Common use of Collaboration Committee Clause in Contracts

Collaboration Committee. (a) The Collaboration Committee shall be charged with responsibility for overseeing and managing the collaboration, marketing and further development of the Product in accordance with the terms of this Agreement, including the establishment and approval of an annual Collaboration Plan, Clinical Study Plan and Promotional Budget. The Collaboration Committee shall be comprised of an equal number of representatives from each party representing the sales, marketing and clinical functions of each party, including the personnel identified on Exhibit 3.8 attached hereto. The Collaboration Committee shall be co-chaired by representatives from Abbott and Cephalon throughout the Collaboration Period. The chair shall be responsible for preparing and distributing the agenda to members in advance of each meeting and for the preparation of minutes for each meeting. In addition to the representatives identified on Exhibit 3.8, it is understood that from time to time additional personnel having specialized experience and training may be requested to assist the Collaboration Committee, including, but not limited to, regulatory, finance, legal, and medical personnel, et. al. Furthermore, upon mutual agreement of the parties, membership on the Collaboration Committee may be expanded or reduced in equal measure from time to time to include additional (or fewer) personnel from each party. The Collaboration Committee shall have the right to establish subcommittees containing any of such members and having such charter(s) as the Collaboration Committee may designate from time to time. The Collaboration Committee shall also have the right to delegate duties to individual designees of each party (i.e., product managers, clinical development managers, et. al.), with the authority to make decisions relevant to their delegated duties, so long as such designees regularly apprise the Collaboration Committee of their activities. The Collaboration Committee shall also have the right to rescind the delegation of any such duties to designees. All matters relating to the responsibilities of the Collaboration Committee (or such duties delegated to designees of the Collaboration Committee) that cannot be resolved shall be referred by any member of the Collaboration Committee to Xxxxxx'x Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaid, the matter shall be submitted to alternative dispute resolution in accordance with Section 18.7 hereof. (b) In accordance with their respective promotional obligations under this Agreement, Abbott and Cephalon shall work together to promote the Product in the Territory and shall present their views on the marketing and promotion of the Product by means of the Collaboration Committee. The Collaboration Committee, by itself or through its designees, shall develop strategies for the promotion of the Product and undertake the activities necessary to implement those strategies, which may include coordinating the parties' detailing messages, methodologies, and their physician and trade targeting and call programs, approving the target list of physicians for detailing efforts, and reviewing Promotional Materials. The parties also agree to share freely with each other all market research data pertaining to the Product that currently exists or that may be generated for a party during the Collaboration Period, subject, however, to the receiving party's obligation to treat such data as Confidential Information pursuant to Article 14. (c) The parties agree that Abbott shall have sole discretion with respect to pricing decisions for the Product, but that the only price increases, price decreases, discounts, allowances or rebates offered by Abbott regarding the Product shall be those that are extended by Abbott in good faith and consistent with price increases, price decreases, discounts, allowances or rebates extended by Abbott on other Abbott products in the ordinary course of business. Abbott agrees that it will not sell the Product in a bundle arrangement with other Abbott products without the prior written approval of the Collaboration Committee. (d) Both parties acknowledge that the minimum level and specifics of each party's detailing obligations shall be as set forth in Sections 3.1(b) and 4.4(a). (e) The parties shall take all necessary steps to ensure that all activities of the Collaboration Committee are performed in compliance with applicable Federal, state and local laws and regulations of the Territory. (f) Within sixty (60) days after the date of this Agreement, representatives of the parties' Quality Assurance departments shall meet to develop and approve a Quality Manual outlining responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Manual include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with FDA current Good Manufacturing Practices, compliance with PDMA and such other quality related concerns deemed appropriate. (g) In addition, the Collaboration Committee shall review the pricing of Sample Packs on an annual basis in accordance with Section 3.6(a).

