Subject and Scope of Agreement. 1.1 The Parties intend that within the scope of the Collaboration MD Xxxxxxxx will conduct the clinical research studies in the Field (each such study a “Study” and all such Studies the “Studies”) pursuant to this Agreement and the relevant Study Schedule and in accordance with applicable laws and GCP. The details, time schedule, responsibility (other than any responsibility required by applicable law) as “sponsor”, including IND filing and monitoring, of the Studies will be mutually agreed upon by the Parties through the JSC. In close consultation with Nanobiotix, MD Xxxxxxxx agrees to design the Studies and use reasonable efforts to conduct the work under each Study Schedule within the timelines, as set forth by the JSC. Studies may be changed as agreed upon by the JSC in accordance with Section 2. 1.2 The Agreement is a Collaboration agreement which shall govern the performance of Studies by MD Xxxxxxxx and one or more Principal Investigator(s) on basis of Study specific documents (“Study Schedule”) as agreed upon by the Parties. This Agreement shall apply to all Studies performed by MD Xxxxxxxx and the MD Xxxxxxxx principal investigator(s) responsible for the performance of such Studies (“Principal Investigator(s)”) upon execution of Study Schedules during the term of this Agreement. Each Study Schedule shall be substantially in the form attached as Exhibit I to this Agreement and shall detail the specifics of the Study to be performed under such Study Schedule including, without limitation, (i) the detailed Protocol, (ii) he Principal Investigator, (iii) responsibility as “sponsor”, including IND filing and monitoring, (iv) identify any project-specific resources or support provided by Nanobiotix. In the event of any conflict of terms of this Agreement and the terms of a Study Schedule, the terms of this Agreement shall govern, unless the Study Schedule specifically and expressly supersedes this Agreement with respect to a specific term, and then only with respect to the particular Study Schedule and specific term. If there is any discrepancy or conflict between the terms contained in a Protocol/workscope and this Agreement and/or the relevant Study Schedule, the terms of the Protocol/workscope shall govern and control with respect to clinical and/or scientific matters and the terms of the Agreement and/or the relevant Study Schedule shall govern and control with respect to all other matters, e.g., legal and financial matters. 1.3 Nanobiotix agrees to commit funding in an amount of Ten Million Six Hundred and Twenty-Five Thousand US dollars ($10,625,000) for the performance of the Studies during the term (collectively, “Collaboration Funding”). If the Parties extend the term by mutual agreement as set forth herein, the Parties shall negotiate in good faith the amount of future Study funding commitments applicable to such extended term. 1.4 The Collaboration Funding shall be due and payable to MD Xxxxxxxx within thirty (30) days upon receipt of an invoice according to the payment schedule: Effective Date $ 963,534.00 January 1, 2020 $ 963,534.00 [***] − End of enrollment* $ Up to [***] Completion of all Studies** $ [***] *MD Xxxxxxxx will be paid [***] per patient enrolled for a total of up to [***] for 339 patients. Payment for patient enrollment will occur on either [***] or [***] following enrollment, whichever comes first. For the avoidance of doubt, if [***] patients are enrolled from the period of [***], [***] will be due and payable to MD Xxxxxxxx on [***]. **Once MD Xxxxxxxx completes all Studies (enrollment of final patient on all Studies), all remaining payment(s) (including previous milestones not paid) shall be due and payable. 1.5 In addition to the Collaboration Funding and as further consideration for the efforts expanded by MD Xxxxxxxx and for the rights and licenses - granted hereunder, Nanobiotix shall make to MD Xxxxxxxx a one-time milestone payment upon grant of the first regulatory approval regarding the Study Drug in the United States of America as follows: [***] $2,222,120 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] $16,434,467 *Per the table, Nanobiotix will pay a one‑time, FDA milestone payment in full after the first FDA approval. The terms of the payment are as follows: Nanobiotix will issue payment sixty (60) days after first FDA approval and 150 patients enrolled in the Studies. For the avoidance of doubt, if the first FDA approval occurs in [***] and the 150th patient in the Studies is enrolled in [***], Nanobiotix will issue a payment of [***] to MD Xxxxxxxx within sixty (60) days of [***]. 1.6 MD Xxxxxxxx shall not, and shall ensure that no Study Team member (i) seeks reimbursement from Medicare, Medicaid, the Study subject, or any other third-party payor, whether public or private, for any costs covered by payments made or goods or services provided by Nanobiotix under this Agreement; or (ii) seeks or retains payment from Nanobiotix for any item, procedure or service that is reimbursed by any patient, third-party payor or any other person or entity. MD Xxxxxxxx hereby agrees that neither participants in the Study nor any third party, will be charged for the Study Drug or any comparator products provided for this Study. 1.7 MD Xxxxxxxx acknowledges and agrees that the amounts payable by Nanobiotix under this Agreement are reasonable compensation for the work performed, and represent the fair market value in an arm’s length transaction of the services provided by MD Xxxxxxxx, Principal Investigator and Study Team associated with the Study. This Agreement has not been determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Nanobiotix and its affiliates and MD Xxxxxxxx, and/or any Study Team member. This Agreement is not related to or made to influence MD Xxxxxxxx, Principal Investigator or any Study Team member with respect to the purchase, sale, referral or recommendation of any product or service sold or marketed by Nanobiotix and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.
