Common use of Steering Committee Clause in Contracts

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnus.

Appears in 3 contracts

Samples: Sales, Marketing and Distribution Agreement (Cygnus Inc /De/), Sales and Distribution Agreement (Cygnus Inc /De/), Sales, Marketing and Distribution Agreement (Cygnus Inc /De/)

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Steering Committee. Within twenty a. Each PARTY shall appoint up to two (202) calendar days from representatives to serve as members of the Effective DateSTEERING COMMITTEE to direct the overall course of activities under this AGREEMENT. Decisions of the STEERING COMMITTEE shall require a unanimous vote. Chairmanship of the STEERING COMMITTEE shall rotate, beginning with a P&G representative, for twelve- (12) month periods. b. Subject to the oversight and approval of the PARTIES, the STEERING COMMITTEE shall be responsible for the following: (i) Overall direction of the DEVELOPMENT PLAN and each individual project thereof, including safety testing, staffing and other requirements for the DEVELOPMENT PLAN; (ii) Monitoring, updating and modifying, if necessary, the overall DEVELOPMENT PLAN; (iii) Scheduling and conducting biannual reviews, or such more frequent reviews as the STEERING COMMITTEE determines necessary; (iv) Recommending to the PARTIES the licensing of technology and/or intellectual property, if any, from third parties to enhance the DEVELOPMENT PLAN projects as needed; (v) Preparation and approval of the Success Criteria, consistent with the terms of this AGREEMENT; and (vi) Reviewing INVENTIONS made pursuant to this AGREEMENT with patent counsel, facilitating patent filings by the appropriate PARTY, and tracking of patent activities. c. Each PARTY shall notify the other within thirty (30) days after the EFFECTIVE DATE of the names of its STEERING COMMITTEE members. The STEERING COMMITTEE shall have no authority to modify or amend the terms of this AGREEMENT. Any dispute or issue that cannot be resolved by the STEERING COMMITTEE shall be referred to senior management of the PARTIES to be resolved by them, if possible. For purposes of this SECTION, "senior management" for P&G shall be Vice President, Research & Development, Global Beauty Care and President, Global Cosmetics & Skin Care and for GCI shall be Vice President, Research and Vice President, Enzyme Cleaning Products 12. CONFIDENTIALITY a. Disclosure of confidential and proprietary information hereunder by either PARTY to the other will form be made in writing or other tangible form, or confirmed in writing within thirty (30) days of disclosure if made in nontangible form, will be clearly marked confidential and will include any confidential information provided to GCI, or P&G under the Non-Disclosure Agreement dated February 3, 2000. b. Such confidential information will be safeguarded by the receiving PARTY. The receiving PARTY shall protect the disclosing PARTY's confidential information against unauthorized disclosure using the same degree of care, but no less than a Steering Committee consisting reasonable degree of care, as the receiving PARTY uses to protect its own confidential information of a like nature. Such confidential information will be used by the receiving PARTY only for the purpose of this AGREEMENT and will not be otherwise utilized or disclosed to third parties without first having obtained written consent of the disclosing PARTY, which consent will not be unreasonably withheld. Disclosing PARTY's confidential information will be made available only to such receiving PARTY's employees and AFFILIATES who have a need to know such information. Subject to the provisions of this SECTION these obligations of confidentiality will apply until the expiration of exclusivity or three (3) people years from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons termination of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyAGREEMENT, and shall document their meetings in written minutes, to:whichever is later. (a) review c. Obligations regarding confidential information received by either PARTY under the sales, marketing and distribution provisions of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; SUBSECTION (b) discuss actions above shall not apply to xxxxxx any such information that: i) becomes publicly available without default hereunder by the attainment receiving PARTY; or ii) is lawfully acquired by the receiving PARTY from a source not under any obligation of sales objectivesconfidentiality to the disclosing PARTY regarding disclosure of such information; or iii) is in the possession of the receiving PARTY in written or other recorded form at the time of its disclosure hereunder; or iv) is nonconfidentially disclosed to any third party by or with the permission of the disclosing PARTY hereunder; or v) is developed by or on behalf of the receiving PARTY by individuals who have not received confidential information hereunder. d. The obligations of confidentiality set forth herein further shall not apply to any information to the extent that such information: i) is required to be disclosed by order of a court of law, provided that the receiving PARTY provides reasonable prior notice of such required disclosure to the disclosing PARTY; (cii) review current marketing, distribution, sales and pricing strategies, including amount and form is used with the prior written consent of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product disclosing PARTY which consent shall not be unreasonably withheld in applications for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus patents on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights INVENTIONS or in financial information in the Territory;usual conduct of business; or (giii) review Cygnus’ proposed product development as set forth has been approved in Section 5.1(hwriting for publication by both of the PARTIES; or iv) in light is submitted to governmental agencies to facilitate the issuance of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) reviewapprovals for materials and products, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan DEVELOPMENT PLAN hereunder provided that reasonable measures shall be mutually agreed upon taken to assure confidential treatment of such information; or v) is product-related information which is reasonably required to be disclosed by Sankyo and Cygnuseither PARTY in connection with its testing or marketing of "relevant products", in such PARTY's discretion.

Appears in 2 contracts

Samples: Commercialization Agreement (Genencor International Inc), Commercialization Agreement (Genencor International Inc)

Steering Committee. Within twenty (20a) calendar days from As soon as reasonably practicable after the Effective Date, the parties Antigenics MA and GSK BIO will form establish a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”), to oversee the activities to be undertaken pursuant to this Agreement. A representative The Steering Committee will facilitate communication between the Parties and provide a forum to review any technology transfer, supply and manufacturing matters pertaining to QS-21. The Steering Committee shall consist of three (3) individuals appointed by each Party or such other number of representatives the Parties may mutually agree upon and may also include additional representatives from each party the Parties, as mutually agreed, on an ad-hoc basis and shall serve as be co-chairpersons chaired by GSK and Antigenics MA. The co-chairs will coordinate agendas and minute-taking for meetings of the Steering Committee. Each Party may replace its Steering Committee representatives at any time upon written notice to the other Party provided that, in the [**] and will [**] to any [**]. The Steering Committee may establish certain ad hoc sub-committees which consider certain matters, including without limitation, one or more subcommittees as appropriate. sub-committees (consisting of at least one (1) individual from each Party) to address (i) technical matters in dispute that have not been resolved under the Quality Agreement and (ii) repetitive, specific cGMP issues. (b) The Steering Committee shall meet (in person, or by teleconference or videoconference as agreed by the Parties) at least quarterly[**] during the first [**] and thereafter [**] (or more frequently as the Parties mutually agree is appropriate, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution or as determined by [**] during any period of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions Antigenics MA’s inability to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations supply under Section 5.1 3.5(c), on such dates and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in at such times as the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this AgreementParties shall agree. The Steering Committee may take action only by (itself or through one or more sub-committes as contemplated in Section 2.2(a) above) will, among other things (i) oversee the unanimous written consent Manufacturing Technology transfer; (ii) review and manage the Manufacturing relationship hereunder, including without limitation, review the Manufacturing requirements for QS-21 for GSK, (iii) discuss and review for Antigenics MA’s reasonable consideration, the [**], discuss [**] = Portions of all members, as indicated by all members signing this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and CygnusCommission.

Appears in 2 contracts

Samples: Manufacturing Technology Transfer and Supply Agreement, Manufacturing Technology Transfer and Supply Agreement (Antigenics Inc /De/)

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form 5.1.1 The Parties shall establish and maintain a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons ) to oversee the Project and the relationship of the Steering CommitteeParties under this Agreement. The Steering Committee shall consist of three (3) members, with one member chosen from JEPLAN, with one member chosen from Axens and one member from IFPEN: - The 1 representatives of JEPLAN is: [**] - The 1 representatives of IFPEN is: [**] - The 1 representative of Axens is: [**] Each Party may establish one or more subcommittees as appropriatereplace its representatives above-mentioned by written notice sent to the other Parties. 5.1.2 All decisions of the Steering Committee shall be resolved and decided by unanimous vote of the Parties. The Steering Committee shall meet at least quarterlytwice a year or at any time upon written request of a Party with one (1) month prior written notice. Axens will be in charge of sending the invitation and the agenda of each meeting to each member of the Steering Committee. Joint Development Agreement No. IFPEN n°2020-0085 The meetings of the Steering Committee may be held with physical attendance or by teleconference or other telecommunication means, and provided that the Parties agree so. The quorum for the conduct of business at each meeting shall document their meetings in written minutes, require the attendance of at least one representative of each Party. 5.1.3 The responsibilities of the Steering Committee shall include (but not limited to) the following activities: (a) review Review the sales, marketing progress and distribution direction of the Product Project and the Work. The initial activities detailed in the Territory, including a review and update Schedule A shall be considered approved upon execution of the Sales, Marketing and Distribution Plan at least annually;this Agreement. (b) Monitor the overall budget of the Project (including CAPEX for New Equipment) in accordance with expenditure report as per Article 6, approve the annual budget proposed by R&D Management Team and discuss actions to xxxxxx the attainment of sales objectives;any budget overruns. (c) review current marketing, distribution, sales Validate the deliverables detailed in Schedule A and pricing strategies, including amount and form of discount and rebate programs;validate the New Equipment to be implemented on the KHP Pilot demo plant. (d) coordinate activities between Sankyo Assess readiness for Commercialization of the Process. This readiness for Commercialization can take place before the end of the Work, according to Schedule A. Should a Party oppose to readiness for Commercialization of the Process, the Parties shall discuss the reasons of such opposition which shall be duly justified; and Cygnusshould the Parties fail to reach an agreement to assess commercial readiness of the Process within two (2) month from Steering Committee meeting stating the opposition, Axens may decide, at its Affiliatessole discretion and risk, designeesto Commercialize the Process (therefore provisions of Article 10.5 will not apply). Additionally, licensees and/or its sublicensees who are promoting the Product Parties will decide upon the opportunity to continue Commercializing the Intermediate Process after the readiness for Cygnus pursuant to Section 2.1(ii);Commercialization of the Process. (e) review Sankyo’s efforts to develop and implement strategies Discuss the repair plan on KHP Pilot demo plant (in case of institutional, governmental and managed care marketing and contracting;dysfunction or defect) as per Article 3.6.3 (f) Review any technical hurdle that may be encountered during the Work as informed by the R&D Management Team and review Cygnus’ obligations under Section 5.1 and receive updates the Process data report from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review site operation of Cygnus Intellectual Property Rights in the Territory;Process prepared by R&D Management Team or one of the Parties. (g) Manage the relationship and interactions of the Parties in performing and administering this Agreement, including ongoing review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product;performance of the Work, intellectual property management and direction of the Results and resolution of questions or conflicts that may arise. (h) review Sankyo’s obligations under Section 4.1;Review and approve or disapprove any changes to Schedule A (Scope of Work) initiated by the Project Leaders (defined below). (i) reviewUpdate, and if when necessary, amend Schedule B of the schedule set forth in Exhibit C hereto;Agreement. (j) resolve Decide at the end of the Scope of Work or at any disputes pursuant Go/No Go date defined by the parties in schedule A whether to Section 7.1; andgo on with the next steps of the Project (“Go/NoGo Decision”). A Go Decision may only be decided unanimously by the Parties. In case a Party opposes to the Go Decision, with a (30) days prior written notice, the Parties shall discuss the reasons of such opposition which shall be duly justified and should the Parties fail to reach an agreement to the Go Decision, a NoGo Decision will be adopted. In case of NoGo Decision, the Project Leaders shall review and amend as need be the Work, convene another Steering Committee in order to reach a Go Decision. Should the Parties fail to reach a Go Decision, the Parties may decide to terminate the Agreement in accordance with the provisions of Article 15.5. (k) agree upon Exchange information regarding the initial SalesCommercialization of the Process and/or Intermediate Process, Marketing subject to third party’s right and Distribution Planto extend legally possible, and acknowledge which Party, JEPLAN or Axens, is bringing the opportunity and the customer for a new potential project. (l) Validate and determine the strategy between the Parties regarding any trademark (registered or not) exploitation on the Product (or any product derived from the Products) and the Process and discuss the sharing of any financial compensation between the Parties linked to the commercialization of such trademark. Each party may change its members Such discussions will be materialized in a separate agreement based on the principles agreed between the Parties in schedule E. (m) Validate the conditions of use of and access to the KHP Pilot demo plant outside the Work (as per Articles 3.6.2 and 3.6.4). (n) Approve the list of Proprietary Equipment submitted by Commercial Committee. (o) Seek for funding programs available or any other sources of funding for the Project (Japanese/French/European). (p) Discuss the possibility to establish any structure including a project company or any joint venture company between the Parties that will support one or several projects in a specific area or globally. Joint Development Agreement No. IFPEN n°2020-0085 (q) Discuss of possible use or incorporation in the Project of technology elements of third parties including, if necessary, from Direct Competitors. (r) Prepare and maintain minutes of all meetings of the Steering Committee. Meeting minutes shall be issued and communicated to all the representatives of the Parties within ten (10) calendar days of the meeting. The minutes shall be considered as accepted if, within fifteen (15) calendar days from sending, no representative has objected in writing with respect to the accuracy of the draft of the minutes. The powers of the Steering Committee at shall be limited to the foregoing. The Steering Committee shall have no authority to take any time upon written noticedecision which would increase the financial commitment of the Parties, and each party will cause its members amend the scope of the Project or otherwise amend this Agreement or decide a waiver of compliance with or breach of provisions of this Agreement. All such matters shall be subject to an amendment agreement to be signed by the Parties. Each member of the Steering Committee may invite the person/experts of his choice to act reasonablyattend meetings of the Steering Committee, provided this person is a permanent member of the staff of the Party or of its Affiliates to which the representative belongs, and is subject to the confidentiality obligations set forth in good faith and consistent with the terms and conditions Article 11 of this Agreement. The Steering Committee may take action only by the unanimous Should a party request that an external person attends a meeting, it shall seek prior written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers approval of the parties for resolution. The initial Sales, Marketing other Parties and Distribution Plan this person shall be mutually agreed upon bound by Sankyo and Cygnusconfidentiality obligations not less stringent as those set forth in Article 11.

