Common use of Responsibilities of the Joint Steering Committee Clause in Contracts

Responsibilities of the Joint Steering Committee. The JSC shall be responsible for reviewing and providing input on and, if expressly specified in this Agreement, approving the overall strategy of the Parties under this Agreement, including development plans and strategies, and for reviewing the Commercialization Program. Specifically, the JSC shall perform the following functions: 3.2.1 recommend a date not to be more than three (3) months from the Effective Date, to transfer to Egalet (i) pharmacovigilance reporting and related activities, including preparation and submission of 15-day reports and preparation of periodic adverse drug event reports (PADER); and (ii) Medical Affairs; 3.2.2 review, at least annually, the Commercialization Program, the Marketing Plan, Manufacturing operations, DEA Quotas, Product development plans and the Product sales forecast (including projected royalties payable to Acura) for the collaboration; 3.2.3 review all material Product development, marketing, Manufacturing (including Product inventory levels and requirements) and regulatory activities, milestones and accomplishments and progress to forecast, in summary fashion on a Calendar Quarter basis and in a reasonably detailed manner on a semi-annual basis; 3.2.4 review the Launch Date for the Product in the United States; 3.2.5 if Acura exercises its Co-Promotion Right, review and approve target health care provider lists, as applicable, and data and reports relating to Product Details undertaken during the prior Calendar Quarter, including the relative priority of such Details; 3.2.6 determine and approve the allocation of overlapping target healthcare providers pursuant to Section 5.3.13; 3.2.7 discuss strategies, plans and updates relating to pending or threatened Infringement Actions and Offensive Infringement Actions; 3.2.8 evaluate the progress of development of the Product in Other Countries and the timing of Launch in such Other Countries following receipt of Regulatory Approval in such Other Countries; 3.2.9 review and provide comment on the protocols and plans for the Required Post-Marketing Studies; 3.2.10 review and approve any Product Line Extension proposed to be conducted by Acura pursuant to Section 4.4.1; 3.2.11 review and approve (by unanimous consent of the JSC members) the proposed budget relating to each of the Product Line Extension Studies and the Required Post-Marketing Studies within ten (10) business days after submission of such proposed budget to the JSC, provided that neither Party shall withhold approval for a proposed budget for the Product Line Extension Studies (determined as a group) or a Required Post-Marketing Studies (determined as a group) that is [*****] or less, and provided further that this Section 3.2.11 is subject to Section 6.14; 3.2.12 identify regular reports and channels of communications for the provision of periodic updates of progress relating to the Commercialization of the Product and the development and filing for Regulatory Approval of Product Line Extensions; and 3.2.13 perform such other responsibilities as may be agreed upon by the Parties in writing from time to time. Egalet will report regularly and no less than semi-annually on any material changes to or material variances from the Commercialization Program and the aforementioned plans and budgets, whether such changes have actually occurred or are expected. Notwithstanding the foregoing, the JSC shall not have the authority to make any determination that either Party is in breach of this Agreement or has complied with its obligations under this Agreement, or to assess any charges or expenses in excess of the amounts allocated to a Party pursuant to the budgets agreed to by the Parties in accordance with Sections 3.2.11 and 6.14, except as provided in Section 6.14.

