering shall keep the Steering Committee for reasonably informed of the status of Schering'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) calendar days, any days of receipt of such minutes). (d) In the event that the Steering Committee member may submit it is unable to reach agreement, the issue in dispute shall be referred to an "OVERSIGHT COMMITTEE" consisting of the Executive Officers Vice President, Discovery Research of the parties Schering-Plough Research Institute (an Affiliate of Schering) and NeoGenesis' Chief Executive Officer, or their respective designees, for resolution. The initial SalesIf the disagreement is not resolved by the Oversight Committee within thirty (30) days, Marketing then Schering shall have the right to make the final decision on such matter; PROVIDED, that in the event and Distribution Plan to the extent that any dispute concerns whether or not budgeted FTE funding for the Screening Program has been expended in accordance with the provisions of this Agreement such matter shall be mutually agreed upon by Sankyo and Cygnusresolved using the procedure specified in Section 9.1.

Appears in 1 contract

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

Steering Committee. Within twenty To facilitate the manufacture of Product hereunder, NOVEN and P&GP shall each, within thirty (2030) calendar days from of the Effective Date, the parties will form nominate representatives from their respective employees, full time consultants or Affiliates to a Steering Committee consisting of three (3) people from each party (the “Steering Committee”)) to serve in an advisory capacity with respect to their respective obligations under this Agreement to (a) review manufacturing operations for the purpose of considering, proposing and developing improvements to the ordering and manufacturing process and to the way the parties communicate and interact, (b) consider strategic planning and facilitate manufacturing operations, (c) provide ongoing advisory services with respect to manufacturing services hereunder, and (d) attempt to resolve amicably any disputes arising between NOVEN and P&GP with respect to day-to-day operations. A representative from each The Steering Committee is intended to provide a mechanism to xxxxxx a better working relationship between the parties. Except as otherwise expressly provided herein, the Steering Committee shall not have any authority or responsibility hereunder or require any matter to be brought (and no party shall serve be required to bring any matter) before the Steering Committee prior to pursuing any available remedy. Furthermore, no action of the Steering Committee shall conflict or be inconsistent with the terms of this Agreement absent an amendment to this Agreement agreed to by the parties in writing. NOVEN and P&GP shall appoint as co-chairpersons members of the Steering Committee a reasonable number of suitably qualified and experienced representatives of each of NOVEN and P&GP and shall each designate one member appointed by it to be the principal contact in relation to the day to day management of and administration of this Agreement. Each of NOVEN and P&GP shall appoint no more than four persons to the Steering Committee. The Steering Committee shall meet at regular intervals on such dates and at such locations as may establish one be agreed upon by NOVEN and P&GP, in person or more subcommittees as appropriateby video or telephone conference. The In particular, the Steering Committee shall strive to meet at least quarterlyonce per quarter, but in any event shall meet no less than twice per year during the Term unless otherwise agreed by NOVEN and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 AgreementP&GP. The Steering Committee may take action only also meet upon fifteen (15) days’ written request by the unanimous written consent of all memberseither NOVEN or P&GP, as indicated should circumstances necessitate such a meeting, and if requested by all members signing the written minutes. If either party, an issue remains unresolved after good faith consideration by the expanded Steering Committee will meet to discuss forecasting assumptions and other information regarding market conditions and expected demand 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 CygnusProduct.

Appears in 1 contract

Sources: Supply Agreement (Noven Pharmaceuticals Inc)