Appears in 2 contracts

Samples: Joint Development Agreement (JEPLAN Holdings, Inc.), Joint Development Agreement (JEPLAN Holdings, Inc.)

Steering Committee. Within twenty 3.1.1 The Parties shall form a “Steering Committee” or “SC” consisting of two (202) permanent members representing Coskata and two (2) permanent members representing TPRF. The Parties agree that TPRF shall have the right to elect its representative from within the personnel of its Affiliates. Each member has the right to invite up to two experts in support of the activities and responsibilities of the SC, provided that: (a) the inviting Party shall provide the other Party with a prior notice of such invitation and (b) the other Party shall have the right to refuse such invitation in case this expert is not a member of the inviting Party’s personnel and (c) such invited expert shall in no event have the right to vote within the SC and (d) any expert attending a SC meeting who is not a member of any Party’s personnel shall have agreed in writing to the confidentiality provisions of Section 11. 3.1.2 Without prejudice to each Party’s responsibilities and liabilities specified herein, the Steering Committee shall be responsible hereunder for those activities conducted under this Agreement that are attributed to the Steering Committee. Accordingly, the responsibilities of the Steering Committee shall consist of: (a) the evaluation of progress made in relation to the work to be performed by the Parties under this Agreement, the confirmation of achievement of milestones directed to the implementation of the IJDP and any ADPs and the decision to enter into a given phase of the IJDP and/or ADP; (b) the review, approval and rejection of proposals relating to the IJDP or an ADPs, including review and approval of the Approved Licensing Conditions and the Approved Package; (c) the discussion and recommendation of any amendments to this Agreement (if any) to be executed by the Parties; (d) the resolving of intellectual property matters; (e) the management of the preparation of the commercialization (industrialisation and licensing) of the Propanol Fermentation Technology; (f) all major decisions relating to the joint implementation of this Agreement between the Parties; and (g) any other responsibility as agreed by the Steering Committee. 3.1.3 The Steering Committee shall meet for the first time to establish an initial path forward for the implementation of the IJDP as described in Appendix 2 at a mutually agreeable date, but no later than forty-five (45) calendar days from after the Effective Date. Details of the form, date, and place of the initial meeting will be as agreed by the Parties within fourteen (14) calendar days of the Effective Date. During the remainder of the term of this Agreement, the parties will form a Steering Committee consisting will meet every six (6) months, or as may otherwise be mutually agreed upon by the Parties, at times and places mutually agreed upon by the Parties. 3.1.4 The Steering Committee shall only take decisions hereunder on the basis [***] of three the votes issued by all its Parties through its permanent members, meaning that each Party represented by its permanent member(s) shall have the specific right to [***] made by or on behalf of any other Party (3through its permanent members or otherwise) people from each party (the “Steering Committee”). A representative from each party shall serve and which without such consent, or if so rejected, such proposal, resolution, or directive does not become valid or effective as co-chairpersons an act of the Steering Committee. The Steering Committee may establish one Any such decision [***] shall require that all permanent members are present or more subcommittees as appropriateotherwise involved in the relevant decision making process. [***] Indicates that text has been omitted which is the subject of a confidential treatment request. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent text has been separately filed with the terms Securities and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and CygnusExchange Commission.

Appears in 2 contracts

Samples: Joint Development Agreement, Joint Development Agreement (Coskata, Inc.)

Steering Committee. Within twenty (20i) calendar days from the Effective Date, the parties The Parties will form establish a Steering Committee consisting of three steering committee (3) people from each party (the “Steering Committee”). A representative , which will be made up of one (1) Representative with decision-making authority from each party Buyer and one (1) Representative with decision-making authority from Seller, provided that the TSA Managers shall serve attend the Steering Committee meetings and shall advise the Steering Committee regarding their ongoing coordination and management of the Services as co-chairpersons ex officio members of the Steering Committee. The Steering Committee may establish one is responsible for: (A) monitoring and managing any issues arising from this Agreement and the Services; and (B) to the extent not resolved through discussions between the TSA Managers, facilitating the resolution of Disputes arising out of this Agreement in the manner contemplated by Section 2.4(c)(iv). (ii) If Buyer or more subcommittees Seller wishes to replace its Representative on the Steering Committee, then such Party will: (A) replace that Representative with another suitably qualified and experienced Representative as appropriatesoon as practicable and (B) give notice of the details of the replacement Representative to the other Party within two (2) Business Days of such appointment. (iii) The Steering Committee is primarily a vehicle for discussion. The Except as expressly set out in clauses (i) and (iv), it has no legal powers or obligations. (iv) During the three (3) months immediately following the date hereof, the Steering Committee shall meet at least quarterly(in person, by telephone or by other mutually agreed electronic means of communication) on a monthly basis. Following such period, the Steering Committee shall meet (in person, by telephone or by other mutually agreed electronic means of communication) every sixty (60) days. In addition, the Steering Committee shall hold a meeting (in person or telephonically) within five (5) Business Days of receiving a request by either of the TSA Managers to discuss any Variation or any dispute, controversy, difference or claim arising out of or in connection with this Agreement or the subject matter of this Agreement (a “Dispute”) and shall document their meetings in written minutesuse its commercially reasonable efforts to bring about a resolution to the Variation or Dispute, to: (a) review the sales, marketing and distribution of the Product in the Territoryas applicable, including a review and update in relation to disputed invoices. If the Steering Committee does not resolve any such Variation or Dispute within twenty (20) calendar days (or such longer period as the Steering Committee Representatives agree) after commencement of the Salesnegotiations to resolve such Variation or Dispute, Marketing and Distribution Plan at least annually; (b) discuss actions then such Variation or Dispute, as applicable, shall be referred to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus binding arbitration pursuant to Section 2.1(ii); (e) review Sankyo’s efforts 9.6. Any decision with respect to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree such Variation or Dispute that is mutually agreed upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it Representatives shall be documented in writing and shall be binding upon the Parties. Notwithstanding anything in this Agreement to the Executive Officers contrary, during the pendency of any Variation or Dispute with respect to this Agreement no Party shall withhold any Service or any payment for any Service until such Service is validly terminated in accordance with the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusterms of this Agreement.

Appears in 2 contracts

Samples: Transition Services Agreement, Transition Services Agreement (Jacobs Engineering Group Inc /De/)

Steering Committee. Within twenty (20) calendar days from the Effective Date, 8.1 Each of the parties will form shall appoint: (A) a project sponsor (the “Project Sponsor”) who shall be generally responsible for managing the overall performance of that party’s obligations under this Agreement and each of the Wider Transaction Documents; and (B) workstream leaders in respect of each of the regulatory, financial, commercial, distribution and clinical workstreams (each a “Workstream Lead”) who shall be generally responsible for coordinating performance of the relevant party’s obligations under this Agreement and the Wider Transaction Documents in respect of the relevant workstream, each Project Sponsor, and Workstream Lead, a “Steering Committee consisting of three Representative”. 8.2 It is envisaged that the Project Sponsors and Workstream Leads shall meet once per week or fortnight (3or as otherwise agreed between them) people from each party as a committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. The Steering Committee may establish one ) in person, by telephone or more subcommittees as appropriate. teleconference to discuss progress towards Completion. 8.3 The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, be the primary forum through which the parties will work together to: (aA) review monitor the sales, marketing and distribution performance of each of the Product in parties’ respective obligations under this Agreement and the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annuallyWider Transaction Documents; (bB) discuss actions to xxxxxx plan for the attainment separation and integration aspects of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1Transaction; and (kC) agree upon resolve disputes under this Agreement and the initial Sales, Marketing and Distribution PlanWider Transaction Documents. 8.4 Either party may substitute or replace any of its Steering Committee Representatives by written notice to the other party with a person it considers to be of equivalent business seniority. Each party may shall promptly notify the other of any temporary or permanent change to the contact details of any of its members of the Steering Committee at any time upon written noticeRepresentatives. 8.5 Both parties will use reasonable endeavours to manage all issues relating to this Agreement and the Wider Transaction Documents. Any dispute or difference which arises between the parties shall, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only if not first resolved within ten (10) Business Days by the unanimous written consent of all membersrelevant Workstream Leads, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by be referred to the Steering Committee for thirty (30) calendar days, any determination. 8.6 If the Steering Committee member may submit it is unable to resolve the Executive Officers matter within ten (10) Business Days, the dispute is to be referred to a senior executive (to be notified after the date hereof) of the parties Novartis Group (on the one hand) and a senior executive (to be notified after the date hereof) of the GSK Group (on the other hand) for resolution. The initial Sales, Marketing and Distribution Plan who shall be mutually agreed upon by Sankyo and Cygnusact in good faith to seek to resolve the dispute.

