Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review report to the JSC on all significant Commercialization activities in the Licensee Territory, including implementation of the Commercialization Plan, and recommend on the activities of the JCC;
(b) review, discuss and approve the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Licensee Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and report to the JEC on all significant Commercialization activities in the Collaborator Territory;(ii) would be competitively harmful if publicly disclosed.
(bc) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Licensee Territory and the Exelixis Territory;
(cd) on an annual basis, discuss review and establish Collaboratorapprove Licensee’s Minimum Commercial Performance thresholds Sales Forecast prepared pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercializationwell as any corrective plans submitted thereunder;
(e) review and approve any recommendation by Licensee not to launch (or to significantly delay the launch of) any Product in any country of the Licensee Territory;
(f) review and discuss the major findings of CollaboratorLicensee’s market research with respect to any Product in the Collaborator Licensee Territory, if any;
(fg) provide input to the JDC on the global publication strategy with respect to the Products and implement such strategy under supervision of the JDC once it has been established;
(h) review and oversee the branding and product positioning strategy for Products in the Collaborator Licensee Territory;
(i) establish pricing corridors for Products in the Licensee Territory and evaluate Collaborator’s brand strategy for the Product in purpose of reimbursement and potential international pricing reference by relevant Regulatory Authorities;
(j) define and coordinate medical messaging worldwide with respect to the Collaborator Territory for consistency Products;
(k) oversee and facilitate the Parties’ communications and activities with the then-current respect to publications under Section 14.4;
(l) design a global brand strategy for the ProductLicensee Territory (e.g., a four-year brand plan, resource plan, , etc.) and submit such strategy to the JSC for review and approval;
(gm) discuss Product list price and status coordinate the manufacture and supply of reimbursement in the Collaborator TerritoryProducts to Licensee for Commercial use; and
(hn) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECJSC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As At least [***] prior to the first anticipated Regulatory Approval of any Licensed Product in the Effective DateLicensed Territory, the Parties have established will form a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”)) to coordinate the overall strategy, composed plans, and responsibilities of up the Parties, facilitate communication between the Parties and provide a forum for the Parties to [ * ] representatives of each Party, review matters pertaining to monitor and discuss the Commercialization of Licensed Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization Field in the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of products similar to Products. The the JCC shall in particularwill be to:
(a) review discuss strategy, progress, and recommend the Commercialization Plans and related activities results with respect to the Licensed Product Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities Field in the Collaborator Licensed Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to review the Commercialization of Products in the Collaborator Territory Plan and the Exelixis Territoryoversee implementation thereof;
(c) on an annual basis, discuss and establish Collaborator’s Minimum review the date of anticipated First Commercial Performance thresholds pursuant Sale of such Licensed Product in the PRC provided by Licensee to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.JCC;
(d) if Mirati exercises the Co-Commercialization Option, (i) review, comment and approve [***], (ii) review and approve the status amount [***] shall pay to [***] for Co-Commercialization activities performed by [***] in addition to [***], and (iii) review and oversee the coordination of material Product manufacturing and supply Co-Commercializing activities and strategies associated with Commercializationto be conducted by the Parties;
(e) solely to the extent that Mirati is supplying Licensee with Compound or Licensed Product for Commercialization purposes, review and discuss the major findings coordinate forecasting and supply of CollaboratorLicensee’s market research with respect to any expected requirements of Compound and Licensed Product in the Collaborator Territory, if anyfor such Commercialization purposes;
(f) review discuss and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy provide a forum for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the exchange of pharmacovigilance and safety matters following commercial launch of Licensed Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as the Parties may be deem appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between Licensed Product in the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECLicensed Territory.
Appears in 1 contract
Samples: Collaboration and License Agreement (Mirati Therapeutics, Inc.)