Steering Committee. Within twenty 5.1 The 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 Committee include: (20i) calendar days from 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, the parties will form a Steering Committee consisting of three this cannot be guaranteed); (3ii) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons regularly providing AEZS with information and an overview of the Steering Committee. 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 one or more subcommittees as appropriate. 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 of which would be chaired by AEZS). 5.3 The Steering Committee consists of an equal number (up to three (3) per Party) of representatives 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 meet 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 chairman for each subsequent meeting shall alternate between the Parties. A secretary of 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 secretary 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 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 tasks, however, at least calendar-quarterly, and shall document their . The meetings in written minutes, to: (a) review the sales, marketing and distribution of the Steering Committee may take place by teleconference, videoconference or face-to-face, whereby at least two (2) meetings per year ideally should take place face-to-face. Each Party 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 cost in connection with the work of the Steering Committee. 5.5 All decisions of the Steering Committee are to be made in good faith and in the best interest of the Agreement, shall be reflected in the minutes of the relevant meeting and the Parties shall use their reasonable efforts to take decisions unanimously. In the event that the Steering Committee is unable to agree on any matter after good faith attempts to resolve such disagreement 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 Chief Executive Officer of CH (or another appropriate representative of CH) which meeting shall take place within fourteen (14) days of the date of the relevant referral. If 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) for 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 vote of AEZS with appropriate consideration of the interests of CH shall be decisive; and (ii) 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 in the Territory), including a review and update the vote of CH with appropriate consideration of the Sales, Marketing and Distribution Plan at least annually; interests of AEZS shall be decisive. The decisive vote of AEZS or CH (bas the case may be) discuss actions may not lead to xxxxxx a financial burden of CH or AEZS respectively or amend or conflict with any of the attainment express terms of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form or override the rights 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 Parties pursuant to Section 2.1(ii); this Agreement. It is acknowledged that any decision of the JSC (e) review Sankyo’s efforts including any decisive vote of CH pursuant to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(hthis Section) in light relation to a change of marketing issues regarding the Product; (h) review SankyoBusiness Plan shall not be deemed to reduce CH’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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 indicated 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 Cygnus14.1.

Appears in 1 contract

Sources: License Agreement (Aeterna Zentaris Inc.)

Steering Committee. (a) Within twenty (20) calendar days from *_____* of the Effective Date, the parties Parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of establish the Steering Committee. The Steering Committee may establish one or more subcommittees will be composed of *_____*. Such representatives will include individuals with expertise and responsibilities in areas such as appropriate. The Steering Committee shall meet at least quarterlypreclinical development, and shall document their meetings in written minutesclinical development, to: (a) review the salesprocess sciences, manufacturing, marketing and distribution or regulatory affairs. Either Party may replace any or all of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee representatives at any time upon written notice, and each party will cause its members of notice to the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreementother Party. The Steering Committee may take action only by the unanimous written consent of all memberswill meet (in person, telephonically, or via videoconference) at least once each calendar quarter, or more frequently, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration agreed to by the Steering Committee. (b) The Steering Committee shall: (i) coordinate development of the Licensed Product in the United States and in the Licensed Territory, in the Field, as envisaged in the Collaboration Agreement, including the coordination of activities and exchange of information regarding ongoing and new clinical studies, regulatory strategy and commercial development (including pricing and product positioning issues) and the establishment of 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 material impact on the Licensed Product in the other Party's territory; and (v) discuss collaboration in the development of the Licensed Product for thirty indications other than the Initial Indication. (30c) calendar daysThe 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 regulatory authority in the Licensed Territory the costs of such a study shall be borne, and its organization and structure shall be determined, solely by SCHERING. Where a study is required by the FDA the costs of such a study shall be borne, and its organization and structure shall be determined, solely by IDEC. If, however, any Steering Committee member may submit it to regulatory authority in the 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 for resolution. The initial SalesCommission in the Company's Application Requesting Confidential Treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusas amended.

