Common use of Composition; Responsibilities Clause in Contracts

Composition; Responsibilities. The JSC will be comprised of three (3) representatives of Paratek and three (3) representatives of WCCI and will continue in effect throughout the Term. Each Party will designate its JSC representatives within thirty (30) days of the Effective Date and shall have the right to replace any of its JSC representatives from time to time by giving prior notice of such replacement to the other Party. The JSC will be chaired by one of the WCCI designated representatives during the Term (the “Chair”). During the period commencing on the Effective Date and continuing until the payment by WCCI of the milestone payment associated with the filing of an IND with respect to a Product pursuant to Section 5.3.1 (the “IND Milestone Date”), the JSC will (a) meet at least four (4) times per Calendar Year and (b) be responsible for (i) reviewing the efforts of the Parties in the conduct of the Backup Compound Research Program, if any, and the Development activities, (ii) reviewing and approving the Backup Compound Research Plans, if any, the Development Plan and/or any amendments, modifications and updates to any such Backup Compound Research Plan and Development Plan, (iii) addressing such other matters as either Party may bring before the JSC, (iv) determining the Development Timelines applicable to the Development of any Lead Candidate during the period from (A) the IND Milestone Date with respect to such Lead Candidate or Product to the completion of Phase II Clinical Trials with respect to such Lead Candidate or Product (the “Phase II Development Timelines”), (B) the Initiation of Phase III Clinical Trials with respect to such Lead Candidate or Product to the filing of an NDA with respect to such Lead Candidate or Product (the “NDA Development Timelines”) and (C) the filing of an NDA with respect to such Lead Candidate or Product to the First Commercial Sale of a Product Derived from such Lead Candidate or Product (the “Launch Development Timelines”) and (v) performing such other tasks and undertaking such other responsibilities as may be set forth in this Agreement, including, without limitation, the responsibilities set forth in Article 3 hereof. The JSC shall determine the Phase II Development Timelines, the NDA Development Timelines and the Launch Development Timelines promptly upon the substantial completion of the material Development activity specified in the immediately preceding Development Timeline. Following the IND Milestone Date (a) at Paratek’s request, which shall not be made more frequently than twice per Calendar Year, the JSC will meet for the sole purpose of serving as a forum for WCCI to update Paratek as to clinical Development and Commercialization progress with respect to Lead Candidates and Products, (b) each Party may continue to exercise its right under this Section 2.2 to replace its JSC representatives from time to time by giving prior notice of such replacement to the other Party and (c) each Party may continue to exercise its right under Section 2.3.2 hereof to have representatives of such Party or of its Affiliates who are not members of the JSC attend JSC meetings as observers at the invitation of such Party with the approval of the other Party, which shall not be unreasonably withheld. At each such meeting of the JSC after the IND Milestone Date, the representatives of WCCI on the JSC shall provide an update to the JSC as to WCCI’s general strategy for the Development and Commercialization of each Product in the Field, including, without limitation, to the extent applicable, (i) an update to each Development Plan concerning the applicable Development Timelines for the Development of each Lead Candidate and Product and Regulatory Filings with respect thereto in Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. the Field in the Territory, (ii) an update concerning the anticipated timelines on a region-by region basis for the commercial launch of each Product and (iii) sales forecast guidance for each Product in the Field in the Territory. If there is a material change in such timelines or guidance after any such meeting, WCCI will promptly notify Paratek thereof.