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review report to the JSC on all significant Commercialization activities in the Licensee Territory, including implementation of the Commercialization Plan, and recommend on the activities of the JCC;
(b) review, discuss and approve the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Licensee Territory;
(bc) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Licensee Territory and the Exelixis Territory;
(cd) on an annual basis, discuss review and establish Collaboratorapprove Licensee’s Minimum Commercial Performance thresholds Sales Forecast prepared pursuant to Section 6.3(b6.3(c) and propose recommendation to JEC; [ * ] = 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercializationwell as any corrective plans submitted thereunder;
(e) review and approve any recommendation by Licensee not to launch (or to significantly delay the launch of) any Product in any country of the Licensee Territory;
(f) review and discuss the major findings of CollaboratorLicensee’s market research with respect to any Product in the Collaborator Licensee Territory, if any;
(fg) provide input to the JDC on the global publication strategy with respect to the Products and implement such strategy under supervision of the JDC once it has been established;
(h) review and oversee the branding and product positioning strategy for Products in the Collaborator Licensee Territory;
(i) establish pricing corridors for Products in the Licensee Territory and evaluate Collaborator’s brand strategy for the Product in purpose of reimbursement and potential international pricing reference by relevant Regulatory Authorities;
(j) define and coordinate medical messaging worldwide with respect to the Collaborator Territory for consistency Products;
(k) oversee and facilitate the Parties’ communications and activities with the then-current respect to publications under Section 14.4;
(l) design a global brand strategy for the ProductLicensee Territory (e.g., a four-year brand plan, resource plan, , etc.) and submit such strategy to the JSC for review and approval;
(gm) discuss Product list price and status coordinate the manufacture and supply of reimbursement in the Collaborator TerritoryProducts to Licensee for Commercial use; and
(hn) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECJSC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As of Within [***] after the Effective Date, the Parties have established shall establish a joint commercialization committee (the “Joint Commercialization Committee” Committee (or the “JCC”), composed ) as a subcommittee of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to ProductsJSC. The JCC shall have an initial term of [***] and shall [***] for successive [***]. The JCC shall have only the powers assigned expressly to it in particularthis Section 3.9 and elsewhere in this Agreement, and the JCC shall not have any power to amend, modify or waive compliance with this Agreement. The JCC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Commercialization of Licensed Products. The role of the JCC shall be to:
(a) review review, discuss and recommend coordinate the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Licensed Products in the Collaborator Territory and the Exelixis Territory;
(c) Parties’ respective territories; [***] Certain information on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, page has been omitted and filed separately with the Securities and Exchange Commission pursuant Commission. Confidential treatment has been requested with respect to Rule 24b-2 the omitted portions.
(b) develop, update and annually approve a global plan for Commercializing the Licensed Product, which plan shall include the strategy for the Commercialization of the Securities Exchange Act Licensed Product on a worldwide basis, certain shared global Commercialization activities (i.e., [***]), and, subject to mutual written agreement of 1934the Parties, as amended.the appropriate allocation of responsibilities and, if applicable, [***] for such activities;
(c) oversee the implementation of the global plans for the branding and Commercialization of the Licensed Product and ensure consistency with the global plan for Commercialization of the Licensed Product;
(d) review and discuss [***] and developments with regards to the status of material Product manufacturing Licensed Product, as described in Section 6.5, and supply activities and strategies associated with Commercializationestablish a strategy for obtaining Pricing Approvals for the Licensed Product;
(e) review and discuss facilitate the major findings sharing of Collaborator’s market research with respect information between the Parties as necessary to any Product in support the Collaborator Territory, if any;
(f) review and oversee Commercialization of the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Licensed Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(hf) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of ProductsAgreement, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed mutually determined by the JECParties.
Appears in 1 contract
Samples: Collaboration Agreement (Takeda Pharmaceutical Co LTD)
Joint Commercialization Committee. As of Within [***] after the Effective Date, the Parties have established shall establish a joint commercialization committee (the “Joint Commercialization Committee” Committee (or the “JCC”), composed ) as a subcommittee of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to ProductsJSC. The JCC shall have an initial term of [***] and shall [***] for successive [***]. The JCC shall have only the powers assigned expressly to it in particularthis Section 3.9 and elsewhere in this Agreement, and the JCC shall not have any power to amend, modify or waive compliance with this Agreement. The JCC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Commercialization of Licensed Products. The role of the JCC shall be to:
(a) review review, discuss and recommend coordinate the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Licensed Products in the Collaborator Territory Parties’ respective territories;
(b) develop, update and annually approve a global plan for Commercializing the Exelixis TerritoryLicensed Product, which plan shall include the strategy for the Commercialization of the Licensed Product on a worldwide basis, certain shared global Commercialization activities (i.e., [***]), and, subject to mutual written agreement of the Parties, the appropriate allocation of responsibilities and, if applicable, [***] for such activities;
(c) on an annual basis, discuss oversee the implementation of the global plans for the branding and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) Commercialization of the Licensed Product and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately ensure consistency with the Securities and Exchange Commission pursuant to Rule 24b-2 global plan for Commercialization of the Securities Exchange Act of 1934, as amended.Licensed Product;
(d) review and discuss [***] and developments with regards to the status of material Product manufacturing Licensed Product, as described in Section 6.5, and supply activities and strategies associated with Commercializationestablish a strategy for obtaining Pricing Approvals for the Licensed Product;
(e) review and discuss facilitate the major findings sharing of Collaborator’s market research with respect information between the Parties as necessary to any Product in support the Collaborator Territory, if any;
(f) review and oversee Commercialization of the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Licensed Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(hf) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of ProductsAgreement, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed mutually determined by the JECParties.
