Specific Responsibilities of the Parties. Subject to the terms of this Agreement, each Party shall use Commercially Reasonable Efforts to (i) supply the quantities of its Compound as needed to conduct a Combined Therapy Trial on a timely basis, with BioXcel packaging, labeling and delivering same to study sites, in accordance with the time frame(s) established by the JDC; (ii) to conduct and complete each Combined Therapy Trial and any Statistical Analysis Plans and Bioanalysis Plans relating thereto on a timely basis in accordance with the Protocol, Bioanalysis Plans, Statistical Analysis Plans and Third Party agreements relating thereto, and (iii) to timely provide Rights of Cross-Reference where required by this Agreement. Each Party shall be responsible for activities assigned to it by the Protocol and/or JDC that such Party is not otherwise obligated to perform by this Agreement, provided that, except as set forth in this Agreement, in no event shall either Party be obligated to perform any such assigned activities without its prior written consent (which may be reflected in the minutes of meetings of the JDC or in the Protocol). As of the Effective Date, each Party shall be responsible for the following activities: (a) Responsibilities of BioXcel. Subject to JDC direction and oversight as provided in Section 2.4 and BioXcel’s Commercially Reasonably Efforts, BioXcel shall be responsible for the following activities, subject in each case (except as expressly provided in Section 4.1(a) with respect to the Manufacture and supply of the BioXcel Compound) to the Parties sharing the applicable Third Party Study Costs related to such activities in accordance with Section 7.1: (i) (A) Manufacturing, packaging and labeling the BioXcel Compound for use in the Combined Therapy Trials, (B) packaging and labeling the vials provided by Nektar of the Nektar Compound and vials provided by the CPI Compound supplier of the CPI Compound for use in the Combined Therapy Trials, and (C) providing the JDC (or a working team designated by the JDC) on a monthly basis with a clinical drug supply forecast for the Nektar Compound and CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the CPI Compound and the BioXcel Compound that includes strategy for drug supply overages, drug supply quantity and required delivery dates; (ii) with the cooperation of Nektar, compiling, amending and filing all necessary Combined Therapy Trial Regulatory Documentation with Regulatory Authority(ies), maintaining and acting as the sponsor of record as provided in 21 C.F.R. 312.50 (and applicable comparable ex-US laws) with responsibility, unless otherwise delegated in accordance with 21 CFR 312.52 (and applicable comparable ex-US laws), for each Combined Therapy Trial and making all required submissions to Regulatory Authorities related thereto on a timely basis; (iii) with the cooperation of Nektar, and subject to the provisions of Section 9.5, listing any Combined Therapy Trial required to be listed on a public database such as ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ or other public registry in any country in which such Combined Therapy Trial is being conducted in accordance with Applicable Law and in accordance with BioXcel’s internal policies relating to clinical trial registration; provided that Nektar shall provide BioXcel with written notice of any comments to a proposed listing within ten (10) Business Days of the date on which BioXcel provides the applicable information to Nektar; (iv) providing Nektar with reasonable advance notice of scheduled meetings or other material non-written communications with a Regulatory Authority and the opportunity to participate in each such meeting or other non-written communication, to the extent that it relates to the Combined Therapy or the Nektar Compound, and providing Nektar with the opportunity to review, provide comments to BioXcel within ten (10) Business Days on, and, if inconsistent with the applicable Protocol(s) or JDC guidance, approve all submissions and written correspondence with a Regulatory Authority that relates to the Combined Therapy or the Nektar Compound; provided, however, in no event shall BioXcel or any Affiliate of BioXcel initiate communications with or respond to any communications initiated by any Regulatory Authority solely with respect to the Nektar Compound without the prior written consent of Nektar and provided further that Nektar, if requested, shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the use of the BioXcel Compound as a monotherapy or in combination with other compounds and BioXcel, if requested, shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the use