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 ▇▇▇▇▇▇ 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
Sources: Sales, Marketing and Distribution Agreement (Cygnus Inc /De/), Sales and Distribution Agreement (Cygnus Inc /De/), Sales, Marketing and Distribution Agreement (Cygnus Inc /De/)
Steering Committee. Within twenty (20) calendar days from a reasonable period of time after the Effective Date, the parties will Orphan Medical and Celltech shall form a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that shall have certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to:
writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical aspects of standards of care in the Territory, (c) review clinical developments across territories, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) review the arrangement for distributing Product on a Named Patient Basis. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product in outside the Territory, including a review and update the views of the SalesOrphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, Marketing packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and Distribution Plan Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party. During each Contract Year, the parties shall hold at least annually;
four (b4) discuss actions to ▇▇▇▇▇▇ regular meetings of the attainment Steering Committee. Members of sales objectives;
the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (c1) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs;
the four (d4) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees Steering Committee meetings shall be conducted in-person. Employees of each party 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 not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Orphan Medical’s designated facility and consistent with the terms and conditions of this Agreementa facility designated by Celltech. The Steering Committee may take action only by the unanimous written consent co-chairpersons 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 shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Orphan Medical Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth co-chairpersons.
Appears in 3 contracts
Sources: License and Distribution Agreement, License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Celltech Group PLC)
Steering Committee. Within twenty (20) calendar days from a reasonable period of time after the Effective Date, the parties will Orphan Medical and Celltech shall form a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that shall have certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to:
writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical aspects of standards of care in the Territory, (c) review clinical developments across territories, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) review the arrangement for distributing Product on a Named Patient Basis. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product in outside the Territory, including a review and update the views of the SalesOrphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, Marketing packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and Distribution Plan Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party. During each Contract Year, the parties shall hold at least annually;
four (b4) discuss actions to ▇▇▇▇▇▇ regular meetings of the attainment Steering Committee. Members of sales objectives;
the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (c1) review current marketing, distribution, sales and pricing strategies, including amount and form of discount and rebate programs;
the four (d4) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees Steering Committee meetings shall be conducted in-person. Employees of each party 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 not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and consistent with the terms and conditions of this Agreementa facility designated by Celltech. The Steering Committee may take action only by the unanimous written consent co-chairpersons 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 shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Orphan Medical Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth co-chairpersons.
Appears in 3 contracts
Sources: License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc)
Steering Committee. Within twenty (20) calendar days from Under the Effective DatePrior Agreement, the parties will form have formed a Steering Committee consisting made up of three (3) people commercial and technical employees from each party (both companies that has certain decision-making authority, and provide oversight for the “Steering Committee”)administration of this Agreement. A representative from each Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairpersons chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, and shall document their meetings be agreed to in written minutes, to:
writing by the parties: (a) review ongoing regulatory issues, (b) review the salesmedical aspects of standards of care in the Territory, (c) review clinical developments across territories to the extent permitted by Jazz Pharmaceuticals’ agreements with Third Parties, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, inventory stocks and ordering, and (g) establish a manufacturing sub-committee which shall review matters relating to the manufacture of Product. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development (except to the extent that such development involves clinical trials that would occur solely in the Territory) or manufacture of the Product, Registration (including pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Jazz Pharmaceuticals Steering Committee members shall prevail. In the event and to the extent that the Steering [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKET BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Committee is unable to come to a consensus on any matter relating to clinical trial activity that would occur solely in the Territory, Registration (including a review and update pre-Registration activities), packaging, labeling, promoting, marketing, sale or distribution of the SalesProduct within the Territory, Marketing and Distribution Plan at least annually;
(b) discuss actions and, if UCB has exercised its manufacturing option under Section 2.2, on any matter relating to ▇▇▇▇▇▇ the attainment manufacture 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 sale within the Territory, the views of the UCB Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to Section 2.1(iisuch matter (as provided in the previous two sentences);
(e) review Sankyo’s efforts to develop and implement strategies of institutional, governmental and managed care marketing and contracting;
(f) review Cygnus’ materially affect the rights or obligations under Section 5.1 this Agreement of such party, Jazz Pharmaceuticals and receive updates from Cygnus UCB shall attempt to resolve the matter in a manner which will minimize the impact on other significant activities relating such rights or obligations of such party, but in default of agreement may be referred by either party to its obligations arbitration under Section 5.115.2. During each Contract Year, including an annual review the parties shall hold at least four (4) regular meetings of Cygnus Intellectual Property Rights the Steering Committee. Members of the Steering Committee may participate in meetings of the Territory;
Steering Committee in person or by conference telephone call. At least one (g1) review Cygnus’ proposed product development as set forth in Section 5.1(hof the four (4) in light Steering Committee meetings shall be conducted in-person. Employees 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 each party may change its who are not members of the Steering Committee at any time upon written notice, and each party will cause its members may attend meetings of the Steering Committee to act reasonably, in good faith as required. In-person Steering Committee meetings shall alternate between Jazz Pharmaceuticals’ designated facility and consistent with the terms and conditions of this Agreementa facility designated by UCB. The Steering Committee may take action only by the unanimous written consent co-chairpersons 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 shall alternate responsibility for thirty (30) calendar daysthe preparation of minutes setting forth discussions made at each committee meeting, any with the Jazz Pharmaceuticals Chairperson preparing minutes for the first Steering Committee member may submit it to the Executive Officers of the parties for resolution. The initial Salesmeeting; provided, Marketing and Distribution Plan however, that such minutes shall be mutually not become official until agreed upon by Sankyo and Cygnusboth co-chairpersons.
Appears in 2 contracts
Sources: License and Distribution Agreement (Jazz Pharmaceuticals Inc), License and Distribution Agreement (Jazz Pharmaceuticals Inc)
Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will 5.3.1. The Parties shall form a Steering Committee consisting to which each Party will delegate [**] executive employees who are familiar with the Project. In the case of three (3Lonza, the executives shall be [**] or their designee(s), provided that such designee(s) people from each party (shall have substantially the “Steering Committee”)same authority and decision making power as the aforementioned executives. A representative from each party In the case of Kolltan, the executives shall serve as co-chairpersons of be at the Steering Committee. The Steering Committee may establish one vice president level or more subcommittees as appropriatehigher. The Steering Committee shall meet at least quarterly, provide strategic guidance for the overall collaboration and have general oversight and review of the activities of each Project Team and shall document their be responsible for resolving any issues referred to the Steering Committee by the Parties. For clarification, while each Project will have its own Project Team, the Steering Committee will have oversight and governance over all Projects. Subject to the mutual written agreement of the Parties and the terms of this Agreement, the Steering Committee shall have the ability to make any necessary adjustments to the governance structure of the collaboration, including the Project Teams, propose amendments to the definition of each Party’s deliverables under the Agreement, as well as review key performance indicators previously agreed to by the Parties, provided, however, in no event shall the Steering Committee take action inconsistent with the terms of this Agreement or any other written agreement between the Parties.
