Product Development. 3.1 Radius shall, at its own expense, carry out all necessary pre-clinical and clinical studies related to Compound and/or Product required by the relevant authorities throughout the Territory to achieve Product registration for the Product in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product in the Territory in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential (taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved and profitability) and for which it has similar rights. 3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product in the Territory as required for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) in those countries in the Territory where Radius seeks to market and sell Products. Attainment and maintenance of regulatory approvals for Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvals. 3.3 The Parties intend and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility for, and control of, pre-clinical and clinical development and commercialization of Products in the Territory, including the authority to make all decisions, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters relating to the Development of Products, and Radius shall not unreasonably refuse to consider such input and suggestions. 3.4 Attached as Appendix C is a plan detailing Radius’ projected activities to Develop Products in the Territory (the “Development Plan”). On or before each anniversary of the Effective Date, Radius shall update, revise and present to Eisai the Development Plan during the term of this Agreement prior to establishment of the SC (as defined in Article 3.5). Eisai shall comment upon each version of the Development Plan within [*] ([*]) days including whether it believes that the performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory. After establishment of the SC, Radius shall update, revise and present to the SC the Development Plan and Eisai may comment upon each version of the Development Plan via its participation in the SC and at the next meeting of the SC. If Eisai indicates that it does not believe performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory, Eisai shall identify the actions or conduct that it would consider to be an acceptable remediation of * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. such inconsistency. Radius shall have [*] ([*]) days to deliver to Eisai a plan for remediation of such inconsistency as rapidly as practicable. Following delivery of such plan, Radius shall use commercially reasonable efforts to carry out the plan and cure the inconsistency. If Radius fails to deliver a plan for remediation within the [*]-day period, or (ii) Radius fails to carry out the corrective plan or actions in accordance with such plan, Eisai may terminate this Agreement pursuant to Article 7.3. 3.5 Radius shall give a written report to Eisai on a quarterly basis with respect to the progress on the pre-clinical and clinical portions of the Development of Products in the Territory from the Effective Date. If Eisai notifies Radius of its intent to Develop Products in Japan, within [*] ([*]) days of the date of the notice, the Parties will establish a Joint Steering Committee (the “SC”) to review progress on the pre-clinical and clinical portions of the Product Development contemplated by this Agreement. The purpose of the SC is to facilitate the exchange of information and the coordination between the Parties relating to the Development of Products, and to serve as a forum for Radius to keep Eisai updated with regard to the Development of Products in the Territory and Eisai to keep Radius updated with regard to the Development of Products in Japan (in the form of summaries of the Development plan, clinical design and strategy, etc.). The SC will be composed of two representatives of each Party, who shall be appointed (and may be replaced at any time) by such Party on written notice to the other in accordance with this Agreement. The SC will meet at least twice per year, or at any other frequency agreed by the SC. The first meeting of the SC shall be held within [*] ([*]) days after establishing the SC. Meetings may be held by telephone or video conference. Minutes of all meetings of the SC shall be prepared by Radius within [*] ([*]) days after each meeting. 3.6 The quorum for SC meetings shall be two (2) members, provided there is at least one member from each of Eisai and Radius is present. The SC will render decisions by unanimous vote. Disagreements among the SC regarding the Program will be resolved via good-faith discussions; provided, that in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. event of a disagreement or deadlock that cannot be resolved within [*] ([*]) days after the date on which the disagreement arose, Radius shall have the right to cast the tiebreaking vote and resolve the matter in the Territory and Eisai shall have the right to cast the tiebreaking vote and resolve the matter in Japan.
Appears in 2 contracts
Sources: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)
Product Development. 3.1 Radius (a) During the term of this Agreement, Schering shall, at its own expense, carry out all necessary pre-clinical conduct a research and clinical development program to evaluate Selected Compounds and Derivative Compounds as potential candidates for commercial development as Licensed Products. Such efforts may include the performance of further medicinal chemical research based upon such Selected Compounds and Derivative Compounds, as well as biological, pharmacokinetic and toxicology studies related to Compound and/or Product required by and other preclinical research activities. Schering shall have sole discretion *= CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. over the relevant authorities throughout scope of such research and development program, and the Territory to achieve Product registration for selection of which Selected Compounds and Derivative Compounds will be the Product focus of such activities.