Appears in 2 contracts

Samples: Implementation Agreement, Implementation Agreement (Glaxosmithkline PLC)

Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties 2.2.1. Animas and DexCom will form establish a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons ) to coordinate and oversee the overall implementation of this Agreement and the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateDevelopment Plan. 2.2.2. The Steering Committee shall meet consist of 3 members (“Steering Committee Members”) from each of Animas and DexCom. The Steering Committee Members shall be comprised of, at least quarterlya minimum, and senior R&D management from each party. The Steering Committee shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including convene on a quarterly basis to review and update of approve work plans and progress. Additionally, the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions Steering Committee shall be available on a more frequent basis to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing address key project issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planthat may arise. Each party may change its members All meetings of the Steering Committee may be by teleconference, videoconference or any other means of communication agreed to by the parties. 2.2.3. Each of Animas and DexCom shall have one vote on the Steering Committee. If more than one representative of a party is present at any time a meeting, such representatives shall agree upon written noticehow that party’s vote shall be cast. If only one representative is present, and each that party will cause its members shall be deemed authorized to vote on the matters raised at the meeting. All decisions of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreementshall be unanimous. The Steering Committee No decision may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration be made by the Steering Committee for thirty (30) calendar daysunless a quorum is present, any such quorum constituted by at least one member present from each of Animas and DexCom. 2.2.4. If the Steering Committee member may submit is unable to reach agreement on any matter, then within ten business days it shall be referred to the Executive Officers President of Animas and the President and CEO of DexCom and they shall endeavour to resolve such matter in good faith within twenty business days of notification by the Steering Committee of the parties for resolutiondisagreement. The initial SalesIf the Presidents are unable to reach an agreement on the matter: (i) with respect to any matter that could require expenditures of funds or utilization of resources by Animas, Marketing Animas shall have the right to make the decision; (ii) with respect to any matter that could require expenditures of funds or utilization of resources by DexCom, DexCom shall have the right to make the decision, and Distribution Plan (iii) with respect to all matters not covered by clauses (i) or (ii), the matter shall be mutually agreed upon by Sankyo and Cygnusresolved pursuant to the provisions of Section 14.9 of this Agreement.

Appears in 1 contract

Samples: Joint Development Agreement (Dexcom Inc)

Steering Committee. Within twenty (20) calendar days from 9.1 Promptly following the Effective Date, Date the parties will form hereto shall establish a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of the Steering Committee. The Steering Committee may establish one shall comprise _______ numbers of representatives of each party (not to exceed ____________ representatives of each party) to consider issues arising from and oversee the progress of the Services. 9.2 Without limiting the functions of the Steering Committee set out elsewhere in this Agreement, the role of the Steering Committee shall be to: 9.2.1 assess the status of Process for introduction into the Facility in connection with the Services and monitor the status of the Facility; 9.2.2 determine appropriate modifications to the requested schedule for delivery of Product, as provided in Clause 5.4 of Schedule 4; 9.2.3 resolve disagreements regarding yield deficiencies, pursuant to Clause 7.8 above; 9.2.4 assess the impact of the new cell lines and products requested to be manufactured by LB, pursuant to Clause 10.1; 9.2.5 resolve disputes arising between the parties under this Agreement, as provided in Clause 20; 9.2.6 monitor the progress of the Services; 9.2.7 plan and assess needs for future supply of Product (subject to the provisions set out elsewhere in this Agreement); 9.2.8 discuss and recommend any changes to the Process(es); 9.2.9 acknowledge or more subcommittees as appropriate. agree to conversion of the draft Specification to a Specification, in accordance with Clauses 2.1 and 10.1; and 9.2.10 review and assess the capacity of the Facility, in accordance with Clause 5.1 above. 9.3 The Steering Committee shall meet at least quarterlysuch times as the Steering Committee determines necessary to resolve issues arising under the Agreement and to perform its responsibilities under the Agreement, and provided that in no event shall document their meetings in written minutes, to: the Steering Committee meet less than ________ per calendar year (a) review unless otherwise mutually agreed). If any issue to be determined by the sales, marketing and distribution Steering Committee is not resolved within __________ after submission of the Product relevant issue to the Steering Committee, such issue shall be referred to the Presidents (or other equivalent) at the time in the Territoryquestion, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product each party hereto for Cygnus dispute resolution pursuant to Section 2.1(ii);Clause 20 of this Schedule 4. (e) review Sankyo’s efforts 9.4 The Steering Committee meetings shall alternate between Abgenix designated facility and a facility designated by LB, provided that the Steering Committee may decide to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development meet at another location or by teleconference as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planappropriate. Each party may change its party's members of the Steering Committee will alternate responsibility for the generation of minutes setting forth discussions made at each Steering Committee meeting within _________ of the meeting. The LB representatives shall prepare minutes for the first Steering Committee meeting. No Steering Committee minutes will become official until agreed upon by the Steering Committee. If no issue is taken with any time upon written notice, and each party will cause its members set of minutes within ten (10) days of their issue then shall be deemed to have been accepted. Any dispute at to the accuracy of the minutes shall be addressed under Clause 20 of this Schedule 4. 9.5 Decisions of the Steering Committee must be unanimous. In default of agreement on any issue to act reasonablybe determined by the Steering Committee, such issue shall be referred to the Presidents (or other equivalent), at the time in good faith and consistent with question, of each party hereto for resolution pursuant to Clause 20 of this Schedule 4. 9.6 For the avoidance of doubt, the Steering Committee shall not be empowered to amend the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnus.

Appears in 1 contract

Samples: Product Supply Agreement (Abgenix Inc)

Steering Committee. 23.2.1 Within twenty thirty (2030) calendar days from following the Effective DateDate of this Master Agreement, the parties Buyer and Company will form a Steering Committee consisting of three steering committee (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of ) in accordance with the Steering Committeeprinciples set forth in this Article and Article 27. The Steering Committee may establish will address and determine a plan to implement: (a) the Parties’ overall business relationship, (b) the implementation of the strategic relationship, (c) the timely deliverable of the Buyer customer-facing Services as will be set forth in one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyPurchase Orders, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo establish the organization structure to address and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); approve/reject any collaboration and innovation ideas and opportunities; (e) review Sankyo’s efforts to develop determine the method by which collaboration and implement strategies of institutional, governmental and managed care marketing and contracting; innovation ideas will be submitted; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; resolve any accounting or finance issues that may exist; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding implement the Product; Dispute Resolution Process; (h) review Sankyo’s obligations under Section 4.1; appoint the members of the Subordinate Steering Committee and set the date for its first meeting; (i) review, operation and if necessary, amend reporting responsibilities of the schedule set forth in Exhibit C hereto; Parties’ Designated Representatives; and (j) resolve any disputes pursuant that have arisen under this Master Agreement. 23.2.2 The Steering Committee will comprise an equal number of representatives from Company and, as a unit, the Buyer Parties, will have no more than eight (8) members, and will include the: (for Buyer) VP and above and (for the Company) VP and above . 23.2.3 The Steering Committee will have at least quarterly meetings and more often as and if necessary to Section 7.1; and (k) agree upon resolve matters escalated to it by the initial Sales, Marketing and Distribution PlanSubordinate Steering Committee in accordance with Article 21.14. Each party may change its members Meetings of the Steering Committee will be held at any a time and place mutually agreed upon written notice, and each party will cause by its members of with the expectation that they will rotate between a Company and an Buyer Party location. 23.2.4 All Steering Committee members will engage in good faith discussions to resolve by consensus all matters to be decided by the Steering Committee. If the Steering Committee cannot reach consensus on an issue, then any Party can escalate the issue to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Executive Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for which will meet within thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers days of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnussuch escalation.

Appears in 1 contract

Samples: Master Agreement for the Purchase of Smart Energy Services Software and Services (Opower, Inc.)

Steering Committee. 5.1 Within twenty five (205) calendar days from Business Days after the Effective Date, the parties will form shall establish a steering committee (“Steering Committee consisting of Committee”) comprising three (3) people senior managers from Psynova and two (2) senior managers from RBM (each party (the such manager being referred to herein as a Steering CommitteeRepresentative”). A representative from each Each party shall serve promptly notify the other party of its Representatives, and may replace its Representatives at any time upon reasonable prior written notice to the other party. 5.2 Each party shall have the right to appoint an alternative representative to attend specified meetings of the Steering Committee in place of a Representative on reasonable prior written notice to the other party. 5.3 Each party shall designate one of its Representatives as co-chairpersons chair of the Steering Committee. , and such co-chairs shall serve as the primary points of contact between the parties with respect to matters relating to this Agreement. 5.4 The Steering Committee may establish one shall meet regularly, either in person, by telephone or more subcommittees by video conference, on such dates, and at such times and locations as appropriate. The are agreed between the parties, providing that the Steering Committee shall meet at least quarterly, and four (4) times every calendar year. 5.5 The quorum for meetings of the Steering Committee shall document their meetings be at least one Representative of each party. 5.6 Each party shall be responsible for its own expenses for participating in written minutes, the Steering Committee. 5.7 The Steering Committee shall have authority to: (a) review 5.7.1 discuss progress made and any difficulties encountered; 5.7.2 plan and establish priorities; 5.7.3 oversee the sales, marketing and distribution execution of the Product R&D Project in accordance with the Territory, including a review R&D Plan for both Phase I and update Phase II; 5.7.4 coordinate and direct the mutual efforts of the Salesparties; and 5.7.5 provide strategic guidance. in relation to the both the R&D Project, Marketing and Distribution Plan at least annually;RBM’s commercialisation of the Testing Services and any Diagnostic Kits under this Agreement. (b) discuss actions 5.8 Each member of the Steering Committee shall have one vote. Subject to xxxxxx clause 5.11, the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant Steering Committee shall have authority to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities decide matters relating to its obligations under Section 5.1purposes as set out in clause 5.7. All such matters shall be decided by majority vote, including an annual review except for the following major matters, which require the unanimous resolution of Cygnus Intellectual Property Rights all of the Steering Committee members: 5.8.1 any additional countries that shall be added to the Targeted Territory in which RBM will sell and market the Testing Services, and any consequent changes to the Marketing Plan, and the revenue forecast, minimum sales targets and performance milestones referred to in clauses 12.11 and 12.12 on account of the addition of such countries to the Targeted Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light 5.8.2 the determination of marketing issues regarding a commercialisation strategy and plan for the ProductDiagnostic Kits; (h) review Sankyo’s obligations under Section 4.15.8.3 the validation studies required to determine whether the Schizophrenia Product complies with the Schizophrenia Product Milestone; (i) review5.8.4 determination of whether the Schizophrenia Product complies with the Schizophrenia Product Milestone; 5.8.5 determination of whether the R&D Plan for Phase II has been completed; 5.8.6 determination of whether the Commercialisation Milestone has been met; 5.8.7 determination of whether the approval of the Steering Committee is required for any proposed sublicense or subcontract by RBM of the Testing Services or the manufacture of Diagnostic Kits, and if necessarythe Steering Committee determines that approval is required, amend whether the schedule set forth in Exhibit C heretoSteering Committee approves such sublicence or subcontract; (j) resolve any disputes pursuant to Section 7.15.8.8 determination of the business plan, revenue forecast, minimum sales target and performance milestones for each Commercialisation Term Year; and 5.8.9 any matter referred to the Steering Committee under clause 6.8 or any other matter described in this Agreement (kincluding the R&D Plan) agree upon that is to be determined by unanimous resolution of all the initial Sales, Marketing and Distribution Plan. Each party may change its Steering Committee members. 5.9 In the event that the members of the Steering Committee at are not able to reach consensus in relation to any time matter requiring unanimous resolution under clause 5.8 within fourteen (14) days of such matter first being considered by the Steering Committee, the matter shall be referred to the respective Executive Officer of each party for resolution. If the Executive Officers are not able to reach resolution within fourteen (14) days of such matter being referred to them, then if the failure to agree is in relation to: 5.9.1 the matter referred to in clause 5.8.1, the country will not be added to the Targeted Territory; 5.9.2 the matter referred to in clause 5.8.2, RBM shall not be licensed under clause 13.3 to market and sell the Diagnostic Kits separately from their use in the provision of the Testing Services; and 5.9.3 any matter arising under clauses 5.8.3 — 5.8.9 (inclusive), or any matter referred to the Steering Committee under clause 6.8, the matter shall be referred to an appropriately qualified independent expert (the costs and expenses for which shall be borne by the parties equally) agreed upon written noticeby the parties, or selected by Centre for Effective Dispute Resolution in the event the parties cannot agree on an expert within fourteen (14) days, and the decision of such expert shall be final and binding on the parties. 5.10 The minutes of each party will cause its members Steering Committee meeting shall be prepared under the direction of the co-chairs of the Steering Committee to act reasonablyCommittee, in good faith and consistent with circulated promptly after each meeting. Such minutes shall include a summary of the terms matters discussed, decisions made and conditions actions agreed upon by the Steering Committee. Each party shall keep a copy of this Agreement. the minutes of each meeting at its premises. 5.11 The Steering Committee may take action only by shall have no authority to: 5.11.1 amend or interpret this Agreement; 5.11.2 determine whether or not a breach of this Agreement has occurred; or 5.11.3 alter the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers rights or obligations of the parties for resolution. The initial Salesas set out in this Agreement, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusexcept in relation to the matters resolved as set out in clause 5.8.