5.3.2. Once Services have commenced, the Steering Committee shall meet on a [**] basis or as otherwise agreed by the Parties. At least [**] meetings per year shall be conducted in–person and such meetings shall alternate between a site designated by Lonza in the United Kingdom and a site designated by Kolltan in the United States. Each Party shall bear its own travel and accommodation costs. Minutes of each meeting shall be taken on a rotational basis between Lonza and Kolltan and shall be distributed for approval by the Steering Committee at the next meeting.
5.3.3. The Steering Committee will take action by unanimous consent of its members, with each representative having a single vote, or by a written minutesresolution signed by all of the representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to a personal meeting (which shall be face-to-face if requested by either Party) between Lonza’s Head of the Custom Manufacturing division or his/her designee and the Chief Executive Officer of Kolltan or his/her designee, who in each case may not be a member of the Steering Committee and both of whom shall act in good faith and discuss the issue to seek a resolution acceptable to both Parties and if resolved the resolution shall be binding and final, provided, however, in no event shall such resolution be inconsistent with the terms of this Agreement or any other agreement between the Parties. In each case, any designee(s) appointed by the Parties must have the authority and decision making power granted by the aforementioned executives to bind the respective Parties to the resolution(s) that may result from such a meeting. The meeting shall take place within [**] calendar days of the relevant referral, or as otherwise mutually agreed. In case such persons cannot agree within a further [**] calendar days after such meeting, then the following shall apply:
(a) review If the salesdispute is predominantly concerned with scientific or technical issues, marketing and distribution then the entire dispute shall be referred to independent experts on whom the Parties agree as set forth hereinafter. Each Party is entitled to propose one (1) unconflicted independent expert, subject to the consent of the Product other Party, and the other Party shall not unreasonably withhold its consent to the appointment of such expert. The Parties will make available the same set of documents to both experts and both experts shall provide their expert opinion in the TerritoryEnglish language within [**] weeks after the second expert has been appointed. The decision of such independent experts shall be in writing and, including a review and update save for manifest error on the face of the Salesdecision, Marketing shall be binding on both Lonza and Distribution Plan Kolltan. If the two (2) experts come to dissenting opinions and are unable to solve the dispute among themselves, a third unconflicted independent expert shall be appointed jointly by the Parties, who is an expert in the particular scientific or technical area at least annually;issue. If the Parties cannot agree as to the third unconflicted independent expert, then such third expert shall be appointed by the CEDR (Centre for Effective Dispute Resolution) in London, England and such decision by the CEDR shall be binding. Such third expert shall have access to the written opinions of the two other experts as well as to all documents that were made available to the two experts. The third expert shall then approve one of the two opinions of the first two experts, and such opinion approved by the third expert shall be considered final and binding on the Parties. The reasonable costs of the experts shall be paid by the non-prevailing Party.
(b) discuss actions If the dispute is predominantly concerned with an issue other than a scientific or technical issue, then the Parties agree to ▇▇▇▇▇▇ attempt in good faith to resolve such dispute by mediation administered by the attainment CEDR in London, England. The parties agree that they shall share equally the cost 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) reviewany mediation fees, 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 cost of the initial Sales, Marketing and Distribution Planmediator. Each party must bear its own attorneys’ fees and associated costs and expenses. The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within [**] calendar days of either Party referring the dispute to mediation either Party may change pursue its members rights in a court of the Steering Committee at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonably, law in good faith and consistent accordance with the terms and conditions Clause 14 of this Agreement. The Steering Committee may take action only by Nothing in this Clause 5.3 shall prevent a Party from exercising any right under this Agreement, including the unanimous written consent right 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 Cygnustermination under Clause 11 below.
Appears in 2 contracts
Sources: Development and Manufacturing Services Agreement (Kolltan Pharmaceuticals Inc), Development and Manufacturing Services Agreement (Kolltan Pharmaceuticals Inc)
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 ▇▇▇▇▇▇ 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
Sources: Commercialization Agreement (Genencor International Inc), Commercialization Agreement (Genencor International Inc)
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 ▇▇▇▇▇▇ 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
Sources: 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 ▇▇▇▇▇▇ 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
Sources: Joint Development Agreement, Joint Development Agreement (Coskata, Inc.)
Steering Committee. Within twenty (20) calendar days from the Effective Date, the parties will form a Steering Committee consisting of The Parties agree that three (3) people from top managers of each party Party shall serve as members of a steering committee to supervise overall performance of this Agreement by each of Parties (the “Steering Committee”). Unless otherwise agreed by the Parties, the three members of each Party shall be (i) the Group Chief Financial Officer, the Chief Innovation and Operating Officer and the Chief Legal Officer of Nokia and (ii) the Chief Executive Officer, the Chief Financial Officer and the General Counsel of the Company. Each Party shall also appoint one deputy for each of its members on the Steering Committee. The Parties may mutually agree upon replacements of such members from time to time during the Term as appropriate. The Steering Committee shall work promptly and in good faith to take decisions relating to the products portfolio as set forth in Section 8.5 and address and resolve issues and contingencies relating to, inter alia, (i) the identification, prioritization and monitoring of deliverables assigned to each Party’s teams, (ii) the specifications, acceptance criteria and due dates for such deliverables, and (iii) resolving any potential disagreements relating to the Fee for Services in accordance with the principles agreed herein. The Steering Committee shall meet whenever necessary and no less than once a month during the first three (3) months following the execution date of this Agreement and no less than once quarterly thereafter. The Steering Committee can be convened at any time by any member with five (5) Business Days prior notice to the other members and without any delay if there is a quorum. The members of the Steering Committee shall notify each other in writing (including by email or fax) at least five (5) Business Days ahead of the next Steering Committee meeting of the items to be included at the agenda of such meeting. The meetings of the Steering Committee may be conducted on either a face-to-face basis or via video or telephone conference call, whichever is mutually agreed to by the Parties at least three (3) Business Days in advance of the scheduled meeting. The Steering Committee may also act without a meeting upon the unanimous written consent of all the members of the Steering Committee (or, as the case may be, their respective deputies). No action may be taken at any meeting of the Steering Committee unless a quorum is present. A quorum of the Steering Committee shall consist of four (4) members, including two (2) members (or their deputies) representing Nokia and two (2) members (or their deputies) representing the Company. Any action by such quorum must be approved by a simple