2.6Obligations transferred to PAREXEL under a Work Order in accordance with 21 C.F.R. 312.52 will be set forth in a “Transfer of Obligations under 21, C.F.R. 312.52 and Applicable Foreign Equivalents” (“TORO”). PAREXEL will assume responsibility for transferred obligations set forth in the TORO and agrees to diligently carry out such transferred obligations in accordance with this Agreement and the applicable Work Order.In addition, and without limiting the foregoing, if called for by the Project and set forth in the Work Order, and further subject to PAREXEL’s SOPs and standard tools and templates, PAREXEL will ensure that all relevant requirements are met with respect to: (a) obtaining informed consent from Study subjects in accordance with 21 C.F.R. Part 50, as amended; (b) obtaining signed authorizations (including Data Privacy Notices) for the collection, processing and transfer of the Personal Data of Data Subjects (each as defined in Section 8.5 below); (c) obtaining both initial and continuing ethics committee and investigational review board review and approval in accordance with 21 C.F.R. Part 56, as amended; (d) obtaining from each Study Investigator and providing to Client a fully completed and signed Form FDA 1572 and any other information required by 21 C.F.R. §312.53(c), as amended; and (e) requiring that each Study Investigator abides by the Study-related commitments and obligations he or she undertook by signing Form FDA 1572.
2.7PAREXEL may use its Affiliates to perform any of its obligations under this Agreement or any Work Order.In addition, any Affiliate of either party may execute a Work Order pursuant to this Agreement.Wherever an Affiliate of either party enters into a Work Order, for the purposes of such Work Order, all references in this Agreement to Client or PAREXEL, as the case may be, shall be read as if they were a reference to that Affiliate only, and only that Affiliate shall be deemed the party to this Agreement for the purpose of the Services provided under such Work Orderand shall be bound as a party by all terms and conditions of this Agreement with respect to such Services. [*], PAREXEL shall [*].
2.10PAREXEL will perform its Services in accordance with PAREXEL’s SOPs, report and file templates, and systems, unless specifically stated otherwise in the applicable Work Order.Notwithstanding the foregoing, Client may request to use Client’s SOPs, or to deviate from PAREXEL’s SOPs, but Client acknowledges that the use of Client’s SOPs, or deviations from PAREXEL’s SOPs may result in a modification of the budget if the requested deviation would result in rework or changes to the resource assumptions contained within the Study budget.
5.1PAREXEL may use Subcontractors (defined in Section 1.11) and Specialty Vendors, as each is defined below, for Services in support of a Study, subject to Client’s prior written approval, which shall not be unreasonably withheld. Subcontractors and Specialty Vendors set forth in a Work Order shall be deemed approved upon execution of the Work Order. PAREXEL will [*].[*], PAREXEL shall be responsible and liable for its own negligence, omissions and/or intentional misconduct, and that of its Affiliates.Subject to the terms of such agreements, PAREXEL will ensure that Client may audit the records of the Services and inspect the facilities (if applicable) of its Subcontractors and any Client-Designated Vendors and Specialty Vendors performing Services in support of the Project where such Services are performed.
5.4[*] (a “Specialty Vendor”), [*].The parties agree that third party vendors providing services that are administrative in nature and not unique to the Project (such as courier or translation services) shall not need to be identified in the Work Order.The parties further agree that a Site will not be deemed a Specialty Vendor. Any Specialty Vendor shall [*]. Any Specialty Vendor [*]. PAREXEL will maintain written agreements with its Specialty Vendors containing terms substantially similar to those in this Agreement with respect to compliance with Applicable Law, obligations of confidentiality and non-use of Client Confidential Information, ownership of Client Intellectual Property and indemnification obligations. If Client reasonably objects to any proposed Specialty Vendor, Client will promptly (prior to use) notify PAREXEL and PAREXEL will make reasonable efforts to promptly propose a qualified replacement Specialty Vendor, and will inform Client if it believes that identifying and qualifying a replacement Specialty Vendor would impact Work Order timelines and requirements. In no event shall PAREXEL be responsible for any delays caused by Client’s rejection of a Specialty Vendor, or, per Section 5.4.1 below, rejection of any medical reviewers employed by a Specialty Vendor.
7.5Upon receipt of notice of termination of this Agreement and/or any Work Order(s) by a party to this Agreement or such Work Order: (a) in compliance with Applicable Laws and with due care for the safety of Study subjects, the parties will cooperate to establish a reasonable and mutually acceptable wind-down plan for Services, and PAREXEL will, as soon as reasonably practicable, discontinue providing the applicable Services, except to the extent reasonably required to safely close out a Project (“Closeout Services”), and (b) PAREXEL will terminate existing third party obligations to the extent practicable and cancelable.Upon expiration and/or termination of this Agreement and/or any Work Order, Client will pay PAREXEL for, or PAREXEL will apply any remaining advance payments to, all mutually agreed and undisputed (1) Services, (2) non-cancelable costs and (3) all Pass-Through Expenses actually incurred by PAREXEL up to and including the completion of Closeout Services, provided that in no event will Client be obligated to pay Pass-Through Expenses exceeding those set forth in a budget established in accordance with the applicable Work Order.Thereafter, any final payment still owed to PAREXEL, or any refund due Client (including with respect to any unused advance, Site fees, Pass-Through Expenses or other third party costs advanced by Client), pursuant to this Section, will be made by Client or PAREXEL, as applicable, within [*] of the final reconciliation invoice(s) from PAREXEL.
11.4PAREXEL Service fees and Pass-Through Expenses associated with audits performed by Client or on behalf of Client, except for Follow-on Audits, are considered outside the scope of Services, unless specifically defined otherwise in a Work Order.Any Service fees or Pass-Through Expenses with respect to Client audits will be billed at reasonable hourly rates to be agreed upon in advance by PAREXEL and Client.
3.1.Unless otherwise specified in a Work Order, Client shall deliver Study Materials to the Facility or Study Site(s) mutually agreed by PAREXEL and Client, in accordance with the Incoterms (“Incoterms 2010”) as specified in the Work Order.In the event the CTSL Services involve PAREXEL purchasing Study Materials on behalf of Client, PAREXEL shall be responsible for obtaining the delivery of such Study Materials to the relevant Facility in accordance with the Incoterms 2010 established between PAREXEL and the seller, and Client shall reimburse PAREXEL for the costs and the expense of such Study Materials and shipment. If PAREXEL purchases Study Materials, in no event shall Client be [*].
3.2.In the event PAREXEL purchases Study Materials on behalf of the Client, any transfer of legal and economic ownership of such Study Materials shall transfer to Client upon allocation of such Study Materials to a Project under the applicable Work Order. Client shall retain all right, title and interest in and to Study Materials purchased by PAREXEL on behalf of Client, and except with respect to the responsibilities and obligations of PAREXEL set forth herein and in the applicable Work Order, responsibility for all costs, including applicable taxes and duties, and insurance associated with shipment of such items to the Facility shall be Client’s responsibility. For the avoidance of doubt, with regards to the transfer of Study Materials to Client and any subsequent shipment of the Study Materials made in accordance with the Agreement and/or the applicable Work Order, Client shall (i) pay directly to the relevant tax authority, or (ii) reimburse PAREXEL for, any and all taxes and duties and insurance incurred in relation to such transfer of such Study Materials.
3.6.PAREXEL acknowledges that some Study Materials may subsequently be sent to designated Sites for the performance of a Study. Unless otherwise stated in the applicable Work Order, at such time as requested by Client, PAREXEL shall ship the Study Materials as designated by Client in writing to the relevant location, and such shipment of the Study Materials shall be in accordance with Applicable Laws and this Agreement. The method of transport for shipments shall be determined and agreed to by the parties in an exhibit to the applicable Work Order incorporating the provisions (if and as applicable) of Exhibit D in the template Work Order. PAREXEL shall ensure that the Study Materials are properly prepared for shipment and delivered in a timely manner.
[*], it has provided accurate and complete information for all Study Materials to facilitate import/export activities, including but not limited to product description, customs values, manufacturer information and other applicable information provided by Client(collectively, “Trade Compliance Information”) to facilitate import/export activities that will be conducted by PAREXEL pursuant to this Agreement and the applicable Work Order.Client acknowledges and agrees that PAREXEL will rely on such Trade Compliance Information in its communications with Regulatory Authorities.
3.1Each Contracted Processor shall comply with all applicable Data Protection Laws in the Processing of Subject Personal Data; shall treat Subject Personal Data as Confidential Information in accordance with the terms of the MSA and shall only Process Subject Personal Data on behalf of Geron, and in accordance with Geron’s documented instructions for the following purposes: (i) Processing in accordance with the MSA and applicable Work Order and (ii) Processing to comply with other documented reasonable instructions provided by Geron (e.g., via email) where such instructions are consistent with the terms of the MSA and/or the applicable Work Order. Contracted Processors shall not perform Services in a manner that causes Geron to violate Data Protection Laws.
4.Details of the Processing. The subject-matter of Processing of Subject Personal Data by PAREXEL is the performance of the Services pursuant to the MSA and the applicable Work Order. The duration of the Processing, the nature and purpose of the Processing, the types of Subject Personal Data and categories of Data Subjects Processed, as well as the location of the Processing performed under this Addendum are further specified in respective Work Orders with an attachment similar to Schedule 1 (Details of Processing Activities) attached to this Addendum.
PAREXEL shall notify Geron without undue delay of when PAREXEL, its Affiliate or Sub-Processor becomes aware of any Security Incident, and further, shall provide Geron with sufficient information to allow Geron to meet any statutory obligations to report or inform Data Subjects and/or Regulators of the Security Incident under the Data Protection Laws.The notification of the Security Incident to Geron shall be by e-mail to the email address(es) identified by Geron within the MSA or the applicable Work Order. Such notification shall include, where possible, the categories and approximate number of Data Subjects concerned, and approximate number of personal data records concerned, the likely consequences of the Security Incident, and the proposed corrective action taken by PAREXEL, its Affiliates or Sub-Processors.PAREXEL (and its Affiliates and Sub-Processors, as applicable) shall co-operate with Geron and take such reasonable commercial steps as are directed by Geron to assist in the investigation, mitigation and remediation of each such Security Incident.
9.Project Oversight.PAREXEL Key Personnel on the project team will meet [*] with GERON Representatives during the term of this Work Order to oversee the performance of the Services hereunder, to foster transparent communication between the parties, ensure quality of performance in alignment with expectations, SOPs and study timelines, Good Clinical Practices, federal regulations and guidelines, and to provide a mechanism for accountability and responsibility in relation to the Project. The parties shall draft and approve a charter or other governance document describing the operational aspects of joint project oversight, including, without limitation, structure and processes for meetings, a schedule for regular review of monitoring plans, assessment of other key performance metrics, and procedures for escalation and resolution of issues. The activities of parties at the project level will be directed toward optimizing the parties’ ability to timely conduct the applicable Project, including PAREXEL’s provision of the requisite deliverables in accordance with this Work Order and the Agreement. Issues which are not resolved at the Project level despite diligent efforts by the parties will be referred to the Executive Committee established under Section 2.5.1 of the Agreement. In addition, as otherwise may be determined to be necessary by GERON depending on a Project, the Executive Committee may operate at the Project level to oversee specific Project activities under this Work Order. The structure and function of the Executive Committee at the Project level shall be determined by the parties in view of Project.
11.Data Privacy.In accordance with the Data Security and Privacy Addendum set forth in Attachment E to the Agreement, the Details of Processing under this Work Order are contained in Exhibit H to this Work Order. In the event of any Security Incident (as defined in Attachment E to the Agreement), notice shall be given to GERON in accordance with the notice provisions of Article 21 of the Agreement, and by email to [*] and [*].
Change in Scope Process.As provided under Section 2.2 of the Agreement, PAREXEL will generate and maintain a Change in Scope Log (“CIS Log”) in accordance with the form attached as Attachment B to the Agreement, capturing the cost impact of changes to Key Specifications under this Work Order.The parties will follow the CIS Log approval and Change Order preparation process as provided under Section 2.2 of the Agreement. The CIS Log monetary threshold at which a Change Order will be prepared for this Work Order is $[*].
Service Fees. PAREXEL will invoice Client for Service fees as provided in the [*] below.The payment schedule is developed in conjunction with the budget and estimated timelines; therefore, any modifications to the foregoing may result in a modification to the payment schedule.The Advances paid by Client under the LOA, in the amount totaling $[*], shall be credited to [*] under this Work Order. PAREXEL will reconcile [*] vs [*].The remaining amount to be invoiced under [*] will be [*]in accordance with the [*] set forth below.
(b) Work Order. The specific details of each assignment or task (each a Project) will be specified in writing on terms acceptable to the parties and otherwise subject to the terms and conditions of this Agreement (each such writing, a Work Order) substantially in the form of Attachment B to this Agreement. Each Work Order shall include Central Laboratory Services terms (including a Laboratory Services Document or Central Laboratory Worksheet) which shall describe the nature, scope and timelines for Services being specifically performed for the applicable study. To the extent there is a conflict between the terms of this Agreement and a Work Order, this Agreement will control, except to the extent that the applicable Work Order expressly and specifically states an intent to supersede this Agreement on a specific matter.
Inflation. If the Services are provided by Q Squared over multiple calendar years, the budget and payment schedule will incorporate the Inflation Factor to Service fees for future year costs at the time the Work Order is executed by both parties, on a prospective basis only, and the Inflation Factor (defined below) shall remain fixed for the duration of the Work Order and subsequent Change Orders to the Work Order. The Inflation Factor shall be calculated using a blend of [***] (Inflation Factor).
(f) In the event this Agreement is terminated, Customer shall pay to Q Squared: (i)any fees for services rendered then due and owing to Q Squared because of any performance of Q Squareds obligations hereunder and all expenses reasonably incurred in performing those Services; (ii)all actual costs (including time spent by Q Squared personnel, which shall be billed at Q Squared standard rates) to complete activities associated with the termination and close out of projects; and (iii)all kit destruction costs as noted in each Work Order. Upon the termination of this Agreement, Q Squared shall either: (i)return to Customer, or (ii)dispose of at the direction and written request of Customer (or as more particularly specified in the Work Order), all data and materials provided by Customer to Q Squared for the conduct of Services under this Agreement.
4. Change Orders. Any material change in the details of the scope of Services set forth in a Work Order or the assumptions upon which the Work Order is based (including, but not limited to, changes in the expected number of investigators, number or schedule of visits, testing requirements, anticipated commencement date, length of project or overall protocol specific database design) may require changes in the Budget and/or time lines, and shall require a written amendment to the Work Order (a Change Order). In such event or if the Services are delayed for reasons beyond the control of the parties, the parties will cooperate with each other in good faith in reaching agreement with respect to any corresponding increase or decrease in the scope of the Work Order, Work Order budget, and associated changes in the schedule of payments, timeline and/or schedule or other items associated with the Work Order. All Change Orders will be in writing and signed by duly authorized officers of each of the parties. [***].
-6- CONFIDENTIAL and its employees only for purposes of performing the receiving partys obligations hereunder. Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without the prior written consent of the disclosing party, provided, however, that Q Squared may disclose limited Confidential Information as necessary in furtherance of a project hereunder, provided that such third party [***] is not a competitor of Customer and is bound by confidentiality obligations substantially similar to those set forth herein, otherwise such disclosure to a third party requires Customers written consent. Each party agrees that the terms of this Agreement and any Work Order shall be considered Confidential Information, and each party agrees that it will not disclose the terms of this Agreement or any Work Order to any third party without the written consent of the other party, which shall not unreasonably be withheld. These obligations of confidentiality and nondisclosure shall remain in effect for a period of [***] after the completion or termination of the applicable Work Order. For the avoidance of doubt, the parties agree that the term Confidential Information shall include data and information disclosed in connection with potential services hereunder, even if the parties do not enter into a Work Order for such services, and if no Work Order is executed such data and information shall be subject to this Agreements confidentiality provisions for a period of [***] from the time of disclosure.
