Common use of Conduct of the Study Clause in Contracts

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Vaccinex file a separate IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Vaccinex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein to the contrary, Merck shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply of Merck Compound. Vaccinex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Compound. Each Party grants to the other Party a non-exclusive, nontransferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex shall maintain reports and all related documentation with respect to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iv) in the case of Merck, determine whether the Study has been performed by Vaccinex in accordance with this Agreement. 3.5 Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.

Appears in 2 contracts

Sources: Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.), Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.)

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Syndax shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for relating to the Study; provided, however, . Merck acknowledges that in no event shall Vaccinex Syndax intends to file a separate IND or CTA for covering the Study unless required by Regulatory Authorities clinical evaluation of the Syndax Compound to do so. For clarity, the Parties anticipate that Vaccinex will conduct treat melanoma and lung-related indications and to perform the Study under Vaccinex’s current such IND. This separate IND # [***] for the Vaccinex Compoundwill not be a combination IND. If a Regulatory Authority requests a separate combination IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex Syndax shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Vaccinex Syndax shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein Further, Syndax shall ensure that all necessary Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the contrary, Merck shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply of Merck CompoundStudy. Vaccinex Syndax shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related Merck Compound. Notwithstanding anything to the Vaccinex contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to its Compound. Each Party grants Merck will authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound CTA to provide data access to Syndax sufficient to support conduct of the Study, which authorization will take the form of a cross-reference letter or similar communication to the other Party applicable Regulatory Authority to effectuate a non-exclusive, nontransferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a Territory. If an appropriate Merck Compound CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possibleavailable in a given country, the Parties Merck will promptly discuss in good faith file its CMC data as appropriate and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such grant right of reference in form and substance reasonably requested by the other Party. Notwithstanding anything to the contrary in this Agreementsuch CMC data; provided, neither Party however, that Syndax shall have any license, or no right to directly access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germanydata. 3.4 Vaccinex Syndax shall maintain reports and all related documentation with respect relating to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, or (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iv) in the case of Merck, determine whether the Study has been performed by Vaccinex in accordance with this Agreement. 3.5 Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such PartyData, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data . Syndax shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof Directive, GCP or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex . 3.6 Syndax shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSCJoint Development Committee. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related theretoto its own Compound. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex Syndax the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex Syndax shall own all data arising from the Sample Testing conducted by or on behalf of VaccinexSyndax. Vaccinex Syndax shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of VaccinexSyndax, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in a writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of ***. Further, Merck covenants not to ***, and Syndax covenants not ***; provided, however, that the Permitted Useforegoing shall not prevent either Party from ***. 3.7 All Clinical Data, including raw data and results, generated under this Agreement shall be jointly owned by Syndax and Merck. For clarity, after It is understood and acknowledged by the publication of a particular item of the other Party’s Sample Testing Results/Parties that positive Clinical Data in compliance with and as permitted under Section 12 of this Agreementcould be used to obtain label changes for the Compounds. In such event, the Parties are permitted will enter into good faith negotiations to use or disclose such published informationdetermine a regulatory submission strategy for the Compounds, and cost structure of the next part of the Study and/or future study(ies) that may be needed for regulatory submission for the Compounds. Note: Reference Merck covenants not to “Merck” in this document refers ***, and Syndax covenants not to ***; provided, however, that the Group of Companies affiliated with Merck KGaA, Darmstadt, Germanyforegoing shall not prevent either Party from ***.

Appears in 2 contracts

Sources: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc), Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Athenex shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for IND/CTA relating to the Study; provided, however, that in no event shall Vaccinex Athenex file a separate IND or IND/CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or IND/CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Vaccinex Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein Further, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the contrary, Merck shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply of Merck CompoundStudy. Vaccinex Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck Lilly shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Lilly Compound. Each Party grants to the other Party a non-exclusive, nontransferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex Athenex shall maintain reports and all related documentation with respect to the Study (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Each Party Athenex shall provide to the other all any Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s the Lilly Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iviii) in the case of Merck, to determine whether the Study has been performed by Vaccinex Athenex in accordance with this Agreement. 3.5 Each Party Athenex shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the United States Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly. 3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples and related to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party Lilly Compound, shall be responsible for conducting the Sample Testing as set forth on the Data Sharing jointly owned by Lilly and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, GermanyAthenex.

