Joint Development Committee. The Parties shall establish a Joint Development Committee (“JDC”) promptly upon commencement of the Co-Detail Term for the first Co-Detail Product, if any. The purpose of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows: 4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management; 4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets; 4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget; 4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product; 4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement; 4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to the conduct of development activities under a Joint Development and Co-Detail Agreement; and 4.7.7 Fulfilling such other responsibilities as may be allocated to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Sources: Research Collaboration and License Agreement (BCTG Acquisition Corp.)
Joint Development Committee. The Within [***] days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee (Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) promptly upon commencement and [***] representatives of the Co-Detail Term for the first Co-Detail ProductEverest, if any. The purpose of the JDC will be to coordinate the development Development and Commercialization of the Co-Detail Product(s)Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC’s oversight shall terminate: JDC shall:
(a) on serve as a Co-Detail Product-by-Co-Detail Product basis, upon receipt forum for discussing Development of the first Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities;
(b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities;
(c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities;
(d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Approval for such Co-Detail Product by a PartyAuthorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (biii) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement;
4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to coordinating the conduct of development activities under the Development activities;
(e) serve as a Joint Development forum at each meeting for discussing and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to the JDC under this Agreement, a Joint Development and Co-Detail Agreementdisclose to Everest’s, or by mutual written agreement of the Parties.its Affiliates’ or Sublicensees’
Appears in 1 contract
Joint Development Committee. The Within [**] following the Effective Date, the Parties shall establish the JDC. The JDC shall:
(a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Territory, or any clinical trial to be performed in whole or in part in the Territory, in each case, that is not set forth in the then-current Clinical Development Plan and is proposed by a Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the Clinical Development Plan, the JDC may approve converting such Local Trial into a Joint Global Trial;
(b) discuss the current Clinical Development Committee Plan and approve any updates or amendments to the Clinical Development Plan, including the addition of any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and discuss the use of any relevant diagnostic in the Territory;
(“JDC”c) promptly upon commencement monitor and discuss the alignment of Hutchmed Entities’ Development of Licensed Products in the Territory with Epizyme’s Development of the Co-Detail Term Licensed Products outside of the Territory, and discuss and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory;
(d) discuss whether Hutchmed shall participate in a global trial for the first Co-Detail ProductLicensed Product presented by Epizyme, which would include clinical sites both in the Territory and outside the Territory;
(e) discuss the clinical sites in the Territory to be included in each Local Trial and each Joint Global Trial;
(f) discuss the protocols for each Local Trial and Joint Global Trial and discuss the status and progress thereof;
(g) coordinate the operations of the Hutchmed Entities and Epizyme Entities with respect to Joint Global Trials;
(h) discuss the budget for the Joint Global Trials (and approve the budget for costs under Section 9.3(c)(iii)) to be conducted under this Agreement; provided that each Party shall solely determine the budget for its activities in its respective territory;
(i) discuss and approve the Permitted Subcontractors defined in Section 1.145(a), if any. The purpose of , that may be used for Joint Global Trials by Hutchmed in the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementTerritory;
4.7.2 Reviewing and discussing each initial Joint Development and Co(j) discuss Pre-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development Clinical Research activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development Licensed Products that any Hutchmed Entity wishes to conduct in the Territory, and discuss the status and progress of Co-Detail Products under a Joint Development and Co-Detail Agreementsuch activities;
4.7.6 Preparing and presenting updates (k) provide a forum for the Parties to the Umbrella Committee share information with respect to the conduct Development of development the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Trials and Joint Global Trials in the Territory and updates regarding interactions with Regulatory Authorities;
(l) coordinate plans and provide updates regarding attendance at conferences and congresses and interactions with key opinion leaders by the Parties, subject to Section 4.9;
(m) discuss the plans for any publication or presentation proposed by Hutchmed and related to the Development of Licensed Products, subject to Section 10.5(a);
(n) discuss the Hutchmed Entities’ Medical Affairs strategy for the Licensed Products in the Territory and take into account Epizyme’s Global Medical Affairs Strategy;
(o) discuss the Hutchmed Entities’ regulatory strategy for the Licensed Products in the Territory in the Field, including regulatory strategy for meetings with the Regulatory Authorities and the clinical and preclinical portions of the Drug Approval Application for the Licensed Product in the Territory;
(p) review and discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory (other than the chemistry, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC);
(q) discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide regular updates to the JDC;
(r) establish, within [**] after the establishment of the JDC, a Subcommittee to oversee and coordinate activities under a Joint Development and Co-Detail Agreementrelated to the ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, which Subcommittee shall meet [**] unless otherwise agreed; and
4.7.7 Fulfilling (s) determine whether to create any other Subcommittee, and perform such other responsibilities duties as may be allocated are specifically assigned to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Joint Development Committee. The Parties (a) No later than its initial meeting, the JSC shall establish a joint Development committee (the “Joint Development Committee (Committee” or “JDC”) promptly upon commencement which shall hold its initial meeting within fifteen (15) days of its establishment. At its first meeting, the JDC shall: (i) [***], and (ii) review, modify as necessary and recommend for approval to the JSC a Development Plan (including the Development Budget). The Illustrative Development Plan/Budget is an illustrative indication of the Co-Detail Term for activities and the budget to be considered and addressed in the first Co-Detail ProductDevelopment Plan and shall not be binding on the Parties, if anythe JSC or the JDC. The purpose of Following its initial meeting, the JDC will meet in person, by teleconference or by video- teleconference at least [***] per [***] to [***].