(c) Q Squared certifies that it has not been debarred under the United States Generic Drug Enforcement Act, or any applicable law in any other country, and that Q Squared will not knowingly employ any person or entity that has been so debarred to perform Services under this Agreement or any Work Order. Q Squared shall promptly notify Customer upon becoming aware of any inquiry concerning, or the commencement of any proceeding or disqualification that is the subject of this Section7(c).
8. Conflict of Agreements. Q Squared represents to Customer that Q Squared is not a party to any agreement which would prevent Q Squared from fulfilling its obligations under this Agreement, and that during the term of this Agreement, Q Squared will not enter into an agreement to provide services which would prevent Q Squared from providing the Services contemplated to be provided by Q Squared under this Agreement or any Work Order. Customer agrees that it will not enter into an agreement with a third party that would alter or affect the regulatory obligations delegated to Q Squared pursuant to any Work Order without the written consent of Q Squared, which will not be unreasonably withheld.
1. Work Order. This document constitutes a Work Order under the Master Agreement and this Work Order and the services contemplated herein are subject to the terms and provisions of the Master Agreement.
(a) Services. Q Squared shall provide genomic, analytical and bioanalytical testing services, as requested by Customer from time to time during the term of the applicable Work Order. Q Squared will use reasonable commercial efforts to perform the Services in accordance with the specifications and timelines set forth in the Work Order.
4.1 Service Fee. Client shall pay Provider a service fee in the amount and manner provided in the applicable Work Order (the Service Fee) for the Services rendered by Provider in accordance with the terms and conditions of this Agreement and the applicable Work Order. The Service Fee shall be charged in accordance with a fixed-sum or other pricing structure as stated in the applicable Work Order. A fixed-sum Service Fee is a fixed amount based on the estimated cost of the Services. The Service Fee is exclusive of any and all applicable taxes of any nature imposed by or under the authority of any governmental authority on sale of services to the Client (such as sales, services and consumption taxes).
4.5 Milestones. If a Work Order includes a payment for completion of a project stage or other kind of milestone, including any delivery of a deliverable (including any Documentation or Product) (Deliverable), then Provider shall notify Client promptly in writing after the milestone is achieved. Client will have [***] ([***]) [***] to review and verify that the milestone meets the requirements agreed to by the parties. If Client rejects a milestone due to non-compliance, then Provider will promptly re-perform the rejected milestone at no additional charge to Client. Client will be deemed to have agreed that the milestone was achieved unless it notifies Provider otherwise within the [***] ([***]) [***] period. Each milestone payment is designed to reflect fair value of the corresponding Services, and is not dependent on any other milestone unless otherwise specified in the Work Order. If Provider is unable to re-perform the milestone within a reasonable period time, then Client may terminate the applicable Work Order and receive a refund of all fees paid for the applicable Work Order. If any Deliverable is a Product, then Section3 of Exhibit B shall apply.
4.8 The Service Fee agreed to by the parties, subject to the Discount, will remain in place for the entire duration of each Work Order. There will be no price adjustment with respect to each Work Order unless agreed by both parties.
The GMP batch fee shall be expressly specified in the applicable Work Order. Client shall own any raw materials paid for by Client.
The terms of the Master Services Agreement between Inhibrx, Inc. with principal place of business located at 11025 North Torrey Pines Road, Suite 200, La Jolla, CA 92037 and WuXi Biologics (Hong Kong) Limited, dated [] (the Master Services Agreement), are hereby incorporated by reference into this work order. References in the Master Services Agreement to a Work Order will be deemed to be references to this Work Order with the necessary modifications. Each capitalized term used but not defined in this work order has the meaning given in the Master Services Agreement.
5.1Company will provide the operational systems, processes and standard operating procedures to be used in performing the Services unless otherwise specified in the Work Order. All Services shall be conducted in accordance with applicable industry standards and laws.
6.2Client shall provide payment to Company in consideration for the Services provided in each Work Order (hereinafter referred to as the “Service Fees”) in accordance with payment terms as specified in this Agreement and the Work Order. In the event that any taxes shall be added to the Services Fee, the Company must, before such taxes are incurred, notified the Client by providing it in the quotation from the Company and specified in the invoices before such taxes. Client shall have the right to reject to pay any taxes that it deems not reasonable.
6.7Unless otherwise specified in applicable Work Order, Client shall provide payment to Company within thirty (30) days after the date of receipt of Company’s invoice for completed Services under the Work Order. Payments by Client shall be made by wire funds transfer into the bank account appointed by Company in accordance with the payment instruction provided in each invoice. 6.8If Client has a good faith dispute regarding a Company invoice submitted to Client, Client may withhold payment for the disputed Services, provided that Client pays the undisputed amount and notifies Company in writing of the specific amount and nature of the dispute within thirty (30) days of Client’s receipt of Company’s invoice.
7.1Client shall provide Company with sufficient amounts of materials and/or sample compounds (“Materials”) to conduct the Services. Company will store such Materials in accordance with the Work Order or otherwise instructed by the Client until use. Client will retain ownership of the Materials, and the Materials shall be used only for the purposes outlined in the Work Order. Any unused Materials shall be returned to Client when the Services are completed, except that Company will retain an archival sample for a duration and manner to be described within the Work Order, after which will be destroyed.
7.2No Materials shall be provided to any third parties or used for any other purpose except as specified in a Work Order. Company agrees that the Materials will: (i) be used in accordance with all applicable national and local laws, rules and regulations; (ii) not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subject without the written consent of Client; (iii) not be reverse engineered or chemically analyzed except as expressly agreed by Client in writing.
10.5Any written termination notice under Sections 10.2-10.4 shall identify whether it seeks to terminate: (i) one or more outstanding Work Order, (ii) all outstanding Work Order, or (iii) the entire Agreement (along with all outstanding Work Orders). Termination of a Work Order shall constitute a termination of such Work Order only and shall not affect this Agreement or other outstanding Work Orders. Unless otherwise provided by Client in its termination notice, Company shall immediately stop working on a Work Order and thereupon use its reasonable efforts to stop any additional costs or expenses from being incurred with respect to such Work Order. 10.6In the event that a Work Order is not fully performed by Company, and terminated by Client without cause pursuant to Section 10.2, Client shall only pay for the portion of the Service Fees for the Services actually performed and for any non-cancelable expenses Company has incurred. Except in the case of termination for cause by the Company, upon request by Client (but not otherwise), Company shall complete such work in progress as Company shall designate, and this Agreement shall in such case be deemed extended until such work is completed and paid for. 10.7Termination or expiration of this Agreement (by either Party) shall not affect the rights and obligations of the parties accrued prior to the effective date of termination or expiration of this Agreement.
9.4 Work Orders. In the event that the parties reach agreement with respect to the provision of Services for a Project, PRC and Sponsor shall execute a Work Order with respect to such Services. Each Work Order shall set forth the nature and scope of the Services to be performed and other specific details relating to the Services for each Project to be performed by PRC. Such Work Order shall include, but not be limited to, an estimate of PRC’s fees, pass-through costs, and third party vendor costs for such Services, the deliverables (if any) for the Project, and such other terms and conditions as shall be deemed appropriate or necessary for the performance of the Services. Sponsor agrees that the Work Order shall be executed by both parties before PRC commences work under the Work Order, unless the parties otherwise agree in writing. Each fully executed Work Order shall be deemed to be attached hereto and incorporated herein. The applicable Work Order and this Agreement shall constitute the entire agreement for each Project. To the extent any terms set forth in a Work Order conflict with the terms set forth in this Agreement, the terms of this Agreement shall control unless otherwise specifically set forth in the Work Order. As required by 21 C.F.R. § 312.52, the specific obligations relating to each Project that are being transferred to PRC by Sponsor shall be listed in the applicable Work Order. Sponsor shall retain responsibility for all other activities related to the Project. Sponsor shall at all times be considered the sponsor of the Project for the purpose of all laws, regulations, and regulatory authority requirements applicable to the conduct of clinical trials. Sponsor shall be solely responsible for review, approval, and adoption of the clinical study protocol for each Project.
1.3Timelines and Delays. PRC shall use commercially reasonable efforts to perform the Services within any timelines specified in the applicable Work Order. However, Sponsor acknowledges that such timelines are estimates and assume the full cooperation of Sponsor, regulatory authorities, Ethics Committees or Institutional Review Boards, investigative sites and investigators, and other third parties not under PRC’s control, and shall be subject to adjustment (including an adjustment in the fees and costs for the performance of Services) if the work for the Services is delayed due to circumstances not attributable to PRC, such as the following: (a) a failure by Sponsor to perform Sponsor’s obligations with respect to the Study in a timely fashion, (b) a delay by Sponsor in providing information or feedback requested by PRC, (c) amendments to the protocol for the Project that occur after the execution of the applicable Work Order, (d) enrollment rates that are lower than anticipated, © changes in applicable regulatory requirements, suspensions or other delays imposed by regulatory authorities, or (f) delays in obtaining required approvals from regulatory authorities, Ethics Committees or Institutional Review Boards. Sponsor acknowledges that, if it materially delays or suspends performance of the Services for more than fifteen (15) calendar days and such delay or suspension is unrelated to any act or omission by PRC in violation of this Agreement, then the personnel and/or resources originally allocated to the delayed or suspended portion of the Services may be re allocated, and PRC will not be responsible for delays due to required re-staffing or re-allocation of resources.
2.3Third Party Vendors. If applicable, PRC will provide a third party vendor budget in each Work Order. All third party vendor costs and associated management fees invoiced to Sponsor shall be approved by Sponsor in advance and shall include documentation reasonably acceptable to Sponsor.
2.4Invoices. Unless otherwise provided in the Work Order, PRC shall invoice Sponsor on a monthly basis for Services and Pass-Through Costs incurred and associated overhead and handling charges via electronic invoice sent to the Financial/Accounts Payable contact designated in the applicable Work Order. Each such invoice shall itemize the Services performed and all Pass-Through Costs with supporting documentation where indicated. Unless otherwise specified in the applicable Work Order, and subject to Section 2.5 below, Sponsor shall pay each monthly invoice for Services and Pass-Through Costs within 25 days of receipt. PRC shall invoice Sponsor for third party vendor costs and associated management fees separately, and all such invoices shall be paid by Sponsor within 5 days of receipt. PRC reserves the right to charge interest in the amount of 1.5% per month for any undisputed invoiced amounts that have not been paid within 25 days of Sponsor’s receipt of the applicable invoice.
2.8Advance and Fixed Fee Payments. If indicated in the applicable Work Order, Sponsor shall provide advance funding for certain projects. The repayment schedule will be specified in the Work Order. This advance funding is needed to cover the cost of hiring staff and making commitments with other vendors to service the Project. As such, should the Project terminate prematurely, the amount of such advance payments would be forfeit by Sponsor. In the event that all Services are completed early relative to the timeline described in the applicable Work Order, all remaining Fixed Fees will be immediately invoiced to and paid by Sponsor in accordance with this Section 2.
2.10Inflationary Adjustments. PRC shall be entitled upon 30 days’ written notice to increase the rates applicable to the performance of Services to include inflationary adjustments, which inflationary adjustments shall not exceed 5% of the labor rates applicable for the prior calendar year under the Work Order. In the event that any such increase is made, the parties shall enter into a Change Order to reflect such revised fees.
3.4 Effect of Termination. The termination of this Agreement by either party shall automatically terminate all Work Orders, unless otherwise agreed in writing. Upon the receipt or provision of a notice of termination of this Agreement or a Work Order, PRC shall cooperate with Sponsor to provide for an orderly wind-down and/or transition of the Services provided by PRC hereunder. Upon termination of this Agreement, Sponsor shall promptly pay PRC in full for all fees for Services performed, Pass-Through Costs and third party vendor expenses, and associated administrative overhead and handling fees, incurred up through the termination date as calculated in accordance with the provisions of this Agreement and the Budget in the applicable Work Order. In addition, Sponsor shall reimburse PRC for all reasonable, future non cancelable obligations to third parties for Pass-Through Costs and third party vendor expenses to be incurred in accordance with the Budget for the applicable Work Order. Promptly after the date of termination or completion of a Work Order or this Agreement, PRC will submit to Sponsor an itemized accounting of Services performed for the applicable Project, the Pass Through Costs and third party vendor expenses incurred as calculated in accordance with the provisions of this Agreement and the Budget in the applicable Work Order, the amount of any non-cancellable obligations to third parties for Pass-Through Costs and third party vendor expenses that were to be incurred by PRC in accordance with the Budget for each terminated Work Order, and the amount of payments received from Sponsor in order to determine the amount of the balance owed by, or the overpayment to be refunded to, Sponsor. Any balance owed by, or any overpayment to be refunded to, Sponsor will be paid or refunded within 25 days of receipt of such an itemized accounting. Sponsor shall pay for all actual costs, including time spent by PRC personnel, incurred to complete activities associated with the termination and close-out of affected Projects, including the fulfillment of any regulatory requirements.
1.11. “Subcontractor” means any entity or individual other than Syneos Health, Syneos Health Affiliates, or Syneos Health Personnel that performs Services under the direction of Syneos Health, which Syneos Health agreed to directly perform for Client in a Work Order. For purposes of clarification, Subcontractors shall not include Third Party Vendors. 1.12. “Syneos Health Personnel” mean employees of Syneos Health or of any Syneos Health Affiliate performing the Services in connection with a given Work Order. For clarification, “Syneos Health Personnel” shall not include Subcontractors or Third Party Vendors or employees thereof. 1.13. “Third Party Vendor” means any entity that performs ancillary services for the Services pursuant to a contract entered into by Client or an Affiliate thereof or, if expressly so authorized in a Work Order, by Syneos Health or an Affiliate thereof. Third Party Vendors may include, but are not limited to, drug depots, transportation companies, translation vendors, scale providers, equipment providers, electronic data capture (EDC) providers, or any other vendor performing services not within those provided by Syneos Health to Client. For purposes of clarification, Third Party Vendors shall not include Subcontractors.
2.2. Work Orders. Each Work Order shall be governed by and will be incorporated into and made an integral part of this Agreement, and shall be subject to mutually agreed Change Orders. The Parties acknowledge and agree that variation may exist in the form of Work Order depending on the Affiliate and/or the nature and type of services provided. Subject to the terms of the Work Order, the Parties agree that the Work Order shall set forth a reasonable schedule for the Services to be performed, and each Party will use Commercially Reasonable Efforts to comply with the timelines stated therein. 2.3. Order of Documents. To the extent that terms and/or provisions of a Work Order conflict with the terms and/or provisions of this Agreement, the terms and/or provisions of this Agreement shall control unless the Work Order expressly states otherwise. 2.4. Start-Up Services. Upon written approval from Client (email is acceptable), Syneos Health may proceed with providing Services prior to the execution of a Work Order (“Work Ahead E-mail”). Each Work Ahead Email shall provide a description of the Services to be performed by Syneos Health and shall also include the Fees and Pass Through Costs associated with said Services and attach the then current Work Order in process. Upon finalization of the Work Order, the Services set forth in the Work Ahead E-mail shall be integrated into, and superseded by, the full Work Order. 2.5. Change Orders. Once a Work Order is executed, if either Party requests a change in the scope of Services, or the assumptions upon which the Work Order is based change, then the Parties shall execute a Change Order prior to implementing such changes. Should any requirements of Applicable Law change, each Party will use Commercially Reasonable Efforts to satisfy the new requirements. In the event that compliance with such new regulatory requirements necessitates a change in the Services, the Parties will evaluate the need for a Change Order.
