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

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 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 a reasonable period of time after Under the Effective DatePrior Agreement, Orphan Medical and Celltech shall form the parties have formed a Steering Committee made up of commercial and technical employees from both companies that shall have has 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 territoriesterritories to the extent permitted by Jazz Pharmaceuticals’ agreements with Third Parties, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) establish a manufacturing sub-committee which shall review matters relating to the arrangement for distributing Product on a Named Patient Basismanufacture of Product. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development (except to the extent that such development involves clinical trials that would occur solely in the Territory) or manufacture of the Product or the RegistrationProduct, Registration (including pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Jazz Pharmaceuticals Steering Committee members shall prevail. In the event and to the extent that the Steering [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKET BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Committee is unable to come to a consensus on any matter relating to clinical trial activity that would occur solely in the RegistrationTerritory, Registration (including pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, and, if UCB has exercised its manufacturing option under Section 2.2, on any matter relating to the manufacture of the Product for sale within the Territory, the views of the Celltech UCB Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical Jazz Pharmaceuticals and Celltech agree to use Commercially Reasonable Efforts UCB shall attempt to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party, but in default of agreement may be referred by either party to arbitration under Section 15.2. During each Contract Year, the 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 Jazz Pharmaceuticals’ designated facility and a facility designated by CelltechUCB. 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 Jazz Pharmaceuticals 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 2 contracts

Samples: Xyrem License and Distribution Agreement (Jazz Pharmaceuticals Inc), Xyrem License and Distribution Agreement (Jazz Pharmaceuticals Inc)

Steering Committee. Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a 2.6.1 A Steering Committee made up composed of commercial two representatives who are employees of each Party (beginning with [*] and technical [*] from Firmenich and [*] and [*] from Amyris, any of whom can be substituted at any time in the sole discretion of their respective employer, Firmenich or Amyris) will meet quarterly until the Termination Date of the last Commercialization Program or as otherwise mutually agreed by the Parties. Additional employees from both companies that shall have certain decision-making authority, of either Party may attend and provide oversight for participate in discussions at Steering Committee meetings with the administration prior approval of this Agreementthe other Party. Each party shall maintain two (2) members on The role of the Steering Committee with other members added as neededwill extend through the Supply Agreement and accordingly will be to set the overall strategy and business direction of each of the Projects. The parties shall Steering Committee's role, in addition, will be to xxxxxx a spirit of collaboration between the Parties and oversee and coordinate each select one Party's activities to optimize capital efficiency. The Steering Committee will be responsible for review and approval, subject to the terms of its representatives section 2.6.3 below, of selection of Commercial Strains, Ingredients, Work Plans (and any change to serve it requiring an increase in the then current Budget for that Project), Target Cost, Target Cost Model, Budgets, Regulatory Plan, Start Up Plan, the Collaboration portfolio of Projects, whether and how to transform an Intermediate into an Ingredient in accordance with section 3.11, commercialization strategy (marketing and distribution) and manufacturing strategy for the Intermediates and Ingredients (including capital expenditure, manufacturing location and proposed manufacturer for the Intermediates and Ingredients, as the case may be), as well as conferring with the Technical Committee on resourcing. The Steering Committee will also be responsible for final approval of resourcing and for resolving any disputes of the Technical Committee where there is a co-chairperson of deadlock. Firmenich (and, at Firmenich's request, Amyris) will nominate new Projects and present the business case for proceeding with such Projects to the Steering Committee. In addition, the Steering Committee will review the anticipated Ingredient Price, and Firmenich Production and Commercialization Costs at least quarterly and review the Maximum Annual Production Cap and recommend changes as necessary. The Steering Committee shall have the authority to conduct the following activities and will perform such other activities duties and functions as may be agreed assigned 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 this Agreement 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 later assigned to the Steering Committee may attend meetings by written agreement of the Parties. The Steering Committee as required. In-person Steering Committee meetings chairman shall alternate initially be [*], and the chairmanship will rotate between Orphan Medical's designated facility and the Parties annually with a facility designated by Celltech. The co-chairpersons new chairman to assume such position after each one year term 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-chairpersonsoffice.

