Common use of Steering Committee Clause in Contracts

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration of this Agreement. 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-chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersons.

Appears in 3 contracts

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

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

Appears in 3 contracts

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

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration of this Agreement. 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-chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s 's designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersons.

Appears in 3 contracts

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

Steering Committee. Within a reasonable period 3.1.1 The Parties shall establish an overall steering committee, which shall be comprised of time after six (6) members, including three (3) members appointed by Weichai and three (3) members appointed by PSI (the Effective Date, Orphan Medical and Celltech shall form a “Steering Committee”). The chairmanship of the Steering Committee made up of commercial shall rotate between Weichai and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration of this Agreement. Each party shall maintain PSI every two (2) members on years, with the chairman for the Steering Committee with for the first two (2) years shall be the representative of Weichai. Where one Party appoints the chairman, the other Party shall have the right to appoint vice-chairman. Each Party, in its sole discretion, would be permitted to change its own Steering Committee members added by providing written notice to the other Party. 3.1.2 The Steering Committee would meet at least once quarterly or as neededotherwise deemed necessary. Either the chairman or vice-chairman of the Steering Committee may call ad hoc Steering Committee meetings upon at least ten (10) Business Days prior written notice if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting. The parties chairman shall provide to give each select one member of the Steering Committee (by email or otherwise) notice and the agenda for each meeting at least five (5) Business Days prior to such meeting. 3.1.3 The location for in-person meetings would alternate between Weichai (or Weichai US if appropriate) and PSI host facilities. Alternatively, the Steering Committee, at its representatives discretion, could conduct these meeting via telephone or video conference, as long as each participating Steering Committee member can hear and be heard by each other participating members. Each Party will be responsible for its own expenses relating to serve as a co-chairperson such meetings. 3.1.4 A quorum for the meeting shall consist of at least four (4) members of the Steering Committee. If a Steering Committee member is not present at two consecutive meetings and/or adjournments of meetings, at the next meeting or adjournment thereof, the presence of such Steering Committee member shall not be required for a quorum and such Steering Committee member shall be deemed to be in attendance of such meeting for the purposes of meeting the quorum requirement. 3.1.5 In general, the functions of the Steering Committee would be to provide strategic direction to and make decisions on the proposals made by the sub-committees as further elaborate below and make informed decisions regarding the direction, management and implementation of the Collaboration Projects. The Steering Committee shall directly report to the Board of each Party. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to overall responsibility in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 relation to the extent that Parties’ cooperation activities under the Steering Committee is unable to come to a consensus on any matter relating to Strategic Collaboration, in particular but without limitation: a. determining the development or manufacture kick-off of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersons.Collaboration Projects;

Appears in 2 contracts

Samples: Strategic Collaboration Agreement (Weichai America Corp.), Strategic Collaboration Agreement (Power Solutions International, Inc.)

Steering Committee. Within a reasonable period of time after 4.1 MTC and the Effective Date, Orphan Medical Participating Cities agree to create and Celltech shall form hereby establish a Steering Committee made up to coordinate the activities of commercial the Program and technical employees make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from both companies that shall have certain decision-making authorityMTC, and provide oversight for one designated representative from each of the administration of this AgreementParticipating Cities. Each party with a designated representative shall maintain two have the right to change its designated representative upon five (25) members on days written notice to the other parties. Each party with a designated representative may appoint an alternate representative that will have full voting rights as the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which 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 with other members added as needed. The parties shall each select one of its representatives will be to serve as reach decisions by a co-chairperson of the Steering Committeeunanimous vote. The Steering Committee shall have endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at two Steering Committee meetings without reaching consensus, at the authority to conduct conclusion of the following activities and such other activities as may second meeting, the decision will be agreed to in writing made by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 BasisMTC. In the event and to the extent that addition, if the Steering Committee is has been unable to come to a reach consensus on any a material matter relating for 30 days since such matter was brought to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus attention of the Steering Committee couldfor any reason, in the good faith judgment of the party who does not including failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the ultimate decision making authority as right to decide such matter (as provided in matter. MTC shall also have the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and Celltech agree right to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact make decisions on such rights or obligations of such party. During each Contract Year, the parties shall hold at least four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who those matters that MTC reasonably believes are not material or to make decisions after consulting with one or more members of the Steering Committee whose Participating City may attend meetings be disproportionately (or solely) affected by such decisions. In no event shall MTC have the right to make any of the decisions enumerated in Section 33. 4.5 A party shall convey all communications and documents intended for the Steering Committee as requiredthrough that party’s designated representative. In-person The Steering Committee meetings shall alternate between Orphan Medicalconvey all communications and documents intended for a party to that party’s designated facility and a facility designated representative. 4.6 Decisions to be made by Celltech. The co-chairpersons Steering Committee shall include, but are not limited to: 4.6.1 Whether Operator is in Default, under Section 18 of the Program Agreement; Agreement; Agreement.‌ 4.6.2 KPI Adjustments, as described in Section 2.6.2(a) of the Program 4.6.3 Title Sponsorship approval, as described in Section 7.1 of the Program 4.7 All decisions made by the Steering Committee or by MTC in accordance with this Section 4 shall alternate responsibility for be binding on the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersonsParticipating Cities.