of the Nektar Compound as a monotherapy or in combination with other compounds; (v) providing to Nektar a written summary of meetings or a summary of other non-written communications with a Regulatory Authority within ten (10) calendar days of such meeting or communication, and copies of any official correspondence to or from a Regulatory Authority within two (2) Business Days of receipt or provision, in each case to the extent that it relates to the Combined Therapy or the Nektar Compound (or, to the extent the communication would adversely impact the performance of a Combined Therapy Trial, the BioXcel Compound), and copies of all Combined Therapy Trial Regulatory Documentation that CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. relate to the Combined Therapy or the Nektar Compound within five (5) Business Days of submission to Regulatory Authorities; (vi) drafting, and, subject to Sections 2.4 and 2.6(d), providing to Nektar (through the JDC or otherwise) for its review and approval, each Protocol and investigator’s brochure for a Combined Therapy Trial, and the related template ICF, template clinical site agreement, Bioanalysis Plan and Statistical Analysis Plan, and any material amendments to each of the foregoing (provided that Nektar shall provide BioXcel such approval or rejection within ten (10) Business Days of the date on which BioXcel provides the applicable document to Nektar); (vii) coordinating with Nektar and providing to the JDC (or a subcommittee designated by the JDC for such purpose) drafts of (1) submissions to the BioXcel IND (if applicable) and/or the Combined Therapy IND (if applicable); and (2) Combined Therapy Trial Regulatory Documentation, or portions thereof, that relate to the Combined Therapy or the Nektar Compound, for JDC review and approval, and providing Nektar with the opportunity to review, comment on and approve all other written correspondence with a Regulatory Authority relating to the Combined Therapy Trials, to the extent such correspondence relates to the Combined Therapy or the Nektar Compound; provided that Nektar shall provide BioXcel with written notice of any such comments (and, where applicable, approvals or rejections) within ten (10) Business Days of the date on which BioXcel provides the applicable document to Nektar; (viii) to the extent necessary for the conduct of any Combined Therapy Trial, providing Nektar a Right of Cross-Reference to the relevant Regulatory Documentation for the BioXcel Compound, provided that, such Right of Cross-Reference shall terminate upon the expiration or termination of this Agreement for purposes of conducting any new clinical studies, except that in the case of termination for a Material Safety Issue pursuant to Section 12.4, such Right of Cross-Reference shall remain in effect solely (1) to the extent necessary to permit BioXcel to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (2) as necessary to permit BioXcel to continue to dose subjects enrolled in each Combined Therapy Trial through completion of the applicable Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws; (ix) managing the operations of the Combined Therapy Trials in accordance with the applicable Protocol, including overseeing compliance by any CRO with the terms of its agreement with BioXcel relating to the Combined Therapy Trial; (x) subject to Sections 2.4 and 2.6(d), providing to Nektar a list of all proposed clinical trial sites and principal investigator(s) for each Combined Therapy Trial; (xi) subject to Sections 2.4 and 2.6(d), ensuring that all clinical trial service agreements and clinical trial site agreements (A) contain intellectual property provisions that retain each of the Parties’ respective intellectual property rights in the BioXcel Compound, Nektar Compound, and Combined Therapy, and (B) allow for Nektar, as well as BioXcel, to the extent permitted by Applicable Law and any Third Party confidentiality restrictions or obligations, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. to audit Combined Therapy Trial study sites for quality assurance and to inspect and copy data, documentation and work products relating to the activities performed by the site, including the medical records of any patient participating in any clinical study; provided that should Nektar seek to audit a study site (1) Nektar shall solely bear the cost and expense for such audit, (2) BioXcel shall accompany Nektar to such audit, at date and time mutually agreed upon by the Parties and the applicable study site, and (3) Nektar shall provide BioXcel with a copy of any reports resulting from such audit. This right to inspect and copy data, documentation, and work