3.3. Relationship of the Parties. Syneos Health is at all times an independent contractor with respect to Client. The Parties are not agents of each other unless otherwise explicitly agreed to in writing. Nothing in this Agreement or any Work Order is intended or shall be deemed to constitute a partnership, principal/agent, employer/employee, or joint venture relationship. Neither Party shall have the power or right to bind or obligate the other Party, nor shall it hold itself out as having such authority, except to the extent, if at all, specifically provided for in this Agreement, Work Order or as authorized in writing. 3.4. Media Buys. Notwithstanding anything to the contrary set forth herein, to the extent the Services include advertising and/or public relations services in any Work Order, Syneos Health may at times, in a Work Order, be authorized to act as Client’s agent in the purchase of media and as such may be given the authority to bind Client to certain terms and conditions which may include but not be limited to indemnification and financial liability, provided however, that Client shall provide its prior written approval of any such purchases and the terms and conditions governing such purchases are within the scope of the authority provided in the Work Order. Syneos Health will be solely liable for payment to the extent that payments from Client for the subject invoices have cleared from Client to Syneos Health for promotional and other materials. No media will be purchased by Syneos Health on behalf of Client if funds have not successfully been received and cleared by Syneos Health. Should these funds not be received and cleared by Syneos Health, all purchases of media shall be made solely in the name of Client.
8.1. Obligations. Either Party may become the recipient of Confidential Information of the other during the term of this Agreement. The Receiving Party shall (i) treat the Disclosing Party’s Confidential Information as confidential and proprietary and protect it with the same level of prudence and care as it would protect its Confidential Information, but in no event less than reasonable care; and (ii) use the Disclosing Party’s Confidential Information only as necessary to perform its obligations or exercise its rights hereunder or under a Work Order. These confidentiality and non-use obligations shall remain in effect for [***] after the expiration or termination of this Agreement. 8.2. Disclosure. Without the prior written consent of the Disclosing Party, the Receiving Party shall not disclose Confidential Information to any third party; provided, however, that Syneos Health may disclose Client’s Confidential Information to Syneos Health’s Subcontractors, Third Party Vendors, agents, representatives, or Affiliates of Syneos Health and the Affiliates’ respective employees that have a need to know such information in connection with the Services where such parties are bound to obligations of confidentiality and non-use substantially similar to those set forth herein.
10.1. Indemnification by Client. Client shall promptly, indemnify, defend, and hold harmless Syneos Health and its Affiliates and its and their respective directors, officers, employees, and agents (“Syneos Health Parties”) from and against any and all losses, liabilities, damages, expenses, costs and fees (including reasonable attorneys’ fees) (collectively, the “Losses”) arising from third party claims, causes of action or suits (“Claims”) relating to, arising from, or in connection with this Agreement or the Services contemplated herein, including without limitation, any product liability claims, whether arising out of warranty, negligence, strict liability (including manufacturing, design, warning or instruction claims), or any other product based statutory claim, any failure by Client to comply with any applicable federal, state, or local laws, regulations, or codes, including but not limited to, the United States Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b) and the related safe harbor regulations, the Federal False Claims Act, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act, in the performance of its obligations under this Agreement or any material breach by Client of its warranties, representations, covenants, agreements and obligations set forth in this Agreement or any Work Order. Client’s indemnity obligations shall not apply to the extent that such Losses result or arise from (y) the negligent acts or omissions by or the willful misconduct of Syneos Health Parties; or (z) any material breach of this Agreement or any Work Order by Syneos Health Parties. 10.2. Indemnification by Syneos Health. Syneos Health shall promptly indemnify, defend, and hold harmless Client and its Affiliates and its and their respective directors, officers, employees, and agents (“Client Parties”) from and against [***].
3.2Covance shall use its reasonable efforts to perform the Services within the timeframe estimated in the Protocol/Scientific Plan or applicable Work Order.The Sponsor agrees and acknowledges that time estimate assumes the full cooperation of the Sponsor, Regulatory Authorities, IECs/IRBs and Investigators (if applicable) and other third parties not under Covance’s reasonable control.
8.2In consideration for the Services provided by Covance under the applicable Work Order, the Sponsor hereby agrees to pay Covance the fees and actual pass through costs incurred as specified in the applicable Work Order, provided, however, that the Sponsor shall have no obligation to pay Covance for any pass through costs incurred by Covance unless (i) such pass through costs are included in the applicable Budget already approved by the Sponsor, or (ii) such pass through costs were otherwise approved by the Sponsor prior to their incurrence .Invoices shall be issued in accordance with the payment schedule or payment terms, in the Work Order. Covance shall have no obligation to make payments of investigator grant payments to any investigator or investigative site until such time as payment of such pass through costs are made by Sponsor to Covance.
8.5If the Sponsor requires a purchase order for the payment of Covance invoices, the Sponsor shall provide the purchase order at the time of returning the signed Work Order. Failure to provide a purchase order shall not preclude Covance from issuing an invoice in accordance with the payment schedule or payment terms, defined in the Work Order for milestones met or work performed and the Sponsor shall be responsible for payment of all invoices.
10.5To the extent reasonably practicable, Covance shall continue to provide the Services pending approval of the Change Order by the Sponsor.Covance shall not be obligated to implement all or any part of the changes without an agreement in writing signed by both Parties.In the event that the Parties cannot agree on such changes, Covance shall not be obliged to provide non-contracted Services to the Sponsor under the relevant Work Order. In the event the Parties agree on such changes and Covance continues to provide services before the execution of the Change Order, Covance shall invoice the Sponsor for Services rendered.
Except as otherwise directed by the Sponsor, Covance shall retain all Results relating to a Study or the Services during the term of the applicable Work Order.Upon completion or earlier termination of a Study or the Services or earlier if requested by the Sponsor, the Results for the applicable Study or the Services shall be delivered to the Sponsor.Covance shall not be required to return ancillary documents related to the Study Records (including invoices and other similar records).Notwithstanding the foregoing, Covance shall be permitted to retain archival copies of such records if and to the extent that such Results are required to be stored or maintained by Covance pursuant to Regulatory Requirements or other requirements.
20.3Unless otherwise agreed in writing between the Parties, any physical Deliverables to be shipped to the Sponsor shall be to the delivery address specified in the Work Order. Upon delivery of any physical Deliverables, the Sponsor shall be responsible for carefully examining such Deliverables. The Sponsor shall be deemed to have accepted such Deliverables if Covance has not been notified by the Sponsor within ten (10) business days of delivery of any defect in such Deliverables.
33.3Waiver. A waiver of any term, provision or condition of this Agreement or Work Order shall be effective only if it is in writing and no waiver, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver or estoppel of any such term, provision or condition or any other term of this Agreement or a Work Order. No failure or delay by either Party in exercising any right or remedy under this Agreement shall constitute a waiver of such right, nor shall it prevent or restrict its further exercise.The Parties acknowledge and agree that they have not relied upon any representations made before contract in deciding to enter into this Agreement and the Parties waive all and any right to pursue any claim for misrepresentation except for fraudulent misrepresentation.
5.2.Invoices and Payment are governed by Sections 8 through 10 of the MSA. In consideration for its performance of the Services under this Work Order, the Sponsor shall pay Covance in accordance with the payment schedule or payment terms set out in this Work Order attached as Annex 3.Any amounts paid by Sponsor to Covance under the preliminary Start-Up Agreement “SUA” executed on June 6, 2017 will be applied to initial invoices under this Work Order.Invoices are due within thirty (30) days of receipt by the Sponsor.
For each Project, BI shall provide all Services (as defined below) and Deliverables as set forth in an applicable Work Order (as defined below) in a [*] manner, in accordance with this Definitive Agreement and all applicable laws at the place of manufacture and any other applicable jurisdiction or other requirements as may be set forth in the applicable Work Order (as defined below). All Services and Deliverables for a Project shall be described in a Work Order (each, a “Work Order”).Each Work Order shall detail the following: (a) the Work Scope; (b) the Services to be provided; (c) the complete fees and payment schedule for the Services; (d) the Deliverables to be delivered by BI during and/or upon completion of the Project; (e) the materials to be provided by each Party; (f) a Project timeline and completion date, and (g) any other information relevant to the Project. A Work Order may include or reference batch records or other documentation which further detail the Services and Deliverables under such Work Order. To become effective, a Work Order must be executed by an authorized representative(s) of each Party.Once effective, each Work Order shall be automatically incorporated as a part of this Definitive Agreement. Services with respect to a given Project shall only be commenced [*].
3.3.2. Performance of Services. The specific Manufacturing activities to be performed by Manufacturer with respect to a Product shall be separately specified in writing in a Work Order. Each Work Order shall be signed by both parties, shall be attached tothis Agreement as part of Exhibit A, and shall set forth, upon terms mutually agreeable to the parties, the specific Services to be performed by Manufacturer, the time line and schedule for the performance of such Services and the compensation tobe paid by Artiva to Manufacturer for the provision of such Services, as well as any other relevant terms and conditions. If any such Services include a technical process transfer or the production of specific deliverables (including, without limitation, engineering or validation Batches of Product, reports, Master Batch Records, Batch Documentation, and analytical results), the specifications of such technical process transfer or deliverables shall be set forth on the relevant Work Order. Each Work Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisionsof this Agreement, the terms and provisions of this Agreement shall control, unless the Work Order expressly states the intent of the parties that a particular provision of such Work Order supersede this Agreement. The parties shallattach a copy of each Work Order to this Agreement, and each such Work Ordershall be incorporated herein by reference. Any changes to such Work Order shall be in writing, executed by each party, attached to the original Work Order and incorporated therein and attached hereto as part of Exhibit A.
3.3.3. Compliance with Work Orders, Law and Schedule. Manufacturer agrees to perform the Services set forth in each Work Order in a competent and professional manner and in strict accordance with the terms and conditions contained in this Agreement and such Work Order. Manufacturer shall perform its obligations hereunder, including but not limited to manufacturing Product for Artivas phase I/II clinical trials, in conformance with all applicable federal, state and local statutes, rules and regulations, including, without limitation, GMP (except to the extent otherwise specified in a Work Order) and the FD&C Act. Manufacturer shall use commercially reasonable efforts to perform the Services for Artivas clinical trials under each Work Order in accordance with the time line and schedule set forth in such Work Order. Manufacturer shall notify Artiva in writing promptly upon becoming aware of any circumstance that will, or could reasonably be expected to, result in any delay in performance of the Services, and the parties shall cooperate in good faith to avoid or minimize any such delay.
6.1. Acceptance. Prior to the delivery of any Batch of Product and within [***] days of completion of such Batch, Manufacturer shall provide Artiva or a third party designated by Artiva with appropriate mutually agreed upon Batch Documentation in accordance with the Work Order. Batch acceptance criteria are defined in the Work Order. Artiva will review the Batch Documentation for each Batch of Product. Artiva will notify Manufacturer in writing of its acceptance or rejection of such Batch within [***] days of receipt of the complete Batch Documentation; provided, however, that in the case of a Batch of Product having any Latent Defect that is [***], Artiva may reject such Batch by giving written notice to Manufacturer ofArtivas rejection thereof within [***] days after delivery of such Batch, but such notice may in no event be given later than the applicable expiration date of such Batch. During the [***] review period specified above, the parties agree to respond promptly within [***] days, to any reasonable inquiry by the other party with respect to the Batch Documentation.
6.2. Delivery. Except as otherwise specified in a Work Order, all shipments of Product shall be shipped FCA (Incoterms 2010) to Artivas designated logistics facility. Artiva has the responsibility of delivery from the place that Manufacturer delivers the Products to Artivas clinical sites. Manufacturer shall deliver the Product within the period of delivery set forth in the Work Order and provide Artiva with advance notice of the anticipated date of delivery of Product. Notice will be provided at least [***] business days before Manufacturer is to deliver that Product. If Artiva is unable to receive the Product at the time of delivery, Manufacturer will store or delay the delivery of the Product at Artivas request and reasonable expense in accordance with the appropriate Work Order. Manufacturer will package and ship Product in accordance with Artivas instructions. A bill of lading will be furnished to Artiva with respect to each shipment. Artiva or its designee will conduct a quality check on delivered Products, including of container labels and container integrity, and will promptly notify Manufacturer in writing of loss, damage, defects or non-delivery of any part of a Product shipment within [***] business days after receipt of such shipment by Artiva or its designee, and if any loss, damage, defects or partial non-delivery are not evident to Artiva or its designee at the time of delivery, such notification by Artiva to Manufacturer will be made no later than [***] days after receipt as stipulated in Section6.1 above.
2.2 Performance of Services. The specific research or development activities to be performed, or other services to be provided, by GCLC for each project under this Agreement (each, a Project) shall be separately specified in writing on terms and in a form acceptable to the parties (each such writing, a Work Order). Each Work Order shall become effective only upon signature by both parties. Each Work Order shall set forth, upon terms mutually agreeable to the parties, the specific Services to be performed by GCLC, the timeline and schedule for the performance of such Services, and the compensation to be paid by Artiva to GCLC for the provision of such Services, as well as any other relevant terms and conditions. Any Protocol applicable to a particular Project shall be attached to, and is hereby incorporated by reference in, the corresponding Work Order. If a Project includes the development of specific Work Product, the specifications of such Work Product shall be set forth in the relevant Work Order. If a Project involves a clinical trial or any other study the results of which are expected or intended to be submitted to any Regulatory Authority, the relevant Work Order shall specify: (a)any particular laws, rules, regulations, guidelines and standards (e.g., current good laboratory practices and/or good clinical practices) of any Regulatory Authority or other body that GCLC agrees to comply with in performing such Project; and (b)any obligations of Artiva, as the sponsor of IND application and otherwise, pursuant to 21 C.F.R. § 312.50 or other applicable laws, rules and regulations in connection with such Project that GCLC agreed to assume from Artiva. There shall be no minimum or maximum number of Work Orders to be entered into under this Agreement. Each Work Order shall be subject to acceptance by GCLC and all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent such Work Order specifically states the parties intent that such Work Order control with respect to a particular matter. Any changes to a Work Order shall be in writing, executed by each party, attached to the original Work Order and incorporated therein.
2.3 Compliance with Work Orders and Law. GCLC agrees to perform the Services set forth in each Work Order in a competent and professional manner and in strict accordance with the terms and conditions contained in this Agreement, the applicable Protocol(s) and such Work Order. Both parties hereto shall perform the obligations set forth herein in conformance with all applicable laws, rules and regulations, including, if applicable, current good laboratory practices and/or current good clinical practices. If government regulatory requirements applicable to any Work Order are changed, then Artiva shall notify GCLC of all such changed requirements, and GCLC shall comply with the new requirements. If compliance with new regulatory requirements necessitates a change in a Work Order, Artiva shall amend the Work Order and obtain GCLCs written consent to such change prior to implementation.
2.4 Subcontractors. Save for subcontracting to its Affiliates, GCLC may not subcontract any of the Services under a Work Order without Artivas prior written consent, except to the extent expressly permitted by such Work Order. GCLC shall at all times be responsible for the compliance of its permitted subcontractors with the terms and conditions of this Agreement.