Appears in 1 contract
Joint Commercialization Committee. As At a time to be determined by the JSC but in no event later than the commencement of the Effective Datefirst filing of an MAA in the ALFRESA Territory, the Parties have established shall establish a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * [***] representatives of each Party, to monitor and discuss the Commercialization of Products in the Field in the ALFRESA Territory at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) report to the JSC on significant Commercialization activities by ALFRESA in the ALFRESA Territory;
(b) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territoryactivities;
(bc) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis ALFRESA Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with CommercializationCommercialization in the ALFRESA Territory;
(e) review and discuss the major findings of CollaboratorXXXXXXX’s market research with respect to any Product in the Collaborator ALFRESA Territory, if any;
(f) review and oversee discuss the branding and product positioning strategy for Products in the Collaborator ALFRESA Territory and evaluate CollaboratorXXXXXXX’s brand strategy for the Product in the Collaborator ALFRESA Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator ALFRESA Territory; and;
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of ProductsProducts in the ALFRESA Territory, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECJSC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Silverback Therapeutics, Inc.)
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the [ * ] = 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. Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review report to the JSC on all significant Commercialization activities in the Licensee Territory, including implementation of the Commercialization Plan, and recommend on the activities of the JCC;
(b) review, discuss and approve the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Licensee Territory;
(bc) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Licensee Territory and the Exelixis Territory;
(cd) on an annual basis, discuss review and establish Collaboratorapprove Licensee’s Minimum Commercial Performance thresholds Sales Forecast prepared pursuant to Section 6.3(b) as well as any corrective plans submitted thereunder;
(e) review and propose approve any recommendation by Licensee not to JEClaunch (or to significantly delay the launch of) any Product in any country of the Licensee Territory;
(f) review and discuss the major findings of Licensee’s market research with respect to any Product in the Licensee Territory;
(g) provide input to the JDC on the global publication strategy with respect to the Products and implement such strategy under supervision of the JDC once it has been established;
(h) review and oversee the branding and product positioning strategy for Products in the Licensee Territory;
(i) establish pricing corridors for Products in the Licensee Territory for the purpose of reimbursement and potential international pricing reference by relevant Regulatory Authorities;
(j) define and coordinate medical messaging worldwide with respect to the Products;
(k) oversee and facilitate the Parties’ communications and activities with respect to publications under Section 14.4;
(l) design a global brand strategy for the Licensee Territory (e.g., a four-year brand plan, resource plan, , etc.) and submit such strategy to the JSC for review and approval;
(m) discuss and coordinate the manufacture and supply of the Products to Licensee for Commercial use; and [ * ] = 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(hn) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECJSC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As (a) At least [*] months prior to the anticipated filing of the Effective Datefirst NDA/MAA in the Territory, the Parties have established will establish a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The primary role of the JCC shall in particular:
(a) review be to exchange information and recommend coordinate the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the support and Commercialization of the Licensed Products in the Collaborator Territory Field in the Territory.
(b) Effective as of the date of the initial approval from the FDA for the Licensed Product in the U.S., the JCC shall become responsible for approving the [*] and [*] by Schering for the Licensed Product in the U.S. The JCC will also provide a forum for discussing U.S. [*] and coordinating the U.S. medical education activities by the Parties, which will include discussion of [*] and the Exelixis Territory;[*] to obtain Novacea’s input. Notwithstanding the foregoing, the JCC will not have any decision making authority with respect to any matters in the Territory related to [*] and [*] (including [*]),[*], or the content of [*].
(c) on an annual basisSchering will have decision making authority with respect to all aspects of the Commercialization of the Licensed Product in the ROW, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant shall keep Novacea reasonably informed with respect to Section 6.3(b) and propose recommendation such activities through periodic reports to JEC; [ * the JCC. [*] = Certain confidential information contained in this documentCERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, marked by bracketsMARKED 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 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 amendedAS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(d) review [*] shall appoint a chairperson of the status JCC from among its members. The chairperson shall be responsible for setting the agenda for, and calling and leading meetings of material Product manufacturing the JCC. Any member of the JCC may request that items be added to the agenda for discussion. The secretary of the meeting, as designated by the chairperson, shall prepare and supply activities distribute meeting minutes to all members of the JCC. Minutes of each JCC meeting shall be approved or disapproved, and strategies associated with Commercialization;revised as necessary, at the next meeting. Final minutes of each meeting shall be distributed to the members of the JCC by the chairperson.