majority, including the vote of at least one representative from of each party Party. The members of the Steering Committee shall serve formalize in writing the minutes of the last meeting for approval at the next meeting unless the decision has been taken by unanimous written consent of all the members of the Steering Committee (or, as co-chairpersons the case may be, their respective deputies) as per the previous paragraph. The minutes of the meetings, and the decisions, of the Steering Committee shall be provided as soon as reasonably practicable to the Chairman of the Committee of Independent Directors by any top manager of the Company which is a member of the Steering Committee. The Steering Committee may establish appoint one or more subcommittees persons that are not members of the Steering Committee as appropriatesecretaries for each meeting. The Steering Committee may decide to appoint Advisors to assist the Steering Committee in performing its obligations. The Steering Committee shall meet at least quarterlyensure that both Parties and their relevant Subsidiaries may have access to the work performed by such Advisors. The Steering Committee shall ensure full cooperation with the Advisors and shall, in particular, grant the Advisors full access to all documents, books, data, other information and appropriate personnel during normal business hours and on reasonable advance notice. The fees, expenses and costs of the Advisors shall be borne equally by the Parties and their relevant Subsidiaries. A quarterly report shall be prepared by the Steering Committee and shall document their meetings in written minutes, to:
(a) review be transmitted to the sales, marketing Committee of Independent Directors and distribution the Nokia Board for information purposes on the implementation of this Agreement. Such quarterly report shall notably include a summary of matters discussed at the Product in the TerritorySteering Committee, including a review presentation of any dispute referred to the Steering Committee during the previous quarter and update the solution that has been decided and implemented, as the case may be. The members of the SalesCommittee of Independent Directors and the Nokia Board may have access, Marketing and Distribution Plan at least annually;
any time (b) discuss actions whether or not there is a Steering Committee Deadlock), to ▇▇▇▇▇▇ all the attainment minutes 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) reviewmeetings, and if necessarythe decisions, 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 and more generally, to any time upon written noticeinformation, data or documents, including audit report, work product of the Expert referred to in section 5.3.2 below and each party will cause its members of the Advisors appointed by the Steering Committee reasonably required to act reasonably, in good faith and consistent with assess the fairness of the terms and conditions of the performance of the Services pursuant to this Agreement. The Agreement or that may be necessary in order to assess the matters referred to it in the event of a 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 CygnusDeadlock.
Appears in 2 contracts
Sources: Master Services Agreement, Master Services Agreement (Alcatel Lucent)
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 ▇▇▇▇▇▇ 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
Sources: 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, 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 ▇▇▇▇▇▇ 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
Sources: Implementation Agreement, Implementation Agreement (Glaxosmithkline PLC)
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 ▇▇▇▇▇▇ 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
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 Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee initial CUSTOMER members 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 be ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ and the attainment initial NeoGenesis members shall be ____________ and _____________. Each member of sales objectives;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 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 current marketingthe 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, distributionMA. Thereafter, sales meetings may be held by telephone or video 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 pricing strategiescirculated to both parties within fifteen (15) days after each meeting, including amount and form 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 discount and rebate programs;receipt of such minutes).
(d) coordinate activities between Sankyo and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product The quorum 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 meetings shall be two, provided there are at any time upon written notice, least one member from each of NeoGenesis 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 AgreementCUSTOMER 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 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
Sources: Confidentiality Agreement (Neogenesis Pharmaceuticals 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 ▇▇▇▇▇▇ 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
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 ▇▇▇▇▇▇ 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
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. 5.1 The Steering Committee shall meet consist of one nominated representative from the Coordinator, each Principal Contractor and Assistant Contractor, and the Commission.
5.2 Steering Committee meetings shall be held periodically, at least quarterlyonce per six months, and additionally as requested, to which all relevant Parties shall document their meetings be invited. The Coordinator shall circulate an agenda at least one week in written minutes, toadvance. All other papers to be presented at the meeting will normally be circulated at least one week in advance.
5.3 The main topics of the Steering Committee shall be:
(a) review reviewing the sales, marketing and distribution progress of the Product Project relative to the schedule and objectives set out in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annuallyMain Contract;
(b) discuss actions to ▇▇▇▇▇▇ the attainment communication of sales objectivesmanagement and administrative arrangements;
(c) making proposals for the 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;amendment of
(i) review, and if necessary, amend the schedule set forth in Exhibit C heretoscope of the Project;
(jii) resolve any disputes pursuant the time schedule of the Main Contract;
d) resolution of differences between the Parties concerning the execution of the Project;
e) agreement on and implementation of actions in the case of defaulting Parties;
f) responsible for approving the appointment of subcontractors.
5.4 The Coordinator shall circulate the minutes of the meeting to Section 7.1; andall Parties within two weeks of the meeting. The Parties will normally supply amendments within one week of receipt of the minutes. All revisions will be incorporated in the minutes including designated actions and time deadlines which will be re-issued within one week of the amendments being supplied.
5.5 All decisions relating to payments to Parties or changes to the Main Contract (kin order to re- allocate work, revise budgets or reschedule delivery dates) agree upon the initial Sales, Marketing and Distribution Plan. Each party may change its members of shall be taken at the Steering Committee meetings. The Parties will aim to reach decisions which are in the best interests of the Project and are also fair to each Party. If a decision is needed before a meeting, the Coordinator shall ask all Parties for their views and then take the decision based on the written responses received. All decisions at any time upon written notice, and each party will cause its members of the Steering Committee to act reasonablymeetings shall be taken jointly by the Parties in attendance. If there is a difference of opinion the issue will be decided by a simple majority vote, in good faith and consistent with each Party having one vote. The Coordinator shall have the terms and conditions casting vote. A decision that may increase any kind of commitment or that increase the burden of a Party, shall not be taken without the consent 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 CygnusParty.
