Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilities: (a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities; (b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory; (c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5. (d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory; (e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory; (f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year; (g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products; (h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory; (i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory; (j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory; (k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and (l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 5 contracts
Sources: Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)
Responsibilities. The JDCC JSC shall be responsible for overseeing the Development serve as a forum to share Know-How and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality learnings from each of the foregoingInhaled Collaboration and Vaccines Collaboration. Specifically, the JDCC shall have the following responsibilitiesJSC shall:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving provide oversight over the Collaboration Program and providing facilitate communication and discussion between the Committee Parties with respect to the Parties sales reports pertaining Collaboration Program; Confidential treatment has been requested with respect to Coportions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(ii) ensure that each of the JVRC and JIRC be kept informed of data and Know-Developed Products in How generated under each of the Co-Developed TerritoryInhaled Plan and Vaccines Plan, respectively, that may have broad applicability or usefulness to both the Vaccines Plan and Inhaled Plan;
(jiii) approving review and approve amendments to the Inhaled Plan and Vaccines Plan and all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryassociated budgets;
(kiv) reviewing discuss and approving resolve any ingredients disputes relating to the Collaboration Program, including any disputed matter referred from the JVRC or JIRC;
(v) from time to time but no more often than quarterly during the JSC Term, in consultation with the JIRC, JVRC and JPC, discuss research that are therapeutically has been conducted by UNC and Consultant under the UNC Research Agreement, the UNC Material Transfer Agreement and the Consulting Agreement in the Liquidia Respiratory Field, the Inhaled Field or biologically active that are proposed by either Party for inclusion with a Co-Developed Product Delivery Vaccine Field, as well as outside the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field that is expected to create relate to General Biological Effects, and review results, University Inventions and other inventions generated by all such research. Notwithstanding the foregoing, discussion of research shall occur more often than quarterly as required for GSK to review such research reasonably prior to publication thereof;
(vi) from time to time but no more often than quarterly during the JSC Term, in consultation with the JIRC, JVRC and JPC, review and approve any research to be conducted by Third Parties under agreements between Third Parties and UNC (which agreements may or may not include Liquidia as a Combination Productparty) using PRINT or PRINT Materials supplied by Liquidia in the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field, including the intellectual property provisions of such agreements, in accordance with Section 5.7;
(vii) from time to time but no more often than quarterly during the JSC Term, in consultation with the JIRC, JVRC and JPC, discuss research that has been conducted by Third Parties under agreements between Third Parties and UNC (which agreements may or may not include Liquidia as a party) using PRINT or PRINT Materials supplied by Liquidia outside the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field that is expected to relate to General Biological Effects, and review results and inventions generated by all such research, to the extent Liquidia becomes aware of such research results. Notwithstanding the foregoing, discussion of research shall occur more often than quarterly as required for GSK to review such research reasonably prior to publication thereof;
(viii) review and discuss manufacturing and supply requirements and obligations related to PRINT Materials, Research Materials and Research Products. Such discussion shall include matters related to any anticipated delay in manufacturing and supply of PRINT Materials and Research Materials, and the impact of such delay on the conduct of the Inhaled Plan or Vaccine Plan. The Parties shall also discuss whether such delay shall be addressed by an extension of the Inhaled Collaboration Term or Vaccine Collaboration Term or a manufacturing technology transfer as described in Section 5.2(c)(i); provided, that the technology transfer described in Section 5.2(c)(i) shall occur only if the Parties agree that such Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. transfer would be more likely to decrease the delay of conducting the Inhaled Plan or Vaccine Plan than allowing Liquidia to cure such delay in supply;
(ix) track expenses against agreed budgets as set forth in the Vaccine Plan and Inhaled Plan; and
(lx) performing perform such activities other functions as may be delegated to the JDCC pursuant to this Agreement, or agreed by mutual written agreement of the Parties after the Approval Datein writing.
Appears in 5 contracts
Sources: Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc)
Responsibilities. The JDCC Joint Steering Committee shall be responsible for overseeing ---------------- perform the following functions:
(a) Manage and oversee the Development and Commercialization of Co-Developed the Collaboration Products in the Co-United States pursuant to the terms of this Agreement;
(b) Review and approve the U.S. Development Territory. Without limiting Plans and the generality U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing Plans;
(c) Coordinate Development and Commercialization of the foregoing, Collaboration Products in the JDCC shall have the following responsibilities:
(a) the development and discussion of strategies for ROW with the Development and Commercialization of each Co-Developed Product the Collaboration Products in the Co-United States with appropriate liaison with the Joint Development Territory, including allocation of responsibilities for such Development Committee and Commercialization activitiesthe Joint Marketing Committee;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing At each meeting of the Joint Steering Committee, review a comparison of actual Development Expenses and providing input in Marketing Expenses for the preparation United States to the budgeted Development Expenses and Marketing Expenses for the United States for the year-to-date, as current as practicable to a date immediately prior to the date of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territorymeeting;
(e) reviewing Review and providing input on approve the short-term and long-term sales forecasts for Co-Developed Products in progress of the Co-Developed Territoryother committees;
(f) presenting sales forecasts Review and approve the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Yeartrademarks selected under Section 2.4;
(g) coordinating Review and approve "go/no-go" decisions and other matters referred to the Detailing efforts Joint Steering Committee, including, without limitation, the continued Development of both Parties in a particular Collaboration Product or the Co-Development Territory with respect to Co-Developed inclusion of Additional Products;
(h) overseeing all recallsLife cycle management of, market withdrawals and any other corrective actions related to Co-Developed intellectual property protection for, the Collaboration Products in the Co-Development TerritoryUnited States;
(i) receiving Approve any and providing to the Parties sales reports pertaining to Co-Developed Products all ** policies and ** in the Co-Developed Territory** for Collaboration Products, including **;
(j) approving all Third Parties to be engaged In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;other committees; and
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing Have such activities other responsibilities as may be delegated assigned to the JDCC Joint Steering Committee pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after from time to time. ** = Certain information on this page has been omitted and filed separately with the Approval DateCommission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 5 contracts
Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)
Responsibilities. The JDCC Joint Steering Committee shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(ai) Oversee the development and discussion of strategies for the Development and Commercialization of each Co-Developed the Licensed Product in the CoTerritory pursuant to the terms of this Agreement. Have joint approval of, designs and protocols (if any) as well as internal publication plans and primary publications of clinical and nonclinical studies featuring a Licensed Product (e.g., publications for major international peer-Development reviewed journals and conferences);
(ii) At each meeting of the Joint Steering Committee, review Net Sales for the year-to-date as available;
(iii) Coordinate and monitor regulatory strategy and activities for the Licensed Product in the Territory in accordance with Article VIII;
(iv) Review and approve the trademarks selected under Section 2.06;
(v) Discuss the state of the markets for the Licensed Product in the Territory and opportunities and issues concerning the Commercialization of the Licensed Product in the Territory, including allocation consideration of responsibilities for such Development marketing and Commercialization activitiespromotional strategy, marketing research plans, labeling and Licensed Product positioning;
(bvi) reviewing Life cycle management of, and discussing a Marketing and Sales Plan for each Co-Developed intellectual property protection for, the Licensed Product in the Co-Development Territory;
(cvii) coordinating At each meeting of the Development and Joint Steering Committee, review the status of the major Commercialization efforts of both Parties in activities related to the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Licensed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productresults therefrom; and
(lviii) performing Have such activities other responsibilities as may be delegated assigned to the JDCC Joint Steering Committee pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after from time to time. Notwithstanding the Approval Dateforegoing, Clinigen (and not the Joint Steering Committee) shall have the authority to establish and adjust pricing, develop go-to-market strategies and develop and implement marketing processes. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 4 contracts
Sources: Commercialization Agreement, Commercialization Agreement (Theravance Biopharma, Inc.), Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The JDCC shall be responsible for overseeing JSC will oversee and supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality overall performance of the foregoing, the JDCC shall have the following responsibilitiesCollaboration Plan and within such scope will:
(ai) Periodically review the development Parties’ efforts and discussion of strategies for progress under the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCollaboration Plan;
(bii) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in Review the Co-Development TerritoryCollaboration Program;
(ciii) coordinating Review any proposed modifications or amendments to the Collaboration Plan and the Collaboration Program;
(iv) Prioritize and oversee execution of specific activities to be performed under the Collaboration Plan and the Collaboration Program;
(v) Review Patent Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vi) Review Collaboration Program Advisory Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vii) Review and select Product Candidates for additional work as part of the Collaboration Program; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(viii) Review and evaluate Product Candidates for which Development work should be performed as part of the Collaboration Program;
(ix) Review and Commercialization efforts approve of both Parties in the Co-Development Territory regulatory plans and strategies for Product Candidates;
(x) Review all Regulatory Filings with respect to CoProduct Candidates;
(xi) Form such other committees (“Sub-Developed ProductsCommittees”) as the JSC may deem appropriate. For purposes of clarityAs soon as practicable (but not later than sixty (60) days) after the Effective Date, the JDCC shall not be responsible for coordinating communications with Regulatory AuthoritiesParties will establish a Sub-Committee comprised of three (3) representatives of Celgene, which is the sole responsibility three (3) representatives of Bluebird, and ▇▇. ▇▇▇▇▇▇, however, ▇ ▇▇▇▇▇▇ . Brenner (the “Collaboration Program Advisory Committee”). The Collaboration Program Advisory Committee will work directly with a regulatory liaison monitor and advise the Parties on the conduct and progress of the Collaboration Program. Each Party may replace its representatives on the Collaboration Program Advisory Committee at any time upon written notice to the other Party. Any such Sub-Committee (including the Collaboration Program Advisory Committee) may make recommendations to the JSC but may not be designated by Enanta on coordinating key regulatory FDA communications on Codelegated JSC decision-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territorymaking authority;
(exii) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Address such other matters relating to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts activities of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by under this Agreement as either Party to provide Representatives to Co-Promote Co-Developed Products in may bring before the Co-Developed Territory;
(k) reviewing and approving JSC, including any ingredients matters that are therapeutically or biologically active that are proposed by either Party expressly for inclusion with a Co-Developed Product the JSC to create a Combination Productdecide as provided in this Agreement; and
(lxiii) performing such activities as may be delegated Attempt to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Dateresolve any disputes on an informal basis.
Appears in 3 contracts
Sources: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Responsibilities. The JDCC Joint Supply Committee shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform ---------------- the following responsibilitiesfunctions:
(a) Manage and oversee the development activities in relation to manufacture and discussion supply of strategies API Compound and Collaboration Products for the use in Development and Commercialization of each Co-Developed and establish procedures and protocols for testing API Compound and Collaboration Products to ensure that such API Compound and Collaboration Products comply with the specifications (the "Testing ------- Protocol"). The Parties will utilize such Testing Protocol with respect to API -------- Compound and Collaboration Product in the Co-Development Territory, including allocation of responsibilities for that they may receive from Product Suppliers to ensure that such Development and Commercialization activitiesAPI Compound or Collaboration Product meets specifications;
(b) reviewing Recommend and discussing a Marketing and Sales Plan coordinate necessary adjustments to the manufacturing schedule to ensure it is meeting the needs for each Co-Developed Product in the Co-Development Territoryall Collaboration Products;
(c) coordinating the Development and Commercialization efforts Coordinate allocation of both Parties API Compound in the Co-Development Territory with respect to Co-Developed Products. For purposes event of claritya shortage between the United States and the ROW, the JDCC shall not be responsible for coordinating communications with Regulatory Authoritiesit being understood that, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territoryevent of a shortage, allocation of API Compound shall be as follows: (i) requirements for use in ** for Commercialization in the ** shall have first priority; (ii) requirements for use in ** for Commercialization in the ** shall have second priority; (iii) requirements for use in ** (other than **) in the ** shall have third priority; (iv) requirements for use in ** (other than **) for Commercialization in the ** shall have fourth priority; and (v) requirements for use in all other ** containing API Compound shall have fifth priority. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep The foregoing priority allocations may be revised by the JDCC informed Joint Supply Committee based on the relative commercial value of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.such **;
(d) Review the quality of the manufacture of the Collaboration Products, reviewing as appropriate reports of the manufacturers of API Compound and providing input in Collaboration Products and reports as to the preparation quality of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in any packaging that bears the Co-Development Territoryrelevant trademarks or housemarks of the Parties (as owned by or licensed to the relevant Party under Section 2.4) as prescribed by this Agreement;
(e) reviewing Recommend and providing input on the short-term implement optimal inventory levels and long-term sales forecasts for Co-Developed Products in the Co-Developed Territorysafety stock targets;
(f) presenting sales forecasts Set improvement targets and the results of all efforts in the Co-Development Territory to the JSC as neededmonitor performance against these targets for cost, but no less often than two (2) times per Calendar Yearyield, delivery and other appropriate measures;
(g) coordinating Establish guidelines to facilitate improved efficiencies and compliance with current Good Manufacturing Practices by Product Suppliers; and ** = Certain information on this page has been omitted and filed separately with the Detailing efforts of both Parties in the Co-Development Territory Commission. Confidential treatment has been requested with respect to Co-Developed Products;the omitted portions.