(b) Without limiting the foregoing, the JDC shall be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminateresponsible for: (ai) reviewing, consulting with the Parties on a Co-Detail Product-by-Co-Detail and modifying (as appropriate) the Development Plan including the Development Budget; (ii) recommending the Development Plan including the Development Budget (as modified) for approval by the JSC; (iii) communicating with the JCC regarding the interrelationship between Development activities and potential Commercialization; (iv) reviewing and monitoring the activities and progress against the Development Plan; (v) reviewing and monitoring the costs and expenses of Development against the Development Budget; (vi) finalizing the Product basis, upon receipt of specifications for inclusion in the first Marketing Approval Regulatory Filings for such Co-Detail Product by a Partythe Territory and Regulatory Approvals and Pricing and Reimbursement Approvals for the Territory; and (bvii) communicating with respect to the Parties regarding all Co-Detail Productsof the foregoing. For the avoidance of doubt, upon a Change of Control of Tango. Subject the CRO used for Clinical Trials shall be selected by Coherus, and such selection shall not be subject to the terms of the Joint Development and Codispute escalation process under Section 3.1(d) (Decision-Detail Agreement(sMaking; Deciding Vote), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement;
4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to the conduct of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Joint Development Committee. 8.2.1 The Parties shall hereby establish a Joint Development Committee joint development committee (“JDC”) promptly upon commencement with the responsibility to oversee, review and coordinate the Development of the Co-Detail Term for Licensed Antibodies and Licensed Products in the first Co-Detail Product, if anyField in the Territory. The purpose Subject to the oversight of the JSC, the JDC will be shall perform the following functions, subject to coordinate the development final decision-making authority of the Co-Detail Product(s). The JDC’s oversight shall terminate: respective Parties as set forth in Section 8.7.4:
(a) in consultation with the JMC (with respect to supply of Licensed Antibodies and Licensed Products), discussing, preparing and submitting to the JSC for approval material amendments to the Joint Development Plan (including the budget therein), on at least an annual basis, and reviewing, discussing and approving all other amendments to the Joint Development Plan (including the budget therein); provided that if either Party’s representative(s) on the JDC believes that an amendment is material, then such amendment shall be submitted to the JSC for approval;
(b) overseeing and monitoring all Development activities for the Territory, including the implementation of the Joint Development Plan and the costs incurred;
(c) creating, implementing and reviewing the overall strategy for Development of the Licensed Antibodies and Licensed Products (including the Global Regulatory Strategy) and the design and objectives of all Clinical Trials and non-clinical studies conducted under the Joint Development Plan;
(d) preparing the Global Regulatory Strategy for inclusion within the Joint Development Plan;
(e) facilitating the exchange of all regulatory information and data between the Parties and ensuring all regulatory reviews by and between the Parties are conducted in parallel (not sequentially) and on a Co-Detail Product-by-Co-Detail Product timely basis, upon receipt of ;
(f) reviewing and approving all Regulatory Documentation for the first Marketing Approval for such Co-Detail Product by a Party; Licensed Antibody or any Licensed Products in the Territory (other than (i) Pricing and Reimbursement Approvals and (bii) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to Clinical Trials under the terms of the Joint Independent Development and Co-Detail Agreement(sPlan), including for consistency with the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including Global Regulatory Strategy; (g) reviewing the regulatory documentation on Schedule 4.2.5 with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement;
4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to the conduct of development activities under a Joint the Independent Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.Plan;
Appears in 1 contract
Sources: Global Co Development and Co Commercialization Agreement (BioNTech SE)
Joint Development Committee. The As of the Effective Date, the Parties shall establish have established a joint Development, Medical Affairs, and regulatory committee (the “Joint Development Committee (Committee” or the “JDC”) promptly upon commencement ), composed of up to [ * ] representatives of each Party, to monitor and coordinate the Co-Detail Term for Development of, and Medical Affairs Activities connected with, the first Co-Detail Product, if anyCompound and Products at the operational level. Each JDC representative shall have knowledge and expertise in the clinical development of products similar to the Products. The purpose of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: in particular:
(a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt coordinate and monitor the Development activities of the first Marketing Approval for such Co-Detail Product by a Party; Parties under the GDP and oversee implementation of the GDP, and report to the JEC on all significant Development activities in the Collaborator Territory;
(b) with respect to all Co-Detail Products, upon provide a Change of Control of Tango. Subject to forum for and facilitate communications between the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports Parties with respect to the development Development of CoProducts in the Collaborator Territory and the Exelixis Territory, including sharing of Development information and Data in accordance with Section 4.7;
(c) review and approve for the Collaborator Territory Clinical Trial protocols, including investigator-Detail initiated and cooperative group clinical trial plans and protocols, and statistical analysis plans for Clinical Trials (and any amendments thereto);
(d) define areas of permissible scientific and medical inquiry and parameters for Phase 4 Clinical Trials in the Collaborator Territory;
(e) review Data resulting from Clinical Trials to determine if progression to additional Clinical Trials or submission of Regulatory Filings in the Collaborator Territory is warranted in terms of regulatory and scientific point of view;
(f) review and recommend amendments to the GDP (including the Development Budget) and propose the recommendation to JEC;
(g) provide a forum for Exelixis to provide Collaborator with a status report, at each regularly-scheduled meeting of the JDC, of any significant potential or proposed change(s) in any of Exelixis’ or its other Product licensee’s Development plans and activities that may [ * ] = 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. result in or require an amendment to the GDP, including any global clinical trial or study of the Product in which Collaborator may wish to participate;
(h) review the status of Product manufacturing and supply activities and strategies associated with Development;
(i) provide a forum for evaluation of Japanese regulatory actions, communications and submissions for the Compound and Products under a Joint Development the GDP, and Co-Detail Agreementpharmacovigilance and safety matters worldwide;
4.7.6 Preparing (j) establish joint working groups (such as clinical, regulatory and presenting updates safety working groups) as it deems necessary or appropriate to oversee the Umbrella Committee day-to-day management of different aspects of the Development work under the GDP;
(k) oversee and coordinate the material Medical Affairs Activities for the Product in all indications, which shall be subject to a Medical Affairs portion of the GDP and may be coordinated through a Medical Affairs working group established and overseen by the JDC;
(l) review and coordinate decisions related to research or Development of Products for new indications, characterization, and Development of [ * ] (if any); and
(m) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the conduct Development of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated Products, including endeavoring to resolve any disputes between the JDC under this Agreement, a Joint Development and Co-Detail AgreementParties arising from the deliberations of the JDC, or as otherwise directed by mutual written agreement of the PartiesJEC.