Appears in 2 contracts

Sources: Clinical Trial Collaboration and Supply Agreement (Athenex, Inc.), Clinical Trial Collaboration and Supply Agreement (Athenex, Inc.)

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Vaximm shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Vaccinex Vaximm file a separate IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study Study, the Parties will promptly meet in the format of the JCSC and mutually agree on an approach to address such requirement. In the event that the JCSC cannot agree, on an approach to address such requirement the matter is elevated in accordance with Section 3.8 for resolution. 3.2 Vaccinex Vaximm shall ensure that the each Study is performed in accordance with this Agreement, the respective Protocol and all Applicable Law, including GCP. 3.3 Vaccinex Vaximm shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein to the contrary, Merck The Alliance shall fully cooperate with Vaccinex Vaximm to comply with such directions, including with respect to supply of the Alliance Compound and related documents and information, as deemed necessary or useful by Merck Compoundto comply with such directions. Vaccinex Vaximm shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck the Alliance shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Vaximm Compound. Each Party grants to the other Party a non-exclusive, nontransferable non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data Results and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by on a need-to-know basis with respect to the other Partyconfidential part of the Drug Master Files of both Parties. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex Vaximm shall maintain reports and all related documentation with respect to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor Subcontractor engaged pursuant to Section 2.4 2.3 hereof, and (iv) in the case of Merckthe Alliance, determine whether the Study has been performed by Vaccinex Vaximm in accordance with this Agreement. 3.5 Each Upon request, each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck the Alliance no more than [***] once every 3 months or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck the Alliance no later than [***]thirty (30) days following completion of the final Study report. Merck The Alliance shall provide pharmacokinetics and anti-drug antibody data regarding Merck the Alliance Compound to Vaccinex Vaximm no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.once every three

Appears in 1 contract

Sources: Clinical Trial Collaboration and Supply Agreement

Conduct of the Study. 3.1 Notwithstanding anything 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution, however their participation in the Study must not cause any serious operating issues. Estimated duration of the Study: until 2.2 Investigator agrees, and commits itself to CRO, to conduct the Study at Institution and warrants that he/she is employed by Institution. Investigator shall personally supervise the conduct of the Study by the Study Personnel to the contrary herein, Vaccinex shall act as full extent contemplated by the Protocol and by Applicable Law. Institution and Investigator agree to provide prompt advance notice to Sponsor and CRO if Investigator will be leaving the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and CRO. 2.3 Investigator and Institution acknowledge that SPONSOR is the sponsor of the Study, and as such is an intended third- party beneficiary of this Agreement, whereas SPONSOR transfers any or all of the SPONSOR's Study-related functions to CRO in compliance with ICH-GCP, sec. 5. 2.1. In addition to the foregoing, Investigator and Institution agree that CRO may disclose any and all Information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study and shall own and hold (including without limitation any Reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to SPONSOR. All references to SPONSOR herein (whether in the IND and/or CTAcontext of delivery of Information, submission of applications, financial terms, or anything else) derive from SPONSOR’s status as such, as applicableset out by Applicable Law and GCP regulations, and Investigator and Institution agree to all such instances. Investigator and Institution will Fully Cooperate with CRO’s requests relating to SPONSOR. 2.4 Investigator and Institution acknowledge that CRO is the recipient of Services described in this Agreement and, for the Study; provided, howeveravoidance of any doubt, that SPONSOR is not the recipient of Services described in no event shall Vaccinex file a separate IND or CTA for the this Agreement. 2.5 Institution and Investigator specifically agree, and commit themselves to CRO, to (and warrant that Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will Personnel will) conduct the Study under Vaccinex’s current IND # [***] for in a diligent, efficient, and skilful manner, in strict compliance with the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study the Parties will promptly meet terms and mutually agree on an approach to address such requirement. 3.2 Vaccinex shall ensure that the Study is performed in accordance with conditions of this Agreement, the Protocol and all including subsequent amendments, any specific Study Instructions, Applicable Law, all requirements of the Institution or facility, and any other professional standards applicable to their professional industries and fields. Neither Institution nor Investigator nor any Study Personnel shall commit any negligent acts or any wilful misconduct in connection with the Study. Neither Institution nor Investigator nor any Study Personnel shall make any unauthorized warranties to any person (including GCPSubjects) concerning the product being tested in the Study. Institution and Investigator accept responsibility for the acts and omissions of all Study Personnel in the Study. 3.3 Vaccinex 2.6 CRO or Sponsor shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over obtain the written approval of the appropriate Ethics Committee (EC) prior to commencement of the Study are followed. Notwithstanding anything else herein and will furnish Investigator with the EC’s letter of approval. 2.7 If required by Applicable Law, CRO shall make, or procure that SPONSOR makes, the necessary submissions or notifications to the contraryregulatory authorities. The Study may not commence until the Investigator has been informed by CRO that such authorization has been granted. 2.8 Investigator shall, Merck shall fully cooperate with Vaccinex prior to comply with such directions, including with respect to supply of Merck Compound. Vaccinex shall participate a Subject’s participation in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that obtain the prior Subject's written informed consent to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Compound. Each Party grants to the other Party a non-exclusive, nontransferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to as well as for processing of Personal Data from the other Party’s Compound Subject including the public disclosure, transfer and Regulatory Approvals. In all other casesprocessing of data collected in accordance with the Protocol, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex shall maintain reports and all related documentation with respect to the Study in good scientific manner and in compliance with Applicable Law, especially data protection law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such PartySubject’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iv) in the case of Merck, determine whether the Study has been performed by Vaccinex in accordance with this Agreement. 3.5 Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data written informed consent shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and in a complete copy of the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database form that is in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law and as agreed upon with the Sponsor and handed over by CRO. Sponsor or CRO, as the case may be, undertake to inform Institution and Investigator in time of the United States in connection with newly approved Study documents. 2.9 Investigator shall enroll the number of duly qualified (according to the Protocol) Subjects for the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing in Exhibit A and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except do so according to the extent otherwise agreed timetable set forth in writing signed by authorized representatives Exhibit A. Notwithstanding the foregoing, Investigator agrees that SPONSOR or CRO may unilaterally revise the number of each PartySubjects that Investigator shall enroll, prior to publication or other public disclosure permitted under this Agreementand/or the timeframe for such enrollment, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germanyvia Study Instructions at any time.