Collaboration Committee. (a) The Promptly after the date hereof, the parties shall form a Collaboration Committee Committee, which shall be charged with responsibility for overseeing and managing the collaboration, marketing and further development of the Product in accordance with the terms of this Agreement, including the establishment and approval of an annual Collaboration Plan, Clinical Study Plan and Promotional Budget. The Collaboration Committee shall be comprised consist of an equal number of representatives from of each party representing the sales, marketing and clinical functions of (expected to be three to five representatives for each party, including the personnel identified on Exhibit 3.8 attached hereto). The Collaboration Committee shall be co-chaired by representatives from Abbott review and Cephalon throughout approve the Collaboration Period. The chair shall be responsible for preparing and distributing the agenda to members in advance of each meeting and protocols for the preparation of minutes for each meeting. In addition Studies and all other activities to be undertaken pursuant to the representatives identified on Exhibit 3.8Program, it is understood that from time including work plans and cost estimates therefor. Each party shall designate its own members to time additional personnel having specialized experience and training may be requested to assist the Collaboration Committee, includingand shall notify the other party in writing if it changes or substitutes any of its members. (b) The Collaboration Committee shall meet at such times as it may select, but not limited to, regulatory, finance, legal, and medical personnel, etin any case at least once in each calendar quarter during the term of this Agreement. al. Furthermore, upon mutual agreement The meetings shall alternate between the offices of the parties, membership on the Collaboration Committee may be expanded or reduced in equal measure from time to time to include additional (or fewer) personnel from each party. The Collaboration Committee shall have the right to establish subcommittees containing may meet in person, by telephone or by video conference, and individual members may participate in any of such members and having such charter(s) as the Collaboration Committee may designate from time to timeforegoing ways. The Collaboration Committee shall also have the right to delegate duties to individual designees of each party (i.e., product managers, clinical development managers, et. al.), with the authority to make decisions relevant to their delegated duties, so long as such designees regularly apprise the Collaboration Committee of their activities. The Collaboration Committee shall also have the right to rescind the delegation of any such duties to designees. All matters relating to the responsibilities of the Collaboration Committee (or such duties delegated to designees of the Collaboration Committee) that cannot be resolved shall be referred by any If a member of the Collaboration Committee is unavailable for any meeting, such member may designate a substitute to Xxxxxx'x Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaid, the matter shall be submitted to alternative dispute resolution in accordance with Section 18.7 hereof. (b) In accordance with their respective promotional obligations under this Agreement, Abbott and Cephalon shall work together to promote the Product participate in the Territory and shall present their views on member's place. The costs of participation by each member in the marketing and promotion of the Product by means activities of the Collaboration Committee. The Collaboration Committee, Committee shall be borne by itself or through its designees, shall develop strategies for the promotion of the Product and undertake the activities necessary to implement those strategies, which may include coordinating the parties' detailing messages, methodologies, and their physician and trade targeting and call programs, approving the target list of physicians for detailing efforts, and reviewing Promotional Materials. The parties also agree to share freely with each other all market research data pertaining to the Product that currently exists or that may be generated for a party during the Collaboration Period, subject, however, to the receiving party's obligation to treat appointing such data as Confidential Information pursuant to Article 14member. (c) The parties agree that Abbott Collaboration Committee shall have sole discretion with respect to pricing decisions for the Product, but that the only price increases, price decreases, discounts, allowances or rebates offered by Abbott regarding the Product a secretary who will keep minutes of its meetings. The secretary shall be those that are extended selected on a rotating basis each year by Abbott in good faith and consistent with price increases, price decreases, discounts, allowances or rebates extended by Abbott on other Abbott products in the ordinary course of business. Abbott agrees that it will not sell the Product in a bundle arrangement with other Abbott products without the prior written approval one of the Collaboration Committeeparties. (d) Both parties acknowledge The presence at any meeting of the Collaboration Committee of at least two members from each party shall constitute a quorum for purposes of any action by the Collaboration Committee. Each member will have one vote, and action shall be authorized by a majority of the votes, so long as the majority vote includes at least one vote cast by a member selected by each party. In the event that the minimum level and specifics Collaboration Committee cannot agree on the protocol for, or the execution of, the Metastases Studies, ALZA will have the tie-breaking vote. If (i) Alkermes disagrees with ALZA's resolution of each party's detailing obligations shall THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH A *** AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. any matter related to the Metastases Studies pursuant to such tie-breaking vote, or (ii) if ALZA disagrees with Alkermes' resolution of a matter relating to a new clinical study (other than the primary Phase III glioma study being planned by Alkermes as of the date hereof) under Section 3.1 (e)(iii) pursuant to a tie-breaking vote, or (iii) if the Collaboration Committee is unable to obtain the vote required with respect to any other matters, then the matter may be as set forth referred to dispute resolution by either party in Sections 3.1(b) and 4.4(a)accordance with Section 7.1. (e) The parties shall take all necessary steps Collaboration Committee will be responsible for (i) approving the amendments, if any, to ensure the protocols for the Studies; (ii) reviewing ongoing clinical activities concerning the Product, (iii) approving new clinical studies of the Product (other than the Studies); provided, however, that all activities of in the event that the Collaboration Committee are performed in compliance with applicable Federalcannot agree on the protocol for, state and local laws and regulations or execution of, such new clinical studies of the Territory. Product, Alkermes will have the tie-breaking vote; (fiv) Within sixty reviewing periodically, during the course of the studies (60including the Studies) days and after the date of they are completed, all Product-related clinical data and related information; (v) reviewing and approving work plans and cost estimates for all development and clinical activities to be undertaken pursuant to this Agreement, representatives of ; (vi) reviewing the parties' Quality Assurance departments shall meet Development Costs incurred by the parties under this Agreement; (vii) reviewing all proposed Product-related regulatory filings prior to develop submission; and approve a Quality Manual outlining responsibilities and key contacts for quality and compliance (viii) coordinating all communication with regulatory agencies concerning regulatory filings related issues. Items to be included in the Quality Manual include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with FDA current Good Manufacturing Practices, compliance with PDMA and such other quality related concerns deemed appropriateProduct. (g) In addition, the Collaboration Committee shall review the pricing of Sample Packs on an annual basis in accordance with Section 3.6(a).