Appears in 1 contract
Sources: Collaboration and License Agreement (Exelixis, Inc.)
Joint Development Committee. (i) The Parties JDC will have the responsibility for the overall coordination and oversight of the Development activities for the Licensed Compounds and Licensed Products. As soon as practicable following the Effective Date (but in no event more than ten (10) days following the Effective Date), each Party shall establish designate its initial three (3) representatives on the JDC. Incyte shall appoint a Joint Development Committee person from among its representatives on the JDC to serve as the chairperson of the JDC. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (“A) calling meetings of the JDC”; (B) promptly preparing and issuing minutes of each such meeting within thirty (30) days thereafter (which minutes will be deemed approved unless any JDC member objects to the accuracy thereof (provided that any such objection shall have no bearing or effect on the effectiveness of any decisions made by Incyte in accordance with Section 3.5) within ten (10) days after receipt); (C) preparing and circulating an agenda for the upcoming meeting; and (D) ensuring that any decision-making delegated to the JDC is carried out in accordance with Section 3.5, including, as applicable, escalating any dispute to the JSC. The JDC shall automatically terminate (A) upon commencement the effectiveness of the exercise by Calithera of the Co-Detail Term Development Opt-Out Right or an Auto Opt-Out Event or (B) if there is no longer at least [ * ] Licensed Compound or Licensed Product being Developed under this Agreement.
(ii) The JDC shall have responsibility for (A) reviewing and approving the first Co-Detail ProductDevelopment Plan and Development Budget and each amendment thereto (in each case, if any. The purpose initial drafts of which shall be prepared by Incyte) and presenting them to the JSC for resolution of any dispute with respect thereto; (B) overseeing, reviewing and coordinating the conduct of activities under the Development Plan; (C) as applicable, overseeing, reviewing and coordinating the work being done under the Development Plan, including reviewing and discussing any reports provided by the Parties; (D) determining the assay for use in measuring the arginase inhibitory activity of any small molecule compound to determine whether such compound is an Arginase Inhibitor; provided that the initial assay shall be determined by the JDC will within [ * ] of [ * ] = 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. the Effective Date and may not thereafter be changed without the Parties’ written consent; (E) determining whether a Phase II Study is a Non-Authorized US Phase II Study; (F) [ * ]; (G) pursuant to coordinate Section 5.3(a) and 5.3(d), [ * ]; (H) discussing any material regulatory communications with and submissions to Regulatory Authorities with respect to Licensed Compounds and Licensed Products in the development of Hematology/Oncology Field in the Co-Detail Product(s). The JDC’s oversight shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt of the first Marketing Approval for such Co-Detail Product by a PartyTerritory; and (bJ) reviewing and approving any amendments to the Initial Preclinical Budget and Initial Preclinical Studies and presenting them to the JSC for resolution of any dispute with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement;
4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to the conduct of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Partiesthereto.
Appears in 1 contract
Sources: Collaboration and License Agreement (Calithera Biosciences, Inc.)
Joint Development Committee. The (a) Within [**] following the Effective Date, the Parties shall establish a Joint the JDC. The JDC shall:
(i) discuss and approve the Development Committee Plan and any proposed updates or amendments to the Development Plan (“JDC”including the addition of indications not set forth in the then-current Development Plan), and propose revisions to the Development Plan in accordance with Section 4.01 (Development in the Field in the Territory);
(ii) promptly upon commencement secure alignment of the Co-Detail Term for Licensee Entities’ Development of Licensed Products in the first Co-Detail Product, if any. The purpose Territory with Agios’ Development of the JDC will be to coordinate the development Licensed Products outside of the Co-Detail Product(s). The JDC’s oversight shall terminate: Territory;
(aiii) discuss and determine, with respect to each Global Study and on a Co-Detail Productan indication-by-Co-Detail Product indication basis, upon receipt whether to include clinical sites in the Territory in such Global Study and whether such Global Study shall be a Joint Global Study;
(iv) discuss and determine the clinical sites in the Territory to be included in each Local Study;
(v) discuss and approve the protocols for each Local Study and Joint Global Study;
(vi) discuss and determine the clinical sites in the Territory to be included in each Joint Global Study;
(vii) for each Joint Global Study, coordinate the operations of the first Marketing Approval for such Co-Detail Product by a Party; Agios Entities and (b) Licensee Entities with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject such Joint Global Study;
(viii) discuss and determine the contract research organizations in the Territory to be used for each Joint Global Study;
(ix) discuss and approve the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development Licensee Entities’ regulatory strategy for such Cothe Licensed Products in the Territory based on the then-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementcurrent Development Plan;
4.7.2 Reviewing (x) discuss and discussing each initial Joint Development and Coapprove Pre-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development Clinical Research activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Licensed Products under a Joint Development and Co-Detail Agreementthat any Licensee Entity wishes to conduct in the Territory;
4.7.6 Preparing and presenting updates (xi) provide a forum for the Parties to the Umbrella Committee share information with respect to the conduct Development of development the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Studies and Joint Global Studies in the Territory and commenting on Development activities under a Joint outside of the Territory and updates regarding interactions with Regulatory Authorities;
(xii) discuss and approve publications and publication plans as to the Development and Co-Detail AgreementCommercialization of Licensed Products in the Territory;
(xiii) discuss, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory;
(xiv) discuss and approve the content of any IND or Drug Approval Application for any Licensed Product in the Territory; and
4.7.7 Fulfilling (xv) perform such other responsibilities duties as may be allocated are specifically assigned to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Joint Development Committee. The Within [***] ([***]) days following the Effective Date, the Parties shall establish a Joint Development Committee (“the JDC”) promptly upon commencement of the Co-Detail Term for the first Co-Detail Product, if any. The purpose of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: shall:
(a) discuss the Preclinical Development Plan and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory);
(b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Territory with Frequency’s Development of the Licensed Products in the Frequency Territory;
(c) discuss, with respect to each clinical study and on a Co-Detail Productan indication-by-Co-Detail Product indication basis, upon receipt whether to include clinical sites in both Parties’ respective portions of the first Marketing Approval Territory and whether such study shall be a Joint Study or a Regional Study; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(d) discuss the clinical sites in the Territory to be included in each Joint Study;
(e) for such Co-Detail Product by a Party; each Joint Study, coordinate the operations of the Frequency Entities and (b) Astellas Entities with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the such Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementStudy;
4.7.2 Reviewing and discussing (f) discuss the contract research organizations in the Territory to be used for each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgetsStudy;
4.7.3 Overseeing (g) provide a forum for the execution of development activities pursuant Parties to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports share information with respect to the development Development of Co-Detail the Licensed Products under a in the Field, including reasonably detailed updates on progress and status of Regional Studies and Joint Studies in the Territory and updates regarding interactions with Regulatory Authorities;
(h) discuss publications and publication plans as to the Development and Co-Detail AgreementCommercialization of Licensed Products in the Territory;
4.7.6 Preparing (i) discuss, coordinate and presenting updates provide strategic guidance on the Development of the Licensed Products in the Field in the Territory;
(j) discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory;
(k) provide a forum for the Parties to the Umbrella Committee share and discuss GCP quality information with respect to each Party’s Development activities;
(l) discuss and establish a GCP Quality Plan within [***] ([***]) days following the conduct of development activities under a Joint Development and Co-Detail AgreementEffective Date;
(m) submit recommendations to the JSC regarding the matters set forth above; and
4.7.7 Fulfilling (n) perform such other responsibilities duties as may be allocated are specifically assigned to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Sources: License and Collaboration Agreement (Frequency Therapeutics, Inc.)
Joint Development Committee. The Within [**] following the Effective Date, the Parties shall establish the JDC. The JDC shall:
(a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Territory, or any clinical trial to be performed in whole or in part in the Territory, in each case, that is not set forth in the then-current Clinical Development Plan and is proposed by a Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the Clinical Development Plan, the JDC may approve converting such Local Trial into a Joint Global Trial;
(b) discuss the current Clinical Development Committee Plan and approve any updates or amendments to the Clinical Development Plan, including the addition of any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and discuss the use of any relevant diagnostic in the Territory;
(“JDC”c) promptly upon commencement monitor and discuss the alignment of Hutchmed Entities’ Development of Licensed Products in the Territory with Epizyme’s Development of the Co-Detail Term Licensed Products outside of the Territory, and discuss and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory;
(d) discuss whether Hutchmed shall participate in a global trial for the first Co-Detail ProductLicensed Product presented by Epizyme, which would include clinical sites both in the Territory and outside the Territory;
(e) discuss the clinical sites in the Territory to be included in each Local Trial and each Joint Global Trial;
(f) discuss the protocols for each Local Trial and Joint Global Trial and discuss the status and progress thereof;
(g) coordinate the operations of the Hutchmed Entities and Epizyme Entities with respect to Joint Global Trials;
(h) discuss the budget for the Joint Global Trials (and approve the budget for costs under Section 9.3(c)(iii)) to be conducted under this Agreement; provided that each Party shall solely determine the budget for its activities in its respective territory;
(i) discuss and approve the Permitted Subcontractors defined in Section 1.145(a), if any. The purpose of , that may be used for Joint Global Trials by Hutchmed in the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementTerritory;
4.7.2 Reviewing and discussing each initial Joint Development and Co(j) discuss Pre-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development Clinical Research activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development Licensed Products that any Hutchmed Entity wishes to conduct in the Territory, and discuss the status and progress of Co-Detail Products under a Joint Development and Co-Detail Agreementsuch activities;
4.7.6 Preparing and presenting updates (k) provide a forum for the Parties to the Umbrella Committee share information with respect to the conduct Development of development the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Trials and Joint Global Trials in the Territory and updates regarding interactions with Regulatory Authorities;
(l) coordinate plans and provide updates regarding attendance at conferences and congresses and interactions with key opinion leaders by the Parties, subject to Section 4.9;
(m) discuss the plans for any publication or presentation proposed by Hutchmed and related to the Development of Licensed Products, subject to Section 10.5(a);
(n) discuss the Hutchmed Entities’ Medical Affairs strategy for the Licensed Products in the Territory and take into account Epizyme’s Global Medical Affairs Strategy;
(o) discuss the Hutchmed Entities’ regulatory strategy for the Licensed Products in the Territory in the Field, including regulatory strategy for meetings with the Regulatory Authorities and the clinical and preclinical portions of the Drug Approval Application for the Licensed Product in the Territory;
(p) review and discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory (other than the chemistry, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC);
(q) discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide regular updates to the JDC;
(r) establish, within [**] after the establishment of the JDC, a Subcommittee to oversee and coordinate activities under a Joint Development and Co-Detail Agreementrelated to the 3▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, which Subcommittee shall meet [**] unless otherwise agreed; and
4.7.7 Fulfilling (s) determine whether to create any other Subcommittee, and perform such other responsibilities duties as may be allocated are specifically assigned to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Parties.