Appears in 2 contracts
Samples: Strategic Collaboration Agreement (Nanobiotix S.A.), Strategic Collaboration Agreement (Nanobiotix S.A.)
Subject and Scope of Agreement. 1.1 The Parties intend that within the initial scope of the Collaboration MD Xxxxxxxx Alliance will conduct the clinical research studies in the Field (each such study a “Study” and all such Studies the “Studies”) pursuant to this Agreement and the relevant Study Schedule and in accordance with applicable laws and GCP. The details, time schedule, responsibility (other than any responsibility required by applicable law) as “sponsor”, including IND filing and monitoring, consist of the Studies will described in Exhibit I, the details of which are to be mutually agreed upon by the Parties through JSC from time to time in accordance with Sections 1.5 – 1.8 below). The Studies and/or the JSC. In close consultation with Nanobiotix, MD Xxxxxxxx agrees to design scope of the Studies and use reasonable efforts to conduct the work under each Study Schedule within the timelines, as set forth by the JSC. Studies Alliance may be replaced and/or changed as agreed upon by the JSC JSC. Adaptimmune shall have responsibility for IND filing and monitoring unless otherwise agreed by JSC. The Alliance Funding (defined in Section 1.3 below) will cover enrollment of a minimum of *** Clinical Study subjects into Clinical Studies (with Clinical Studies in this context excluding any screening Study or long term follow-up Study) (“Minimum Patient Numbers”). MD Xxxxxxxx represents and undertakes that (a) *** and (b) that the *** (together (a) and (b) being the ***):
1.2 Adaptimmune shall be the sponsor of any Clinical Study. MDACC shall be responsible for the conduct of each Study in accordance with Section 2.
1.2 the relevant protocol and/or workscope. The Agreement is a Collaboration agreement which shall govern the performance of Studies by MD Xxxxxxxx and one or more Principal Investigator(s) on basis of *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Study specific documents (“Study ScheduleOrders”) as agreed upon by the Parties. This Agreement shall apply to all Studies set out in the Study Orders performed by MD Xxxxxxxx and the MD Xxxxxxxx principal investigator(s) responsible for the performance of such Studies (“Principal Investigator(s)”) upon execution of Study Schedules Orders during the term of this Agreement. Each Study Schedule Order shall be substantially in the form attached as Exhibit I III to this Agreement and shall detail the specifics of the Study to be performed under such Study Schedule Order including, without limitation, (i) the detailed ProtocolProtocol or workscope, (ii) he the Principal Investigator, Investigator and (iii) responsibility as “sponsor”, including IND filing and monitoring, (iv) identify any project-specific resources or support provided by NanobiotixAdaptimmune. In the event of any conflict of terms of this Agreement and the terms of a Study ScheduleOrder, the terms of this Agreement shall govern, unless the Study Schedule Order specifically and expressly supersedes this Agreement with respect to a specific term, and then only with respect to the particular Study Schedule Order and specific term. If there is any discrepancy or conflict between the terms contained in a Protocol/Protocol or workscope and this Agreement and/or the relevant Study ScheduleOrder, the terms of the Protocol/Protocol or workscope shall govern and control with respect to clinical and/or clinical/scientific matters and the terms of the Agreement and/or the relevant Study Schedule Order in that order shall govern and control with respect to all other matters, e.g., legal and financial matters.
1.3 Nanobiotix Adaptimmune agrees to commit funding in an amount of Ten Million Six Hundred and Twenty-Five Thousand at least *** Dollars US dollars ($10,625,000***) for the performance of the Studies as set out in Exhibit I during the term (collectively, “Collaboration Alliance Funding”). The JSC may allocate and/or re-allocate funds to Studies as necessary and agreed by JSC. The basic per patient estimate for Clinical Studies is as follows: for screening Clinical Studies: $***, for long term follow-up Clinical Studies: $*** and for other Clinical Studies: $***. If the Parties extend the term by mutual agreement as set forth herein, the Parties shall negotiate in good faith the amount of future Study funding commitments by Adaptimmune applicable to such extended term.