Appears in 1 contract
Sources: Collaboration Agreement
Steering Committee. Within twenty thirty (2030) calendar days from following the Effective Date, the parties will form Parties 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 ) to oversee, review and coordinate the Development, Manufacture and Commercialization of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriateLumacan Products. The Steering Committee shall meet at least quarterly, serve as a forum for the regular exchange of information between the Parties and shall document their meetings in written minuteshave no [*] Confidential treatment requested. authority to bind, toor limit the rights, of either Party. Without limiting the foregoing or any other functions the Parties agree to delegate to the Steering Committee, the Steering Committee shall:
(a) review and approve protocols for all clinical trials commenced after 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 annuallyEffective Date;
(b) discuss actions review progress of all clinical trials (including any on-going clinical trials commenced prior to ▇▇▇▇▇▇ the attainment of sales objectivesEffective Date);
(c) review current marketing, distribution, sales the progress of obtaining MAA Approvals and pricing strategies, including amount other Regulatory Approvals in the Salix Territory and form of discount and rebate programsthe Photocure Territory;
(d) review pre-launch and launch activities, and seek to coordinate Commercialization activities between Sankyo of the Parties in the Salix Territory and Cygnus, its Affiliates, designees, licensees and/or its sublicensees who are promoting the Product for Cygnus pursuant to Section 2.1(ii)Photocure Territory with the objective of maximizing global sales of Lumacan Products;
(e) review Sankyo’s efforts to develop discuss strategy and implement strategies of institutionalprincipal sales and promotion plans, governmental including the Marketing Plan, Product Labeling and managed care marketing and contractingPromotional Materials;
(f) review Cygnus’ obligations under Section 5.1 and receive updates from Cygnus on other significant activities relating to its obligations under Section 5.1progress of Commercialization efforts, including an annual review of Cygnus Intellectual Property Rights in the Territorysales results, sales activities and any material factors impeding such efforts;
(g) review Cygnus’ proposed product development as set forth in Section 5.1(h) in light discuss and analyze any future developments or other circumstances affecting MAA Approvals or sales and marketing of marketing issues regarding the ProductLumacan Products;
(h) review Sankyo’s obligations under Section 4.1establish such subcommittees or task forces to investigate and make recommendations with respect to particular matters, including Development and Commercialization, as the Steering Committee deems necessary or advisable;
(i) review, and if necessary, amend coordinate establishment of an appropriate website for the schedule set forth Lumacan Products that may be used by each Party in Exhibit C hereto;connection with the exercise of its rights in its respective Territory; and
(j) resolve any disputes pursuant otherwise facilitate communications between the Parties, including by coordinating and maintaining contact information for key personnel in each Party’s organization with oversight of Development or Commercialization activities relating 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 CygnusLumacan Products.
Appears in 1 contract
Steering Committee. Within twenty (20) calendar days from the Effective Date2.1. Upon execution of this Agreement, the parties Parties will form promptly establish a Steering Committee consisting of three (3) people from each party steering committee (the “Steering Committee”)) to perform the functions specifically assigned to the Steering Committee under this Agreement. A representative The Steering Committee will be comprised of an equal number of members from each party Party, initially four (4) in total, all of whom are and shall serve be full time employees of the appointing Party. Each Party may, in its sole discretion, replace its assigned representatives at any time as conecessary, by providing written notice to the other Party of such change.
(a) The Steering Committee will (i) provide general oversight regarding the Parties’ performance of their respective obligations under this Agreement; (ii) review metrics regarding key performance indicators such as order fulfilment and on-chairpersons time delivery; (iii) review and respond to Change Order Requests, as more particularly described in Section 4.15; (iv) attempt to resolve any disputes between the Parties, as more particularly described in Section 25.2; (v) act as the point of information exchange between the Parties; and (vi) make any other decisions expressly assigned to the Steering Committee by this Agreement and perform other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties. Each Party will use good faith efforts to facilitate and assist the efforts of the Steering Committee. The .
(b) All decisions of the Steering Committee may establish one or more subcommittees as appropriateshall be made by unanimous consent and documented in writing. In the event the Steering Committee is unable to reach agreement on a matter within the Steering Committee’s authority, the issue shall be resolved by first escalating the matter to a senior executive of each Party, and then following the dispute resolution provisions in Section 25.2.
(c) The Steering Committee shall meet at least quarterlyevery twelve (12) months during the term of this Agreement, and such annual meetings shall document their meetings in written minutes, to:
(a) review be in-person unless otherwise agreed upon by the sales, marketing and distribution Steering Committee. The location of the Product in the Territory, including a review and update annual meetings of the Sales, Marketing and Distribution Plan Steering Committee to be held in-person shall alternate between the reasonable locations selected by each Party. Each Party shall bear all the expenses of its representatives on the Steering Committee. Either Party may call additional meetings of the Steering Committee (which may be by telephone or video conference) by providing written notice of the meeting to the other Party at least annually;
five (b5) discuss actions to ▇▇▇▇▇▇ Business Days in advance of such meeting, provided that 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 may waive the notice requirement at any time upon written noticetime. Responsibility for keeping the minutes of Steering Committee meetings shall alternate between COMPANY and ORION.
(d) Other than with respect to approving Change Order Requests, and each party will cause its members of the Steering Committee does not have the authority to act reasonably, in good faith and consistent amend or waive compliance 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 1 contract
Sources: Contract Manufacturing Agreement (Pelthos Therapeutics Inc.)
Steering Committee. 7.1. Steering Committee organization Within twenty thirty (2030) calendar days from the Effective Dateexecution date of this Agreement, the parties Parties will form set up a Steering Committee consisting of three (3) people from each party (the “Steering Committee”). A representative from each party shall serve as in order to provide for efficient co-chairpersons operation and to manage the relationship 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 Parties 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 ▇▇▇▇▇▇ 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. The Steering Committee may take action only shall consist of a minimum of four (4) designated representatives, of which two will be appointed by GGS and two by Sercel. Depending upon 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 matters reviewed by the Steering Committee for thirty (30any additional person(s) may be invited. Either Party shall have the right to unilaterally remove or replace any of its representatives, which removal or replacement shall be notified in writing to the other Party. The Committee shall meet at least twice per calendar daysyear and any such time as a meeting is requested by one of the Parties, at dates to be agreed. Meetings shall be held in any place as agreed by the Parties or by video conference. In addition to the periodic meetings of the Steering Committee, the CEOs and COOs of both companies shall meet, at least annually, to hold conceptual discussions on the future technology directions and market conditions.
7.2. Matters to be reviewed by the Steering Committee member may submit it In addition to any matter that needs to be reviewed by the Steering Committee to ensure an efficient cooperation, the following points shall be reviewed at least at the beginning of the cooperation:
(i) Technological requirement for future products to address the seismic acquisition market;
(ii) Any support or commercial issues related to the Executive Officers acquisition market as needed;
(iii) Any possible papers and joint presentations to accelerate the acceptance in the market for GGS’s Services or Sercel’s products.
7.3. Settlement of dispute within the Committee Should the members of the parties for resolution. The initial SalesCommittee fail to reach an agreement on any matter related to the Agreement or on any matter raised by one Party to the attention of the other or, Marketing and Distribution Plan more generally, when a disagreement occurs between the members on any aspect which might have an impact, either technical, financial or other on the fruitful development of the cooperation, the dispute shall be mutually agreed upon by Sankyo referred to the Chief-Executives of the Parties and Cygnus.the Chief-Executives shall then meet each other within the best limits in order to resolve the matter in dispute. At coming into force of the Agreement, the respective Chief Executives of the Parties shall be: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ for GGS ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ for SERCEL
Appears in 1 contract
Sources: Cooperation Agreement
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 Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee initial Tularik members shall meet at least quarterly, be ▇▇▇ ▇▇▇▇ 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 ▇▇▇▇ ▇▇▇▇▇▇▇ and the attainment initial NeoGenesis members shall be ▇▇▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇ ▇▇▇▇. Tularik shall have the right to appoint one of sales objectives;its members to be the chairperson of the Steering Committee.