Appears in 1 contract
Sources: License Agreement (Epizyme, Inc.)
Joint Development Committee. The […***…] after the Effective Date, the Parties shall establish will form a Joint Development Committee joint development and regulatory committee (the “JDC”) promptly upon commencement to coordinate the overall strategy, plans, and responsibilities of the Co-Detail Term Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the first Co-Detail ProductParties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, if anyand to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. The purpose Except as otherwise provided herein, the role and responsibilities of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: are:
(a) on a Co-Detail Product-by-Co-Detail to oversee strategy, progress, and results with respect to Licensed Product basis, upon receipt of Development in the first Marketing Approval for such Co-Detail Product by a Party; and Field […***…];
(b) to review and approve the conduct by Mirati of any Development activities with respect to all Co-Detail Productsany Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementother than […***…];
4.7.2 Reviewing (c) to review and discussing each initial Joint approve the Development and Co-Detail Plan, with the understanding that the Initial Development Plan and Joint Development and Co-Detail Budget has been approved by the Parties, and any updates to any of the foregoing plans material amendments or budgetsrevisions thereto;
4.7.3 Overseeing the execution (d) to review and coordinate forecasting and supply of development activities pursuant BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 15 *** Confidential Treatment Requested
(e) to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budgetreview all material […***…];
4.7.4 Reviewing (f) to provide a forum for discussion of and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Productcoordinate interactions with Regulatory Authorities […***…];
4.7.5 Reviewing progress reports (g) to review any material Regulatory Filings with respect to the development of Co-Detail Products under a Joint Development and Co-Detail AgreementLicensed Product to be submitted to any Regulatory Authority […***…];
4.7.6 Preparing (h) to review and presenting updates discuss […***…];
(i) to discuss and provide a forum for the Umbrella Committee exchange of pharmacovigilance and safety matters;
(j) to provide a forum for discussion of and coordinate decisions related to […***…]; and
(k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and
(l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the conduct Development of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated to Licensed Products in the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the PartiesLicensed Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Mirati Therapeutics, Inc.)
Joint Development Committee. The Within [***] of the Effective Date or a period otherwise mutually agreed to by the Parties, the Parties shall establish will form a Joint Development Committee joint development and regulatory committee (the “JDC”) promptly upon commencement to coordinate the overall strategy, plans, and responsibilities of the Co-Detail Term Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the first Co-Detail ProductParties to review Development and regulatory matters pertaining to the Licensed Products in the Licensed Territory and outside the Licensed Territory, if anyand to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. The purpose Except as otherwise provided herein, the role and responsibilities of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: are:
(a) on a Co-Detail Product-by-Co-Detail Product basisto oversee strategy, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; progress, and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports results with respect to the development Development of Co-Detail Products under a Joint Development and Co-Detail Agreementthe Licensed Product in the Field in the Licensed Territory;
4.7.6 Preparing (b) to review and presenting updates to the Umbrella Committee discuss any material Development activities, including any Clinical Trials, with respect to any Licensed Product in the conduct of development activities under Field both in the Licensed Territory and outside the Licensed Territory;
(c) to review and approve the initial Clinical Development Plan and any material amendments or revisions to the Clinical Development Plan;
(d) to develop (but not approve): (i) for each Existing Global Study, the [***] enrollment allocation (the [***] Enrollment Allocation”) for each [***] in the Enrollment Period, and (ii) for each additional Global Study deemed a Joint Development Global Study (1) the Minimum Enrollment Threshold, and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may (2) if the Parties agree to include an obligation for Licensee to meet [***] Enrollment Allocations, the [***] Enrollment Allocation. Each [***] Enrollment Allocation shall be allocated to mutually agreed upon or amended in writing by the JDC under this AgreementParties, and for each additional Global Study deemed a Joint Global Study, the applicable Minimum Enrollment Threshold shall be mutually agreed upon in writing by the Parties;
(e) to review and coordinate forecasting and supply of Licensee’s expected requirements of Licensed Product for Development and Co-Detail Agreement, or by mutual written agreement purposes;
(f) to review all material Clinical Data obtained from Clinical Trials of the Parties.Compound and any Licensed Product in the Licensed Territory; (g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan;
Appears in 1 contract
Sources: Collaboration and License Agreement (Mirati Therapeutics, Inc.)