1.4 . In the event a Study is terminated early, then in relation to any funds allocated to such Study, the Parties shall promptly discuss and agree upon a replacement of that Study with a new study of similar scope that is of mutual scientific interest to the Parties and that is approved by the JSC, and that will be funded by the Alliance Funding. If there is any Alliance Funding at the expiration or termination of this Agreement, it will be allocated to studies, research or tests agreed by the JSC, and such Alliance Funding will be payable in accordance with agreed milestones relevant to such agreed studies, research or tests. The Collaboration Funding shall be due and payable Parties understand that the compensation being paid to MD Xxxxxxxx within thirty (30) days upon receipt under this Agreement constitutes the fair market value of an invoice according the services to the payment schedule: Effective Date $ 963,534.00 January 1, 2020 $ 963,534.00 [***] − End of enrollment* $ Up to [***] Completion of all Studies** $ [***] *be provided hereunder. Neither MD Xxxxxxxx will be paid [***] per patient enrolled for a total of up to [***] for 339 patients. Payment for patient enrollment will occur on either [***] nor Principal Investigator shall seek or [***] following enrollment, whichever comes first. For the avoidance of doubt, if [***] patients are enrolled from the period of [***], [***] will be due and payable to MD Xxxxxxxx on [***]. **Once MD Xxxxxxxx completes all Studies (enrollment of final patient on all Studies), all remaining payment(s) (including previous milestones not paid) shall be due and payable.
1.5 In addition to the Collaboration Funding and as further consideration for the efforts expanded by MD Xxxxxxxx and for the rights and licenses - granted hereunder, Nanobiotix shall make to MD Xxxxxxxx a one-time milestone payment upon grant of the first regulatory approval regarding the Study Drug in the United States of America as follows: [***] $2,222,120 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] $16,434,467 *Per the table, Nanobiotix will pay a one‑time, FDA milestone payment in full after the first FDA approval. The terms of the payment are as follows: Nanobiotix will issue payment sixty (60) days after first FDA approval and 150 patients enrolled in the Studies. For the avoidance of doubt, if the first FDA approval occurs in [***] and the 150th patient in the Studies is enrolled in [***], Nanobiotix will issue a payment of [***] to MD Xxxxxxxx within sixty (60) days of [***].
1.6 MD Xxxxxxxx shall not, and shall ensure that no Study Team member (i) seeks accept reimbursement from Medicare, Medicaid, the Study subject, or any other third-party payor, whether public or private, for any costs covered by payments made or goods or services provided by Nanobiotix under this Agreement; or (ii) seeks or retains payment from Nanobiotix for any item, procedure or service that is reimbursed by any patient, third-party payor for any Study items or any other person procedures supplied by or entitypaid for by Adaptimmune under this Agreement. MD Xxxxxxxx hereby acknowledges that Adaptimmune may be obligated to disclose all payments made hereunder, including the provision of non-monetary items of value, as may be required under Applicable Law, including the Physician Payments Sunshine Act, passed as Section 6002 of the 2010 Patient Protection and Affordable Care Act and, to the extent required by Applicable Laws, agrees to keep and maintain relevant records of such and, upon Adaptimmune’s reasonable request, provide such records to Adaptimmune to the extent such information is not already in Adaptimmune’s possession, but only to the extent required for Adaptimmune to comply with its legally required reporting obligations. MD Xxxxxxxx consents to such disclosure, to the extent such disclosure is required for Adaptimmune to comply with Applicable Laws. MD Xxxxxxxx shall ensure that neither participants the Principal Investigator provides in a timely manner all such reasonable information to Adaptimmune necessary for Adaptimmune to comply with any disclosure requirements to the extent required by and in accordance with 21 C.F.R. Part 54, including but not limited to, any information required to be disclosed in connection with any financial relationship between Adaptimmune and the Principal Investigators and sub-investigators involved in the Study nor Study, as well as any third party, will be charged for the Study Drug or any comparator products provided for this Study.
1.7 immediate family members thereof. MD Xxxxxxxx acknowledges will ensure that Principal Investigator promptly updates any provided information if any relevant changes occur during the performance of any Study and agrees that for one year following completion of any Study. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. No amounts payable by Nanobiotix paid under this Agreement are reasonable intended to be for, nor shall they be construed as, an offer or payment made in exchange for any explicit or implicit agreement to purchase, prescribe, recommend, or provide a favorable formulary status, for any Adaptimmune product or service. Any such compensation for the work performed, and represent the will be consistent with fair market value in an arm’s arms-length transaction of the services provided by MD Xxxxxxxx, Principal Investigator transactions and Study Team associated with the Study. This Agreement has will not been be determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Nanobiotix the Parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs. MD Xxxxxxxx and Adaptimmune each confirm that in entering into this Agreement they have not accepted any bribes or illegal inducements to enter into this Agreement or to perform any Study and will not accept any bribe or illegal inducement or offer any bribe or illegal inducement in the performance of or for the performance of any Study whether during or after the termination or expiry of this Agreement.
1.4 The *** Dollars US ($***) for the Studies shall be due and payable to MD Xxxxxxxx according to the schedule outlined in Table 2 in Exhibit II. The JSC retains the right to prioritize and replace Studies as necessary subject to Section 1.6.