Appears in 1 contract

Sources: Clinical Trial Agreement

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Ideaya shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for relating to the Study; provided, however, that in no event shall Vaccinex Ideaya file a separate IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex Ideaya shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. In the event that any Regulatory Authority, ethics committee or institutional review board has questions related to the Protocol or the conduct of the Study that relate to the Pfizer Compound, Pfizer will provide reasonable assistance in responding to such questions. 3.3 Vaccinex Ideaya shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein to the contraryFurther, Merck Ideaya shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply of Merck Compound. Vaccinex shall participate in and lead ensure that all discussions with Regulatory Approvals from any Regulatory Authority regarding and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck . Pfizer shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Pfizer Compound. Each Party grants to the other Party a non-exclusive, nontransferable non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities)Territory, with respect to Study Clinical Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. reference. 3.4 Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its CompoundCompounds. Note: Reference If necessary, Pfizer shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Pfizer Compound U.S., EU and Australia Regulatory Approvals to provide data access to Ideaya solely to the extent necessary to support conduct of the Study. If the cross-references to such Regulatory Approvals are not deemed sufficient by a Regulatory Authority in any given country, Pfizer shall file the complete CMC components of the Common Technical Document for its Compound (the Merck” CMC Data”) with such Regulatory Authority, with a letter of authorization for Ideaya to cross-reference the CMC Data for the review of the CTA; however, Ideaya shall have no right to directly access the CMC Data. Ideaya shall reimburse Pfizer for the costs for preparing the CMC Data for filing with such Regulatory Authority(ies) and related filing costs. In addition to the foregoing, Pfizer shall provide the materials described in Appendix B to Ideaya in accordance with Appendix B, and shall provide such other documents and information as may be requested by a Regulatory Authority, to the extent such documents and information are reasonably available to Pfizer. Pfizer hereby agrees that it shall review Section D of the European Clinical Trials Database (EudraCT) Application Form [***] Certain information in this document refers has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the Group registrant if publicly disclosed. Worksheets and Medicines section of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex shall maintain reports and all related documentation the Clinical Trial Notification (CTN) Form completed by Ideaya with respect to the Pfizer Compound for purposes of the CTA and CTN, respectively, no later than [***] days following receipt from Ideaya, provide any corrections or additions required for accuracy and completeness of such Worksheets. 3.5 Ideaya shall ensure that all reports and related documentation required for the Study are maintained in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iv) in the case of MerckPfizer, determine whether the Study has been performed by Vaccinex Ideaya in accordance with this Agreement. 3.5 Each Party 3.6 Ideaya shall provide to the other Party Pfizer copies of all Clinical Data to the extent generated by such PartyData, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck Pfizer no later than [***]] days following Study Completion. Merck Pfizer shall provide pharmacokinetics and anti-drug antibody data regarding Merck the Pfizer Compound to Vaccinex no less than [***]Ideaya on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocoldatabase. Vaccinex Ideaya shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, GermanyPfizer.