Joint Development Committee. The […***…] after the Effective Date, the Parties shall establish will form a Joint Development Committee joint development and regulatory committee (the “JDC”) promptly upon commencement to coordinate the overall strategy, plans, and responsibilities of the Co-Detail Term Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the first Co-Detail ProductParties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, if anyand to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. The purpose Except as otherwise provided herein, the role and responsibilities of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: are:
(a) on a Co-Detail Product-by-Co-Detail to oversee strategy, progress, and results with respect to Licensed Product basis, upon receipt of Development in the first Marketing Approval for such Co-Detail Product by a Party; and Field […***…];
(b) to review and approve the conduct by Mirati of any Development activities with respect to all Co-Detail Productsany Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle managementother than […***…];
4.7.2 Reviewing (c) to review and discussing each initial Joint approve the Development and Co-Detail Plan, with the understanding that the Initial Development Plan and Joint Development and Co-Detail Budget has been approved by the Parties, and any updates to any of the foregoing plans material amendments or budgetsrevisions thereto;
4.7.3 Overseeing the execution (d) to review and coordinate forecasting and supply of development activities pursuant BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 16 *** Confidential Treatment Requested
(e) to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budgetreview all material […***…];
4.7.4 Reviewing (f) to provide a forum for discussion of and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Productcoordinate interactions with Regulatory Authorities […***…];
4.7.5 Reviewing progress reports (g) to review any material Regulatory Filings with respect to the development of Co-Detail Products under a Joint Development and Co-Detail AgreementLicensed Product to be submitted to any Regulatory Authority […***…];
4.7.6 Preparing (h) to review and presenting updates discuss […***…];
(i) to discuss and provide a forum for the Umbrella Committee exchange of pharmacovigilance and safety matters;
(j) to provide a forum for discussion of and coordinate decisions related to […***…]; and
(k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and
(l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the conduct Development of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling such other responsibilities as may be allocated to Licensed Products in the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the PartiesLicensed Territory.
Appears in 1 contract
Sources: Collaboration and License Agreement (Mirati Therapeutics, Inc.)
Joint Development Committee. The Parties (a) Each Member shall establish appoint four (4) members of a joint development oversight and management committee (the “Joint Development Committee (Committee” or “JDC”). Gilead Sub shall appoint one (1) promptly upon commencement of the Co-Detail Term for the first Co-Detail Productmembers designated by Gilead Sub, if any. The purpose to serve as chairperson of the JDC will be to coordinate through the development first anniversary of the Co-Detail Product(s)Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The JDC’s oversight shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basisinitial JDC members and the chairperson are identified in Annex A hereto. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; and 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.
(b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms oversight of the Joint Development and Co-Detail Agreement(s)JEC, the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing JDC shall have the following powers and discussing development strategy duties: to (x) review and propose to the JEC for such Co-Detail its approval each annual update of the Development Plan and Development Budget and (y) review and approve each interim update of the Development Plan and Development Budget, in each case proposed pursuant to Section 3.7; to oversee and coordinate the Parties’ activities under the Development Plan; to oversee and manage matters relating to clinical supply of the Combination Product, including including, without limitation, Manufacturing requirements, inventory projections and inventory control; with the Alliance Managers, (x) to assist in coordinating scientific interactions between the Parties during the course of implementing the Development Plan and (y) to facilitate the exchange among the Parties of data, information, materials and results relating to clinical manufacturing, clinical trials, and communications and filings with Regulatory Authorities for the Combination Product (in each case solely to the extent that such data, information and materials are required to be exchanged among the Parties, or with respect to which indicationsone Member Party has the right to gain access from the other Member Party or the JV, markets pursuant to this Agreement or the Operating Agreement); to oversee regulatory matters for the JV, including, without limitation, approving all Combination Product Regulatory Documentation to the extent required pursuant to Section 3.4, overseeing Gilead’s activities as the JV’s liaison with Regulatory Authorities in the Territory, and populations overseeing the activities conducted pursuant to pursue the SDEA and matters other pharmacovigilance and safety reporting; to oversee the Member Parties’ activities pursuant to their respective Supply Agreements and to oversee and coordinate with the JCC with respect to life cycle management;
4.7.2 Reviewing matters relating to the monitoring of Manufacturing capacity, forecasts and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any orders for the active pharmaceutical ingredients of the foregoing plans or budgets;
4.7.3 Overseeing Combination Product; to resolve disputes between the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports Member Parties with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the development other Member Party with access to certain of Co-Detail Products under a Joint Development such Member Party’s records, documentation and Co-Detail Agreement;
4.7.6 Preparing data; to oversee medical affairs and presenting medical communications activities; to review and approve or reject proposals for Phase IV clinical studies of the Combination Product; to provide updates on the JDC’s activities and achievements to the Umbrella Committee with respect JEC each Calendar Quarter; and to the conduct of development activities under a Joint Development and Co-Detail Agreement; and
4.7.7 Fulfilling perform such other responsibilities functions as the Member Parties may be allocated mutually agree in writing from time to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of the Partiestime.
Appears in 1 contract
Joint Development Committee. The Within [****] ([****]) days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee (Committee” or the “JDC”), composed of [****] ([****]) promptly upon commencement representatives of each Party (or such other equal number of representatives from each Party as the CoParties may agree in writing from time-Detail Term for the first Coto-Detail Producttime), if any. The purpose of the JDC will be to coordinate the development Development of the Co-Detail Product(s)Compound and Licensed Products and Commercialization Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC’s oversight shall terminate: JDC shall:
(a) on serve as a Co-Detail Product-by-Co-Detail Product basis, upon receipt forum for discussing and supervising Development of the first Marketing Approval for such Co-Detail Product Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Sinovant with a Partyforum to disclose to Angion Sinovant’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Sinovant or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the Development Plan, including approving amendments and updates to the Development Plan, and (iii) coordinating the conduct of the Development activities;
(b) serve as a forum for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Sinovant with a forum to disclose to Angion Sinovant’s, or its Affiliates’ or Sublicensees’ Commercialization activities with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to Licensed Products in the terms of Territory; (ii) reviewing the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development Commercialization strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing Territory; (iii) reviewing the execution of development activities pursuant to each Joint Development and Co-Detail Commercialization Plan, including adherence approving amendments and updates to the associated Joint Development Commercialization Plan, and Co-Detail Budget(iv) coordinating the conduct of the Commercialization activities;
4.7.4 Reviewing (c) discuss intellectual property-related matters affecting, and discussing reimbursement strategy affected by, the foregoing and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products other activities under a Joint Development and Co-Detail this Agreement;
4.7.6 Preparing and presenting updates to (d) coordinate the Umbrella Committee with respect to the conduct of development Parties’ activities under a Joint Development and Co-Detail this Agreement; and
4.7.7 Fulfilling (e) perform such other responsibilities functions as are set forth herein or as the Parties may be allocated mutually agree in writing, except where in conflict with any provision of this Agreement unless such provision is first amended in accordance herewith in order to the avoid such conflict (including pursuant to such written agreement). The JDC under shall have only such powers as are expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, The JDC shall not have any right, power or authority: (i) to determine any issue in a Joint Development manner that would conflict [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED with the express terms and Co-Detail conditions of this Agreement, ; or by mutual written agreement (ii) to modify or amend the terms and conditions of the Partiesthis Agreement.