(h) overseeing all recalls, market withdrawals and any Have such other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities responsibilities as may be delegated assigned to the JDCC Joint Supply Committee pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 3 contracts
Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)
Responsibilities. The JDCC CCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development TerritoryPromotion Activities. Without limiting the generality of the foregoingforegoing and except as otherwise specified in a Co-Promotion Agreement, the JDCC CCC shall have the following responsibilities:
(a) the development and discussion of strategies for the Development promotion and Commercialization marketing of each Co-Developed Promoted Product to the Co-Promotion Target Audience in the Co-Development Promotion Territory, including allocation of responsibilities for such Development and Commercialization activitiesCo-Promotion Activities;
(b) reviewing and discussing a Marketing and Sales implementing the Product Commercialization Plan for each with respect to the Co-Developed Promotion Activities for the Co-Promoted Product in the Co-Development Promotion Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Promoted Products in the Co-Developed Promotion Territory;
(fd) presenting sales forecasts and the results of all Commercialization efforts for Co-Promoted Products in the Co-Development Promotion Territory to the JSC Parties as needed, but no less often than two four (24) times per Calendar Year;
(ge) coordinating the Detailing efforts of both Parties with respect to the Co-Promotion Target Audience in the Co-Development Promotion Territory with respect to Co-Developed Promoted Products;
(hf) overseeing providing a forum for discussing all recalls, market withdrawals and any other corrective actions related to Co-Developed Promoted Products in the Co-Development Promotion Territory;
(ig) receiving and providing to the Parties sales reports with respect to the Co-Promotion Target Audience pertaining to Co-Developed Promoted Products in the Co-Developed Promotion Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(lh) performing such activities as may be delegated to the JDCC CCC pursuant to this Agreement, in any Co-Promotion Agreement or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 3 contracts
Sources: Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development TerritoryJSC may discharge its responsibilities through one or more subcommittees. Without limiting the generality of the foregoingThe JSC’s responsibilities will include, without limitation, the JDCC shall have the following responsibilitiesfollowing:
(a) the development and discussion overseeing implementation of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesPlan;
(b) reviewing and discussing evaluating progress under the Development Plan (including compliance with the Development Budget contained therein and payment arrangements) on a Marketing quarterly basis and Sales Plan for each Co-Developed Product in advising the Co-Development TerritoryParties as to any necessary amendments thereto;
(c) coordinating allocating and assigning Development activities in the Development and Commercialization efforts Plan between the Parties, consistent with the terms of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Agreement;
(d) reviewing approving (or establishing procedures to approve) protocols for pre-clinical studies and providing input in the preparation Clinical Trials for Development of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryCollaboration Products;
(e) reviewing making modifications to and providing input on the shortperforming quarterly monitoring of progress of pre-term clinical studies and long-term sales forecasts Clinical Trials and proposing additional studies for Co-Developed Products in the Co-Developed TerritoryCollaboration Products;
(f) presenting sales forecasts reviewing and the results of all efforts in the Co-Development Territory approving any proposed modifications to the JSC Development Plan, including advising the Parties as needed, but no less often than two (2) times per Calendar Yearto whether a Back-Up Compound should be developed in lieu of a Collaboration Compound;
(g) coordinating the Detailing efforts Manufacture of both Parties in the Co-Development Territory with respect to Co-Developed Productsglobal supplies of a Collaboration Compound and Collaboration Product for (i) Clinical Trials and (ii) Commercialization;
(h) overseeing all recalls, market withdrawals reviewing and any other corrective actions related commenting on Regulatory Submissions relating to Co-Developed Products in the Co-Development TerritoryCollaboration Products;
(i) receiving and providing facilitating the exchange of all data, information, material or results relating to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryDevelopment of Collaboration Products;
(j) approving all Third Parties establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Pharmacovigilance Agreement to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products entered into in the Co-Developed Territoryaccordance with Section 4.3.5;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Cofacilitating the transfer of Know-Developed Product How pursuant to create a Combination Product; andthis Agreement;
(l) developing a strategy for performing Translational Research Activities and Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as may are contemplated under this Agreement and that the Parties mutually agree shall be delegated the responsibility of the Joint Steering Committee. Notwithstanding the foregoing, in no event shall the JSC or any subcommittee of the JSC have the authority to (i) reduce or expand the JDCC pursuant to this Agreement, or by mutual written agreement obligations of the Parties after the Approval Dateunder this Agreement; (ii) determine that a breach has occurred under this Agreement; (iii) waive a Party’s rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in this Agreement as being made by one or both Parties.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Hutchison China MediTech LTD), License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The JDCC Patent Committee shall perform the following functions, subject to the final decision-making authority of the Person set forth in Section 4.3.6: (a) discuss material issues and provide input to each other regarding the Prosecution and Maintenance of Jounce Patents, Celgene Patents, Collaboration Patents and Joint Collaboration Patents, including recommending whether or not to file a Collaboration Patent in all Core Countries; (b) serve as a forum for exchanging information and facilitating discussions regarding patentability and freedom to operate assessments; and (c) perform such other responsibilities as CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. may be mutually agreed by the Parties from time to time, including those matters identified in Sections 7.2 to 7.8. The Patent Committee shall be responsible for overseeing coordinating the Development and Commercialization implementation of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilities:
(a) the development and discussion of each Party’s strategies for the protection of the foregoing intellectual property rights related to Pre-LO Targets, Collaboration Targets, Collaboration Candidates, Development Candidates and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Diagnostic Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, the Patent Committee shall not have any authority beyond the specific matters set forth in this would Section 4.3.4, and in particular shall not apply have any power to routine regulatory submissions amend, modify, interpret or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep waive the JDCC informed terms of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-this Agreement or any Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this & Commercialization Agreement, or to alter, increase, expand or waive compliance by mutual written agreement of a Party with, a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the Parties Patent Committee’s authority arises, the Patent Committee shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the Approval Datematter is first brought to the Patent Committee’s attention (or, if earlier, at the next regularly scheduled Patent Committee meeting).
Appears in 2 contracts
Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)
Responsibilities. The JDCC JDC shall be responsible for overseeing the Development and Commercialization by the Parties of Co-Developed Products Development Candidates in the Co-Development Territory; provided, that, any such Development is consistent with the global Development Plan for each such Co-Developed Development Candidate, for which MERCK ultimately bears responsibility. Without limiting the generality of the foregoing, the JDCC JDC shall have the following responsibilities:
(a) preparing or directing the development preparation and discussion recommending to the JSC for its approval of strategies for the an Annual Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product Development Candidate in the Co-Development Territory;
(cb) coordinating monitoring the Development activities of, and Commercialization efforts reconciling issues between, the Parties with respect to the Parties’ respective share of both Parties in the Co-Development Territory Costs and Co-Development Regulatory Costs incurred with respect to Co-Developed Products. For purposes Development Candidates; Portions of clarity, this Exhibit were omitted and have been filed separately with the JDCC shall not be responsible for coordinating communications Secretary of the Commission pursuant to to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
(c) preparing or directing the preparation of and approving amendments to JSC-approved Annual Development Plans with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison respect to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed Development Candidates as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling it deems appropriate in furtherance of the objectives of the Development Program as set forth in the CoAnnual Development Plan and, if any member of the JDC asserts that any such JDC-Developed Territory. For clarityapproved amendment would change the objectives of such Annual Development Plan, this would not apply submitting such amendment to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.JSC for its consideration;
(d) reviewing and providing input in monitoring the preparation progress of a Marketing and Sales each Annual Development Plan containing a Co-Promotion Plan for each with respect to Co-Developed Product in the Co-Development TerritoryCandidates and of each Party’s activities thereunder;
(e) reviewing and providing input on a forum for consensual decision making with respect to the short-term and long-term sales forecasts for Development of Co-Developed Products Development Candidates;
(f) reviewing data, reports or other information submitted by either Party with respect to work conducted in the Development of Co-Developed Development Candidates affecting the Co-Developed Territory;
(fg) presenting sales forecasts and the results of all efforts in the Co-Development Territory to preparing for the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating on at least a semi-annual basis a progress report for the Detailing efforts Development of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products Development Candidates in the Co-Development Territory;
(i) receiving reasonable detail and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination ProductJSC such additional information as it may request; and
(lh) performing such activities as may be delegated to the JDCC JDC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(ai) oversee the development preparation and discussion implementation of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of Plans; Confidential treatment requested by ▇▇▇▇▇▇, however▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ will work directly Squibb Biologics Company and ImClone Systems Incorporated.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(iv) discuss the state of the markets for Products in the Territory and opportunities and issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the Marketing Plans;
(v) review and approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy for the Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the JCC, review a regulatory liaison comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xiii) review and approve the general guidelines applicable to particular Products to be designated followed by Enanta on coordinating key regulatory FDA communications on Co-Developed Products ERS in its development of promotional materials and will keep Enanta’s liaison informed as promotional activities to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling be used by ERS and the Company in the Co-Developed promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance ;
(xv) review and approve the joint publication strategy together with FDA guidelines. the PDC; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and milestone meetings as specified in Section 4.5.5ImClone Systems Incorporated.
(dxvi) reviewing evaluate and providing input in determine the preparation existence or non-existence of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Problem referred to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties JCC in the Co-Development Territory accordance with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination ProductSection 5.6(e); and
(lxvii) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 2 contracts
Sources: Development, Promotion, Distribution and Supply Agreement (Bristol Myers Squibb Co), Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc/De)
Responsibilities. The JDCC JSC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesfor:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving reviewing and providing approving the initial Global Development Plan prepared by the JDC, including all budgets relating to development activities to be conducted by MERRIMACK hereunder;
(ii) periodically reviewing the Global Development Plan and suggesting or approving such updates or amendments to the Parties sales reports pertaining to Global Development Plan as the JSC deems appropriate, including all budget amendments;
(iii) as long as MERRIMACK does not opt out of Co-Developed Products in Promotion, reviewing and approving the initial Commercialization Plan for the Co-Developed TerritoryPromoted Product(s) prepared by the JCC, including all budgets;
(jiv) approving all Third Parties to be engaged by either Party to provide Representatives to as long as MERRIMACK does not terminate Co-Promote Co-Developed Products in Promotion, periodically reviewing the Commercialization Plan for the Co-Developed TerritoryPromoted Product(s) and suggesting or approving such updates or amendments to such Commercialization Plan as the JSC deems appropriate, including all budget amendments;
(kv) reviewing providing overall strategic direction with respect to research, development, regulatory and approving manufacturing activities conducted under the Global Development Plan, and with respect to commercialization activities conducted under the Commercialization Plan (if any);
(vi) overseeing the JDC and, if applicable, the JCC, and the Parties’ progress in the conduct of activities under the Global Development Plan and the Commercialization Plan (if any) hereunder;
(vii) establishing a projected Marketing Authorization application filing date for the United States (“US Filing Date”) for each Licensed Product, which planned US Filing Date may be periodically updated by the JSC based on its reasonable assessment of the clinical progress of such Licensed Product;
(viii) keeping MERRIMACK apprised, through MERRIMACK’s representatives on the JSC, of the planned US Filing Date for each Licensed Product, including any ingredients updates thereto;
(ix) attempting to resolve disputes arising under this Agreement that are therapeutically referred to the JSC by the JDC, JCC or biologically active that are proposed by either of the Parties (for clarity, the JSC shall not have the authority to resolve disputes between the Parties regarding whether a Party for inclusion with a Co-Developed Product to create a Combination Producthas fulfilled or breached any obligation under this Agreement); and
(lx) performing such activities other tasks and undertaking such other responsibilities as may be delegated to the JDCC pursuant to set forth in this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc), License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Responsibilities. The JDCC JMC shall be responsible for overseeing the Development and Commercialization Co-Promotion of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC JMC shall have the following responsibilities:
(a) preparing or directing the development preparation of a Co-Development Marketing and discussion of strategies Sales Plan containing a Co-Promotion Plan and a brand plan for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including such Plan to include allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each approving all Additional Co-Developed Product in the Co-Development TerritoryPromotion Activities to be conducted by either Party pursuant to Section 5.7;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the preparing short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Development Territory;
(fd) presenting sales forecasts and the results of all Co-Promotion efforts in the Co-Development Territory to the JSC as needed, but no less often than two four (24) times per Calendar Year;
(ge) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(hf) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(ig) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Development Territory;
(jh) approving all consulting the Parties in the selection of Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Development Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(li) performing such activities as may be delegated to the JDCC JMC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 2 contracts
Sources: Collaborative Development and License Agreement (Immunogen Inc), Collaborative Development and License Agreement (Immunogen Inc)
Responsibilities. The JDCC Research Committee shall be responsible for overseeing supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality execution of the foregoingResearch Plan and administer the Funded Project, the JDCC and its responsibilities shall have the following responsibilitiesinclude, without limitation:
(a) To periodically review whether there is need to amend or supplement the development Research Plan and discussion to recommend changes thereto to the Steering Committee, as may be reasonably required to meet the goals of strategies the Research Plan and the Collaboration; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the Development information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;Exchange Commission.
(b) reviewing To recommend to the Steering Committee changes in assays and discussing a Marketing validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Sales Plan for each Co-Developed Product in the Co-Development TerritoryPreferred Mode of Use;
(c) coordinating To recommend to the Development Steering Committee amendments, modifications and Commercialization efforts supplements to the Research Plan, and changes to validation criteria of both Parties Collaboration Hit Homologs Special Collaboration Hits and Preferred Modes of Use;
(d) At least sixty (60) days prior to the commencement of each Collaboration Year, to review and approve, subject to final approval by the Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the Steering Committee shall automatically constitute an amendment to and part of the Research Plan;
(e) To discuss ways for Monsanto to assist the gene discovery and identification of Preferred Modes of Use processes, such as by providing Evogene with certain know-how and Monsanto Data, including to periodically review whether there is need to supplement the [* * *] set forth in [* * *] ([* * *]) and to [* * *] to the Co-Development Territory Steering Committee, as may be reasonably required to meet the goals of the Research Plan and the Collaboration;
(f) To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each party as set forth in Sections 2.8.1 and 2.8.2) and to review and amend the format of the parties’ reports, as may be reasonably required in order to enable the Research Committee to monitor the parties’ performance of their respective Diligence Obligations;
(g) To discuss, at a general level, information provided on Collaboration Hit Homologs and Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to Cothe validation of the Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Use in the Monsanto Pipeline;
(h) To receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and to discuss information provided by Evogene on Internal Non-Developed ProductsField Hits which underwent the Core Validation and met the Validated Hit criteria as set forth in Section 4.2.2; *** Confidential treatment has been requested for redacted portions of this exhibit. For purposes This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of claritythis exhibit has been provided separately to the Securities and Exchange Commission.
(i) To review issues relating to Publications resulting from the activities conducted under the Collaboration, in accordance with Section 2.10;
(j) To keep a record of the JDCC shall not be responsible for coordinating communications with Regulatory AuthoritiesCollaboration Hit Sets, which is the sole responsibility of Special Collaboration Hits, PlaNet Genes, PlaNet ▇▇▇▇ ▇▇▇▇▇▇, howeverRePack Recommendations and GeneDex Recommendations licensed to Monsanto hereunder, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products termination of any such license in accordance with the Co-Development Territory;
terms of this Agreement (i) receiving and providing to For the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving avoidance of doubt, all Third Parties to GeneSpec Genes, including those that are Homologs of Collaboration Hits, shall be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryrecorded as such);
(k) reviewing To meet no less than annually to discuss field trial results;
(l) To approve amendments to Evogene Project Hits, as contemplated by Section 1.72;
(m) To approve the use of Collaboration Hit Homologs and approving PlaNet Gene Homologs for Model Plant Validation, as contemplated by Sections 1.134, 5.2.3, 5.2.4(b), 5.2.6(b), 5.4.3(a)(ii), 5.4.3(a)(iv), 5.5.3(a)(ii), 5.5.3(a)(iv) and 5.5;
(n) To amend the forms of Exhibits I, J and Q, pursuant to Sections 2.8.1, 2.8.2 and 5.12.4;
(o) To approve assays for model plant validation of certain Special Collaboration Hits pursuant to Section 4.2.1(a)(v);
(p) To make any ingredients that are therapeutically or biologically active that are proposed other decisions expressly assigned to the Research Committee by either Party for inclusion with a Co-Developed Product to create a Combination Productthis Agreement; and
(lq) performing To exercise such activities additional responsibilities as may be delegated to the JDCC pursuant to this Agreement, or Research Committee by mutual written agreement of the Parties after the Approval DateSteering Committee.