(e) review and discuss the major findings The JCC shall have [*] of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;representatives from each Party.
(f) review and oversee the branding and product positioning strategy for Products Novacea’s membership in the Collaborator Territory JCC shall be at its sole discretion as a matter of right and evaluate Collaborator’s brand strategy not obligation for the Product sole purpose of participation in information sharing and coordination with respect to Commercialization activities. At any time prior to disbanding of the JCC pursuant to Section 7.1(g) below, Novacea shall have the right to withdraw from participation in the Collaborator Territory for consistency JCC upon thirty (30) days’ prior written notice to Schering, which notice shall be effective upon expiration of such thirty (30) day period (“Withdrawal Notice”). Following the issuance of a Withdrawal Notice and subject to this Section 7.1(f): (i) the JCC shall be disbanded; (ii) Schering shall have the right to make the final decision on all matters previously within the scope of authority of the JCC; (iii) in its sole discretion, Schering may terminate its funding obligations with the then-current global brand strategy for the respect to Novacea MSLs and, in such case, Novacea MSLs shall cease activities related to Licensed Product;; and (iv) Schering may, in its sole discretion, replace existing Novacea MSLs with Schering MSLs.
(g) discuss Product list price and status The JCC shall be automatically disbanded upon the earlier of reimbursement (i) termination of the Royalty Term in the Collaborator Territory; and
U.S. or (hii) perform such other functions as may be appropriate to further the purposes discontinuation of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed MSL support by the JECNovacea.
Appears in 1 contract
Samples: License Agreement (Novacea Inc)
Joint Commercialization Committee. As (i) The Program 1 JCC shall oversee Commercialization of Program 1 Products worldwide. At least [*] prior to anticipated NDA filing of a Program 1 Product in the United States, each Party shall designate its initial [*] representatives on the Program 1 JCC. A representative of Incyte shall act as the chairperson of the Effective Date, Program 1 JCC. The chairperson shall not have any greater authority than any other representative on the Parties have established a joint commercialization committee Program 1 JCC and shall conduct the following activities of the Program 1 JCC: (A) calling meetings of the “Joint Commercialization Committee” or the “Program 1 JCC”), composed of up to [ * ] representatives ; (B) preparing and issuing minutes of each Partysuch meeting within [*] thereafter; (C) preparing and circulating an agenda for the upcoming meeting; and (D) ensuring that any decision-making delegated to the Program 1 JCC is carried out in accordance with Section 3.5. The Program 1 JCC shall automatically terminate if Program 1 Product terminated or dropped from this Agreement.
(ii) The Program 1 JCC shall be responsible for: (A) overseeing, to monitor reviewing and discuss coordinating the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Program 1 Products in the Collaborator TerritoryField worldwide; (B) discussing, and report if agreed pursuant to Section 7.4(a), developing and overseeing the JEC on all significant Commercialization activities in the Collaborator Territory;
Global Branding Strategy; (bC) provide a forum for setting overall strategic objectives and facilitate communications and coordination between the Parties with respect plans related to the Commercialization of the Program 1 Products in the Collaborator Territory Field in each of the United States and the Exelixis Incyte Territory;
, consistent with the Parties’ rights under this Agreement and Section 7.2(a); (cD) reviewing Commercialization issues for the Program 1 Products in the Incyte Territory that will have an impact on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(bCommercialization of the Program 1 Products in the United States; (E) and propose recommendation to JEC; [ * reviewing Commercialization issues for the Program 1 Products in the United States that will [*] = Certain confidential information contained in this document, marked by brackets, document 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested Under 17 C.F.R.§§ 200.80(b)(4) and 240-24b-2 have an impact on Commercialization of Products, including endeavoring to resolve any disputes between the Program 1 Products in the Incyte Territory; (F) providing a forum for the Parties arising from to discuss the deliberations Commercialization of the JCC, Program 1 Products in the Field worldwide; and (G) such other responsibilities as may be assigned to the Program 1 JCC pursuant to this Agreement or as otherwise directed may be mutually agreed upon by the JECParties from time to time.
