Common use of Development Committee Clause in Contracts

Development Committee. Arcadia and ▇▇▇▇▇▇ shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and ▇▇▇▇▇▇. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

Development Committee. Arcadia The PARTIES agree to work together in good faith in the collaboration under this Agreement and ▇▇▇▇▇▇ shall establish to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a development four-member committee (the “Development Committee”) comprised ), equally represented by EAGLE and SCIDOSE, for the management of no more than three (3) representatives the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of Arcadia EAGLE and ▇▇▇▇▇▇SCIDOSE. The Development Committee Each Party shall be chaired by a member thereof designated have the right, from time to time by Arcadia. The Development Committee shall oversee the Research Plantime, Milestones and development and production to substitute new members, on a permanent or temporary basis, for any of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the its previously designated members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions Each Party shall bear its own costs associated with participation in the Development Committee. 4.1.1 The Development Committee shall generally oversee and facilitate the development of the Products. Each party shall promptly provide the other and the Development Committee with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the Development Committee, to create an appropriate response thereto. 4.1.2 During the Term, the Development Committee shall meet at least once each calendar quarter or at such other frequency as the Development Committee determines. The PARTIES shall meet on a date and time and at a location determined by the Development Committee; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the Development Committee shall may be made held in person at a location to be agreed to by a written consent signed the PARTIES, or by all six (6) members thereof. The Development Committee shall keep minutes videoconference to teleconference. 4.1.3 In the event of its deliberations setting forththe PRODUCT FAILURE, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Partiesselect a REPLACEMENT PRODUCT within one hundred twenty (120) days of such failure. The Development Committee by unanimous consent may delegate to one Party or to a specific representative In the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within event the Development Committee shall be subject fails to select the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of REPLACEMENT PRODUCT within such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement EAGLE shall be submitted for ADR as provided entitled to a refund in accordance with Section 12(a)3.1.2.

Development Committee. Arcadia The PARTIES agree to work together in good faith in the collaboration under this Agreement and ▇▇▇▇▇▇ shall establish to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a development four-member committee (the “Development Committee”) comprised ), equally represented by EAGLE and SCIDOSE, for the management of no more than three (3) representatives the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of Arcadia EAGLE and ▇▇▇▇▇▇SCIDOSE. The Development Committee Each Party shall be chaired by a member thereof designated have the right, from time to time by Arcadia. The Development Committee shall oversee the Research Plantime, Milestones and development and production to substitute new members, on a permanent or temporary basis, for any of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the its previously designated members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions Each Party shall bear its own costs associated with participation in the Development Committee. 4.1.1 The Development Committee shall generally oversee and facilitate the development of the Products. Each party shall promptly provide the other and the Development Committee with a copy of any FDA correspondence within 48 hours of receipt thereof and it will be the responsibility of EAGLE, with the oversight and approval of the Development Committee, to create an appropriate response thereto. 4.1.2 During the Term, the Development Committee shall meet at least once each calendar quarter or at such other frequency as the Development Committee determines. The PARTIES shall meet on a date and time and at a location determined by the Development Committee; the PARTIES anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the PARTIES, or sooner if warranted by the circumstances. Notices requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the Development Committee shall may be made held in person at a location to be agreed to by the PARTIES, or by videoconference to teleconference. 4.1.3 In the event of a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forthPRODUCT FAILURE, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Partiesselect a REPLACEMENT PRODUCT within one hundred twenty (120) days of such failure. The Development Committee by unanimous consent may delegate to one Party or to a specific representative In the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within event the Development Committee shall be subject fails to select the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of REPLACEMENT PRODUCT within such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement EAGLE shall be submitted for ADR as provided entitled to a refund in accordance with Section 12(a)3.1.2.

Development Committee. Arcadia and ▇▇▇▇▇▇ (a) All the work performed in conducting the Development Program shall establish a development committee (be under the “supervision of the Development Committee through its directives to the investigators who shall directly supervise the Development Program. Promptly after the Effective Date, the Parties shall form the Development Committee”) , which shall be comprised of no more than three an equal number of members, with half of the members appointed by each Party. Each member of the Development Committee shall have the appropriate level of skill, experience and familiarity with the Development Program. An officer of MoliChem shall serve as chairman of the Development Committee. Each Party shall have the right to substitute different representatives as members on the Development Committee as may be necessary from time to time, and each Party may bring additional representatives to attend meetings of the Development Committee in a non-voting, ad hoc capacity. The Parties hereby agree that the Development Committee shall be bound by all obligations and commitments of contracts and agreements approved by the Development Committee and entered into by one Party or the other and all those contracts and agreements previously entered into by MoliChem related to Moli1901 and set forth in Exhibit B hereto; provided however, neither InterMune nor the Development Committee shall be bound by the financial obligations set forth in the letters awarding grant support to MoliChem from Cystic Fibrosis Foundation, listed in Exhibit B. (3b) representatives The Development Committee shall meet at least once every other month at such times and at such meeting places as shall be mutually agreed upon by the Parties. Each Party shall be responsible for its own expenses and costs related to attendance at such meetings of each of Arcadia the Development Committee. The Development Committee meetings may be held by telephone or videoconference, if agreed by the Development Committee members. Each Party will designate an individual to serve as the liaison between the Parties to undertake and ▇▇▇▇▇▇coordinate any day-to-day communications as may be required between the Parties relating to the Development Program. The Development Committee shall be chaired operate by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Planmajority decision of its members, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee members shall use good faith efforts to reach agreement on all matters to be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as decided. In the members of event the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are is unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than reach agreement on any matter before it within thirty (30) days; (iii) If days of undertaking consideration of such matter, then the two executives are unable to resolve this disagreement, the disagreement matter shall be submitted for ADR as provided in resolved pursuant to Section 12(a)12.