Appears in 1 contract

Samples: Co Development and Commercialization Agreement (Rules-Based Medicine Inc)

Steering Committee. Within twenty (20) calendar days from 18.1. In order to permanently favor dialogue and to permit each of the Effective DateParties to satisfy the obligations stipulated in the agreement, the parties will form Parties have decided that a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”). A representative from each party shall serve ) will be set up as co-chairpersons of soon as the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyagreement is signed, and shall document their meetings in written minutes, whose task it will be to: (a) review draft a quarterly report on the sales, marketing and distribution implementation of the Product agreement. b) amicably resolve any dispute which may arise among the Parties regarding the validity, interpretation or execution of the agreement c) handle in the Territory, including a review and update interest of both parties the consequences of any force majeure event on the execution of the Sales, Marketing and Distribution Plan at least annually;agreement (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting propose to the Product for Cygnus pursuant Mediation Board any proposed amendment to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreementagreement e) agree upon the annual change in costs as discussed in Article 12. f) manage the evolution of toll prices, both for their impact on the purchase of raw materials and on the toll drying services rendered. In this respect, the Steering Committee shall act as the first level of recourse for the resolution of problems arising from the execution of the agreement. The Steering Committee shall be comprised of 2 members, designated by each of the Parties. Each Party may be accompanied, for consultation purposes, by associates of their choice, subject to approval by the other Party. This Steering Committee will be obligated to meet at least once a quarter and, in any case shall meet whenever one or the other of its members considers it necessary in light of its abovementioned mission. No meeting of the Steering Committee shall be held without at least one member of the Committee representing each of the two Parties being present. The decisions of the Steering Committee shall be made unanimously, with each Party having one vote. The decisions of the Steering Committee shall apply immediately; the Parties expressly commit to this, subject to the dispositions given below. Failing agreement within the Steering Committee, the members of the Steering Committee, after a second meeting to consider the subject matter, shall declare the Steering Committee’s failure to fulfill its mission. The mediation procedure discussed in Article 19 below will then be invoked. 18.2. The Steering Committee may take action only by create an operational technical committee whose members it will designate, so as to handle in an operational manner any issues related to delivery schedules, quality, Contract Specifications and the unanimous written consent treatment of all membersWhey compliances. 18.3. Once a year, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to shall meet with the Executive Officers members of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusoperational technical committee to draft a report on the implementation of the agreement.

Appears in 1 contract

Samples: Whey Supply Agreement (Synutra International, Inc.)

Steering Committee. Within twenty (20) calendar days from the Effective Date2.1 Promptly upon execution of this Agreement, the parties will shall form a Steering Committee consisting which shall be primarily responsible for managing all Alliance and shall in particular: 2.1.1 coordinate the identification of three potential customers and consider each proposed Project and whether or not the parties wish to agree to proceed with such Project; 2.1.2 coordinate and monitor the conduct of each Project; 2.1.3 coordinate and monitor the funding and resources required for each Project and the receipt and allocation of payments under Clause 9; 2.1.4 monitor generally the conduct of the Alliance and the contribution of each of the parties in the Alliance; and 2.1.5 establish Alliance IP by creating and maintaining the Alliance Database. It is agreed that two members of the Steering Committee (3one from Proteus and one from ChemBridge) people from shall create and maintain records of each party (and all Alliance Database additions which shall contain the “Steering Committee”). A representative from each party shall serve as co-chairpersons approval signatures of all members of the Steering Committee. ; and 2.1.6 consider and recommend provisions for the acquisition and maintenance of registered protection in respect of any Alliance IP under Clause 7.3. 2.2 The Steering Committee may establish one or more subcommittees as appropriateshall comprise four individuals, two individuals to be appointed in writing by each party. Each party shall be entitled by notice in writing to the other at any time to remove and appoint a new representative to sit on the Steering Committee. 2.3 All decisions of the Steering Committee shall be by unanimous vote. There shall be no Chairman appointed and no casting vote in the event of a deadlock. 2.4 The Steering Committee shall meet on a regular basis at least quarterlysuch times and at such locations as the parties shall agree in writing. In addition, the Steering Committee shall liaise regularly by fax, post, telephone and shall document their meetings in written minutes, to: (a) review e-mail as may be necessary to ensure the sales, marketing and distribution proper performance of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in Clause 2.1. 2.5 In the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of event that the Steering Committee cannot reach unanimous agreement upon any matter such matter may (at any time upon written notice, and the request of either party) be referred to the Chief Executive Officers ("CEO's") (or such other senior officer of each party will cause its members of as shall be nominated by the Steering Committee CEO to act reasonably, in good faith such respect) of each of Proteus and consistent with ChemBridge and the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of CEOs shall promptly use all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, reasonable endeavours to resolve any Steering Committee member may submit it such matter referred to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusthem.

Appears in 1 contract

Samples: Alliance Agreement (Proteus International P L C /Fi)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form MITEK and ANIKA shall establish a Steering Committee consisting of three (3) people from each party (the “Steering Committee”)) consisting of four (4) members. A representative from Each of MITEK and ANIKA shall appoint two (2) individuals to serve on the Steering Committee. (b) Within thirty (30) days after the execution and delivery of this Agreement by both Parties, ANIKA and MITEK shall each party shall appoint its initial representatives to serve as co-chairpersons of on the Steering Committee. Each Party may change its representatives upon notice to the other Party. (c) The Steering Committee may establish shall be chaired by one representative of either ANIKA or more subcommittees as appropriateMITEK for each successive twelve (12) month period during the Term of this Agreement, and the chair shall alternate between the Parties. During the first twelve (12) month period, the Steering Committee shall be chaired by a representative of MITEK. (d) The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: two (a2) review times each year during the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions Term of this Agreement, at such dates and times as agreed to by the Parties, with the intention that the meetings should occur at least once during each Calendar Quarter. Meetings in person shall alternate between the offices of the Parties or such other place as may be mutually agreed upon by the Parties. The Steering Committee may take action only also convene or be polled or consulted from time to time by the unanimous written consent means of all memberstelecommunications or correspondence, as indicated and members will be deemed “present” at “meetings” for purposes of this Article 14 if participating by all members signing the written minutessuch means. If an issue remains unresolved after good faith consideration All decisions made or actions taken by the Steering Committee shall require the affirmative vote of a majority of its entire membership. A quorum for thirty a meeting shall require at least one ANIKA member and at least one MITEK member. (30e) calendar days, any The duties and responsibilities of the Steering Committee member shall include: (i) reviewing and commenting on any Development being conducted by MITEK; (ii) reviewing and commenting on development relating to Licensed Product being conducted by ANIKA outside the Territory; (iii) review and comment on marketing and sales activities being carried out by MITEK in the Territory including trademark and website issues, including review of an annual marketing plan; (iv) review and comment on marketing and sales activities being conducted by ANIKA outside the Territory; and (v) review and discuss any manufacture and supply issues that may submit it arise. In connection with any meeting of the Steering Committee, the Parties will endeavor to provide to the Executive Officers other Party all materials in connection with this Article 14(e) at least five (5) Business Days in advance of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnussuch meeting.

Appears in 1 contract

Samples: License Agreement (Anika Therapeutics Inc)

Steering Committee. Within twenty sixty (2060) calendar days from the Effective DateDate hereof, the parties will form Parties shall establish a Steering Committee consisting steering committee composed of three (3) people senior representatives from each party Party (the “Steering Committee”). A representative from each party Each Party shall serve as co-chairpersons communicate to the other Party the names and functions of its representatives in the Steering Committee. The Steering Committee Each representative may establish one or more subcommittees as appropriatebe replaced by the appointing Party at any time by written notice to the other Party. The Steering Committee shall meet at least quarterlytwo (2) times per year (one time in Switzerland, and one time in Denmark) until filing of the first application for an Authority Approval in any of the Major Markets. Additional meetings may be organized as may be deemed opportune by both Parties. Each Party shall document their meetings bear its own expenses in written minutes, toparticipating in the Steering Committee. 5.5.1. The Steering Committee shall: (ai) review discuss and advise generally on the sales, marketing and distribution interpretation of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annuallyZEALAND Know-How; (bii) discuss actions to xxxxxx and advise generally on the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product global development plan for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (hiii) review Sankyo’s obligations under Section 4.1discuss and advise generally on the results of preclinical and clinical studies; (iiv) review, discuss and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve advise generally on any disputes pursuant to Section 7.1other issue as may be deemed appropriate or advisable by both Parties; and (kv) agree upon discuss and advise generally in relation to the initial SalesCompound, Marketing the Products and Distribution Planthe Combination Products. 5.5.2. Each party may change its members The role of the Steering Committee at shall be advisory in nature, with the main purpose of serving as a forum for the sharing of information and facilitating communications and discussions between the Parties. HELSINN shall have no obligation [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. to follow any time upon written notice, and each party will cause its members recommendations of the Steering Committee and shall at all times be free to act reasonablyultimately decide on all steps to be taken in connection with, in good faith and consistent with have sole responsibility for, the terms and conditions of this Agreement. The Steering Committee may take action only by development and/or, subject to Article 3 above, the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers commercialization of the parties for resolution. The initial SalesProduct or Combination Product, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusincluding but not limited to any decision regarding suspension or withdrawal of the Product or Combination Product from any market in the Territory.