Appears in 1 contract

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

Steering Committee. Within twenty 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 (202) calendar 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 nominate the members to the Steering Committee within thirty (30) days from 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 parties will form a Government shall be designated as the Chairman of the Steering Committee consisting and the alternative representative to the Chairman shall be designated as the Deputy Chairman. One of three 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:- (3a) people from each party 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”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). A representative from each party shall serve as co-chairpersons ; (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 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 (180) days, unless provided otherwise in the Contract, the matter shall be referred to the Government 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 may establish one or more subcommittees as appropriate. shall obtain such approval/ decision and convey the same to the Contractor with utmost expedition. 6.11 The Steering Committee shall meet at least quarterlyonce 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 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 document their meetings include in written minutes, to: (a) review the sales, marketing and distribution such notice a provisional agenda for such meeting. The Chairman shall be responsible for processing of the Product final agenda for such meeting and the agenda shall include all items of business requested by the members for inclusion, provided such requests are received by the Secretary at least ten (10) days prior to the date fixed for the meeting. The Secretary shall forward the agenda to the members at least nine (9) days prior to the date fixed for the meeting. Matters not included in the Territoryagenda may be taken up at the 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, including a review and update as may be the case, shall preside over the meetings of the SalesSteering Committee, Marketing and, in their absence, any other member representing Government and Distribution Plan at least annually;present shall preside over the meetings. (b) discuss actions 6.13 The Secretary to xxxxxx the attainment Steering Committee will be responsible, inter alia, for preparation of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form the minutes 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 every meeting in the Territory;English language and circulate to every member of the Steering Committee with two copies of the minutes not later than fourteen (14) days after the date of the meeting with the approval of the Chairman. (g) review Cygnus’ proposed product development as set forth 6.14 The meetings of the Steering Committee shall be held in Section 5.1(h) in light of marketing issues regarding India, unless otherwise mutually agreed by the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee 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 any time upon written notice, and each party will cause its members the meeting. 6.16 A member of the Steering Committee who is unable to act reasonably, in good faith attend a meeting may give prior written notice to all other members and consistent with appoint a member representing another Party who consents to such appointment as its proxy to attend a meeting and to exercise the terms and conditions of this Agreement. The Steering Committee may take action only appointing member’s right to vote at that meeting whether as directed by the unanimous written consent appointing member or otherwise. A member appointed as a proxy and attending a meeting shall be present in two separate capacities and vote accordingly. 6.17 There shall be a quorum of all members, as indicated 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 holding a meeting and making decisions with each Party to the Contract represented by at least one of its nominated members in the 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.either present in person or represented as per Article

Appears in 1 contract

Sources: Exploration and Production Agreement

Steering Committee. Within twenty (20) calendar days from the Effective DateIn order to monitor, the parties will form a Steering Committee consisting coordinate and facilitate implementation of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. The Steering Committee 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 Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, 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, 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 initial Steering Committee representatives shall be Xxxxxx X. Xxxxx, who shall also serve as the initial chairman of the Steering Committee, Xxx Wilhlelm, the divisional financial representative of Verso, and Xxxxxx X. Ashbumer, the divisional financial representative of NewPage. The Steering Committee may take action only representatives shall meet at least quarterly (or more frequently if needed or reasonably requested by a representative) during the unanimous written consent of all membersTerm to determine the Shared Services to be provided and the payments to be made pursuant to this Agreement. Such determination with respect to the Shared Services to be provided shall include the scope, as indicated by all members signing the written minutesmanner, level and place or places where such Shared Services shall be provided. If an issue remains unresolved after good faith consideration by the members of the Steering Committee for thirty are unable (30) calendar days, any whether by majority vote or in such other manner as the members of the Steering Committee member may submit it decide) to determine whether a Shared Service is to be provided, or the Executive Officers 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 the members of the parties for resolutionSteering Committee determine the relevant matters. The initial SalesSteering Committee representative(s) for NewPage or Verso, Marketing as the case may be, shall stay reasonably apprised of the activities of the employees, agents and Distribution Plan shall be mutually agreed upon by Sankyo contractors of NewPage or Verso, as the case may be, who are providing or receiving the Shared Services in order to maximize efficiency in the provision and Cygnusreceipt of the Shared Services.

Appears in 1 contract

Sources: Shared Services Agreement (Verso Paper Holdings LLC)