1.5 The Parties will establish a Joint Steering Committee (“JSC”) of equal representation, comprised of three (3) representatives (employees, directors or consultants who are subject to appropriate confidentiality obligations) from each Party, with the representatives of each Party collectively having one vote on all matters to be decided upon by the JSC. Each Party can appoint and replace its representatives in the JSC at its own discretion through timely written notice to the other Party.
1.6 The JSC will have meetings (either in person, by teleconference or via electronic means) at least quarterly. At least one meeting per year will be conducted in person or by videoconference (including the kick-off meeting). The JSC will decide on matters by unanimous vote with each of MD Xxxxxxxx and Adaptimmune exercising one vote each provided, however, that no action may lawfully be taken at any meeting unless at least two representatives of each Party (including for this purpose any proxy representative appointed as provided below) are present at the meeting. If a member of the JSC is unable to attend a meeting, he or she may appoint, in writing, a proxy to participate and vote in his or her stead. Decisions may also be made by electronic mail, provided such electronic mail is provided by at least two representatives from Adaptimmune and MD Xxxxxxxx and such electronic mail is acknowledged to be received by the recipient. Although decision will be made by mutual agreement of the JSC, in the event of any disagreement, *** .
1.7 The main task of the JSC will be to oversee the Alliance. In order to achieve the objectives of the Alliance, the JSC will oversee each Study under the Alliance. The JSC will provide technical, scientific, clinical, and regulatory guidance to the Studies and will be responsible for monitoring progress of these Studies. Additional representatives can be invited by the JSC on a case by case basis should discussion of certain topics require so, provided that such guests will be subject to an obligation of confidentiality and non-use at least as strict as Section 5 below. In the event a Study is terminated early or does not initiate, the Parties shall promptly replace that Study with a new study similar in scope that is of mutual scientific interest to the Parties. Once agreed by the JSC, such replacement study will be funded by the Alliance Funding and payable in accordance with agreed milestones for such replacement study. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
1.8 In addition, the JSC will be responsible for coordinating resolution of problems arising in the Studies or in the Alliance as a whole. In the event of any matter to which the JSC cannot reach resolution, or in the event of any dispute arising as to any matter subject to JSC responsibility and save where Adaptimmune has the deciding vote in accordance with Section 1.6 above, such matter or dispute will be escalated to executive management of MD Xxxxxxxx and Adaptimmune for good faith resolution. Both Parties shall use all reasonable efforts to resolve any matter or dispute on a timely basis.
1.9 MD Xxxxxxxx represents and certifies that neither MD Xxxxxxxx nor Principal Investigator will, directly or indirectly, offer or pay, or authorize an offer or payment of, any money or anything of value to any Public Official (defined below) or public entity, with the knowledge or intent that the payment, promise or gift, in whole or in part, will be made in order to improperly influence an official act or decision that will assist Adaptimmune in securing an improper advantage or in obtaining or retaining business or in directing business to any person or entity in relation to the Study. In addition to other rights or remedies under this Agreement or at law, Adaptimmune may terminate the affected Study Order if MD Xxxxxxxx breaches any of the representations or certifications contained in this Section or if Adaptimmune learns that improper payments are being or have been made to any Public Official by MD Xxxxxxxx or Investigator. For the purposes of this Agreement, “Public Official” means any officer or employee of a government, a public international organization or any department or agency thereof, or any person acting in an official capacity, including, for a public agency or enterprise; and any political party or party official, or any candidate for public office. Adaptimmune acknowledges and agrees that MD Xxxxxxxx is an agency of the State of Texas, and its affiliates investigator, employees, and officers do constitute a Public Official, as used in this paragraph, for purposes of this Section. Notwithstanding anything in this Section 1.9, nothing in this Section shall constitute a limitation on MD Anderson’s ability to operate within its legal capacity as an agency of the State of Texas, nor shall anything in this Agreement require MD Xxxxxxxx to violate any law or to refrain from complying with any law applicable to MD Xxxxxxxx, and/or any Study Team member. This Agreement is not related to or made to influence MD Xxxxxxxx, Principal Investigator or any Study Team member with respect to the purchase, sale, referral or recommendation of any product or service sold or marketed by Nanobiotix and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.
Appears in 1 contract
Samples: Strategic Alliance Agreement (Adaptimmune Therapeutics PLC)
Subject and Scope of Agreement. 1.1 The Parties intend that within the initial scope of the Collaboration MD Xxxxxxxx Alliance will conduct the clinical research studies in the Field (each such study a “Study” and all such Studies the “Studies”) pursuant to this Agreement and the relevant Study Schedule and in accordance with applicable laws and GCP. The details, time schedule, responsibility (other than any responsibility required by applicable law) as “sponsor”, including IND filing and monitoring, consist of the Studies will described in Exhibit I, the details of which are to be mutually agreed upon by the Parties through JSC from time to time in accordance with Sections 1.5 – 1.8 below). The Studies and/or the JSC. In close consultation with Nanobiotix, MD Xxxxxxxx agrees to design scope of the Studies and use reasonable efforts to conduct the work under each Study Schedule within the timelines, as set forth by the JSC. Studies Alliance may be replaced and/or changed as agreed upon by the JSC JSC. Adaptimmune shall have responsibility for IND filing and monitoring unless otherwise agreed by JSC. The Alliance Funding (defined in Section 1.3 below) will cover enrollment of a minimum of *** Clinical Study subjects into Clinical Studies (with Clinical Studies in this context excluding any screening Study or long term follow-up Study) (“Minimum Patient Numbers”). MD Xxxxxxxx represents and undertakes that (a) *** and (b) that the *** (together (a) and (b) being the ***):
1.2 Adaptimmune shall be the sponsor of any Clinical Study. MDACC shall be responsible for the conduct of each Study in accordance with Section 2.