2.5 Results. GCLC shall solely own all data generated by GCLC or its employees, agents, consultants, Artiva-approved subcontractors or other representatives in the course of conducting a Project, whether in written, graphic or electronic form or contained in any computer database or in any computer readable form (collectively, the Results). GCLC hereby confirms that such Results that fall within the definition of GCLC Core Technology or Selected Product Technology (each as defined in the Master Agreement) are included in the licenses granted to Artiva under the Master Agreement and the applicable Selected Product License Agreement, respectively. GCLC shall record, or cause to be recorded, all Results in a timely, accurate and complete manner. Copies of all Results collected shall be delivered to Artiva by GCLC in a timely manner throughout the performance of the Project and in accordance with the applicable Work Order. Subject to Section9.6 of the Master Agreement, GCLC shall have the right to review, publish, disclose and use any Results as GCLC, in its sole discretion, deems appropriate, including, without limitation, in submission to a Regulatory Authority. Any copyrightable work created in connection with the performance of a Project and contained in or relating to the Results will not be considered a work made for hire, whether published or unpublished, and all rights therein shall be the property of GCLC as author and owner of copyright in such work. For purposes of clarification, this section shall apply to each Project individually.
3.2 Invoices; Payment. Unless otherwise agreed by the parties in writing, GCLC shall provide to Artiva for each Work Order one or more separate invoices (to be delivered at intervals specified in such Work Order), such invoice summarizing the Services performed during that period of time under that Work Order and the costs therefor. Artiva shall pay each invoice within [***] days of receipt thereof, in accordance with the applicable schedule of payments specified in such Work Order. Artiva shall not be obligated to pay any amounts in excess of the budget or other payments specified in a Work Order that have not been approved in writing by Artiva in advance.
3.3 Compliance with Work Orders and Law. GCLC agrees to perform the Services set forth in each Work Order in a competent and professional manner and in strict accordance with the terms and conditions contained in this Agreement, the applicable Protocol(s) and such Work Order. Both parties hereto shall perform the obligations set forth herein in conformance with all applicable laws, rules and regulations, including, if applicable, current good laboratory practices. If government regulatory requirements applicable to any Work Order are changed, then Artiva shall notify GCLC of all such changed requirements, and GCLC shall comply with the new requirements. If compliance with new regulatory requirements necessitates a change in a Work Order, Artiva shall amend the Work Order and obtain GCLCs written consent to such change prior to implementation. During the Merck Product Term, all employees and subcontractors of a party or its Affiliates performing research, development, commercialization or other activities contemplated hereunder on behalf of such party or its Affiliates shall be obligated to undertake in writing obligations of ownership of Information, discoveries and inventions which are the same as those undertaken by the parties pursuant to Section6.
a.Work Orders; Services. At Amazon’s request and as specified in one or more work orders that are executed and delivered by Amazon and Carrier (“Work Orders”), Carrier will provide transportation, delivery, and related services (whether on foot, by bicycle, by motor vehicle, or otherwise) (“Services”, as such term is further described in any Work Order) in accordance with the terms and conditions of this Agreement, the Program Policies, and any performance standards set forth in each applicable Work Order. This Agreement and the Program Policies govern each Work Order, and if Carrier commences Services in the absence of a Work Order, this Agreement and the Program Policies will nevertheless apply.
a.In consideration of performing Services, Amazon will pay Carrier in accordance with the rate structure included in each applicable Work Order. [***].
4. Invoicing. Unless otherwise directed by Amazon, Carrier will provide weekly invoices (at no charge) in a form acceptable to Amazon. Each invoice will include at least the following data in addition to any other itemized data reasonably requested by Amazon: service date, service type, number of Planned Routes per Service Area by shift (if applicable), and total cost. At Amazon’s request, Carrier will issue separate invoices for each account established under this Agreement or any Work Order. The payment obligation under each invoice is a separate obligation of the account to which the invoiced Services were provided pursuant to the applicable Work Order, and no other account has any obligation under such invoice or Work Order. Amazon will pay, or cause to be paid, all undisputed portions of Carrier’s properly submitted invoices within [***] of receipt. Amazon has no obligation to pay, or cause to be paid, any fees or expenses invoiced more than [***] after the applicable Services are performed, and Carrier waives any claim for payment of amounts not invoiced within that [***] period. Amazon or its designee may conduct invoice audits to verify accuracy. Discrepant invoices will be rejected or short paid with appropriate explanation of the discrepancy. The parties will use their commercially reasonable efforts to resolve any disputes promptly.
7.Insurance. Carrier will, at all times during which Carrier provides the Services and for at least [***] after all Services are completed, carry, at Carrier’s expense, the types of insurance and minimum limits of insurance, in each case, that are specified in the Program Policies and each applicable Work Order. Carrier will submit certificates of insurance evidencing required insurance coverages to Amazon prior to the commencement of the Services and at each policy renewal thereafter. Carrier consents to Amazon disclosing Carrier’s certificates of insurance or other information to third parties for the purpose of verifying Carrier’s compliance with this Section 7.
We have entered into a Master Services Agreement and a Supply Agreement with the Centre for Probe Development and Commercialization, or CPDC, under which CPDC provides products and services to us, including preclinical and manufacturing services, administrative support services, access to laboratory facilities and laboratory technicians and products for human safety and efficacy clinical trials. In connection with the Supply Agreement, we pay CPDC $45,000 per month, plus fees for production, packaging and distribution of products supplied to us. In connection with the Master Services Agreement, we pay CPDC periodically pursuant to the amounts set forth in each work order. During the years ended December31, 2017, 2018 and 2019, we made payments to CPDC in connection with the services described above of $0.6million, $1.0million and $1.2million, respectively. John Valliant, our Chief Executive Officer, is the founder and a member of the board of directors of CPDC.
4. PERFORMANCE OF WORK: CPDC shall perform the Services described and defined in each Work Order in a professional, diligent workman-like manner and in accordance with the terms and provisions of this Agreement and such Work Order. When performing any Services for FUSION, CPDC shall use reasonable best efforts to [***]. Each Work Order shall provide specific details [***]. CPDC will not change or modify any services required by such Work Order unless CPDC and FUSION mutually agree in writing in advance to the changes. Any such agreement shall be in compliance with any applicable federal regulations governing the applicable Service, including any amendments or changes. CPDC shall maintain complete and accurate records of documents, information, computed and raw data, and materials used or generated in performance of the Services in a professional manner so as to permit FUSION to review such records in full in accordance with this Agreement. Final Service reports shall be delivered to FUSION according to the timelines specified in the applicable Work Order. During the course of providing Services and following completion or termination thereof, CPDC will promptly reply to any questions regarding the summary of results or any other matter relating to such Services. CPDC shall report to and consult with representatives, agents, consultants or sublicensees of FUSION as required by the applicable Work Order and as may be reasonably requested in writing by FUSION.
7. FUSION MATERIALS: FUSION may provide FUSION Materials (as defined below) to CPDC in order for CPDC to perform the Services, which will be explicitly identified in each Work Order. FUSION Materials include but are not limited to: [***]. FUSION Materials are and shall remain the sole and exclusive property of FUSION, and shall not be transferred to any other party without prior written permission from FUSION. During the term of this Agreement, FUSION hereby grants CPDC a limited, royalty-free, non-transferable, non-exclusive license to use FUSION Materials solely as is necessary to perform the Services. For the sake of clarity, FUSION has not granted CPDC a license to use FUSION Materials in any services performed by CPDC for the benefit of third parties. No right or license is granted under this Agreement by either Party to the other, either expressly or by implication, except those specifically set forth herein. Without limiting any of the foregoing, all discoveries and inventions (whether or not patentable) that arise from or relate to FUSION Materials shall be the exclusive property of FUSION.
16. EQUIPMENT: FUSION may provide or pay for equipment in performance of the Services (Equipment). Such Equipment shall be fully specified in the applicable Work Order and the value of all Equipment will be itemized in the applicable Work Order and/or in attachments thereto. The title to and maintenance of Equipment shall be agreed to and specified the applicable Work Order. While in its possession, CPDC will maintain Equipment provided for use in good operating condition and in a secure environment, subject to the following: the cost of maintenance and repair necessary for proper operation of the Equipment during the course of the Services will be paid for by FUSION, but only if authorized in advance by FUSION.
The Parties recognize that the utility of the Services to be done by CPDC under this Agreement is dependent upon the timely completion of such Services in accordance with the schedule set forth in the applicable Work Order. However, the Parties likewise recognize that the exigencies which may arise during CPDCs performance may require, from time to time, non-material deviations from the scheduled completion of increments of said performance. To the extent that said non-material deviations do not affect the quality of the performance and do not delay delivery of any Work Product within the time scheduled (as such time may be extended under the provisions of this Section29) such non-material deviations in time shall not be considered as being a default or breach of this Agreement.
2.1Services and Work Orders.From time to time, Atara may wish to engage Manufacturer to perform Services for Atara.Such Services will be set forth in a Work Order.Each Work Order will be appended to this Agreement, will include the material terms for the project, and may include the scope of work, specified Services, Specifications, deliverables, timelines, milestones (if any), quantity, budget, payment schedule and such other details and special arrangements as are agreed to by the Parties with respect to the activities to be performed under such Work Order.No Work Order will be effective unless and until it has been agreed to and signed by authorized representatives of both Parties.Documents relating to the relevant project, including Specifications, proposals, quotations and any other relevant documentation, will only be effective if attached to the applicable Work Order and incorporated in the Work Order by reference. Each fully signed Work Order will be subject to the terms of this Agreement and will be incorporated herein and form part of this Agreement.Manufacturer will perform the Services in consideration of payment therefor by Atara specified in each fully signed Work Order, as amended by any applicable Change Order(s), and in accordance with the terms and conditions of such Work Order and this Agreement.Notwithstanding the foregoing, nothing in this Agreement will obligate either Party to enter into any Work Order under this Agreement beyond the Initial Work Order executed and delivered simultaneously with this Agreement.
3.1Representatives.Each Party will appoint a representative having primary responsibility for day-to-day interactions with the other Party for the Services (each, a “Representative”), who will be identified in the applicable Work Order.Each Party may change its Representative by providing written notice to the other Party in accordance with Section 15.4; provided that each Party will use [ * ] to provide the other Party with at least [ * ] prior written notice of any change in its Representative for the Services.Except for notices or communications required or permitted under this Agreement, which will be subject to Section 15.4, or unless otherwise mutually agreed by the Parties in writing, all communications between Manufacturer and Atara regarding the conduct of the Services pursuant to such Work Order will be addressed to or routed directly through the Parties’ respective Representatives.
3.3Subcontracting.Manufacturer may not subcontract with any third party including any Affiliate of Manufacturer, to perform any of its obligations under this Agreement without the prior written consent of Atara (each such subcontractor, a “Permitted Subcontractor”).For clarity, execution of the Work Order constitutes prior written approval that such subcontractors shall be deemed Permitted Subcontractors for purposes of the preceding sentence to the extent such subcontractors are specified in the applicable Work Order.Manufacturer will be [ * ] Permitted Subcontractor, and [ * ].Manufacturer will cause any such Permitted Subcontractor to be bound by, and to comply with, the terms of this Agreement, as applicable, including all confidentiality, quality assurance, regulatory and other obligations and requirements of Manufacturer set forth in this Agreement.In no event will Manufacturer be responsible for the performance of any third party retained by Atara to perform any services in connection with the Services rendered by Manufacturer, including suppliers, distributors, consultants, agents or testing entities, [ * ].
3.4Duty to Notify.Manufacturer will [ * ] notify Atara if at any time during the term of this Agreement Manufacturer believes that it will be unable to perform or complete the Services in accordance with the production schedule agreed in any Work Order.Compliance by Manufacturer with this Section 3.4 will not relieve Manufacturer of any other obligation or liability under this Agreement; provided that Manufacturer’s failure to provide notice under this Section 3.4 will not relieve Atara of any obligation or liability it has under this Agreement unless Atara is materially prejudiced by such failure to receive notice.
4.1Supply of Materials.Manufacturer will supply, in accordance with the payment schedule(s) included in the applicable Work Order, and in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order (other than Atara Materials and Atara-Supplied RawMaterials) (collectively, the “Manufacturer-Supplied Raw Materials”).Without limiting the foregoing, any such materials that the Parties mutually agree (in writing, email being sufficient) require prepayment will be subject to the financial terms set forth in the applicable Work Order.Atara or its designees will provide Manufacturer with those Atara Materials in accordance with the schedule established at the applicable Operations Meeting.Notwithstanding Manufacturer’s obligation to procure all Manufacturer-Supplied Raw Materials for the provision of Services and Manufacture of Product, Atara may, [ * ], procure and deliver to Manufacturer up to [ * ] of all raw materials used by Manufacturer (other than Atara Materials, of which Atara may supply [ * ]) in the performance of Services and/or Manufacture of Product. Manufacturer agrees (a) to acknowledge receipt of all Atara-Supplied Raw Materials and Atara Materials received by Manufacturer; (b) not to provide Atara-Supplied Raw Materials, Manufacturer-Supplied Raw Materials (that have been pre-paid for by Atara) or Atara Materials to any third party without the express prior written consent of Atara; (c) not to use Atara-Supplied Raw Materials, Manufacturer-Supplied Raw Materials (that have been pre-paid for by Atara) or Atara Materials for any purpose other than conducting the Services, and without limiting the generality of the foregoing, will not analyze, characterize, modify or reverse engineer any Atara Materials or take any action to determine the structure or composition of any Atara Materials unless required pursuant to a signed Work Order (or necessary to confirm that all applicable standards are met, solely in connection with [ * ]Atara’s prior written consent); and (d) to destroy or return to Atara all unused quantities of Atara-Supplied Raw Materials, Manufacturer-Supplied Raw Materials (that have been pre-paid for by Atara) and Atara Materials according to Atara’s written directions and at Atara’s sole cost and expense.
4.4Supply of Equipment.Unless otherwise agreed in a Work Order, Manufacturer will supply all Equipment necessary to perform the Services, except that Atara will supply the Atara Equipment, if any.Manufacturer will not use the Atara Equipment except in performance of Services under the applicable Work Order.The Atara Equipment will be delivered to Manufacturer’s Facility free and clear of all liens and encumbrances.Title to any such delivered Atara Equipment will remain with Atara and Manufacturer will ensure that the Atara Equipment is properly labeled as Atara property and remains free and clear of any liens or encumbrances.At Atara’s written request, the Atara Equipment will be returned to Atara, or to Atara’s designee, at Atara’s sole cost and expense.Manufacturer will be responsible, at Atara’s cost, for maintenance of the Atara Equipment.To the extent Atara provides spare parts for the Atara Equipment, such spare parts will remain the property of Atara and will be used by Manufacturer only for maintenance of the Atara Equipment.Manufacturer will [ * ] notify Atara if [ * ]any Atara Equipment has been damaged, lost or stolen.
(a)Records.Manufacturer will keep complete and accurate records (including reports, accounts, notes, data, and records of all information and results obtained from performance of Services) of all work done by it under this Agreement, in form and substance as specified in the applicable Work Order, the applicable Quality Agreement, and this Agreement (collectively, the “Records”).All such Records will be the property of Atara.Except as required by or necessary to comply with Applicable Law, enforce its rights or perform its obligations under this Agreement, any Work Order, or the Quality Agreement, Manufacturer will not transfer, deliver or otherwise provide any such Records to any Party other than Atara, without the prior written approval of Atara.All original Records of the performance of Services, including without limitation, the Manufacture of Product under this Agreement will be retained and archived by Manufacturer in accordance with cGMP (if applicable) and Applicable Law, but in no case for less than a period of [ * ] following completion of the applicable Work Order.Such archived Records will be available at reasonable, mutually agreed times, during normal business hours, for inspection, examination and copying by or on behalf of Atara, [ * ].For the sake of clarity, costs and expenses in connection with Atara’s review of Records [ * ] in connection with the Release of a Batch or Disposition is included in the Batch Fees.Upon Atara’s request and [ * ], Manufacturer will [ * ] provide Atara with hard copies of such Records following written request therefor.Atara will be provided electronic access to completed Records [ * ].[ * ] after completion of a Work Order, all of the aforementioned records will be sent to Atara or Atara’s designee at Atara’s sole cost and expense; provided, however, that [ * ] such Records retained in Manufacturer’s archives for an additional period of time at a [ * ] charge to Atara.Manufacturer will retain copies of all of such Records and Atara will provide Manufacturer full access to all original Records if Manufacturer is required or compelled to furnish any of such original Records in connection with a regulatory inspection by any Authority or otherwise in connection with Applicable Law.