Appears in 1 contract

Samples: Collaboration Agreement (Amyris, Inc.)

Steering Committee. Within a reasonable period of time after SECRETARIAT Paper Profile is an initiative driven by major pulp, paper and paperboard industry companies in Europe. The companies guide the Effective Date, Orphan Medical and Celltech shall form a initiative through the Paper Profile Steering Committee. The Steering Committee made up of commercial and technical employees from both companies that shall have certain is the decision-making authority, and provide oversight body responsible for the administration functioning and development of this Agreementthe initiative. Each party shall maintain two (2) members on the The Steering Committee with consists of one representative from each member company registered to use the Paper Profile scheme. National Forest Industry associations and other members added as needed. The parties shall each select one of its representatives experts may be invited to serve as a co-chairperson support the work 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 constitutes a quorum if more than half 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 Basisits company members are present. In the event and to the extent that Primarily the Steering Committee is unable will work on every proposal in order to come to reach consensus. If 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 proposal cannot be adopted by the Steering Committee is unable to come to a consensus unanimously the Steering Committee may vote on any matter relating the proposal. The proposal may only be referred to the Registrationvoting if the Steering Committee has not reached consensus within one meeting. The proposal to be voted on, packaging, labeling, promoting, marketing, sale or distribution is the proposal modified by the Steering Committee during the above mentioned time period and that one which has already got highest level of support in the Steering Committee. The voting proposal is adopted if 90 % of the Product within Member Companies vote in favour of the Territoryproposal. If there are less than ten Member Companies the decision is carried if all except one of the Member Companies vote in favour of the proposal. The voting may be arranged by a written procedure. Only votes given will be counted. The Steering Committee will monitor the functioning of the Paper Profile based on this Agreement on Paper Profile Administration. The experiences will be analysed no later than five years after the present agreement has entered into force. Based on the experiences and analysis, the views of the Celltech Steering Committee may propose changes to the Agreement on Paper Profile Administration. The decisions to change the Agreement on Paper Profile Administration are primarily made based on the consensus. The above mentioned procedure for the possible voting will be applied accordingly. Member companies have equal voting power. Association representatives and experts do not have the right to vote. Company members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, or their substitutes are assumed to have a mandate to make decisions. A member company wishing to participate in the good faith judgment of the party who does voting is not have the ultimate allowed to transfer its right to vote to another company. Decision-making may also be carried out in writing. The written decision making authority procedure includes e-mails or letters. The member companies must take the decision (decision rules 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 stated above) to use Commercially Reasonable Efforts to resolve the written decision-making procedure before the matter in a manner which will minimize question has been resolved. The decision must be made in no less than three weeks and shall not exceed six weeks from the impact on such rights or obligations of such partytime the proposal was sent to all Member Companies. During each Contract Year, the parties shall hold The Steering Committee meets at least four once a year. The members will be notified at least three months in advance of the meeting date and the agenda (4with separate items for decision- making and discussion items) regular meetings will be distributed at least three weeks in advance. The Steering Committee makes decisions on how the Paper Profile form and manual can be revised. The Committee may meet frequently if considered necessary by the chairperson or on the request of two or more members acting together. The Committee may establish specific ad hoc working groups for certain assignments e.g. producing brochures or conducting surveys under the Paper Profile. The Chairperson is selected every year from company representatives in the Annual Meeting of the Steering Committee. Members Circulation order of the Steering Committee may participate in meetings Chairmanship is based on the order of companies joining the initiative. The Chairmanship turn can only be refused due to a force majeure. The order of the Steering Committee in person or by conference telephone call. At least one chairmanship: • LEIPA (12023) of the four • Xxxxxxxx-Munksjö (42024) 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.• Xxxxxxx Paper (2025) • Lessebo Paper (2026) • Xxxxx Xxxxxxx (2027) • Maxauer Papierfabrik • Stora Enso • Metsä Board • UPM • Norske Xxxx • SAPPI • Arctic Paper • Holmen Paper • Sylvamo • Navigator Company • Clairefontaine • Mondi • Xxxxx Group • LECTA • Lenzing Papier • MM Group • Laakirchen Papier

Appears in 1 contract

Samples: paperprofile.com

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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: Supply Agreement (Versartis, Inc.)