Appears in 2 contracts

Samples: Coordination Agreement, Coordination Agreement

Steering Committee. Within a reasonable period 30 days of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration execution of this Agreement, LTX and Ando shall establish a joint steering committee (the "Steering Committee"), consisting of four representatives of LTX and four representatives of Ando. Each One of each party's representatives shall be appointed Chairman by each party in its sole discretion, and such Chairman shall maintain two (2) members on be charged with formally making any decision of the Steering Committee with other members added representing LTX or Ando, as neededthe case may be. The parties shall each select one of its representatives to Each Steering Committee member will serve as a co-chairperson at the pleasure of the Steering Committeeparty designating such member and may be replaced, with or without cause, at any time by the designating party, effective upon notice to the other party. The Steering Committee shall have be responsible for strategic management decisions concerning the authority to conduct the following activities Fusion Division and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations strategic operating decisions under this Agreement of such party, Orphan Medical and 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees reasonably made based upon reasonable allocation of each party who are not members resources in light of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltechmarket conditions for such business. The co-chairpersons of the Steering Committee shall alternate responsibility also review the organizational structure and management personnel for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Fusion Division. The Steering Committee meetingshall 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 execution of this Agreement; provided, however, that in the event the Steering Committee cannot make a strategic management or operating decision as a result of a "deadlock", LTX and Ando agree that the matter shall be provided to each party's respective President, and such minutes 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 become official until agreed upon be undertaken by both co-chairpersonsthe Fusion Division. The Steering Committee shall then meet to discuss mutually acceptable alternatives.

Appears in 2 contracts

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

Steering Committee. Within The Parties shall establish a reasonable period steering committee which will be responsible for overseeing the Development Plan, including without limitation (i) the monitoring of time after progress against the Effective DateDevelopment Plan, Orphan Medical (ii) the oversight of any clinical studies to be performed pursuant to the Development Plan, (iii) the review and Celltech shall form a approval of amendments to the Development Plan, and (iv) regulatory developments relating to any Product (“Steering Committee”). The Steering Committee made up will be comprised of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration of this Agreement. Each party shall maintain two (2) members on representatives from Actavis 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-employee to be a representative. The Steering Committee will make decisions by unanimous consent with each Party having one vote. In making decisions, the Steering Committee will consider the interests of both Parties and will act in good faith in the interest of the Development Plan and the Product. In the event the Parties fail to agree upon any matter before the Steering Committee, such matter would be escalated to Actavis’ President of Global Generics (or his designee) and Merrimack’s President, Merrimack Healthcare Solutions (or his designee) for resolution by mutual agreement; provided that, if such matter is an intellectual property matter related to whether the 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 other members added as neededrespect 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 parties shall each select one of its representatives to serve Steering Committee will meet every [**] months, or more or less frequently as a co-reasonably agreed by the Parties. Meetings will occur in person, via teleconference or videoconference, or otherwise, as reasonably agreed by the Parties. An Actavis representative will act as the chairperson of the Steering CommitteeCommittee and will be responsible for taking minutes of each meeting. The Steering Committee shall have the authority to conduct the following activities and such other activities as may Such minutes will be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 circulated 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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product entire committee 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at [**] business days after each committee meeting, with and comments, if any, will be promptly provided. If the Orphan Medical Chairperson preparing committee members cannot agree on the minutes, the chairperson will have authority to finalize the minutes for and the first Steering Committee meeting; providedother committee members will have the right to note their specific objections, however, that such minutes shall not become official until agreed upon by both co-chairpersonswhich will be included in the minutes.