8.1Price.The price of Product and/or the fees and expenses for the performance of Services will be set forth in the applicable Work Order.All dollar ($) amounts specified in this Agreement are United States dollar amounts and all payments to be made under this Agreement will be made in United States dollars.
the applicable payment terms under this Agreement or the applicable Work Order.Manufacturer will invoice Atara according to the invoice schedule in the applicable Work Order, referencing in each such invoice the Work Order(s) to which such invoice relates.Unless otherwise specified in the applicableWork Order, payment of [ * ] amounts ([ * ]) will be due[ * ] after Atara’s receipt of electronic transmission of the invoice (and reasonable supporting documentation pertaining to any disbursements).Payments will be made in United States Dollars.A [ * ] service charge will be applied to all [ * ] overdue balances ([ * ]).
14.7Payment Reconciliation.Within [ * ] after the close-out of a Work Order, Manufacturer will provide to Atara a written statement of all work performed by it in connection with the terminated Work Order, breakdown of the costs associated with that work, and a final invoice for that Work Order. [ * ].
Sponsor and the Research Organisation are [authorised Affiliates of] Parties to a Master Services Agreement dated DD MMM YYYY (MSA), the terms of which will govern the performance of this Work Order. Upon signature by Sponsor and by the Research Organisation, this Work Order is incorporated in and becomes part of the MSA.
3.1.Rentschler shall provide the Services as more particularly described in a Work Order. Each Work Order is hereby incorporated by reference in this Agreement. Each Work Order shall (i) reference this Agreement and be governed by and subject to the terms of this Agreement, including all schedules and documents incorporated by reference herein; (ii) describe all of the Services that Rentschler is required to provide to Customer thereunder; and (iii) describe the fees and expenses, if any, for the Services being provided thereunder. Rentschler shall not be obliged to begin work on any Services without a fully executed Work Order.
7.5.If Customer provides Customer Material to Rentschler, such material remains in Customer’s property until it is used for the performance of the Services specified in the respective Work Order. Rentschler shall keep the Customer Material in confidence at the Facility and use the Customer Material solely for performing the Services pursuant to this Agreement and/or the respective Work Order. Rentschler shall not disclose or transfer any Customer Material to anyone who is not an employee or approved subcontractor of Rentschler assigned to perform activities in connection with the Services. Rentschler shall not attempt to reverse engineer any such Customer Material or perform any testing to determine the chemical structure, molecular composition, or make-up of the Customer Material, or make any derivatives or alternative forms of the Customer Material, except as provided in this Agreement and/or the respective Work Order. Rentschler will return to Customer any Customer Material which is not or not fully used after the completion of the services FCA Facility (Incoterms 2010).
10.6.One audit of one day and two auditors is inclusive in the Fees, even if not mentioned in an Work Order. Further audits or audits of another scope are charged according to Section 10.2.
10.7.The invoices are issued according to the payment plan in the respective Work Order. All payments by Customer to Rentschler shall be made in Euros within thirty (30) days after having received the invoice for the respective Services via bank wire transfer to a bank named by Rentschler. If any invoice properly issued by Rentschler to the Customer is not settled by Customer on or before the respective due date, any unpaid overdue amount shall bear interest at a rate equal to nine (9) percentage points above the basic interest rate (Basiszins) of the European Central Bank p.a.
11.1.Work Orders referring to this Agreement and containing services of upstream processing, during which proteins are produced by cells genetically engineered to contain the human gene which will express the protein of interest (“USP Services”) and/or downstream processing, during which the produced proteins are isolated and purified (“DSP Services”) contain also a binding reservation of the respective cGMP Facility for the dates as indicated in the respective Work Order (the “USP/DSP Reservation”), to be accepted by Customer together with the Work Order. If the dates or timelines in the Work Order are changed by mutual agreement of the Parties in writing (telefax, e-mail or other modern form of written communication sufficient), the USP/DSP Reservation will be changed accordingly.
12.1.In case the Services do not conform to the terms of this Agreement, the Quality Agreement and/or the Work Order, including in the event of a Non-Conforming Product, if Rentschler performs a severe and uncured default or in delay in the Services, and such non-conformance was not the result of factors that are outside of Rentschler’s reasonable control and without its fault, Rentschler will repeat the Services free of charge as soon as reasonably possible considering Rentschler’s pre-existing obligations and commercial commitments to third parties. Rentschler shall ensure that such amounts of Product manufactured under any Work Order are delivered to Customer in accordance with the timelines specified in the Work Order. Rentschler shall notify Customer promptly in writing, if it has reason to believe that it will be unable to fulfil all or part of a Work Order, and/or of any delay in meeting the specified delivery date (as the case may be) (a “Supply Failure”) together with estimate of the dates for delivery of the Product, if available. In such event the Parties shall determine a reasonable course of action (including revised timelines) to rectify the matter as soon as possible. Customer’s further remedies under the applicable statutory law for the delivery of Non-Conforming Product or Non-Conforming Services, for delayed delivery or non-delivery shall remain unaffected.
17.3.Upon completion of a Work Order, Rentschler will transfer to Customer full copies of the Records pertaining to such Work Order. Customer shall be entitled to use the Records solely in order to utilize the New Customer Intellectual Property and/or the Product, any intermediates or the API and/or any Customer technology further developed hereunder, as well as for regulatory purposes, including without limitation any applications for regulatory approval of the Product or in order to prepare or file an IND or IMPD. Customer shall have the right, subject to the confidentiality obligations of Section 18, and specifically Section 18.5 with respect to consultants and regulatory authorities, to (i) disclose such data or information to regulatory authorities and/or its consultants to the extent necessary to comply with applicable law and the requirements of regulatory authorities or (ii) use such data or information (including batch records) to the extent necessary to produce (or have produced by its consultants) information required by regulatory authorities to obtain regulatory approvals for the Product and/or any medicinal product containing or developed from the Product.
23.1.During the term of the Agreement the Parties shall use the Extranet that enables the Parties to exchange information and ideas related to the respective Work Order in a secure way. The users who use Extranet and contributions, messages, comments and documents (the “Contributions”), have to comply with the terms and conditions described in this Section 23 and bear the responsibility for the Contributions. The access to Contributions shall end with the termination of the respective Work Order. Therefore, Rentschler recommends Customer to save exchanged documents on its own infrastructure.
23.7.Rentschler shall establish a workspace for each Work Order. Rentschler may change the system of the Extranet at its discretion. Rentschler can close the workspace ninety (90) days after the termination of each Work Order.
23.16.Cellca and Leukocare which are strategic partners of Rentschler may come in contact with Confidential Information if they participate in a Work Order. This shall, however, not constitute a breach of confidentiality, provided that Cellca and Leukocare are bound to terms of confidentiality no less stringent than stipulated in the Agreement.
2.1Starting on the Effective Date and continuing through the Term, TGA will perform the Work in accordance with the terms of this Agreement and of the applicable Approved Work Order. Upon signature or written approval of an Approved Work Order by both Parties, the terms of the applicable Approved Work Order, together with the terms of this Agreement, will become a binding contract between the Parties with respect to its subject matter. The Parties intend to memorialize each Work Order using the form attached hereto as Annex 3 (Form of Work Order).
2.Compensation. As compensation for Contractors Services and the discharge of all Contractors obligations hereunder, Client shall pay Contractor fees in the amount and according to the schedule agreed upon by the Parties and as stated in the applicable Work Order. Amounts outlined in the applicable Work Order will not be adjusted without prior written approval of Client through a Change Order. Pass-through expenses exceeding specific amounts that may be set forth in a Work Order will not be adjusted without prior written approval of Client.
3.Expenses. Client shall reimburse Contractor for all reasonable expenses actually incurred by Contractor in performing the Services, including shipping, postage, federal express, supplies, copying and other printing as long as such expenses are reasonable and necessary and are set forth in a Work Order. Contractor shall maintain adequate books and records relating to any expenses to be reimbursed and shall submit requests for reimbursement in a timely manner.
On June 12, 2020, the Company and Pharmsynthez entered into the MSA to advance the development of the Company’s XCART technology for B-cell malignancies. Under the MSA, Pharmsynthez agreed to provide services pursuant to work orders agreed upon by the parties from time to time, which services include, but are not limited to, acting as the Company’s primary contract research organization to assist in managing collaborations with multiple academic institutions in Russia and Belarus. The Company is required to pay reasonable fees, expenses and pass-through costs incurred by Pharmsynthez in providing the services in accordance with a budget and payment terms set forth in each work order. Additionally, in the event that a work order provides for milestone payments, the Company is required to make such payments to Pharmsynthez, or third party service providers designated by Pharmsynthez, in accordance with the terms set forth in the work order, which milestone payments may be made, at the sole discretion of the Company, in cash or shares of the Company’s common stock. The MSA terminated and superseded the SRA between the Company and Pharmsynthez.
The Company and Pharmsynthez executed a work order on June 12, 2020 (the “Work Order”) under the MSA pursuant to which Pharmsynthez agreed to conduct a Stage 1 study of the Company’s XCART technology under the research program as set forth in the Work Order. The activities to be performed under the Work Order are currently expected to take approximately 20 months unless earlier terminated in accordance with the MSA. Under the terms of the Work Order, the Company is required to pay Pharmsynthez $51,000 as an initial payment for trial startup costs, which amount is credited against the amounts paid under the SRA. The Work Order provides for additional pass-through costs to be invoiced by Pharmsynthez upon execution of contracts with third party sites, which will be further credited against the SRA. The total cost under the Work Order is currently estimated to be approximately $1.8 million. Additionally, the Work Order provides for milestone payments of up to an aggregate of $1,050,000, or, in the Company’s sole discretion, up to an aggregate of 1,000,000 shares of the Company’s common stock, to be paid or issued, as applicable, by the Company upon achievement of milestones associated with completion of early stages of the research program as set forth in the Work Order. No costs were incurred under the Work Order during the three and six months ended June 30, 2020, respectively.
1.3Work Orders. The specific details of each project under this Agreement (each “Project” or “Study”) shall be separately negotiated and specified in writing on terms and in a form acceptable to the parties (each such writing, a “Work Order”). A sample Work Order is attached hereto as Exhibit B. Each Work Order will include, as appropriate, the scope of work, timeline, and budget and payment schedule. Each Work Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the relevant Work Order expressly and specifically states an intent to supersede this Agreement on a specific matter. All Work Orders and other exhibits hereto shall be deemed to be incorporated herein by reference. The terms and conditions of this Agreement shall apply to all work performed on each Project, including work performed prior to the effective date of the Project at the request of Sponsor.
1.5Affiliates and CRO Partners. Sponsor agrees that Pharms may use the services of its CRO partners and affiliates (“Subcontractors”) to fulfill Pharms’s obligations under this Agreement or any Work Order and Pharms shall remain responsible for all such Services performed by its Subcontractors. To the extent that Pharms uses the services of its CRO partners or affiliates to fulfill any obligation under this Agreement or any Work Order, Pharms shall provide a copy of any CRO partner or affiliate agreement to Sponsor prior to entry for review and comment and Pharms shall not enter into an agreement with a CRO partner or affiliate without first obtaining Sponsor’s written consent. Sponsor shall also be provided a copy of the final, signed agreement entered into under this Section 1.5 with a CRO partner or affiliate. The terms, conditions and rights in this Agreement shall be incorporated into the Work Order and such affiliate, notwithstanding the foregoing, shall be solely responsible for the performance of the Services under such Work Order. The term “affiliate” shall mean all entities controlling, controlled by or under common control with Pharms or Sponsor, as the case may be. The term “control” shall mean the ability to vote more than fifty percent (50%) of the voting securities of any entity or otherwise having the ability to direct the management and policies of an entity. Any Subcontractors utilized to perform Services will be named in the Work Order.
2.1Project Budget. Sponsor will pay Pharms the reasonable fees, expenses and pass-through costs incurred in providing the Services in accordance with the budget and payment terms contained in each Work Order. Reasonable pass-through costs will be estimated in the budget and Sponsor shall pay the actual costs incurred.
3.5Identification of Work Order. Any written termination notice shall identify the specific Work Order or Work Orders that are being terminated.
8.1General. Pharms agrees that its Services will be conducted in compliance with all applicable laws, rules and regulations and with the standard of care customary in the contract research organization industry. Sponsor agrees that its obligations in connection with the clinical trial will be conducted in compliance with all applicable laws rules and regulation in the clinical trial industry. Pharms’s standard operating procedures will be used in performance of the Services, unless otherwise specifically stated in the applicable Work Order. Pharms certifies that it has not been debarred under the United States Generic Drug Enforcement Act or any applicable law in any other country and that it will not knowingly employ any person or entity that is so debarred to perform any Services under this Agreement. Sponsor further represents that it will cooperate with Pharms in taking any actions that Pharms reasonably believes are necessary to comply with the regulatory obligations that have been transferred to Pharms.
21.0 Project Steering Committee. To facilitate communication between the Parties and the review of the strategic decisions under this Agreement, the Parties shall appoint a Project Steering Committee. The Project Steering Committee shall be comprised of appropriate representatives of both Parties, initially consisting of two (2) representatives from each of Sponsor and Pharms. Each Party shall appoint a Project Steering team leader (and other key contacts, as necessary) to serve as principal Project Steering Committee liaisons for the Parties. Employees of each Party who are not on the Project Steering Committee may attend meetings of the Project Steering Committee, as required to further the efforts set forth in the Work Order. The initial team leader and Party representatives shall be identified in each Work Order that is entered into pursuant to the terms of this Agreement.
4. MANUFACTURE AND SUPPLY PYRAMID will manufacture the Products in strict accordance with the Specifications and the Regulatory Standards. PYRAMID will supply cGMP Grade Product to XERIS in the quantities, on the schedule, and at the price stated in the Work Order. PYRAMID will store all starting materials and in-process products in accordance with cGMP.
6.7.3 It is recognized that all or part of any formulation development and/or analytical development Services may be terminated upon notification from XERIS. It is PYRAMIDS policy to assess a fee for studies terminated after the initiation of its Work Order. The fee will be prorated based upon the stage of completion of the Phase, and in any event PYRAMID will only be paid for Services completed up to the effective date of such termination, 6.8 In the event of default in the payment of Services rendered or expenses incurred by PYRAMID for XERIS, pursuant to this Agreement, XERIS shall be responsible for all collection fees and reasonable expenses incurred by PYRAMID, including attorneys fees.
11. RECORDS 11.1 Unless stated otherwise in the Quality Agreement or the Specifications, PYRAMID will, at its expense, store all testing and quality control records relating to a particular Work Order onsite for [***]; and for a period of [***] offsite following completion of the Work Order. At the end of the [***], XERIS will be notified to determine whether the records may be destroyed, provided to XERIS, or continue to be stored at XERIS request or expense.