products of a study site may be exercised at any time during the Term, or such longer period as shall be required by Applicable Law; (xii) providing Nektar with copies of each final site template ICF (if requested by Nektar); (xiii) providing Nektar with minutes from any and all external drug safety monitoring boards for the Combined Therapy Trials, if applicable, within two (2) Business Days (or as soon as practicable) after receipt by BioXcel; (xiv) providing Nektar with updates on the status of the Combined Therapy Trials at each teleconference for the clinical execution working group, or upon Nektar’s reasonable request, including information regarding the number and status of study sites, the number of screened subjects (actual to target), the number of randomized subjects (actual to target), the number of dosed, ongoing, discontinued and completed subjects, and any safety updates as contemplated by the applicable Protocol, Section 2.1(c), and/or routinely performed by a Party in its normal course of trial management and reporting; (xv) subject to the provisions of Section 2.2, owning and being responsible for (or appointing a Third Party reasonably acceptable to Nektar to be responsible for) the maintenance of the Global Safety Database and safety reporting for the Combined Therapy, collecting, evaluating and reporting serious adverse events, other safety data and any further pharmacovigilance information from the Combined Therapy Trials, and providing Nektar with the opportunity to participate in and comment on such pharmacovigilance activities; (xvi) providing Nektar with access to all safety information (including any updates to the investigator’s brochure for the BioXcel Compound) in the Global Safety Database through the provision of case safety reports (“CSRs”) and listings related to the Combined Therapy or the Nektar Compound during the Combined Therapy Trials in accordance with Section 2.2; (xvii) analyzing the Study Data in a timely fashion and providing Nektar with access to the Study Data from the applicable Combined Therapy Trial as follows: (1) pursuant to an appropriate timetable determined by the JDC : (A) sharing with Nektar for review and comment drafts of interim, ongoing and/or final clinical trial reports (and/or statistical analyses in accordance with the Statistical Analysis Plan) from the Combined Therapy Trial and (B) providing the raw Study Data in electronic or other mutually agreed format; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (2) providing Nektar with a report of the safety data; (3) within approximately six (6) weeks from the completion of the Combined Therapy Trial, provide to Nektar case report forms or patient profiles for all patients in each Combined Therapy Trial; (4) within sixty (60) calendar days of the creation of a quality checked and closed database for the Combined Therapy Trial, copies of the Form 1572s, financial disclosures and other relevant documents required to meet regulatory requirements related to the Combined Therapy Trial (including any data or documents that may be required to provide Aggregate Safety Information to a Regulatory Authority with respect to the Nektar Compound); (5) within approximately six (6) weeks of the creation of an electronic quality checked and closed database for the Combined Therapy Trial, an electronic copy of the such database; and (6) providing Nektar with any programs or SAS codes to be used for the Statistical Analysis Plan for the Combined Therapy Trial; (xviii) obtaining supplies of any co-medications, to the extent any such co-medications are required for use in any Combined Therapy Trial, and providing to Nektar any information related to each Combined Therapy Trial that is provided to the manufacturer of any co-medication pursuant to Section 9.5 herein within five (5) Business Days after the provision of the information to the manufacturer; (xix) providing Nektar with any information regarding the pharmacokinetics, efficacy and safety of the Nektar Compound alone or in combination with the BioXcel Compound and/or the CPI Compound; (xx) providing for the release by a Qualified Person (as such term will be defined in the Quality Agreement), or providing the necessary documentation in support of such quality release, of the BioXcel Compound if such release is required for any Combined Therapy Trial; (xxi) performing either directly or through Third Parties collection of Samples; and (xxii) such other responsibilities as may be agreed to by the Parties or determined by the JDC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Appears in 1 contract
Sources: Clinical Trial Collaboration Agreement (BioXcel Therapeutics, Inc.)