Appears in 1 contract
Joint Development Committee. (a) The Parties shall establish PARTIES agree to form a Joint Development Committee joint DEVELOPMENT COMMITTEE comprised of senior management of each PARTY (“JDCDEVELOPMENT COMMITTEE”) promptly upon commencement ). The PARTIES shall use COMMERCIALLY REASONABLE EFFORTS to have a meeting of the CoDEVELOPMENT COMMITTEE within forty-Detail Term five days after the EFFECTIVE DATE and thereafter once every CALENDAR QUARTER, or more frequently if mutually agreed upon by the PARTIES, (i) to discuss and coordinate clinical development plans for PRODUCTS, (ii) to update the first Co-Detail Productother PARTY on and discuss the design, if any. The purpose analysis plan, execution plan, timeline of any proposed clinical trial and any related proposal developed in accordance with the clinical development plans (provided however that the PHASE III CLINICAL TRIAL and any other existing ongoing clinical trials with respect to NUMAX and the liquid formulation of SYNAGIS will not be subject to discussion under this Section 6.6), (iii) to review and approve any proposed clinical trials of the JDC will be PRODUCTS in the TERRITORY consistent with Section 6.8, (iv) to coordinate the development strategy of submissions of the Co-Detail Product(s)REGULATORY FILINGS to REGULATORY AUTHORITIES in the TERRITORY with respect to NUMAX, (v) to review and approve or reject the publication of data and information with respect to the PRODUCTS as set forth in Section 6.11 and (vi) to provide updates of the status of and coordinate completion of the project to remove animal proteins from the working cell banks for the PRODUCT. The JDC’s oversight DEVELOPMENT COMMITTEE shall terminate: (a) on a Co-Detail Product-by-Co-Detail Product basis, upon receipt not make the decision to take any action or inaction which conflicts with or fails to conform to the applicable laws in any country in the TERRITORY. A deadlock with respect to any matter submitted to the DEVELOPMENT COMMITTEE shall be referred to the respective executive officers of the first Marketing Approval PARTIES for resolution, who shall have ten (10) business days to resolve the deadlock. If such Co-Detail Product executive officers are unable to resolve the deadlock, MEDIMMUNE shall have the final decision with respect to the deadlock. For clarity, no clinical trials for PRODUCTS will be initiated by a Party; and ▇▇▇▇▇▇ without approval of the DEVELOPMENT COMMITTEE.
(b) with respect to all CoMEDIMMUNE shall periodically, and at least semi-Detail Productsannually, upon a Change of Control of Tango. Subject submit comprehensive and complete reports to the terms DEVELOPMENT COMMITTEE, in MEDIMMUNE’s format, regarding activities undertaken by or on behalf of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports MEDIMMUNE with respect to the development of CoNUMAX, and specifically on activities and studies/trials undertaken by MEDIMMUNE pursuant to MEDIMMUNE’s development plan for NUMAX, including their progress, status and outcome as well as major findings and major decision points, as applicable, so as to keep the DEVELOPMENT COMMITTEE fully advised of MEDIMMUNE’s development activities with respect to NUMAX.
(c) ▇▇▇▇▇▇ shall periodically, and at least semi-Detail Products under a Joint Development annually, submit comprehensive and Co-Detail Agreement;
4.7.6 Preparing and presenting updates complete reports to the Umbrella Committee DEVELOPMENT COMMITTEE, in ▇▇▇▇▇▇’▇ format, regarding activities previously approved by the DEVELOPMENT COMMITTEE and undertaken by or on behalf of ▇▇▇▇▇▇ with respect to the conduct development of NUMAX, including their progress, status and outcome as well as major findings and major decision points, as applicable, so as to keep the DEVELOPMENT COMMITTEE fully advised of ▇▇▇▇▇▇’▇ development activities under a Joint Development and Co-Detail Agreement; andwith respect to NUMAX.
4.7.7 Fulfilling such other responsibilities as may be allocated (d) Notwithstanding anything in this Section 6.6 to the JDC under this Agreementcontrary, a Joint Development following approval of NUMAX by the REGULATORY AUTHORITIES in the MAJOR MARKETS the PARTIES shall meet from time to time to review and Co-Detail Agreement, or by mutual written agreement revise as necessary the obligations of the PartiesDEVELOPMENT COMMITTEE to meet regularly and to receive regular reports (but any such changes will not, in any event, affect the responsibilities of the DEVELOPMENT COMMITTEE set forth in this AGREEMENT).