12.2 XERIS right of rejection will be exercised by delivery of written notice to PYRAMID in accordance with the procedures set out in the Quality Agreement or Work Order. Any quantities of Product that are rejected pursuant to this section will be returned to PYRAMID at PYRAMIDS expense and either (a)will be promptly replaced by PYRAMID at PYRAMIDS sole cost and expense if requested by XERIS not to exceed the paid amount or (b)PYRAMID will return the fees for that portion of the Services that is determined to be nonconforming or made of limited, nominal, or no value to XERIS due to the said nonconforming portion. PYRAMID will be responsible for the replacement cost of any XERIS Materials rendered unusable by PYRAMIDS failure to comply with its warranty in Section16.
(b)Facility Validation.Atara will be responsible for performing all validation of any Atara Equipment, unless otherwise agreed in any Work Order.Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Agreement (if any), Applicable Law, and in accordance with any other validation procedures established by Atara and agreed to in writing by Manufacturer.
Moreover, the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with the Specifications, cGMP (if applicable) and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Work Order via a Change Order, or to terminate such Work Order.For clarity, whether the parties agree a Batch is non-conforming or if a Batch is determined to be non-conforming pursuant to Section 6.5, in no event will Manufacturer be responsible for [ * ] under clause (A) above or for [ * ] under clause (B) above, if the failure of the Batch to conform is caused by any of the (x) [ * ], (y) [ * ], or (z) [ * ] (except, in each case, to the extent caused by (i) [ * ] or (ii) [ * ]).
14.8Payment Reconciliation.Within [ * ] after the close-out of a Work Order, Manufacturer will provide to Atara a written statement of all work performed by it in connection with the terminated Work Order, breakdownof the costs associated with that work, and a final invoice for that Work Order.[ * ].
Conflict.All terms and conditions of the Agreement will apply to this Work Order. In the event of any conflict between this Work Order and the terms of the Agreement, the terms of the Agreement will control.
1. Work Order. ICONIC shall submit to Zymeworks a work order substantially in the format of the template attached as Appendix A to this Exhibit 3.4.4 at least 5 days prior to the requested delivery date, specifying (a)the quantity of the Lead Linker-Cytotoxin ordered for delivery; (b)the requested delivery date for that order; (c)the requested address of the delivery location; and (d)any special shipping instructions (each a Work Order). A Work Order hereunder shall not be effective unless and until signed by the Parties and delivered to both Parties.
2. Delivery Terms. Zymeworks shall deliver the quantities of the Lead Linker-Cytotoxin set forth in each Work Order EXW (Incoterms 2010) the Facilities designated in such Work Order. Unless otherwise provided in the [ *** ]2, each shipment of the Lead Linker-Cytotoxin supplied hereunder shall be accompanied by [ *** ]3. [ *** ]4. Unless otherwise provided in the [ *** ]5, Zymeworks will provide shipping documentation in each shipment of the Lead Linker-Cytotoxin that will specify the following: (a)the Lead Linker-Cytotoxin name, (b)batch number(s), (c) quantity packed per batch number, (d)Work Order number, (e)seal numbers, and (f)number of pallets, containers, dimensions and weight of pallets and containers, and quantity of the Lead Linker-Cytotoxin per container for each batch.
The terms and conditions set forth in Sections 1 7 of this Exhibit 3.4.4 shall only apply to the first order of Lead Linker-Cytotoxin manufactured and supplied under the License Agreement, as evidenced by a Work Order. Any additional orders of Lead Linker-Cytotoxin under the Agreement shall be subject to the terms and conditions of a mutually agreeable supply agreement which the Parties agree to negotiate in good faith if any such additional orders are required.
The terms and conditions of the Agreement will apply to this Work Order. A portable document format (.pdf) copy of this Work Order, including the signature pages, will be deemed an original.
3.2 Subject to Section3.1, unless otherwise agreed to by Quantum-Si and the Participant in the Services Work Order, all rights, title and interest in and to any inventions, works-of-authorship, idea, data or know-how invented, made, created or developed by the personnel (employees, contractors or consultants) of the party in the course of conducting services for the other party pursuant to a Services Work Order (the “Recipient Participant”) shall be owned by the Recipient Participant (“Created IP”). Each Originating Participant (defined below) hereby makes any assignments necessary to accomplish the foregoing ownership provision, and agrees to execute any documents reasonably requested by the Recipient Participant to further effect or provide evidence of such assignment. Each party agrees that it has and will have appropriate agreements with all of its personnel to fully effect the provisions of this Section3.2. Unless otherwise agreed to by Quantum-Si and the Participant in the Services Work Order, each Recipient Participant hereby grants to the party that had its personnel provide the services that resulted in the creation of the Created IP (the “Originating Participant”) a royalty-free, perpetual, limited, worldwide, non-exclusive, sublicensable (and with respect to software, sublicensable in object code only) license to utilize the Created IP only in the core business field of the Originating Participant, including the license to create and use derivative works based on the Created IP in the Originating Participant’s core business field, subject to any restrictions as may be set forth in this Agreement and the applicable Services Work Order. Notwithstanding the foregoing, Quantum-Si and each Participant agree that no Recipient Participant will use Created IP to compete directly or indirectly in the core business area of the Originating Participant.
2.1 Services and Work Orders. From time to time, Rhythm may wish to engage Manufacturer to perform Services for Rhythm. Such Services will be set forth in a Work Order. Each Work Order will be appended to this Agreement, will include the material terms for the project, and may include the scope of work, specified Services, Specifications, deliverables, timelines, milestones (if any), quantity, budget, payment schedule and such other details and special arrangements as are agreed to by the parties with respect to the activities to be performed under such Work Order. No Work Order will be effective unless and until it has been agreed to and signed by authorized representatives of both parties. Documents relating to the relevant project, including without limitation Specifications, proposals, quotations and any other relevant documentation, will only be effective if attached to the applicable Work Order and incorporated in the Work Order by reference. Each fully signed Work Order will be subject to the terms of this Agreement and will be incorporated herein and form part of this Agreement. Manufacturer will perform the Services specified in each fully signed Work Order, as amended by any applicable Change Order(s), and in accordance with the terms and conditions of such Work Order and this Agreement. Notwithstanding the foregoing, nothing in this Agreement will obligate either party to enter into any Work Order under this Agreement.
3.1 Representatives. Each party will appoint a representative having primary responsibility for day-to-day interactions with the other party for the Services (each, a Representative), who will be identified in the applicable Work Order. Each party may change its Representative by providing written notice to the other party in accordance with Section15.3; provided that Manufacturer will use reasonable efforts to provide Rhythm with at least forty-five (45) days prior written notice of any change in its Representative for the Services. Except for notices or communications required or permitted under this Agreement, which will be subject to Section15.3, or unless otherwise mutually agreed by the parties in writing, all communications between Manufacturer and Rhythm regarding the conduct of the Services pursuant to such Work Order will be addressed to or routed directly through the parties respective Representatives.
(a) Records. Manufacturer will keep complete and accurate records (including, without limitation, reports, accounts, notes, data, and records of all information and results obtained from performance of Services) of all work done by it under this Agreement, in form and substance as specified in the applicable Work Order, the applicable Quality Agreement, and this Agreement (collectively, the Records). All such Records will be the property of Rhythm. Manufacturer will not transfer, deliver or otherwise provide any such Records to any party other than Rhythm, without the prior written approval of Rhythm. Records will be available at reasonable times for inspection, examination and copying by or on behalf of Rhythm All original Records of the Development and Manufacture of Product under this Agreement will be retained and archived by Manufacturer in accordance with cGMP (if applicable) and Applicable Law, but in no case for less than a period of five (5)years following completion of the applicable Work Order. Upon Rhythms request, Manufacturer will promptly provide Rhythm with copies of such Records. Five (5)years after completion of a Work Order, all of the aforementioned records will be sent to Rhythm or Rhythms designee; provided, however, that Rhythm may elect to have such records retained in Manufacturers archives for an additional period of time at a reasonable charge to Rhythm.
7. Shipping and Delivery. Manufacturer agrees not to ship Product to Rhythm or its designee until it has received a written approval from Rhythm or Rhythms designee to release and ship. Manufacturer will ensure that each Batch will be delivered to Rhythm or Rhythms designee, (a)on the delivery date and to the destination designated by Rhythm in writing, and (b)in accordance with the instructions for shipping and packaging specified by Rhythm in the applicable Work Order or as otherwise agreed to by the parties in writing. Delivery terms will be FCA (Incoterms 2000), or as specified in the applicable Work Order. A bill of lading will be furnished to Rhythm with respect to each shipment.
14.7 Payment Reconciliation. Within thirty (30) days after the close-out of a Work Order, Manufacturer will provide to Rhythm a written itemized statement of all work performed by it in connection with the terminated Work Order, an itemized breakdown of the costs associated with that work, and a final invoice for that Work Order. If Rhythm has pre-paid to Manufacturer more than the amount in a final invoice then Manufacturer agrees to promptly refund that money to Rhythm, or to credit the excess payment toward another existing or future Work Order, at the election of Rhythm.
4.1 Supply of Materials. Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a)to account for all Rhythm Materials, (b)not to provide Rhythm Materials to any third party without the express prior written consent of Rhythm, (c)not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required pursuant to a signed Work Order, and (d)to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythms written directions.
(c) Rhythm agrees to pay to Manufacturer the applicable fees and success milestone payment set forth in the Revised Milestone Schedule within [***] ([***]) days of the successful completion of each milestone as set forth in Appendix B1. The successful completion of each milestone, as defined by the associated deliverable, and the determination of the date of completion shall be governed by the terms of the Agreement and the Quality Agreement, and in particular Section 6 of the Agreement (Testing and Acceptance Process), which – to the extent the respective Work Order covers the performance of Services which do not comprise Manufacturing of Setmelanotide API – may be applied mutatis mutandis for those Service deliverables as may be further described in the respective Work Order. The quality of the Setmelanotide API shall be in accordance with the respective mutually agreed specifications including all intermediate specifications. Due to the nature of the timelines, Rhythm acknowledges that Manufacturer has to timely initiate performance of certain milestones even before preceding milestones are met. Thus, the commencement of a milestone may be independent of the completion of the preceding milestone, and each successfully completed milestone shall be paid for separately.
2.1Work Order. Each Work Order will specify the basic parameters of a Study, including, without limitation, the scope of work, Study-specific assumptions, estimated time period for completing Services, estimated budget, payment and currency schedules, resource allocation and/or, as applicable, other specific Services to be performed by INC Research. Each Work Order is hereby incorporated herein by reference, subject to mutually agreeable Change Orders.
The major Study milestones and target dates will be described in the applicable Work Order. Subject to mutually agreed Change Order(s), both Parties agree that the Work Order shall set forth a reasonable schedule for the Services to be performed, and each Party will use Commercially Reasonable Efforts to comply with the timelines stated therein.
The transfer of obligations and/or responsibilities from Sponsor to INC Research pursuant to Applicable Laws and Regulations will be mutually agreed and set forth in each individual Work Order. Any such regulatory responsibilities not specifically transferred to INC Research shall remain the regulatory responsibility of Sponsor. Under no circumstance shall INC Research be required to accept responsibilities and conduct itself contrary to Applicable Laws and Regulations.
As set forth in a Work Order, INC Research may negotiate the Investigator grants, and/or Site Clinical Trial Agreement terms and/or other Study-related agreements on behalf of Sponsor and at Sponsor’s direction. Sponsor shall be obligated to provide timely feedback in connection with any such negotiations, and INC Research shall not be responsible for any undue delays attributable to Sponsor’s failure to provide approvals and timely responses, if Sponsor was properly and promptly notified by INC Research of the need for a timely response. The initial Investigator grant payment shall be set forth in the Work Order as applicable. As the Study progresses, such initial grant payment will be applied to Investigator grant fees and other approved Site fees, including payments for screening failures and non-complete subjects, all as estimated in the applicable Work Order. INC Research will invoice Sponsor in accordance with each applicable Work Order in a manner that will enable INC Research to make timely payments to the Investigator or Site in accordance with the applicable Clinical Trial Agreement, unless Sponsor has agreed to make payments directly to the Site or Investigator. Said fees shall be paid in advance of INC Research’s expectation to pay the Investigator and/or Site, and Sponsor shall be responsible for any adverse action taken by an Investigator or Site as a result of Sponsor’s failure to pay amounts and other costs due and payable in a timely manner. INC Research shall have no liability for any failure to make payments if required funding is not provided to INC Research by Sponsor in advance. Each Clinical Trial Agreement with Investigators shall contain a statement to that effect. INC Research shall have no duty to pursue collection of allegedly unearned fees paid to Investigators and/or Sites.
4.6Currency. Unless otherwise agreed in the applicable Work Order, Sponsor shall make all payments to INC Research in United States dollars (“US Currency”), and accordingly INC Research shall invoice Sponsor for all Direct Costs and Pass Through Costs in US Currency. If Direct Costs are incurred in a currency other than US Currency, then INC Research and Sponsor will define the mechanism for currency exchange adjustment in the Work Order. If Pass Through Costs are incurred in a currency differing from US Currency, then INC Research shall invoice Sponsor using the exchange rate published in oanda.com at the average bid rate on the day the expense invoice is generated by INC Research.
5.3Termination Obligations. Upon receipt of a termination notice, the Parties will promptly meet and agree upon any winding down activities and associated costs for any Study prior to the performance of any additional tasks not otherwise addressed in a Work Order. Costs associated with any winding down period will be invoiced to Sponsor on fee for service basis using the rates in effect as of the termination date unless otherwise agreed upon by the Parties. If the Study is suspended or terminated, no further Study subjects shall be enrolled, however, routine follow-up actions needed to monitor the safety of Study Subjects shall continue subject to Section 5.4.
INC Research will not retain any regulatory responsibility for the Study Records and will not store Sponsor’s Study Records on its premises on Sponsor’s behalf after the termination or expiration of the Work Order. The Parties may mutually agree to extend Services related to the Study Records in a Change Order, or in a separate agreement, that details the terms for the extended retention period and compensation for such retention. In the event that Sponsor is unable or refuses to accept the return of the Study Records for any reason, INC Research may elect to dispose of any Study Records according to its policies and in a confidential manner unless otherwise prohibited by Applicable Laws and Regulations. INC Research will demonstrate due diligence in contacting Sponsor to provide notification of the intention to dispose of Study Records at least ninety (90) days prior to disposition.
10.2 Company shall have full power to reject any part of the Work that is considered to be defective, or inferior in quality of materials, workmanship, or design and/or not in accordance with the requirements of the Agreement or Work Order. Contractor shall immediately correct, re-perform or replace rejected part or whole of the Work at no cost to Company.
13.2 Company shall have the right to withhold income or other tax from payments due to Contractor under this Agreement or a Work Order to the extent that the pertinent taxation authorities may require such withholding. Unless otherwise provided to the contrary a Work Order, such taxes are deemed to be included in the rates and fees and Contractor bears full and complete responsibility for any and all taxes levied or assessed on the agreed upon rates and fees unless otherwise required by the Production Sharing Contract or by local laws. Should Company withhold any income or other taxes for the account of Contractor on payments otherwise due to Contractor under this Agreement or a Work Order, Company shall provide Contractor with receipts evidencing payments to the pertinent tax authorities of the taxes or amounts so withheld. Such receipts are to be in the form generally acceptable by the pertinent tax authorities in their allowance of an offset of income taxes, which may otherwise be owed by Contractor with respect to the performance of this Agreement or Work Order. All tax receipts are to be provided in due time to the Contractor after the Company has withheld such income taxes from payment otherwise due to Contractor.