Development Committee. Arcadia and ▇▇▇▇▇▇ Promptly after Sankyo's designation of a Licensed Compound pursuant to Section 4.4, the parties shall establish designate a development committee (the “"Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and ▇▇▇▇▇▇"). The In addition to any other responsibilities designated herein, the Development Committee shall be chaired by a member thereof designated meet from time to time by Arcadiaon an as-needed basis to discuss at such meetings the preclinical or clinical development, or the marketing, of Licensed Compounds or Products, as well as any anticipated regulatory filings with respect to possible Products. The Development Committee shall oversee parties may designate and appoint any reasonable number of scientific or technical personnel of the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance parties to interact with each other regarding the Research PlanLicensed Compounds or the products to be marketed hereunder. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings Members of the Development Committee shall may be represented at least biannual and at such times and places any meeting by another member of the Development Committee, or in such form (e.g.by a deputy. Any approval, in person, telephonic determination or video conference) as other action agreed to by all of the members of the Development Committee shall determine. Representatives of both Parties or their deputies present at the relevant Development Committee meeting shall be present at any meeting the approval, determination or other action of the Development Committee; provided that at least two representatives of each party are present at such meeting. Decisions of Each party shall bear its own costs in connection with the Development Committee shall be made by a written consent signed by all six (6) members thereofmeetings. The Development Committee shall keep minutes have only such powers as are specifically delegated to it hereunder, and, notwithstanding the creation of its deliberations setting forththe Development Committee, among other matterseach party to this Agreement shall retain the rights, all proposed actions powers and all votes thereon. All records of discretion granted to it hereunder, and the Development Committee shall at all times not be available vested with any such rights, powers or discretion except as expressly provided herein or as expressly agreed to both Partiesby the parties in writing. The Development Committee by unanimous consent shall not have the power to amend this Agreement, which may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority be amended only by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR parties as provided in Section 12(a)20.4 hereof.

Development Committee. Arcadia and ▇▇▇▇▇▇ Promptly after exercise of Sankyo's option --------------------- to license a Licensed Compound pursuant to Section 4.4, the parties shall establish designate a development committee (the “"Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and ▇▇▇▇▇▇"). The In addition to any other responsibilities designated herein, the Development Committee shall be chaired by a member thereof designated meet from time to time by Arcadiaon an as-needed basis to discuss at such meetings the preclinical or clinical development, or the marketing, of Licensed Compounds or Products, as well as any anticipated regulatory filings with respect to possible Products. The Development Committee shall oversee parties may designate and appoint any reasonable number of scientific or technical personnel of the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance parties to interact with each other regarding the Research PlanLicensed Compounds or the Products to be marketed hereunder. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings Members of the Development Committee shall may be represented at least biannual and at such times and places any meeting by another member of the Development Committee, or in such form (e.g.by a deputy. Any approval, in person, telephonic determination or video conference) as other action agreed to by all of the members of the Development Committee shall determine. Representatives of both Parties or their deputies present at the relevant Development Committee meeting shall be present at any meeting the approval, determination or other action of the Development Committee, provided -------- that at least two representatives of each party are present at such meeting. Decisions of Each party shall bear its own costs in connection with the Development Committee shall be made by a written consent signed by all six (6) members thereofmeetings. The Development Committee shall keep minutes have only such powers as are specifically delegated to it hereunder, and, notwithstanding the creation of its deliberations setting forththe Development Committee, among other matterseach party to this Agreement shall retain the rights, all proposed actions powers and all votes thereon. All records of discretion granted to it hereunder, and the Development Committee shall at all times not be available vested with any such rights, powers or discretion except as expressly provided herein or as expressly agreed to both Partiesby the parties in writing. The Development Committee by unanimous consent shall not have the power to amend this Agreement, which may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority be amended only by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR parties as provided in Section 12(a)20.3 hereof.