(cb) The Steering Committee shall be responsible for the management and conduct of the Program and shall in particular: (i) consider, review current marketingand 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, 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 that the Product Steering Committee may not amend ATTACHMENT A in a manner that would conflict with the time period for Cygnus pursuant to designating Designated Screening Compounds specified in 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’ 2.8 or the time period for designating Designated Shared Compounds specified in Section 4A.1 or the 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 specified in the Territory;
last sentence of Section 2.5(b), in each case without the prior written agreement of both Tularik and NeoGenesis; (gii) review Cygnus’ proposed product development monitor progress of the Program; (iii) report regularly to the management of both parties upon the progress of the Program; (iv) be the conduit for transfer of information between the parties; and (v) conduct such other activities 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
Sources: Confidentiality Agreement (Neogenesis Pharmaceuticals Inc)
Steering Committee. In accordance with the terms and conditions set forth below, the commercial development of Licensed Products in the Field ("Development Work") will be conducted by or on behalf of the Parties pursuant to the mutually agreed development plan to be attached hereto as Exhibit A (the --------- "Development Plan"). Within twenty ten (2010) calendar days from after the Effective Date, each of the parties will form a Steering Committee consisting of Parties shall appoint three (3) people from each party persons to serve as its representatives on a joint steering committee (the “"Steering Committee”"). A representative from each party Each Party shall serve as co-chairpersons have the right to change any or all of its representatives on the Steering CommitteeCommittee upon written notice to the other Party. The Steering Committee may establish one shall:
(a) Establish the Development Plan, including without limitation milestones, go/no-go criteria, timelines and responsibilities, and ensure that each Party completes its respective work in compliance with the Development Plan;
(b) Monitor and make recommendations regarding the performance of the Development Plan and the conduct of the Development Work;
(c) Propose modifications to the Development Plan;
(d) Establish regulatory strategies;
(e) Determine how Improvements should be incorporated into the Development Plan;
(f) Determine whether to recommend that an Improvement be incorporated or more subcommittees as appropriatethat a New Product be developed, and if so whether such incorporation or development should occur in lieu of or in addition to the then-current activities with respect to existing Licensed Product(s); and
(g) Review any and all proposed publications or communications relating to the Development Plan, and activities relating to an Improvement or a New Product, if applicable, and the results therefrom and any and all proposed filings of patent applications in connection therewith. The Steering Committee shall meet not less frequently than once per calendar quarter during the Development Period, on such dates and at least quarterlysuch times as agreed to by the Parties. All decisions made or actions taken by the Steering Committee shall be made unanimously, and shall document their meetings in written minutes, to:
with each Party entitled to one (a1) 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 ▇▇▇▇▇▇ 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 Planvote. Each party may change its members A quorum of the Steering Committee shall consist of two members, provided that at any time upon written notice, and least one member appointed by each party will cause its members Party is present. Members of the Steering Committee to act reasonably, in good faith and consistent with the terms and conditions may attend a meeting 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 either in person or by telephone conference call, but not by proxy. In the event of a deadlock vote regarding a matter before the Steering Committee, the Responsible Executives of the Parties shall meet to resolve the matter. If resolution of the matter is not achieved by the Responsible Executives of the Parties within thirty (30) calendar daysdays of the deadlock vote, TGC shall have the right to resolve such deadlock until the start of the first Phase II Clinical Trial; provided, however, that Medeva shall have the right to resolve any Steering Committee member may submit it deadlock with respect to the Executive Officers design and location of Phase II Clinical Trials and the parties for resolution. The initial Sales, Marketing and Distribution Plan determination of which Party shall be mutually agreed upon by Sankyo and Cygnusresponsible to conduct such trials. Thereafter, Medeva shall have the right to resolve any deadlock.
Appears in 1 contract
Sources: License and Collaboration Agreement (Targeted Genetics Corp /Wa/)
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 ▇▇▇▇▇▇ 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
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 ▇▇▇▇▇▇ 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
Steering Committee. Within twenty (20a) calendar days from The Parties shall establish and maintain throughout the Effective Date, the parties will form term of this Agreement a Steering Committee consisting of three (3) people from each party committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of ) to oversee the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, implementation 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 ▇▇▇▇▇▇ 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 operation of this Agreement. The Steering Committee may take action only by the unanimous written consent shall consist of all members, as indicated by all four people. Seller shall be entitled to appoint two members signing the written minutes. If an issue remains unresolved after good faith consideration by of the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it and Buyer shall be entitled to the Executive Officers appoint two members of the parties for resolutionSteering Committee. The initial Sales, Marketing and Distribution Plan members of the Steering Committee appointed by Seller shall be the Managing Director of Europe, Africa and The Middle East and the Director of U.S. Sales of Seller, and the initial members of the Steering Committee appointed by Buyer shall be the Category Manager — Proppants and the Vice President of Production Enhancement of Buyer. Seller shall be entitled to remove and replace at any time one or more of the members of the Steering Committee appointed by Seller and Buyer shall be entitled to remove and replace at any time one or more of the members of the Steering Committee appointed by Buyer.
(b) The Steering Committee shall oversee the implementation and operation of this Agreement with the purpose of ensuring that each Party’s relevant interests, as summarized in the Recitals to this Agreement, have and are being addressed in a satisfactory manner consistent with the broad principles of cooperation underlying the execution of this Agreement. If and to the extent the Steering Committee determines that such relevant interests are not being addressed in a fully satisfactory manner as contemplated herein, then they will attempt to agree on what action, if any, is required in view of their joint determination. Without limiting the foregoing, the Steering Committee shall meet to discuss:
A. Product purchase prices under this Agreement
B. Product lead times
C. Payment issues (past due, credit holds, etc)
D. Discuss pertinent end customer information
1. Input from end customers relating to the Products
2. Discuss end customer service issues and opportunities
E. Marketing & sales information
F. Evaluate and discuss market status and strategy
G. Delivery performance
H. Foreign Corrupt Practices Act and OFAC Compliance issues For the avoidance of doubt, each Party will retain independent pricing authority and will determine on its own the pricing for its sales of Products to third parties.