Steering Committee. Within a reasonable period of time after Columbia shall make all decisions with respect to 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 strategy for the administration marketing and Promotion of the Products. However, other issues may arise under the terms of this Agreement. Each party shall maintain two (2) members on Agreement or between the Steering Committee with parties while operating under this Agreement which are appropriate for consultation between the parties to ensure maximum productivity of the Sales Force, including, but not limited to, the establishment of work rules or the response to greater than expected Sales Force turnover and other members added as neededchanging market conditions. The parties shall, therefore, establish a Steering Committee, chaired by Columbia and consisting of up to three (3) members from each party. The chairperson's duties shall each select one of its representatives include site selection, logistics, agenda and facilitation; provided however, that an Innovex Committee member may submit agenda items to serve as a co-chairperson the Chair and such items shall be included in the next regular meeting of the Steering Committee. The Steering Each member of the 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 an employee or manufacture member of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution Board 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 Directors of the party who does not have that appointed such member. Initial appointments shall be made within fourteen (14) days of the ultimate decision making authority as date of this Agreement. A member of the Committee may be removed at any time, with or without cause, by the party that appointed such member. The Committee shall meet each quarter, or otherwise at the call of the chairperson to such matter (as provided in review, coordinate, and discuss issues regarding 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 partyPromotional Program. During each Contract YearIn addition, the parties Committee shall hold at least four (4) regular meetings of the Steering Committeereview and resolve issues pertaining to this Agreement. 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 The members of the Steering Committee may attend meetings will use reasonable efforts to reach consensus on all decisions. In Witness Whereof, Columbia and Innovex have caused this Work Order # 8872 to be duly executed on their behalf by their authorized representatives and made effective as of Effective Date of Work Order appearing above. Accepted and Agreed to by: Columbia Laboratories, Inc. INNOVEX LP by: Innovex America Holding Company, its General Partner /S/ Xxxx Xxxxxxxxx /S/ Xxxxx X. Xxxxx ------------------ ------------------ By: Xxxx Xxxxxxxxx By: Xxxxx X. Xxxxx Title: President & CEO Title: CFO Date: March 5, 2003 Date: 3/5/03 [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Attachment A to Sales Force Work Order SALES FORCE EXPENSE ALLOCATION Project # 8872 --------------------------------------------------------------------------------------------------------------- Category Innovex Pass Through Columbia Direct Expenses Direct Expenses Expenses --------------------------------------------------------------------------------------------------------------- Salary, including payroll taxes, for Sales Representatives, District X Managers --------------------------------------------------------------------------------------------------------------- Incentive compensation (bonus) for Sales Representatives, District X Manager, plus [***]% --------------------------------------------------------------------------------------------------------------- Benefits package, including (401k), ESOP, ESPP, medical, dental, Rx, X vacation, holidays --------------------------------------------------------------------------------------------------------------- Auto Costs in territory, including monthly allowance, parking and tolls. X --------------------------------------------------------------------------------------------------------------- Basic Business Expenses in territory, including phone, paper X supplies, postage and voice mail. --------------------------------------------------------------------------------------------------------------- Business Cards & Detail Bags X --------------------------------------------------------------------------------------------------------------- Call Reporting ; SFA X --------------------------------------------------------------------------------------------------------------- Computers for Sales Representatives, including software, helpdesk X support, data/replication lines --------------------------------------------------------------------------------------------------------------- Computers for DMs, NSM, including software, helpdesk support, X data/replication lines --------------------------------------------------------------------------------------------------------------- Infrastructure support (operations, HR, finance, legal) X --------------------------------------------------------------------------------------------------------------- Liability Insurance: employment, workers comp, E & O, CGL, auto X --------------------------------------------------------------------------------------------------------------- Recruitment and re-recruitment, includes drug screens, background and X motor vehicle checks --------------------------------------------------------------------------------------------------------------- Meetings: Columbia national, regional and district meetings; product X launches --------------------------------------------------------------------------------------------------------------- Promotional Expense Budget (access money) X --------------------------------------------------------------------------------------------------------------- Promotional Program and Promotional Materials (sales aids) X --------------------------------------------------------------------------------------------------------------- Promotional marketing expenses, including sales data X --------------------------------------------------------------------------------------------------------------- Training program, materials and facilities; initial and follow-up X --------------------------------------------------------------------------------------------------------------- Travel Expenses (air, hotel, meals, T&E) for Sales Reps, District X Managers, National Sales Manager X *Interviewing X *Training X *Territory travel for field management purposes X --------------------------------------------------------------------------------------------------------------- [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXHIBIT 1 to Sales Force Work Order ADDITIONAL SALES REPRESENTATIVE REQUEST FORM This Request for Additional Sales Representative is issued pursuant to the Master Sales Services Agreement between Columbia and Innovex LP, dated as of July 31, 2002, and Work Order/Sales Force # 8872. ---------------------------------------------------------------------------------------------------- PART 1 To be completed by Columbia Attach any relevant, helpful information ---------------------------------------------------------------------------------------------------- NUMBER OF SALES REPRESENTATIVES REQUESTED ---------------------------------------------------------------------------------------------------- TERRITORY LOCATION(S) ---------------------------------------------------------------------------------------------------- REQUESTED START DATE ---------------------------------------------------------------------------------------------------- AUTHORIZED COLUMBIA REPRESENTATIVE Signature: SUBMITTING REQUEST ------------------------------ Name: Title: Date: Phone: Fax: ---------------------------------------------------------------------------------------------------- PART 2 To Be Completed by Innovex Innovex shall respond within ten (10) business days after receipt of the Steering Committee as requiredAdditional Sales Representatives Request. In---------------------------------------------------------------------------------------------------- This Additional Sales Representative Request is Accepted, and Recruitment shall begin immediately: Request Form was Received by Innovex on the following date: ----------------------------------------- (sign and date) Contact Person: --------------------- Phone: ---------------------------------------------------------------------------------------------------- Request is Not Accepted (identify above information which must be clarified or changed before Request may be accepted by Innovex): ----------------------------------------- (sign and date) Contact Person: Phone: ---------------------------------------------------------------------------------------------------- [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXHIBIT 2 to Sales Force Work Order ANNUAL TRAVEL BUDGET 6/2/03 - 6/1/04 ("Year One"): [***] for Initial Sales Force Training [***] for POA Meetings and Field Based Travel Year One budget plus [***]% Seven-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and a facility designated by Celltech. The co-chairpersons twelfths of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meetingYear Two budget, 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-chairpersonsplus [***]% [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Appears in 1 contract