Appears in 1 contract
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.;
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As At least [***] prior to the first anticipated Regulatory Approval of any Licensed Product in the Effective DateLicensed Territory, the Parties have established will form a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”)) to coordinate the overall strategy, composed plans, and responsibilities of up the Parties, facilitate communication between the Parties and provide a forum for the Parties to [ * ] representatives of each Party, review matters pertaining to monitor and discuss the Commercialization of Licensed Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization Field in the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of products similar to Products. The the JCC shall in particularwill be to:
(a) review discuss strategy, progress, and recommend the Commercialization Plans and related activities results with respect to the Licensed Product Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities Field in the Collaborator Licensed Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to review the Commercialization of Products in the Collaborator Territory Plan and the Exelixis Territoryoversee implementation thereof;
(c) on an annual basis, discuss and establish Collaborator’s Minimum review the date of anticipated First Commercial Performance thresholds pursuant Sale of such Licensed Product in the PRC provided by Licensee to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.JCC;
(d) if Mirati exercises the Co-Commercialization Option, (i) review, comment and approve [***], (ii) review and approve the status amount [***] shall pay to [***] for Co-Commercialization activities performed by [***] in addition to [***], and (iii) review and oversee the coordination of material Product manufacturing and supply Co-Commercializing activities and strategies associated with Commercialization;to be conducted by the Parties; [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
(e) solely to the extent that Mirati is supplying Licensee with Compound or Licensed Product for Commercialization purposes, review and discuss the major findings coordinate forecasting and supply of CollaboratorLicensee’s market research with respect to any expected requirements of Compound and Licensed Product in the Collaborator Territory, if anyfor such Commercialization purposes;
(f) review discuss and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy provide a forum for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the exchange of pharmacovigilance and safety matters following commercial launch of Licensed Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as the Parties may be deem appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between Licensed Product in the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECLicensed Territory.
Appears in 1 contract
Joint Commercialization Committee. As of At a time to be determined by the Effective DateJSC, the Parties have established shall establish a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of an equal number of up to [ * ] four (4) representatives of each Party, to monitor and discuss oversee the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise Product in the commercialization of products similar to ProductsField in and outside the Territory. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC JSC on all significant Commercialization activities by VIT in the Collaborator TerritoryMajor Market Countries and by ChemoCentryx in the U.S., including on the implementation of the Commercialization Plan of VIT for the Major Market Countries, and on activities of the JCC;
(b) review and discuss the initial Commercialization Plan of VIT for the Major Market Countries and all proposed amendments to such Commercialization Plan, for submission to the JSC;
(c) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products the Product in the Collaborator Territory Field in and outside the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.
(d) review discuss any VIT decision not to launch (or to significantly delay the status of material launch of) the Product manufacturing in a particular country in the Territory based on Pricing and supply activities and strategies associated with CommercializationReimbursement Approval;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the global branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(gf) discuss provided VIT has exercised the CKD Option in accordance with Section 2.10(a) and the Parties have entered into a Co-Promotion Agreement in accordance with Section 2.10(b), coordinate the Parties’ Co-Promotion of the Product list price and status of reimbursement in the Collaborator TerritoryU.S. after Regulatory Approval of the Product in CKD in the U.S.; and
(hg) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Productsthe Product in the Field in and outside the Territory, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JECJSC. For clarity, the JCC will not have any decision-making authority with respect to the Commercialization of the Product in the Territory.
Appears in 1 contract
Samples: Collaboration and License Agreement (ChemoCentryx, Inc.)
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:: [ * ] = 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.
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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.;
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the [ * ] = 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. Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
: (a) review report to the JSC on all significant Commercialization activities in the Licensee Territory, including implementation of the Commercialization Plan, and recommend on the activities of the JCC; (b) review, discuss and approve the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Licensee Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
; (bc) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Licensee Territory and the Exelixis Territory;
; (cd) on an annual basis, discuss review and establish Collaboratorapprove Licensee’s Minimum Commercial Performance thresholds Sales Forecast prepared pursuant to Section 6.3(b) as well as any corrective plans submitted thereunder; (e) review and propose approve any recommendation by Licensee not to JEClaunch (or to significantly delay the launch of) any Product in any country of the Licensee Territory; (f) review and discuss the major findings of Licensee’s market research with respect to any Product in the Licensee Territory; (g) provide input to the JDC on the global publication strategy with respect to the Products and implement such strategy under supervision of the JDC once it has been established; (h) review and oversee the branding and product positioning strategy for Products in the Licensee Territory; (i) establish pricing corridors for Products in the Licensee Territory for the purpose of reimbursement and potential international pricing reference by relevant Regulatory Authorities; (j) define and coordinate medical messaging worldwide with respect to the Products; (k) oversee and facilitate the Parties’ communications and activities with respect to publications under Section 14.4; (l) design a global brand strategy for the Licensee Territory (e.g., a four-year brand plan, resource plan, , etc.) and submit such strategy to the JSC for review and approval; (m) discuss and coordinate the manufacture and supply of the Products to Licensee for Commercial use; and [ * ] = 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.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Appears in 1 contract
Samples: Collaboration and License Agreement