Appears in 2 contracts

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

Steering Committee. Within The sales and marketing program for the Test will be managed by a reasonable period steering committee having equal representation of time after the Effective Date, Orphan Medical and Celltech shall form a parties (the “Steering Committee”). The Steering Committee made up will include three (3) members from each party and will meet in-person at least quarterly while more frequent meetings or teleconferences will be held anytime they are needed and requested by the Steering Committee’s members of commercial and technical employees from both companies either party. If an in-person meeting is impracticable, meetings may be held by videoconference or teleconference. When meetings are held in person, individual members of the Steering Committee may nonetheless participate by videoconference or teleconference. If unable to attend in person or by videoconference or teleconference, an individual member of the Steering Committee may grant a proxy to another individual member of the Steering Committee in order to act on his or her behalf on any matter to be acted upon at any meeting of the Steering Committee. Other representatives of the parties may attend Steering Committee meetings as non-voting participants. At least one week prior to any meeting of the Steering Committee, the parties shall agree upon a proposed agenda of the matters to be discussed at such meeting. The parties shall agree, at the first meeting of the Steering Committee, upon procedures for maintaining meeting minutes. The Steering Committee may take action on a matter at a meeting only if a quorum exists with respect to that shall have certain decision-making authority, and provide oversight for the administration matter. The attendance of this Agreement. Each party shall maintain at least two (2) members on of the Steering Committee with other members added as neededof each party at a meeting shall constitute a quorum for the transaction of business. The parties Each member of the Steering Committee shall each select be entitled to cast one of its representatives (1) vote, either in person or by proxy, on any matter to serve as a co-chairperson be acted upon at any meeting of the Steering Committee. The All decisions made by the Steering Committee shall have require a majority vote by the authority members of the Steering Committee, either in person or by proxy. Any action required or permitted to conduct be taken at any meeting of the following activities and such other activities as Steering Committee may be agreed to in writing taken without a meeting if the action is taken by all members of the parties: (a) review ongoing regulatory issues, (b) review Steering Committee. Such action must be evidenced by one or more written consents describing the medical aspects action taken and signed by each member 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 BasisSteering Committee. In the event and to the extent that the Steering Committee is unable to come to achieve a consensus majority vote on any matter relating to issue, then the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, dispute resolution process set forth 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 Section 5.3 hereof will be followed with respect 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersonsissue.

Appears in 2 contracts

Samples: Co Promotion Agreement (Veracyte, Inc.), Co Promotion Agreement (Veracyte, Inc.)

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech 5.3.1. The Parties shall form a Steering Committee made up to which each Party will delegate [**] executive employees who are familiar with the Project. In the case of commercial and technical employees from both companies Lonza, the executives shall be [**] or their designee(s), provided that such designee(s) shall have certain decision-substantially the same authority and decision making authoritypower as the aforementioned executives. In the case of Kolltan, and provide oversight for the administration of this Agreement. Each party executives shall maintain two (2) members on be at the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairperson of the Steering Committeevice president level or higher. The Steering Committee shall provide strategic guidance for the overall collaboration and have general oversight and review of the activities of each Project Team and shall 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 authority ability to conduct make any necessary adjustments to the following activities 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 other activities as may 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 agreed to in writing taken on a rotational basis between Lonza and Kolltan and shall be distributed for approval by the parties: (a) review ongoing regulatory issuesSteering Committee at the next meeting. 5.3.3. The Steering Committee will take action by unanimous consent of its members, (b) review with each representative having a single vote, or by a written resolution signed by all of the medical 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 Basisrepresentatives. In the event and to the extent that If the Steering Committee is unable to come reach unanimous consent on a particular matter, then the matter will be referred to a consensus on any matter relating to the development or manufacture personal meeting (which shall be face-to-face if requested by either Party) between Lonza’s Head of the Product Custom Manufacturing division or his/her designee and the RegistrationChief Executive Officer of Kolltan or his/her designee, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to who in each case may not be a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus member of the Steering Committee couldand 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 good faith judgment 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 party who does relevant referral, or as otherwise mutually agreed. In case such persons cannot have agree within a further [**] calendar days after such meeting, then the ultimate decision making authority following shall apply: (a) If the dispute is predominantly concerned with scientific or technical issues, then the entire dispute shall be referred to independent experts on whom the Parties agree as set forth hereinafter. Each Party is entitled to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least propose one (1) unconflicted independent expert, subject to the consent of the four (4) Steering Committee meetings other Party, and the other Party shall not unreasonably withhold its consent to the appointment of such expert. The Parties will make available the same set of documents to both experts and both experts shall provide their expert opinion in the English language within [**] weeks after the second expert has been appointed. The decision of such independent experts shall be conducted in-person. Employees of each party who are not members in writing and, save for manifest error on the face of the Steering Committee may attend meetings decision, shall be binding on both Lonza and Kolltan. If the two (2) experts come to dissenting opinions and are unable to solve the dispute among themselves, a third unconflicted independent expert shall be appointed jointly by the Parties, who is an expert in the particular scientific or technical area at 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 Steering Committee two other experts as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltechwell as to all documents that were made available to the two experts. The co-chairpersons third expert shall then approve one of the Steering Committee shall alternate responsibility for the preparation two opinions of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; providedtwo experts, howeverand 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) If the dispute is predominantly concerned with an issue other than a scientific or technical issue, then the Parties agree to attempt in good faith to resolve such dispute by mediation administered by the CEDR in London, England. The parties agree that such minutes they shall not become official until agreed upon by both co-chairpersonsshare equally the cost of any mediation fees, and the cost of the mediator. 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 pursue its rights in a court of law in accordance with Clause 14 of this Agreement. Nothing in this Clause 5.3 shall prevent a Party from exercising any right under this Agreement, including the right of termination under Clause 11 below.