Appears in 1 contract

Samples: License Agreement (Zealand Pharma a/S)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form a A Steering Committee consisting (STEERING COMMITTEE) shall be responsible for day-to-day management of three (3) people from each Program. The Steering Committee shall consist of four members, two members to be appointed by each of NeoGenesis and CUSTOMER and such members may be appointed on a Target-by-Target basis. Each party (may with notice to the “Steering Committee”)*= CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. A representative from each party shall serve as co-chairpersons other substitute any of its members serving on the Steering Committee. The initial CUSTOMER members shall be Xxxxxxxx Xxxxxx and Xxxxxxx Xxxxxx and the initial NeoGenesis members shall be ____________ and _____________. Each member of the Steering Committee will have one vote and all decisions of the Steering Committee will be by unanimous agreement. (b) The Steering Committee shall be responsible for the management and conduct of the Program and shall in particular: (i) consider, review and amend the Program from time to time in such manner as may establish be appropriate; (ii) monitor progress of the Program; (iii) report regularly to the management of both parties upon the progress of the Program; (iv) be the initial medium for transfer of information between the parties; and (v) approve the allocation of FTEs for Program services beyond those specified in paragraphs 1-7 and 9 of ATTACHMENT A (i.e., optimization of [*] Selected Compounds to a Kd value of [*] and one round of optimization on [*] Selected Compounds). (c) The Steering Committee shall hold meetings as mutually agreed by the parties (but in no event less than three (3) times during the Screening Period) to review the Program. The first meeting of the Steering Committee shall be held within forty-five (45) days of each Target being designated and shall be held in Cambridge, MA. Thereafter, meetings may be held by telephone or more subcommittees as appropriatevideo conference if requested by either party in writing to the other, PROVIDED THAT the parties shall meet in person at least two (2) times during the Screening Period. Minutes of all meetings setting forth decisions of the Steering Committee relative to the Screening Program shall be prepared by the host party and circulated to both parties within fifteen (15) days after each meeting, but minutes shall not become official until approved by both parties (which approval the parties shall use reasonable efforts to give within thirty (30) days of receipt of such minutes). (d) The quorum for Steering Committee meetings shall be two, provided there are at least one member from each of NeoGenesis and CUSTOMER present. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planwill render decisions by unanimous vote. Each party may change its members of Disagreements among the Steering Committee at any time upon written noticeregarding the Program will be resolved via good-faith discussions; PROVIDED, and each party will cause its members that in the event of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for a disagreement that cannot be resolved within thirty (30) calendar days after the date on which the disagreement arose, the matter shall be referred to CUSTOMER's Vice President Research and NeoGenesis's Chief Scientific Officer or their respective designees. Thereafter, if any such disagreement is not resolved within sixty (60) days, any Steering Committee member may submit it then CUSTOMER shall have the right to make the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusfinal decision.

Appears in 1 contract

Samples: Confidentiality Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form a A Steering Committee consisting (STEERING COMMITTEE) shall be responsible for day-to-day management of three (3) people from each Program. The Steering Committee shall consist of four members, two members to be appointed by each of NeoGenesis and CUSTOMER and such members may be appointed on a Target-by-Target basis. Each party (may with notice to the “Steering Committee”)* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. A representative from each party shall serve as co-chairpersons other substitute any of its members serving on the Steering Committee. The initial CUSTOMER members shall be [*] and [*] and the initial NeoGenesis members shall be ____________ and ____________. Each member of the Steering Committee will have one vote and all decisions of the Steering Committee will be [*]. (b) The Steering Committee shall be responsible for the management and conduct of the Program and shall in particular: (i) consider, review and amend the Program from time to time in such manner as may establish be appropriate; (ii) monitor progress of the Program; (iii) report regularly to the management of both parties upon the progress of the Program; (iv) be the initial medium for transfer of information between the parties; and (v) approve the allocation of FTEs for Program services beyond those specified in paragraphs 1-7 and 9 of ATTACHMENT A (i.e., optimization of [*] Selected Compounds to a Kd value of [*] and one round of optimization on [*] Selected Compounds). (c) The Steering Committee shall hold meetings as mutually agreed by the parties (but in no event less than three (3) times during the Screening Period) to review the Program. The first meeting of the Steering Committee shall be held within forty-five (45) days of each Target being designated and shall be held in Cambridge, MA. Thereafter, meetings may be held by telephone or more subcommittees as appropriatevideo conference if requested by either party in writing to the other, PROVIDED THAT the parties shall meet in person at least two (2) times during the Screening Period. Minutes of all meetings setting forth decisions of the Steering Committee relative to the Screening Program shall be prepared by the host party and circulated to both parties within fifteen (15) days after each meeting, but minutes shall not become official until approved by both parties (which approval the parties shall use reasonable efforts to give within thirty (30) days of receipt of such minutes). (d) The quorum for Steering Committee meetings shall be two, provided there are at least one member from each of NeoGenesis and CUSTOMER present. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planwill render decisions [*]. Each party may change its members of Disagreements among the Steering Committee at any time upon written noticeregarding the Program will be resolved via good-faith discussions; PROVIDED, and each party will cause its members that in the event of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for a disagreement that cannot be resolved within thirty (30) calendar days after the date on which the disagreement arose, the matter shall be referred to CUSTOMER's Vice President Research and NeoGenesis's Chief Scientific Officer or their respective designees. Thereafter, if any such disagreement is not resolved within sixty (60) days, any Steering Committee member may submit it then CUSTOMER shall have the right to make the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusfinal decision.

Appears in 1 contract

Samples: Screening and Analysis Services Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form The Parties shall establish a Joint Steering Committee consisting comprised of three (3) people an equal number of representatives from each party Fresenius Kabi and Cerus (the “Steering Committee”). A representative from each party , which members shall serve as co-chairpersons of initially be the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. individuals identified on Exhibit E. The Steering Committee shall meet at least quarterly, twice per calendar year and shall document their meetings in written minutes, have primary responsibility for providing oversight with respect to: : (ai) review the sales, marketing and distribution execution of the Product Business Continuity Plan; (ii) the overall stability and long-term viability of the Facility for purposes of enabling Cerus to evaluate its rights and obligations under [ * ]; (iii) [ * ] upon termination or expiration of Cerus’ contractual commitments as described in Section 2.3(b) and (iv) the Territorypreparation of detailed project plans, including a review scope, roles and update of responsibilities, prioritization and timelines with respect to the Sales, Marketing and Distribution Plan at least annually;Funded Projects. (b) discuss actions In addition to xxxxxx the attainment of sales objectives;responsibilities set forth in Section 4.3(a), the Steering Committee shall meet at least twice per calendar year to perform the following tasks: AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (FRESENIUS KABI – CERUS) [ * ] = 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. (i) Review and prioritize cost reduction initiatives, at which time, Cerus and Fresenius Kabi shall identify projects for implementation (if any), and estimate and allocate related costs (including, but not limited to, engineering time, operating and capital expenses), and risks and benefits. (ii) Review and prioritize New Products and product improvements, and anticipated changes. (c) review current marketingIn the event that the Steering Committee is unable to reach a decision on any matter after [ * ] business days, distributionthe decision will be escalated to the Chief Executive officer of Cerus and the designated member of the Management Board of Fresenius Kabi (together, sales and pricing strategiesthe “Business Heads”), including amount and form who will have an additional [ * ] business days to reach a mutually agreeable decision. If the Business Heads are unable in good faith to reach resolution, the Parties shall submit the issue to an independent third party jointly selected by the parties for resolutions. The parties shall jointly bear the costs, if any, of discount and rebate programs;such third party. (d) coordinate activities between Sankyo For the avoidance of doubt, and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant subject to Section 2.1(ii2.2, (i) Fresenius Kabi shall be able, without Cerus’ consent (or Steering Committee involvement);, to implement any projects or other process improvements that do not affect product specifications or registrations, provided that such projects or process improvements do not result in an increase in pricing, and (ii) Cerus shall not unreasonably withhold or delay its consent to initiate any projects or other process improvements that affect product registrations, provided that such projects or process improvements shall not be implemented without Cerus’ consent and approval until any required Regulatory Approvals are obtained. (e) review Sankyo’s efforts For the avoidance of doubt, and subject to develop Sections 2.2 and implement strategies of institutional6.2, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) reviewCerus shall be able, and if necessary, amend the schedule set forth in Exhibit C hereto; without Fresenius Kabi consent (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the or Steering Committee at involvement), to implement any time upon written noticeprojects or other process improvements, and each party will cause its members of provided that the Steering Committee to act reasonably, parties shall negotiate in good faith any adjustment to pricing that may result from such projects or process improvements, and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written (ii) Fresenius Kabi shall not unreasonably withhold or delay its consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, to any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusnew products or product design changes.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Cerus Corp)

Steering Committee. Within twenty (20) calendar days 4.1 With effect from the Effective Date, Signature Date the parties will form affairs of the Parties in connection with this Agreement shall be supervised on behalf of the Parties by a Steering Committee consisting Committee, subject to and in accordance with the provisions of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons this clause 4. 4.2 The role of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyshall, and shall document their meetings in written minutesinter alia, be to: (a) review the salesmonitor, marketing coordinate and distribution facilitate implementation of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. ; (b) consider and approve, from time to time, the Project Services which shall, inter alia, include: (i) considering and approving the work plan for the Project, taking into account the matters provided for in this Agreement; and (ii) providing for a suitable and efficient administrative process to facilitate payments in accordance with the Project Budget. (c) facilitate communication on and address issues arising from the execution of the Project; (d) receive and consider periodical reports compiled by Exxaro advising on the progress of the Project; (e) monitor the achievement of the objectives related to the periodical reports referred to in 4.2(d) as contemplated in this Agreement including the Schedule of Services; and (f) discuss the projected budgetary requirements for the Project on an ongoing basis. 4.3 Without derogating from the generality of clause 4.2, the Steering Committee shall facilitate communication and monitor progress, as applicable, with regard to matters contemplated in this Agreement and the Project Services specifically. 4.4 The Steering Committee shall provide general oversight of the terms and conditions of this Agreement and shall work in good faith to resolve any disputes arising under this Agreement as set forth under clause 12. 4.5 The Steering Committee shall stay reasonably apprised of the activities of the employees, agents and contractors of the Parties who are providing or receiving the Project Services in order to maximize efficiency in the provision and receipt of the Project Services. 4.6 The Steering Committee shall be authorized to approve any expense reasonably incurred by Exxaro pursuant to the provisions of this Agreement. 4.7 The Steering Committee may take action only by develop a Governance Framework and authorize members’ approval authority accordingly. 4.8 Without derogating from the unanimous written consent generality of the above clauses, all memberscommunications which relate to the provision of the Project Services and pertain to the following issues shall be directed, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by in writing, to the Steering Committee for thirty approval:: (30a) calendar daysadditional expenditure or a potential loss estimated to equal or exceed R80 000; or (b) conduct which may give rise to a breach of this Agreement or an agreement with a third party; or (c) any Variation in content of the Project Services; or (d) any Variation in manner in which the Project Services are to be provided; or (e) any fact, matter or circumstance of significance which could have a material effect on the provision of Project Services or on any provision or undertaking of this Agreement. 4.9 The composition of the Steering Committee member may submit it and process to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan be followed shall be mutually agreed upon by Sankyo and Cygnusas set out in Schedule 1, Annexure 9.

Appears in 1 contract

Samples: Project Services Agreement (Tronox LTD)

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Steering Committee. Within twenty (20a) calendar A Steering Committee (STEERING COMMITTEE) shall be responsible for the oversight of the day-to-day management of the Program. The Steering Committee shall consist of four members, two members to be appointed by each of NeoGenesis and Aventis. Each party may, with notice to the other, substitute any of its members serving on the Steering Committee. The initial Aventis members shall be Xxxx Xxxxxxx and Xxxxxxx Xxxxx and the initial NeoGenesis members shall be Xxxxx Xxxxxxxx and Xxx Xxxx. Aventis shall have the right to appoint one of its members to be the chairperson of the Steering Committee. *=CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. (b) The Steering Committee shall be responsible for the management and conduct of the Program and shall in particular: (i) consider, review and amend the Program from time to time in such manner as may be appropriate; (ii) monitor progress of the Program; (iii) report regularly to the management of both parties upon the progress of the Program; and (iv) be the initial medium for transfer of information between the parties. (c) The Steering Committee shall hold meetings as mutually agreed by the parties (but in no event less than four (4) times during the Screening Period) to review the Program. The first meeting of the Steering Committee shall be held within forty-five (45) days from of the Effective DateDate and shall be held in Cambridge, MA. Thereafter, meetings may be held by telephone or video conference if requested by either party in writing to the other, PROVIDED that the parties will form a shall meet in person at least two (2) times during the Screening Period. Draft Minutes of all meetings setting forth decisions of the Steering Committee consisting relative to the Screening Process shall be prepared by the Chairman, or his designate and circulated by the Chairman to both parties within fifteen (15) days after each meeting, but minutes shall not become official until approved by both parties (which approval the parties shall use reasonable efforts to give within thirty (30) days of three receipt of such minutes). (3d) people The quorum for Steering Committee meetings shall be two, provided there is at least one member from each party (the “Steering Committee”)of NeoGenesis and Aventis present. A representative from Aventis and NeoGenesis shall each party shall serve as co-chairpersons of have one vote at the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriatewill render decisions by unanimous vote. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of Disagreements among the Steering Committee at regarding the Program will be resolved via good-faith discussions; PROVIDED, that in the event of a disagreement that cannot be resolved within fifteen (15) days after the date on which the disagreement arose, the matter shall be referred to Aventis' Head of Drug Innovation and Approval for France and NeoGenesis' Chief Executive Officer or their respective designees. Thereafter, if any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for such disagreement is not resolved within thirty (30) calendar days, any Steering Committee member may submit it then Aventis will have the right to make the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusfinal decision.