Collaboration Committee. (a) 4.1 The Parties shall establish a Collaboration Committee ("CC") which shall be charged with responsibility for overseeing the management and managing the collaboration, marketing and further development administration of the Product Collaboration and the promotion, distribution and sale of the Products in accordance with the terms of this Agreement, including the establishment and approval of an annual Collaboration Plan, Clinical Study Plan and Promotional BudgetTerritory. The Collaboration Committee shall be comprised of an equal number of representatives from each party representing the sales, marketing and clinical functions of each party, including the personnel identified on Exhibit 3.8 attached hereto. The Collaboration Committee shall be co-chaired by representatives from Abbott and Cephalon throughout the Collaboration Period. The chair shall be responsible for preparing and distributing the agenda to members in advance of each meeting and for the preparation of minutes for each meeting. In addition to the representatives identified on Exhibit 3.8, it is understood that from time to time additional personnel having specialized experience and training may be requested to assist the Collaboration Committee, including, but not limited to, regulatory, finance, legal, and medical personnel, et. al. Furthermore, upon mutual agreement of the parties, membership on the Collaboration Committee may be expanded or reduced in equal measure from time to time to include additional (or fewer) personnel from each party. The Collaboration Committee CC shall have the right responsibility to establish subcommittees containing any take all decisions as to the marketing of such members the Products, their manufacture and having such charter(s) as distribution, the approval of the Annual Operating Plan **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission. pursuant to Clause 7 and the setting of annual budgets and forecasts for the Collaboration Committee may designate from time to time. The Collaboration Committee shall also have the right to delegate duties to individual designees of each party (i.e., product managers, clinical development managers, et. al.), with the authority to make decisions relevant to their delegated duties, so long as such designees regularly apprise the Collaboration Committee of their activities. The Collaboration Committee shall also have the right to rescind the delegation of any such duties to designees. All matters relating to the responsibilities of the Collaboration Committee (or such duties delegated to designees of the Collaboration Committee) that cannot be resolved shall be referred by any member of the Collaboration Committee to Xxxxxx'x Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaid, the matter shall be submitted to alternative dispute resolution in accordance with Section 18.7 hereof. (b) In accordance with their respective promotional obligations under this Agreement, Abbott and Cephalon shall work together to promote the Product in the Territory and shall present their views on the marketing have full authority and promotion of the Product by means of the Collaboration Committee. The Collaboration Committee, by itself or through its designees, shall develop strategies for the promotion of the Product and undertake the activities necessary to implement those strategies, which may include coordinating the parties' detailing messages, methodologies, and their physician and trade targeting and call programs, approving the target list of physicians for detailing efforts, and reviewing Promotional Materials. The parties also agree to share freely with each other all market research data pertaining to the Product that currently exists or that may be generated for a party during the Collaboration Period, subject, however, to the receiving party's obligation to treat such data as Confidential Information pursuant to Article 14. (c) The parties agree that Abbott shall have sole discretion with respect to pricing decisions the management of the Collaboration, subject to (i) the authority of the EC in certain matters as set out in Clause 5 and (ii) the budget for the Product, but that first three years of the only price increases, price decreases, discounts, allowances or rebates offered Collaboration being set out in Schedule 4 hereto. 