Scope of Collaboration; Governance of Agreement. (a) The Parties shall, pursuant to this Agreement, collaborate to conduct the following clinical trials (each, a “Combined Therapy Trial”) (i) a Phase 1/2 clinical trial evaluating the Combined Therapy (the “Initial Trial”), and (ii) such other clinical trials evaluating the Combined Therapy as may be mutually agreed upon by the Parties. Each Combined Therapy Trial shall be conducted in accordance with a protocol (each, a “Protocol”) to be drafted by BioXcel (in consultation with Nektar) and mutually agreed upon by the Parties at a meeting of the JDC. No 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. Protocol, including the Protocol for the Initial Trial, shall be approved by the JDC unless the corresponding budget is also approved by the JDC either in advance of the approval of the Protocol or contemporaneously with the approval of the Protocol. Any substantive amendments to each Protocol and related budget will be subject to mutual agreement of the Parties at a meeting of the JDC or by written agreement (including by email acknowledgment) of the JDC Co-Chairs without a meeting. A trial overview (“Trial Overview ”) for the Initial Trial is attached hereto as Exhibit A, which shall be used by BioXcel for the drafting of the Protocol for the Initial Trial, for submission to the JDC.
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Samples: Trial Collaboration Agreement, Clinical Trial Collaboration Agreement (BioXcel Therapeutics, Inc.)
Scope of Collaboration; Governance of Agreement. (a) The Parties shallintend, pursuant to this Agreement, to collaborate to conduct the following clinical trials (each, a “Combined Therapy Trial”) (i) a Phase 1/2 the clinical trial evaluating the Combined Therapy trials identified in Exhibit A (referred to as the “Initial TrialTrials”), ) and (ii) such other clinical trials evaluating the a Combined Therapy of the BMS Compound(s) with the Exelixis Compound as the Parties may agree to conduct pursuant to the terms of this Agreement (any such trial in (i) or (ii), a “Combined Therapy Trial”). A clinical study protocol (including a clinical protocol synopsis) for each Combined Therapy Trial will be mutually agreed upon approved by the PartiesJDC (each, a “Protocol”). The Parties will also use good faith efforts to consult with each other and to finalize the Protocol for the Initial Trial for Renal Cell Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit B and the Protocol for the Initial Trial for Hepatocellular Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit C) as promptly as practicable after the Effective Date. Each Combined Therapy Trial shall be conducted in accordance with a protocol (each, a “its Protocol”) to . The Protocol for each Combined Therapy Trial shall be drafted by BioXcel the Conducting Party (in consultation with Nektarthe Non-Conducting Party), and shall be subject to review and approval of the JDC before such Combined Therapy Trial can be Initiated. Protocol amendment(s) shall be subject to review and mutually agreed upon by the Parties at a meeting approval of the JDC. No 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. Protocol, including although the Protocol JDC may discuss and agree in writing upon circumstances where it may be feasible for the Initial Trial, shall be approved by Conducting Party to make specific Protocol amendments without the need for JDC unless the corresponding budget is also approved by the JDC either in advance of the approval of the Protocol or contemporaneously with the approval of the Protocol. Any substantive amendments to each Protocol and related budget will be subject to mutual agreement of the Parties at a meeting of the JDC or by written agreement (including by email acknowledgment) of the JDC Co-Chairs without a meeting. A trial overview (“Trial Overview ”) for the Initial Trial is attached hereto as Exhibit A, which shall be used by BioXcel for the drafting of the Protocol for the Initial Trial, for submission to the JDCagreement.