(c) Unless otherwise agreed by the Parties, through their representatives on the Steering Committee, until the first anniversary of the Effective Date, the Steering Committee shall meet monthly at a mutually agreed date and location to review the Parties’ performance under this Agreement. Following the first anniversary of the Effective Date, the Steering Committee shall meet as agreed upon by Sankyo and Cygnusthe Parties, through their representatives on the Steering Committee, but in no event shall the Steering Committee meet less than quarterly.
Appears in 1 contract
Steering Committee. 3.2.1 Within twenty (20) calendar business days from after the Effective Date, the parties will form shall establish a Steering Committee consisting of three (3) people from each party (the “"Steering Committee”"). A representative from each party Each Party shall appoint two (2) of its executives or managers to serve as co-chairpersons of its representatives on the Steering Committee. The total number of representatives on a Steering Committee may establish one be changed by mutual agreement of the Parties; provided that there will at all times be an equal number of representatives of each of GPCR and EXICURE on the Steering Committee. In accordance with the provisions and objectives of this Agreement, the Steering Committee shall:
(i) review progress of Development and discuss future Development activities.
(ii) review and recommend patent strategy, including prosecution, protection, and enforcement, of patent on GPCR Technology.
(iii) advise on any patent or more subcommittees as appropriate. other Intellectual Property issues that may arise concerning or affecting the Development or Commercialization of the Product.
3.2.2 The Steering Committee shall meet as needed but not less than once each quarter during the Term. EXICURE shall prepare updates on Development activities and present such updates to the Steering Committee. Steering Committee meetings shall be held at least quarterlytimes and places or in such form, and shall document their meetings such as by telephone or video conference, as the Steering Committee determines, unless otherwise agreed in written minutes, to:writing by the Parties.
(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 ▇▇▇▇▇▇ 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 3.2.3 Decisions of the Steering Committee will be by unanimous vote of nominated representatives or their substitutes, with each parties' representatives collectively having one
(1) vote which may be exercised by a party's sole attendee at any time upon written notice, and each party will cause its members of a meeting if the party's other representative cannot attend. In the event that the Steering Committee is unable to agree on a matter or proposal submitted by either party, the matter or proposal shall be considered in Dispute Resolution.
3.2.4 The Steering Committee will have only the powers expressly delegated to them and will have no authority to (a) amend, modify, or waive compliance with this Agreement; (b) act reasonably, on behalf of either Party in good faith and consistent relation to any third party; or (c) decide any issues in a manner that would conflict with the express terms and conditions of this Agreement. The Steering Committee may take action only by Each Party will retain the unanimous written consent of all membersrights, as indicated by all members signing the written minutes. If an issue remains unresolved after good faith consideration by powers, and discretion granted to it under this Agreement, and no such rights, powers, or discretion will be delegated to or vested in the Steering Committee unless such delegation or vesting of rights is expressly provided for thirty (30) calendar days, any Steering Committee member may submit it to in this Agreement or the Executive Officers of the parties for resolution. The initial Sales, Marketing and Distribution Plan shall be mutually agreed upon by Sankyo and CygnusParties otherwise expressly agree in writing.
Appears in 1 contract
Sources: License and Collaboration Agreement (Exicure, 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 ▇▇▇▇▇▇ 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
Sources: Screening and Analysis Services Agreement (Neogenesis Pharmaceuticals 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 ▇▇▇▇▇▇ 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
Sources: Development, License and Marketing Agreement (Kos Pharmaceuticals Inc)
Steering Committee. Day-to-Day Activities. Within twenty thirty (2030) calendar days from after the Effective Date, the parties will form Parties shall establish a Steering Committee consisting joint steering committee comprised of three (3) people an equal number of representatives from each party Aptevo and Alligator to oversee and guide the Development Activities , and the collaboration of the Parties under this Agreement (the “Steering Committee”). A representative from The Steering Committee will act as a forum for information exchange between the Parties, provide high-level guidance and strategy to both Parties with respect to Development Activities, and be responsible for making key strategic decisions in connection with the Development Activities and the conduct thereof, but it is not intended to manage the day-to-day operations of either Party. For the avoidance of doubt, the day-to-day decision making of either Party with respect to its operations and its implementation of the Development Activities for which it is responsible is outside of the purview of the JSC, except to the extent that the JSC defines such roles in the Development Plan, [***] and, [***]. Without limiting the foregoing, and except to the extent that the Steering Committee expressly agrees to delegate any function or decision to the responsible Party (or to a sub-committee formed by the Steering Committee), the Steering Committee shall perform the following functions and be responsible for the following key decisions:
3.1.1 Review, coordinate and discuss the overall strategy for Development Activities, including the overall strategy for seeking Regulatory Approvals for the Product, and approve such overall strategy for Developing the Product, in each party shall serve case under the Development Plan;
3.1.2 Manage and oversee the preparation and implementation of the Development Plan;
3.1.3 Review and discuss updates and non-material amendments to the Development Plan;
3.1.4 Approve all matters expressly referred to in the Development Plan as corequiring the joint approval of the Parties;
3.1.5 Review and approve (or decline to recommend) any material amendments to the Development Plan (including, for example, adding or modifying a Stage Gate(s) described in the then-chairpersons current Development Plan), and decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity;
3.1.6 Review and discuss inclusion of Excess Overage Amounts;
3.1.7 Review, discuss and approve Clinical Trials or other Development Activities proposed by either Party to be included in the Development Plan; [*** ] = 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.
3.1.8 Facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing of Development Data and establishing procedures for the efficient sharing of other information;
3.1.9 Coordinate and facilitate exchange by both Parties of [***] Regulatory Data and Regulatory Materials in support of filings and facility inspections;
3.1.10 Review, discuss and approve a plan for (a) the conduct of [***], (b) the conduct of [***] and (c) the conduct of [***];
3.1.11 Review, discuss and approve the design of the Clinical Trial protocols and endpoints and oversee the conduct of all Clinical Trials required as set forth in the Development Plan;
3.1.12 Review and discuss the contents of informed consent form templates and case report form templates;
3.1.13 Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto;
3.1.14 Discuss, and during Development approve, which Party will be responsible for the maintenance of the global safety database;
3.1.15 Review and approve all content of any CTA and any annual regulatory filings prior to submission;
3.1.16 Review, discuss and oversee issues regarding pharmacovigilance and safety (including the maintenance of the global safety database);
3.1.17 Oversee and discuss the [***];
3.1.18 Establish procedures for seeking Third Party Licensees and the negotiation of Third Party License Agreements;
3.1.19 Review and discuss the amounts and timelines of Product for supply of Development Activities;
3.1.20 Review the progress of the subcommittees of the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly;
3.1.21 Discuss and approve the drafts of reports resulting from activities conducted under the Development Plan; [*** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and shall document their meetings in written minutes, to:
(a) review filed separately with the sales, marketing Securities and distribution Exchange Commission pursuant to Rule 24b-2 of the Product Securities Exchange Act of 1934, as amended.