Composition; Responsibilities. The JSC will Parties shall establish a cross-functional Joint Program Team that is composed of representatives designated by each Party. Representatives must be comprised appropriate for the tasks then being undertaken and the stage of three (3) representatives Development, Manufacturing or Commercialization, as the case may be, in terms of Paratek their seniority, availability, function in their respective organizations, training and three (3) representatives of WCCI and will continue in effect throughout the Termexperience. Each Party will shall designate its JSC representatives within thirty (30) days of the Effective Date and shall have the right to replace any one of its JSC representatives as its primary JPT contact. Each Party may replace its representatives from time to time by giving prior upon written notice of such replacement to the other Party; provided, however, if a Party’s representative is unable to attend a meeting, such Party may designate a knowledgeable alternate to attend such meeting and perform the functions of such representative. The JSC will be chaired by one JPT will, subject to the oversight of the WCCI designated representatives during applicable Operating Committee, undertake the Term following activities: (i) preparing proposed changes, amendments, or other updates to the “Chair”). During Development Plan (including the period commencing on Development Budget) for submission to the Effective Date JDC (other than those changes, amendments and continuing until the payment by WCCI of the milestone payment associated with the filing of an IND updates with respect to a Product pursuant to Section 5.3.1 (the “IND Milestone Date”), the JSC will (a) meet at least four (4) times per Calendar Year and (b) be responsible for (i) reviewing the efforts of the Parties in the conduct of the Backup Compound Research Program, if any, and the CMC Manufacturing Development activities, which are addressed below in (iii)), (ii) reviewing and approving preparing the Backup Compound Research Plans, if any, the Development Plan and/or any amendments, modifications and updates to any such Backup Compound Research Plan and Development Plan, (iii) addressing such other matters as either Party may bring before the JSC, (iv) determining the Development Timelines applicable to the Development of any Lead Candidate during the period from (A) the IND Milestone Date with respect to such Lead Candidate or Product to the completion of Phase II Clinical Trials with respect to such Lead Candidate or Product (the “Phase II Development Timelines”), (B) the Initiation of Phase III Clinical Trials with respect to such Lead Candidate or Product to the filing of an NDA with respect to such Lead Candidate or Product (the “NDA Development Timelines”) and (C) the filing of an NDA with respect to such Lead Candidate or Product to the First Commercial Sale of a Product Derived from such Lead Candidate or Product (the “Launch Development Timelines”) and (v) performing such other tasks and undertaking such other responsibilities as may be set forth in this Agreement, including, without limitation, the responsibilities set forth in Article 3 hereof. The JSC shall determine the Phase II Development Timelines, the NDA Development Timelines and the Launch Development Timelines promptly upon the substantial completion of the material Development activity specified in the immediately preceding Development Timeline. Following the IND Milestone Date (a) at Paratek’s request, which shall not be made more frequently than twice per Calendar Year, the JSC will meet for the sole purpose of serving as a forum for WCCI to update Paratek as to clinical Development and Commercialization progress with respect to Lead Candidates and Products, (b) each Party may continue to exercise its right under this Section 2.2 to replace its JSC representatives from time to time by giving prior notice of such replacement to the other Party and (c) each Party may continue to exercise its right under Section 2.3.2 hereof to have representatives of such Party or of its Affiliates who are not members of the JSC attend JSC meetings as observers at the invitation of such Party with the approval of the other Party, which shall not be unreasonably withheld. At each such meeting of the JSC after the IND Milestone Date, the representatives of WCCI on the JSC shall provide an update to the JSC as to WCCI’s general regulatory strategy for the Development and Commercialization of each Product in the Field, including, without limitation, to the extent applicable, (i) an update to each Development Plan concerning the applicable Development Timelines for the Development of each Lead Candidate and Product and Regulatory Filings with respect thereto in Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. the Field in the Territory, (ii) an update concerning the anticipated timelines on a region-by region basis for the commercial launch of each Product and (iii) sales forecast guidance for each Product Products in the Field in the TerritoryTerritory for submission to the JDC, (iii) preparing the Manufacturing Plan and any proposed changes, amendments, or other updates to the Manufacturing Plan for submission to the JMC, (iv) preparing any amendment to the Development Plan for CMC Manufacturing Development activities for submission to the JMC, (v) preparing the Co-Commercialization Plan and any proposed changes, amendments, or other updates to the Co-Commercialization Plan for submission to the JCC, (vi) preparing the PCD Strategy and the Global Brand Strategy for each Product, (vii) any other responsibilities delegated to the JPT by an Operating Committee, and (viii) discuss and coordinate any desired or planned publications or presentations (or other public disclosure of any Development Data, or any other results of any Clinical Trial or analysis therefor) relating to Product in the Territory and coordinate publications in either Party’s clinical trials registry. If there is a material change in The JPT shall meet at least [****] by audio or video teleconference or as otherwise agreed by such timelines JPT. The JPT shall not have the authority to interpret or guidance after any such meeting, WCCI will promptly notify Paratek thereofotherwise amend this Agreement.

Composition; Responsibilities. The JSC will be Parties shall establish a joint steering committee (the "Joint Steering Committee"), comprised of (i) three (3) representatives of Paratek and Becton Dickxxxxx xxx three (3) representatives senior executives of WCCI MPMx, and will continue in effect throughout (ii) the TermProgram Directors. Each Party will designate shall make its JSC designation of its representatives within not later than thirty (30) days of after the Effective Date. Each Party shall use reasonable efforts to designate as its representatives individuals that shall have the requisite experience and knowledge to oversee the Research Program and the Development Program. The Joint Steering Committee shall meet within forty-five (45) days after the Effective Date and shall have and, thereafter, at least quarterly during the right to replace any of its JSC representatives from time to time by giving prior notice of such replacement to the other Party. The JSC will be chaired by one course of the WCCI designated representatives Research Program and at least once every six (6) months during the Term (the “Chair”). During the period commencing on the Effective Date and continuing until the payment by WCCI course of the milestone payment associated with the filing Development Program or until termination of an IND with respect this Agreement, if earlier, to a Product pursuant to Section 5.3.1 (the “IND Milestone Date”), the JSC will (a) meet at least four (4) times per Calendar Year and (b) be responsible for (i) reviewing review the efforts of the Parties in the conduct of the Backup Compound Research Program, if any, Program and the Development activitiesProgram, (ii) reviewing review and approving approve amendments to the Backup Compound Research Plans, if any, the Development Plan and/or any amendments, modifications and updates to any such Backup Compound Research Plan and Development Plan, (iii) addressing review the annual development plan to be prepared by Becton Dickxxxxx xxx the Development Program, (iv) review and approve the committed staffing and funding levels and scientific rationale for each Product Area that is proposed by a Party as an Exclusive Product Area and for each Pharmacogenomic Product Opportunity that is proposed by a Party as an Exclusive Colon Pharmacogenomic Product Opportunity or a Co-Exclusive Pharmacogenomic Product Opportunity, (v) establish Performance Specifications in accordance with subsection (b) below, (vi) determine whether the Year [**] Milestone (as defined in Section 2.8) has been accomplished, (vii) approve the determination of the Program Directors as to which, if any, Program Candidate Markers have been validated as Program Validated Markers, (viii) determine the allocation of the Funding Amount for each Contract Year after the First Contract Year, (ix) consider and act upon such other matters as either are specified in this Agreement and (x) attempt to resolve any disputes relating to this Agreement that may arise between the Parties. The location of such meetings of the Joint Steering Committee shall alternate between Massachusetts and Maryland, or as otherwise agreed by the Parties. The Joint Steering Committee may also meet by means of a telephone conference call. Each Party may bring before the JSC, (iv) determining the Development Timelines applicable change any one or more of its representatives to the Development of Joint Steering Committee at any Lead Candidate during the period from (A) the IND Milestone Date with respect to such Lead Candidate or Product to the completion of Phase II Clinical Trials with respect to such Lead Candidate or Product (the “Phase II Development Timelines”), (B) the Initiation of Phase III Clinical Trials with respect to such Lead Candidate or Product to the filing of an NDA with respect to such Lead Candidate or Product (the “NDA Development Timelines”) and (C) the filing of an NDA with respect to such Lead Candidate or Product to the First Commercial Sale of a Product Derived from such Lead Candidate or Product (the “Launch Development Timelines”) and (v) performing such other tasks and undertaking such other responsibilities as may be set forth in this Agreement, including, without limitation, the responsibilities set forth in Article 3 hereof. The JSC shall determine the Phase II Development Timelines, the NDA Development Timelines and the Launch Development Timelines promptly time upon the substantial completion of the material Development activity specified in the immediately preceding Development Timeline. Following the IND Milestone Date (a) at Paratek’s request, which shall not be made more frequently than twice per Calendar Year, the JSC will meet for the sole purpose of serving as a forum for WCCI to update Paratek as to clinical Development and Commercialization progress with respect to Lead Candidates and Products, (b) each Party may continue to exercise its right under this Section 2.2 to replace its JSC representatives from time to time by giving prior notice of such replacement to the other Party. Each Party and (c) each shall use reasonable efforts to cause its representatives to attend the meetings of the Joint Steering Committee. If a representative of a Party is unable to attend a meeting, such Party may continue designate an alternate to exercise its right under Section 2.3.2 hereof to have representatives of attend such Party or of its Affiliates who are not members meeting in place of the JSC attend JSC meetings as observers at the invitation of such Party with the approval of the other Party, which shall not be unreasonably withheld. At each such meeting of the JSC after the IND Milestone Date, the representatives of WCCI on the JSC shall provide an update to the JSC as to WCCI’s general strategy for the Development and Commercialization of each Product in the Field, including, without limitation, to the extent applicable, (i) an update to each Development Plan concerning the applicable Development Timelines for the Development of each Lead Candidate and Product and Regulatory Filings with respect thereto in Portions of this Exhibit, indicated by the xxxx “[***],” were absent Confidential Materials omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amendedand Exchange Commission. the Field in the Territory, (ii) an update concerning the anticipated timelines on a region-by region basis for the commercial launch of each Product and (iii) sales forecast guidance for each Product in the Field in the Territory. If there is a material change in such timelines or guidance after any such meeting, WCCI will promptly notify Paratek thereofAsterisks denote omissions.