Samples: Columbia Laboratories Inc

Steering Committee. Within a reasonable period In order to monitor, coordinate and facilitate implementation of time after the Effective Date, Orphan Medical terms 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 conditions of this Agreement. Each party , Verso and NewPage shall maintain two establish a “Steering Committee” consisting of at least one executive officer from each of Verso and NewPage and whereby each of Verso and NewPage is equally represented (2) members provided that the chairman of the Steering Committee shall in all cases be deemed a representative of both Verso and NewPage for purposes of determining equal representation on the Steering Committee with other members added as neededCommittee). The parties initial Steering Committee representatives shall each select one of its representatives to be Xxxxxx X. Xxxxx, who shall also serve as a co-chairperson the initial chairman of the Steering Committee, Xxx Wilhlelm, the divisional financial representative of Verso, and Xxxxxx X. Ashbumer, the divisional financial representative of NewPage. The Steering Committee representatives shall have meet at least quarterly (or more frequently if needed or reasonably requested by a representative) during the authority Term to conduct determine the following activities Shared Services to be provided and such other activities as may the payments to be agreed made pursuant 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 Basisthis Agreement. In the event and Such determination with respect to the extent that Shared Services to be provided shall include the Steering Committee is unable to come to a consensus on any matter relating to the development scope, manner, level and place 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 places where 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 Shared Services shall be conducted in-personprovided. Employees of each party who are not If the members of the Steering Committee may attend meetings are unable (whether by majority vote or in such other manner as the members of the Steering Committee decide) to determine whether a Shared Service is to be provided, or the scope, manner, level and place or places at which such Shared Service shall be provided, such Shared Service shall not be provided until such time as required. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and a facility designated by Celltech. The co-chairpersons the members of the Steering Committee shall alternate responsibility for determine the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first relevant matters. The Steering Committee meeting; providedrepresentative(s) for NewPage or Verso, howeveras the case may be, that such minutes shall not become official until agreed upon by both co-chairpersonsstay reasonably apprised of the activities of the employees, agents and contractors of NewPage or Verso, as the case may be, who are providing or receiving the Shared Services in order to maximize efficiency in the provision and receipt of the Shared Services.

Appears in 1 contract

Samples: Shared Services Agreement (Verso Paper Holdings LLC)

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 by both co-chairpersonsthe Closing.

Appears in 1 contract

Samples: Purchase and Subscription Agreement (Ioneer LTD)

Steering Committee. Within a reasonable period 2.1 General Responsibilities of time after the Effective DateSteering Committee. A four-person steering committee, Orphan Medical consisting initially of Paul Xxxxx xxx Kennxxx Xxxxxxx xxx MSS and Celltech shall form a [ * ] for the University (the "Steering Committee"), will make joint decisions and provide high level management with respect to the Project. [ * ] will also serve on the Steering Committee made up as a representative of commercial the employees, faculty, consultants and technical employees from both companies that shall staff working on the Project. Each person on the Steering Committee will have certain decision-making authority, and provide oversight for the administration of this Agreementone vote. Each party shall maintain two (2) may nominate alternative or replacement members to serve 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 the consent of the Steering Committeeother party, which consent will not be unreasonably withheld. 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 will meet on a Named Patient Basisregular basis as the committee members may determine to be necessary. 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 Written minutes 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 callwill be kept and will be promptly circulated after each meeting to the committee members for approval. At least one (1) The Project will consist of the four (4) Steering Committee meetings shall be conducted inan initial phase and any follow-person. Employees of each party who are not members of on phases that the Steering Committee may attend meetings of determine to pursue. During the initial phase, the parties will, in accordance with their respective responsibilities set forth in Section 3 below, file and prosecute U.S. and international patents covering the Initial Eye Disease Test and any other Innovations that the Steering Committee as requiredmay determine, conduct clinical studies to generate appropriate clinical data and, if such data demonstrates strong clinical utility of potential Products, identify and engage an appropriate Third Party. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and a facility designated by Celltech. The co-chairpersons of If the Steering Committee shall alternate responsibility for determines that the preparation of minutes setting forth discussions made at each committee meetingclinical data is not strong enough to seek a Third Party, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; providedwill determine the next step(s) that should be taken. After completion of the initial phase of the Project, howeverthe Steering Committee will review and make decisions as to the next step(s) that should be taken, that such minutes shall not become official until agreed upon by both co-chairpersonswhich may include additional research and/or development and testing of Products, seeking of additional Third Parties, direct sales, or termination of the Project.

Appears in 1 contract

Samples: Project Agreement (Medical Science Systems Inc)

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