3.1.22 Discuss and approve the potential development of possible modifications of Product, as well as any combination products, follow-on or backup products in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually;
(b) discuss actions relation 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 3.1.23 Discuss and approve the potential development of possible modifications of the Product under Section 4.1Development;
(i) review, 3.1.24 Discuss and if necessary, amend approve the schedule set forth in Exhibit C heretopotential development of possible diagnostic products;
(j) resolve any 3.1.25 Review, discuss and approve subcontractors for Development Activities, including the material terms of subcontract agreements;
3.1.26 Resolve disputes pursuant and other matters referred 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 by any time upon written noticeother subcommittee, and each party will cause its members of the Steering Committee if any;
3.1.27 Resolve disputes which are stated herein 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 be referred to the Steering Committee for thirty (30) calendar daysresolution;
3.1.28 Review and approve publications, any including scientific articles, conference presentations and press releases; and
3.1.29 Have 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 in writing from time to time.
Appears in 1 contract
Sources: Collaboration and Option Agreement (Aptevo Therapeutics Inc.)
Steering Committee. Within twenty (20a) calendar days from The parties shall establish and maintain throughout the Effective Date, the parties will form Term of this Agreement a Steering Committee consisting of three (3) people from each party committee (the “Steering Committee”). A representative from each party shall serve as co-chairpersons of ) to oversee the Steering Committee. The Steering Committee may establish one or more subcommittees as appropriate. The Steering Committee shall meet at least quarterly, implementation 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 ▇▇▇▇▇▇ 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 operation of this Agreement. The Steering Committee may take action only by the unanimous written consent shall consist of all members, as indicated by all six natural Persons. Aviall shall be entitled to appoint three members signing the written minutes. If an issue remains unresolved after good faith consideration by of the Steering Committee for thirty (30) calendar days, any Steering Committee member may submit it and GE shall be entitled to the Executive Officers appoint three members of the parties for resolutionSteering Committee. The initial Sales, Marketing and Distribution Plan members of the Steering Committee appointed by Aviall shall be mutually agreed upon the Senior Managing Director of Engine Programs, Director of GE Engine Program and Director of Procurement of Aviall, and the initial members of the Steering Committee appointed by Sankyo GE shall be the Spares General Manager, Spares Customer and CygnusFulfillment Leader and CF6 Platform representative of GE. Aviall shall be entitled to remove and replace at any time, at the sole discretion of Aviall, one or more of the members of the Steering Committee appointed by Aviall and GE shall be entitled to remove and replace at any time, at the sole discretion of GE, one or more of the members of the Steering Committee appointed by GE.
(b) The Steering Committee shall oversee the implementation and operation of this Agreement with the purpose of ensuring that each Party’s relevant interests, as summarized in the Recitals to this Agreement, have and are being addressed in a satisfactory manner consistent with the broad principles of cooperation underlying the execution of this Agreement. If and to the extent the Steering Committee determines that such relevant interests are not being addressed in a fully satisfactory manner as contemplated herein, then they will attempt to agree on what action, if any, is required in view of their joint determination. Without limiting the foregoing, the Steering Committee shall meet to:
(i) Review and discuss the following items as it pertains to Product support:
A. Catalog List prices
B. Catalog Lead Times
C. Manufacturing Lead Times
(ii) Payment Issues (Past Due, Credit Holds, etc) General Electric Company
(iii) Discuss pertinent Customer Information
A. Input from Customers relating to the Products and other GE Engines
B. Discuss Customer Service issues and opportunities
C. Review Potential Customers not yet approved by GE
D. Administration of Special Customer Agreements
(iv) Marketing & Sales Information
A. Evaluate and discuss market status and strategy
B. Evaluate and discuss sales opportunities
C. Market intelligence and competitive information for GE Engines
(v) Review Six Sigma training and projects
(vi) Discuss and review new business plans or Fleet Programs
(vii) Configuration Management
A. Product Control Board Decisions
B. Airworthiness Directives
(viii) Discuss any required IT infrastructure and changes
(ix) Metrics
A. Delivery Performance
B. Material Delinquencies
C. Other Metrics (x) Compliance Issues A. Blacklisted Countries General Electric Company
Appears in 1 contract
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 ▇▇▇▇▇▇ 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
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 ▇▇▇▇▇▇ 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
Sources: 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 ▇▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇▇▇▇ implement any change to the Specifications without Ultragenyx’s prior written consent and, in the event of a disagreement between Ultragenyx and ▇▇▇▇▇▇▇▇▇▇, 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 issues arising therefrom. Each Party may call for an extraordinary meeting of the SalesSteering Committee up to [***] times per calendar year with [***] day advance notice.
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, Marketing and Distribution Plan at least annually;
(b) discuss actions the issues shall be referred to a personal face-to-face meeting between senior executives of ▇▇▇▇▇▇▇▇▇▇ the attainment and Ultragenyx both 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 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
Sources: Development and Clinical Supply Agreement (Ultragenyx Pharmaceutical 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 ▇▇▇▇▇▇ 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
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 ▇▇▇▇▇▇ 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
Sources: 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 ▇▇▇▇▇▇ 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
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 unanimity of 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 withhold consent for or to reject any proposal, resolution or other directive 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 taken on the basis of unanimity shall require that all permanent members are present 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 otherwise involved in the Territory, including a review and update of the Sales, Marketing and Distribution Plan at least annually;
(b) discuss actions 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 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 Cygnusrelevant decision making process.