Appears in 1 contract

Sources: Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.)

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Context shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for relating to the Study; provided, however, that in no event shall Vaccinex Context file a separate IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study Study, the Parties will promptly meet and mutually agree on to discuss an approach to address such requirement, with Context having final decision-making authority regarding such separate IND, provided that Context shall reasonably consider any input provided by Menarini. 3.2 Vaccinex Prior to the initiation of the Study or as may otherwise be necessary during the course of the Study, either Party shall ensure share with the other Party any information related to the pre-clinical and clinical studies it performed regarding their respective Compound, as may be reasonably requested by the other Party in view of the evaluation of the Study. 3.3 Context agrees that the Study is shall be performed in accordance with this Agreement, its obligations under the Related Agreements, the Protocol and all Applicable Law, including GCP, other than any Study activities to be performed by Menarini for which Menarini shall ensure that such Study activities are performed in accordance with this Agreement, its obligations under the Related Agreements, and all Applicable Law, including GCP. In the event that any Regulatory Authority, ethics committee or institutional review board has ACTIVE/117982251.1 questions related to the Protocol or the conduct of the Study that relate to the Menarini Compound, Menarini will provide reasonable assistance in responding to such questions. 3.3 Vaccinex 3.4 Context agrees that all its Study activities shall be in compliance with all directions from, and that have been agreed with, any Regulatory Authority and/or ethics committee with jurisdiction over the Study. Further, Context shall ensure that all directions Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein obtained prior to initiating performance of the Study (in particular and to the contraryextent applicable, Merck shall fully cooperate with Vaccinex to comply with such directions, including with respect to supply Context will follow the FDA Guidance on co-development of Merck Compoundtwo or more investigational drugs). Vaccinex Context shall participate in and, if required, lead any and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck Menarini shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Compounddiscussions. Each Party Menarini grants to the other Party Context a non-exclusive, nontransferable non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities)Territory, with respect to Study Data and results related to CompoundsMenarini’s Regulatory Approvals for the Menarini Compound, solely as necessary for the other Party Context to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties will promptly discuss in good faith and agree on how to provide the required documentation Approvals for CTA of the Study. Further, each Party Menarini shall provide to the other Context a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Party. reference. 3.5 Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s 's CMC data Data (as hereinafter defined) with respect to its CompoundCompounds unless it is requested or required by the Regulatory Authority. Note: Reference If necessary, each Party shall authorize FDA and other applicable Regulatory Authorities to “Merck” in this document refers cross-reference the U.S. and EU Regulatory Approvals of its Compound to provide data access to the Group other Party solely to the extent necessary to support conduct of Companies affiliated the Study. If the cross-references to such Regulatory Approvals are not deemed sufficient by a Regulatory Authority in any given country, then such Party shall file the complete CMC components of the Common Technical Document for its Compound (the “CMC Data”) with Merck KGaAsuch Regulatory Authority, Darmstadtwith a letter of authorization for the other Party to cross-reference the CMC Data for the review of the CTA; however, Germanythe other Party shall have no right to directly access the CMC Data. If direct access to CMC Data of the other Party is required for any regulatory filing submission, the Parties will discuss in good faith a potential solution; however in the absence of an agreement, the Parties shall refrain from using the CMC Data for any such filing. 3.4 Vaccinex 3.6 In addition to the foregoing, Menarini shall use its Commercially Reasonable Efforts to: (i) provide the first tranche of Menarini Compound described in Appendix B to Context no later than [***] days from the written order from Context, and (ii) provide such other documents and information as may be requested by a Regulatory Authority, to the extent such documents and information are reasonably available to Menarini. 3.7 Context shall maintain reports and all related documentation with respect to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or or, subject to Section 3.4 and Section 3.5 above, such Party’s Compound's Compounds, (ii) conduct the Sample TestingTesting (in the case of Context), (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof2.4, and (iv) in the case of MerckMenarini, determine whether the Study has been performed by Vaccinex Context in accordance with this Agreement. 3.5 Each Party 3.8 Context shall provide to the other Party copies of own all Clinical Data Data. Context hereby grants Menarini a worldwide, perpetual, fully paid up, royalty free, sublicensable limited license to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck no more than [***] or as otherwise mutually agreed by the Parties; and a complete copy of use the Clinical Data shall be provided to Merck no later than [***]. Merck shall provide pharmacokinetics and anti-drug antibody data regarding Merck Compound to Vaccinex no less than [***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocol. Vaccinex shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.ACTIVE/117982251.1