(b) Schering shall notify NeoGenesis in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product writing in the Territory event that Schering, in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential sole discretion (taking into account issues of safety, efficacy, product profile, the competitiveness based on Schering's good faith evaluation of the marketplace, the proprietary position satisfaction of the productapplicable Success Criteria by such Selected Compound or Derivative Compound), decides to proceed with a development program for any Selected Compounds or Derivative Compounds as suitable candidates for drug development (thereafter, each a "DESIGNATED COMPOUND"). A Selected Compound or Derivative Compound will be deemed to be a Designated Compound upon the regulatory structure involved earlier of that date on which (i) Schering (or its Affiliate) formally approves proceeding with full development of such Compound, or (ii) Schering (or its Affiliate) initiates IN VIVO toxicology trials necessary, and profitabilitymeeting U.S. FDA (or corresponding European or Japanese) standards, for obtaining approval for use of such Compound in human clinical trials, unless Schering sooner designates such Selected Compound or Derivative Compound as a Designated Compound with notice to NeoGenesis. Upon Schering's designation of a Designated Compound, Schering shall thereafter, at its expense, use Commercially Reasonable Efforts to develop and for which it has similar rights.
3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product commercialize Licensed Products incorporating the Designated Compound in the Territory as required Territory. Schering shall be solely responsible for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) determining in those which countries in the Territory where Radius seeks to develop and commercialize each Licensed Product, provided that it shall use Commercially Reasonable Efforts to obtain Regulatory Approval and to market and sell Products. Attainment and maintenance of regulatory approvals for each Licensed Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvalsMajor Market Countries.
3.3 The (c) Subject to Schering's diligence obligations under this Agreement, the Parties intend acknowledge and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility forall business decisions regarding research, and control of, pre-clinical and clinical development and commercialization of Designated Compounds and Licensed Products in the Territoryincluding, including the authority to make all decisionswithout limitation, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters decisions relating to the Development design, development, manufacture, sale, price, distribution, marketing and promotion of ProductsLicensed Products under this Agreement, and Radius the decision of whether to develop a particular Designated Compound, or to develop and commercialize a particular Licensed Product, shall not unreasonably refuse to consider such input and suggestionsbe within the sole discretion of Schering.
3.4 Attached (d) Schering shall have no quotas or other minimum diligence obligations with regard to the number of Designated Compounds and/or Licensed Products to be developed and commercialized hereunder. The parties acknowledge and agree that so long as Appendix C Schering is a plan detailing Radius’ projected activities using Commercially Reasonable Efforts to Develop Products in the Territory (the “Development Plan”). On or before each anniversary of the Effective Datediscover, Radius shall update, revise develop and present to Eisai the Development Plan during the term of this Agreement prior to establishment of the SC (as defined in Article 3.5). Eisai shall comment upon each version of the Development Plan within commercialize [*] ([*]) days including whether it believes that the performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory. After establishment of the SC, Radius shall update, revise and present to the SC the Development Plan and Eisai may comment upon each version of the Development Plan via its participation in the SC and at the next meeting of the SC. If Eisai indicates that it does not believe performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Licensed Product in the Territory, Eisai Schering shall identify the actions or conduct that it would consider be deemed to be an acceptable remediation of * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately in compliance with the Commission. such inconsistency. Radius shall have [*] ([*]) days to deliver to Eisai a plan for remediation of such inconsistency as rapidly as practicable. Following delivery of such plan, Radius shall use commercially reasonable efforts to carry out the plan and cure the inconsistency. If Radius fails to deliver a plan for remediation within the [*]-day period, or (ii) Radius fails to carry out the corrective plan or actions in accordance with such plan, Eisai may terminate this Agreement pursuant to Article 7.3.