Appears in 1 contract
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 ▇▇▇▇▇▇ 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
Steering Committee. Within twenty (201) 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 ▇▇▇▇▇▇ 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 Members of the Steering Committee at are: ▪ the ENCORA Coordinator, ▪ the Coordinators of the National Networks ▪ the Coordinators of the Thematic Networks
(2) The Steering Committee shall, in accordance with this Agreement and the Contract, take the necessary decisions relating to the Network and shall in this regard particularly deal with the following: ▪ with respect to the Consortium Institutions obligations under the Contract and their relation with the Commission, any time revision of the current Programme of Networking Activities and adoption of any new Programme of Networking Activities; ▪ on a twelve-months basis, adoption and any revision of the Programme of Networking Activities in accordance with Article 22 (Obligations) of this Agreement; ▪ on a twelve-months basis, agreement on the Network Budget (as part of the Programme of Networking Activities) ▪ exchange of information on any third party receipts by a Consortium Institution in relation to the ▪ in accordance with Article 17 (Work Packages) of this Agreement, establishment of Work Packages for the implementation of the Programme of Networking Activities as well as appointment and revocation of appointment of the respective Work Package chairpersons and, after the first year of the Coordination Action, of the chairperson of the Executive Committee; ▪ establishment of an Advisory Board, including the appointment, revocation of appointment and determination of the rules for selection of its members in accordance with Article 21 (Advisory Board) of this Agreement; ▪ in a manner not unduly obstructing the timely delivery of such reports, approval of any reports to be delivered under the Contract; ▪ acceptance of new Consortium Institutions to this Agreement; ▪ the acceptance of new Consortium Institutions to the Contract, in consideration of the respective steps to be taken in such case in accordance with the Contract including the modalities of the accession process; ▪ the amendment of terms of this Agreement ▪ the review and/or amendments of terms of the Contract; ▪ subject to and in accordance with the provisions of Article 35 (Relation to Contract Provisions) of this Agreement, deciding on additional procedures and policies on management of Knowledge; ▪ in case of the Default of a Consortium Institution, decision on any actions to be taken, including decisions on serving any notices required and a request to the Commission for an audit on Contract issues, assign such Consortium Institution’s tasks and if appropriate to agree upon written noticea new entity to join the Consortium for that purpose; ▪ in case of a Default of the ENCORA Co-ordinator in the performance of its tasks as a ENCORA Co- ordinator, this also includes the possible nomination of a new ENCORA Co-ordinator; ▪ appointing additional Signatories for the withdrawal of funds in accordance with Article 30 (Custody) of this Agreement; ▪ agreement on the suspension of all or part of the activities under this Agreement or the Coordination Action, or to terminate all or part of the Contract, and each party will cause its the modalities for such suspension or termination, including bringing forward such proposal to the Commission; ▪ any decision to instruct the ENCORA Co-ordinator to ask the Commission on behalf of the Consortium to terminate the participation of one or more Consortium Institutes.
(3) The Steering Committee may, upon request by a Consortium Institution and after hearing the members of the Steering Committee to act reasonablyExecutive Committee, in good faith and consistent with the terms and conditions of this Agreement. The Steering Committee may take action only also overrule any decision taken by the unanimous written consent of all members, as indicated Work Package teams and by all members signing the written minutes. If an issue remains unresolved after good faith consideration by Executive Committee
(4) Each Party in the Steering Committee for thirty (30) calendar days, any shall have one vote. The Consortium Institutions shall not deliberate and are not able to decide validly in the Steering Committee member may submit it to the Executive Officers unless all of the parties for resolution. The initial Sales, Marketing Consortium Institutions but two are represented in the respective meeting and Distribution Plan shall be mutually agreed upon by Sankyo and Cygnus.the Steering Committee has been duly convened in accordance with the provisions of Article 20
Appears in 1 contract
Sources: Consortium Agreement
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 ▇▇▇▇▇▇ 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
Sources: Master Agreement for the Purchase of Smart Energy Services Software and Services (Opower, 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 ▇▇▇▇▇▇ 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
Sources: Commercial Manufacturing Agreement (Pharmacyclics Inc)
Steering Committee. 6.1.1 Within twenty five (205) calendar days from after the Effective Date, each Party shall appoint two (2) representatives of appropriate seniority and experience to a steering committee with responsibility for: (a) acting as a first-level forum for discussing and seeking to resolve any disputes related to this Agreement, including any operational or technical issues faced by a Party as a result of the parties will form other Party’s use of the Ligado L-band MSS Spectrum or Ligado L-band Assets but other than any disputes related to any Financial Report (which shall be addressed according to the provisions of Section 8.3); (b) overseeing Ligado’s progress towards terminating any Commercial Agreements pursuant to Section 2.1.1(b) and discussing any technical requirements or issues with transitioning any counterparties using capacity on the Ligado GEO Satellites under any Commercial Agreement off such capacity; (c) discussing the status of the Takings Litigation and the Inmarsat Litigation and the potential resolution of either of them (in a Steering Committee consisting of three manner that preserves attorney-client privilege, attorney work product protection or other legal privilege); and (3d) people from each party the matters described in Section 2.2, Section 2.3, and Sections 6.2 and any other matters agreed by the Parties (the “Steering Committee”), in each case, subject to compliance with applicable law. A representative from Without each party Party’s prior written consent, the steering committee shall serve as co-chairpersons not make any determination or take any action that is inconsistent with the terms of this Agreement.
6.1.2 Each Party’s representatives on the Steering CommitteeCommittee shall be authorized to make decisions on behalf of such Party with respect to the day-to-day implementation and overall management of this Agreement (but not to amend this Agreement). The Either Party may (i) within five (5) Business Days after the nomination of Steering Committee may establish representatives by the other Party, provide written notice to the other Party to object to its nominated representatives on the Steering Committee if such nominated representatives do not reasonably have the appropriate seniority, experience or authority to serve on the Steering Committee (and any disputes regarding nominated representatives shall be resolved in accordance with the dispute resolution provisions in Section 13.2) and (ii) replace one or more subcommittees as appropriate. of its representatives on the Steering Committee at any time by written notice to the other Party’s representatives; provided, that the Steering Committee shall at all times be comprised of an equal number of Ligado and SpectrumCo representatives, unless otherwise agreed to by the Parties in writing.
6.1.3 The Steering Committee shall meet at least quarterlyonce per quarter during the Term, unless otherwise agreed by both Parties. Meetings may be held in person or via telephone or videoconference as may be agreed by the Steering Committee members. The Parties shall be jointly responsible for convening meetings of the Steering Committee, agreeing the dates, times, and shall document their meetings in written minutes, to:
(a) review the sales, marketing and distribution places of the Product meetings, and compiling and distributing relevant information, agendas, and other similar materials in the Territory, including a review and update advance of the Sales, Marketing and Distribution Plan each such meeting. Meetings shall be held on at least annually;
five (b5) discuss actions to ▇▇▇▇▇▇ the attainment of sales objectives;
(c) review current marketingBusiness Days’ notice, 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 except where all members of the Steering Committee at agree otherwise. In the event of an issue of a serious nature arising in respect of any time upon written noticeobligations relating to this Agreement, and each party will cause its members Party shall have the right to convene an emergency meeting of the Steering Committee on no less than forty-eight (48) hours’ notice to act reasonably, in good faith and consistent with the terms and conditions of this Agreementmembers thereof. The Each Party shall ensure that its Steering Committee may take action representatives (or their alternatives) are available at reasonable times and on reasonable notice in accordance with this Section 6.1.3. Steering Committee meetings shall only be held if an equal number of representatives from each Party are in attendance (including virtually), unless waived by the unanimous written consent of all members, as indicated Party represented 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 Cygnusfewer representatives.
Appears in 1 contract
Sources: Strategic Collaboration and Spectrum Usage Agreement (AST SpaceMobile, Inc.)