4.2 The CC shall comprise six members of whom three shall be appointed by Abbott regarding the Product each of Cephalon ("Cephalon Members") and Novartis ("Novartis Members"). The initial CC members shall be those persons listed in Schedule 6 Part I. 4.3 A Party may remove any CC Member appointed by it and appoint any person in his place. Any appointment or removal shall be in writing signed by the appointing Party and shall take effect (unless the appointment or removal specifies to the contrary) upon delivery to the other Party of the appropriate notice. The Parties shall procure that are extended the persons appointed to the CC shall be suitably qualified and experienced to carry out the responsibilities thereof as set out herein in a competent and professional manner. 4.4 The provisions of this Clause 4.4 shall apply to meetings of the CC: 4.4.1 No business shall be transacted at any meeting of the CC unless at least one member appointed by Abbott in good faith Cephalon and consistent with price increases, price decreases, discounts, allowances or rebates extended one member appointed by Abbott on other Abbott products Novartis is present. The Cephalon Members shall collectively have one vote and the Novartis Members shall collectively have one vote and in the ordinary course event that the Cephalon Members or the Novartis Members shall not agree as to which way to exercise their respective collective vote they shall be deemed to have voted against the proposed resolution in question; 4.4.2 A resolution of businessthe CC shall be binding on the Parties if approved by the collective vote of the Cephalon Members present and the collective vote of the Novartis Members present and reflected in minutes of the relevant meeting signed by a Cephalon Member and a Novartis Member; **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. Abbott agrees that it will not sell The omitted portions have been filed separately with the Product Commission. 4.4.3 Meetings of the CC shall take place alternately at premises nominated by Cephalon and premises nominated by Novartis. It shall be the responsibility of the Party at whose premises a meeting is to take place to prepare and issue a notice of meeting, agenda and minutes of the meeting and to nominate the Chairman of the meeting; 4.4.4 Not less than 5 Working Days' notice of any meeting of the CC (including a detailed agenda) shall be given to each of the CC Members unless such notice is waived by all the CC Members. 4.5 Any CC Member may participate in a bundle arrangement meeting of the CC by means of a conference telephone, video link or similar communicating equipment whereby all persons participating in the meeting can hear each other. Resolutions and decisions of the kind normally made or taken at a physical meeting of the CC can accordingly be so made or taken in circumstances where none or only some of the CC Members are physically present with other Abbott products each other. Such a meeting shall be deemed to take place where the largest group of those participating is assembled, or, if there is no such group, where the chairman of the meeting is. 4.6 A meeting of the CC shall be held on a quarterly basis (unless otherwise agreed) for the purpose, without limitation, of: (i) reviewing all financial information and reports provided under Clause 7.2 during or in respect of the prior written approval previous quarterly period or in respect of any accounting period terminating at the end of that period; (ii) reviewing the cash flow and funding position of the Collaboration Committee.during such quarterly period and considering, and if thought fit, approving any measures necessary for easing any adverse situation in the ensuing periods; (diii) Both parties acknowledge that reviewing and approving the minimum level and specifics of each party's detailing obligations shall be as set forth in Sections 3.1(b) and 4.4(a).Annual Operating Plan for the Collaboration for the following year presented by the Operating Committee pursuant to Clause 7.2; and (eiv) The parties shall take all necessary steps reporting to ensure that all activities the Executive Committee in respect of the Collaboration Committee are performed in compliance with applicable Federal, state and local laws and regulations of the Territory. (f) Within sixty (60) days after the date above matters. **Certain portions of this Agreement, representatives of exhibit have been omitted based upon a request for confidential treatment that has been filed with the parties' Quality Assurance departments shall meet to develop and approve a Quality Manual outlining responsibilities and key contacts for quality and compliance related issuesCommission. Items to be included in The omitted portions have been filed separately with the Quality Manual include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with FDA current Good Manufacturing Practices, compliance with PDMA and such other quality related concerns deemed appropriateCommission. (g) In addition, the Collaboration Committee shall review the pricing of Sample Packs on an annual basis in accordance with Section 3.6(a).