Steering Committee. Within twenty (20a) calendar days from Fiat and General Motors shall immediately after the Effective Date, the parties will form date hereof establish a Steering Committee consisting (the "Steering Committee"), which shall be comprised of three (3) people from members appointed by each party (party. Unless otherwise agreed to by the “Steering Committee”). A representative from each party shall serve as co-chairpersons of parties, the three members appointed to the Steering Committee. Committee by General Motors shall be the General Motors Worldwide President, the General Motors European operations President, the General Motors Latin America operations President and the three members to the Steering Committee appointed by Fiat shall be the Fiat CEO, the Fiat Auto Worldwide CEO, and the Fiat Auto Latin America CEO. (b) The Steering Committee may establish one or more subcommittees as appropriateshall have full power and responsibility for the supervision and governance of the Joint Ventures and the Credit Cooperative and the cooperation contemplated by Section 5.04 hereof. The Steering Committee shall meet at least quarterlyfocus exclusively on cooperation, development and achievement of synergies and the operation of the Joint Ventures and the Credit Cooperative, and shall document their meetings be responsible for (i) general oversight of the consummation of the Transactions, including, without limitation, implementation of this Agreement and the formation of the Joint Ventures and the Credit Cooperative, (ii) oversight of the management of the Joint Venture Businesses and the identification and implementation of any synergies in written minutessuch businesses, to: (aiii) the achievement of appropriate levels of synergies, (iv) review the sales, marketing and distribution approval of annual business plans for each of the Product in Joint Ventures and the TerritoryCredit Cooperative and (v) compliance with applicable Law, including a review antitrust and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives;competition Laws. (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 Steering Committee shall meet as frequently as the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if parties deem necessary, amend but at least four times per year. The selection of the schedule set forth time and place of the first meeting shall be made by Fiat and shall alternate between the parties for each meeting thereafter, in Exhibit C hereto; (j) resolve any disputes pursuant each case subject to Section 7.1; and (k) agree upon the initial Salesconsent of the other party, Marketing and Distribution Planwhich shall not be unreasonably withheld or delayed. Each party By the unanimous consent of its members, the Steering Committee may change its the location and frequency of such meetings. The members of the Steering Committee at any time upon written notice, and each appointed by one party will cause its members may call a special meeting of the Steering Committee at least twice per year upon providing reasonable notice to act reasonablythe other party. (d) In order to efficiently implement the provisions contained in this Article V, the parties shall identify suitable forms of collaboration, including, but not limited to, consortia, coordination centers, Groupement Europ-en d'Inter-t Economique ("GEIEs") or such other legal entity or branch structures which are the most tax efficient to both parties and which allow the proper functioning of the Steering Committee as a governance board of the Joint Ventures and the Credit Cooperative. (e) Fiat Auto Holdings shall establish an appropriate organizational structure and designate appropriate staff members to provide support to the Steering Committee. (f) The Steering Committee shall perform all responsibilities set forth in good faith this Section 5.05 in a manner which represents and is 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 indicated 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 principle of the parties for resolution. The initial Sales, Marketing independence and Distribution Plan shall be mutually agreed upon by Sankyo continued competitive relationship of Fiat and CygnusGeneral Motors.

Appears in 1 contract

Sources: Master Agreement (General Motors Corp)

Steering Committee. Within twenty (20a) calendar days from The Parties shall establish and maintain throughout the Effective Date, the parties will form term of this Agreement a Steering Committee consisting of three (3) people from each party committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of ) to oversee the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, implementation and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions operation of this Agreement. The Steering Committee may take action only by the unanimous written consent shall consist of all members, as indicated by all four people. Seller shall be entitled to appoint two members signing the written minutes. If an issue remains unresolved after good faith consideration by of the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it and Buyer shall be entitled to the Executive Officers appoint two members of the parties for resolutionSteering Committee. The initial Sales, Marketing and Distribution Plan members of the Steering Committee appointed by Seller shall be the Managing Director of Europe, Africa and The Middle East and the Director of U.S. Sales of Seller, and the initial members of the 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 members of the Steering Committee appointed by Seller and Buyer shall be entitled to remove and replace at any time one or more of the 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 being addressed in a satisfactory manner consistent with the broad principles of cooperation underlying the execution of this Agreement. If and to the extent the Steering Committee determines that such relevant interests are not being addressed in a fully satisfactory manner as contemplated herein, then they will attempt to agree on what action, if any, is required in view of their joint determination. Without limiting the foregoing, the Steering Committee shall meet to discuss: A. Product purchase prices under this Agreement 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, each Party will retain independent pricing authority and will determine on its own the pricing for its sales of Products to third parties. (c) Unless otherwise agreed by the Parties, through their representatives on the Steering Committee, until the first anniversary of the Effective Date, the Steering Committee shall 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, the Steering Committee shall meet as agreed upon by Sankyo and Cygnusthe Parties, through their representatives on the Steering Committee, but in no event shall the Steering Committee meet less than quarterly.