Specific Responsibilities of the Parties. Subject to the terms of this Agreement, each Party shall use Commercially Reasonable Efforts to (i) supply the quantities of its Compound Compound(s) as needed to conduct a Combined Therapy Trial on a timely basis, with BioXcel packaging, labeling and delivering package and deliver same to study sites, in accordance with the time frame(s) established by the JDCJDC ; (ii) to conduct and complete each Combined Therapy Trial and any Statistical Analysis Plans and Bioanalysis Plans relating thereto on a timely basis in accordance with the Protocol, Bioanalysis Plans, Statistical Analysis Plans and Third Party agreements relating thereto, and (iii) to timely provide Rights of Cross-Reference where required by this Agreement, and (iv) in the case of the Conducting Party, to provide sufficient resources and personnel to conduct and perform the Combined Therapy Trial for which it is the Conducting Party, and to adequately fund the Combined Therapy Trial, on a timely basis in accordance with the Protocol for same and the terms of this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Each Party shall be responsible for activities assigned to it by the Protocol and/or JDC in furtherance of the conduct of a Combined Therapy Trial, or the Statistical Analysis Plan that such Party is not otherwise obligated to perform by this Agreement, provided that, except as expressly set forth in this Agreement, in no event shall either Party be obligated to perform any such assigned activities without its prior written consent (which may be reflected in the minutes of meetings of the JDC or in the Protocoland signed by both representatives). As of the Effective Date, each Party shall be responsible for the following activities:
(a) Responsibilities of BioXcel. Subject to JDC direction and oversight as provided in Section 2.4 and BioXcel’s Commercially Reasonably Efforts, BioXcel shall be responsible for the following activities, subject in each case (except as expressly provided in Section 4.1(a) with respect to the Manufacture and supply of the BioXcel Compound) to the Parties sharing the applicable Third Party Study Costs related to such activities in accordance with Section 7.1:
(i) (A) Manufacturing, packaging and labeling the BioXcel Compound for use in the Combined Therapy Trials, (B) packaging and labeling the vials provided by Nektar of the Nektar Compound and vials provided by the CPI Compound supplier of the CPI Compound for use in the Combined Therapy Trials, and (C) providing the JDC (or a working team designated by the JDC) on a monthly basis with a clinical drug supply forecast for the Nektar Compound and CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the CPI Compound and the BioXcel Compound that includes strategy for drug supply overages, drug supply quantity and required delivery dates;
(ii) with the cooperation of Nektar, compiling, amending and filing all necessary Combined Therapy Trial Regulatory Documentation with Regulatory Authority(ies), maintaining and acting as the sponsor of record as provided in 21 C.F.R. 312.50 (and applicable comparable ex-US laws) with responsibility, unless otherwise delegated in accordance with 21 CFR 312.52 (and applicable comparable ex-US laws), for each Combined Therapy Trial and making all required submissions to Regulatory Authorities related thereto on a timely basis;
(iii) with the cooperation of Nektar, and subject to the provisions of Section 9.5, listing any Combined Therapy Trial required to be listed on a public database such as ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ or other public registry in any country in which such Combined Therapy Trial is being conducted in accordance with Applicable Law and in accordance with BioXcel’s internal policies relating to clinical trial registration; provided that Nektar shall provide BioXcel with written notice of any comments to a proposed listing within ten (10) Business Days of the date on which BioXcel provides the applicable information to Nektar;
(iv) providing Nektar with reasonable advance notice of scheduled meetings or other material non-written communications with a Regulatory Authority and the opportunity to participate in each such meeting or other non-written communication, to the extent that it relates to the Combined Therapy or the Nektar Compound, and providing Nektar with the opportunity to review, provide comments to BioXcel within ten (10) Business Days on, and, if inconsistent with the applicable Protocol(s) or JDC guidance, approve all submissions and written correspondence with a Regulatory Authority that relates to the Combined Therapy or the Nektar Compound; provided, however, in no event shall BioXcel or any Affiliate of BioXcel initiate communications with or respond to any communications initiated by any Regulatory Authority solely with respect to the Nektar Compound without the prior written consent of Nektar and provided further that Nektar, if requested, shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the use of the BioXcel Compound as a monotherapy or in combination with other compounds and BioXcel, if requested, shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the use of the Nektar Compound as a monotherapy or in combination with other compounds;