Appears in 2 contracts
Sources: Collaboration Agreement (Evogene Ltd.), Collaboration Agreement (Evogene Ltd.)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving Develop and providing subsequently review and make decisions relating to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryCommercialization Plan including a budget for PSMM Expenses;
(jii) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in Oversee implementation of the Co-Developed TerritoryCommercialization Plan, throughout the Calendar Year, including managing the budget for PSMM Expenses;
(kiii) reviewing Discuss the markets for Product in the Territory and approving opportunities and issues concerning Commercialization of Product, including consideration of marketing and promotional strategy, marketing research plans, labelling, Product positioning and Product profile, including [***];
(iv) Oversee and coordinate the sales efforts of the Parties;
(v) Review and make decisions regarding post-Initial Indication Approval Development activities, taking into consideration the appropriateness of any ingredients that are therapeutically or biologically active that are proposed Development activities including line extensions, Clinical Trials for purposes of new indications and Phase IV Clinical Trials in the context of the overall marketing and promotional strategy for Product;
(vi) Review and direct all indigent care use of Product;
(vii) Support the review of and approve Manufacturing, sales and prescription forecasts of Product;
(viii) Review data and reports arising from and generated in connection with Commercialization of Product under the Commercialization Plan, market research studies, actual Product sales, Product prescription trends and Product sales forecasts;
(ix) At each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Commercialization Plan, with such information covering a time period ending as closely as practicable to the date of the meeting;
(x) Review and approve the general guidelines applicable to Product Commercialization to be followed in the development of promotional materials and promotional activities to be used by either Party for inclusion the Parties in the co-promotion of Product;
(xi) Lead the review and direct Product publication strategy, in consultation with a Co-Developed Product the PDC;
(xii) Following review and approval by the Parties’ internal promotional materials review committees, review and approve packaging and related materials, prior to create a Combination Productany commercial use; and
(lxiii) performing Have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 2 contracts
Sources: Collaboration Agreement (Allergan Inc), Collaboration Agreement (MAP Pharmaceuticals, Inc.)
Responsibilities. The JDCC JCC shall be responsible perform the following functions:
(i) oversee the preparation and implementation of the Marketing Plans; Squibb Biologics Company and ImClone Systems Incorporated.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(iv) discuss the state of the markets for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting Territory and opportunities and issues concerning the generality commercialization of the foregoingProducts, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the JDCC shall have priority for same and the following responsibilities:
(a) amount and kind of marketing and selling effort appropriate, in accordance with the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesMarketing Plans;
(bv) reviewing review and discussing a Marketing and Sales Plan for each Coapprove Non-Developed Product Registrational Studies, taking into consideration the appropriateness in the Cocontext of the overall marketing and promotional strategy for the Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-Development to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xiii) review and approve the general guidelines applicable to particular Products to be followed by ERS in its development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(cxv) coordinating review and approve the Development and Commercialization efforts of both Parties in joint publication strategy together with the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of PDC; Confidential treatment requested by ▇▇▇▇▇▇, however▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co▇▇-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings Squibb Biologics Company and milestone meetings as specified in Section 4.5.5ImClone Systems Incorporated.
(dxvi) reviewing evaluate and providing input in determine the preparation existence or non-existence of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Problem referred to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties JCC in the Co-Development Territory accordance with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination ProductSection 5.6(e); and
(lxvii) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement
Responsibilities. The JDCC Subject to oversight by the JSC, the Joint Development Committee shall be responsible for overseeing oversee and supervise the Development of the Named Compounds and Commercialization of Co-Developed corresponding Licensed Products in the Co-Development Territory. Without limiting the generality of the foregoingU.S. In addition, the JDCC it shall have perform the following responsibilitiesfunctions:
(a) Manage and oversee the development preparation and discussion implementation of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesPlans;
(b) reviewing Review and discussing a Marketing approve updates and Sales Plan for each Co-Developed Product in amendments to the Co-Development TerritoryPlans;
(c) coordinating Approve the Development strategy, regulatory strategy, formulation and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of claritymanufacturing process development strategy, the JDCC shall not be responsible and protocols for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated Clinical Studies as such strategies and protocols are proposed by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Pfizer;
(d) reviewing Review and providing input coordinate regulatory activities to be undertaken by the Parties in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;accordance with ARTICLE 8.
(e) reviewing and providing input on If the short-term and long-term sales forecasts for Co-Developed Products Parties are sharing Net Profit/Net Loss, at each meeting of the Joint Development Committee, review a comparison of actual Development Costs to the budgeted Development Costs in the CoDevelopment Plan for the Calendar Year-Developed Territoryto-date, as current as practicable to a date immediately prior to the date of the meeting;
(f) presenting sales forecasts Review and the results of all efforts in the Co-Development Territory recommend to the JSC as needed, but no less often than two (2) times per Calendar YearJoint Steering Committee “go/no-go” decisions for Development of the Licensed Products;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory Review activities conducted, if any, by a Party with respect to Co-Developed Productsadditional indications for Named Compounds and activities conducted, if any, related to Unnamed Compounds;
(h) overseeing all recalls, market withdrawals Manage and any other corrective actions related to Co-Developed Products in oversee the Co-Development Territory;execution of the Manufacturing Transfer; and
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing Have such activities other responsibilities as may be delegated assigned to the JDCC Joint Development Committee pursuant to this AgreementAgreement or as may be mutually agreed upon by the Parties from time to time. For clarity, and without limiting the foregoing, the JDC shall not have decision-making authority regarding the exercise of a New Collaboration Compound Option, Additional Indication Proposal, or by mutual written agreement of any development plans for Unnamed Compounds. Rather, the Parties after JDC shall only provide the Approval Datenon-developing Party a forum at which to review and comment upon research and development plans and results for Unnamed Compounds and to review Additional Indication Proposals.
Appears in 1 contract
Responsibilities. The JDCC USJCC shall be responsible for overseeing the Development conduct and progress of the Co-Commercialization of each Co-Developed Products Commercialized Licensed Product in the Co-Development Commercialization Territory. Without limiting the generality of the foregoing, the JDCC USJCC shall have the following responsibilities:
(a) the development serving as a forum for sharing information of, and discussion of strategies for the Development and Commercialization of discussing each Co-Developed Product Commercialization Plan for Co-Commercialized Licensed Products in the Co-Development Commercialization Territory, including allocation of responsibilities for such Development and Commercialization activitiesamendments thereto;
(b) reviewing determining style guidelines and discussing a Marketing and Sales Plan for each the appearance of Co-Developed Product Commercialized Licensed Products in the Co-Development Commercialization Territory, including packaging;
(c) coordinating the Development determining managed health care strategy and Commercialization efforts of both Parties tactics, including Pricing, rebates, discounts and charge-backs for Co-Commercialized Licensed Products in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Commercialization Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.;
(d) reviewing and providing input determining the appropriate use of medical science liaisons in the preparation support of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryCommercialized Licensed Products;
(e) determining the format and quantities of promotional sales, marketing and educational materials for the Co-Commercialized Licensed Products;
(f) reviewing and providing input on the short-term and long-term sales forecasts approving any proposals for modifications of existing Co-Developed Commercialized Licensed Products, including, without limitation, new formulations after First Commercial Sale and line extensions;
(g) agreeing upon the design and implementation of all Co-Commercialized Licensed Product launch activities;
(h) monitoring the progress of Co-Commercialization of Co-Commercialized Licensed Products in the Co-Developed Commercialization Territory under the Co-Commercialization Plan and each Party’s activities thereunder;
(i) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Licensed Products in the Co-Commercialization Territory;
(fj) presenting determining appropriate targets for sales forecasts force staffing and territory mapping purposes, determining the results appropriate level of all efforts Detailing effort to be provided by each Party in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) Commercializing such Co-Commercialized Licensed Product and coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Commercialized Licensed Products;
(hk) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development TerritoryCommercialized Licensed Products;
(il) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryCommercialized Licensed Products;
(jm) approving all Third Parties to be engaged by either Party ARQULE to provide Representatives representatives to Co-Promote Commercialize Co-Developed Products Commercialized Licensed Products, which approval shall be reflected in the Co-Developed Territoryminutes of the USJCC;
(kn) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Product Promotional Materials related to Co-Developed Product to create a Combination ProductCommercialized Licensed Products; and
(lo) performing making such activities other decisions as may be delegated to the JDCC USJCC pursuant to this Agreement, Agreement or by mutual written agreement of the Parties after during the Approval DateTerm.
Appears in 1 contract
Sources: License and Co Commercialization Agreement (Arqule Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC JSC shall have the following responsibilities:
(a) overseeing the development JDC’s performance of its responsibilities, the JFC’s performance of its responsibilities and discussion the JMC’s performance of strategies its responsibilities;
(b) reviewing data, reports or other information submitted to it by the JDC, JMC and JFC from time to time;
(c) resolving all JDC, JMC or JFC matters that are referred to the JSC for resolution;
(d) making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties after the Effective Date; and
(e) the JSC will meet in accordance with Section 2.1.3 for the purpose of (i) serving as a forum for Biotest and/or ImmunoGen, as applicable, to update each other as to Development and Commercialization progress with respect to Licensed Products, including monitoring the progress of the Development of each Licensed Product in accordance with the Development Plan and the Commercialization of each Co-Developed Product in accordance with the applicable Co-Development Marketing and Sales Plan and reviewing each annual update to each Co-Development Marketing and Sales Plan; and (ii) resolving any matters that require a Unanimous Decision. At each such meeting of the JSC the members of Biotest on the JSC shall provide an update as to Biotest’s general strategy for the Development and Commercialization of each Licensed Product in the Field to the extent applicable. In the event ImmunoGen exercises a Co-Development Option, the members of Biotest and ImmunoGen on the JSC shall provide (i) an update as to the Co-Promotion strategy for the Development and Commercialization of each Co-Developed Product in the Field set forth in the Co-Development Territory, including allocation of responsibilities for such Plan and/or Co-Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan (ii) an update concerning the anticipated timelines on a region-by-region basis for the Development of each Co-Developed Product and Regulatory Filings with respect thereto in the Field in the Territory, (iii) an update concerning the anticipated timelines on a region-by-region basis for the commercial launch of each Co-Developed Product and (iv) sales forecast guidance for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties Field in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarityTerritory; provided, that, in proving such update, the JDCC members of Biotest on the JSC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility entitled to omit discussion of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison Confidential Information of Biotest that Biotest reasonably determines to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and materially sensitive. If there is a material change in such timelines or guidance after any such meeting, Biotest will keep Enanta’s liaison informed as endeavor to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in notify ImmunoGen thereof through the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation convenience of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement special meeting of the Parties after the Approval DateJSC.
Appears in 1 contract
Sources: Collaborative Development and License Agreement (Immunogen Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development TerritoryJSC may discharge its responsibilities through one or more subcommittees. Without limiting the generality of the foregoingThe JSC’s responsibilities will include, without limitation, the JDCC shall have the following responsibilities:following:
(a) the development and discussion overseeing implementation of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;Plan;
(b) reviewing and discussing evaluating progress under the Development Plan (including compliance with the Development Budget contained therein and payment arrangements) on a Marketing quarterly basis and Sales Plan for each Co-Developed Product in advising the Co-Development Territory;Parties as to any necessary amendments thereto;
(c) coordinating allocating and assigning Development activities in the Development and Commercialization efforts Plan between the Parties, consistent with the terms of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Agreement;
(d) reviewing approving (or establishing procedures to approve) protocols for pre-clinical studies and providing input in the preparation Clinical Trials for Development of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryCollaboration Products;
(e) reviewing making modifications to and providing input on the shortperforming quarterly monitoring of progress of pre-term clinical studies and long-term sales forecasts Clinical Trials and proposing additional studies for Co-Developed Products in the Co-Developed Territory;Collaboration Products;
(f) presenting sales forecasts reviewing and the results of all efforts in the Co-Development Territory approving any proposed modifications to the JSC Development Plan, including advising the Parties as needed, but no less often than two (2) times per Calendar Year;to whether a Back-Up Compound should be developed in lieu of a Collaboration Compound;
(g) coordinating the Detailing efforts Manufacture of both Parties in the Co-Development Territory with respect to Co-Developed Products;global supplies of a Collaboration Compound and Collaboration Product for (i) Clinical Trials and (ii) Commercialization;
(h) overseeing all recalls, market withdrawals reviewing and any other corrective actions related commenting on Regulatory Submissions relating to Co-Developed Products in the Co-Development Territory;Collaboration Products;
(i) receiving and providing facilitating the exchange of all data, information, material or results relating to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;Development of Collaboration Products;
(j) approving all Third Parties establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Pharmacovigilance Agreement to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products entered into in the Co-Developed Territory;accordance with Section 4.3.5;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Cofacilitating the transfer of Know-Developed Product How pursuant to create a Combination Productthis Agreement; and
(l) developing a strategy for performing Translational Research Activities and Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as may are contemplated under this Agreement and that the Parties mutually agree shall be delegated the responsibility of the Joint Steering Committee. Notwithstanding the foregoing, in no event shall the JSC or any subcommittee of the JSC have the authority to (i) reduce or expand the JDCC pursuant to this Agreement, or by mutual written agreement obligations of the Parties after the Approval Dateunder this Agreement; (ii) determine that a breach has occurred under this Agreement; (iii) waive a Party’s rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in this Agreement as being made by one or both Parties.