Appears in 1 contract

Sources: Proppant Supply Agreement (Carbo Ceramics Inc)

Steering Committee. Within twenty (20) calendar days from 4.1 MTC and the Effective Date, the parties will form Participating Cities agree to create and hereby establish a Steering Committee consisting to coordinate the activities of three (3) people the Program and make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from each party (the “Steering Committee”). A MTC, and one designated representative from each of the Participating Cities. Each party with a designated representative shall serve 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 co-chairpersons the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which 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. The Steering Committee may establish one or more subcommittees as appropriatewill be to reach decisions by a unanimous vote. The Steering Committee shall meet endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at least quarterlytwo Steering Committee meetings without reaching consensus, and shall document their meetings in written minutes, to: (a) review at the sales, marketing and distribution conclusion of the Product in second meeting, the Territorydecision will be made by MTC. In addition, if the Steering Committee has been unable to reach consensus on a material matter for 30 days since such matter was brought to the attention of the Steering Committee for any reason, including a review and update of failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions right to xxxxxx decide such matter. MTC shall also have the 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 right to make decisions on those matters that MTC reasonably believes are promoting the Product for Cygnus pursuant not material or to Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its make decisions after consulting with one or more members of the Steering Committee at whose Participating City may be disproportionately (or solely) affected by such decisions. In no event shall MTC have the right to make any time upon written notice, of the decisions enumerated in Section 33. 4.5 A party shall convey all communications and each party will cause its members of documents intended for the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreementthrough that party’s designated representative. The Steering 4.6 Decisions to be made by Steering Committee may take action only by shall include, but are not limited to: 4.6.1 Whether Operator is in Default, under Section 18 of the unanimous written consent of all membersProgram 4.6.2 KPI Adjustments, as indicated by all members signing described in Section 2.6.2(a) of the written minutes. If an issue remains unresolved after good faith consideration 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 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 or by Sankyo and Cygnus.MTC in accordance

Appears in 1 contract

Sources: Coordination Agreement

Steering Committee. Within twenty (20a) calendar days from Promptly after the Effective Date, the parties will form shall establish a Steering Committee consisting of three (3) people from each party joint committee (the “Steering Committee”). A representative from each party shall serve as co"STEERING COMMITTEE") having oversight responsibility for the day-chairpersons to-day management and performance of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateScreening Program. The Steering Committee shall meet at least quarterlyconsist of six (6) members, three (3) members to be appointed by each of NeoGenesis and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the 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 Section 2.1(ii); (e) review Sankyo’s efforts to develop 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 Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution PlanSPL. Each party may change shall notify the other party of the names and contact information for its members of the Steering Committee at any time upon written noticeCommittee, and each party will cause thereafter may with notice to the other substitute any of its members serving on the Steering Committee. Each member of the Steering Committee to act reasonablywill have one vote and all decisions of the Steering Committee will be by [*]. The quorum for Steering Committee meetings shall be two, in good faith provided there is at least one member from each of NeoGenesis and consistent with the terms and conditions of this AgreementSPL present. The Steering Committee will render decisions by [*]. * = 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 Screening Program and shall in particular: (i) consider, review and amend the Screening Program from time to time in such manner as may take action only by be appropriate; (ii) monitor progress of the unanimous written consent Screening Program; (iii) report regularly to the management of all members, as indicated by all members signing both parties upon the written minutesprogress of the Screening Program; and (iv) be the initial medium for transfer of information between the parties. If an issue remains unresolved after good faith consideration by SPL shall keep the Steering Committee for 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) calendar days, any days of receipt of such minutes). (d) In the event that the Steering Committee member may submit it is unable to reach agreement, the issue in dispute shall be referred to an "OVERSIGHT COMMITTEE" consisting of the Executive Officers Vice President, Discovery Research of the parties Schering-Plough Research Institute (an Affiliate of SPL) and NeoGenesis' Chief Executive Officer, or their respective designees, for resolution. The initial SalesIf the disagreement is not resolved by the Oversight Committee within thirty (30) days, Marketing then SPL shall have the right to make the final decision on such matter; PROVIDED, that in the event and Distribution Plan to the extent that any dispute concerns whether or not budgeted FTE funding for the Screening Program has been expended in accordance with the provisions of this Agreement such matter shall be mutually agreed upon by Sankyo and Cygnusresolved using the procedure specified in Section 9.1.

Appears in 1 contract

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