Appears in 1 contract

Samples: Cooperation and Licensing Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties will form a A Steering Committee consisting (STEERING COMMITTEE) shall be responsible for oversight of three the Program. The Steering Committee shall consist of four (34) people from members, two (2) members to be appointed by each of NeoGenesis and Tularik, except as otherwise provided in Section 4A.7. Each party (may, with notice to the “Steering Committee”). A representative from each party shall serve as co-chairpersons other, substitute any of its members serving on the Steering Committee. The initial Tularik members shall be Xxx Xxxx and Xxxx Xxxxxxx and the initial NeoGenesis members shall be Xxxxxx Xxxxxx and Xxx Xxxx. Tularik shall have the right to appoint one of its members to be the chairperson of the Steering Committee may establish one or more subcommittees as appropriate. Committee. (b) The Steering Committee shall meet at least quarterly, be responsible for the management and conduct of the Program and shall document their meetings in particular: (i) consider, review and amend ATTACHMENT A from time to time in such manner as may be appropriate; *=CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. 11 PROVIDED, that the Steering Committee may not amend ATTACHMENT A in a manner that would conflict with the time period for designating Designated Screening Compounds specified in Section 2.8 or the time period for designating Designated Shared Compounds specified in Section 4A.1 or the obligations specified in the last sentence of Section 2.5(b), in each case without the prior written minutes, to: agreement of both Tularik and NeoGenesis; (aii) review the sales, marketing and distribution monitor progress of the Product in Program; (iii) report regularly to the Territory, including a review and update management of both parties upon the progress of the Sales, Marketing Program; (iv) be the conduit for transfer of information between the parties; and Distribution Plan at least annually; (bv) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate conduct such other activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product;4A. (hc) The Steering Committee shall hold meetings as mutually agreed by the parties (but in no event less than eight (8) times during the term of the Screening Program if the parties enter into the Expanded Collaboration, unless mutually agreed by the parties) to review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution PlanProgram. Each party may change its members The first meeting of the Steering Committee shall be held within forty five (45) days of the Effective Date and shall be held in Cambridge, Massachusetts. Thereafter, meetings may be held by telephone or video conference, PROVIDED THAT the parties shall meet in person at any time upon written notice, and each party will cause its members least two (2) times during the Screening Program. Minutes of all meetings setting forth decisions of the Steering Committee relative to act reasonablythe Program shall be prepared by the host party and circulated to both parties within twenty five (25) days after each meeting, in good faith but minutes shall not become official until approved by both parties (which approval the parties shall use reasonable efforts to give within thirty (30) days of receipt of such minutes). (d) The quorum for Steering Committee meetings shall be two (2) members, provided there is at least one member from each of NeoGenesis and consistent with the terms and conditions of this AgreementTularik present. The Steering Committee may take action only will render decisions by the unanimous written consent of all members, as indicated by all members signing the written minutesvote. If an issue remains unresolved after good faith consideration by Disagreements among the Steering Committee for regarding the Program will be resolved via good-faith discussions; PROVIDED, that in the event of a disagreement that cannot be resolved within thirty (30) calendar days after the date on which the disagreement arose, the matter shall be referred to Tularik's Chief Executive Officer and NeoGenesis's Chief Executive Officer or their respective designees. Thereafter, if any such disagreement is not resolved within forty five (45) days, any then Tularik will have the right to make the final decision, unless it is otherwise expressly provided in Section 4A that a particular decision of the Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusunanimous.

Appears in 1 contract

Samples: Confidentiality Agreement (Neogenesis Pharmaceuticals Inc)

Steering Committee. Within twenty 5.1 The Steering Committee oversees the Development and Commercialising of the Licensed Product in the Territory and the success of the collaboration between AEZS and CH, and provides a forum for communication and consultation between the Parties. The tasks of the Steering Committee include: (20i) calendar days from regularly informing CH about the status of and consulting with CH in relation to progress with the PCT and related activities, and keeping CH (a) informed about all commercial activities in other territories outside of the Territory about which AEZS has information, and (b) fully appraised of any ongoing development of the Licensed Product or any therapeutic product containing the same active ingredient as the Licensed Product; in each case provided that this information can be shared by AEZS with CH without infringing any confidentiality obligation in existence as at the Effective Date. Where AEZS is under a confidentiality obligation as at the Effective Date which would prevent it sharing the relevant information with CH it will seek consent from the relevant third party to share such information with CH (it being acknowledged that whilst AEZS will use all reasonable endeavours to persuade the relevant third party to give such consent, the parties will form a Steering Committee consisting of three this cannot be guaranteed); (3ii) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons regularly providing AEZS with information and an overview of the Steering Committee. Commercialisation of the Licensed Product in the Territory including the status of pricing and reimbursement negotiations and approvals on a country and country basis; (iii) regularly exchanging a copy (in electronic format, where possible) of all promotional materials, including sales representative training materials, sales literature and brochures, used by AEZS or by or on behalf of CH to promote the Licensed Product; (iv) reporting on progress against the Business Plan; (v) reviewing time frames for the completion of the PCT and for submission of applications for and status of Regulatory Approvals etc.; and (vi) coordinating patents and other IPR applications regarding Joint Inventions and/or improvements. 5.2 The Steering Committee may establish one or more subcommittees as appropriate. sub-committees, which, e. g., are responsible for Commercialisation and for co-ordination of Regulatory activities (each of which would be chaired by CH), and for the Development, for IPR and/or for the supply of Licensed Product (each of which would be chaired by AEZS). 5.3 The Steering Committee consists of an equal number (up to three (3) per Party) of representatives of AEZS and representatives of CH. The representatives in the Steering Committee are to have the necessary experience, expertise and seniority in order to address all strategic questions, which the Steering Committee is to deal in accordance with Section 5.1. Each Party may invite guests to the meetings, in order to discuss special technical or commercial topics. A chairman for each meeting of the Steering Committee shall meet be appointed on an alternate basis, whereby AEZS designates the chairman for the first meeting, the chairman for the second meeting shall be designated by CH, and chairman for each subsequent meeting shall alternate between the Parties. A secretary of the Steering Committee shall be appointed on an alternate basis, whereby CH designates the secretary for the first meeting, the secretary for the second meeting shall be designated by AEZS, and the secretary for each subsequent meeting shall alternate between the Parties. The secretary is responsible for scheduling the quarterly meetings, the distribution of documents before the meetings and the minutes of the meetings. Each Party shall have the right to call for an extraordinary meeting. The Party, on whose request the extraordinary meeting is being held, will send relevant information and an agenda for such meeting to the other Party and to each member of the Steering Committee. 5.4 The Steering Committee meets for the first time as soon as reasonable after the Effective Date (but not later than January 2021) and afterwards as needed, in order to fulfil its tasks, however, at least calendar-quarterly, and shall document their . The meetings in written minutes, to: (a) review the sales, marketing and distribution of the Steering Committee may take place by teleconference, videoconference or face-to-face, whereby at least two (2) meetings per year ideally should take place face-to-face. Each Party may call for an extraordinary meeting of the Steering Committee up to two (2) times per calendar year with fifteen (15) days advance notice. The meeting place alternates between the company seats of the Parties, unless they agree otherwise. Each Party bears its own cost in connection with the work of the Steering Committee. 5.5 All decisions of the Steering Committee are to be made in good faith and in the best interest of the Agreement, shall be reflected in the minutes of the relevant meeting and the Parties shall use their reasonable efforts to take decisions unanimously. In the event that the Steering Committee is unable to agree on any matter after good faith attempts to resolve such disagreement in a commercially reasonable fashion, then either Party may refer the disagreement to a personal face-to-face meeting between the Chief Executive Officer of AEZS (or another appropriate representative of AEZS) and the Chief Executive Officer of CH (or another appropriate representative of CH) which meeting shall take place within fourteen (14) days of the date of the relevant referral. If these persons are not able to resolve such disagreement in a mutually acceptable manner within a further fourteen (14) days after such face-to-face meeting, then: (i) for or in respect of any decisions which relate to the IPR or the Development of the Licensed Product (including conducting the PCT) or matters outside of the Territory, the vote of AEZS with appropriate consideration of the interests of CH shall be decisive; and (ii) for decisions on all other matters (including for or in respect of the Commercialisation and/or the Regulatory Approval procedures in respect of the Licensed Product in the Territory), including a review and update the vote of CH with appropriate consideration of the Sales, Marketing and Distribution Plan at least annually; interests of AEZS shall be decisive. The decisive vote of AEZS or CH (bas the case may be) discuss actions may not lead to xxxxxx a financial burden of CH or AEZS respectively or amend or conflict with any of the attainment express terms of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form or override the rights of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus Parties pursuant to Section 2.1(ii); this Agreement. It is acknowledged that any decision of the JSC (e) review Sankyo’s efforts including any decisive vote of CH pursuant to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(hthis Section) in light relation to a change of marketing issues regarding the Product; (h) review SankyoBusiness Plan shall not be deemed to reduce CH’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnus14.1.

Appears in 1 contract

Samples: License Agreement (Aeterna Zentaris Inc.)

Steering Committee. Within twenty (20a) calendar days from The Research Program and the Effective Date, Development Program shall be conducted under the parties will form a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as co-chairpersons overall direction of the Steering CommitteeCommittee comprised of four (4) members, with two (2) appointed by Ligand and two (2) appointed by Lilly. The Steering *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 12 Committee established by this Agreement shall be the same committee as the Steering Committee established by the Collaboration Agreement. All actions of the Steering Committee with respect to the activities contemplated by this Agreement shall be governed by the terms of this Agreement. The initial members of the Steering Committee shall be: (a) for Ligand, D. Rxxxxxxx xxx A. Negro-Vilar, and (b) for Lilly, J. Hxxxxx xxx J. Cxxx. *** Either party may establish change its representative on the Steering Committee at any time by prior written notice to the other party. The party hosting the meeting of the Steering Committee shall prepare and deliver to the other party one or more subcommittees as appropriateweek prior to the meeting the agenda for the meeting. The party hosting the meeting of the Steering Committee shall prepare and deliver to the other party within ten (10) days after the date of such meeting, minutes of the meeting that set forth all decisions of the Steering Committee relating to the Research Program and the Development Program in form and content reasonably acceptable to the other party. Minutes shall be deemed approved unless any member of the Steering Committee objects to the accuracy of such minutes in writing to the other party within ten (10) business days of receipt. If a party objects to the minutes and the objection is not resolved, the objection will be deemed a dispute and resolved pursuant to Section 2.6. (b) The purpose of the Steering Committee shall be to make key strategy, policy and resource decisions regarding the Research Program and the Development Program and to carry out its other responsibilities described in this Agreement. The Steering Committee shall meet at least quarterlyonce in each Calendar Quarter, at such times and shall document their meetings in written minutesplaces as are agreed to by Ligand and Lilly, to: (a) review alternating between San Diego and Indianapolis, or such other locations as the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written noticeshall agree. Meetings of the Steering Committee may be attended by such other directors, officers and employees of each party as such party deems necessary, and by such consultants and non-employee agents of each party will cause its as the members of the Steering Committee may from time to act reasonablytime agree, in good faith and consistent but only members of the Steering Committee shall have the right to vote at such meetings. The Steering Committee, by unanimous consent, shall have the authority to amend or waive compliance with the terms provisions of this Agreement relating to the scheduling and conditions conduct of the meetings of all committees established pursuant to this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, Any dispute regarding any Steering Committee member may submit it such amendment or waiver shall not be subject to the Executive Officers dispute resolution provisions of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and CygnusSection 2.6.

