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.

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.

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.

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.

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.

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.

Steering Committee. Within a reasonable period of time To plan, manage and oversee work on the Development Program and to approve, update and modify the Work Plan as may be necessary, NOVAVAX and ESPRIT shall promptly after the Effective DateDate organize a steering committee (the “Steering Committee"), Orphan Medical consisting of three (3) members from NOVAVAX and Celltech shall form a Steering Committee made up of commercial and technical employees three (3) members from both companies that ESPRIT. ESPRIT 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 right to appoint one of its representatives members to serve as a co-be the chairperson of the Steering Committee. The Steering Committee Parties shall each have the authority right, upon notifying the other, 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 change its 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 at any time during the good faith judgment Term of this Agreement and to invite such non-Steering Committee members to a meeting of the party who does not have the ultimate decision making authority Steering Committee 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 partyParty shall reasonably determine. During each Contract Year, the parties The Parties shall hold at least four (4) regular meetings of the Steering Committee. Members of Committee as mutually agreed by the Steering Committee may participate Parties (but in no event less than once per Calendar Quarter) to review the Development Program and to discuss future activities under this Agreement; provided, however, that each Party shall have the right to call additional meetings of the Steering Committee in order to discuss new material events upon twenty (20) days’ prior Novavax Esprit License and Development Agreement — written notice (one of which may require an in person or by conference telephone callmeeting). At least one Not later than ten (110) days prior to each of the four (4) regularly scheduled Steering Committee meetings meetings, ESPRIT shall be conducted in-person. Employees of each party who are not members of prepare a report for the Steering Committee detailing the progress of the Development, Program including successes, difficulties, milestone achievements and a comparison of the status of the Development Program as compared to the timeline contained in the Work Plan. Such report shall also contain any recommendations for updates or modifications to the Work Plan. Consultants and non-Steering Committee member employees of the Parties may attend meetings of the Steering Committee as requiredrequired to further the Development Program only upon written notice to the Party not bringing the consultants and non-Steering Committee members. In-person Unless otherwise mutually agreed by the Parties, the Steering Committee meetings shall be in-person and shall alternate between Orphan MedicalESPRIT’s designated facility and a facility NOVAVAX’s designated by Celltechfacility. The co-chairpersons first meeting shall be held at ESPIRT’s designated facility. Minutes of all such meetings setting forth decisions of the Steering Committee relative to the Development Program shall be prepared. Responsibility for the minutes shall alternate responsibility between NOVAVAX and ESPRIT, with NOVAVAX being responsible for the preparation minutes 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, provided that such minutes shall not become official until agreed upon approved by both coeach of the Parties. Any vote of the Steering Committee shall include at least one (1) representative of each of NOVAVAX and ESPRIT. The Steering Committee shall make all decisions only by consensus. Any non-chairpersonsconcurrence of the Steering Committee relating to any issue, question or dispute shall be elevated to the Head of Research and Development of ESPRIT and to the Head of Research and Development of NOVAVAX Novavax Esprit License and Development Agreement — for resolution and failing resolution by such individuals, to the President and Chief Executive Officer of NOVAVAX and President and Chief Operating Officer of ESPRIT for resolution, recognizing that, in the event of continuing disagreement, the final decision and ultimate resolution shall rest with ESPRIT.

Steering Committee. Within The sales and marketing program for the Test in the Territories will be managed by a reasonable period steering committee having equal representation of time after the Effective Dateparties (the “Steering Committee”), Orphan Medical and Celltech shall form a which Steering Committee made up of commercial and technical employees from both companies that shall have certain decisionmay be the same as the “Steering Committee” (as defined in the U.S. Co-making authority, and provide oversight for Promotion Agreement) managing the administration of this U.S. Co-Promotion Agreement. Each The Steering Committee will include three (3) members from each party and will meet in-person at least quarterly with at least one (1) meeting per year being conducted in person while more frequent meetings or teleconferences will be held anytime they are needed and requested by the Steering Committee’s members of 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 maintain 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 matter. The attendance of 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.

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.

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.