Collaboration Committee. (a) The Collaboration Committee Promptly after the Effective Date, the parties shall establish a committee with the duties and responsibilities set forth in this Agreement that shall be charged with responsibility for overseeing comprised of personnel from Focal and managing Genzyme (the collaboration, marketing and further development of the Product in accordance with the terms of this Agreement, including the establishment and approval of an annual "Collaboration Plan, Clinical Study Plan and Promotional BudgetCommittee"). The Collaboration Committee shall include four (4) voting members, two (2) of whom shall be comprised appointed by Genzyme and two (2) of an equal number whom shall be appointed by Focal. Each party shall make its designation of its initial representatives from each not later than fifteen (15) days after the Effective Date. Each party representing shall use reasonable efforts to designate as its representatives, individuals that shall have the sales, marketing requisite experience and clinical functions of each party, including knowledge to oversee the personnel identified commercialization activities contemplated by this Agreement. Vacancies on Exhibit 3.8 attached hereto. The the Collaboration Committee shall be co-chaired by representatives from Abbott and Cephalon throughout filled within ten (10) days after the date such vacancy occurs. In addition, each party may designate any number of additional persons to serve as advisors to the Collaboration PeriodCommittee. The chair Each party shall be responsible for preparing and distributing the agenda designate its members to members in advance of each meeting and for the preparation of minutes for each meeting. In addition to the representatives identified on Exhibit 3.8, it is understood that from time to time additional personnel having specialized experience and training may be requested to assist the Collaboration Committee, including, but not limited to, regulatory, finance, legal, and medical personnel, etshall notify the other party in writing each time it permanently replaces and appoints a new designated member. al. Furthermore, upon mutual agreement of the parties, membership on the Collaboration Committee may be expanded or reduced in equal measure from time to time to include additional (or fewer) personnel from each party. The Collaboration Committee shall have the right to establish subcommittees containing any of such members and having such charter(s) as the Collaboration Committee may designate from time to time. The Collaboration Committee shall also have the right to delegate duties to individual designees of each party (i.e., product managers, clinical development managers, et. al.), with the authority to make decisions relevant to their delegated duties, so long as such designees regularly apprise the Collaboration Committee of their activities. The Collaboration Committee shall also have the right to rescind the delegation of any such duties to designees. All matters relating to the responsibilities of the Collaboration Committee (or such duties delegated to designees of the Collaboration Committee) that cannot be resolved shall be referred by any If a member of the Collaboration Committee is unable to Xxxxxx'x Vice President, Pharmaceutical Commercial Operations, and Cephalon's Chief Operating Officer for resolution. If such dispute cannot be resolved as aforesaidattend a meeting, the matter party that appointed such member may designate a substitute to participate in lieu of the absent member. One member of the Collaboration Committee shall be submitted elected by the Collaboration Committee to alternative dispute resolution in accordance with Section 18.7 hereof. (b) In accordance with their respective promotional obligations under this Agreementserve as its Chairman for any term approved by the Collaboration Committee. The Chairman shall preside at all meetings of the Collaboration Committee, Abbott and Cephalon shall work together prepare the agenda for each meeting, shall cause minutes of each meeting to promote the Product in the Territory be taken and shall present their views on maintain the marketing and promotion of the Product by means records of the Collaboration Committee. The Collaboration Committee, by itself or through its designees, shall develop strategies for the promotion of the Product and undertake the activities necessary to implement those strategies, which may include coordinating the parties' detailing messages, methodologies, and their physician and trade targeting and call programs, approving the target list of physicians for detailing efforts, and reviewing Promotional Materials. The parties also agree to share freely with each other all market research data pertaining to the Product that currently exists or that may be generated for a party during the Collaboration Period, subject, however, to the receiving party's obligation to treat such data as Confidential Information pursuant to Article 14. (c) The parties agree that Abbott shall have sole discretion with respect to pricing decisions for the Product, but that the only price increases, price decreases, discounts, allowances or rebates offered by Abbott regarding the Product There shall be those no limit on the number of alternate or successive terms that are extended by Abbott in good faith and consistent with price increases, price decreases, discounts, allowances or rebates extended by Abbott on other Abbott products in the ordinary course of business. Abbott agrees that it will not sell the Product in a bundle arrangement with other Abbott products without the prior written approval of the Collaboration Committeemember may serve as Chairman. (d) Both parties acknowledge that the minimum level and specifics of each party's detailing obligations shall be as set forth in Sections 3.1(b) and 4.4(a). (e) The parties shall take all necessary steps to ensure that all activities of the Collaboration Committee are performed in compliance with applicable Federal, state and local laws and regulations of the Territory. (f) Within sixty (60) days after the date of this Agreement, representatives of the parties' Quality Assurance departments shall meet to develop and approve a Quality Manual outlining responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Manual include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with FDA current Good Manufacturing Practices, compliance with PDMA and such other quality related concerns deemed appropriate. (g) In addition, the Collaboration Committee shall review the pricing of Sample Packs on an annual basis in accordance with Section 3.6(a).