Appears in 1 contract

Sources: Clinical Trial Collaboration and Supply Agreement (Context Therapeutics Inc.)

Conduct of the Study. 3.1 Notwithstanding anything to the contrary herein, Vaccinex Syndax shall act as the sponsor of the Study and shall own and hold the IND and/or CTA, as applicable, for the Study; provided, however, that in no event shall Vaccinex Syndax file a separate IND or CTA for the Study unless required by Regulatory Authorities to do so. For clarity, the Parties anticipate that Vaccinex will conduct the Study under Vaccinex’s current IND # [***] for the Vaccinex Compound. If a Regulatory Authority requests a separate IND or CTA for the Study the Parties will promptly meet and mutually agree on an approach to address such requirement. 3.2 Vaccinex Syndax shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Vaccinex Syndax shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Notwithstanding anything else herein to the contrary, Merck The Alliance shall fully cooperate with Vaccinex Syndax to comply with such directions, including with respect to supply of Merck the Alliance Compound. Vaccinex Syndax shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that to the extent practicable (e.g. ad hoc conversations with Regulatory Authorities requiring an immediate response will be excluded) and if not prohibited by such Regulatory Authority, Merck shall have the right (but no obligation) to have a representative participate in any discussions with a Regulatory Authority regarding matters related to the Study; provided further that the Parties acknowledge and agree that such right does not apply to discussions regarding general Study matters that are solely related to the Vaccinex Compound***. Each Party grants to the other Party a non-exclusive, nontransferable non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory (only if possible, i.e., a CTA for the respective Compound was already submitted to the local Health Authorities), with respect to Study Data and results related to Compounds, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions in respect of the Study related to the other Party’s Compound and Regulatory Approvals. In all other cases, where a “right of reference” is not possible, the Parties parties will promptly discuss in good faith and agree on how to provide the required documentation for CTA of the Study. Further, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate such right of reference in form and substance reasonably requested by the other Partyreference. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any license, or right to access the other Party’s CMC data with respect to its Compound. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 3.4 Vaccinex Syndax shall maintain reports and all related documentation with respect to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iv) in the case of Merckthe Alliance, determine whether the Study has been performed by Vaccinex Syndax in accordance with this Agreement. 3.5 Each Party shall provide to the other Party copies of all Clinical Data to the extent generated by such Party, in an agreed electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines; provided, however, that Clinical Data shall be provided to Merck no more than [the Alliance ***] or as otherwise mutually agreed by the Parties; and a complete copy of the Clinical Data shall be provided to Merck the Alliance no later than [***]* following completion of the final Study report. Merck The Alliance shall provide pharmacokinetics and anti-drug antibody data regarding Merck the Alliance Compound to Vaccinex no less than [Syndax ***]. “Study Completion” shall be deemed to occur upon lock of the Study database in accordance with the Protocoldatabase. Vaccinex Syndax shall use commercially reasonable efforts to ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive 95/46/EC or subsequent revised versions thereof or any other similar Applicable Law of the United States in connection with the Study permit such sharing of Clinical Data with Merck. Vaccinex shall provide Samples to Merck as specified in the Protocol or as agreed to by the JCSC. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing as set forth on the Data Sharing and Sample Testing Schedule, including all expenses related thereto. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Vaccinex the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Vaccinex shall own all data arising from the Sample Testing conducted by or on behalf of Vaccinex. Vaccinex shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Vaccinex, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in writing signed by authorized representatives of each Party, prior to publication or other public disclosure permitted under this Agreement, each Party shall use or disclose the other Party’s Sample Testing Results only for the purposes of the Permitted Use. For clarity, after the publication of a particular item of the other Party’s Sample Testing Results/Clinical Data in compliance with and as permitted under Section 12 of this Agreement, the Parties are permitted to use or disclose such published information. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, GermanyAlliance.

Appears in 1 contract

Sources: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)