1.2 the relevant protocol and/or workscope. The Agreement is a Collaboration agreement which shall govern the performance of Studies by MD Xxxxxxxx and one or more Principal Investigator(s) on basis of *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Study specific documents (“Study ScheduleOrders”) as agreed upon by the Parties. This Agreement shall apply to all Studies set out in the Study Orders performed by MD Xxxxxxxx and the MD Xxxxxxxx principal investigator(s) responsible for the performance of such Studies (“Principal Investigator(s)”) upon execution of Study Schedules Orders during the term of this Agreement. Each Study Schedule Order shall be substantially in the form attached as Exhibit I III to this Agreement and shall detail the specifics of the Study to be performed under such Study Schedule Order including, without limitation, (i) the detailed ProtocolProtocol or workscope, (ii) he the Principal Investigator, Investigator and (iii) responsibility as “sponsor”, including IND filing and monitoring, (iv) identify any project-specific resources or support provided by NanobiotixAdaptimmune. In the event of any conflict of terms of this Agreement and the terms of a Study ScheduleOrder, the terms of this Agreement shall govern, unless the Study Schedule Order specifically and expressly supersedes this Agreement with respect to a specific term, and then only with respect to the particular Study Schedule Order and specific term. If there is any discrepancy or conflict between the terms contained in a Protocol/Protocol or workscope and this Agreement and/or the relevant Study ScheduleOrder, the terms of the Protocol/Protocol or workscope shall govern and control with respect to clinical and/or clinical/scientific matters and the terms of the Agreement and/or the relevant Study Schedule Order in that order shall govern and control with respect to all other matters, e.g., legal and financial matters.
1.3 Nanobiotix Adaptimmune agrees to commit funding in an amount of Ten Million Six Hundred at least nineteen million six hundred and Twenty-Five Thousand forty four thousand Dollars US dollars ($10,625,00019,644,000) for the performance of the Studies as set out in Exhibit I during the term (collectively, “Collaboration Alliance Funding”). The JSC may allocate and/or re-allocate funds to Studies as necessary and agreed by JSC. The basic per patient estimate for Clinical Studies is as follows: for screening Clinical Studies: $***, for long term follow-up Clinical Studies: $*** and for other Clinical Studies: $***. If the Parties extend the term by mutual agreement as set forth herein, the Parties shall negotiate in good faith the amount of future Study funding commitments by Adaptimmune applicable to such extended term.
1.4 . In the event a Study is terminated early, then in relation to any funds allocated to such Study, the Parties shall promptly discuss and agree upon a replacement of that Study with a new study of similar scope that is of mutual scientific interest to the Parties and that is approved by the JSC, and that will be funded by the Alliance Funding. If there is any Alliance Funding at the expiration or termination of this Agreement, it will be allocated to studies, research or tests agreed by the JSC, and such Alliance Funding will be payable in accordance with agreed milestones relevant to such agreed studies, research or tests. The Collaboration Funding shall be due and payable Parties understand that the compensation being paid to MD Xxxxxxxx within thirty (30) days upon receipt under this Agreement constitutes the fair market value of an invoice according the services to the payment schedule: Effective Date $ 963,534.00 January 1, 2020 $ 963,534.00 [***] − End of enrollment* $ Up to [***] Completion of all Studies** $ [***] *be provided hereunder. Neither MD Xxxxxxxx will be paid [***] per patient enrolled for a total of up to [***] for 339 patients. Payment for patient enrollment will occur on either [***] nor Principal Investigator shall seek or [***] following enrollment, whichever comes first. For the avoidance of doubt, if [***] patients are enrolled from the period of [***], [***] will be due and payable to MD Xxxxxxxx on [***]. **Once MD Xxxxxxxx completes all Studies (enrollment of final patient on all Studies), all remaining payment(s) (including previous milestones not paid) shall be due and payable.