Appears in 1 contract
Sources: License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development conduct and Commercialization progress of the SYNTA Co-Developed Products Commercialization Activities and GSK Co-Commercialization Activities for each Co-Commercialized Product in the Co-Development Commercialization Territory. Without limiting the generality of the foregoing, the JDCC JCC shall have the following responsibilities:
(a) preparing, or directing the development and discussion of strategies for preparation by the Development and Commercialization of Parties of, each Product Co-Developed Product Commercialization Plan for Co-Commercialized Products in the Co-Development Commercialization Territory, including allocation of responsibilities for such Development and Commercialization activitiesthe budgets with respect thereto;
(b) reviewing and discussing a Marketing and Sales preparing, or directing the preparation by the Parties of, each amendment to any Product Co-Commercialization Plan for each Co-Developed Product Commercialized Products in the Co-Development TerritoryCommercialization Territory or the related budget with respect thereto;
(c) coordinating the Development reviewing and Commercialization efforts of both Parties approving [***] matters for Co-Commercialized Products in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Commercialization Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.;
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a approving [***] matters for Co-Promotion Plan for each Co-Developed Product Commercialized Products in the Co-Development Commercialization Territory, including Co-Commercialization Trademarks;
(e) reviewing and providing input on approving [***] of Co-Commercialized Products in the Co-Commercialization Territory, including [***]; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
(f) reviewing and approving [***], including [***] for Co-Commercialized Products in the Co-Commercialization Territory;
(g) determining the appropriate use of [***] in support of the Co-Commercialized Products;
(h) determining the format and quantities of promotional sales, marketing and educational materials for the Co-Commercialized Products;
(i) in conjunction with the JDC, reviewing and approving any proposals for [***] of existing Co-Commercialized Products, including, without limitation, [***] after First Commercial Sale and [***];
(j) agreeing upon the design and implementation of all Co-Commercialized Product [***] activities;
(k) monitoring the progress of Commercialization of Co-Commercialized Products in the Co-Commercialization Territory under each Product Co-Commercialization Plan and of each Party’s activities thereunder;
(l) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Products in the Co-Commercialization Territory;
(m) reconciling issues between the Parties with respect to the Parties’ respective share of Operating Income (Loss) with respect to Co-Commercialized Products in the Co-Commercialization Territory;
(n) preparing or directing the preparation by the Parties of short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed TerritoryCommercialized Products;
(fo) presenting determining appropriate targets for sales forecasts force staffing and territory mapping purposes, determining the results appropriate level for, and allocation of all efforts in the Co-Development Territory to the JSC as neededPromotional Efforts to, but no less often than two (2) times per Calendar Year;
(g) each Party and coordinating the Detailing efforts conduct of Promotional Efforts and sales training of both Parties in the Co-Development Territory with respect to Co-Developed Commercialized Products;
(hp) overseeing all recalls, market withdrawals and any other corrective actions agreed to by the Parties related to Co-Developed Products in the Co-Development TerritoryCommercialized Products;
(iq) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryCommercialized Products;
(jr) approving all Third Parties subject to be engaged by either Party Sections 12.4.1 and 12.5.2, monitoring compliance of marketing activities throughout the U.S. Territory with Applicable Laws and GSK Internal Policies, and the corporate governance codes and policies of SYNTA to provide Representatives the extent they do not conflict with GSK Internal Policies and Applicable Laws; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to Co-Promote Co-Developed Products in the Co-Developed Territory;Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
(ks) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; andthe Commercialization Transition Plan;
(lt) performing in conjunction with the JDC, approving the overall strategy for [***] in support of Products in the U.S. Territory as determined by the Publication Committee;
(u) making such activities other decisions as may be delegated to the JDCC JCC pursuant to this Agreement, Agreement or by the JSC or by mutual written agreement of the Parties after during the Approval DateTerm;
(v) establishing any subcommittees or teams as deemed necessary; and
(w) resolving any other disputes raised to the JCC.
Appears in 1 contract
Sources: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)
Responsibilities. The JDCC shall be responsible for overseeing JSC’s responsibilities will include, among others: (i) approving the Development and Commercialization Regulatory Plan and any amendments to such plan (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), including, without limitation, approval of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilities:
(a) the development and discussion of strategies for any amendment to the Development and Regulatory Plan to undertake Development of a Combination Product that includes the Licensed Compound and another active pharmaceutical ingredient, (ii) approving (or establishing procedures to approve) protocols for pre-clinical or clinical studies (including Post-Approval Research) and any amendments or modifications to such protocols or studies and amendments thereto (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iii) approving any proposed amendment to the Launch Plan (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iv) performing quarterly reviews of progress of pre-clinical and clinical studies and proposed additional studies, (v) reviewing and commenting on the Commercialization Plan (and amendments thereto) prepared and presented by Astellas, (vi) reviewing and commenting on Regulatory Submissions relating to the Product prepared by Astellas, (vii) facilitating the exchange of each Co-Developed data and information relating to the development of the Product in and outside the Territory, (viii) receiving updates on the strategy for Commercializing the Product in the Co-Development TerritoryField in the Territory (including strategies related to reimbursement, including allocation of responsibilities advertising and promotion, brand integrity, sales, and launch sequence), (ix) receiving updates on the annual marketing plans and activities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed the Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties Field in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarityTerritory, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(dx) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input commenting on the short-term target product profile for the Product (including current and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
future formulations, indications, and delivery forms, and key labeling claims), and (f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(lxi) performing such activities other functions as may be delegated are expressly assigned to the JDCC pursuant to it in this Agreement. The JSC may appoint additional committees as agreed by the Parties. For the avoidance of doubt, the JSC shall not have the authority to amend or modify any term or condition, or by mutual written agreement of the Parties after the Approval Datetake any action inconsistent with or in violation of, this Agreement.
Appears in 1 contract
Responsibilities. The JDCC JPC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(ai) Consult with THERAVANCE in the development case of the Development Plan and discussion with MYLAN in the case of strategies the Commercialization Plan in connection with such Party’s preparing and updating of the Development Plan and Commercialization Plan and their associated budgets in a timely manner (providing any comments within thirty (30) days of the submission thereof by the applicable Party) and submit them to the JSC for review and approval;
(ii) At an appropriate and regular frequency, review the Development strategy (and, when appropriate, the Commercialization strategy) for the Licensed Product in the Field;
(iii) Review and discuss whether or not to recommend to the JSC any material amendments or modifications to the Development Plan or the Commercialization Plan;
(iv) Coordinate and monitor regulatory strategy and activities for the Licensed Product in accordance with Article 7;
(v) Review and recommend to the JSC operational and other decisions for the Development and Commercialization of each Co-Developed Licensed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesField;
(bvi) reviewing Discuss the state of the markets for Licensed Product and discussing a Marketing opportunities and Sales Plan for each Co-Developed Product in issues concerning the Co-Development TerritoryCommercialization of the Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, and labeling;
(cvii) coordinating At an appropriate and regular frequency, review the Development status of all studies conducted on Licensed Product and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territoryany results therefrom;
(eviii) reviewing At an appropriate and providing input on regular frequency, review Net Sales of Licensed Product for the shortyear-term to-date, and longa current outlook for Net Sales for the remainder of the then-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per current Calendar Year;
(gix) coordinating the Detailing efforts of both Parties Plan and review all publications described in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recallsSection 9.03, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving review and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party approve a publications policy for inclusion with a Co-Developed Product to create a Combination Productsuch publications; and
(lx) performing Have such activities other responsibilities as may be delegated assigned to the JDCC JPC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after through the Approval DateJSC from time to time. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The JDCC JCC shall be responsible perform the following functions:
(i) oversee the preparation and implementation of the Marketing Plans;
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(iv) discuss the state of the markets for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting Territory and opportunities and issues concerning the generality commercialization of the foregoingProducts, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the JDCC shall have priority for same and the following responsibilities:
(a) amount and kind of marketing and selling effort appropriate, in accordance with the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesMarketing Plans;
(bv) reviewing review and discussing approve the total annual budget for all Phase IV Clinical Trials, but not the budget or protocol for the individual studies themselves which must be approved by the PDC and the JEC pursuant to Section 4.3(f);
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the JCC, review a Marketing comparison of actual sales and Sales Plan for each Co-Developed Product marketing expenses to the budgeted expenses in the Corelevant Marketing Budget for the year-Development to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xiii) review and approve the general guidelines applicable to particular Products to be followed in the development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(cxv) coordinating review and approve the Development and Commercialization efforts of both Parties in joint publication strategy together with the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.PDC;
(dxvi) reviewing evaluate and providing input in determine the preparation existence or non-existence of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product Problem referred to the JCC in the Co-Development Territory;accordance with Section 5.6(e); and
(exvii) reviewing and providing input on have such other responsibilities as may be assigned to the short-term and long-term sales forecasts for Co-Developed Products in JCC pursuant to this Agreement or as may be mutually agreed upon by the Co-Developed Territory;Parties from time to time."
(f) presenting sales forecasts Section 2.4(d) is hereby deleted in its entirety and replaced with the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.following:
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesJMC will:
(a) consistent with the development provisions of Section 6.2, designate the team leader and discussion other members of strategies for the Development Manufacturing Working Group, which team leader and Commercialization members shall be chosen from among the personnel of each Co-Developed Product in the Co-Development TerritoryParties having relevant experience, including allocation of responsibilities for and allocate the respective roles on the Manufacturing Working Group among such Development and Commercialization activitiesmembers;
(b) reviewing review on a periodic basis and discussing a Marketing make any necessary changes to the team leader and Sales Plan for each Co-Developed Product in other members of the Co-Development TerritoryManufacturing Working Group, or the allocation of roles among such members;
(c) coordinating oversee the Development and Commercialization efforts of both Parties Manufacturing Working Group, in consultation with the Co-Development Territory JDC, with respect to Comatters relating to the pre-Developed clinical or clinical Manufacture of the Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.;
(d) reviewing and providing input oversee the Manufacturing Working Group, in consultation with the preparation JCC, with respect to matters relating to the commercial Manufacture of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryProducts;
(e) reviewing and providing input on oversee the short-term and long-term sales forecasts Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for Co-Developed Products in the Co-Developed TerritoryProducts;
(f) presenting sales forecasts and oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the review of the results of all efforts regulatory and environmental, health and safety inspections and audits related to the Manufacture of the Products and the review and discussion of steps taken by CRISPR to address any deficiencies noted;
(g) oversee the Manufacture of the Products in the Co-Development Field in the Territory, in consultation with the JDC or JCC, as applicable;
(h) allocate responsibilities for Manufacturing activities with respect to the Products in the Field in the Territory between the Parties;
(i) review, discuss and approve, in consultation with the JDC or the JCC, as applicable, the initial Global Manufacturing Plan, including the Manufacturing Budget, and any updates or amendments thereto proposed by the Manufacturing Working Group, and submit such Global Manufacturing Plan, updates or amendments to the JSC as neededfor review and discussion; [***] = Certain confidential information contained in this document, but marked by brackets, has been omitted because it is both (i) not material and (ii) would cause competitive harm if publicly disclosed.
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no less often later than two (2) times per [***] of each Calendar Year;
(gk) coordinating review, discuss and approve the Detailing efforts Manufacturing process for each Shared Product proposed by the Manufacturing Working Group, and review, discuss and approve any changes to such Manufacturing process proposed by the Manufacturing Working Group, in each case, in consultation with the JDC or JCC, as applicable;
(l) review, discuss and approve any recommendations of both Parties in the Co-Development Territory with respect to Co-Developed Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Products;
(hm) overseeing all recalls, market withdrawals select and approve each CMO and contract testing facility to be engaged with respect to each phase of the Manufacture of any other corrective actions related to Co-Developed Products in the Co-Development TerritoryProduct [***];
(in) receiving and providing to determine whether any Manufacturing technology transfer between the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryis necessary;
(jo) approving all Third Parties review, discuss and approve any proposed use of a Subcontractor to be engaged by either Party conduct a Party’s activities under the Global Manufacturing Plan, where the applicable Subcontract is anticipated to provide Representatives to Co-Promote Co-Developed Products entail payments in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productexcess of $[***], as set forth in ARTICLE 9; and
(lp) performing perform such activities other duties as are specifically assigned to the JMC under this Agreement or as may be delegated to the JDCC pursuant to this Agreement, or JMC by mutual written agreement of the Parties after the Approval DateJSC.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC JSC shall have the following responsibilities:
(a) overseeing the development JDC’s performance of its responsibilities, the JFC’s performance of its responsibilities and discussion the JMC’s performance of strategies its responsibilities;
(b) reviewing data, reports or other information submitted to it by the JDC, JMC and JFC from time to time;
(c) resolving all JDC, JMC or JFC matters that are referred to the JSC for resolution;
(d) making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties after the Effective Date; and
(e) the JSC will meet in accordance with Section 2.1.3 for the purpose of (i) serving as a forum for Biotest and/or ImmunoGen, as applicable, to update each other as to Development and Commercialization progress with respect to Licensed Products, including monitoring the progress of the Development of each Licensed Product in accordance with the Development Plan and the Commercialization of each Co-Developed Product in accordance with the applicable Co-Development Marketing and Sales Plan and reviewing each annual update to each Co-Development Marketing and Sales Plan; and (ii) resolving any matters that require a Unanimous Decision. At each such meeting of the JSC the members of Biotest on the JSC shall provide an update as to Biotest’s general strategy for the Development and Commercialization of each Licensed Product in the Field to the extent applicable. In the event ImmunoGen exercises a Co-Development Option, the members of Biotest and ImmunoGen on the JSC shall provide (i) an Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. update as to the Co-Promotion strategy for the Development and Commercialization of each Co-Developed Product in the Field set forth in the Co-Development Territory, including allocation of responsibilities for such Plan and/or Co-Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan (ii) an update concerning the anticipated timelines on a region-by-region basis for the Development of each Co-Developed Product and Regulatory Filings with respect thereto in the Field in the Territory, (iii) an update concerning the anticipated timelines on a region-by-region basis for the commercial launch of each Co-Developed Product and (iv) sales forecast guidance for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties Field in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarityTerritory; provided, that, in proving such update, the JDCC members of Biotest on the JSC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility entitled to omit discussion of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison Confidential Information of Biotest that Biotest reasonably determines to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and materially sensitive. If there is a material change in such timelines or guidance after any such meeting, Biotest will keep Enanta’s liaison informed as endeavor to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in notify ImmunoGen thereof through the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation convenience of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement special meeting of the Parties after the Approval DateJSC.