Appears in 1 contract
Scope of Collaboration; Governance of Agreement. (a) The Parties shallintend, pursuant to this Agreement, to collaborate to conduct the following clinical trials (each, a “Combined Therapy Trial”) (i) a Phase 1/2 the clinical trial evaluating the Combined Therapy trials identified in Exhibit A (referred to as the “Initial TrialTrials”), ) and (ii) such other clinical trials evaluating the a Combined Therapy of the BMS Compound(s) with the Exelixis Compound as the Parties may agree to conduct pursuant to the terms of this Agreement (any such trial in (i) or (ii), a “Combined Therapy Trial”). A clinical study protocol (including a clinical protocol synopsis) for each Combined Therapy Trial will be mutually agreed upon approved by the PartiesJDC (each, a “Protocol”). The Parties will also use good faith efforts to consult with each other and to finalize the Protocol for the Initial Trial for Renal Cell Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit B and the Protocol for the Initial Trial for Hepatocellular Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit C) as promptly as practicable after the Effective Date. Each Combined Therapy Trial shall be conducted in accordance with a protocol (each, a “its Protocol”) to . The Protocol for each Combined Therapy Trial shall be drafted by BioXcel the Conducting Party (in consultation with Nektarthe Non-Conducting Party), and shall be subject to review and approval of the JDC before such Combined Therapy Trial can be Initiated. Protocol amendment(s) shall be subject to review and mutually agreed upon by the Parties at a meeting approval of the JDC, although the JDC may discuss and agree in writing upon circumstances where it may be feasible for the Conducting Party to make specific Protocol amendments without the need for JDC approval or mutual written agreement. No CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH (b) The Party primarily responsible for the conduct of a Combined Therapy Trial (such Party, with respect to such Combined Therapy Trial, the “[***]Conducting Party”) for each of the Initial Trials is identified in Exhibit A. The Parties shall determine, through the JDC, which Party shall be the Conducting Party for any other Combined Therapy Trial. 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 Subject to the oversight of the JDC, as between the Parties, the Conducting Party shall have decision-making authority with Page 11 [ * ] = 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 AMENDEDas amended. Protocolrespect to all non-material operational issues in the conduct of the Combined Therapy Trial, including pursuant to Section 5.1(a), and shall be the regulatory lead and the sponsor of record with respect to a Combined Therapy Trial. Each Combined Therapy Trial shall be conducted under a combination IND unless a Regulatory Authority requires otherwise, for which the Conducting Party will be the sponsor of record (the “Combined Therapy IND”). BMS shall have a beneficial one-half interest in such Combined Therapy IND and Exelixis shall have a beneficial one-half interest in such Combined Therapy IND; provided, however, that: (i) in no event will a Party be required to obtain the consent of the other Party to transfer or encumber its interest in the Combined Therapy IND; provided, that the transferee or encumbrance holder agrees to abide by the terms and conditions of this Agreement, and provided, that any transfer occurs only in connection with, and to the same transferee of, a transfer of all of a Party’s rights in its Single Agent Compound, (ii) the Conducting Party shall be the sole holder of all legal interests in the Combined Therapy IND, and no Party shall have any obligation to share with the other Party any consideration received in connection with the sale, license or use of the Combined Therapy IND where permitted by this Agreement, and (iii) no Party shall be permitted to grant any Third Party any Right of Cross-Reference with respect to any portion of the Combined Therapy IND relating to the other Party’s Single Agent Compound(s) for use as monotherapy or for use in combination with any other molecules (other than, in the case of BMS, for use with the BMS Compound(s) (alone or in combination with other BMS-controlled molecules), and, in the case of Exelixis, for use with the Exelixis Compound (alone or in combination with other Exelixis-controlled molecules), in each case as permitted by this Agreement. For clarity, each Party shall have a Right of Cross-Reference to all Combined Therapy INDs, whether such Party is the Conducting Party or the Non-Conducting Party, on its own behalf. Each Party shall provide to the other Party a Right of Cross-Reference to its existing respective IND for its respective Single Agent Compound(s) as necessary to allow a Combined Therapy Trial to be conducted under the Combined Therapy IND. For the avoidance of doubt, each Party shall be responsible for (i) drafting and updating as necessary the investigator’s brochure for its respective Single Agent Compound(s), and (ii) filing all necessary Regulatory Documentation to the existing IND for its respective Single Agent Compound(s), including, but not limited to, the submission to such existing IND of serious adverse event and adverse drug reaction cases emerging from any Combined Therapy Trial, as required by a Regulatory Authority and/or Applicable Law. (c) Promptly after the Effective Date, if not previously provided pursuant to the CDA and continuing until finalization of the Protocol for the applicable Initial Trial, the Conducting Party shall provide the Non-Conducting Party with the following relating to the Conducting Party Compound(s): (i) the latest investigator’s brochure, (ii) new and/or changing safety signals and safety issues pertinent to the Initial Trials, and (iii) new and/or changing toxicology and efficacy signals and/or issues pertinent to the Initial Trials. The Conducting Party shall also provide such other safety data on the Conducting Party Compound(s) as set forth in the Pharmacovigilance Agreement. The Non-Conducting Party shall use any such data provided pursuant to this Section 2.1(c)(1) or pursuant to the Pharmacovigilance Agreement solely to evaluate the safety and efficacy of (1) the Conducting Party Compound(s) for use in Combined Therapy Trials and (2) the Combined Therapy. All