1.5 In addition to the Collaboration Funding and as further consideration for the efforts expanded by MD Xxxxxxxx and for the rights and licenses - granted hereunder, Nanobiotix shall make to MD Xxxxxxxx a one-time milestone payment upon grant of the first regulatory approval regarding the Study Drug in the United States of America as follows: [***] $2,222,120 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] $16,434,467 *Per the table, Nanobiotix will pay a one‑time, FDA milestone payment in full after the first FDA approval. The terms of the payment are as follows: Nanobiotix will issue payment sixty (60) days after first FDA approval and 150 patients enrolled in the Studies. For the avoidance of doubt, if the first FDA approval occurs in [***] and the 150th patient in the Studies is enrolled in [***], Nanobiotix will issue a payment of [***] to MD Xxxxxxxx within sixty (60) days of [***].
1.6 MD Xxxxxxxx shall not, and shall ensure that no Study Team member (i) seeks accept reimbursement from Medicare, Medicaid, the Study subject, or any other third-party payor, whether public or private, for any costs covered by payments made or goods or services provided by Nanobiotix under this Agreement; or (ii) seeks or retains payment from Nanobiotix for any item, procedure or service that is reimbursed by any patient, third-party payor for any Study items or any other person procedures supplied by or entitypaid for by Adaptimmune under this Agreement. MD Xxxxxxxx hereby acknowledges that Adaptimmune may be obligated to disclose all payments made hereunder, including the provision of non-monetary items of value, as may be required under Applicable Law, including the Physician Payments Sunshine Act, passed as Section 6002 of the 2010 Patient Protection and Affordable Care Act and, to the extent required by Applicable Laws, agrees to keep and maintain relevant records of such and, upon Adaptimmune’s reasonable request, provide such records to Adaptimmune to the extent such information is not already in Adaptimmune’s possession, but only to the extent required for Adaptimmune to comply with its legally required reporting obligations. MD Xxxxxxxx consents to such disclosure, to the extent such disclosure is required for Adaptimmune to comply with Applicable Laws. MD Xxxxxxxx shall ensure that neither participants the Principal Investigator provides in a timely manner all such reasonable information to Adaptimmune necessary for Adaptimmune to comply with any disclosure requirements to the extent required by and in accordance with 21 C.F.R. Part 54, including but not limited to, any information required to be disclosed in connection with any financial relationship between Adaptimmune and the Principal Investigators and sub-investigators involved in the Study nor Study, as well as any third party, will be charged for the Study Drug or any comparator products provided for this Study.
1.7 immediate family members thereof. MD Xxxxxxxx acknowledges will ensure that Principal Investigator promptly updates any provided information if any relevant changes occur during the performance of any Study and agrees that for one year following completion of any Study. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. No amounts payable by Nanobiotix paid under this Agreement are reasonable intended to be for, nor shall they be construed as, an offer or payment made in exchange for any explicit or implicit agreement to purchase, prescribe, recommend, or provide a favorable formulary status, for any Adaptimmune product or service. Any such compensation for the work performed, and represent the will be consistent with fair market value in an arm’s arms-length transaction of the services provided by MD Xxxxxxxx, Principal Investigator transactions and Study Team associated with the Study. This Agreement has will not been be determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Nanobiotix the Parties for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs. MD Xxxxxxxx and Adaptimmune each confirm that in entering into this Agreement they have not accepted any bribes or illegal inducements to enter into this Agreement or to perform any Study and will not accept any bribe or illegal inducement or offer any bribe or illegal inducement in the performance of or for the performance of any Study whether during or after the termination or expiry of this Agreement.
1.4 The nineteen million six hundred and forty four thousand Dollars US ($19,644,000) for the Studies shall be due and payable to MD Xxxxxxxx according to the schedule outlined in Table 2 in Exhibit II. The JSC retains the right to prioritize and replace Studies as necessary subject to Section 1.6.
1.5 The Parties will establish a Joint Steering Committee (“JSC”) of equal representation, comprised of three (3) representatives (employees, directors or consultants who are subject to appropriate confidentiality obligations) from each Party, with the representatives of each Party collectively having one vote on all matters to be decided upon by the JSC. Each Party can appoint and replace its representatives in the JSC at its own discretion through timely written notice to the other Party.
1.6 The JSC will have meetings (either in person, by teleconference or via electronic means) at least quarterly. At least one meeting per year will be conducted in person or by videoconference (including the kick-off meeting). The JSC will decide on matters by unanimous vote with each of MD Xxxxxxxx and Adaptimmune exercising one vote each provided, however, that no action may lawfully be taken at any meeting unless at least two representatives of each Party (including for this purpose any proxy representative appointed as provided below) are present at the meeting. If a member of the JSC is unable to attend a meeting, he or she may appoint, in writing, a proxy to participate and vote in his or her stead. Decisions may also be made by electronic mail, provided such electronic mail is provided by at least two representatives from Adaptimmune and MD Xxxxxxxx and such electronic mail is acknowledged to be received by the recipient. Although decision will be made by mutual agreement of the JSC, in the event of any disagreement, *** .