3.5 Radius shall give a written report to Eisai on a quarterly basis with respect to the progress on the pre-clinical and clinical portions of the Development of Products in the Territory from the Effective Date. If Eisai notifies Radius of its intent to Develop Products in Japan, within [*] ([*]) days of the date of the notice, the Parties will establish a Joint Steering Committee (the “SC”) to review progress on the pre-clinical and clinical portions of the Product Development contemplated by diligence obligations under this Agreement. The purpose of the SC is to facilitate the exchange of information and the coordination between the Parties relating to the Development of Products, and to serve as a forum for Radius to keep Eisai updated with regard to the Development of Products in the Territory and Eisai to keep Radius updated with regard to the Development of Products in Japan (in the form of summaries of the Development plan, clinical design and strategy, etc.). The SC will be composed of two representatives of each Party, who shall be appointed (and may be replaced at any time) by such Party on written notice to the other in accordance with this Agreement. The SC will meet at least twice per year, or at any other frequency agreed by the SC. The first meeting of the SC shall be held within [*] ([*]) days after establishing the SC. Meetings may be held by telephone or video conference. Minutes of all meetings of the SC shall be prepared by Radius within [*] ([*]) days after each meeting.
3.6 The quorum for SC meetings shall be two (2) members, provided there is at least one member from each of Eisai and Radius is present. The SC will render decisions by unanimous vote. Disagreements among the SC regarding the Program will be resolved via good-faith discussions; provided, that in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. event of a disagreement or deadlock that cannot be resolved within [*] ([*]) days after the date on which the disagreement arose, Radius shall have the right to cast the tiebreaking vote and resolve the matter in the Territory and Eisai shall have the right to cast the tiebreaking vote and resolve the matter in Japan.
Appears in 1 contract
Sources: Confidentiality Agreement (Neogenesis Pharmaceuticals Inc)
Product Development. 3.1 Radius shall, at its own expense, carry out all necessary pre-clinical and clinical studies related to Compound and/or Product required by the relevant authorities throughout the Territory to achieve Product registration for the Product in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product in the Territory in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential (taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved and profitability) and for which it has similar rights.
3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product in the Territory as required for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) in those countries in the Territory where Radius seeks to market and sell Products. Attainment and maintenance of regulatory approvals for Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvals.
3.3 The Parties intend and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility for, and control of, pre-clinical and clinical development and commercialization of Products in the Territory, including the authority to make all decisions, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters relating to the Development of Products, and Radius shall not unreasonably refuse to consider such input and suggestions.
3.4 Attached as Appendix C is a plan detailing Radius’ projected activities to Develop Products in the Territory (the “Development Plan”). On or before each anniversary of the Effective Date, Radius shall update, revise and present to Eisai the Development Plan during the term of this Agreement prior to establishment of the SC (as defined in Article 3.5). Eisai shall comment upon each version of the Development Plan within [*] sixty ([*]60) days including whether it believes that the performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory. After establishment of the SC, Radius shall update, revise and present to the SC the Development Plan and Eisai may comment upon each version of the Development Plan via its participation in the SC and at the next meeting of the SC. If Eisai indicates that it does not believe performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory, Eisai shall identify the actions or conduct that it would consider to be an acceptable remediation of * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. such inconsistency. Radius shall have [*] ninety ([*]90) days to deliver to Eisai a plan for remediation of such inconsistency as rapidly as practicable. Following delivery of such plan, Radius shall use commercially reasonable efforts to carry out the plan and cure the inconsistency. If Radius fails to deliver a plan for remediation within the [*]-day 90-day period, or (ii) Radius fails to carry out the corrective plan or actions in accordance with such plan, Eisai may terminate this Agreement pursuant to Article 7.3.
3.5 Radius shall give a written report to Eisai on a quarterly basis with respect to the progress on the pre-clinical and clinical portions of the Development of Products in the Territory from the Effective Date. If Eisai notifies Radius of its intent to Develop Products in Japan, within [*] thirty ([*]30) days of the date of the notice, the Parties will establish a Joint Steering Committee (the “SC”) to review progress on the pre-clinical and clinical portions of the Product Development contemplated by this Agreement. The purpose of the SC is to facilitate the exchange of information and the coordination between the Parties relating to the Development of Products, and to serve as a forum for Radius to keep Eisai updated with regard to the Development of Products in the Territory and Eisai to keep Radius updated with regard to the Development of Products in Japan (in the form of summaries of the Development plan, clinical design and strategy, etc.). The SC will be composed of two representatives of each Party, who shall be appointed (and may be replaced at any time) by such Party on written notice to the other in accordance with this Agreement. The SC will meet at least twice per year, or at any other frequency agreed by the SC. The first meeting of the SC shall be held within [*] ninety ([*]90) days after establishing the SC. Meetings may be held by telephone or video conference. Minutes of all meetings of the SC shall be prepared by Radius within [*] thirty ([*]30) days after each meeting.