such information and disclosures, to the extent pertaining to the Conducting Party Page 12 [ * ] = 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. Compound(s) as monotherapy (or used with agents other than the Non-Conducting Party Compound(s)), are Confidential Information of the Conducting Party. (d) The Conducting Party shall provide the Non-Conducting Party with the following relating to the Combined Therapy: (i) safety analyses for each Combined Therapy Trial where required by and in accordance with the applicable Protocol, and/or Statistical Analysis Plan, (ii) new and/or changing safety signals and safety issues pertinent to the Combined Therapy Trials and such other safety data for each Combined Therapy as set forth in the Pharmacovigilance Agreement (as defined in Section 2.2), and (iii) new and/or changing toxicology and efficacy signals and/or issues pertinent to the Combined Therapy Trials. The Conducting Party shall also provide the Non-Conducting Party with the Study Data and the final Clinical Study Reports (CSRs) for all Protocol arms relating to this Agreement. Each final CSR shall comply with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and shall be approved by the JDC unless JDC. Each Party shall use any such data provided pursuant to this Section 2.1(d) solely: (A) to evaluate the corresponding budget is also approved by the JDC either in advance safety and efficacy of the approval Combined Therapy in Combined Therapy Trials, (B) to meet any regulatory requirements pertaining to its Compound(s) and to the conduct of the Combined Therapy Trials, and (C) as permitted elsewhere in this Agreement. All such information and disclosures: (x) to the extent pertaining to a Combined Therapy, are Confidential Information of all of the Parties, (y) to the extent pertaining to the Exelixis Compound as monotherapy (or used with agents other than the BMS Compound(s)), are Confidential Information of Exelixis and (z) to the extent pertaining to the BMS Compound(s) as monotherapy (or used with agents other than the Exelixis Compounds), are Confidential Information of BMS. (e) The Conducting Party shall provide the Non-Conducting Party with the following relating to the Non-Conducting Party Compound(s): (i) safety analyses for the Non-Conducting Party Compound(s) as monotherapy from each Combined Therapy Trial if required by and in accordance with the applicable Protocol, and/or Statistical Analysis Plan, and (ii) such other safety data for the Non-Conducting Party Compound(s) as set forth in the Pharmacovigilance Agreement. The Non-Conducting Party may use such information for any purpose. All such information and disclosures to the extent pertaining to the BMS Compound(s) as monotherapy (or used with agents other than the Exelixis Compound), shall be Confidential Information of BMS and all such information and disclosures to the extent pertaining to the Exelixis Compound as monotherapy (or used with agents other than the BMS Compound(s)), shall be Confidential Information of Exelixis. (f) Promptly after the Effective Date, if not previously provided pursuant to the CDA and continuing until finalization of the Protocol or contemporaneously for the applicable Initial Trial, the Non-Conducting Party shall provide the Conducting Party with the approval following relating to the Non-Conducting Party Compound(s): (i) the latest investigator’s brochure, (ii) any new and/or changing safety signals and safety issues pertinent to the Initial Trial, and (iii) new and/or changing toxicology and efficacy signals and/or issues pertinent to the Initial Trial. The Non-Conducting Party shall also provide such other safety data on the Non-Conducting Party Compound(s) as set forth in the Pharmacovigilance Agreement. The Conducting Party shall use any such data provided pursuant Page 13 [ * ] = 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 ProtocolSecurities Exchange Act of 1934, as amended. to this Section 2.1(f) or pursuant to the Pharmacovigilance Agreement solely (A) to evaluate the safety and efficacy of (1) the Non-Conducting Party Compound(s) for use in Combined Therapy Trials and (2) the Combined Therapy and (B) to meet any regulatory requirements pertaining to the conduct of the Combined Therapy Trials. All such information and disclosures are Confidential Information of the Non-Conducting Party. (g) Any substantive amendments amendment to each Protocol and related budget will be subject this Agreement, a Bioanalysis Plan, a Statistical Analysis Plan, the Pharmacovigilance Agreement, the CRO Agreement (to the extent provided in Section 2.4(o)) or Quality Agreement shall require the written mutual agreement of the Parties at and shall be executed in the form of a meeting written amendment in accordance with Section 13.7. (h) If further studies, including but not limited to toxicity studies, are required or suggested by a Regulatory Authority as a prerequisite for conducting any of the JDC Combined Therapy Trials, then the Parties agree to hold good faith discussions in a timely manner to agree upon a protocol for such studies, each of which will be considered a Combined Therapy Trial and conducted on substantially the same terms as set forth herein; provided that, if the Parties are unable to agree upon a protocol for such study or if the conduct of such study shall cause a delay deemed unsatisfactory by written a Party, then any disputed matters precluding agreement shall be referred to the Executive Officers (including by email acknowledgment) of the JDC Co-Chairs without a meeting. A trial overview (“Trial Overview ”or their respective designees) for resolution. If the Initial Executive Officers are unable to reach resolution within [ * ] after such referral to them (and do not mutually agree to an extension of time to arrive at such resolution), then this Agreement shall automatically terminate following the conclusion of any then-active Combined Therapy Trial is attached hereto as Exhibit A, which shall be used by BioXcel for the drafting of (unless and until the Protocol for the Initial Trial, for submission such required/suggested study(ies) is finalized by mutual agreement prior to the JDC.completion of such Combined Therapy Trial) and the provisions of Section 12.5 shall apply to any such termination. 2.2
Appears in 1 contract
Samples: Trial Collaboration Agreement