13.5 If applicable, Contractor shall comply with all applicable customs requirements and procedures and shall be responsible for obtaining customs clearance for the importation, exportation or re-exportation of Contractor product and Equipment to or from the country of origin, including spare parts, supplies and belongings of Contractors Personnel. With respect to such procedures, Contractor shall prepare, issue and submit the documents required in due time to customs authority and/or to Company, as the latter may so instruct. Contractor shall contact Company to determine import procedures regarding equipment, supplies, materials, consumables and spare parts intended to be incorporated for the performance of the Work and/or intended to become property of Company within the framework of the applicable Work Order. In any instance that Contractor fails to follow Company instructions or procedures, or otherwise fails to comply with all applicable customs requirements and procedures, Contractor shall defend, indemnify and hold Company harmless from the consequences of any such failures, including any errors or omissions in documents prepared and/or submitted by Contractor, resulting in failure of customs authorities to provide timely authorizations. Company shall bear, at its sole cost and expense, all assessments and charges for customs duties, and other similar import or export/re-export charges imposed on Contractor for Product and Equipment, including spare parts and supplies, but only to the extent imported or exported/re-exported solely due to the Work (i.e., materials etc. already in-country and used for the Work shall not be covered by this sentence). Contractor shall bear at its sole cost, risk and expense port dues, brokerage fees, other administrative charges, and all assessments and charges for the belongings of Contractors Personnel.
15.2 In the event of cancellation or termination of any Work Order, however arising, Company shall promptly return to Contractor all Contractor Equipment which is in Companys possession or under its control under such terminated Work Order. Company shall pay Contractor for all Contractor Equipment and services provided in accordance with this Agreement and the applicable Work Order and any reasonable documented costs that Contractor incurs as a result of such termination.
17.1 Company, at its sole option, may at any time and from time to time (including, without limitation during a Force Majeure Event asserted by Company) suspend the performance of all or part of the Work by giving fifteen (15) days written notice to Contractor. Such suspension shall not in any way invalidate this Agreement or any Work Order. Contractor shall use its best efforts to minimize and mitigate costs associated with such suspension.
17.5 Without prejudice to Contractors other rights under this Agreement, Contractor shall have the right to suspend the Contract where Company is in breach of the payment terms of the Contract and remains in breach of such terms ten (10)days following notice by Contractor of such breach. Company will be responsible for reasonable documented costs and liabilities incurred by Contractor during and due to the suspension, including any stand by rates as set forth in the Work Order. Operation will be resumed when breach has been corrected by Company.
17.6 During any period of Suspension of the Work, Contractor shall be compensated at the standby rate agreed in the applicable Work Order. After twenty-one (21) days of consecutive suspension, Contractor shall have the right to terminate the applicable Work Order and receive full compensation for all Work done including any mobilization, demobilization and other reasonable and documented costs due.
17.7 Contractor may terminate the Work Order without penalty if suspension continues for more than sixty (60) days provided Company is unwilling to continue to pay stand-by rates. Company will reimburse Contractor for demobilization, remobilization and direct costs reasonably incurred by Contractor by reason of Companys suspension of the Work. Stand-by rates are the rates identified as such in the Work Order. Company will grant no compensation or extension of time for any suspension that might result from an action or default caused by Contractor.
28.1 In connection with performance of the Work, Contractor warrants that it will perform all such Work in a good and workmanlike manner. It is specifically understood that all Work will be rendered subject to all the terms and conditions of this Agreement and the Work Order. Contractor shall utilize only Personnel who by education, training and experience are suited to competently perform their intended functions. If Contractor fails to perform the Work in a competent manner in accordance with the Agreement, Contractor will correct the specific errors or omissions regarding the Work that are notified to Contractor in writing within thirty (30) days after the Work is completed or before demobilization from the Worksite, whichever is earlier. Contractor will give Company the benefit of its best judgment based on its experience interpreting information and making written or oral recommendations concerning logs or tests or other data, type or amount of material or service required, manner of performance or predicting results.
28.2 All goods furnished or sold by the Contractor shall be of the best quality for their purposes and in accordance with applicable specifications and other provisions of this Agreement and the Work Order. Contractor represents and warrants that such goods shall be free from defects in material and workmanship for a period of twelve (12) months from the date of installation or eighteen (18) months from the date of shipment, whichever occurs first. Without limiting any other remedy Company may have at law, in equity or under this Agreement, Contractor agrees to remove, replace, remedy and correct, as applicable, promptly and at no cost to Company, the specific goods that are unsuitable, defective or not in compliance with applicable specifications under the Work Order, provided Contractor has access to the goods during the applicable warranty periods specified in this article above or the performance or refund of an equitable portion of the purchase price of the Work, at Companys sole option. A Company claim made pursuant to these warranties shall be made immediately upon discovery and confirmed in writing within thirty (30) days after discovery of the defect. Defective goods must be held for inspection and returned to Contractor point upon request and as agreed by Company. Contractor shall have the right to inspect the goods claimed to be defective and shall have the right to determine the cause of such defect. Returned goods shall become the property of Contractor.
times be responsible for the compliance of its permitted subcontractors with the terms and conditions of this Agreement and the applicable Work Order. However, Provider shall have no responsibility for the acts or omission of any subcontractors that Synthorx requires Provider to use for subcontracted Services.
3.2Invoices; Payment. Unless otherwise agreed by the parties in writing, Provider shall provide to Synthorx for each Work Order one or more separate invoices (to be delivered at intervals specified in such Work Order), such invoice summarizing the Services performed during that period of time under that Work Order and the fees and costs therefor. Synthorx shall pay each invoice within [ *** ] of receipt thereof, in accordance with the applicable schedule of payments specified in such Work Order. Late payments are subject to an interest charge of [ *** ]% per month on the outstanding balance. Providers failure to bill for interest due shall not be a waiver of Providers right to charge interest. Synthorx shall not be obligated to pay any amounts in excess of the fixed fee, budget or other payments (as applicable) specified in a Work Order that have not been approved in writing by Synthorx in advance.
(e)Dispute Regarding Batch. In case of any disagreement between the parties as to whether a Batch conforms to the relevant Work Order or cGMP (if applicable) Synthorx shall notify Provider in writing, including a detailed explanation of the non-conformity. The quality assurance representatives of the Parties will attempt in good faith to resolve any such disagreement and Synthorx and Provider will follow their respective standard operating procedures to determine the conformity of the Batch to the Work Order and cGMP (if applicable). If the foregoing discussions do not resolve the disagreement in a reasonable time (which must not exceed [ *** ]), a representative sample of such Batch and/or relevant documentation will be submitted to an independent testing laboratory (in the case of an alleged failure to conform to the relevant Work Order) and/or independent cGMP consultant (in the case of an alleged failure to comply with cGMP), mutually agreed upon by the parties, for tests and final determination of whether the Batch conforms with such Work Order and/or cGMP (if applicable). The laboratory and retesting of the Batch must comply with cGMP (if applicable). The laboratory or consultant, as applicable, must be of recognized standing in the industry. Neither party may unreasonably withhold consent to the appointment of such laboratory and consultant. Such laboratory will use the test methods contained in the relevant Work Order. The determination of conformance by such laboratory and/or cGMP consultant, as applicable, with respect to all or part of such Batch will be final and binding on the parties absent manifest error. The fees and expenses of the laboratory and/or consultant, as applicable, incurred in making such determination shall be paid by the party against whom the determination is made.
4.1Direct Cost Compensation. In exchange for valuable consideration with regard to INC Research’s performance of the Services hereunder, Sponsor shall pay INC Research for Direct Costs in accordance with a detailed budget as described in each applicable Work Order. Unless otherwise agreed to in the requisite Work Order, INC Research may submit, at its discretion, at a minimum, monthly invoices or other substantiating internal documentation to Sponsor for timely payment in accordance with this Section 4.
4.3Invoicing. Sponsor shall render all payments due and payable to INC Research within forty-five (45) days of the receipt of an invoice. Sponsor further agrees to reasonably consider payments schedules within each Work Order to allow INC Research to maintain cash neutrality by invoicing in advance as stipulated in the Work Order. Sponsor shall pay INC Research interest in an amount equal to one and one-half percent (1 ½%) (or such maximum lesser amount allowed by Applicable Laws and Regulations) per month with regard to all undisputed amounts past due and payable. Sponsor shall also reimburse INC Research for all costs incurred in collecting any late payments, including, without limitation, attorneys’ fees.
5.3Termination Obligations. Upon receipt of a termination notice, the Parties will promptly meet and agree upon any winding down activities and associated costs for any Study prior to the performance of any additional tasks not otherwise addressed in a Work Order. Costs associated with any winding down period will be invoiced to Sponsor on fee for service basis using the rates in effect as of the termination date unless otherwise agreed upon by the Parties.
1.6FCPA. In performing the Services, Consultant will comply with all applicable laws and regulations applicable to its operations, including, but not limited to, the U.S. Foreign Corrupt Practices Act. Consultant further agrees that, if applicable, it will educate its directors, officers, employees, agents, contractors and consultants engaged in providing Services to Ironwood hereunder in relation to such legislation. Consultant agrees not to pay, offer or promise to pay, or authorize the payment directly or indirectly of any monies or anything of value to any government official or employee, or any political party or candidate for political office, for the purpose of influencing any act or decision of the government in connection with the activities of Consultant under the Work Order.Consultant warrants that no officer, director, partner, owner, principal, employee or agent of Consultant is an official or employee of a governmental agency or instrumentality or a government owned company in a position to influence action or a decision regarding the activities of Consultant contemplated under the Work Order.
2.1Purpose; Work Order; Quality Agreement. All Services to be performed by KindredBio under this Agreement shall be set forth in a Work Order mutually agreed to in writing by the Parties. Each Work Order shall expressly reference this Agreement and, upon execution by both Parties, this Agreement shall be incorporated into such Work Order by this reference and made a part of such Work Order. To the extent of any conflict between a Work Order and this Agreement, this Agreement shall control, except to the extent such Work Order specifically states that such Work Order controls with respect to the conflicting provisions. No Work Order shall be deemed to amend this Agreement. Each Work Order shall be agreed upon by the Parties on a project-by-project basis, with no required minimum or maximum number of Work Orders. This Agreement and the Quality Agreement (as defined below), together with each WO (including any attachments or schedules thereto), but separate and apart from any other WO, shall constitute the entire agreement between the Parties for the performance of Services defined in such WO. Upon or around the execution of this Agreement, the Parties will execute a mutually acceptable quality agreement (“Quality Agreement”), which will allocate to each Party the roles and responsibilities with respect to quality control and regulatory compliance as they apply to the Services provided by KindredBio to Vaxart under each Work Order. This Agreement shall be incorporated into the Quality Agreement by this reference and made a part of the Quality Agreement. To the extent of any conflict between the Quality Agreement and this Agreement, the Quality Agreement shall control with respect to quality-related matters, and this Agreement shall control with respect to all other matters. The Quality Agreement shall not be deemed to amend this Agreement.
Such compensation will be paid in installments. 20% of the costs listed above are due upon signing of this Work Order. The remaining payments are due upon completion of the Services and delivery of the resulting material. RADIUS and Manufacturer must agree in advance of either party making any change in the compensation due hereunder. Manufacturer will invoice RADIUS to the attention of Nick Harvey, SVP and CFO, for Services rendered under this Agreement. Manufacturer will invoice RADIUS for all amounts due under this Work Order. All undisputed payments will be made by RADIUS within thirty (30) days of receipt of invoice.
Such work will be performed in accordance with Exhibits A and B of this Work Order plus such additional requirements as discussed below. The Services are identified in terms of a particular numbered activity (each, an Activity). All Services under this Work Order, including Manufacture of any Batches, will be conducted in compliance with standards suitable for an NDA filing by RADIUS. All Batches will be Manufactured in compliance with cGMP, will conform to Specifications provided to Manufacturer prior to commencement of the applicable Batch, and the other requirements of the Agreement and this Work Order. Except for Activities 1 and 6, Manufacturer will not proceed to a subsequent numbered Activity until it provides a report to RADIUS with the status of and results of the prior numbered Activity and RADIUS provides Manufacturer with written authorization to proceed to the next Activity.
Sponsor shall compensate Study Site for the work performed under each Study pursuant to the terms set forth in Article 4 of the Collaboration Agreement (Research Support) and the approved Work Order. To the extent that the discounted pricing set forth in Exhibit C of the Collaboration Agreement is different from the pricing agreed to by the Parties in an approved Work Order, the Work Order pricing will control. Each Work Order shall further specify the schedule for any payments and the amounts applicable to the Study. The Investigator shall not personally receive any remuneration by Sponsor under this Agreement.
I confirm that I have received a copy of the Agreement under which this Work Order is issued, and that I have read and understand the Agreement and this Work Order. I further agree to ensure that any subinvestigators and research staff and all collaborating physicians who are assisting in the conduct of the Study are informed of their obligations under the Agreement and this Work Order.
1.43 “Work Order.” The term “Work Order” shall mean the Parties’ agreement on specific Services and Deliverables based on a proposal of SOLMIC in accordance with the template attached as Exhibit 1.43 to this Agreement, whereas each Work Order shall define amongst other things, and only to the extent applicable, (a) the scope and nature of Services (including the applicable conditions, e.g. cGMP, research laboratory or non-cGMP conditions), (b) a description of any Deliverables, (c) the quantity and quality of Materials required for the Services, (d) a research plan or, as applicable, development plan, including methods and timelines in which the Services shall be performed, (e) Specifications, (f) budget for expenses (including costs for consumables) and (g) fees and payment schedule.
2.1 Work Order. The precise Services to be performed by SOLMIC shall be mutually agreed upon by the Parties and set forth in one or more Work Orders. Each Work Order shall be signed by an authorized representative of each Party and shall include detailed information concerning a given project, including a description of the specific Services to be provided, project milestones and target completion dates, a detailed budget, and a schedule of payments. Upon PIVOT’s acceptance of a Work Order proposed by SOLMIC, and pursuant to the terms and conditions of this Agreement, SOLMIC shall perform the Services for PIVOT.
2.8 Material. To enable SOLMIC to start and continue the Services in accordance with the timelines of the Work Order, PIVOT shall provide to SOLMIC in due time as agreed in a Work Order (or if no timeline is agreed therein, promptly upon SOLMIC’s confirmation of a Work Order) the documents, materials and information necessary for performance of the Services in a form and quantity agreed in the Work Order (“Material”), including, for example, the PIVOT API. Material shall be provided by PIVOT free of charge or, if SOLMIC acquires Material on behalf of PIVOT pursuant to the Parties’ agreement in a Work Order, PIVOT shall reimburse SOLMIC for Material purchased by SOLMIC. PIVOT is solely responsible for the suitability and quality of any Material, independent of whether such Material was provided by it to SOLMIC or whether such Material was acquired by SOLMIC on behalf of PIVOT. All Material shall be delivered DDP (Incoterms, 2010) SOLMIC’s designated facility upon SOLMIC’s prior confirmation of the delivery date. PIVOT represents and warrants that none of the Material is of a “dangerous or hazardous nature” or contains substances of that nature and that Material shall be in conformity with the Specifications for such Material agreed in the Work Order. PIVOT shall notify SOLMIC of Material of a dangerous or hazardous nature and SOLMIC shall have the right to refuse to provide the Services associated therewith. Any additional costs resulting from the handling of dangerous or hazardous Material shall be borne by PIVOT. SOLMIC may, to a reasonable extent, request additional quantities of Material during the performance of the Services.