3.6 The quorum for SC meetings shall be two (2) members, provided there is at least one member from each of Eisai and Radius is present. The SC will render decisions by unanimous vote. Disagreements among the SC regarding the Program will be resolved via good-faith discussions; provided, that in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. event of a disagreement or deadlock that cannot be resolved within [*] thirty ([*]30) days after the date on which the disagreement arose, Radius shall have the right to cast the tiebreaking vote and resolve the matter in the Territory and Eisai shall have the right to cast the tiebreaking vote and resolve the matter in Japan.
Appears in 1 contract
Product Development. 3.1 Radius shall, at its own expense, carry out all necessary pre-clinical and clinical studies related to Compound and/or Product required by the relevant authorities throughout the Territory to achieve Product registration for the Product in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product in the Territory in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential (taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved and profitability) and for which it has similar rights.
3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product in the Territory as required for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) in those countries in the Territory where Radius seeks to market and sell Products. Attainment and maintenance of regulatory approvals for Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvals.
3.3 The Parties intend and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility for, and control of, pre-clinical and clinical development and commercialization of Products in the Territory, including the authority to make all decisions, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters relating to the Development of Products, and Radius shall not unreasonably refuse to consider such input and suggestions.
3.4 Attached as Appendix C is a plan detailing Radius’ projected activities to Develop Products in the Territory (the “Development Plan”). On or before each anniversary of the Effective Date, Radius shall update, revise and present to Eisai the Development Plan during the term of this Agreement prior to establishment of the SC (as defined in Article 3.5). Eisai shall comment upon each version of the Development Plan within [*] sixty ([*]60) days including whether it believes that the performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory. After establishment of the SC, Radius shall update, revise and present to the SC the Development Plan and Eisai may comment upon each version of the Development Plan via its participation in the SC and at the next meeting of the SC. If Eisai indicates that it does not believe performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory, Eisai shall identify the actions or conduct that it would consider to be an acceptable remediation of * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. such inconsistency. Radius shall have [*] ninety ([*]90) days to deliver to Eisai a plan for remediation of such inconsistency as rapidly as practicable. Following delivery of such plan, Radius shall use commercially reasonable efforts to carry out the plan and cure the inconsistency. If Radius fails to deliver a plan for remediation within the [*]-day 90-day period, or (ii) Radius fails to carry out the corrective plan or actions in accordance with such plan, Eisai may terminate this Agreement pursuant to Article 7.3.
3.5 Radius shall give a written report to Eisai on a quarterly basis with respect to the progress on the pre-clinical and clinical portions of the Development of Products in the Territory from the Effective Date. If Eisai notifies Radius of its intent to Develop Products in Japan, within [*] thirty ([*]30) days of the date of the notice, the Parties will establish a Joint Steering Committee (the “SC”) to review progress on the pre-clinical and clinical portions of the Product Development contemplated by this Agreement. The purpose of the SC is to facilitate the exchange of information and the coordination between the Parties relating to the Development of Products, and to serve as a forum for Radius to keep Eisai updated with regard to the Development of Products in the Territory and Eisai to keep Radius updated with regard to the Development of Products in Japan (in the form of summaries of the Development plan, clinical design and strategy, etc.). The SC will be composed of two representatives of each Party, who shall be appointed (and may be replaced at any time) by such Party on written notice to the other in accordance with this Agreement. The SC will meet at least twice per year, or at any other frequency agreed by the SC. The first meeting of the SC shall be held within [*] ninety ([*]90) days after establishing the SC. Meetings may be held by telephone or video conference. Minutes of all meetings of the SC shall be prepared by Radius within [*] thirty ([*]30) days after each meeting.
3.6 The quorum for SC meetings shall be two (2) members, provided there is at least one member from each of Eisai and Radius is present. The SC will render decisions by unanimous vote. Disagreements among the SC regarding the Program will be resolved via good-faith discussions; provided, that in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. event of a disagreement or deadlock that cannot be resolved within [*] thirty ([*]30) days after the date on which the disagreement arose, Radius shall have the right to cast the tiebreaking vote and resolve the matter in the Territory and Eisai shall have the right to cast the tiebreaking vote and resolve the matter in Japan.
Appears in 1 contract
Product Development. 3.1 Radius shall, at its own expense, carry out all necessary pre-clinical and clinical studies related to Compound and/or Product required by the relevant authorities throughout the Territory to achieve Product registration for the Product in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product in the Territory in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential (taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved and profitability) and for which it has similar rights.
3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product in the Territory as required for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) in those countries in the Territory where Radius seeks to market and sell Products. Attainment and maintenance of regulatory approvals for Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvals.
3.3 The Parties intend and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility for, and control of, pre-clinical and clinical development and commercialization of Products in the Territory, including the authority to make all decisions, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters relating to the Development of Products, and Radius shall not unreasonably refuse to consider such input and suggestions.
3.4 Attached as Appendix C is a plan detailing Radius’ projected activities to Develop Products in the Territory (the “Development Plan”). On or before each anniversary of the Effective Date, Radius shall update, revise and present to Eisai the Development Plan during the term of this Agreement prior to establishment of the SC (as defined in Article 3.5). Eisai shall comment upon each version of the Development Plan within [*] sixty ([*]60) days including whether it believes that the performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory. After establishment of the SC, Radius shall update, revise and present to the SC the Development Plan and Eisai may comment upon each version of the Development Plan via its participation in the SC and at the next meeting of the SC. If Eisai indicates that it does not believe performance of the Development Plan is consistent with Radius’ obligations to use its commercially reasonable efforts in Developing Compound and/or Product in the Territory, Eisai shall identify the actions or conduct that it would consider to be an acceptable remediation of * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. such inconsistency. Radius shall have [*] ninety ([*]90) days to deliver to Eisai a plan for remediation of such inconsistency as rapidly as practicable. Following delivery of such plan, Radius shall use commercially reasonable efforts to carry out the plan and cure the inconsistency. If Radius fails to deliver a plan for remediation within the [*]-day 90-day period, or (ii) Radius fails to carry out the corrective plan or actions in accordance with such plan, Eisai may terminate this Agreement pursuant to Article 7.3.
3.5 Radius shall give a written report to Eisai on a quarterly basis with respect to the progress on the pre-clinical and clinical portions of the Development of Products in the Territory from the Effective Date. If Eisai notifies Radius of its intent to Develop Products in Japan, within [*] thirty ([*]30) days of the date of the notice, the Parties will establish a Joint Steering Committee (the “SC”) to review progress on the pre-clinical and clinical portions of the Product Development contemplated by this Agreement. The purpose of the SC is to facilitate the exchange of information and the coordination between the Parties relating to the Development of Products, and to serve as a forum for Radius to keep Eisai updated with regard to the Development of Products in the Territory and Eisai to keep Radius updated with regard to the Development of Products in Japan (in the form of summaries of the Development plan, clinical design and strategy, etc.). The SC will be composed of two representatives of each Party, who shall be appointed (and may be replaced at any time) by such Party on written notice to the other in accordance with this Agreement. The SC will meet at least twice per year, or at any other frequency agreed by the SC. The first meeting of the SC shall be held within [*] ninety ([*]90) days after establishing the SC. Meetings may be held by telephone or video conference. Minutes of all meetings of the SC shall be prepared by Radius within [*] thirty ([*]30) days after each meeting.
3.6 The quorum for SC meetings shall be two (2) members, provided there is at least one member from each of Eisai and Radius is present. The SC will render decisions by unanimous vote. Disagreements among the SC regarding the Program will be resolved via good-faith discussions; provided, that in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. event of a disagreement or deadlock that cannot be resolved within [*] thirty ([*]30) days after the date on which the disagreement arose, Radius shall have the right to cast the tiebreaking vote and resolve the matter in the Territory and Eisai shall have the right to cast the tiebreaking vote and resolve the matter in Japan.
Appears in 1 contract