Appears in 1 contract

Samples: Development and License Agreement (Ligand Pharmaceuticals Inc)

Steering Committee. Within twenty (20) calendar days from 4.1. In order to manage the Effective DateDebrand process, the parties will form VEL and Virgin Orbit shall establish a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”)) consisting of at least one representative of VEL and at least one representative of Virgin Orbit. A Effective the date of this letter, the VEL representative shall be Xxxxxxx Xxxxxxx ([***]) and the Virgin Orbit representative shall be Xxx Xxxxxxx ([***]) or any alternative representative nominated by Xxxxxx Xxxxx and notified to VEL in writing. Each Party shall have the right from each party shall serve as co-chairpersons time to time to nominate, by written notice to the other, a maximum of two additional representatives to join the Steering Committee. The No meeting of the Steering Committee may establish one or more subcommittees as appropriatewill be quorate without a representative from each Party. 4.2. The Steering Committee shall meet at least quarterlyon a fortnightly basis until 30 Sept 2023, by video conference call, or as otherwise agreed in writing between VEL and Virgin Orbit. Virgin Orbit shall document their meetings report to each Steering Committee meeting on all relevant matters arising in written minutesrelation to the Debrand process including, but not limited to: (a) review 4.2.1. the sales, marketing and distribution overall progress of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1Debrand process; and (k) agree upon 4.2.2. any other matters that might reasonably impact on the initial Sales, Marketing value and Distribution Plan. Each party may change its members reputation of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this AgreementVirgin brand. 4.3. The Steering Committee may take action only by shall review all aspects of the unanimous written consent of all membersDebrand process with a specific focus on aspects which impact the Virgin brand. In particular, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, shall review: 4.3.1. the implementation of the Debranding Plan; 4.3.2. any Steering Committee member changes which may submit it be necessary or appropriate to the Executive Officers Debranding Plan; 4.3.3. alignment of communications regarding the parties Debrand process with the Joint Communications Strategy or, to the extent not already agreed under the Joint Communications Strategy, approval of communications regarding the Debrand process by Virgin Group’s Communications Director; and 4.3.4. any reputational or public relations issues arising. 4.4. All correspondence and requests for resolutionVEL’s consent should be addressed to Xxxxxxx Xxxxxxx ([***]) or to such other addressee as VEL may notify to Virgin Orbit in writing from time to time. 4.5. The initial Sales, Marketing All correspondence and Distribution Plan shall requests for Xxxxxx Xxxxx’s consent should be mutually agreed upon by Sankyo and Cygnusaddressed to Xxx Xxxxxxx ([***]) or to such other addressee as Virgin Orbit may notify to VEL in writing from time to time.

Appears in 1 contract

Samples: Trade Mark Licence Agreement (Virgin Orbit Holdings, Inc.)

Steering Committee. Within twenty The Parties shall establish a joint steering committee (20“Steering Committee”) calendar days consisting of an equal number of representatives from the Effective Dateeach of Kos and Jagotec, the parties will form a exact number of which shall be as the Parties may agree, from time to time. Initially, the Steering Committee consisting shall consist of six (6) individuals; three (3) people from each party of whom shall be nominated by Jagotec; and three (3) of whom shall be nominated by Kos. The initial members of the Steering Committee”)Committee are set out on Schedule 3.1. A representative from each party shall serve as co-chairpersons Any member of the Steering Committee may designate a substitute to attend and perform the functions of that member at any meeting of the Steering Committee. The Each Party may with the consent of the other Party, such consent not to be unreasonably withheld or delayed, invite non-member, non-voting representatives of such Party to attend meetings of the Steering Committee. A chairperson and secretary of the Steering Committee shall serve co-terminus one (1) year terms, commencing on the Effective Date or an anniversary thereof, as the case may establish one be. The right to name the chairperson and the secretary of the Steering Committee shall alternate annually between the Parties, and each chairperson shall be named no later than ten (10) days after the commencement of his or more subcommittees as appropriateher term. The initial chairperson shall be selected by Jagotec, the initial secretary shall be selected by Kos and each is designated on Schedule 3.1. The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, toperform the following responsibilities: 3.1.1 coordinate the overall strategy for the Development Program and the Commercialization Program; 3.1.2 review and coordinate the manufacturing, supply and packaging of the Product (a) review or authorize a committee to do so); 3.1.3 determine the sales, marketing and distribution date of the anticipated First Commercial Sale of the Product in the TerritoryTerritory for the purposes of establishing a date for the Parties’ respective obligations under Sections 3.3 and 5.1.3; 3.1.4 undertake a bi-annual review and comparison of the status of each Annual Development Plan and Annual Commercialization Plan, including, without limitation, the applicable timelines, and provide direction to the conduct of the Development Program and Commercialization Program, as necessary; 3.1.5 authorize the formation of additional committees, including but not limited to, a technical operations committee; 3.1.6 coordinate and delegate the activities of other committees; 3.1.7 review and update of approve each Annual Development Plan and any amendments or modifications thereto as submitted by the Sales, Marketing and Distribution Plan at least annuallyDevelopment Committee; (b) discuss actions 3.1.8 review and comment upon each Annual Commercialization Plan and any amendments or modifications thereto as submitted by the Commercialization Committee; provided that Kos shall have ultimate decision making authority with respect to xxxxxx each such Annual Commercialization Plan but shall give reasonable consideration to the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of the Steering Committee at any time upon written notice, and each party will cause its members of comments made by the Steering Committee to act reasonablymodify or amend such Annual Commercialization Plans; 3.1.9 determine if any Improved Product should be selected as a Product pursuant to Section 4.7, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by thereof; 3.1.10 review and approve “go/no-go” decisions and other matters referred to the Steering Committee by the Development Committee, Commercialization Committee, or any other committee and make recommendations, as appropriate; 3.1.11 review the product lifecycle plans for thirty (30) calendar daysthe Product in the Field for the Territory, any including indication and label expansions, new dosage forms, and new formulations or delivery systems; 3.1.12 in accordance with the procedures established in this Agreement, resolve disputes, disagreements and deadlocks unresolved by the Development Committee or Commercialization Committee; and 3.1.13 perform such other responsibilities as may be assigned to the Steering Committee member pursuant to this Agreement or as may submit it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusthe Parties from time to time.

Appears in 1 contract

Samples: Development, License and Marketing Agreement (Kos Pharmaceuticals Inc)

Steering Committee. Within twenty (20) Each Party shall name a mutually agreed upon equivalent number of representatives for the Steering Committee, which shall meet up to [**] times per calendar days from year, or as otherwise mutually agreed by the Effective Date, Parties. In the parties will form event that a Steering Committee consisting dispute cannot be resolved, such dispute shall be escalated to a senior executive of three each of Pharmacyclics and Lonza. If such executives cannot resolve the dispute, either Party may pursue a resolution through a court action in accordance with Section 16.4 below. The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also undertake the following responsibilities: · Discuss and seek resolution of issues relating to management of Manufacturing; · Agree to and monitor deadlines and milestones for the Manufacturing; · Discuss and recommend any changes to the Manufacturing (3) people from each party (the “Steering Committee”although such changes will not take effect until incorporated herein and made a part hereof by written amendment signed by both Parties). A representative from The Parties will use commercially reasonable efforts to ensure that their representatives attend each party shall serve as co-chairpersons meeting and discuss events in good faith with the aim of furthering and successfully concluding the Manufacturing to be performed under this Agreement. At each meeting of the Steering Committee, Lonza shall present to Pharmacyclics [**]. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterlyIf, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution within [**] calendar days of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members date of the Steering Committee at meeting on which the [**] was presented to Pharmacyclics by Lonza (any time upon written notice, and each party will cause its members such period of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) [**] calendar days, a “Notice Period”), Pharmacyclics provides to Lonza [**]of Pharmacyclics’ desire to utilize a part or all of any Steering Committee member may submit it [**]. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Executive Officers omitted portions. V. Please amend Clause 6.1 of the parties for resolutionAgreement to read as follows. 6.1 Pharmacyclics shall provide Lonza with [**] on a routine basis, or immediately if a shift in order patterns or volume is recognized by Pharmacyclics. The initial Sales, Marketing and Distribution Plan [**]such Forecast Schedule shall be mutually agreed upon provided to Lonza on the [**]. Subject to Section 6.2 below, Pharmacyclics shall be permitted to order more than the [**] and Lonza shall make commercially reasonable efforts to meet any such order. [**]. At any time, but no more than [**]under this Agreement, Pharmacyclics may increase the [**] by Sankyo up to [**] and Cygnusprovided that it is commercially reasonable for Lonza to Manufacture the [**] in the ordinary course of Lonza’s operations [**] Lonza shall accept such increase [**] and exert its best efforts to Manufacture and supply the [**] Purchase Orders shall be submitted within [**]by facsimile or in any other written or electronic form. Each calendar year, Lonza and Pharmacyclics shall agree on the [**]. VI. Please amend Clause 6.6 of the Agreement to read as follows.

Appears in 1 contract

Samples: Commercial Manufacturing Agreement (Pharmacyclics Inc)