Responsibilities of the Joint Steering Committee. The JSC shall be responsible In addition to the other functions and responsibilities of the Joint Steering Committee provided for reviewing and providing input on and, if expressly specified in this Agreement, approving the overall strategy of the Parties under this Agreement, including development plans and strategies, and for reviewing the Commercialization Program. Specifically, the JSC Joint Steering Committee shall perform the following functions, subject to compliance with Section 2.4 in all respects: 3.2.1 recommend a date not to be more than three (3a) months from Reviewing available quarterly gross sales, quarterly Net Sales, and other Product performance data as determined by the Effective Date, to transfer to Egalet (i) pharmacovigilance reporting and related activities, including preparation and submission of 15-day reports and preparation of periodic adverse drug event reports (PADER); and (ii) Medical AffairsJoint Steering Committee; 3.2.2 review(b) Reviewing and approving new Promotional Materials or changes to existing Promotional Materials, at least annuallysubject to Section 5.5(d); (c) Reviewing coupon demand forecast and data on coupon usage / redemption; (d) Reviewing the efforts of sales representatives employed by, the Commercialization Programor on behalf of, the Marketing Plan, Manufacturing operations, DEA Quotas, GSK and Auxilium who engage in Product development plans Details and other promotional efforts with respect to the Product sales forecast (including projected royalties payable to Acura) for the collaboration; 3.2.3 review all material Product development, marketing, Manufacturing (including Product inventory levels and requirements) and regulatory activities, milestones and accomplishments and progress to forecast, in summary fashion on a Calendar Quarter basis and in a reasonably detailed manner on a semi-annual basis; 3.2.4 review the Launch Date for the Product in the United States; 3.2.5 if Acura exercises its Co-Promotion Right, review and approve target health care provider lists, as applicable, and data and reports relating to maintain desired frequency of Product Details undertaken during the prior Calendar Quarter, including the relative priority and to avoid unintended duplication of such Product Details; 3.2.6 determine and approve the allocation of overlapping target healthcare providers pursuant (e) Subject to Section 5.3.13; 3.2.7 discuss strategies2.2, plans reviewing and updates relating to pending or threatened Infringement Actions and Offensive Infringement Actions; 3.2.8 evaluate approving the progress of development of the Product in Other Countries and the timing of Launch in such Other Countries following receipt of Regulatory Approval in such Other Countries; 3.2.9 review and provide comment on the protocols and plans Annual Marketing Plan for the Required Post-Marketing Studies; 3.2.10 review and approve any Product Line Extension proposed to be conducted by Acura pursuant to Section 4.4.1; 3.2.11 review and approve (by unanimous consent of the JSC members) the proposed budget relating to each of the Product Line Extension Studies and the Required Post-Marketing Studies within ten (10) business days after submission of such proposed budget to the JSCProduct, provided that neither Party shall withhold approval for a proposed budget for the Product Line Extension Studies (determined as a group) or a Required Post-Marketing Studies (determined as a group) that is [*****] or less, and provided further that this Section 3.2.11 is subject to Section 6.14; 3.2.12 identify regular reports and channels of communications including appropriate budgets for the provision of periodic updates Samples; (f) Subject to Section 2.2, reviewing and approving the Annual Scientific Engagement Plan; (g) Reviewing the Parties’ respective training needs and training schedule; (h) Discussing Compliance Disputes referred to the Joint Steering Committee by the Compliance Committee; (i) Establishing monthly reporting forms related to each Party’s Product Detailing; (j) Discussing any changes to Product pricing; (k) Discussing the progress and results of progress any studies relating to the Commercialization Product; (l) Reviewing medical inquiry procedures related to the Product that have been established by the Compliance Committee; (m) Discussing any events affecting the integrity or reputation of the Parties, in accordance with Section 7.8; (n) Discussing and approving any Auxilium Trademarks for use with the Product and the development and filing for Regulatory Approval of Product Line Extensionspursuant to Section 9.7; and 3.2.13 perform (o) Performing such other responsibilities as may be mutually agreed upon by the Parties in writing from time to time. Egalet will report regularly and no less than semi-annually on any material changes ; provided, however, that, notwithstanding anything to or material variances from the Commercialization Program and the aforementioned plans and budgets, whether such changes have actually occurred or are expected. Notwithstanding the foregoing, the JSC shall not have the authority to make any determination that either Party is contrary in breach of this Agreement or has complied with its obligations under this Agreement, the Joint Steering Committee shall have no authority to (1) amend any provision of this Agreement; (2) determine any dispute related to the interpretation or performance of this Agreement; or (3) increase (with respect to assess GSK) or decrease (with respect to Auxilium) any charges or expenses in excess obligation of the amounts allocated to a Party pursuant to the budgets agreed to by the Parties in accordance with Sections 3.2.11 and 6.14Parties, except as provided in Section 6.14financial or otherwise.