Appears in 1 contract
Sources: Collaborative Development and License Agreement (Immunogen Inc)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving review and providing to approve the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryannual Marketing Plan developed by Endo;
(jii) approving all Third Parties oversee the implementation of the Marketing Plans and approve modifications to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed TerritoryMarketing Plan throughout the year;
(kiii) reviewing discuss the state of the markets for the Product in the Territory and approving opportunities and issues concerning the Commercialization of the Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues;
(iv) if applicable under Sections 5.5 and 5.8, oversee and coordinate the sales efforts of Endo and DURECT;
(v) review and approve the Post-Registration Plan, taking into consideration the appropriateness of any ingredients that development activities including line extensions, clinical trials for purposes of new indications and Phase IV clinical trials in the context of the overall marketing and promotional strategy for the Product;
(vi) review and direct all indigent care use of the Product;
(vii) review and approve Sales Projections in accordance with Section 6.3;
(viii) review, in consultation with the JMC, the efficacy of the forecasting procedure set forth in Section 8.3, including whether any modifications thereto are therapeutically or biologically active that are proposed necessary following the second anniversary of the First Commercial Sale;
(ix) review data and reports arising from and generated in connection with the Commercialization of the Product, Finished Product and Implanter, including the Marketing Plan, Marketing Budgets, market research studies, and Product, Finished Product and Implanter sales and prescription trends and sales forecasts;
(x) at each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xi) at least once each calendar year by either Party for inclusion with a Co-Developed date no later than [* * *], review and approve the Marketing Plan as updated by Endo;
(xii) review and approve the general guidelines applicable to the Product to create a Combination be followed by Endo in its development of promotional materials and promotional activities to be used by Endo in the promotion of the Product, Finished Product and Implanter (such guidelines to be consistent with the then current Marketing Plan applicable to the Product);
(xiii) evaluate and approve use of any technical support representatives;
(xiv) review and direct the publication strategy, in consultation with the PDC;
(xv) in consultation with the PDC, review and approve the Specifications for the Finished Product, including the packaging and related materials, prior to Commercial use;
(xvi) develop3 appropriate procedures, pursuant to Section 8.13 and in consultation with the JMC, regarding the manufacture and sale of Implanters;
(xvii) review and, if appropriate, approve the supplemental call plan, if any, submitted by DURECT pursuant to Section 5.8;
(xviii) evaluate and determine whether to market and sell an Implant Kit; and
(lxix) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: License Agreement (Durect Corp)
Responsibilities. The JDCC TELAVANCIN Product Management Team shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions as approved by the JSC:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving Prepare the Medical Marketing Plan for submission to and providing review and approval by the JSC, [*] — in every case subject to consistency with the Basic Development Plan and Basic Commercial Plan (and, consistent with Section 3.05(c), certain decisions ASTELLAS is entitled to make) as further outlined in Section 5.01; [*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(ii) Prepare and present to the Parties sales reports pertaining JSC for approval [*], including but not limited to Co-Developed Products in [*] (subject to consistency with the Co-Developed TerritoryBasic Commercial Plan);
(jiii) approving all Third Parties On an annual rolling basis beginning within six (6) months of the Effective Date, update and amend the Medical Marketing Plan for the following Calendar Year so that it can immediately thereafter submit to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed TerritoryJSC such proposed Medical Marketing Plan for review and approval;
(kiv) reviewing Recommend to the JSC any material amendments or modifications to the Medical Marketing Plan during the Calendar Year with respect to the US;
(v) Provide reports to the JSC regarding the state of the markets for Licensed Product and approving any ingredients opportunities and issues concerning the Commercialization of the Licensed Product, including consideration of [*];
(vi) Review Net Sales for the year-to-date, as available, and provide reports with assessments and recommendations to the JSC;
(vii) Regularly review ASTELLAS’ progress to [*] in the United States that are therapeutically or biologically active that are proposed is consistent with the Medical Marketing Plan. Such [*] will be undertaken by either Party for inclusion with a Co-Developed Product to create a Combination ProductASTELLAS; and
(lviii) performing Have such activities other responsibilities as may be delegated assigned to the JDCC TELAVANCIN Product Management Team pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after through the Approval DateJSC in final, undisputed written minutes from time to time.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Theravance Inc)
Responsibilities. The JDCC shall JSC will be responsible for directing and overseeing the Development Research Collaboration during the Research Term. The responsibilities and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality authority of the foregoing, the JDCC JSC shall have the following responsibilitiesbe as follows:
(a1) Establishing, determining the development content of, reviewing, and discussion approving each Program of strategies Work for each Collaboration Target selected and designated by GSK for prosecution under the Development Research Collaboration, and Commercialization of each Co-Developed Product in reviewing and approving changes or further refinements to the Co-Development Territory, including allocation of responsibilities same or to the Lead Criteria or Lead Compound Criteria for such Development and Commercialization activitiesany Collaboration Target;
(b2) reviewing Monitoring all of the activities under the Research Collaboration. The JSC will monitor the progress of research activities under each Program of Work within the Research Plan and discussing a Marketing and Sales Plan for each Co-Developed Product in may at any time request reports describing it with as much specificity as the Co-Development TerritoryJSC may determine;
(c3) coordinating Declaration of when a relevant Collaboration Compound has become a Lead by achievement of the Lead Criteria for selection by GSK as a relevant Target Compound;
(4) Declaration of when a Lead within the relevant Target Compounds has become a Lead Compound (or a Backup Compounds) by achievement of the Lead Compound Criteria; [***]*.
(5) Identification, implementation and oversight of a strategy to generate Backup Compounds for each Collaboration Target;
(6) Recommendation to GSK of Lead Compounds or Backup Compounds for progression by GSK, at GSK’s sole discretion, for Development by GSK hereunder;
(7) Determination that a Collaboration Target is no longer suitable for further research and Commercialization efforts development under the collaboration under the relevant Program, subject to GSK’s rights under Section 6 regarding termination of both Parties in the Co-Development Territory a Program;
(8) Facilitating transfer of information as provided by GSK with respect to Coany Licensed Products or Lead Compounds in Development, or development thereof by Sirna pursuant to Section 3.5;
(9) Establish a process by which GSK can submit task orders to Sirna for FTE-Developed Productsbased research in support of Development; and * Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. For purposes of clarity, Confidential treatment has been requested with respect to the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5omitted portions.
(d10) reviewing Establishment of an IP Subcommittee to develop, monitor and providing input in the preparation of oversee a Marketing and Sales Plan containing a Comutually-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory agreed strategy with respect to Cofiling, prosecution and enforcement of all Sirna Patents, Sirna Know-Developed Products;
(h) overseeing all recallsHow, market withdrawals GSK Patents, GSK Know-How, Joint Patents and any other corrective actions related to CoJoint Know-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports How pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties any Collaboration Target, Lead, Target Compound, Lead Compound, Backup Compounds or Licensed Product, subject to be engaged GSK’s rights under Article 9 after Development has been initiated by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval DateGSK.
Appears in 1 contract
Sources: Strategic Alliance Agreement (Sirna Therapeutics Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesJMC will:
(a) consistent with the development provisions of Section 6.2, designate the team leader and discussion other members of strategies for the Development Manufacturing Working Group, which team leader and Commercialization members shall be chosen from among the personnel of each Co-Developed Product in the Co-Development TerritoryParties having relevant experience, including allocation of responsibilities for and allocate the respective roles on the Manufacturing Working Group among such Development and Commercialization activitiesmembers;
(b) reviewing review on a periodic basis and discussing a Marketing make any necessary changes to the team leader and Sales Plan for each Co-Developed Product in other members of the Co-Development TerritoryManufacturing Working Group, or the allocation of roles among such members;
(c) coordinating oversee the Development and Commercialization efforts of both Parties Manufacturing Working Group, in consultation with the Co-Development Territory JDC, with respect to Comatters relating to the pre-Developed clinical or clinical Manufacture of the Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.;
(d) reviewing and providing input oversee the Manufacturing Working Group, in consultation with the preparation JCC, with respect to matters relating to the commercial Manufacture of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryProducts;
(e) reviewing oversee the Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for the Products; [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and providing input on filed separately with the short-term Securities and long-term sales forecasts for Co-Developed Products in Exchange Commission pursuant to Rule 24b-2 of the Co-Developed Territory;Securities Exchange Act of 1934, as amended. Table of Contents
(f) presenting sales forecasts and oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the review of the results of all efforts regulatory and environmental, health and safety inspections and audits related to the Manufacture of the Products and the review and discussion of steps taken by CRISPR to address any deficiencies noted;
(g) oversee the Manufacture of the Products in the Co-Development Field in the Territory, in consultation with the JDC or JCC, as applicable;
(h) allocate responsibilities for Manufacturing activities with respect to the Products in the Field in the Territory between the Parties;
(i) review, discuss and approve, in consultation with the JDC or the JCC, as applicable, the initial Global Manufacturing Plan, including the Manufacturing Budget, and any updates or amendments thereto proposed by the Manufacturing Working Group, and submit such Global Manufacturing Plan, updates or amendments to the JSC as needed, but for review and discussion;
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no less often later than two (2) times per [***] of each Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing review, discuss and approving any ingredients that are therapeutically or biologically active that are approve the Manufacturing process for each Shared Product proposed by either Party for inclusion the Manufacturing Working Group, and review, discuss and approve any changes to such Manufacturing process proposed by the Manufacturing Working Group, in each case, in consultation with a Co-Developed Product to create a Combination Product; andthe JDC or JCC, as applicable;
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreementreview, or by mutual written agreement discuss and approve any recommendations of the Parties after Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Approval Date.Products;
Appears in 1 contract
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving review and providing to approve the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryannual Marketing Plan developed by Endo;
(jii) approving all Third Parties oversee the implementation of the Marketing Plans and approve modifications to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed TerritoryMarketing Plan throughout the year;
(kiii) reviewing discuss the state of the markets for the Product in the Territory and approving opportunities and issues concerning the Commercialization of the Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues;
(iv) if applicable under Sections 5.5 and 5.8, oversee and coordinate the sales efforts of Endo and DURECT;
(v) review and approve the Post-Registration Plan, taking into consideration the appropriateness of any ingredients that development activities including line extensions, clinical trials for purposes of new indications and Phase IV clinical trials in the context of the overall marketing and promotional strategy for the Product;
(vi) review and direct all indigent care use of the Product;
(vii) review and approve Sales Projections in accordance with Section 6.3;
(viii) review, in consultation with the JMC, the efficacy of the forecasting procedure set forth in Section 8.3, including whether any modifications thereto are therapeutically or biologically active that are proposed necessary following the second anniversary of the First Commercial Sale;
(ix) review data and reports arising from and generated in connection with the Commercialization of the Product, Finished Product and Implanter, including the Marketing Plan, Marketing Budgets, market research studies, and Product, Finished Product and Implanter sales and prescription trends and sales forecasts;
(x) at each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xi) at least once each calendar year by either Party for inclusion with a Co-Developed date no later than ***, review and approve the Marketing Plan as updated by Endo;
(xii) review and approve the general guidelines applicable to the Product to create a Combination be followed by Endo in its development of promotional materials and promotional activities to be used by Endo in the promotion of the Product, Finished Product and Implanter (such guidelines to be consistent with the then current Marketing Plan applicable to the Product);
(xiii) evaluate and approve use of any technical support representatives;
(xiv) review and direct the publication strategy, in consultation with the PDC;
(xv) in consultation with the PDC, review and approve the Specifications for the Finished Product, including the packaging and related materials, prior to Commercial use;
(xvi) develop appropriate procedures, pursuant to Section 8.13 and in consultation with the JMC, regarding the manufacture and sale of Implanters;
(xvii) review and, if appropriate, approve the supplemental call plan, if any, submitted by DURECT pursuant to Section 5.8;
(xviii) evaluate and determine whether to market and sell an Implant Kit; and
(lxix) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: License Agreement (Endo Pharmaceuticals Holdings Inc)
Responsibilities. The JDCC Program Steering Committee shall be responsible for overseeing and directing the Parties’ interaction and performance of their respective research and Development and Commercialization of Co-Developed Products in the Co-Development Territoryobligations under this Agreement. Without limiting the generality of the foregoing, its duties shall include: · Preparing such procedures as may be necessary for the JDCC shall have operation of the following responsibilities:
(a) Program Steering Committee and the development JRC; · Approving strategy for the Research Collaboration and discussion of strategies for the Development of Collaboration Compounds and/or Products, including the approval of new Master Development Plans and Commercialization any amendments thereto or to the initial Master Development Plan; · Determining the timing of each Co-Developed Product Development/Regulatory Milestone payments in the Co-Development Territory, including allocation event of responsibilities for such Development a combination of phases as described in Section 12.4.1 b); [***] Certain information in this document has been omitted and Commercialization activities;
(b) reviewing submitted separately to the Securities and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory Exchange Commission. Confidential treatment has been requested separately with respect to Co-Developed Productsthe omitted portions. For purposes · Reviewing the activities of claritythe JRC and ensuring that the JRC performs its obligations; · Resolving matters within the responsibilities of the JRC as to which the members of the JRC are unable to reach a consensus; · Addressing issues and resolving differences that may arise between the Parties; and · After the Research Collaboration has ended, ensuring that the JDCC Data Room is updated on a regular basis and that progress reports on the Development of Collaboration Compounds and Products are submitted five (5) days prior to Program Steering Committee meetings. The Program Steering Committee shall not be responsible for coordinating communications with Regulatory Authorities, which is have the sole responsibility power to amend or interpret the terms of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory waive compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed this Agreement or determine whether or not a breach of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5this Agreement has occurred.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: License and Collaboration Agreement (Zealand Pharma a/S)
Responsibilities. The JDCC shall be responsible for overseeing Subject to Section 3.1.1(a), the JDC’s responsibilities will be: (i) reviewing and approving the Development Plan no less than once per Year and Commercialization any amendments thereto; (ii) reviewing and approving the Development Budget no less than once per Year and any amendments thereto; (iii) approving (or establishing procedures to approve) protocols for non-clinical or clinical studies (including Post-Approval Research) conducted for purposes of Co-Developed Products seeking Regulatory Approval for the Product in the CoTerritory; (iv) making modifications to and performing quarterly monitoring of progress of such non-clinical and clinical studies and proposing additional studies for the Product in the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Territory; (v) reviewing and commenting on Regulatory Submissions relating to the Product in the Territory and approving such Regulatory Submissions as specified in Exhibit D; (vi) subject to Section 3.8, developing and coordinating a strategy for publications relating to the Product in the Territory to be made by the Parties and their respective Affiliates, licensees and Sublicensees; (vii) subject to Sections 3.2.2, 3.2.3 and 3.2.4 and any other applicable terms of this Agreement, facilitating the exchange of all data, information, material or results relating to the Development of the Product in the Territory; (viii) facilitating the exchange of Ironwood Know-How that is necessary or useful for AstraZeneca to conduct Development activities; and (ix) developing procedures for monitoring Third Party submissions to Regulatory Authorities in the Territory with respect to the Products. The JDC may appoint additional committees as desired. Without limiting the generality foregoing, AstraZeneca acknowledges and agrees that any Development Plan approved by the JDC will be subject to review by the Joint Development Committee constituted under the Forest Agreement, and that no clinical Development of the foregoing, Product may be conducted in the JDCC shall have Forest Territory which Forest reasonably believes may adversely affect the following responsibilities:
(a) the timely development and discussion of strategies for the Development and Commercialization of each Co-Developed any Product in the Co-Development Forest Territory, including allocation ; provided that the foregoing provisions of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not sentence apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory solely to the JSC extent and for so long as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating Forest has such rights under the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Forest Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration Agreement (Ironwood Pharmaceuticals Inc)
Responsibilities. The JDCC STEERING COMMITTEE shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesfollowing:
(a) designating AVAILABLE TARGETS to the development categories set forth in Section 2.2.1, designating which new PROJECTS shall be initiated, determining the timing for each PROJECT, deciding which AVAILABLE TARGET may become an EXCLUDED TARGET prior to the applicable time periods set forth in Section 2.2.1 and discussion determining the minimum number of strategies for the Development and Commercialization of AVAILABLE TARGETS in category IV with respect to which each Co-Developed Product party is obliged to perform High Throughput Screening as contemplated in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesSection 2.2.2;
(b) reviewing and discussing a Marketing and Sales Plan devising, in collaboration with the RESEARCH COMMITTEE for each Co-Developed Product in PROJECT, an initial research plan for the Co-Development TerritoryPROJECT setting forth the principal goals to be achieved during the RESEARCH STAGE of the PROJECT, the principal activities to be conducted during such STAGE, the relative priorities of the parties and the proposed timetables for achieving the goals and conducting the activities;
(c) coordinating the Development establishing criteria regarding pharmacological profile, stability, pharmacokineticprofile, bioavailability, synthesis and Commercialization efforts of both Parties safety profile which must be satisfied in the Co-Development Territory with respect order for a LEAD to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with become a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.CANDIDATE;
(d) reviewing and providing input establishing criteria regarding the in the preparation of vivo therapeutic profile which must be satisfied in order for a Marketing and Sales Plan containing COMPOUND to be considered a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryLEAD;
(e) reviewing preparing such procedures and providing input on mechanisms as may be necessary for the short-term STEERING COMMITTEE and long-term sales forecasts for Co-Developed Products each RESEARCH COMMITTEE to operate in a manner which will ensure the Co-Developed Territoryefficient conduct of each PROJECT hereunder;
(f) presenting sales forecasts and the results of all efforts in the Codeciding to start Good Laboratory Practices four-Development Territory week toxicology studies with respect to the JSC as neededa LEAD, but no less often than two (2) times per Calendar Yearthereby rendering such LEAD a CANDIDATE;
(g) coordinating monitoring and directing the Detailing efforts activities of both Parties in the Co-Development Territory with respect to Co-Developed Productseach RESEARCH COMMITTEE;
(h) overseeing all recallspreparing, market withdrawals for review and any other corrective actions related approval by each party, a detailed schedule of activities proposed to Co-Developed Products be conducted during the EARLY DEVELOPMENT STAGE with respect to each CANDIDATE, as well as a proposed budget of costs associated with certain of such activities (such proposed budget to be prepared in the Co-Development Territory;accordance with Section 3.1.3 below); and
(i) receiving monitoring and providing directing the activities conducted during the EARLY DEVELOPMENT STAGE with respect to each CANDIDATE and, if determined to be appropriate, proposing for consideration and approval by each party, revisions to any previously approved schedule of activities and/or budget. The STEERING COMMITTEE shall not, in any year, withhold its approval of any increases in a previously approved BUDGET proposed by one party so long as the Parties sales reports pertaining to Co-Developed Products aggregate of such 15 increases is less than 50% of the entire BUDGET for such year. To the extent that the aggregate of proposed increases in any year exceed 50% of the Co-Developed Territory;entire BUDGET for such year, the STEERING COMMITTEE shall not unreasonably withhold its approval thereof.