Steering Committee. Within twenty (20a) calendar days from The Parties shall establish a Joint Steering Committee (“JSC”) to oversee and review the Effective Dateresearch and development activities of the Parties with respect to Licensed Product. The JSC in turn may establish additional committees to achieve this result (“JSC Subcommittees"). Upon notice by BioCryst to co-promote pursuant to ARTICLE 3, the parties will form JSC shall establish a Steering Co-Promotion Committee consisting to oversee and address issues related to the parties’ activities under ARTICLE 3. All committees established under this Agreement, including the JDC and all JSC Subcommittees, shall be subordinate to the JSC. (b) The JSC shall consist of an equal number of representatives of each Party, which shall be at least three (3) people ), who are experts in their field and who shall not serve on the JDC or any other group or committee, including a Subcommittee established pursuant to this Agreement. The size of the JSC may be changed by agreement of the Parties but shall always have an equal number of representatives from each party (Party. Each Party may select representatives to replace the “Steering Committee”). A representative from each party shall serve initial JSC members selected by such Party as co-chairpersons of the Steering Committeenecessary. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee JSC shall meet at least quarterlyfour (4) times per calendar year, and shall document their meetings in written minutes, to: (a) review more often as mutually agreed by the sales, marketing and distribution Parties as appropriate for the continued Development of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives;Licensed Products. (c) review current marketingThe JSC shall be responsible for overseeing, distributionmanaging and providing strategic direction to the Parties in Development of Licensed Products and otherwise carrying out their obligations under this Agreement, sales including: (i) discussing all matters of strategic relevance or other importance to the Parties under this Agreement, (ii) quarterly reviewing and pricing strategiesapproving all Development Plans (including setting key efficacy endpoints of clinical studies, including amount clinical and form regulatory plans) and changes in Development Plans recommended by the JDC; (iii) reviewing and monitoring the activities and verbally communicating the progress of discount the JDC and rebate programs; Subcommittees, if any; (div) coordinate activities between Sankyo considering disputes, disagreements and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who deadlocks that are promoting not resolved by the Product for Cygnus other committees established under this Agreement pursuant to Section 2.1(ii4.1(a) or Section 4.2(a); ; (ev) review Sankyo’s efforts to develop overseeing the integration and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members coordination of the Steering Committee at any time upon written notice, and each party will cause its members Development of the Steering Committee to act reasonably, Licensed Products in good faith and consistent accordance with the terms and conditions of this Agreement. The Steering Committee may take action only by ; (vi) undertaking and/or approving such other matters as are specifically provided for the unanimous written consent of all membersJSC under this Agreement, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30vii) calendar days, any Steering Committee member may submit it reviewing and approving a global clinical trial program prior to the Executive Officers conduct of any clinical trials for Licensed Products (including Special Indication Products) and the plans for any individual clinical trial of Licensed Product in advance of the parties anticipated commencement thereof, (viii) updating BioCryst on Roche’s sublicensing activities, and (ix) updating Roche on the activities of BioCryst or the licensors of the Pre-Existing Third Party License, the U.S. government, the National Cancer Institute or the New Zealand Foundation for resolutionResearch, Science and Technology in connection with the Compound or Backup Compounds in the Field to the extent BioCryst is aware of such activities. At Roche’s request, BioCryst shall use its commercially reasonable efforts to obtain from its licensors under the Pre-Existing Third Party License and provide to Roche requested information related to the activities of the licensors of the Pre-Existing Third Party License, the U.S. government, the National Cancer Institute or the New Zealand Foundation for Research, Science and Technology in connection with the Compound or Backup Compounds in the Field. (d) The initial SalesParties shall report to the JSC on all significant clinical and regulatory issues related to Licensed Product, Marketing and Distribution Plan the JSC shall be mutually agreed upon by Sankyo make recommendations and Cygnusprovide strategic guidance with respect to such issues. (e) Neither Party shall commence any clinical trial of Licensed Product until the JSC has approved plans therefor. (f) Each Party shall keep the JSC informed of the progress and results of activities for which it is responsible under this Agreement through its members on the JSC and as otherwise provided herein. BioCryst shall keep the JSC informed regarding its plans for developing any Special Indication Product, including sufficient information to determine potential safety issues and target population. Once per calendar year, Roche shall advise the JSC of its Commercialization plans and activities. Once per calendar year, Roche shall provide BioCryst with a written Commercialization plan, to the extent one exists.

Appears in 1 contract

Samples: Development and License Agreement (Biocryst Pharmaceuticals Inc)

Steering Committee. Within twenty (20) calendar days from 7.1 The Parties shall—if not before—promptly after the Effective Date, form the parties will form a Steering Committee consisting which shall comprise a minimum of three two (32) people and an equal number of representatives (“Representatives”) from each party of Xxxxxxxxxx and Ultragenyx, and each Party shall notify the other of its elected Representatives. Each Representative shall carry an equal vote and proxy votes may be granted by Representatives to their fellow Representative(s) if they are unable to attend meetings. The Steering Committee will take action by unanimous consent of its Representatives. 7.2 Each Party shall be entitled to change their respective nominated Representatives at any time and shall promptly give written notice of the change to the other Party including the new contact details of the new Representative(s) in any event no less than [***] Business Days after the change has been implemented. 7.3 The quorum for the Steering Committee shall be a minimum of two (the “Steering Committee”). A representative 2) Representatives from each party shall serve as co-chairpersons of the Steering CommitteeParty. The Steering Committee may establish one meet in person or more subcommittees as appropriateby telephone and advance written notice of not less than two (2) Business Days must be communicated to no less than two (2) Representatives of each Party should a meeting be requested. 7.4 The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under the Project. The Parties agree that their Representatives will endeavour to attend each meeting and both the Representatives and each Party shall discuss events in good faith with the aim of furthering and successfully concluding the Project. In addition to the primary function described above the Steering Committee shall also to take on the following responsibilities: 7.4.1 Discuss and seek resolution of issues around management of the Project; 7.4.2 Agree and monitor deadlines and milestones for the Project; 7.4.3 Agree and discuss amendments to the Specifications, including amendments due to comments or requirements from regulatory agencies, provided that in no event shall Xxxxxxxxxx implement any change to the Specifications without Ultragenyx’s prior written consent and, in the event of a disagreement between Ultragenyx and Xxxxxxxxxx, and not withstanding anything to the contrary in Section 7.6, the Parties must jointly agree on changes to the Specifications; 7.4.4 Agree and discuss any changes to the Services, provided that any change to the Services must be evidenced by a signed Change Order in accordance with Section 2.7. 7.5 The Steering Committee shall meet at least quarterly, and shall document their meetings in written minutes, to: (a) review such times as the sales, marketing and distribution Steering Committee determines reasonably necessary to monitor the progress of the Product in the Territory, including a review Services and update of the Sales, Marketing and Distribution Plan at least annually; (b) discuss actions to xxxxxx the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (h) review Sankyo’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Planarising therefrom. Each party Party may change its members call for an extraordinary meeting of the Steering Committee at any time upon written up to [***] times per calendar year with [***] day advance notice, and each party will cause its members of . 7.6 Should the Steering Committee be unable to reach agreement on any issue or should the Steering Committee not have met for a requested extraordinary meeting with the quorum according to Section 7.3 even after the second call for such a meeting, the issues shall be referred to a personal face-to-face meeting between senior executives of Xxxxxxxxxx and Ultragenyx both of whom shall act reasonably, in good faith and consistent with discuss the terms issues to seek a resolution amicably acceptable to both Parties and conditions of this Agreementif resolved the resolution shall be binding and final. The Steering Committee may meeting shall take action only place within [***] days of the date of the relevant referral. In case such persons cannot agree within further [***] days after such face-to-face meeting, then the following shall apply: 7.6.1 If the dispute is predominantly concerned with a scientific or technical issue then the entire dispute shall be referred to an independent third party expert (appointed jointly by the unanimous written consent Parties who is an expert in the particular scientific or technical area at issue and who shall act as an expert and not an arbitrator). In the event the Parties are unable to agree within [***] calendar days on the person of all memberssuch third party, as indicated each Party may request the appointment of such third party by all members signing the written minutesPresident of the Zurich Chamber of Commerce. The costs of such expert opinion shall be borne equally by the Parties. The decision of the independent expert shall be given in writing and in English and considered final and binding on the Parties except if there has been a manifest error on the face of the decision whereupon the Parties may revert to their respective remedies under Section 16.2. 7.6.2 If the dispute is predominantly concerned with an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit other than scientific or technical then it to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusresolved in accordance with Section 16.2 below.

Appears in 1 contract

Samples: Development and Clinical Supply Agreement (Ultragenyx Pharmaceutical Inc.)

Steering Committee. Within twenty (20a) calendar days from the Effective Date, the parties GE and Provider will form each appoint an equal number of representatives to comprise a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of ) to perform the Steering Committeefunctions set forth in this Agreement. The Steering Committee may establish one will meet either in person or more subcommittees as appropriate. The Steering Committee shall meet via teleconference at a regularly scheduled time at least quarterly, and shall document their meetings in written minutes, to: (a) review the sales, marketing and distribution of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually;once per month. (b) discuss actions to xxxxxx The Steering Committee will: (i) review and approve project milestones, objectives and other procedures and the attainment performance of sales objectivesall obligations under this Agreement and the Customer SOWs; (cii) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; discuss any significant business or operational issues raised by either Provider or the Customer Group under this Agreement or any Customer SOW in accordance with Section 22.5 (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(iiDispute Resolution); (eiii) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contractingevaluate the Services for competitiveness; (fiv) review Cygnus’ obligations under Section 5.1 at least once each year assess GE’s compliance with the MVCs and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1Provider’s compliance with the Transaction Productivity commitments in this Agreement and the Customer SOWs, including an annual review by reviewing Provider’s business plans related to the Customer Group, Provider’s audited financial statements prepared in accordance with GAAP, the Transaction Productivity gains in Provider’s performance of Cygnus Intellectual Property Rights in the TerritoryServices, the actual purchase dollar volumes of the Customer Group under this Agreement, the Services being provided to the Customer Group under all Customer SOWs, the Critical Performance Standards under all Customer SOWs, and Provider’s compliance with such Critical Performance Standards; (gv) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding facilitate the Product; (h) review SankyoCustomer Group’s obligations under Section 4.1; (i) review, and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve any disputes pursuant to Section 7.1; and (k) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members support of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, Services in good faith and consistent accordance with the terms and conditions of this AgreementAgreement and the Customer SOWs; and [[[***]]] CONFIDENTIAL TREATMENT REQUESTED. The Steering Committee may take action only by the unanimous written consent of all members, CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION. (vi) perform such other duties and responsibilities as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty deems necessary or appropriate. (30c) calendar daysNotwithstanding anything to the contrary in this Agreement or a Customer SOW, any the Steering Committee member may submit it will have no authority to the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusamend or modify this Agreement or any Customer SOW.

Appears in 1 contract

Samples: Master Services Agreement (Genpact LTD)

Steering Committee. Within twenty sixty (2060) calendar days from the Effective DateDate hereof, the parties will form Parties shall establish a Steering Committee consisting steering committee composed of three (3) people senior representatives from each party Party (the “Steering Committee”). A representative from each party Each Party shall serve as co-chairpersons communicate to the other Party the names and functions of its representatives in the Steering Committee. The Steering Committee Each representative may establish one or more subcommittees as appropriatebe replaced by the appointing Party at any time by written notice to the other Party. The Steering Committee shall meet at least quarterlytwo (2) times per year (one time in Switzerland, and one time in Denmark) until filing of the first application for an Authority Approval in any of the Major Markets. Additional meetings may be organized as may be deemed opportune by both Parties. Each Party shall document their meetings bear its own expenses in written minutes, toparticipating in the Steering Committee. 5.5.1. The Steering Committee shall: (ai) review discuss and advise generally on the sales, marketing and distribution interpretation of the Product in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annuallyZEALAND Know-How; (bii) discuss actions to xxxxxx and advise generally on the attainment of sales objectives; (c) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs; (d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product global development plan for Cygnus pursuant to Section 2.1(ii); (e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting; (f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1, including an annual review of Cygnus Intellectual Property Rights in the Territory; (g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light of marketing issues regarding the Product; (hiii) review Sankyo’s obligations under Section 4.1discuss and advise generally on the results of preclinical and clinical studies; (iiv) review, discuss and if necessary, amend the schedule set forth in Exhibit C hereto; (j) resolve advise generally on any disputes pursuant to Section 7.1other issue as may be deemed appropriate or advisable by both Parties; and (kv) agree upon discuss and advise generally in relation to the initial SalesCompound, Marketing the Products and Distribution Planthe Combination Products. 5.5.2. Each party may change its members The role of the Steering Committee at shall be advisory in nature, with the main purpose of serving as a forum for the sharing of information and facilitating communications and discussions between the Parties. HELSINN shall have no obligation to follow any time upon written notice, and each party will cause its members recommendations of the Steering Committee and shall at all times be free to act reasonablyultimately decide on all steps to be taken in connection with, and have sole responsibility for, the development and/or, subject to Article 3 above, the commercialization of the Product or Combination Product, including but not limited to any decision regarding suspension or withdrawal of the Product or Combination Product from any market in good faith the Territory. [***] Certain information in this document has been omitted and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only by the unanimous written consent of all members, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it submitted separately to the Executive Officers of Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnusomitted portions.

Appears in 1 contract

Samples: License Agreement (Zealand Pharma a/S)

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