1.7 The main task of the JSC will be to oversee the Alliance. In order to achieve the objectives of the Alliance, the JSC will oversee each Study under the Alliance. The JSC will provide technical, scientific, clinical, and regulatory guidance to the Studies and will be responsible for monitoring progress of these Studies. Additional representatives can be invited by the JSC on a case by case basis should discussion of certain topics require so, provided that such guests will be subject to an obligation of confidentiality and non-use at least as strict as Section 5 below. In the event a Study is terminated early or does not initiate, the Parties shall promptly replace that Study with a new study similar in scope that is of mutual scientific interest to the Parties. Once agreed by the JSC, such replacement study will be funded by the Alliance Funding and payable in accordance with agreed milestones for such replacement study. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
1.8 In addition, the JSC will be responsible for coordinating resolution of problems arising in the Studies or in the Alliance as a whole. In the event of any matter to which the JSC cannot reach resolution, or in the event of any dispute arising as to any matter subject to JSC responsibility and save where Adaptimmune has the deciding vote in accordance with Section 1.6 above, such matter or dispute will be escalated to executive management of MD Xxxxxxxx and Adaptimmune for good faith resolution. Both Parties shall use all reasonable efforts to resolve any matter or dispute on a timely basis.
1.9 MD Xxxxxxxx represents and certifies that neither MD Xxxxxxxx nor Principal Investigator will, directly or indirectly, offer or pay, or authorize an offer or payment of, any money or anything of value to any Public Official (defined below) or public entity, with the knowledge or intent that the payment, promise or gift, in whole or in part, will be made in order to improperly influence an official act or decision that will assist Adaptimmune in securing an improper advantage or in obtaining or retaining business or in directing business to any person or entity in relation to the Study. In addition to other rights or remedies under this Agreement or at law, Adaptimmune may terminate the affected Study Order if MD Xxxxxxxx breaches any of the representations or certifications contained in this Section or if Adaptimmune learns that improper payments are being or have been made to any Public Official by MD Xxxxxxxx or Investigator. For the purposes of this Agreement, “Public Official” means any officer or employee of a government, a public international organization or any department or agency thereof, or any person acting in an official capacity, including, for a public agency or enterprise; and any political party or party official, or any candidate for public office. Adaptimmune acknowledges and agrees that MD Xxxxxxxx is an agency of the State of Texas, and its affiliates investigator, employees, and officers do constitute a Public Official, as used in this paragraph, for purposes of this Section. Notwithstanding anything in this Section 1.9, nothing in this Section shall constitute a limitation on MD Anderson’s ability to operate within its legal capacity as an agency of the State of Texas, nor shall anything in this Agreement require MD Xxxxxxxx to violate any law or to refrain from complying with any law applicable to MD Xxxxxxxx, and/or any Study Team member. This Agreement is not related to or made to influence MD Xxxxxxxx, Principal Investigator or any Study Team member with respect to the purchase, sale, referral or recommendation of any product or service sold or marketed by Nanobiotix and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.
Appears in 1 contract
Samples: Strategic Alliance Agreement (Adaptimmune Therapeutics PLC)
Subject and Scope of Agreement. 1.1 The Parties intend that within the scope of the Collaboration MD Xxxxxxxx will conduct the clinical research studies in the Field (each such study a “Study” and all such Studies the “Studies”) pursuant to this Agreement and the relevant Study Schedule and in accordance with applicable laws and GCP. The details, time schedule, responsibility (other than any responsibility required by applicable law) as “sponsor”, including IND filing and monitoring, consist of the Studies will included in Appendix I, attached hereto, the details of which are to be mutually agreed upon by the Parties through Parties. Cyclacel and MD Axxxxxxx agree to jointly design and write the JSC. In close consultation with Nanobiotix, MD Xxxxxxxx agrees to design Protocols for the Studies and based on a first draft provided by Cyclacel. MD Axxxxxxx will use reasonable efforts to conduct the work under each Study Schedule within the timelines, as set forth by the JSCStudy. Studies may be changed as agreed upon by the JSC Parties in accordance with Section 2writing.