(j) approving all Third Parties determining to commence PHASE III TRIALS, it being understood that such determiantion shall be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in made following the Co-Developed Territory;
(k) reviewing completion of phase II a clinical trials and approving any ingredients that no party shall block such determination. In addition, the STEERING COMMITTEE shall have such other responsibilities as are therapeutically set forth herein or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Datecontemplated hereby.
Appears in 1 contract
Sources: Cooperation Agreement (Synaptic Pharmaceutical Corp)
Responsibilities. The JDCC USJMC shall be responsible for overseeing the Development conduct and progress of the Co-Commercialization of each Co-Developed Products Commercialized Product in the Co-Development Commercialization Territory. Without limiting the generality of the foregoing, the JDCC USJMC shall have the following responsibilities:
(a) preparing or directing the development and discussion of strategies for preparation by the Development and Commercialization of Parties of, each Co-Developed Product Commercialization Plan for Co-Commercialized Products in the Co-Development Commercialization Territory, including allocation of responsibilities for such Development and Commercialization activitiesthe budgets with respect thereto;
(b) reviewing and discussing a Marketing and Sales preparing or directing the preparation by the Parties of each amendment to any Co-Commercialization Plan for each Co-Developed Product Commercialized Products in the Co-Development TerritoryCommercialization Territory or the related budget with respect thereto;
(c) coordinating determining style guidelines and the Development and Commercialization efforts appearance of both Parties Co-Commercialized Products in the Co-Development Territory with respect to Commercialization Territory, including packaging and promotional materials;
(d) determining managed health care strategy and tactics, including Pricing, rebates, discounts and charge-backs for Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Commercialized Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Commercialization Territory;
(e) determining the appropriate use of medical science liaisons in support of the Co-Commercialized Products;
(f) determining the format and quantities of promotional sales, marketing and educational materials for the Co-Commercialized Products;
(g) reviewing and providing input on the short-term and long-term sales forecasts approving any proposals for modifications of existing Co-Developed Commercialized Products, including, without limitation, new formulations after First Commercial Sale and line extensions;
(h) agreeing upon the design and implementation of all Co-Commercialized Product launch activities;
(i) monitoring the progress of Commercialization of Co-Commercialized Products in the Co-Developed Commercialization Territory under each Co-Commercialization Plan and of each Party’s activities thereunder;
(j) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Products in the Co-Commercialization Territory;
(fk) presenting determining appropriate targets for sales forecasts force staffing and territory mapping purposes, determining the results appropriate level of all efforts Detailing effort to be provided by each Party in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) Commercializing such Co-Commercialized Product and coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Commercialized Products;
(hl) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development TerritoryCommercialized Products;
(im) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryCommercialized Products;
(jn) approving all Third Parties to be engaged by either Party to provide Representatives representatives to Commercialize Co-Promote Co-Developed Products Commercialized Products, which approval shall be reflected in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productminutes of the USJMC; and
(lo) performing making such activities other decisions as may be delegated to the JDCC USJMC pursuant to this Agreement, Agreement or by the JSC or by mutual written agreement of the Parties after during the Approval DateTerm.
Appears in 1 contract
Sources: License, Co Development and Co Commercialization Agreement (Arqule Inc)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development conduct and progress of the Commercialization of Co-Developed Products each Product in the U.S. Territory and the Co-Development Promotion of each Co-Promoted Product in the U.S. Territory. Without limiting the generality of the foregoing, the JDCC JCC shall have the following responsibilities:
(a) preparing or directing the development and discussion of strategies for preparation by the Development and Parties of, each Product Commercialization of each Co-Developed Product in the Co-Development TerritoryPlan, including allocation of responsibilities for such Development and Commercialization activitiesthe budget;
(b) reviewing and discussing a Marketing and Sales preparing or directing the preparation by the Parties of, each amendment to any Product Commercialization Plan for each Co-Developed Product in or the Co-Development Territoryrelated budget;
(c) coordinating the Development deciding Pricing and Commercialization efforts of both Parties Branding matters in the CoU.S. Territory;
(d) deciding appearance of the Product, packaging and promotional materials;
(e) determining managed health care strategy and tactics, including pricing, rebates, discounts and charge-Development Territory backs;
(f) agreeing upon the market definition against which the Product will be measured for internal and external reporting purposes;
(g) determining the appropriate use of medical science liaisons in support of the Product;
(h) determining the format and quantities of promotional sales, marketing and educational materials for the Product;
(i) reviewing and approving any proposals for development of additional Product or modifications of existing Products, including, without limitation, new formulations after First Commercial Sale and line extensions;
(j) agreeing upon the design and implementation of all Product launch activities;
(k) monitoring the progress of Commercialization of Products under each Annual Product Commercialization Plan and of each Party’s activities thereunder;
(l) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Products;
(m) reconciling issues between, the Parties with respect to the Parties’ respective share of Operating Income (Loss) with respect to Co-Developed Promoted Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(en) reviewing and providing input on preparing or directing the preparation by the Parties of short-term and long-term sales forecasts for Co-Developed Products in Products;
(o) determining appropriate targets for sales force staffing and territory mapping purposes, determining the Co-Developed Territory;
(f) presenting sales forecasts and the results Promotion Percentage of all efforts in each Party, provided that the Co-Development Territory to the JSC as neededPromotion percentage of neither Party shall be [***], but no less often than two (2) times per Calendar Year;
(g) and coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Promoted Products;
(hp) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development TerritoryProducts;
(iq) receiving and providing to the Parties sales reports pertaining to Co-Developed Products Collaboration Products;
(r) subject to the requirement in the Co-Developed Territory;
(j) Promotion Agreement that Third Parties shall only be used to Co-Promote if the other Party has been given the option to conduct the extra Details and be reimbursed on the basis set forth in the Co-Promotion Agreement and turned down the option, approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products Collaboration Products, any such approval to be reflected in the Co-Developed Territoryminutes of the JCC;
(ks) reviewing monitoring compliance of marketing activities throughout the Territory with Applicable Laws and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; andthe corporate governance codes and policies of the Parties;
(lt) performing making such activities other decisions as may be delegated to the JDCC JCC pursuant to this Agreement, Agreement or by the JSC or by mutual written agreement of the Parties after during the Approval DateTerm;
(u) reviewing the MERCK ROW Product Commercialization Plan as set forth in Section 3.5.2 and providing a forum for discussion with respect to the Commercialization of Products in the ROW Territory.
Appears in 1 contract
Sources: Collaboration Agreement (Ariad Pharmaceuticals Inc)
Responsibilities. (i) All Sub-contractors are required to provide coverage for the following; Superannuation , Workers Compensation , Public Liability , Full Comprehensive Insurance for Motor Vehicle and Registration. The JDCC Sub-Contractors must comply with the Workers Compensation requirement of providing a Certificate of Currency as a Proprietary Limited (Pty Ltd) company.
(ii) It is the responsibility of the Sub-Contractor to be available for work on all days, not declared as public holidays, between Monday and Friday inclusive or at other time that the Company may reasonably require them.
(iii) It is the responsibility of the Sub-Contractor to notify the duty supervisor or leading hand of his/her inability to report to work at least 30 minutes before his/her designated start time. The Sub-Contractor must make all reasonable efforts to notify the Company of inability to attend work.
(iv) The Sub-Contractor shall observe the commencement times appropriate to the work he/she is assigned. The Company may vary the start times with prior consultation with the affected Sub-Contractor and his/her representative.
(v) Sub-Contractor(s) will carry out duties such as the delivery and pick up of freight, loading and unloading of their own PUD (pick up and delivery) vehicles, raising connotes and other business related paperwork, scanning, check weighing and cubing as required. All Sub- Contractor(s) will work as directed except where there is a bona fide safety issue or possible breach of the Determination and /or this Agreement. Such issues must be raised immediately with the Sub-Contractor's representative and the manager.
(vi) During the course of a delivery and/or pick up run, the Sub-Contractor will ensure that the vehicle is kept in a secure/locked condition at all times.
(vii) Upon returning to the depot, the Sub-Contractor shall unload his/her vehicle and place the freight in the appropriate location. All freight must display the appropriate identifications with the required consigning details completed.
(viii) The Sub-Contractor shall not perform duties other than the Company's business during working hours or carry any goods/freight other than goods/freight lodged for consignment with the Company.
(ix) All freight identified as valuable goods or security freight shall be treated in a secure manner and must be brought to the attention of the supervisor/leading hand.
(x) The Sub-Contractor shall not carry any animals or unauthorised passengers in the vehicle during company business hours/ time without the consent of the manager.
(xi) The Sub-Contractor must ensure his/her vehicle is carrying the appropriate equipment for the run including but not limited to Personal Palm-top Terminal (PPT), Priority connotes, B- stickers, trolley, and current street directory relevant stationery/equipment, necessary to adhere to policy issued by the Company from time to time.
(xii) The Sub-Contractor will ensure that all paperwork is handed in on completion of work on a daily basis and all paperwork is fully completed as per the employer's requirements prior to the commencement of the next shift.
(xiii) The Sub-Contractor shall at all times maintain standard of conduct that supports superior customer service.
(xiv) The Sub-Contractor shall ensure that his/her permanent pick up run sheet is current. The Company will provide the run sheet format and amend the run sheet upon request.
(xv) The Sub-Contractor must comply with all reasonable special delivery instructions. If for any reason he/she is unable to do so then he/she must bring this to the immediate attention of the supervisor/leading hand.
(xvi) Sub-Contractors will be made familiar with all Company policies/procedures and must comply with such policies, as amended from time to time.
(xvii) Should a Sub-Contractor miss a pick up or thinks a pick up maybe in jeopardy they are to contact the Radio Operator immediately.
(xviii) The Sub-contractor will be responsible for overseeing the Development all deliveries and Commercialization of Co-Developed Products pick ups with in the Co-Development Territory. Without limiting the generality of the foregoinghis/her designated run area, although should it be necessary, the JDCC shall have Company reserves the following responsibilities:
(a) right to redirect drivers into other areas to satisfy service demands. This may be required to maintain service levels. If a pickup or delivery is outside the development and discussion designated boundary of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of claritythat run area, the JDCC shall not Sub-Contractor will be responsible paid a kilometre rate of $0.30 cents per kilometre to effect the pickup or delivery. The Sub-Contractor and radio operator concerned, must advise the depot prior to any out of area pick up or delivery so that authorisation for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ payment can be provided by management. The designated areas for deliveries and pickups will work directly with a regulatory liaison be assigned to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products each Sub- Contractor and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings their area and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreementvaried at management discretion with consultation with affected parties , or by mutual written agreement of the Parties after the Approval Date.i.e.;
Appears in 1 contract
Sources: Contract Agreement
Responsibilities. The JDCC RYCOM Responsibilities ----------------------- In addition to the structure of the relationship outlined above RYCOM will architect, develop and operate a fully managed signature verification authentication, and other solutions offering using SNaulrs platform and proprietary IP for the Canadian market. RYCOM will provide all necessary hardware, secure facility and engineering, sales, marketing support to deliver the service. This solution will be co-developed and revenue shared with SiVault however, RYCOM wig operate and manage the solution in its entirety signature verification and other solutions wig be marketed to End Users, and white labeled for Channel Markets requiring speed to market.