Development Committee. Arcadia (a) Shionogi and ▇▇▇▇▇▇ Peninsula shall establish a development committee Joint Development Committee (the “Development Committee”"JDC") comprised which will consist of no more than three (3) [*] from Shionogi and Peninsula. The representatives of each of Arcadia and ▇▇▇▇▇▇. The Development Committee shall Party may be chaired by a member thereof designated changed from time to time at the discretion of the Party making such change upon written notice by Arcadiathe Party to the other. (b) The JDC shall meet periodically, in principle semi-annually, in alternating home office locations or via videoconference or teleconference, whichever is appropriate. Each Party shall bear its costs associated with attendance at the JDC meetings. (c) The Development Committee JDC shall oversee discuss and decide on the Research Plandevelopment plan and strategy for the development in the Territory of the Licensed Product, Milestones including [*]. It is agreed by the Parties that the underlying concept in establishing such development plan and strategy shall be reasonably consistent with that employed by Shionogi for the development of the product containing the Compound in Japan. Further, the JDC shall review the progress of the development activities conducted by Peninsula. Shionogi and production Peninsula shall make the minutes of plants and microorganisms that produce Transgenic Oil the JDC meetings jointly in accordance with order to confirm the Research Plan. The Development Committee may revise the Research Plan matters discussed and the Milestones as deemed necessary and appropriate by unanimous written consent of all membersdecision made at the JDC meetings. Meetings [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (d) All decisions of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee JDC shall be made by a written unanimous consent. In case the JDC cannot reach unanimous consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records because of the Development Committee shall at all times be available to both difference in opinions between the Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke , such authority by the written consent of four members. All disagreements within the Development Committee dispute shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement referred to the President of ▇▇▇▇ Products Division Peninsula and the President [*] of Arcadia or their respective designeesShionogi, who will meet promptly and the two executives shall endeavor use diligent good faith efforts to resolve the disagreement for seek a period of not more than thirty (30) days; (iii) resolution. If the two matter is not resolved by such executives are unable to resolve this disagreementwithin [*] days, the disagreement it shall be submitted for ADR as provided resolved according to the mechanism set forth in Section 12(a)Article 21.

Development Committee. Arcadia The Development Committee shall develop and ▇▇▇review a program for compliance with the requirements to obtain Regulatory Approval and commercialize Finished Products in countries in the Territory and monitor such program. The Development Committee will meet no less frequently than once each Calendar Quarter to review clinical studies underway and to discuss and consider clinical studies covering, among other things, additional cancer indications and/or improvements to formulation and performance of Finished Product. Each Party may appoint substitutes for its committee members and each Party shall be permitted to send additional observers to committee meetings to discuss other strategic issues, to include, but not be limited to, regulatory, intellectual property, licensing and litigation matters. The site for such Development Committee meetings shall alternate between the NaPro and Abbott facilities, or be held at such other locations as may be mutua▇▇▇ shall establish a development committee (▇▇reed. Travel by the “Development Committee”) comprised of no more than three (3) representatives of Development Committee members (or their designees) from each of Arcadia Abbott and NaPro shall be considered a reimbursable expense of the De▇▇▇▇▇▇ent Program pursuant to Sections 6.2.1 or 6.2.2, as applicable. The Development Committee shall be chaired Travel by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings attendees of the Development Committee meetings other than the three (3) Development Committee members (or their designees) from each Party shall not be considered a reimbursable expense of the Development Program pursuant to Sections 6.2.1 or 6.2.2, as applicable. Decisions required or permitted under this Agreement to be made by the Development Committee, shall be at least biannual with each member of the Development Committee having one (1) vote and at such times and places or in such form (e.g.the affirmative vote of a simple majority of the members being required to constitute action by the Development Committee. In the event of an absence of a member, in person, telephonic or video conference) another member representing the same Party as the absent member may cast a vote on behalf of the absent member. In the event that the members of the Development Committee shall determine. Representatives of both Parties cannot agree on a matter, the matter shall be present at any meeting submitted: (a) first, to the Divisional Vice President of Pharmaceutical and Clinical Development of the Development Committee. Decisions Abbott Laboratories Hospital Products Division or in the case of matt▇▇▇ ▇▇ecifically applicable to Canada, his or her equivalent in Abbott International and the Development Committee shall be made by a written consent signed by all six Chief Executive Officer of NaPro for res▇▇▇▇▇▇n and if no resolution is reached, then (6b) members thereof. The Development Committee shall keep minutes of its deliberations setting forthsecond, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of the Abbott Hospital Products Division or his or her designee or in the ca▇▇ ▇▇ matters specifically applicable to Canada, his or her equivalent in Abbott International and the CEO of NaPro, or his or her designee, fo▇ ▇▇▇▇ Products Division ▇rmination. If a determination is not made through either (a) or (b) above, the matter shall be resolved in accordance with the ADR procedures set forth in Exhibit G. In the event that one Party desires to pursue additional indication(s) (other than as described in the Development Plan) for the Finished Product and the President of Arcadia or their respective designeesDevelopment Committee cannot make a determination by majority vote to pursue such additional indication, then the Party proposing the new indication may pursue and fund the two executives shall endeavor research and development required for such new indication at its own expense; provided, however, with respect to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreementsuch new indication, the disagreement shall be submitted data and right of reference for ADR as provided in Section 12(a).any Application for Regulatory Approval for any uses outside the Field or outside the Territory