Appears in 2 contracts

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

Steering Committee. Within The ongoing operations of the Services shall be overseen by a reasonable period steering committee (the “Steering Committee”), comprised of time after the Effective Date, Orphan Medical at least three (3) members appointed by Advanta and Celltech shall form a three (3) members appointed by Supplier. The Steering Committee made up of commercial shall be responsible for strategic direction and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration Services, including: (i) addressing disputes that arise hereunder; (ii) overseeing the financial performance of this Agreement. Each party shall maintain two the Services; (2iii) members on addressing strategic improvements to technology used to provide the Steering Committee with Services; (iv) addressing continuous improvement of the Services; (v) addressing adjustments in the scope of the Services; and (vi) reviewing all other members added as needed. The parties shall each select one of its representatives to serve as a co-chairperson of matters that the Parties agree should be reviewed by the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not initial Advanta members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltechbe ******. The co-chairpersons initial Supplier members of the Steering Committee shall alternate responsibility for be ******. In the preparation event a member of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meetingis to be replaced, such replacement shall be made by the Party whose employee is to be replaced; provided, however, that any replacement member of the Steering Committee shall have at least substantially the same qualifications of the member that is replaced and, prior to making such replacement, such Party shall consult in good faith with the other Party on such matter. In the event a Party raises any concerns as to the performance of a member of the Steering Committee appointed by the other Party, the other Party shall, subject to requirements of Laws, react appropriately to alleviate such concerns. The Steering Committee shall meet from time to time as its members consider necessary, but in no event less than once per quarter. Meetings may be held in person or wholly or partly by way of telephone or video conference; provided that the Steering Committee conduct at least one in-person meeting annually. In addition, representatives of the Parties shall meet periodically throughout the Term, or as requested by Advanta, to discuss matters arising under this Agreement. For each Steering Committee meeting, upon Advanta’s request, Supplier shall prepare and distribute an agenda (including any topics designated by Advanta) in advance of such meeting to all anticipated participants, and shall record and promptly distribute minutes shall not become official until agreed upon for such meeting for review and approval by both co-chairpersonsAdvanta.

Appears in 1 contract

Samples: Master Services Agreement (Advanta Corp)

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form The Parties have formed a Steering Committee, in which each Party has appointed [*] executive employees as such Party’s members of the Steering Committee made up (the “Members”), all of commercial whom shall be familiar with and technical employees from both companies that shall have certain decision-making authority, and provide responsibility for oversight for of the administration of activities under this Agreement. Each party shall maintain two (2) members on Party may with written notice to the Steering Committee with other members added as needed. The parties shall each select Party, change one or more of its representatives Members appointed to serve as a co-chairperson of the Steering Committee. The Steering Committee shall have general oversight and review of the authority to conduct the following activities and results under this Agreement and shall be the initial forum for seeking to resolve any issues referred to the Steering Committee by either Party or both. Specifically, but without limitation, the Steering Committee shall seek in good faith to resolve any disputes or issues regarding the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Commercial Supply Agreement, BI/ VERSARTIS Execution Version manufacturing schedule or manufacturing processes for Drug Substance and/or Drug Product. The Steering Committee shall meet, in person or via teleconference or video-conference, on a reasonably regular basis, as planned and agreed by the Steering Committee Members, and in any event within [*] calendar days after receipt of a written request for such a meeting by one Party to the other activities Party. The request shall describe the matters or issues to be discussed, including any matter in dispute, and the solution which the requesting Party proposes to be decided. Each Party may invite other employees to attend the Steering Committee meeting from particular departments/areas of expertise as may be agreed necessary to discuss the agenda topics, or matters or issues in writing dispute. Any action or decision by the parties: (a) review ongoing regulatory issuesSteering Committee shall be taken by unanimous consent of the Steering Committee, (b) review with the medical aspects Members of standards each Party collectively having a single vote, or by a written resolution signed by all 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 BasisMembers. In the event and to the extent that If the Steering Committee is unable to come to a consensus reach unanimous consent 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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of issue being discussed by the Steering Committee, then the matter or issues will be referred by each Party to a responsible member of senior management to be designated by each Party, who will use good faith efforts to resolve such matter or issue. If such matter is not resolved by the chief executive officers, then arbitration shall be used according to Section 14.8. The Members of the Steering Committee may participate in meetings of the Steering Committee Parties are set forth in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall Appendix 6 attached hereto, which may be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersonsamended from time to time to reflect any changes.