A. End User Market Development RYCAM shag use its best commercial efforts to engage End-Users, sell Products and license software contained within or delivered with such Products. Company Technology shall be licensed by End-Users pursuant to the End-User License Agreement ("E▇▇▇") contained In the Product. E-132
B. Distribution and Channel Market Development: RYCOM may sell to third parties ('Sub-Reseller & Integrators') to market and sell the Products and license the Software Products under the terns of this Agreement applicable to RYCOM. Each Sub-Reseller shall execute a written agreement (a 'Sub-Reseller Agreement") with RYCOM binding the Sub-Reseller to provisions substantially similar to (and no less advantageous to Company than) those contained In this Agreement, and all associated Addenda. Each obligation of RYCOM under each such provision shall also be applicable to each Sub-Reseller. Each Sub-Reseller Agreement shall also contain any other provisions necessary for RYCOM to satisfy its commitments under this Agreement. RYCOM shag keep executed Sub-Reseller Agreements and records pertaining to each Sub-Reseller, and shall provide copies of such information on a monthly basis. RYCOM agrees to enforce the terms of its Sub-Reseller Agreements so as to affect a timely cure of any Sub-Reseller breach of the SutrReseller Agreement and to notify Company of any known breach of such terms. SiVault Responsibilities and Consideration
a) SiVault will provide RYCOM at no charge with an unlimited capacity signature verification software solution license to architect and develop a fully managed service offering for the Canadian market RYCOM will be responsible for overseeing purchasing all necessary hardware components required. Revenue generated from the Development signature verification serv'f- wig be shared between RYCOM and Commercialization of Co-Developed Products SiVault as outlined in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilities:attached Addendum RYCOM and StVVault Pricing and Revenue Share Arrangement
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing SiVault will provide at no charge RYCOM and discussing a its Engineering and Sales, Marketing personnel with the necessary product training and Sales Plan for each Cosupport to successfully develop, market and sell the signature verification, authentication and other solution's. Such training wig include literature, collateral, presentations, CD's, web based training and on-Developed Product in the Co-Development Territory;site training.
(c) coordinating the Development SIVault will at no charge provide technical assistance fix software support and Commercialization efforts of both Parties in the Co-Development Territory with respect configuration support to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5RYCOM engineering personnel.
(d) reviewing SiVault will at no charge provide to RYCOM all necessary signature verification solution product updates, features, changes, revisions etc as and providing input in when they become available to deliver the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;signature verification service.
(e) reviewing SiVault will furnish RYCOM with all third party product market evaluation and providing input on the short-term and long-term sales forecasts testing reports for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Datesignature verification solution.
Appears in 1 contract
Sources: Strategic Alliance and Exclusive Management Agreement (SiVault Systems, Inc.)
Responsibilities. The JDCC JCC shall be responsible for overseeing perform the Development following functions with the objective of maximizing Net Sales and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality profitability of the foregoingProduct, subject to applicable Laws and the JDCC shall have the following responsibilitiesApplicable Commercial Practices Policies:
(a) 3.5.1 Discuss the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product manner in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ Sales Representatives and Cephalon Sales Representatives will work directly with a regulatory liaison to be designated by Enanta Promote and Detail the Product in the ADHD marketplace based on coordinating key regulatory FDA communications on Co-Developed Products the available information and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in data regarding the safety and efficacy of the Product;
3.5.2 Coordinate the Co-Developed Territory. For clarity, this would not apply Promotion and Detailing activities related to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. the Product of the Cephalon Sales Representatives and ▇▇▇▇▇▇ will keep Sales Representatives in the JDCC informed Territory; **Portions of key regulatory communications involving key regulatory filings the Exhibit have been omitted and milestone meetings have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as specified in Section 4.5.5amended.
(d) reviewing and providing input 3.5.3 Discuss the state of the markets for the Product in the preparation of a Marketing Territory and Sales Plan containing a opportunities and issues concerning the Co-Promotion Plan for each Co-Developed and Detailing of the Product in the Co-Development Territory;
(e) reviewing and providing input on 3.5.4 Discuss marketing support for the short-term and long-term sales forecasts for Product;
3.5.5 Discuss the pricing of the Product in a manner whereby Cephalon agrees to consider in good faith any ▇▇▇▇▇▇ suggestions with respect to such matters, but Cephalon retains sole discretion with respect to all final pricing decisions relating to the Product;
3.5.6 Discuss issues raised by Sales Representatives relating to Co-Developed Products Promotion and Detailing of the Product in the Co-Developed Territory;
(f) presenting sales forecasts 3.5.7 Discuss incentive compensation programs for the Sales Representatives;
3.5.8 Discuss the Plans and the results of all efforts Marketing Budget in the Co-Development Territory a manner whereby Cephalon agrees to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties consider in the Co-Development Territory good faith any ▇▇▇▇▇▇ suggestions with respect to Cosuch matters, but, subject to Sections 2.3.5, 3.7, 6.4 and 6.6, Cephalon retains final decision-Developed Productsmaking authority with respect to the Plans and the Marketing Budget;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product3.5.9 Discuss [**]; and
(l) performing 3.5.10 Having such activities other responsibilities as may be delegated mutually agreed upon by the Parties from time to time; provided that the JCC shall not have responsibility for (a) any aspect of the marketing, sale or promotion of CONCERTA®, or (b) with respect to the JDCC pursuant Product, any interactions with customers concerning rebating or discounting of any type or, subject to this AgreementSection 3.5.5, other terms or by mutual written agreement conditions of sale or the Parties after development or implementation of strategies for the Approval Datemanaged care market.
Appears in 1 contract
Responsibilities. The JDCC purpose of the JSC will be to provide a forum for open communication and coordination between the Parties regarding the conduct, progress and results achieved under the Territory Specific Development Plan and to oversee the Collaboration. Subject to the express rights of the Parties as set forth herein, the role of the JSC is to:
(i) review, discuss and approve proposals by either Party to amend the Territory Specific Development Plan;
(ii) review, discuss and approve proposals to add any Additional Program to the Collaboration, which approval shall also subsequently require the approval of the Parties themselves;
(iii) review the results of the QTPP Testing and determine if the QTPP Testing results achieve the specifications that are set forth in the Territory Specific Development Plan;
(iv) coordinate the supply of Materials (including Vector Supply) between the Parties for use under the Territory Specific Development Plan;
(v) act as liaison between the Parties to ensure open and regular communication channels, and more particularly to ensure the Parties are informed of, and have a forum to discuss, the ongoing progress of the Collaboration;
(vi) review and discuss (but for clarity, not approve) the Development of the Product by JW in the JW Territory after Completion of the Phase I Trial;
(vii) review and discuss (but for clarity, not approve) the Commercialization Plan for the Product by JW;
(viii) establish such subcommittees and working groups as it may deem appropriate to carry out the goals of the Collaboration; and
(ix) perform such other activities as the Parties agree in writing will be responsible for overseeing the responsibility of the JSC.
(x) Notwithstanding the foregoing, in the event that the Product Developed by JW under the Territory Specific Development Plan will be the same as a TSVT Product (as determined by Regulatory Authorities) (such Product, the “Shared Product”), then the Parties will revise the governance provisions under this Article II to extend the JSC’s responsibilities to review and approve any Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting JW Product by JW, provided that such revision shall be subject to the generality of the foregoing, the JDCC shall have the following responsibilities:
(a) the development Parties’ mutual agreement and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect not subject to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co’s final decision-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in making authority under Section 4.5.52.3(d).
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration Agreement
Responsibilities. The JDCC JPC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(ai) Consult with THERAVANCE in the development case of the Development Plan and discussion with MYLAN in the case of strategies the Commercialization Plan in connection with such Party's preparing and updating of the Development Plan and Commercialization Plan and their associated budgets in a timely manner (providing any comments within thirty (30) days of the submission thereof by the applicable Party) and submit them to the JSC for review and approval;
(ii) At an appropriate and regular frequency, review the Development strategy (and, when appropriate, the Commercialization strategy) for the Licensed Product in the Field;
(iii) Review and discuss whether or not to recommend to the JSC any material amendments or modifications to the Development Plan or the Commercialization Plan;
(iv) Coordinate and monitor regulatory strategy and activities for the Licensed Product in accordance with Article 7;
(v) Review and recommend to the JSC operational and other decisions for the Development and Commercialization of each Co-Developed Licensed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesField;
(bvi) reviewing Discuss the state of the markets for Licensed Product and discussing a Marketing opportunities and Sales Plan for each Co-Developed Product in issues concerning the Co-Development TerritoryCommercialization of the Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, and labeling;
(cvii) coordinating At an appropriate and regular frequency, review the Development status of all studies conducted on Licensed Product and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territoryany results therefrom;
(eviii) reviewing At an appropriate and providing input on regular frequency, review Net Sales of Licensed Product for the shortyear-term to-date, and longa current outlook for Net Sales for the remainder of the then-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per current Calendar Year;
(gix) coordinating the Detailing efforts of both Parties Plan and review all publications described in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recallsSection 9.03, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving review and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party approve a publications policy for inclusion with a Co-Developed Product to create a Combination Productsuch publications; and
(lx) performing Have such activities other responsibilities as may be delegated assigned to the JDCC JPC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after through the Approval Date.JSC from time to time. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The JDCC Joint Manufacturing Committee shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitieswith respect to each Joint DDC and/or Joint Product:
(a) determining the development best Manufacturing procedures and discussion processes to be used to produce necessary volumes of strategies for such Joint DDC and/or Joint Product with reproducible high quality and at a competitive cost (including whether or not to authorize the Development and Commercialization use of each Co-Developed Product in a proprietary manufacturing technology of a Party that such Party would be unwilling to transfer to the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesother Party pursuant to Section 4.9.5);
(b) reviewing and discussing a Marketing and Sales Plan determining the Lead Manufacturing Party for each Co-Developed such Joint DDC and/or Joint Product in accordance with the Co-Development Territoryprovisions of Section 6.3;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect maintaining global oversight over all Manufacturing activities relating to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.such Joint DDC and/or Joint Product;
(d) reviewing and providing input in overseeing the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan all Manufacturing Plans for each Co-Developed Product in such Joint DDC and/or Joint Product, subject to review by the Co-Development TerritoryJoint Executive Committee;
(e) reviewing and providing input on monitoring the short-term and long-term sales forecasts for Co-Developed Products in Parties' compliance with their respective obligations under the Co-Developed TerritoryManufacturing Plans;
(f) presenting sales forecasts overseeing regulatory compliance with respect to Manufacturing activities; Confidential Materials omitted and filed separately with the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;Securities and Exchange Commission. Asterisks denote omissions.
(g) coordinating reviewing a detailed breakdown of the Detailing efforts components of both Parties in the Co-Development Territory with respect to Co-Developed ProductsStandard Cost of Goods Sold for such Joint DDC and/or Joint Product;
(h) overseeing all recallsdetermining (i) whether the Manufacturing of such Joint DDC and/or Joint Product requires any Special Purpose Equipment; (ii) the budgeted capital costs for the acquisition of such Special Purpose Equipment and the manner in which such capital costs shall be financed (e.g., market withdrawals whether the Parties will share the costs up-front or whether the Lead Manufacturing Party shall incur such costs and recover such costs over the Capital Recovery Period); (iii) the period over which the capital costs relating to such Special Purpose Equipment shall be recovered and reflected in Standard Cost of Goods Sold (the "Capital Recovery Period"); and (iv) the manner in which the Lead Manufacturing Party (or the Parties if the capital costs are shared up-front) shall recover any other corrective actions related to Co-Developed Products unrecovered capital costs in the Co-Development Territory;event that the Joint Manufacturing Committee terminates the Manufacturing rights of the Lead Manufacturing Party prior to the expiration of the Capital Recovery Period; and
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities other tasks and undertaking such other responsibilities as may be delegated to the JDCC pursuant to set forth in this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesJCC will:
(a) oversee the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product the Shared Products by the Parties in the Co-Development Field in the Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing develop and discussing approve a Marketing and Sales Global Commercialization Plan for each Co-Developed Shared Product in and submit such Global Commercialization Plan to the Co-Development TerritoryJSC for review and discussion;
(c) coordinating amend the Development Global Commercialization Plan for each Shared Product on an annual basis (or more frequently as needed), approve such amendments and submit such updated Global Commercialization efforts of both Parties in Plans to the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible JSC for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products review and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.discussion;
(d) reviewing review, discuss and providing input in approve the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan initial Regional Commercialization Plans for each Co-Developed Shared Product in the Co-Development Territoryand any amendments or updates thereto submitted by Parties;
(e) reviewing and providing input on select product Trademarks for each Shared Product throughout the short-term and long-term sales forecasts for Co-Developed Products in world consistent with the Co-Developed TerritoryGlobal Brand Strategy;
(f) presenting sales forecasts and advise the results JMC in connection with its oversight of all efforts the Manufacturing Working Group with respect to matters relating to the commercial Manufacture of the Shared Products;
(g) advise the JMC in connection with its oversight of the commercial Manufacture of the Shared Products in the Co-Development Territory Field in the Territory;
(h) advise the JMC in connection with its review and discussion of any updates to the Global Manufacturing Plan, including the Manufacturing Budget, proposed by the Manufacturing Working Group;
(i) submit the approved updated Global Commercialization Budget for the subsequent Calendar Year to the JSC as needed, but for inclusion in the Integrated Budget no less often later than two (2) times per [***] of each Calendar Year;
(gj) coordinating advise the Detailing efforts JMC in connection with its review, discussion and approval of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recallsManufacturing process, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territorychanges thereto, for each Shared Product;
(k) reviewing review, discuss and approving approve any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with use of a Co-Developed Product Subcontractor to create conduct a Combination ProductParty’s activities under a Global Commercialization Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(l) performing perform such activities other duties as are specifically assigned to the JCC under this Agreement or as may be delegated to the JDCC JCC by the JSC. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to this Agreement, or by mutual written agreement Rule 24b-2 of the Parties after the Approval Date.Securities Exchange Act of 1934, as amended. Table of Contents
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)
Responsibilities. The JDCC JCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have perform the following responsibilitiesfunctions:
(ai) oversee the development preparation and discussion implementation of strategies for the Development and Commercialization of each CoMarketing Plans; Confidential treatment requested by Bristol-Developed Product in the CoMyers Squibb Company, Bristol-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of Myers Squibb Biologics ▇▇▇▇▇▇▇ ▇▇▇ ▇mClone Systems Incorp▇▇▇▇▇▇.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(iv) discuss the state of the markets for Products in the Territory and opportunities and issues concerning the commercialization of the Products, howeverincluding consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the Marketing Plans;
(v) review and approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy for the Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the JCC, review a comparison of actual sales and marketing expenses to the budgeted expenses in the relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xiii) review and approve the general guidelines applicable to particular Products to be followed by ERS in its development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC; Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers Squibb Biologics ▇▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇ ▇mClone Systems Incorp▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5▇.
