Commercialization Committee. 7.1.1 The Commercialization Committee shall comprise one (1) representative of EyePoint and one (1) representative of Imprimis, each with appropriate decision making authority on behalf of such Party. Each Party shall appoint its representative to the Commercialization Committee prior to the first meeting thereof, and may substitute its representative from time to time, in its sole discretion, effective upon written notice to the other Party of such change, but shall use commercially reasonable efforts to maintain stability of Commercialization Committee representation. 7.1.2 The purpose of the Commercialization Committee under this Agreement shall be (a) to facilitate the exchange of information between the Parties, (b) to review and discuss the activities of the Parties under this Agreement, (c) to review, consider and make recommendations for modifications to the Marketing Materials, (d) to add Third Parties referred under Section 3.4 as Customers to this Agreement and to determine the Baseline Period for such Customers pursuant to criteria mutually agreed by the Parties in writing, and (e) to review other information relating to Products. 7.1.3 The Commercialization Committee shall meet at such places or in such forms (such as by telephone conference) as determined by mutual agreement of the Parties. Each Party may permit such visitors to a meeting of the Commercialization Committee as mutually agreed by the Parties prior to such meeting; provided, that a Party may require each such visitor to execute an appropriate confidentiality agreement. Each Party shall be responsible for its own costs in connection with the meetings of the Commercialization Committee. The representative of each Party shall be entitled to one (1) vote. Except as expressly provided herein, each determination or other action of the Commercialization Committee shall require unanimous approval by the representatives of both Parties. If the Commercialization Committee is unable to reach such unanimous approval, then each Party shall have the right to escalate the applicable issue to the Joint Steering Committee upon written notice to the other Party. 7.1.4 The first meeting of the Commercialization Committee shall occur within two (2) business days after the Effective Date. Thereafter, for the first thirty (30)-day period following the Effective Date, the Commercialization Committee shall meet weekly. After such thirty (30)-day period, the Commercialization Committee shall meet no less frequently than monthly. 7.1.5 Within ten (10) days after each Commercialization Committee meeting, a Commercialization Committee representative of one of Parties, on an alternating basis, shall prepare and provide to each Party a copy of the minutes of such meeting which shall set forth, in reasonably specific detail, the discussions and any approval, determination or other action agreed to by all of the members of the Commercialization Committee. Such minutes shall be subject to the reasonable comment and approval by the other Party.
Appears in 2 contracts
Samples: Commercial Alliance Agreement (Harrow Health, Inc.), Commercial Alliance Agreement (EyePoint Pharmaceuticals, Inc.)
Commercialization Committee. 7.1.1 (a) The Parties hereby establish a committee, separate from the Development Committee, which shall provide a forum for open communication between the Parties regarding Product Commercialization activities in the Field, and which shall be responsible for such matters related to Commercialization of the Products in the Field in the Territory as may be described below. The Commercialization Committee shall comprise one (1) representative of EyePoint and one (1) representative of Imprimis, each with appropriate decision making authority on behalf consist of such Partyeven number as shall be agreed by the Parties, fifty percent (50%) of whom shall be Par designees and fifty percent (50%) of whom shall be Alfacell designees (the “Commercialization Committee”). Each Party shall appoint its representative to have the Commercialization Committee prior to the first meeting thereof, right at any time and may substitute its representative from time to timetime to designate a replacement, in on a permanent or temporary basis, for any or all of its sole discretion, effective upon written notice to the other Party of such change, but shall use commercially reasonable efforts to maintain stability of Commercialization Committee representation.
7.1.2 The purpose previously-designated members of the Commercialization Committee. At the beginning of each calendar year during the Term, each Party shall appoint one of its designees to serve as a Co-Chair of the Commercialization Committee. The initial Commercialization Committee under this Agreement shall consist of six (6) members (including the Co-Chairs of such Committee), who shall be designated by each Party within ten (a10) to facilitate business days after the exchange Effective Date. For the sake of information between clarity, an individual may serve on both the Parties, (b) to review Development Committee and discuss the activities of the Parties under this Agreement, (c) to review, consider and make recommendations for modifications to the Marketing Materials, (d) to add Third Parties referred under Section 3.4 as Customers to this Agreement and to determine the Baseline Period for such Customers pursuant to criteria mutually agreed by the Parties in writing, and (e) to review other information relating to Products.
7.1.3 Commercialization Committee. The Commercialization Committee shall meet at such places or in such forms (such as by telephone conference) as determined by mutual agreement of the Parties. Each Party may permit such visitors to a meeting of the Commercialization Committee least once per calendar quarter, and more frequently as mutually agreed by the Parties, on such dates, and at such places and times, as the Parties prior shall agree.
(b) Par agrees to such meeting; providedkeep the Commercialization Committee reasonably informed in respect of its Commercialization of Products in the Field in the Territory pursuant to its authority and responsibility set forth in Section 5.1, that a Party may require each such visitor to execute an appropriate confidentiality agreement. Each Party and in particular Par shall be responsible for (a) provide the Commercialization Committee at its own costs regularly scheduled meetings with copies of Par’s annual Product marketing plans, information regarding Par’s Commercialization strategy, and updates regarding the foregoing and the progress of Par’s Commercialization activities, (b) promptly advise the Commercialization Committee of any unforeseen material problems or delays encountered since the date of its last report in connection with the meetings Commercialization activities, and (c) provide Alfacell as soon as reasonably practicable with such other material information as Alfacell’s Commercialization Committee members may reasonably request in writing from time to time with respect to the status of the Commercialization activities and progress. Alfacell’s members shall provide advice, suggestions and constructive feedback on such Commercialization strategy, plans and activities (especially in view of Alfacell’s retained rights regarding Product commercialization outside of the Field and outside of the Territory, and Alfacell’s desire to achieve (to the extent appropriate) global harmonization of Product commercialization (including branding) worldwide). Par will reasonably and in good faith consider any comments and recommendations that the Commercialization Committee may have with respect to the Commercialization of the Product.
(c) The Commercialization Committee shall (i) review and recommend (or decline to recommend), in consultation with the Development Committee, (A) activities related to the publication and/or dissemination of the clinical data and reports related to Product Studies, including publications, posters, abstracts and presentations and (B) matters that intersect or overlap with Product development and/or manufacturing activities, (ii) support Par’s strategy and plans regarding Commercialization (to the extent that such strategy and plans have been provided to the Commercialization Committee), and (iii) perform such other activities and discharge such other responsibilities as may be assigned to the Commercialization Committee by the Parties pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. Par will reasonably and in good faith consider any comments and recommendations that the Commercialization Committee may have with respect to the Commercialization of the Product.
(d) The Commercialization Committee has no decision-making authority except as expressly set forth herein. All Commercialization issues related to the initial medical claims for the core launch materials for the Product that will be submitted to the FDA for pre-clearance review (the “Material Commercialization Decision”) shall be determined by a vote of the Commercialization Committee. The representative of each Party shall be entitled to one (1) vote. Except as expressly provided herein, each determination or other action of the Commercialization Committee shall require unanimous approval by the representatives of both Parties. If the Commercialization Committee is unable to reach agree on the Material Commercialization Decision, such unanimous approval, then each Party dispute or disagreement shall have the right to escalate the applicable issue be referred to the Joint Steering Committee upon written notice CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the matter (without resort to the other Party.
7.1.4 The first meeting Section 14.5). All decisions of the Commercialization Committee shall occur within two (2) business days after the Effective Datebe made by unanimous vote or unanimous written consent of both Parties, with each Party having, collectively among its respective designees, one vote in all decisions. Thereafter, for the first thirty (30)-day period following the Effective Date, The members of the Commercialization Committee shall meet weekly. After such thirty (30)-day period, use Commercially Reasonable Efforts to decide all matters assigned to the Commercialization Committee shall meet no less frequently than monthly.
7.1.5 Within under this Agreement or otherwise referred to it by mutual agreement of the Parties; provided, however, that if the members of the Commercialization Committee are unable to make a decision by unanimous vote or unanimous written consent within ten (10) days after each commencing discussions regarding such decision, then, except in respect of any Material Commercialization Decision, Par shall have the final decision-making authority with respect to such decision (subject to any limitations on such authority expressly set forth herein); provided, however, that if Commercialization timing constraints make submission of the matter to the Commercialization Committee meetingimpracticable, a Commercialization Committee representative of one of Parties, on an alternating basis, then Par shall prepare and provide have the discretion to each Party a copy of the minutes of make such meeting which shall set forth, in reasonably specific detail, the discussions and any approval, determination or other action agreed to by all of the members of the Commercialization Committee. Such minutes shall be subject to the reasonable comment and approval by the other Partydetermination.
Appears in 2 contracts
Samples: License Agreement (Par Pharmaceutical Companies, Inc.), License Agreement (Alfacell Corp)
Commercialization Committee. 7.1.1 If the Joint Technology from any Association Discovery has not been commercialized within two years of the Association Discovery Notice, the Party that is not the Commercializing Party may request that further commercialization efforts be the responsibility of a joint Commercialization Committee. Within thirty (30) days after such request, the Parties shall establish a Commercialization Committee having a total of four (4) members. Gemini and CuraGen each shall select and have the right to replace up to two (2) representatives to serve as members of the Commercialization Committee, each of whom shall have senior management responsibilities for the Party appointing such member. Either Party may designate a substitute for a committee member to participate in the event one of that Party's regular committee members is unable to be present at a meeting. The Commercialization Committee shall comprise one (1) representative operate by consensus and shall seek to make decisions on the basis of EyePoint and one (1) representative of Imprimis, each with appropriate decision making authority on behalf of such Party. Each Party shall appoint its representative to the Commercialization Committee prior to the first meeting thereof, and may substitute its representative from time to time, in its sole discretion, effective upon written notice to the other Party of such change, but shall use commercially reasonable efforts to maintain stability of Commercialization Committee representation.
7.1.2 The purpose consensus after a discussion of the Commercialization Committee under this Agreement shall be (a) matters as to facilitate which decisions are being made. In the exchange of information between the Parties, (b) to review and discuss the activities of the Parties under this Agreement, (c) to review, consider and make recommendations for modifications to the Marketing Materials, (d) to add Third Parties referred under Section 3.4 as Customers to this Agreement and to determine the Baseline Period for such Customers pursuant to criteria mutually agreed by the Parties in writing, and (e) to review other information relating to Products.
7.1.3 The Commercialization Committee shall meet at such places or in such forms (such as by telephone conference) as determined by mutual agreement of the Parties. Each Party may permit such visitors to a meeting of the Commercialization Committee as mutually agreed by the Parties prior to such meeting; provided, that a Party may require each such visitor to execute an appropriate confidentiality agreement. Each Party shall be responsible for its own costs in connection with the meetings of the Commercialization Committee. The representative of each Party shall be entitled to one (1) vote. Except as expressly provided herein, each determination or other action of the Commercialization Committee shall require unanimous approval by the representatives of both Parties. If event the Commercialization Committee is unable to reach such unanimous approvalagree upon a particular matter, then such matter shall be submitted for resolution to an executive officer of each Party shall have for resolution by good faith discussion. If such matter is not resolved by such officers within thirty (30) days of submission, and the right to escalate the applicable issue matter relates directly to the commercialization of a particular item of Joint Steering Committee Technology, then the matter will be submitted to an independent expert in the pharmaceutical (or other appropriate related) industry acting as an expert and not as an arbitrator, the identity of whom shall be agreed upon written notice to the other Party.
7.1.4 The first meeting of by the Commercialization Committee shall occur within two (2) business days after or failing such agreement, by the Effective Date. Thereafterindependent experts, for the first thirty (30)-day period following the Effective Date, the Commercialization Committee shall meet weekly. After where one such thirty (30)-day period, the Commercialization Committee shall meet no less frequently than monthly.
7.1.5 Within ten (10) days after expert is identified and nominated by each Commercialization Committee meeting, a Commercialization Committee representative of one of Parties, on an alternating basis, shall prepare and provide to each Party a copy of the minutes Parties in their respective discretion) who shall resolve the matter by determining objectively what is the best means of such meeting which shall set forth, in reasonably specific detail, commercializing the discussions and any approval, determination applicable Joint Technology on a stand alone basis disregarding the individual subjective needs or other action agreed to by all preferences of the members Parties. In the absence of the Commercialization Committeemanifest error, such determination shall be conclusive. Such minutes shall be matters are not subject to the reasonable comment and approval by the other Partydispute resolution through arbitration or litigation under Article 11.
Appears in 1 contract
Samples: Research Collaboration Agreement (Gemini Genomics PLC)