1.2 The Agreement is a Collaboration agreement which shall govern the performance of Studies by MD Xxxxxxxx Axxxxxxx and one or more Principal Investigator(s) ), as defined below, on the basis of Study specific documents (“Study ScheduleOrders”) as agreed upon by the Parties. This Agreement Once the Parties have agreed to the precise nature of each Study to be performed, MD Axxxxxxx shall apply to all Studies performed review the Protocol for such Study as proposed by Cyclacel. It is understood between the Parties that the sample size of each Study will not exceed [***] Subjects unless otherwise agreed in writing by the Parties. “Subject” shall mean, as the term is defined in the U.S. Code of Federal Regulations 21 CFR §312.3(b), a human who participates in the Study, either as a recipient of the investigational new drug or as a control. Once the Protocol has been agreed and has been approved by MD Xxxxxxxx Anderson’s Institutional Review Board (“Institutional Review Board” or “IRB”) under Section 2.2 below, (i) Cyclacel, as Study sponsor, shall obtain regulatory approval for the Study as required by FDA; and (ii) the detailed provisions for performance of the Study by the Parties including by MD Axxxxxxx and the MD Xxxxxxxx Axxxxxxx principal investigator(s) responsible for the performance of such Studies Study (“Principal Investigator(s)” or “Investigator(s)”) upon execution of Study Schedules during the term of this Agreement. Each Study Schedule ), shall be set out in a Study Order to be agreed between the Parties but substantially in the form attached as Exhibit I Appendix III to this Agreement and which shall detail the specifics of the Study to be performed under such Study Schedule Order including, without limitation, (i) the detailed Protocol, (ii) he the Principal Investigator, (iii) responsibility as “sponsor”, including IND filing and monitoring, (iv) identify any project-specific resources or support provided by NanobiotixCyclacel including quantities of Cyclacel Drug Candidate and timing of delivery. In the event of any conflict of terms of this Agreement and the terms of a Study Schedule, the terms of this Agreement shall govern, unless the Study Schedule specifically and expressly supersedes this Agreement with respect to a specific term, and then only with respect Any changes to the particular Study Schedule and specific term. If there is any discrepancy Protocol must be agreed upon in writing in advance by Cyclacel unless necessary to protect the safety, rights or conflict between the terms contained in a Protocol/workscope and this Agreement and/or the relevant Study Schedule, the terms welfare of the Protocol/workscope shall govern and control with respect to clinical and/or scientific matters and the terms of the Agreement and/or the relevant Study Schedule shall govern and control with respect to all other matters, e.g., legal and financial mattersSubjects.
1.3 Nanobiotix agrees to commit funding in an amount of Ten Million Six Hundred and Twenty-Five Thousand US dollars ($10,625,000) for the performance of the Studies during the term (collectively, “Collaboration Funding”). If the Parties extend the term by mutual agreement as set forth herein, the Parties shall negotiate in good faith the amount of future Study funding commitments applicable to such extended term.
1.4 The Collaboration Funding shall be due and payable to MD Xxxxxxxx within thirty (30) days upon receipt of an invoice according to the payment schedule: Effective Date $ 963,534.00 January 1, 2020 $ 963,534.00 [***] − End of enrollment* $ Up to [***] Completion of all Studies** $ [***] *MD Xxxxxxxx will be paid [***] per patient enrolled for a total of up to [***] for 339 patients. Payment for patient enrollment will occur on either [***] or [***] following enrollment, whichever comes first. For the avoidance of doubt, if [***] patients are enrolled from the period of [***], [***] will be due and payable to MD Xxxxxxxx on [***]. **Once MD Xxxxxxxx completes all Studies (enrollment of final patient on all Studies), all remaining payment(s) (including previous milestones not paid) shall be due and payable.
1.5 In addition to the Collaboration Funding and as further consideration for the efforts expanded by MD Xxxxxxxx and for the rights and licenses - granted hereunder, Nanobiotix shall make to MD Xxxxxxxx a one-time milestone payment upon grant of the first regulatory approval regarding the Study Drug in the United States of America as follows: [***] $2,222,120 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] $16,434,467 *Per the table, Nanobiotix will pay a one‑time, FDA milestone payment in full after the first FDA approval. The terms of the payment are as follows: Nanobiotix will issue payment sixty (60) days after first FDA approval and 150 patients enrolled in the Studies. For the avoidance of doubt, if the first FDA approval occurs in [***] and the 150th patient in the Studies is enrolled in [***], Nanobiotix will issue a payment of [***] to MD Xxxxxxxx within sixty (60) days of [***].
1.6 MD Xxxxxxxx shall not, and shall ensure that no Study Team member (i) seeks reimbursement from Medicare, Medicaid, the Study subject, or any other third-party payor, whether public or private, for any costs covered by payments made or goods or services provided by Nanobiotix under this Agreement; or (ii) seeks or retains payment from Nanobiotix for any item, procedure or service that is reimbursed by any patient, third-party payor or any other person or entity. MD Xxxxxxxx hereby agrees that neither participants in the Study nor any third party, will be charged for the Study Drug or any comparator products provided for this Study.
1.7 MD Xxxxxxxx acknowledges and agrees that the amounts payable by Nanobiotix under this Agreement are reasonable compensation for the work performed, and represent the fair market value in an arm’s length transaction of the services provided by MD Xxxxxxxx, Principal Investigator and Study Team associated with the Study. This Agreement has not been determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Nanobiotix and its affiliates and MD Xxxxxxxx, and/or any Study Team member. This Agreement is not related to or made to influence MD Xxxxxxxx, Principal Investigator or any Study Team member with respect to the purchase, sale, referral or recommendation of any product or service sold or marketed by Nanobiotix and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.
Appears in 1 contract
Samples: Clinical Collaboration Agreement (Cyclacel Pharmaceuticals, Inc.)