Appears in 1 contract
Joint Development Committee. The Within [***] days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee (Committee” or the “JDC”), composed of [***] representatives of S▇▇▇▇ (if S▇▇▇▇ elects to participate) promptly upon commencement and [***] representatives of the Co-Detail Term for the first Co-Detail ProductEverest, if any. The purpose of the JDC will be to coordinate the development Development and Commercialization of the Co-Detail Product(s)Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, S▇▇▇▇ has the right but not the obligation to participate in the JDC. The JDC’s oversight shall terminate: JDC shall:
(a) on serve as a Co-Detail Product-by-Co-Detail Product basis, upon receipt forum for discussing Development of the first Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities;
(b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities;
(c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities;
(d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Approval for such Co-Detail Product by a PartyAuthorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (biii) coordinating the conduct of the Development activities;
(e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’ Commercialization activities with respect to all Co-Detail ProductsLicensed Products in the Territory; (ii) reviewing the Commercialization strategy for the Territory; (iii) reviewing the Commercialization Plan and, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), with the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Productapproval, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and making any updates to any of the foregoing plans amendments or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports with respect to the development of Co-Detail Products under a Joint Development and Co-Detail Agreement;
4.7.6 Preparing and presenting updates to the Umbrella Committee with respect to Commercialization Plan; and (iv) coordinating the conduct of development the Commercialization activities;
(f) coordinate the activities of S▇▇▇▇ and Everest under a Joint Development and Co-Detail this Agreement; and
4.7.7 Fulfilling (g) perform such other responsibilities functions as are set forth herein or as the Parties may be allocated mutually agree in writing, except where in conflict with any provision of this Agreement. The JDC shall have only such powers as are expressly assigned to the JDC under it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, the JDC shall not have any right, power or authority: (i) to determine any issue in a Joint Development manner that would conflict with the express terms and Co-Detail conditions of this Agreement, ; or by mutual written agreement (ii) to modify or amend the terms and conditions of the Partiesthis Agreement.
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Joint Development Committee. The Within [***] of the Effective Date or a period otherwise mutually agreed to by the Parties, the Parties shall establish will form a Joint Development Committee joint development and regulatory committee (the “JDC”) promptly upon commencement to coordinate the overall strategy, plans, and responsibilities of the Co-Detail Term Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the first Co-Detail ProductParties to review Development and regulatory matters pertaining to the Licensed Products in the Licensed Territory and outside the Licensed Territory, if anyand to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. The purpose Except as otherwise provided herein, the role and responsibilities of the JDC will be to coordinate the development of the Co-Detail Product(s). The JDC’s oversight shall terminate: are:
(a) on a Co-Detail Product-by-Co-Detail Product basisto oversee strategy, upon receipt of the first Marketing Approval for such Co-Detail Product by a Party; progress, and (b) with respect to all Co-Detail Products, upon a Change of Control of Tango. Subject to the terms of the Joint Development and Co-Detail Agreement(s), the JDC’s specific responsibilities are as follows:
4.7.1 Reviewing and discussing development strategy for such Co-Detail Product, including with respect to which indications, markets and populations to pursue and matters with respect to life cycle management;
4.7.2 Reviewing and discussing each initial Joint Development and Co-Detail Plan and Joint Development and Co-Detail Budget and any updates to any of the foregoing plans or budgets;
4.7.3 Overseeing the execution of development activities pursuant to each Joint Development and Co-Detail Plan, including adherence to the associated Joint Development and Co-Detail Budget;
4.7.4 Reviewing and discussing reimbursement strategy and medical affairs strategy for such Co-Detail Product;
4.7.5 Reviewing progress reports results with respect to the development Development of Co-Detail Products under the Licensed Product in the Field in the Licensed Territory;
(b) to review and discuss any material Development activities, including any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory and outside the Licensed Territory;
(c) to review and approve the initial Clinical Development Plan and any material amendments or revisions to the Clinical Development Plan;
(d) to develop (but not approve): (i) for each Existing Global Study, the [***] enrollment allocation (the [***] Enrollment Allocation”) for each [***] in the Enrollment Period, and (ii) for each additional Global Study deemed a Joint Development Global Study (1) the Minimum Enrollment Threshold, and Co-Detail Agreement(2) if the Parties agree to include an obligation for Licensee to meet [***] Enrollment Allocations, the [***] Enrollment Allocation. Each [***] Enrollment Allocation shall be mutually agreed upon or amended in writing by the Parties, and for each additional Global Study deemed a Joint Global Study, the applicable Minimum Enrollment Threshold shall be mutually agreed upon in writing by the Parties;
4.7.6 Preparing (e) to review and presenting updates coordinate forecasting and supply of Licensee’s expected requirements of Licensed Product for Development purposes;
(f) to review all material Clinical Data obtained from Clinical Trials of the Umbrella Committee Compound and any Licensed Product in the Licensed Territory; [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
(g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan;
(h) to review all material Reference Data Controlled by a Party and generated or produced in connection with any Development activities conducted for any Licensed Product in the Licensed Territory and outside the Licensed Territory;
(i) to provide a forum for discussion of and coordinate interactions with Regulatory Authorities in the Licensed Territory and outside the Licensed Territory;
(j) to review any material Regulatory Filings with respect to the conduct Licensed Products to be submitted to any Regulatory Authority in the Licensed Territory;
(k) to review and discuss any proposals from Mirati regarding any Additional Global Studies;
(l) to discuss and provide a forum for the exchange of development activities under pharmacovigilance and safety matters prior to commercial launch of the Licensed Product;
(m) to provide a Joint forum for discussion of and coordinate decisions related to research and Development of new Indications, new Licensed Product formulations, and Co-Detail AgreementCombined Therapy Development; and
4.7.7 Fulfilling (n) to perform such other responsibilities functions as the Parties may be allocated allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the JDC under this Agreement, a Joint Development and Co-Detail Agreement, or by mutual written agreement of Licensed Products in the PartiesLicensed Territory.
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