Common use of Collaboration Committee Clause in Contracts

Collaboration Committee. (a) Promptly after the date hereof, the parties shall form a Collaboration Committee, which shall consist of an equal number of representatives of each party (expected to be three to five representatives for each party). The Collaboration Committee shall review and approve the protocols for the Studies and all other activities to be undertaken pursuant to the Program, including work plans and cost estimates therefor. Each party shall designate its own members to the Collaboration Committee, and 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 in any case at least once in each calendar quarter during the term of this Agreement. The meetings shall alternate between the offices of the parties. The Collaboration Committee may meet in person, by telephone or by video conference, and individual members may participate in any of the foregoing ways. If a member of the Collaboration Committee is unavailable for any meeting, such member may designate a substitute to participate in the member's place. The costs of participation by each member in the activities of the Collaboration Committee shall be borne by the party appointing such member. (c) The Collaboration Committee shall have a secretary who will keep minutes of its meetings. The secretary shall be selected on a rotating basis each year by one of the parties. (d) 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 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 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 referred to dispute resolution by either party in accordance with Section 7.1. (e) The Collaboration Committee will be responsible for (i) approving the amendments, if any, to 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 in the event that the Collaboration Committee cannot agree on the protocol for, or execution of, such new clinical studies of the Product, Alkermes will have the tie-breaking vote; (iv) reviewing periodically, during the course of the studies (including the Studies) and after 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; (vi) reviewing the Development Costs incurred by the parties under this Agreement; (vii) reviewing all proposed Product-related regulatory filings prior to submission; and (viii) coordinating all communication with regulatory agencies concerning regulatory filings related to the Product.

Collaboration Committee. (a) Promptly after the date hereofEffective Date, the parties shall form establish a committee with the duties and responsibilities set forth in this Agreement that shall be comprised of personnel from Focal and Genzyme (the "Collaboration Committee, which shall consist of an equal number of representatives of each party (expected to be three to five representatives for each party"). The Collaboration Committee shall review include four (4) voting members, two (2) of whom shall be appointed by Genzyme and approve two (2) of whom shall be appointed by Focal. Each party shall make its designation of its initial representatives not later than fifteen (15) days after the protocols for Effective Date. Each party shall use reasonable efforts to designate as its representatives, individuals that shall have the Studies requisite experience and all other knowledge to oversee the commercialization activities contemplated by this Agreement. Vacancies on the Collaboration Committee shall be filled within ten (10) days after the date such vacancy occurs. In addition, each party may designate any number of additional persons to be undertaken pursuant serve as advisors to the Program, including work plans and cost estimates thereforCollaboration Committee. Each party shall designate its own members to the Collaboration Committee, and shall notify the other party in writing if each time it changes or substitutes any of its members. (b) The Collaboration Committee shall meet at such times as it may select, but in any case at least once in each calendar quarter during the term of this Agreement. The meetings shall alternate between the offices of the parties. The Collaboration Committee may meet in person, by telephone or by video conference, permanently replaces and individual members may participate in any of the foregoing waysappoints a new designated member. If a member of the Collaboration Committee is unavailable for any unable to attend a meeting, the party that appointed such member may designate a substitute to participate in lieu of the absent member's place. The costs of participation by each One member in the activities of the Collaboration Committee shall be borne elected by the party appointing such member. (c) The Collaboration Committee shall have a secretary who will keep minutes of its meetings. The secretary shall be selected on a rotating basis each year by one of the parties. (d) The presence at any meeting of the Collaboration Committee of at least two members from each party shall constitute a quorum to serve as its Chairman for purposes of any action term approved by the Collaboration Committee. Each member will have one voteThe Chairman shall preside at all meetings of the Collaboration Committee, shall prepare the agenda for each meeting, shall cause minutes of each meeting to be taken and action shall maintain the records of the Collaboration Committee. There shall be authorized by a majority no limit on the number of the votes, so long as the majority vote includes at least one vote cast by alternate or successive terms that a member selected by each party. In the event that the 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 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 may serve 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 referred to dispute resolution by either party in accordance with Section 7.1Chairman. (e) The Collaboration Committee will be responsible for (i) approving the amendments, if any, to 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 in the event that the Collaboration Committee cannot agree on the protocol for, or execution of, such new clinical studies of the Product, Alkermes will have the tie-breaking vote; (iv) reviewing periodically, during the course of the studies (including the Studies) and after 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; (vi) reviewing the Development Costs incurred by the parties under this Agreement; (vii) reviewing all proposed Product-related regulatory filings prior to submission; and (viii) coordinating all communication with regulatory agencies concerning regulatory filings related to the Product.