(v) providing to Nektar a written summary of meetings or a summary of other non-written communications with a Regulatory Authority within ten (10) calendar days of such meeting or communication, and copies of any official correspondence to or from a Regulatory Authority within two (2) Business Days of receipt or provision, in each case to the extent that it relates to the Combined Therapy or the Nektar Compound (or, to the extent the communication would adversely impact the performance of a Combined Therapy Trial, the BioXcel Compound), and copies of all Combined Therapy Trial Regulatory Documentation that CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. relate to the Combined Therapy or the Nektar Compound within five (5) Business Days of submission to Regulatory Authorities;
(vi) drafting, and, subject to Sections 2.4 and 2.6(d), providing to Nektar (through the JDC or otherwise) for its review and approval, each Protocol and investigator’s brochure for a Combined Therapy Trial, and the related template ICF, template clinical site agreement, Bioanalysis Plan and Statistical Analysis Plan, and any material amendments to each of the foregoing (provided that Nektar shall provide BioXcel such approval or rejection within ten (10) Business Days of the date on which BioXcel provides the applicable document to Nektar);
(vii) coordinating with Nektar and providing to the JDC (or a subcommittee designated by the JDC for such purpose) drafts of (1) submissions to the BioXcel IND (if applicable) and/or the Combined Therapy IND (if applicable); and (2) Combined Therapy Trial Regulatory Documentation, or portions thereof, that relate to the Combined Therapy or the Nektar Compound, for JDC review and approval, and providing Nektar with the opportunity to review, comment on and approve all other written correspondence with a Regulatory Authority relating to the Combined Therapy Trials, to the extent such correspondence relates to the Combined Therapy or the Nektar Compound; provided that Nektar shall provide BioXcel with written notice of any such comments (and, where applicable, approvals or rejections) within ten (10) Business Days of the date on which BioXcel provides the applicable document to Nektar;
(viii) to the extent necessary for the conduct of any Combined Therapy Trial, providing Nektar a Right of Cross-Reference to the relevant Regulatory Documentation for the BioXcel Compound, provided that, such Right of Cross-Reference shall terminate upon the expiration or termination of this Agreement for purposes of conducting any new clinical studies, except that in the case of termination for a Material Safety Issue pursuant to Section 12.4, such Right of Cross-Reference shall remain in effect solely (1) to the extent necessary to permit BioXcel to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (2) as necessary to permit BioXcel to continue to dose subjects enrolled in each Combined Therapy Trial through completion of the applicable Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws;
(ix) managing the operations of the Combined Therapy Trials in accordance with the applicable Protocol, including overseeing compliance by any CRO with the terms of its agreement with BioXcel relating to the Combined Therapy Trial;
(x) subject to Sections 2.4 and 2.6(d), providing to Nektar a list of all proposed clinical trial sites and principal investigator(s) for each Combined Therapy Trial;
(xi) subject to Sections 2.4 and 2.6(d), ensuring that all clinical trial service agreements and clinical trial site agreements (A) contain intellectual property provisions that retain each of the Parties’ respective intellectual property rights in the BioXcel Compound, Nektar Compound, and Combined Therapy, and (B) allow for Nektar, as well as BioXcel, to the extent permitted by Applicable Law and any Third Party confidentiality restrictions or obligations, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. to audit Combined Therapy Trial study sites for quality assurance and to inspect and copy data, documentation and work products relating to the activities performed by the site, including the medical records of any patient participating in any clinical study; provided that should Nektar seek to audit a study site (1) Nektar shall solely bear the cost and expense for such audit, (2) BioXcel shall accompany Nektar to such audit, at date and time mutually agreed upon by the Parties and the applicable study site, and (3) Nektar shall provide BioXcel with a copy of any reports resulting from such audit. This right to inspect and copy data, documentation, and work products of a study site may be exercised at any time during the Term, or such longer period as shall be required by Applicable Law;