Responsibilities of the Joint Steering Committee. (a) The JSC Joint Steering Committee shall be responsible monitor the activities of each Detailed Development Plan. In particular, the responsibilities of the Joint Steering Committee shall include: (a) determining whether or not the criteria for continued development under a particular Detailed Development Plan have been met; (b) defining the Target Dossier in accordance with Section 1.91; (c) approving the Detailed Development Plan for each Selected Collaboration Combination and Selected Licensed Combination; (d) planning, reviewing and providing input on andapproving preclinical and clinical study designs; (e) planning, if expressly specified in this Agreement, reviewing and approving the overall strategy of the Parties under this Agreementtimelines to complete such studies, including development plans any amendments to the timeline necessitated by Permitted Delays; (f) ensuring that clinical Phase I and strategiesPhase II studies, in accordance with the Target Dossier, are designed such that results from such studies can be used to initiate Phase III Studies in the United States and Europe; (g) approving formulation technologies and license terms, as appropriate, for reviewing the Commercialization Program. Specifically, the JSC shall perform the following functions: 3.2.1 recommend a date not developing commercial formulations to be more than three used to conduct the Phase III Studies for treating FOE Disease and/or BOE Disease; (3h) months from ensuring proper communication between the Effective Date, to transfer to Egalet Parties; and (i) pharmacovigilance reporting recommending to the CEOs of each Party adjustments to any deadlines described in the Development Plans, in the event such adjustments are needed. (b) The Joint Steering Committee shall also coordinate preclinical and related activities, including preparation and submission clinical studies of 15-day reports and preparation of periodic adverse drug event reports (PADER); and (ii) Medical Affairs; 3.2.2 review, at least annually, Selected Collaboration Combinations that are being developed in the Commercialization Program, the Marketing Plan, Manufacturing operations, DEA Quotas, Product development plans Collaboration Combination Field by both Parties and the Product sales forecast (including projected royalties payable to Acura) for publication of data from these studies, which studies will be conducted in a manner consistent with CombinatoRx's global development activities of the collaboration; 3.2.3 review all material Product developmentSelected Collaboration Combinations. All of Fovea's preclinical and clinical plans, marketingprotocols, Manufacturing (including Product inventory levels and requirements) investigators and regulatory activitiessubmissions related to the Selected Collaboration Combination shall each be subject to prior approval by the Joint Steering Committee. CombinatoRx shall disclose to the Joint Steering Committee all CombinatoRx Generated Data related to Selected Collaboration Combinations. Adverse experiences shall be promptly communicated by each Party to the other, milestones and accomplishments and progress to forecast, in summary fashion on a Calendar Quarter basis and along with all supporting documentation in a reasonably detailed manner on a semi-annual basis; 3.2.4 review the Launch Date for the Product in the United States; 3.2.5 if Acura exercises its Co-Promotion Right, review and approve target health care provider lists, as applicable, and data and reports relating to Product Details undertaken during the prior Calendar Quarter, including the relative priority of such Details; 3.2.6 determine and approve the allocation of overlapping target healthcare providers pursuant to Section 5.3.13; 3.2.7 discuss strategies, plans and updates relating to pending or threatened Infringement Actions and Offensive Infringement Actions; 3.2.8 evaluate the progress of development of the Product in Other Countries and the timing of Launch in such Other Countries following receipt of Regulatory Approval in such Other Countries; 3.2.9 review and provide comment on the protocols and plans for the Required Post-Marketing Studies; 3.2.10 review and approve any Product Line Extension proposed to be conducted by Acura pursuant to Section 4.4.1; 3.2.11 review and approve (by unanimous consent of the JSC members) the proposed budget relating to each of the Product Line Extension Studies and the Required Post-Marketing Studies within ten (10) business days after submission of such proposed budget to the JSC, provided that neither Party shall withhold approval for a proposed budget for the Product Line Extension Studies (determined as a group) or a Required Post-Marketing Studies (determined as a group) that is [*****] or less, and provided further that this Section 3.2.11 is subject to Section 6.14; 3.2.12 identify regular reports and channels of communications for the provision of periodic updates of progress relating to the Commercialization of the Product and the development and filing for Regulatory Approval of Product Line Extensions; and 3.2.13 perform such other responsibilities as may be agreed upon by the Parties in writing from time to time. Egalet will report regularly and no less than semi-annually on any material changes to or material variances from the Commercialization Program and the aforementioned plans and budgets, whether such changes have actually occurred or are expected. Notwithstanding the foregoing, the JSC shall not have the consistent with applicable regulatory authority to make any determination that either Party is in breach of this Agreement or has complied with its obligations under this Agreement, or to assess any charges or expenses in excess of the amounts allocated to a Party pursuant to the budgets agreed to by the Parties in accordance with Sections 3.2.11 and 6.14, except as provided in Section 6.14reporting requirements.