Collaboration Committee. 4.1 The Parties shall establish a Collaboration Committee (a"CC") Promptly after which shall be charged with the date hereofmanagement and administration of the Collaboration and the promotion, distribution and sale of the Products in the Territory. The CC shall have the responsibility to take all decisions as to the marketing of the Products, their manufacture and distribution, the parties 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 and shall form a have full authority and discretion with respect to 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 first three years of the Collaboration Committee, which being set out in Schedule 4 hereto. 4.2 The CC shall consist comprise six members of an equal number whom three shall be appointed by each of representatives of each party Cephalon (expected to be three to five representatives for each party"Cephalon Members") and Novartis ("Novartis Members"). The Collaboration Committee initial CC members shall review be those persons listed in Schedule 6 Part I. 4.3 A Party may remove any CC Member appointed by it and approve appoint any person in his place. Any appointment or removal shall be in writing signed by the protocols for appointing Party and shall take effect (unless the Studies and all other activities to be undertaken pursuant appointment or removal specifies to the Program, including work plans and cost estimates therefor. Each party shall designate its own members contrary) upon delivery to the Collaboration Committee, other Party of the appropriate notice. The Parties shall procure that the persons appointed to the CC shall be suitably qualified and shall notify experienced to carry out the other party responsibilities thereof as set out herein in writing if it changes or substitutes any of its membersa competent and professional manner. (b) 4.4 The Collaboration Committee shall meet at such times as it may select, but in any case at least once in each calendar quarter during the term provisions of this Agreement. The Clause 4.4 shall apply to meetings shall alternate between the offices of the parties. The Collaboration Committee may meet in person, by telephone or by video conference, and individual members may participate in any of the foregoing ways. If a member of the Collaboration Committee is unavailable for any meeting, such member may designate a substitute to participate in the member's place. The costs of participation by each member in the activities of the Collaboration Committee CC: 4.4.1 No business shall be borne by the party appointing such member. (c) The Collaboration Committee shall have a secretary who will keep minutes of its meetings. The secretary shall be selected on a rotating basis each year by one of the parties. (d) The presence transacted 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 CC unless at least one member appointed by Cephalon and one member appointed by Novartis is present. The Cephalon Members shall collectively have one vote cast by a member selected by each party. In and the event that the Collaboration Committee cannot agree on the protocol for, or the execution of, the Metastases Studies, ALZA will Novartis Members shall collectively have the tie-breaking vote. If (i) Alkermes disagrees with ALZA's resolution of 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 one vote required with respect to any other matters, then the matter may be referred to dispute resolution by either party in accordance with Section 7.1. (e) The Collaboration Committee will be responsible for (i) approving the amendments, if any, to 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 and in the event that the Collaboration Committee canCephalon 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 the CC shall be binding on the protocol for, or execution of, such new clinical studies Parties if approved by the collective vote of the ProductCephalon 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. The omitted portions have been filed separately with the 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, Alkermes will have agenda and minutes of the tie-breaking vote; 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 (ivincluding 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 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 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 periodically, all financial information and reports provided under Clause 7.2 during the course or in respect of the studies previous quarterly period or in respect of any accounting period terminating at the end of that period; (including ii) reviewing the Studies) cash flow and after they are completedfunding position of the Collaboration during such quarterly period and considering, all Product-related clinical data and related information; if thought fit, approving any measures necessary for easing any adverse situation in the ensuing periods; (viii) reviewing and approving work plans and cost estimates the Annual Operating Plan for all development and clinical activities to be undertaken the Collaboration for the following year presented by the Operating Committee pursuant to this AgreementClause 7.2; and (viiv) reviewing the Development Costs incurred by the parties under this Agreement; (vii) reviewing all proposed Product-related regulatory filings prior to submission; and (viii) coordinating all communication with regulatory agencies concerning regulatory filings related reporting to the ProductExecutive Committee in respect of the above matters. **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.

Collaboration Committee. (a) Promptly after The Collaboration Committee shall be charged with responsibility for overseeing and managing the date hereofcollaboration, marketing and further development of the parties 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 form a Collaboration Committee, which shall consist be comprised of an equal number of representatives from each party representing the sales, marketing and clinical functions of each party (expected to be three to five representatives for each party), including the personnel identified on Exhibit 3.8 attached hereto. The Collaboration Committee shall review be co-chaired by representatives from Abbott and approve Cephalon throughout the protocols Collaboration Period. The chair shall be responsible for preparing and distributing the agenda to members in advance of each meeting and for the Studies and all other activities to be undertaken pursuant preparation of minutes for each meeting. In addition to the Programrepresentatives identified on Exhibit 3.8, including work plans it is understood that from time to time additional personnel having specialized experience and cost estimates therefor. Each party shall designate its own members 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 notify have the other party in writing if it changes or substitutes right to establish subcommittees containing any of its memberssuch 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) The Collaboration Committee shall meet at such times as it may select, but in any case at least once in each calendar quarter during the term of In accordance with their respective promotional obligations under this Agreement. The meetings , Abbott and Cephalon shall alternate between work together to promote the offices Product in the Territory and shall present their views on the marketing and promotion of the partiesProduct by means of the Collaboration Committee. The Collaboration Committee may meet in personCommittee, by telephone itself or by video conferencethrough 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 individual members 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 participate in any of the foregoing ways. If be generated for a member of party during the Collaboration Committee is unavailable for any meetingPeriod, subject, however, to the receiving party's obligation to treat such member may designate a substitute data as Confidential Information pursuant to participate in the member's place. The costs of participation by each member in the activities of the Collaboration Committee shall be borne by the party appointing such memberArticle 14. (c) The Collaboration Committee parties agree that Abbott shall have a secretary who will keep minutes of its meetings. The secretary 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 selected 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 rotating basis each year by one bundle arrangement with other Abbott products without the prior written approval of the partiesCollaboration Committee. (d) The presence at any meeting Both parties acknowledge that the minimum level and specifics 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 party's detailing obligations 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 Collaboration Committee cannot agree on the protocol for, or the execution of, the Metastases Studies, ALZA will have the tie-breaking vote. If (iset forth in Sections 3.1(b) Alkermes disagrees with ALZA's resolution of 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 referred to dispute resolution by either party in accordance with Section 7.1and 4.4(a). (e) The Collaboration Committee will be responsible for (i) approving the amendments, if any, parties shall take all necessary steps to the protocols for the Studies; (ii) reviewing ongoing clinical ensure that all activities concerning the Product, (iii) approving new clinical studies of the Product (other than the Studies); provided, however, that in the event that the Collaboration Committee cannot agree on the protocol forare performed in compliance with applicable Federal, or execution of, such new clinical studies state and local laws and regulations of the ProductTerritory. (f) Within sixty (60) days after the date of this Agreement, Alkermes will have the tie-breaking vote; (iv) reviewing periodically, during the course representatives of the studies (including the Studies) parties' Quality Assurance departments shall meet to develop and after they are completed, all Product-approve a Quality Manual outlining responsibilities and key contacts for quality and compliance related clinical data and related information; (v) reviewing and approving work plans and cost estimates for all development and clinical activities issues. Items to be undertaken pursuant included in the Quality Manual include, but are not limited to this Agreement; 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. (vig) reviewing In addition, the Development Costs incurred by Collaboration Committee shall review the parties under this Agreement; (vii) reviewing all proposed Product-related regulatory filings prior to submission; and (viii) coordinating all communication pricing of Sample Packs on an annual basis in accordance with regulatory agencies concerning regulatory filings related to the ProductSection 3.6(a).