(dxvi) reviewing evaluate and providing input in determine the preparation existence or non-existence of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Problem referred to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties JCC in the Co-Development Territory accordance with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination ProductSection 5.6(e); and
(lxvii) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc/De)
Responsibilities. The JDCC Joint Commercialization Committee shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitieswith respect to all Joint DDCs and Joint Products:
(a) maintaining global oversight of the development Commercialization process for all Joint DDCs and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesJoint Products;
(b) reviewing appointing a global new product pre-launch team at or prior to the commencement of Phase IIIA Studies for such Joint DDC (a "Global New Product Pre-Launch Team"), which shall be responsible for the preparation of the Global Commercialization Framework, pursuant to Section 7.2.1, for such Joint DDC and discussing a Marketing the transition of such Global Commercialization Framework to the U.S. Joint Commercialization Product Team and Sales Plan for each Co-Developed the ROW Commercialization Product in the Co-Development TerritoryTeam;
(c) coordinating reviewing and approving the Development Global Commercialization Framework for each Joint DDC and Commercialization efforts Joint Product;
(d) appointing a joint commercialization product team comprised of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes an equal number of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility representatives designated by each of ▇▇▇▇▇▇, however, ▇ and Millennium to prepare and implement the U.S. Commercialization Plan and prepare the U.S. Commercialization Budget for each Joint DDC and Joint Product in the United States (each a "U.S. Joint Commercialization Product Team") and reviewing recommendations from and advising all U.S. Joint Commercialization Product Teams;
(e) approving the appointment by ▇▇▇▇▇▇ will work directly with of a regulatory liaison to be commercialization product team comprised of representatives designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep to prepare and implement the JDCC informed of key regulatory communications involving key regulatory filings ROW Commercialization Plan and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in prepare the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan ROW Commercialization Budget for each Co-Developed Joint DDC and/or Joint Product in the Co-Development Territory;
ROW (eeach a "ROW Commercialization Product Team") and reviewing recommendations from and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territoryadvising all ROW Commercialization Product Teams;
(f) presenting sales forecasts reviewing and approving the U.S. Commercialization Plan and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar YearROW Commercialization Plan for each Joint DDC and Joint Product;
(g) coordinating reviewing and approving the Detailing efforts of both Parties in U.S. Commercialization Budget and the Co-Development Territory with respect ROW Commercialization Budget for each Joint DDC and Joint Product, setting permitted deviations therefrom that do not require an amendment to Co-Developed Productsthe budget, and determining the geographic breakdown for the ROW Commercialization Budget;
(h) overseeing the implementation of the Commercialization Plans for all recalls, market withdrawals Joint DDCs and any other corrective actions related to Co-Developed Products in the Co-Development TerritoryJoint Products;
(i) receiving and providing to monitoring the Parties sales reports pertaining to Co-Developed Products in Parties' compliance with the Co-Developed Territoryrequirements of the Commercialization Plans;
(j) approving monitoring the allocation of Commercialization strategic activities between the Parties across all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed of the Joint Products in the Co-Developed TerritoryUnited States to ensure that such allocation is consistent with the provisions of Sections 7.3 and 7.4;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a establishing Co-Developed Promotion Guidelines, if applicable, pursuant to Section 7.6;
(l) developing recommendations with the Joint Manufacturing Committee regarding the manufacturing and supply chain strategy for a Joint DDC and Joint Product, including, without limitation, which Party (or Third Party) shall be responsible for specific activities within the supply chain;
(m) developing procedures regarding the collection, sharing and reporting of adverse information related to such Joint Product on a global basis;
(n) making recommendations to create a Combination Productthe Joint Executive Committee with respect to any appropriate actions to be taken concerning adverse event information under any Commercialization Plan;
(o) performing duties with respect to Program Diagnostics pursuant to Article 5;
(p) overseeing the preparation of, and approving, protocols for, and otherwise overseeing and monitoring Phase IV Studies under the Commercialization Program; and
(lq) performing such activities other tasks and undertaking such other responsibilities as may be delegated to the JDCC pursuant to set forth in this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)
Responsibilities. The JDCC a. Heads of agencies shall:
(1) Cooperate with the Secretary of the Budget and the Secretary of General Services to implement the Contractor Responsibility Program, including the amendment of existing regulations, when appropriate.
(2) Have primary responsibility for reporting instances of contractor nonresponsibility, deficient contractor performance, including performance on requirements contracts (commonly
(3) Designate a senior manager to carry out the agency’s responsibilities under this directive and report to the Department Security Coordinator (DSC) the name of the individual. This person shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesfor:
(a) authorizing updates to the development Central Contractor Responsibility File and discussion of strategies for designating who has the Development update capability and Commercialization of each Co-Developed Product in who is authorized to access the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesfile;
(b) reviewing and discussing a Marketing and Sales Plan ensuring that the overall security of the Central Contractor responsibility File is maintained for each Co-Developed Product in the Co-Development Territory;his agency; and
(c) coordinating making a written determination that the Development agency has followed the procedures in section 7a, in determining the contractor to be responsible.
(4) Consult with the Office of General Counsel and Commercialization efforts the Office of both Parties State Inspector General in the Co-Development Territory with respect to Co-Developed Products. For purposes implementation and operation of claritythis program and in investigating complaints of contractor nonresponsibility.
(5) Incorporate design and/or per- formance standards in contracts, the JDCC shall where applicable, so that contract monitoring can be accomplished.
(6) Ensure that Invitations for Bids contain language stating that if a contractor has been suspended or debarred, its bids will not be responsible accepted or considered.
(7) Ensure that all solicitations include a provision that the prospective contractor and subcontractor certify that they have not been suspended/debarred from any other state or federal government.
(8) Ensure that all contracts include a provision permitting the termination of any subcontracts with contractors who have been suspended or debarred by the Commonwealth consistent with the provision of section 5d (5).
(9) Ensure that the policies and proce- dures prescribed through the Directive Manage- ment System are implemented within the agency. (10) Require that contractors and pro- posed subcontractors provide their name and federal identification number in response to solicitations for coordinating communications bids.
b. Secretary of the Budget shall:
(1) Develop jointly with Regulatory Authorities, which is the sole responsibility Secretary of ▇▇▇▇▇▇, however, ▇General Services a Contractor Responsibility Program.
(2) Direct the development and mainte- ▇▇▇▇▇ will work directly with cooperation from the Department of General Services of a regulatory liaison centralized system to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products collect and will keep Enanta’s liaison informed disseminate reports of contractor nonresponsi- bility and deficient performance as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings well as specified in Section 4.5.5sanctions imposed against contractors.
(d3) reviewing Assist the Department of General Services and providing input the Office of State Inspector General in the preparation of a Marketing developing and Sales Plan containing a Co-Promotion Plan maintaining policies, procedures, and guidelines for each Co-Developed Product in the Co-Development Territory;agencies to investigate and report contractor nonresponsibility and deficient perform- ance.
(e4) reviewing Exempt specific grant and providing input on loan programs from this directive and notify the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results Secretary of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts General Services of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Datethese exemptions.
Appears in 1 contract
Sources: Memorandum of Understanding
Responsibilities. The JDCC shall be responsible for overseeing the Development and Joint Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC Committee shall have the following responsibilities:
: 33 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (a) establishing the development and discussion of strategies strategy for the Development and Commercialization of each Co-Developed Product Licensed Products in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
Field in North America; (b) reviewing developing and discussing a Marketing approving the Commercialization Plan/Budget in accordance with Section 2.5, as well as updating the Commercialization Plan/Budget and Sales Plan for each Co-Developed Product in amending the Co-Development Territory;
Commercialization Plan/Budget from time to time as appropriate; (c) coordinating subject to the Development specific terms and conditions hereof, allocating responsibilities under the Commercialization efforts of both Plan/Budget to the Parties in accordance with the Co-Development Territory with respect Parties’ abilities to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling perform such activities in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings most efficient and milestone meetings as specified in Section 4.5.5.
cost effective manner; (d) reviewing and providing input overseeing the implementation of the strategy for Commercializing the Licensed Products in the preparation of a Marketing Field in North America (including strategies related to regulatory approvals, reimbursement, advertising and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product promotion, brand integrity, sales, and launch sequence as set forth in the Co-Development Territory;
Commercialization Plan/Budget); (e) reviewing and providing input on to the short-term Joint Development Committee regarding the target product profile for the Licensed Products and long-term sales forecasts for Co-Developed Products in making recommendations regarding changes to the Co-Developed Territory;
same; (f) presenting sales forecasts and approving the results licensing of all efforts Third Party technology, as described in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
Section 5.6.3(d); (g) coordinating reviewing the Detailing efforts of both Parties Parties’ marketing and promotional activities in North America to ensure that such activities are consistent with the Co-Development Territory with respect to Co-Developed Products;
Commercialization Plan/Budget; and (h) overseeing all recalls, market withdrawals performing such other activities as are contemplated under this Agreement and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to that the Parties sales reports pertaining to Co-Developed Products in mutually agree shall be the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement responsibility of the Parties after the Approval DateJoint Commercialization Committee.
Appears in 1 contract
Responsibilities. The JDCC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality responsibilities of the foregoing, the JDCC shall have the following responsibilities:
Steering Committee (a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to sub-groups by approval of the JDCC pursuant Steering Committee) will include, without limitation:
5.2.1 approving the Annual Commercial Plan (including the budget therein); provided, however, the Annual Commercial Plan approved by the Steering Committee must conform with the requirements of Section 3.2;
5.2.2 determining the types and forms of Ad/Prom Materials to be created (e.g., printed materials, television media, digital media such as website content or e-marketing) and reviewing and approving all Ad/Prom Materials for the Test and sales force training materials before first use in the Territory; provided, however, that the Steering Committee may delegate review and approval of the Ad/Prom Materials to Genzyme’s and Veracyte’s respective marketing review committees, and if the marketing review committees of both parties separately approve the Ad/Prom Materials, the Steering Committee shall be deemed to have approved such Ad/Prom Materials;
5.2.3 planning, monitoring and evaluating the overall sales and marketing program for the Test in the Territory and ensuring the program is compliant with best practices in the Territory and all applicable laws and regulations;
5.2.4 implementing the marketing and promotion strategy for the Test in the Territory, including the planned number of Calls for each calendar year, provided that the average minimum number of calls per quarter per FTE shall be *** and the targets for such Calls, in order to market, promote and detail the Test in the most effective and efficient fashion; provided, however, the Steering Committee may not require Genzyme to make more or fewer than an average of *** (***) Calls per Territory Sales Force FTE during each calendar quarter; and
5.2.5 any other activities specifically provided for in this Agreement. The members of the Steering Committee from each party shall have the right to comment upon and make recommendations to the members of the other party regarding the other party’s activities under this Agreement, or by mutual written agreement of which recommendations the Parties after the Approval Dateother party shall be reasonably considered.
Appears in 1 contract
Responsibilities. The JDCC duties of the Alternate Dispute Resolution Committee include but are not limited to the following:
i) Maintain a list of persons qualified by temperament and experience, and with technical or legal expertise in matters likely to be the subject of disputes, to serve as mediators or arbitrators under these PJM Dispute Resolution Procedures;
ii) Determine the rates and other costs and charges that shall be responsible paid to mediators, advisors and arbitrators for overseeing the Development or in connection with their services;
iii) Determine whether mediation is not warranted in a particular dispute;
iv) Provide to disputing parties lists of mediators, advisors or arbitrators to resolve particular disputes;
v) Compile and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoingmake available to parties to disputes, the JDCC shall have the following responsibilities:
(a) the development arbitrators, and discussion of strategies other interested persons suggested procedures for the Development and Commercialization arbitration of each Co-Developed Product disputes in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesaccordance with Section 4.5;
(bvi) reviewing Maintain and discussing a Marketing make available to parties to disputes, mediators, advisors, arbitrators, and Sales Plan for each Co-Developed Product in other interested persons the Co-Development Territorywritten decisions required by Section 4.12;
(cvii) coordinating Establish such procedures and schedules, in addition to those specified herein, as it shall deem appropriate to further the Development prompt, efficient, fair and Commercialization efforts equitable resolution of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productdisputes; and
(lviii) performing Provide such activities oversight and supervision of the dispute resolution processes and procedures instituted pursuant to the Related PJM Agreements as may be delegated appropriate to facilitate the JDCC pursuant to this Agreementprompt, or efficient, fair and equitable resolution of disputes. SCHEDULE 6 ---------- Revision No. 1 REGIONAL TRANSMISSION EXPANSION PLANNING PROTOCOL ------------------------------------------------- Issued: June 2, 1997 Effective: January 1, 1998
1. REGIONAL TRANSMISSION EXPANSION PLANNING PROTOCOL Purpose and Objectives This Regional Transmission Expansion Planning Protocol shall govern the process by mutual written agreement which the Members shall rely upon the Office of the Parties after Interconnection to prepare a plan for the Approval Dateenhancement and expansion of the Transmission Facilities in order to meet the demands for firm transmission service in the PJM Control Area. The Regional Transmission Expansion Plan to be developed shall enable the transmission needs in the PJM Control Area to be met on a reliable, economic and environmentally acceptable basis.
Appears in 1 contract
Responsibilities. The JDCC JCC shall be responsible perform the following functions:
(i) oversee the preparation and implementation of the Marketing Plans;
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(iv) discuss the state of the markets for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting Territory and opportunities and issues concerning the generality commercialization of the foregoingProducts, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the JDCC shall have priority for same and the following responsibilities:
(a) amount and kind of marketing and selling effort appropriate, in accordance with the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesMarketing Plans;
(bv) reviewing review and discussing approve the total annual budget for all Phase IV Clinical Trials, but not the budget or protocol for the individual studies themselves which must be approved by the PDC and the JEC pursuant to Section 4.3 (f);
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time; • (x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts; •
(xii) at each meeting of the JCC, review a Marketing comparison of actual sales and Sales Plan for each Co-Developed Product marketing expenses to the budgeted expenses in the Corelevant Marketing Budget for the year-Development to-date, as current as practicable to a date immediately prior to the date of the meeting;
(xiii) review and approve the general guidelines applicable to particular Products to be followed in the development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(cxv) coordinating review and approve the Development and Commercialization efforts of both Parties in joint publication strategy together with the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.PDC;
(dxvi) reviewing evaluate and providing input in determine the preparation existence or non-existence of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Problem referred to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties JCC in the Co-Development Territory accordance with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination ProductSection 5.6(e); and
(lxvii) performing have such activities other responsibilities as may be delegated assigned to the JDCC JCC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time."
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement