Common use of Development Activities Clause in Contracts

Development Activities. 2.1 The Steering Committee shall be comprised of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Development Activities, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 2 contracts

Samples: Co Development and Option Agreement (Biotime Inc), Stock Purchase Agreement (Biotime Inc)

AutoNDA by SimpleDocs

Development Activities. 2.1 The Steering Committee shall be comprised of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under During the Development ActivitiesPhase, Nordion and engaging Molecular Insight Pharmaceuticals shall carry out their respective obligations described and attributed in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommitteesSchedule A, it being understood that some activities may be reasonably delayed to the extent it may find it convenient that such activity is premised on the work or appropriateprovision of data, with information or technology by the objective of keeping each Party aware of relevant issues other party. It is understood and decisions relating acknowledged that due to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none developmental nature of the activities of the Steering Committee shall give it authority to direct be carried out during the Development Activities Phase, the time for completion and sequence for carrying out the activities as set out in Schedule A shall serve as a guide. Each party shall use their commercially reasonable best efforts in order to carry out, in a timely manner, their respective obligations and responsibilities set out in Schedule A. If either party, acting in good faith, materially fails to satisfy any milestone or otherwise is unable to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially meet such milestone in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoingtiming set out in Schedule A, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai such party shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon provide written notice thereof to the other Partyparty and the parties shall determine a reasonable corrective action plan and revised milestone schedule. If the parties are unable to determine a reasonable corrective action plan and revised milestone schedule, subject the parties may submit such matter to binding arbitration in Vancouver, British Columbia, pursuant to and conducted under the provisions International Commercial Arbitration Act of Article 11British Columbia, which arbitration shall be conducted before a single arbitrator possessing appropriate industry experience as selected by the parties. Termination If the parties cannot agree on a single arbitrator, the arbitrator shall be appointed in accordance with the International Commercial Arbitration Act of this Agreement in such event British Columbia. The decision of the arbitrators shall not be considered a termination for breachfinal and binding. In order to xxxxxx The parties acknowledge and agree that Schedule A may be amended during the collaborative nature course of the Development ActivitiesPhase to accommodate unforeseen events and results. All such changes to Schedule A shall be made by written agreement of the parties. If any change to Schedule A materially impacts the scope of work to be provided by Nordion, Nordion will provide a written estimate of the Parties acknowledge that LifeMap will request that Mount Sinai hostincrease in hours of work at the rates set forth in Section 6.3, during the term which must be approved in advance by Molecular Insight Pharmaceuticals. No work on such scope change shall be carried out by [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Nordion prior to Nordion's receipt of Molecular Insight Pharmaceuticals' written approval of such change. The parties, upon signing this Agreement, LifeMap employees shall each designate a program manager, who shall be responsible for coordinating communication and monitoring performance under this Agreement. The program managers shall meet monthly, in person or contractors in Mount Sinai facilities solely by telephone, for the purpose of conducting reviewing the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement status of the Parties project, assessing progress against the milestones and activities set forth in Schedule A, and determining the percentage of each milestone completed and the payments earned, if any, in connection with each milestone. Minutes of meetings shall be limited prepared, maintained and provided to no more than [*Certain information has been omitted under a request for confidential treatment, and each of the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policiesparties. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 2 contracts

Samples: Confidentiality Agreement (Molecular Insight Pharmaceuticals, Inc.), Confidentiality Agreement (Molecular Insight Pharmaceuticals, Inc.)

Development Activities. 2.1 (i) The Steering Committee Commercializing Party shall be comprised responsible for conducting all Development activities as may be contemplated under the Development Plan for each Split Program with respect to such Commercializing Party’s portion of [*Certain information has been omitted under a request the Territory (i.e., the US Territory for confidential treatment, Agios and the omitted information has been filed with the Commission]ROW Territory for Celgene). The Steering Committee Neither Commercializing Party shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions conduct any Development activities for any Split Program outside such Party’s portion of the Steering Committee shall be to oversee Territory (even if such Development activities are for purposes of Development in such Party’s portion of the collaborative research and joint development Territory), unless the JDC by Mutual Consent approves of such activities, including monitoring progress under any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development Plan. (ii) The Parties will share all Global Development Costs in accordance with Section 9.4(b); provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development ActivitiesCost Initiation Date. For clarity, and engaging in exchanges of information and joint planning activities. The Steering Committee Celgene’s obligation to share Global Development Costs shall also appoint task forces or subcommittees, not include any Development Costs incurred prior to the extent it may find it convenient Development Cost Initiation Date or appropriate, with any Development Costs related to any Clinical Trial for which the objective of keeping each Party aware of relevant issues and decisions relating FPD occurred prior to the collaborative research and joint development under Development Cost Initiation Date even if completed following the Development Activities. The Steering Committee may propose from time Cost Initiation Date; instead, Celgene’s obligations will be limited to time, during Development activities related to any company-sponsored Phase II Studies or later stages of Development. (iii) If either Party proposes to undertake any Development activities for a Split Program in such Party’s portion of the term of this Agreement, Territory that the other Party reasonably determines are reasonably likely to amend or augment have a material adverse impact on the Development Activities hereunder including or Commercialization of Split Compounds or Split Products in the addition other Party’s portion of statements of work to update or improve any Developed Intellectual Property hereunder. Each the Territory, such amendment or additional statement of work proposing Party shall be developed and not proceed with such Development activities unless approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially JDC (with any disputes resolved in accordance with the terms and conditions dispute resolution procedure of this Agreement. Notwithstanding Section 2.8, including the foregoing, LifeMap acknowledges that Mount Sinai will have Lead Party having the freedom final decision-making authority to conduct the Development Activities extent provided in a manner consistent with Mount Sinai’s educational and research missionsSection 2.8(b)). 2.3 If (iv) With respect to each Split Program, each Party shall be entitled to use the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap data and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the results (including clinical data) from all Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to activities conducted by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject ; provided that a Party shall not interpret such data or results in a different manner than the Party who performed the Development activity giving rise to the provisions of Article 11. Termination of this Agreement in such event shall not data or results without the performing Party’s prior written consent (which may be considered a termination for breachgiven through the Party’s representatives on the JDC). In order furtherance thereof, each Commercializing Party shall update the other Party pursuant to xxxxxx Section 3.8(c) on the collaborative nature status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure the Development Activitiesother Party has access to such data and results, the Parties acknowledge that LifeMap will request that Mount Sinai hostincluding, during the term of this Agreementif appropriate, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary providing for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing access in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply agreement with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretiona Third Party Contractor. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 2 contracts

Samples: Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc), Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc)

Development Activities. 2.1 The Steering Committee 4.3.1 Licensor shall retain responsibility for, sponsor and conduct (or ensure the conduct by its relevant Affiliates or permitted Third Parties) the Existing Pivotal Trials (including any follow-up treatment of patients therein following the conclusion or termination of such trials), each as included in the Development Plan and in accordance with the Development Plan. In the event of either (a) on Licensee’s request upon a Change of Control of Licensor or (b) subject to Section 19.9 and a determination by the JSC, a breach by Licensor of its obligation to diligently perform the Existing Pivotal Trials (a “Licensor Development Breach), Licensor, at Licensee’s cost, shall promptly handover responsibility for, sponsorship of and the conduct of the Existing Pivotal Trials to Licensee (or its nominated Affiliate or Third Party) in a smooth, efficient and timely manner, and as directed by the JSC. 4.3.2 Licensor shall perform such additional Development activities in relation to ImmTOR as are reasonably necessary to support Development of Products capable of attaining Regulatory Approval in the Territory and approved by the JSC (“Additional ImmTOR Development Activities”). In addition, Licensor shall perform such additional Development activities in relation to the Compound as are reasonably necessary to support Development of Products capable of attaining Regulatory Approval in the Territory or Exploitation of Products in the Territory, and approved by the JSC (“Additional Compound Development Activities”). Licensee shall have the right to unilaterally terminate the provision of the Additional ImmTOR Development Activities and the Additional Compound Development Activities upon notice to the Licensor via the JSC. Upon receipt of such notice, Licensor, at Licensee’s cost, shall promptly handover responsibility for, sponsorship of (to the extent relevant) and the conduct of the same to Licensee (or its nominated Affiliate or Third Party) in a smooth, efficient and timely manner, and as directed by the JSC. 4.3.3 Licensor shall conduct the Licensor Development Activities promptly, using reasonable skill and care and in a professional and diligent manner, at least to the same degree of accuracy, completeness, efficiency, quality, responsiveness and timeliness as Licensor would utilize in performing similar activities for the Development of its own products that are at a similar stage of Development and have similar market potential for Licensor, in accordance with sound and ethical business and scientific practices, and in compliance with the Development Plan, the Development Budget, all applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws. 4.3.4 Licensor shall be comprised permitted to utilize the services of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference its Affiliates or its material Third Party subcontractors listed on Annex E or other electronic means if agreed upon by all Steering Committee members. The functions Third Party subcontractors to which Licensee gives its prior written approval (such approval not to be unreasonably withheld, conditioned or delayed) in the performance of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Licensor Development Activities, provided that Licensor shall remain at all times fully liable for the performance of the Licensor Development Activities in compliance with this Agreement. In all cases, the rights granted to any subcontractor shall be subject and engaging subordinate to the applicable terms and conditions of this Agreement. Licensor shall oversee the performance by its subcontractors of the subcontracted Licensor Development Activities in exchanges a manner that would be reasonably expected to result in their timely and successful completion of information such activities, and joint planning activitiesLicensor shall remain responsible and primarily and fully liable for the performance of such activities in accordance with this Agreement. The Steering Committee Licensor hereby expressly waives any requirement that Licensee exhaust any right, power or remedy, or proceed against such subcontractor for any obligation or performance hereunder, prior to proceeding directly against Licensor. Licensor shall also appoint task forces or subcommitteesensure compliance with the applicable terms of this Agreement by any such subcontractor, including with respect to provisions on confidentiality and intellectual property ownership and compliance with legal requirements. Without limiting the foregoing, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating that Licensor uses a subcontractor to the collaborative research and joint development under the perform Licensor Development Activities. The Steering Committee may propose from time , Licensor shall ensure that such subcontractors are obligated to time, during the term of this Agreement, assign rights to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each Inventions made by such amendment or additional statement of work shall subcontractors so that such rights can be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially conveyed in accordance with the terms and conditions of this Agreement. 4.3.5 Licensor shall not use in any capacity, in connection with its performance of the Licensor Development Activities, any Person who has been debarred pursuant to Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or who is the subject of a conviction described in such section, and shall inform Licensee in writing promptly if it or any Person who is performing services for Licensor hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensor’s knowledge, is threatened, relating to the debarment of Licensor or any Person used in any capacity by Licensor in connection with its performance of the Licensor Development Activities. 4.3.6 Licensor shall maintain (and cause each of its Affiliates and subcontractors to maintain) complete, current and accurate hard and electronic records of all Licensor Development Activities conducted by it and all data and other information resulting from such work (which records shall include, as applicable, books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof (e.g., samples of materials and other graphic or written data generated in connection with the Licensor Development Activities)). Notwithstanding Such records shall properly reflect all work done and results achieved in the foregoing, LifeMap acknowledges that Mount Sinai will have performance of the freedom to conduct the Licensor Development Activities in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes. Licensor shall (and shall cause each of its Affiliates and subcontractors to) document all preclinical studies and clinical trials to be conducted in formal written study reports according to applicable national and international (e.g., ICH, GCP and GLP) guidelines. Licensee shall have the right to receive and retain a manner consistent copy of all such records and to review them in person upon written notice to Licensor, during regular business hours. Licensee shall also have the right to conduct reasonable quality assurance inspections and audits with Mount Sinairespect to all facilities, operations and laboratories (and any records related thereto) operated by Licensor, its Affiliates and subcontractors where Licensor Development Activities are conducted, as is reasonably necessary for the purposes of verifying Licensor’s educational compliance with this Agreement and research missionsall applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws. All audits initiated by Licensee will be at Licensee’s sole expense, upon written notice to Licensor, during regular business hours. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate 4.3.7 [*Certain information has been omitted under a request **], Licensor shall Manufacture, supply (or have Manufactured and supplied) and have delivered the Product for confidential treatment, and the omitted information has been filed with purposes of conducting the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Licensor Development Activities. If [***]. 4.3.8 Licensee shall not use in any capacity in connection with the Exploitation of the Products, any Person who has been debarred pursuant to Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or who is the subject of a substitute Principal Investigator has not been designated within ninety conviction described in such section. Licensee shall inform Licensor in writing promptly if it or any Person who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA (90) days after or similar applicable Law outside of the original Principal Investigator ceases his U.S.), or her services under this Agreementif any action, LifeMap may request an additional ninety (90) dayssuit, which extension must be grantedclaim, investigation or legal administrative proceeding is pending or, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search periodLicensee’s knowledge, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigatoris threatened, and Mount Sinai has agreed in writing relating to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause debarment of Licensee or any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement Person used in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature any capacity by Licensee in connection with its Exploitation of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities Product. 4.3.9 Licensee shall (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, cause each of its Affiliates and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined Sublicensees engaged in the Development Activitiesof the Products to) maintain current and accurate records of all Development activities conducted by it and all data and other information resulting from such work (which records shall include, obligates Mount Sinai to sequence direct consumer patient biological as applicable, books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof (e.g., samples of materials and other graphic or written data generated in its New York State laboratory facilities or otherwise provide genetic testing for connection therewith)). Such records shall properly reflect all work done and results achieved in the performance of such direct-to-consumer patient samples Development activities in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, sufficient detail and in good faithscientific manner appropriate for regulatory and patent purposes. Licensee shall, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit shall cause each of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing Affiliates and its Sublicensees engaged in the LMN Engine Development of the Products to, document all preclinical studies and clinical trials to be conducted in formal written study reports according to applicable national and international (ie.g., ICH, GCP and GLP) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engineguidelines.

Appears in 1 contract

Samples: License and Development Agreement (Selecta Biosciences Inc)

Development Activities. 2.1 3.1 The Steering Committee shall be comprised selection and development of [*Certain information has been omitted under Development Candidate(s) that are suitable for development into a request Product for confidential treatment, commercialization and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions approval of the Steering Committee shall development and final commercial formulation and specifications for the Product will be to oversee the collaborative research sole responsibility of XXXXXXX and joint development activities, including monitoring progress under XXXXXXX will bear all costs and expenses related thereto. At any stage in the Development ActivitiesProgram, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, it will be XXXXXXX’x sole decision to evaluate whether the extent it may find it convenient or appropriate, with results generated warrant the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator continuation of the Development Activities. If Program with respect to a substitute Principal Investigator has not been designated Development Candidate. 3.2 NANO will disclose to XXXXXXX within ninety (90) days after a reasonable period of time the original Principal Investigator ceases his Nano Know-How and any Improvements that NANO believes are necessary or her services under this Agreementuseful in connection with the Development Program, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take based on the role of Principal Investigatorinformation, requests and Mount Sinai has agreed in writing reports provided to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be it by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total XXXXXXX during the term of this Agreement. XXXXXXX will disclose to NANO within a reasonable period of time any Improvements developed or invented during the term of this Agreement by XXXXXXX or its Affiliates. 3.3 From the Effective Date hereof, XXXXXXX will proceed with the development of the Development Candidate selected by XXXXXXX, such development already having been initiated under the terms of the Feasibility Agreement. 3.4 The Parties further activities to be undertaken in the course of the Development Program will be monitored by the Development Team. The Development Team shall review and monitor the progress made during the Development Program and will discuss important milestone events. The Development Team will be chaired by XXXXXXX. 3.5 Prior to NANO commencing supporting activities in relation to the Development Program, XXXXXXX and XXXX will agree on the specific activities to be undertaken by NANO, including timelines and related budget and such timelines and budget will be attached to the Development Plan. XXXXXXX acknowledges that all in the event it requests additional support activities from NANO that are not contemplated under this Agreement or in the Development Plan, NANO may not be in a position to readily provide such LifeMap Visiting Scientists shall support in view of other commitments NANO may have to Third Parties. In such event, XXXXXXX and XXXX will in good faith discuss how and within what timeframe such additional support activities may be subject performed by NANO. In performing such support activities in relation to Mount Sinaithe Development Program, NANO will use reasonable efforts to comply with its commitments, including the commitment to dedicate sufficient staff with adequate skills to such Development Program, as set forth in the Development Plan and as agreed upon prior to the start of the Development Program. 3.6 If XXXX’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign development efforts include the Visiting Scientist Agreementuse of a Third Party, attached hereto as Attachment CNANO will, prior to being hosted at Mount Sinaiappointing such Third Party, discuss with XXXXXXX the activities to be undertaken by such Third Party and the terms and conditions thereof. Notwithstanding XXXX will not proceed with such Third Party without the foregoingprior written approval of XXXXXXX, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting which approval shall not be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policiesunreasonably withheld. 2.4 The Parties acknowledge 3.7 NANO will provide XXXXXXX with regular written reports on the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may progress of the support activities to be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in undertaken by it under the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention Program(s) and will create detailed descriptions of any applicable law. Should LifeMap desire Mount Sinai methodologies, development formulations or processes directed to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code Development Candidates in order to function enable XXXXXXX to prepare and file any regulatory filings in relation to the Product. 3.8 XXXXXXX will provide NANO on a quarterly basis with written reports on the progress of activities undertaken by it relating to the Development Program. XXXXXXX agrees to use reasonable efforts, consistent with its intended fashion. Should Mount Sinai reasonably believe normal business practices and in line with the efforts it needs devotes to utilize such Open Source Code in projects of similar sales and technical potential, to carry out the LMN Engine, it shall discuss in good faith development activities directed to a Development Candidate with LifeMap such need and follow the processes specified by aim of developing the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN EngineProduct that can be commercialized.

Appears in 1 contract

Samples: License Agreement (Alkermes Plc.)

Development Activities. 2.1 The Steering Committee shall (i) Inspire will be comprised of [*Certain information has been omitted under a request responsible for confidential treatment, and undertaking the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Development Activities, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Inspire Development Activities hereunder including and will use Commercially Reasonable Efforts to perform the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Inspire Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms Development Timeline. Faes will be responsible for undertaking the Faes Development Activities and conditions of this Agreement. Notwithstanding will use Commercially Reasonable Efforts to perform the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Faes Development Activities in accordance with the Development Timeline. The Joint Project Team will monitor each Party’s respective obligations and progress towards achieving the goals set forth in the Development Plan. Each Party acknowledges and agrees that the drug development process is a manner consistent with Mount Sinaiprocess of scientific discovery and as such is inherently unpredictable and delays to the Development Timeline may occur for reasons beyond a Party’s educational control as Subject Products are developed, and research missionsthat the drug development process is subject to a high level of governmental regulation and the requirements of the regulatory process of seeking drug approval may result in delays beyond a Party’s control and that such delays or other similar delays beyond a Party’s control, without evidence of some other lack of Commercially Reasonable Efforts, are not a breach of this Section 3.2(b)(i). 2.3 If (ii) Without limiting Section 3.2(b)(i), Inspire shall be responsible, at Inspire’s sole cost and expense, for conducting all Phase 3 Clinical Trials in the services United States on the Compound as necessary to obtain Regulatory Approval in the United States of a Principal Product for the Primary Indication. (iii) Without limiting Section 3.2(b)(i), Faes shall be responsible, at Faes’s sole cost and expense, for continuing and completing the Definitive QT Study in accordance with current good clinical practices and any comments received from the FDA. Promptly upon completion of the Principal Investigator become unavailable Definitive QT Study, Faes shall report the results thereof to Mount Sinai Inspire. Faes shall prepare or cause to be prepared, at its sole cost and expense, a final, audited study report with respect to the Definitive QT Study in compliance with applicable guidelines and suitable for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts submission to designate [*Certain information has been omitted under a request for confidential treatmentthe FDA, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable Faes shall provide such report to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated Inspire within ninety sixty (9060) days after completion of such study. Inspire shall have the original Principal Investigator ceases his or her services right to use and refer to the Definitive QT Study solely in connection with Inspire’s permitted activities under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 1 contract

Samples: License Agreement (Inspire Pharmaceuticals Inc)

Development Activities. 2.1 (a) The Steering Committee Parties shall Develop the Product for the Nocturia Indication for use in the Field in the United States in accordance with Articles 3, 4 and 5 pursuant to the Nocturia Development and Supply Plan. The Nocturia Development and Supply Plan shall be comprised of [*Certain information has been omitted under a request the governing document directing Development activities for confidential treatmentthe Nocturia Indication, and neither Party shall conduct Development activities for the omitted information has been Nocturia Indication except as set forth in the Nocturia Development and Supply Plan. Serenity shall have primary responsibility for the clinical Development of the Products for the United States as set forth in the Nocturia Development and Supply Plan, and shall be solely responsible for day-to-day clinical and supply operations and completion of activities as defined in the Nocturia Development and Supply Plan, subject to oversight by and control of the JDC and the JSC, as applicable. For clarity, Regulatory Filings for the Products Developed pursuant to the Nocturia Development and Supply Plan in the United States shall be prepared and filed as set forth in Article 5. Allergan will be Serenity’s authorized agent for the Nocturia Indication in all interactions with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates FDA after preparation and places, including meeting submission of all formal Regulatory Filings by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Development Activities, and engaging Serenity as set forth in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached heretoArticle 5. Notwithstanding the foregoing, nothing contained herein (i) Serenity shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the conduct all Development activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted under a request and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. with respect to the Products for confidential treatment, the Nocturia Indication as set forth in the Nocturia Development and Supply Plan; (ii) the JDC shall determine when any and all Development activities shall commence and the omitted information has been filed with regulatory strategy for seeking (if and when appropriate) Regulatory Approvals for Products in the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the Territory other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely than Products for the purpose of conducting PNE Indication unless Allergan is Developing or Commercializing such Products, and, if the JDC so decides, Serenity shall seek and (if appropriate) file for such Regulatory Approvals in the United States; and (iii) the JDC shall have the responsibility for determining such strategy. Allergan shall have sole responsibility for the clinical Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties of, and shall be limited to no more than [*Certain information has been omitted under a request solely responsible for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment clinical and hosting supply operations and completion of Development activities for, the Products other than Products for the PNE Indication, outside of the United States, provided that Allergan shall be jointly created by Mount Sinai consult with the JDC and LifeMap to the extent such procedures and details do not violate any Mount Sinai policiesSerenity. 2.4 (b) The Parties acknowledge that the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing initial Nocturia Development and that certain permit(s) and/or approval(s) may be necessary Supply Plan activities shall focus on Development of the Product for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined Nocturia Indication in the United States and NDA approval for the Nocturia Indication, and that, following receipt of such NDA approval, *** and the Parties shall enter into a subsequent Development Activitiesand Supply Plan for the *** Field accordingly. Any and all subsequent Development and Supply Plans will be structured and governed as set forth above with the exception that Allergan shall have final approval rights over any matter in dispute. Other than with respect to Product for the PNE Indication Developed or Commercialized by or on behalf of Serenity, obligates Mount Sinai to sequence direct consumer patient biological samples Serenity shall not, and shall not have the right to, conduct any Product Development activities outside of the Nocturia Development and Supply Plan, or subsequent Development and Supply Plan, without the prior written consent of Allergan. If Allergan, in its New York State laboratory facilities sole discretion elects to ***, then Serenity shall have the right but not the obligation ***, or otherwise provide genetic testing for portion thereof; provided that Serenity has and will ***. Prior to commencing any such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testingactivities, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with shall ***. Without limiting the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officerforegoing, prior to incorporating beginning the conduct of any ***, Serenity shall demonstrate to Allergan that it has and will ***. For clarity, if prior to ***, Serenity has *** that Serenity has on the Effective Date, Serenity shall be deemed to have the ***. (c) Prior to commencing any Clinical Studies for the PNE Indication in accordance with Section 2.4(c), Serenity will provide Allergan with a plan that includes the general timelines for Serenity’s conduct of Development activities with respect to the Products for the PNE Indication, and descriptions of all such Open Source Code Clinical Studies proposed to be conducted for the PNE Indication, which may be updated from time to time by Serenity (the “PNE Development Plan”). (d) Without limiting Allergan’s rights and remedies hereunder, Serenity shall devote and maintain the personnel and other resources necessary to conduct and complete the Development activities set forth in the LMN Engineapplicable Development and Supply Plan using Commercially Reasonable Efforts to meet the timetables set forth in such applicable Development and Supply Plan, including without limitation the filing of any *** update and the response to any and all questions or requests, including without limitation any additional tasks, ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.

Appears in 1 contract

Samples: License Agreement (Allergan Inc)

Development Activities. 2.1 The Steering Committee shall (a) Licensee will not Develop or have Developed the Products (including conducting medical or clinical trials of the Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product) without the prior written approval of Allergan and pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct such studies without the prior written approval of Allergan, such approval not to be comprised of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at unreasonably withheld. (b) If mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Development Activities, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, Licensee shall be executed Develop or co-Develop Products for sale in the Territory via participation in clinical trials conducted by Allergan outside of the Territory, via stand-alone trials within the Territory, via investigator-initiated clinical trials within the Territory or otherwise as agreed to by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development ActivitiesParties. 2.2 Mount Sinai (c) If Allergan has finalized a development plan and LifeMap will commence budget to develop the Development Activities after Product for any New Indication for Regulatory Approval in the Effective Date of this AgreementUnited States, it shall notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the “New Indication Notice”). The Parties will use reasonable efforts to undertake If Licensee is interested in such New Indication included within the Development Activities substantially Field, it shall notify Allergan within [redacted in accordance with Section 12.2(3) of National Instrument 51-102] from the terms and conditions of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services date of the Principal Investigator become unavailable New Indication Notice, whereupon the parties shall discuss and seek to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate agree within [*Certain information has been omitted under a request for confidential treatment, and redacted in accordance with Section 12.2(3) of National Instrument 51-102] from the omitted information has been filed with date of the Commission] or another member of its faculty who is acceptable to both Parties to serve as New Indication Notice on (i) the Principal Investigator portion of the Development Activitiescosts associated with the Development of such New Indication payable by Licensee and (ii) the date upon which such New Indication shall be deemed included in the Field. If a substitute Principal Investigator has Licensee does not been designated make the election set forth in the preceding sentence within ninety (90such [redacted in accordance with Section 12.2(3) days after of National Instrument 51-102] period, or if the original Principal Investigator ceases his or her services under this AgreementParties do not reach agreement on Development cost sharing with respect to such New Indication within such [redacted in accordance with Section 12.2(3) of National Instrument 51-102] period, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement then such New Indication shall not be unreasonably objected included in the Field and Licensee shall have no rights with respect to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policiesNew Indication. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s(d) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai Allergan shall use good faith efforts to avoid utilizing in the LMN Engine Commercially Reasonable Efforts to: (i) any open source, free, community, or similar software, including any libraries or software licensed under file with applicable Governmental Authorities in Canada and Switzerland all documents necessary for the General Public License or any other license agreement or arrangement obliging Product to be used in a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or single dose regimen in such countries. (ii) any code that requires conduct pediatric studies of the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the LMN Engine, it shall discuss Territory (except for the Special Countries). (iii) complete all post-Regulatory Approval actions for the Product in good faith with LifeMap such need and follow the processes specified Territory (except for the Special Countries) as required by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code applicable Regulatory Authorities in the LMN EngineTerritory (except for the Special Countries).

Appears in 1 contract

Samples: License Agreement (Cardiome Pharma Corp)

AutoNDA by SimpleDocs

Development Activities. 2.1 The Steering Committee shall (a) POZEN will be comprised of [*Certain information has been omitted under a request responsible for confidential treatment, undertaking the POZEN Development Activities and will use Commercially Reasonable Efforts to perform the omitted information has been filed POZEN Development Activities in accordance with the Commission]POZEN Development Timeline. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates Joint Project Team will monitor each Party’s respective obligations and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee membersprogress towards achieving the goals set forth in the Development Plan. The functions POZEN may outsource the performance of any part of the Steering Committee shall be POZEN Development Activities subject to oversee Section 14.1. If POZEN elects to outsource the collaborative research and joint development activities, including monitoring progress under performance of any part of the POZEN Development Activities, and engaging POZEN will notify GSK in exchanges writing regarding the nature of information and joint planning such proposed activities. After receiving such notice, GSK may provide POZEN feedback regarding such activities. (b) GSK will be responsible for undertaking the GSK Development Activities and will use Commercially Reasonable Efforts to perform the GSK Development Activities in accordance with the Formulation Development Timeline. The Steering Committee shall also appoint task forces or subcommitteesJoint Project Team will be responsible for monitoring the achievement of the Formulation Development Timeline. (c) Promptly after the Execution Date and subject to the terms of Article 11 below, GSK will disclose to POZEN [***] to the extent it known by GSK. POZEN will limit access to such information to those employees (or legal counsel subject to confidentiality obligations no less rigorous than those contained herein) that have a need to know. POZEN may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues reasonably request additional materials and decisions information relating to the collaborative research foregoing and joint will engage in an evaluation of the Formulation based upon the information disclosed by GSK. (d) POZEN may raise any concerns it may have regarding the Formulation at the Joint Project Team meetings and the Parties will work in good faith to address such concerns. POZEN may request that the Joint Project Team develop a course of action to achieve the Formulation Development Timeline if it determines that such timeline may be subject to delay for any reason. Promptly upon such request, the Parties will share information regarding the status of GSK’s development under of the Development Activities. The Steering Committee may propose from time to time, during solid oral dose of the term of this Agreement, to amend or augment Formulation and the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall Joint Project Team will consider whether alternative actions should be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed implemented by the Parties (including the cooperation between the Parties to pursue a parallel formulation effort) taking into account the scientific evidence then available and become a part the best interests in the timely development of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct MT 400 in accordance with the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development ActivitiesPlan. 2.2 Mount Sinai and LifeMap will commence the Development Activities (e) At any time after the Effective Date of this Agreementif GSK determines that it must acquire rights to any intellectual property Controlled by a Third Party in order to practice the Formulation it will promptly send written notice to POZEN to that effect. The Parties GSK will use commercially reasonable efforts to undertake negotiate rights to such Third Party technology that include the Development Activities substantially right to sublicense such technology to POZEN as otherwise provided herein. If GSK is unable to secure such sublicense rights or if in accordance order to secure such sublicense rights, the total consideration for acquiring such sublicense rights would be materially higher than if GSK did not acquire such sublicense rights, GSK promptly will send written notice to POZEN to that effect. Within 30 days of receipt of such notice, POZEN may elect whether or not it wishes to pay such additional amounts for the inclusion of such sublicense rights. If POZEN elects to pay such amounts it will reimburse GSK for such costs within 30 days of receipt of an invoice for such amounts. If POZEN elects not to pay such additional amounts or fails to give notice of its intent to do so within the 30 day period provided above, GSK may enter into such agreement without the inclusion of such sublicense rights. Failure to include such sublicense rights [***] under this Section 3.4(e) if [***] with such Third Party for the terms and conditions inclusion of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missionssuch rights. 2.3 If (f) GSK may outsource the services performance of any part (but not all) of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the GSK Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after GSK elects to outsource the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role performance of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the GSK Development Activities, the Parties acknowledge that LifeMap it will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors notify POZEN in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details writing regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent nature of such procedures and details do not violate any Mount Sinai policiesproposed activities. After receiving such notice, POZEN may provide GSK feedback regarding such activities. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 1 contract

Samples: Product Development and Commercialization Agreement (Pozen Inc /Nc)

Development Activities. 2.1 3.1 The Steering Committee shall be comprised selection and development of [*Certain information has been omitted under Development Candidate(s) that are suitable for development into a request Product for confidential treatment, commercialization and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions approval of the Steering Committee shall development and final commercial formulation and specifications for the Product will be to oversee the collaborative research sole responsibility of XXXXXXX and joint development activities, including monitoring progress under XXXXXXX will bear all costs and expenses related thereto. At any stage in the Development ActivitiesProgram, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, it will be XXXXXXX’x sole decision to evaluate whether the extent it may find it convenient or appropriate, with results generated warrant the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator continuation of the Development Activities. If Program with respect to a substitute Principal Investigator has not been designated Development Candidate. 3.2 NANO will disclose to XXXXXXX within ninety (90) days after a reasonable period of time the original Principal Investigator ceases his Nano Know-How and any Improvements that NANO believes are necessary or her services under this Agreementuseful in connection with the Development Program, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take based on the role of Principal Investigatorinformation, requests and Mount Sinai has agreed in writing reports provided to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be it by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total XXXXXXX during the term of this Agreement. XXXXXXX will disclose to NANO within a reasonable period of time any Improvements developed or invented during the term of this Agreement by XXXXXXX or its Affiliates. 3.3 From the Effective Date hereof, XXXXXXX will proceed with the development of the Development Candidate selected by XXXXXXX, such development already having been initiated under the terms of the Feasibility Agreement. 3.4 The Parties further activities to be undertaken in the course of the Development Program will be monitored by the Development Team. The Development Team shall review and monitor the progress made during the Development Program and will discuss important milestone events. The Development Team will be chaired by XXXXXXX. 3.5 Prior to NANO commencing supporting activities in relation to the Development Program, XXXXXXX and NANO will agree on the specific activities to be undertaken by NANO, including timelines and related budget and such timelines and budget will be attached to the Development Plan. XXXXXXX acknowledges that all in the event it requests additional support activities from NANO that are not contemplated under this Agreement or in the Development Plan, NANO may not be in a position to readily provide such LifeMap Visiting Scientists shall support in view of other commitments NANO may have to Third Parties. In such event, XXXXXXX and NANO will in good faith discuss how and within what timeframe such additional support activities may be subject performed by NANO. In performing such support activities in relation to Mount Sinaithe Development Program, NANO will use reasonable efforts to comply with its commitments, including the commitment to dedicate sufficient staff with adequate skills to such Development Program, as set forth in the Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Securities and Exchange Commission. Development Plan and as agreed upon prior to the start of the Development Program. 3.6 If NANO’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign development efforts include the Visiting Scientist Agreementuse of a Third Party, attached hereto as Attachment CNANO will, prior to being hosted at Mount Sinaiappointing such Third Party, discuss with XXXXXXX the activities to be undertaken by such Third Party and the terms and conditions thereof. Notwithstanding NANO will not proceed with such Third Party without the foregoingprior written approval of XXXXXXX, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting which approval shall not be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policiesunreasonably withheld. 2.4 The Parties acknowledge 3.7 NANO will provide XXXXXXX with regular written reports on the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may progress of the support activities to be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in undertaken by it under the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention Program(s) and will create detailed descriptions of any applicable law. Should LifeMap desire Mount Sinai methodologies, development formulations or processes directed to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code Development Candidates in order to function enable XXXXXXX to prepare and file any regulatory filings in relation to the Product. 3.8 XXXXXXX will provide NANO on a quarterly basis with written reports on the progress of activities undertaken by it relating to the Development Program. XXXXXXX agrees to use reasonable efforts, consistent with its intended fashion. Should Mount Sinai reasonably believe normal business practices and in line with the efforts it needs devotes to utilize such Open Source Code in projects of similar sales and technical potential, to carry out the LMN Engine, it shall discuss in good faith development activities directed to a Development Candidate with LifeMap such need and follow the processes specified by aim of developing the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN EngineProduct that can be commercialized.

Appears in 1 contract

Samples: License Agreement (Alkermes Plc.)

Development Activities. 2.1 In order for OSG Norwich to start the Manufacture of the Product for ViroPharma, it will be necessary that the activities listed in the Development Plan be completed. The Steering Committee shall be comprised responsibilities of each of OSG Norwich and ViroPharma in relation to the Development Plan, and the timeframes for completion of the Development Plan, are also set forth in the Development Plan. [*Certain information **] shall pay OSG Norwich the fees designated in the Price Exhibit under the heading Development Activity Costs (“Development Costs”). OSG [***] Indicates material that has been omitted under a request and for which confidential treatment, and the treatment has been requested. All such omitted information material has been filed with the Commission]Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Norwich acknowledges that the Development Costs represent OSG Norwich’s entire compensation for performance of activities related to completion of the Development Plan. The Steering Committee parties agree to make commercially reasonable efforts to continue to complete the Development Plan in accordance with its terms. OSG Norwich and ViroPharma acknowledge that certain development activities may be required in connection with API that is received from any source other than Alpharma, Inc. (“Third Party API”). OSG Norwich and ViroPharma shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions to discuss in good faith the parameters of the Steering Committee shall be to oversee the collaborative research and joint such development activities, including monitoring progress under timelines and cost. OSG Norwich shall not commence any work using the Development Activities, and engaging in exchanges of information and joint planning activitiesThird Party API without ViroPharma’s prior written approval. The Steering Committee shall also appoint task forces or subcommittees, Subject to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with the terms and conditions of this Agreement. Notwithstanding the foregoingset forth herein, LifeMap acknowledges that Mount Sinai will have the freedom ViroPharma hereby grants to conduct the Development Activities in OSG a manner consistent with Mount Sinailimited, non-exclusive, royalty free license under ViroPharma’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reasonPatents and, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing ViroPharma’s Know-How relating to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai manufacture of Product (the “Manufacturing Process Technology”), with no right to cause any Mount Sinai faculty member to act as Principal Investigator against sublicense or assign such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periodslicensed rights, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting performing OSG’s obligations under this Project Agreement, which are limited solely to manufacturing Product for and selling Product to ViroPharma, and any incidental purposes related thereto solely for the Development Activities (“LifeMap Visiting Scientists”)benefit of ViroPharma. The Parties OSG and ViroPharma acknowledge and agree that hosting (a) without limiting the generality of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, OSG shall not have any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed rights under the General Public License Manufacturing Process Technology to develop, manufacture or sell Product or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties product for any party other than ViroPharma; (collectivelyb) the Manufacturing Process Technology is, “Open Source Code”in whole and in part, the Confidential Information of ViroPharma; and (c) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any and since November 9, 2004, Lilly has been providing the Manufacturing Process Technology to OSG as a Representative of ViroPharma, and that it is the parties’ intention that, since such Open Source Code date, OSG has been operating solely in accordance with the LMN Enginelicense granted herein.

Appears in 1 contract

Samples: Project Agreement (Viropharma Inc)

Development Activities. 2.1 In order for OSG Norwich to start the Manufacture of the Product for ViroPharma, it will be necessary that the activities listed in the Development Plan be completed. The Steering Committee responsibilities of each of OSG Norwich, Lilly and ViroPharma in relation to the Development Plan, and the time frames for completion of the Development Plan, are also set forth in the Development Plan. Except as set forth on the attached Schedule of Exceptions, OSG Norwich represents that all activities set forth in the Development Plan required to be completed by either OSG Norwich and/or Lilly on or prior to the Project Agreement Effective Date have been completed. [***] shall pay OSG Norwich the fees designated in the Price Exhibit under the heading Development Activity Costs due following the Regulatory Approval Date (“[***] Development Costs”). OSG Norwich acknowledges that [***] shall be comprised responsible for all fees designated in the Price Exhibit under the heading Development Activity Costs due and owing prior to or as of the Regulatory Approval Date (“[*Certain information **] Development Costs”, together with the [***] Development Costs, the “Development Costs”). OSG Norwich acknowledges that the Development Costs represent OSG Norwich’s entire compensation for performance of activities related to completion of the Development Plan. The parties agree to make commercially reasonable efforts to continue to complete the Development Plan in accordance with its terms. OSG Norwich acknowledges that Lilly has agreed (i) to keep ViroPharma advised of all significant actions under the Lilly Project Agreement, including, without limitation any deviation from the Lilly Project Agreement; (ii) to share information, consult with ViroPharma and include ViroPharma in material decisions, including decisions regarding the Development Plan; and (iii) to amend the Lilly Project Agreement, subject to ViroPharma’s approval, following ViroPharma’s and OSG’s entry into this Project Agreement such that the Lilly Project Agreement will be limited to the supply of products identified therein for sale solely in [***] (the “Lilly Agreements”). OSG Norwich will use commercially reasonable efforts to ensure that Lilly complies with the Lilly Agreements. OSG Norwich and ViroPharma acknowledge that certain development activities may be required in connection with API that is received from any source other than Alpharma, Inc. (“Third Party API”). OSG Norwich and ViroPharma shall meet to discuss in good faith the parameters of such development activities, including timelines and cost. OSG Norwich shall not commence any work using the Third Party API without ViroPharma’s prior written approval. [***] Indicates material that has been omitted under a request and for which confidential treatment, and the treatment has been requested. All such omitted information material has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates Securities and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee members. The functions of the Steering Committee shall be Exchange Commission pursuant to oversee the collaborative research and joint development activities, including monitoring progress Rule 24b-2 under the Development ActivitiesSecurities Exchange Act of 1934, as amended. OSG Norwich and engaging ViroPharma also agree to negotiate in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to undertake the Development Activities substantially in accordance with good faith the terms and conditions of this Agreement. Notwithstanding under which OSG Norwich shall undertake development activities in connection with process improvements (including but not limited to increasing the foregoing, LifeMap acknowledges that Mount Sinai will have batch size) for the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services Manufacture of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development ActivitiesProduct. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing Subject to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai terms and conditions set forth herein, ViroPharma hereby grants to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty memberOSG a limited, non-exclusive, royalty free license under ViroPharma’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periodsPatents and, only then may either Party terminate this Agreement upon written notice thereof ViroPharma’s Know-How relating to the other Partymanufacture of Product (the “Manufacturing Process Technology”), subject with no right to the provisions of Article 11. Termination of this Agreement in sublicense or assign such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the Development Activitieslicensed rights, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting performing OSG’s obligations under this Project Agreement, which are limited solely to manufacturing Product for and selling Product to ViroPharma, and any incidental purposes related thereto solely for the Development Activities (“LifeMap Visiting Scientists”)benefit of ViroPharma. The Parties OSG and ViroPharma acknowledge and agree that hosting (a) without limiting the generality of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, OSG shall not have any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed rights under the General Public License Manufacturing Process Technology to develop, manufacture or sell Product or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties product for any party other than ViroPharma; (collectivelyb) the Manufacturing Process Technology is, “Open Source Code”in whole and in part, the Confidential Information of ViroPharma; and (c) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any and since November 9, 2004, Lilly has been providing the Manufacturing Process Technology to OSG as a Representative of ViroPharma, and that it is the parties’ intention that, since such Open Source Code date, OSG has been operating solely in accordance with the LMN Enginelicense granted herein.

Appears in 1 contract

Samples: Project Agreement (Viropharma Inc)

Development Activities. 2.1 The Steering Committee shall (a) POZEN will be comprised of [*Certain information has been omitted under a request responsible for confidential treatment, undertaking the POZEN Development Activities and will use Commercially Reasonable Efforts to perform the omitted information has been filed POZEN Development Activities in accordance with the Commission]POZEN Development Timeline. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates Joint Project Team will monitor each Party’s respective obligations and places, including meeting by teleconference or other electronic means if agreed upon by all Steering Committee membersprogress towards achieving the goals set forth in the Development Plan. The functions POZEN may outsource the performance of any part of the Steering Committee shall be POZEN Development Activities subject to oversee Section 14.1. If POZEN elects to outsource the collaborative research and joint development activities, including monitoring progress under performance of any part of the POZEN Development Activities, and engaging POZEN will notify GSK in exchanges writing regarding the nature of information and joint planning such proposed activities. After receiving such notice, GSK may provide POZEN feedback regarding such activities. (b) GSK will be responsible for undertaking the GSK Development Activities and will use Commercially Reasonable Efforts to perform the GSK Development Activities in accordance with the Formulation Development Timeline. The Steering Committee shall also appoint task forces or subcommitteesJoint Project Team will be responsible for monitoring the achievement of the Formulation Development Timeline. (c) Promptly after the Execution Date and subject to the terms of Article 11 below, GSK will disclose to POZEN [* *] to the extent it known by GSK. POZEN will limit access to such information to those employees (or legal counsel subject to confidentiality obligations no less rigorous than those contained herein) that have a need to know. POZEN may find it convenient or appropriate, with the objective of keeping each Party aware of relevant issues reasonably request additional materials and decisions information relating to the collaborative research foregoing and joint will engage in an evaluation of the Formulation based upon the information disclosed by GSK. (d) POZEN may raise any concerns it may have regarding the Formulation at the Joint Project Team meetings and the Parties will work in good faith to address such concerns. POZEN may request that the Joint Project Team develop a course of action to achieve the Formulation Development Timeline if it determines that such timeline may be subject to delay for any reason. Promptly upon such request, the Parties will share information regarding the status of GSK’s development under of the Development Activities. The Steering Committee may propose from time to time, during solid oral dose of the term of this Agreement, to amend or augment Formulation and the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall Joint Project Team will consider whether alternative actions should be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed implemented by the Parties (including the cooperation between the Parties to pursue a parallel formulation effort) taking into account the scientific evidence then available and become a part the best interests in the timely development of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the activities of the Steering Committee shall give it authority to direct MT 400 in accordance with the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development ActivitiesPlan. 2.2 Mount Sinai and LifeMap will commence the Development Activities (e) At any time after the Effective Date of this Agreementif GSK determines that it must acquire rights to any intellectual property Controlled by a Third Party in order to practice the Formulation it will promptly send written notice to POZEN to that effect. The Parties GSK will use commercially reasonable efforts to undertake negotiate rights to such Third Party technology that include the Development Activities substantially right to sublicense such technology to POZEN as otherwise provided herein. If GSK is unable to secure such sublicense rights or if in accordance with order to secure such sublicense rights, the terms and conditions total consideration for acquiring such sublicense rights would be materially higher than if GSK did not acquire such sublicense rights, GSK promptly will send written notice to POZEN to that effect. Within 30 days of receipt of such notice, [* *]. If [* *]. If [* *] under this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missionsSection 3.4(e) if [* *]. 2.3 If (f) GSK may outsource the services performance of any part (but not all) of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the GSK Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after GSK elects to outsource the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role performance of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to xxxxxx the collaborative nature of the GSK Development Activities, the Parties acknowledge that LifeMap it will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors notify POZEN in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details writing regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent nature of such procedures and details do not violate any Mount Sinai policiesproposed activities. After receiving such notice, POZEN may provide GSK feedback regarding such activities. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the work outlined in the Development Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to make Source Code or object code available to third parties (collectively, “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the LMN Engine.

Appears in 1 contract

Samples: Product Development and Commercialization Agreement (Pozen Inc /Nc)

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!