Appears in 1 contract

Samples: Commercial Supply Agreement (Versartis, Inc.)

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a 6.1 The Steering Committee made up shall be composed of commercial the Project Co-ordinator, his Deputy, the Administrative Manager and technical employees from both companies that all Work Package Leaders. 6.2 Each Work Package Leader and each member of the Management Team shall have certain decision-making authority, and provide oversight for the administration of this Agreement. Each party shall maintain two (2) members on the one vote. 6.3 The Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a cobe chaired by the Project Co-chairperson of the Steering Committeeordinator or his Deputy. The Steering Committee shall have the authority to conduct the following activities meet as often as deemed necessary by its members and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 typically four (4) regular times a year. 6.4 All meetings shall be convened by the Co-ordinator (Administrative Manager), who shall give at least fourteen (14) calendar days prior written 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 Steering Committee. Members of the Steering Committee may participate in 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 person or writing to the chairperson. 6.5 Decisions shall be taken by conference telephone call. At least one (1) a majority of two-thirds of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members votes of the Steering Committee may attend meetings 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 as requiredmembers being present or represented and voting. InIn 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-person 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 meetings shall alternate between Orphan Medical’s designated facility members and a facility designated that all Steering Committee members have given their written approval of the proposal to vote by Celltech. The coe-chairpersons of mail; and that the decision so taken is approved by the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made members that would have been required to take that decision at each committee meetinga meeting where all entitled to vote would have been present or represented and voting. 6.7 The Steering Committee, with due respect to the Orphan Medical Chairperson preparing minutes for Grant Agreement including Annex 1 (Description of Work) thereto, shall in particular: (a) ensure the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon implementation of decisions taken by both cothe Governing Board; (b) monitor the progress of the work and review Project Deliverables; (c) assist the Co-chairpersons.ordinator in ensuring compliance by the Parties of their obligations under the Grant Agreement; (d) take executive decisions on administrative and scientific issues, (e) adopt or amend the Project Management Plan;

Appears in 1 contract

Samples: Consortium Agreement

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Steering Committee. Within a reasonable period (a) To facilitate the Manufacture of time after Product hereunder, Manufacturer and Principal shall each within 30 days of the Effective DateDate nominate representatives from their respective employees, Orphan Medical and Celltech shall form full time consultants or Affiliates to a Steering Committee made up (the "Steering Committee") to serve in an advisory capacity with respect to their respective obligations under this Agreement to (i) review manufacturing operations for the purpose of commercial considering, proposing and technical employees from both companies that shall have certain decision-making authoritydeveloping improvements to the ordering and manufacturing process and to the way the parties communicate and interact, (ii) consider strategic planning and facilitate manufacturing operations, (iii) provide ongoing advisory services with respect to manufacturing services hereunder, and (iv) attempt to resolve amicably any disputes arising between Manufacturer and Principal with respect to day-to-day operations. The Steering Committee is intended to provide oversight for 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 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. (b) Manufacturer and Principal shall appoint as members of the Steering Committee a reasonable number of suitably qualified and experienced representatives of each of Manufacturer and Principal 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 party of Manufacturer and Principal shall maintain two appoint no more than four persons to the Steering Committee. (2c) members The Steering Committee shall meet at regular intervals on such dates and at such locations as may be agreed upon by Manufacturer and Principal, by video or telephone conference. In particular, the Steering Committee with other members added as needed. The parties shall each select one strive to meet at least once per quarter, but in any event shall meet no less than twice per year during the term of its representatives to serve as a co-chairperson of the Steering Committeethis Agreement unless otherwise agreed by Manufacturer and Principal. The Steering Committee shall have the authority to conduct the following activities and may also meet upon 15 days' written request by either Manufacturer or Principal, should circumstances necessitate such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersons.

Appears in 1 contract

Samples: Transaction Agreement (Noven Pharmaceuticals Inc)

Steering Committee. Within a reasonable period of time (a) Promptly after the Effective Date, Orphan Medical and Celltech the Parties shall form a steering committee (the “Steering Committee made up of commercial and technical employees from both companies that Committee”) to which CELTIC shall have certain decision-making authority, the right to designate such number of representatives as CELTIC deems appropriate from time to time and provide oversight for NTI shall have the administration of this Agreement. Each party shall maintain right to designate two (2) members on the Steering Committee with other members added as neededrepresentatives. The parties CELTIC’s representatives shall each select include one or more of its managing partners from time to time and NTI’s representatives shall be its chief executive officer and such other representative as it deems fit from time to serve as a co-chairperson time. CELTIC shall designate the Chairman of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 Subject to the extent that foregoing, the respective individual representatives of any Party to the Steering Committee is unable may be removed and replaced from time to come time at the discretion of such Party by sending written notice of such action to the other Party. Each representative of NTI and CELTIC shall have one (1) vote to cast in matters coming 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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of vote before the Steering Committee. Members of the Steering Committee may participate Except as provided in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons Section 2.11, all decisions of the Steering Committee shall alternate responsibility for be made by majority vote of the preparation of minutes setting forth discussions made at each committee meeting, with representatives on the Orphan Medical Chairperson preparing minutes for Steering Committee. In the first event an issue arises that the Steering Committee meetingcannot resolve by majority vote, the Chairman shall cast an additional tie-breaking vote; provided, however, that no such vote shall require NTI to spend money or devote human resources above those committed herein, without NTI’s express written approval. (b) The Steering Committee shall meet once per Calendar Quarter, or at such other intervals as the Steering Committee may decide, at such times and at such locations as shall be decided by the Steering Committee, provided such meetings shall be held only outside of the territories of the United States or the United Kingdom. Meetings may be held in person or via teleconference. At least fifteen (15) business days prior to each regularly scheduled meeting of the Steering Committee, the Steering Committee shall cause a written report to be submitted to the Parties concerning the progress of any Collaboration Work, such report to include a summary of (i) progress achieved since the previous meeting; (ii) critical issues or problems encountered or anticipated; and (iii) a statement of goals for the scheduled activities. CELTIC shall provide an agenda and minutes of each meeting of the Steering Committee. Minutes shall be deemed approved unless NTI objects to the accuracy of such minutes within ten (10) days of its receipt thereof. The parties agree that the Steering Committee shall not become official meet and otherwise exercise its functions and duties only outside of the territories of the United States or the United Kingdom and their respective territories. (c) Notwithstanding any of the foregoing, until agreed upon by both co-chairpersonsthe earlier of: (x) FDA approval of the First Indication, (y) the third anniversary of the Effective Date or (z) the consummation of a Change of Control with respect to NTI, all decisions relating to clinical trial designs and regulatory affairs, including regulatory submissions and communications with the FDA in respect of the First Indication in the U.S. shall be subject to the unanimous consent of the Steering Committee.

Appears in 1 contract

Samples: Collaboration and Services Agreement (Neurobiological Technologies Inc /Ca/)

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical xxxxxx Xxxxxx and Celltech shall form Investor Parent hereby establish a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for (the administration of this Agreement. 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-chairperson of the Steering Committee”), which shall consist of up 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 have meet to discuss and review issues of a commercial, financial and technical nature concerning the authority to conduct Project, including the following activities and such other activities as may be agreed to in writing work being performed by the parties: (a) review ongoing regulatory issuesConsulting Firm as set forth in this Agreement and matters with respect to risks, (b) review the medical aspects of standards of care in the TerritoryPermits, (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 technical assurance to the extent that Consolidated Project Budget and the 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 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 outside the Territory, the views of the Orphan Medical Steering Committee members and ioneer Parent shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, consider in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment any matters related thereto and comments thereon raised by Investor Parent and representatives 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 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 partyInvestor Parent. During each Contract Year, the parties shall hold at least four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons Each member of the Steering Committee shall alternate responsibility for be permitted to conduct at least four site visits per year at reasonable intervals of time and upon reasonable advance notice to the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meetingCompany; provided, however, that such minutes site visits may be conditioned upon such Steering Committee members executing any applicable liability waivers or other documents reasonably requested by the Company and complying with all applicable policies and procedures of the Company with respect to site visitors. The Steering Committee shall not become official until 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, any member of the Steering Committee may call a meeting of the Steering Committee on no less than 72 hours’ advance notice. The Steering Committee shall be disbanded upon the Closing.” (o) The first sentence of Section 5.17 of the Agreement is hereby amended and restated in its entirety as 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 both co-chairpersonsthis Agreement as required by the HSR Act no later than June 30, 2023.” (p) Article V of the Agreement is hereby amended by adding new Section 5.20, Section 5.21, Section 5.22 and Section 5.23, which shall appear in their respective corresponding location immediately following Section 5.19 of the Agreement, and which shall read as follows:

Appears in 1 contract

Samples: Unit Purchase and Subscription Agreement (Ioneer LTD)

Steering Committee. (a) Within a reasonable period of time thirty (30) days after the Effective Datedate of this Agreement, Orphan Medical and Celltech the Parties shall form a Steering Committee made up consisting of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration an equal number of this Agreement. Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall representatives of each select one of its representatives to serve as a co-chairperson of the Steering CommitteeParty. The Steering Committee shall have general authority over the strategic direction and overall management of the Product Development Plan and shall operate and have the further authority to conduct the following activities and such other activities as may be agreed to described in writing by the parties: (a) review ongoing regulatory issues, this Section 4.2. (b) review ACTII and Amylin shall each appoint three (3) representatives as their representatives to serve on the medical aspects of standards of care in Steering Committee. A Party may change its representatives from time to time by giving written notice to the Territory, other Party. (c) review clinical developments across territoriesThe Steering Committee shall generally meet at such times as it may decide and at least once per calendar quarter. The location of Steering Committee meetings shall alternate between ACTII's offices and Amylin's offices unless otherwise agreed by the Parties, with the first meeting being held at Amylin's office. Minutes of a meeting setting forth decisions of the Steering Committee shall be prepared by the Party hosting the meeting. Minutes will become official when agreed to by all members of the Steering Committee. Each Party will bear all expenses associated with attendance of its representatives at meetings. If the Steering Committee members all agree, a meeting may be held by telephone. * CONFIDENTIAL TREATMENT REQUESTED (d) review marketing campaigns and new marketing plansDecisions of the Steering Committee shall be made by unanimous vote, (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 Basiswith each member having one vote. In the event and to the extent that If the Steering Committee is unable to come to reach a consensus unanimous vote on any matter relating issue, the issue shall be referred to the development President of ACTII (or manufacture successor position), and the Vice President of Corporate Development of Amylin (or successor position) for resolution. These individuals shall, as soon as practicable, attempt in good faith to decide the issue. If the issue is not decided within fifteen (15) days after it has been referred to such individuals, it shall be referred to Amylin's Chief Executive Officer (or successor position), who shall make the final decision regarding such issue. (e) Within fifteen (15) days after the receipt of the proposed Product Development Plan or any amendments thereto from the Registration, packaging, labeling, promoting, marketing, sale Project Working Team or distribution any appeals of decisions of the Product outside the TerritoryProject Working Team, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation meet to consider approval of minutes setting forth discussions made at each committee meetingsuch plan or amendments, with the Orphan Medical Chairperson preparing minutes for the first or appeal of such decision, as applicable. The Steering Committee meeting; providedshall periodically review the Product Development Plan from a strategic perspective, however, the status of efforts to implement it and to make any changes to it that such minutes it deems necessary to accomplish the purpose of this Agreement. The Steering Committee shall not become official until agreed upon by both co-chairpersonsalso settle any disputes among the Project Working Team.

Appears in 1 contract

Samples: Development and License Agreement (Amylin Pharmaceuticals Inc)

Steering Committee. Within a reasonable period (a) Upon execution of time after the Effective DatePrior Agreement, Orphan Medical Cellegy and Celltech shall form Licensee established a Steering Committee made up of commercial and technical employees from both companies that (the “Steering Committee”) which shall have certain decision-making authoritythe responsibilities described in this Article 4. The Steering Committee shall be initially comprised of a total of six (6) members, of which three (3) members shall be appointed by Licensee and three (3) members shall be appointed by Cellegy. The total number of Steering Committee members may be changed by the Steering Committee from time to time as appropriate, but in all cases it will be comprised of an equal number of members designated by each of Cellegy and Licensee, and provide oversight for in no event shall the administration Steering Committee be comprised of an aggregate of less than six (6) members. Each of Cellegy and Licensee may substitute its representatives from time to time and the substitution shall be effective upon notice to the other Party. The Steering Committee shall meet once every quarter during the first year of the term of this AgreementAgreement and thereafter at such other times as the Steering Committee may agree (but at least one time each year), on such dates and at such places as to be agreed upon between the Parties. Each party shall maintain two (2) members representative on the Steering Committee with other members added as needed. The parties shall each select will have one of its representatives vote in decisions submitted to serve as a co-chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee be held in person or in any other reasonable manner, including, without limitation, by telephone, video conference telephone callor e-mail. (b) [*] shall designate a Chairperson who will serve as such. At least one The Chairperson shall send notices (1not less than 15 business days in advance of such meetings) of the four (4) and agendas for all regular Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the to all Steering Committee may attend meetings members. The location of the Steering Committee as required. In-person regularly scheduled Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated among the offices of the Parties, unless otherwise agreed. Meetings may be held telephonically or by Celltechvideo conference, but each member shall attend at least one meeting in person each year. The co-chairpersons Party hosting any Steering Committee meeting shall appoint one person (who need not be a member of the Steering Committee shall alternate responsibility for Committee) to attend the preparation meeting and record the minutes of minutes setting forth discussions made at each committee the meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such . Such minutes shall not become official until agreed upon by both co-chairpersonsbe circulated to the Parties promptly following the meeting for review, comment and approval.

Appears in 1 contract

Samples: Exclusive License Agreement (Cellegy Pharmaceuticals Inc)

Steering Committee. Within (a) The Parties shall establish and maintain throughout the term of this Agreement a reasonable period of time after committee (the Effective Date, Orphan Medical “Steering Committee”) to oversee the implementation and Celltech shall form a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration operation of this Agreement. Each party The Steering Committee shall maintain consist of four people. Seller shall be entitled to appoint two (2) members on of the Steering Committee with other and Buyer shall be entitled to appoint two members added as needed. The parties shall each select one of its representatives to serve as a co-chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not 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 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 four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not initial members of the Steering Committee may attend meetings 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 as requiredappointed by Buyer shall be the Category Manager — Proppants and the Vice President of Production Enhancement of Buyer. In-person Steering Committee meetings Seller shall alternate between Orphan Medical’s designated facility be entitled to remove and a facility designated by Celltech. The co-chairpersons replace at any time one or more of the members of the Steering Committee appointed by Seller and Buyer shall alternate responsibility for be entitled to remove and replace at any time one or more of the preparation members of minutes setting forth discussions made at each committee meeting, the Steering Committee appointed by Buyer. (b) The Steering Committee shall oversee the implementation and operation of this Agreement with the Orphan Medical Chairperson preparing minutes 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 meeting; providedshall 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, however, that such minutes the Steering Committee shall not become official until meet as agreed upon by both co-chairpersonsthe Parties, through their representatives on the Steering Committee, but in no event shall the Steering Committee meet less than quarterly.

Appears in 1 contract

Samples: Proppant Supply Agreement (Carbo Ceramics Inc)

Steering Committee. Within a reasonable period of time after 4.1 MTC and the Effective Date, Orphan Medical Participating Cities agree to create and Celltech shall form hereby establish a Steering Committee made up to coordinate the activities of commercial the Program and technical employees make decisions regarding its overall operation. 4.2 The Steering Committee will consist of one designated representative from both companies that shall have certain decision-making authorityMTC, and provide oversight for one designated representative from each of the administration of this AgreementParticipating Cities. Each party with a designated representative shall maintain two have the right to change its designated representative upon five (25) members on days written notice to the other parties. Each party with a designated representative may appoint an alternate representative that will have full voting rights as the representative. 4.3 The Steering Committee shall hold such meetings as it deems necessary, which 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 with other members added as needed. The parties shall each select one of its representatives will be to serve as reach decisions by a co-chairperson of the Steering Committeeunanimous vote. The Steering Committee shall have endeavor in good faith to reach consensus in resolving all material matters. However, if a pending decision has been discussed at two Steering Committee meetings without reaching consensus, at the authority to conduct conclusion of the following activities and such other activities as may second meeting, the decision will be agreed to in writing made by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (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 BasisMTC. In the event and to the extent that addition, if the Steering Committee is has been unable to come to a reach consensus on any a material matter relating for 30 days since such matter was brought to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus attention of the Steering Committee couldfor any reason, in the good faith judgment of the party who does not including failure to achieve quorums at scheduled meetings or inability to schedule timely meetings, MTC shall have the ultimate decision making authority as right to decide such matter (as provided in matter. MTC shall also have the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and Celltech agree right to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact make decisions on such rights or obligations of such party. During each Contract Year, the parties shall hold at least four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who those matters that MTC reasonably believes are not material or to make decisions after consulting with one or more members of the Steering Committee whose Participating City may attend meetings be disproportionately (or solely) affected by such decisions. In no event shall MTC have the right to make any of the decisions enumerated in Section 33. 4.5 A party shall convey all communications and documents intended for the Steering Committee as requiredthrough that party’s designated representative. In-person The Steering 4.6 Decisions to be made by Steering Committee meetings shall alternate between Orphan Medical’s designated facility and a facility designated include, but are not limited to: 4.6.1 Whether Operator is in Default, under Section 18 of the Program 4.6.2 KPI Adjustments, as described in Section 2.6.2(a) of the Program 4.6.3 Title Sponsorship approval, as described in Section 7.1 of the Program 4.7 All decisions made by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon or by both co-chairpersons.MTC in accordance

Appears in 1 contract

Samples: Coordination Agreement

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