(xii) providing Nektar with copies of each final site template ICF (if requested by Nektar);
(xiii) providing Nektar with minutes from any and all external drug safety monitoring boards for the Combined Therapy Trials, if applicable, within two (2) Business Days (or as soon as practicable) after receipt by BioXcel;
(xiv) providing Nektar with updates on the status of the Combined Therapy Trials at each teleconference for the clinical execution working group, or upon Nektar’s reasonable request, including information regarding the number and status of study sites, the number of screened subjects (actual to target), the number of randomized subjects (actual to target), the number of dosed, ongoing, discontinued and completed subjects, and any safety updates as contemplated by the applicable Protocol, Section 2.1(c), and/or routinely performed by a Party in its normal course of trial management and reporting;
(xv) subject to the provisions of Section 2.2, owning and being responsible for (or appointing a Third Party reasonably acceptable to Nektar to be responsible for) the maintenance of the Global Safety Database and safety reporting for the Combined Therapy, collecting, evaluating and reporting serious adverse events, other safety data and any further pharmacovigilance information from the Combined Therapy Trials, and providing Nektar with the opportunity to participate in and comment on such pharmacovigilance activities;
(xvi) providing Nektar with access to all safety information (including any updates to the investigator’s brochure for the BioXcel Compound) in the Global Safety Database through the provision of case safety reports (“CSRs”) and listings related to the Combined Therapy or the Nektar Compound during the Combined Therapy Trials in accordance with Section 2.2;
(xvii) analyzing the Study Data in a timely fashion and providing Nektar with access to the Study Data from the applicable Combined Therapy Trial as follows:
(1) pursuant to an appropriate timetable determined by the JDC : (A) sharing with Nektar for review and comment drafts of interim, ongoing and/or final clinical trial reports (and/or statistical analyses in accordance with the Statistical Analysis Plan) from the Combined Therapy Trial and (B) providing the raw Study Data in electronic or other mutually agreed format; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(2) providing Nektar with a report of the safety data;
(3) within approximately six (6) weeks from the completion of the Combined Therapy Trial, provide to Nektar case report forms or patient profiles for all patients in each Combined Therapy Trial;
(4) within sixty (60) calendar days of the creation of a quality checked and closed database for the Combined Therapy Trial, copies of the Form 1572s, financial disclosures and other relevant documents required to meet regulatory requirements related to the Combined Therapy Trial (including any data or documents that may be required to provide Aggregate Safety Information to a Regulatory Authority with respect to the Nektar Compound);
(5) within approximately six (6) weeks of the creation of an electronic quality checked and closed database for the Combined Therapy Trial, an electronic copy of the such database; and
(6) providing Nektar with any programs or SAS codes to be used for the Statistical Analysis Plan for the Combined Therapy Trial;
(xviii) obtaining supplies of any co-medications, to the extent any such co-medications are required for use in any Combined Therapy Trial, and providing to Nektar any information related to each Combined Therapy Trial that is provided to the manufacturer of any co-medication pursuant to Section 9.5 herein within five (5) Business Days after the provision of the information to the manufacturer;
(xix) providing Nektar with any information regarding the pharmacokinetics, efficacy and safety of the Nektar Compound alone or in combination with the BioXcel Compound and/or the CPI Compound;
(xx) providing for the release by a Qualified Person (as such term will be defined in the Quality Agreement), or providing the necessary documentation in support of such quality release, of the BioXcel Compound if such release is required for any Combined Therapy Trial;
(xxi) performing either directly or through Third Parties collection of Samples; and
(xxii) such other responsibilities as may be agreed to by the Parties or determined by the JDC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Appears in 1 contract
Sources: Clinical Trial Collaboration Agreement (Exelixis, Inc.)