3.1 Time, Place. Unless otherwise specified in the Work Order, Deliverables shall be delivered EXW (Incoterms, 2010) SOLMIC’s facility to PIVOT within ten (10) business days of the due dates outlined in the Work Order. Title and risk of loss and damage of any Deliverable shall pass to PIVOT accordingly upon PIVOT’s receipt of a delivery notification of SOLMIC. All Deliverables shall be appropriately packaged by SOLMIC, at PIVOT’s expense, for safe shipment, and, if applicable for a given Deliverable and specified in the Work Order, shall be accompanied by a Certificate of Analysis.
7.1 Service Fee. In consideration of the Services provided by SOLMIC pursuant to the Work Order, PIVOT shall pay SOLMIC the agreed service fees in accordance with the payment schedule agreed in the Work Order. Solmic will be the exclusive service provider for the formulation and clinical development.
(c)Rhythm agrees to fund [***] FTEs (as defined below) to be employed by Manufacturer with adequate skills and experience to undertake all tasks associated with the Setmelanotide Work Order.Each of the FTEs shall be dedicated to the Setmelanotide Work Order or other Services agreed upon by Rhythm and shall be fully supported by other site functions and staff of Manufacturer to complete the program.Manufacturer shall invoice Rhythm on a monthly basis commencing on [***]for the FTEs in an amount not to exceed [***] ([***]) per month.In addition, Manufacturer shall invoice Rhythm on or after [***]for a one-time FTE administrative fee in the amount of [***] ([***]). “FTE” means a full-time employee or equivalent individual having the appropriate skill and experience to conduct the specified activity and who is dedicated to the conduct of the specified activity a total of at least [***] ([***]) hours per week.
(A) The Parties will follow the Change Control Procedure as set out in Exhibit B of this Agreement for Changes (as defined in Exhibit B) to this Agreement or any Work Order. Customer will follow the Change Control Procedure as set out in this Agreement for any request for a change to the Services or a change to Product specifications. Customer will follow the Change Control Procedure as set out in Exhibit B (Governance) for change requests required to Product specifications due to an applicable change of Applicable Laws during the term of this Agreement.
4.2 Purchase Volume. Customer agrees to collaborate with Supplier, and Supplier agrees to manufacture and deliver EVs to Customer as agreed to in separate Purchase Orders as specified below. Supplier agrees to maintain capacity to manufacture and deliver EVs to support the indicative Production Forecast in Section4.3. All purchases and deliveries of EVs shall be made pursuant to separate Purchase Orders issued by Customer/its Affiliates and accepted by Supplier/its Affiliates under this Work Order. The actual amount of EVs ordered by Customer is subject to the Customers sole discretion. In determining the amount of EVs that Customer may purchase, Customer may consider a variety of considerations including but not limited to operational needs, network design, capital constraints, underlying business case, changes to vehicle landscape, and shifts in regulatory conditions for like or similar products. All commercial orders are subject to the completion of a definitive and signed Purchase Order as per the proforma order in Exhibit D. In the event that the EVs ordered by Customer during a calendar year fall below the signed Purchase Order (the Purchase Commitment) for that build wave, Customer shall pay Supplier a compensation (calculated in accordance with the formula below) for failing to meet the Purchase Commitment (the Compensation). In the event that Arrival is able to reuse components and other materials (Reusable Costs) purchased to support build then Arrival will reduce the Compensation by the amount of Reusable Costs. This will be applied on a per vehicle model basis. Supplier shall invoice Customer for the Compensation for the applicable calendar year in the fourth calendar of that calendar year and Customer shall pay such invoice within 30 days from the date of invoice. The Compensation will only apply to orders executed by both parties in the form of an Exhibit D where the reason for failing to meet the Purchase Commitment is not a result of the Suppliers actions.
As a “master” form of contract, this Agreement allows the parties to contract for multiple, distinct and discrete elements of the Services, which will be specified in a written work order describing the Services to be performed by Contractor (each, a “Work Order”). Each Work Order will specify the particular Services to be performed under that Work Order and the items, documents, systems or reports to be delivered by Contractor to CPP in connection with that Work Order (each item, document, system or report a “Deliverable,” and, collectively, the “Deliverables”), and the content, design or performance requirements for each Deliverable (the “Specifications”). At those times as CPP desires Contractor to perform particular Services, CPP will issue a Work Order in the form attached hereto as ExhibitA. Upon execution by each party’s Party Representative (as defined below), each Work Order will be incorporated in, and made an integral part of, this Agreement, and the Services provided under that Work Order will be subject to, and governed by, this Agreement. If the Services are performed in connection with CPP’s conduct of the Study, the specific obligations transferred by CPP to Contractor as a designated contract research organization under 21 C.F.R. Part 312.52 for purposes of the Study will be set forth and identified as such in the applicable Work Order. Notwithstanding anything in this Agreement, CPP and Contractor acknowledge and agree that Contractor is developing independently a software as a service platform called “onevoice,” which is not subject to the terms of this Agreement as a Deliverable.
SECTION 2.3. Deliverables. Contractor must present and deliver to CPP the Deliverables according to each Work Order. Upon receipt of each Deliverable, CPP will have ten business days to review and examine that Deliverable (the “Deliverable Acceptance Period”). On or before the expiration of the Deliverable Acceptance Period, CPP must provide Contractor written notice if CPP determines that any Deliverable is not acceptable. That written notice must be accompanied by a reasonably detailed statement specifying the basis for rejection. If CPP does not deliver Contractor written notice that CPP has rejected that Deliverable on or before the expiration of the applicable Deliverable Acceptance Period, then CPP will be deemed to have accepted that Deliverable. If CPP timely rejects that Deliverable, Contractor must modify, supplement, enhance or replace that Deliverable to address the bases for rejection of that Deliverable and deliver it, as modified, supplemented, enhanced or replaced as promptly as possible and, in any event, within the time period specified for delivery in the Work Order or in CPP’s notice of non-acceptance or such other period as may otherwise be mutually agreed to in writing by CPP and Contractor. If CPP rejects the modified Deliverable, then that Deliverable will be deemed finally rejected, and CPP will have no obligation to pay any fees or make any payments remaining outstanding for the Services rendered under a Work Order pertaining to that Deliverable. CPP must act in good faith in determining whether to reject any Deliverable, and Contractor must act in good faith in making any modification, supplementation, enhancement or replacement of a rejected Deliverable.
SECTION 3.2. Taxes. The invoiced amounts specified in each Work Order include all taxes, including sales tax, excise tax, value added tax, goods and services tax, consumption tax, business tax, and similar taxes, unless expressly provided for in that Work Order. CPP has no obligation to pay any additional taxes or other charges not expressly specified in the applicable Work Order. Each party is responsible for all taxes imposed on its income, assets or capital.
Provider and Company shall execute a copy of each mutually acceptable Work Order.In the event of a conflict between the terms contained in any Work Order and this Agreement, the terms of this Agreement shall control, unless specifically agreed upon to the contrary in the Work Order.No obligation shall be incurred by either party unless a Work Order has been executed by the authorized agents of both parties.
Work Order.This document constitutes a “Work Order” under the Agreement and this Work Order and the services contemplated herein are subject in all respects to the terms and provisions of the Agreement.
(f) New Services. *************************************************** unless otherwise set forth in the Work Order. Company acknowledges that any bids for any new Services must be competitive.
1.1 Products and Services; Orders. Manufacturer will provide the goods and services identified in each Order issued pursuant to this Agreement (such goods, Products; such services, Services). Order means either a statement of work executed by Manufacturer and Purchaser (Work Order) or a purchase order delivered by Purchaser and accepted by Manufacturer (along with accompanying purchase details, a Purchase Order). The initial Work Order is attached as Addendum B to this Agreement. Any additional Work Orders entered into hereunder will be in substantially the same form as the initial Work Order. A Work Order shall be binding on both Parties only after it is signed by both Parties. Unless a different acceptance process is specified in a Work Order, then a Purchase Order is deemed to have been accepted and therefore binding on both Parties if Manufacturer: (a)signs and returns it to Purchaser; (b)begins performance; or (c)acknowledges acceptance in writing by e-mail, facsimile, or any other commercially reasonable means.
(D) In the event of a delay in delivery that is not an Excusable Delay, and without limiting Purchasers right receive any applicable delay credits as set forth in the applicable Work Order, Purchaser may, at Purchasers option, terminate the portion of the affected Order relating to Products that are delayed at no charge and without liability if the Product has not been delivered within (x)ninety (90) days after its Delivery Date, if the Product is a truck or tractor (e.g., the BEVs contemplated to be purchased pursuant to the initial Work Order); or (y)thirty (30) days after its Delivery Date, for any other Product and except as otherwise set forth in the applicable Work Order. For clarity, if any delay credits have accrued or have been received by Purchaser and Purchaser elects to terminate any portion of an affected Order, such delay credits remain payable (if not yet paid) and nonrefundable (i.e., not required to be repaid to Manufacturer concurrently with or following the termination).
(A) General. In the event that the applicable Work Order does not include a performance or product warranty provision for a Product (e.g., such as the product warranty provision for BEVs contained in Section4.4 of the initial Work Order or the product warranties for Parts described in Sections 4.3 and 4.4 of the initial Work Order), the performance warranties contained in this Section4.2(A) will apply to each Product in that Work Order. Manufacturer represents, warrants, and covenants to Purchaser that, beginning at the time of delivery of each Product covered by this Section4.2(A) and continuing for [***] following acceptance: (i)the Products will be free from defects in design, materials, and workmanship; and (ii)the Products will conform to the specifications provided by Manufacturer to Purchaser for the Products and Services (the warranties contained in the applicable Work Order or the warranties referenced in this Section4.2(A), the Product Warranties). Notwithstanding the foregoing, Manufacturer will not be deemed to be in breach of the Product Warranty set forth in this Section4.2(A) to the extent that any defect or non-conformance is caused by use of the Product for purposes other than those for which it was designed (including unauthorized attachments or modifications) or any failure to operate and maintain the Product in accordance with applicable Law or Manufacturers standard maintenance procedures communicated to Purchaser, or the use of the Products in an abusive manner, or as otherwise set forth as exclusions in the applicable Product Warranties.
(B) Manufacturer may subcontract or delegate any of its obligations under this Agreement to any subcontractors or delegates (Subcontractors) or Dealers without Purchasers prior written consent, provided that Manufacturer will be responsible for the full performance of its obligations under this Agreement and for its Subcontractor(s) and Dealers acts or omissions in connection with this Agreement. Manufacturers right to subcontract or delegate any of its obligations under this Agreement is subject to Amazons prior and continuing approval of any and all Subcontractors; provided, however, that if Amazon does not continue to approve a Subcontractor that was previously approved by Amazon, Manufacturer will have a commercially reasonable time period to either insource those duties that were subcontracted or find a replacement Subcontractor that is approved by Amazon. A list of pre-approved Subcontractors and the activities they may perform will be attached to the applicable Work Order. For clarity, the Parties acknowledge and agree that upstream suppliers of parts, components and services to Manufacturer and any Personnel or Affiliates of Manufacturer performing services or other obligations in favor of Manufacturer in relation to this Agreement will not be considered Subcontractors.
1. General. This Work Order incorporates all of the terms and conditions of, and is made a part of, the Agreement. The purpose of this Work Order is to set forth the general terms and conditions (in addition to those set forth in Addendum A to the Agreement (General Terms and Conditions) (the T&Cs)) governing the manufacture, purchase, and sale of the Products (as defined below). As further described in Section6 (Ordering Process), pursuant to this Work Order, the Parties may enter into one or more Purchase Orders for Products, which will be governed by all of the terms and conditions of the Agreement, including this Work Order. This Work Order does not establish any minimum purchase commitment, and no Party is obligated with respect to any particular transaction for any quantity of Products unless and until Purchaser issues a Purchase Order for such Products and the Purchase Order is accepted in accordance with the terms and conditions of the Agreement. Acceptance of a Purchase Order will constitute each Partys reaffirmation of the terms and conditions of the Agreement.
(B) Parts: The performance warranties contained in Section4.2(A) of the T&Cs (General) will not apply to Parts sold under this Work Order. However, Section4.2(B) of the T&Cs (Third-Party Warranties) will apply to Parts manufactured by third parties and sold under this Work Order and Section4.3 of this Work Order will apply to the Parts manufactured by Manufacturer and sold under this Work Order. If Amazon purchases replacement batteries, then the battery warranty contained in Schedule2 would apply to such Parts.
6.2 For BEVs, the Delivery Date requested will be no less than [***] (such time period referred to as Lead Time) from the date of acceptance by Manufacturer of the Purchase Order in accordance with the terms and conditions of the Agreement (including this Work Order). Manufacturer will confirm acceptance or rejection of each Purchase Order in writing (email is sufficient): (a) within [***] following its receipt thereof, in the case of any Purchase Order relating to one or more BEVs with Product Specifications within the specifications set forth in Schedule 1 to this Work Order, or (b)as soon as practically reasonable in the case of any portion of a Purchase Order for one or more BEVs with Product Specifications that are not within the specifications set forth in Schedule1 to this Work Order. Manufacturer will accept all Purchase Orders for BEVs that comply with each of the following parameters: (i)the Product Specifications; (ii)the required Lead Time; (iii)the Delivery Schedule; and (iv)the Forecasted Volumes (listed in the table in Section7.2). Manufacturer will use commercially reasonable efforts to accept any other Purchase Orders for BEVs (e.g., ones that that do not comply with the Product Specifications, the required Lead Time, the Delivery Schedule or the Forecasted Volumes).
2.1.4 Testing. Without intending to relieve Insurer of its responsibility for testing the System hereunder, AFS shall cooperate with such professionals and advisers as Insurer reasonably may request or require for the purpose of assisting Insurer in its completion of any applicable acceptance tests under each Work Order. Insurer also may elect to have the Underwriting System Provider, if any, test AFS data linking output to the Underwriting System, and to have the Policy Administration Provider, if any, test AFS data linking output to the Policy Administration System.
3.4 Fee Payments. In consideration of the license to use the System and the Services, Insurer agrees to pay to AFS all fees of AFS in accordance with the fees for services described in the Pricing Exhibit attached hereto as Schedule 3 and, in particular, all royalty-based payments calculated in accordance therewith. Insurer also shall pay such fees for Services, if any, as from time to time are invoiced as permitted under this Agreement or any Work Order hereunder, including without limitation the Initial Work Order. Insurer shall be responsible for any federal, state or local sales or use taxes imposed by an applicable taxing authority within the United States (Sales Tax). Unless specifically identified in this Agreement all other taxes, tariffs, duties, costs, expenses and charges, including taxes based on AFSs income, shall be the responsibility of AFS.
3.5 Insurer Subsidiaries. Insurer may extend this Agreement to its Subsidiaries and their successors. Each Work Order will be executed by either Insurer or its Subsidiary requesting Services particular to such entity. When an Insurer Subsidiary seeks Services under this Agreement, it will step into the shoes of Insurer, satisfying all of Insurers representations, warranties, covenants and obligations hereunder, as they pertain to that Insurer Subsidiary. AFS acknowledges and agrees that it will seek fulfillment of Insurers obligations only from the signatory Insurer Subsidiary of such Work Order. To the extent that these obligations are not being satisfied by such Insurer Subsidiary, AFS shall put Insurer on notice of such perceived failure pursuant to the Communication section herein, and Insurer will see to its internal resolution. Neither Insurer, nor any other Insurer Subsidiary will be a guarantor of any of its other Subsidiaries contractual or financial obligations hereunder. AFS shall not seek, nor receive, satisfaction of the Insurer obligations hereunder from any Insurer Subsidiary.
2. Engagement. Upon the terms and conditions set forth herein, Sponsor hereby engages Cancer Insight to provide Services, as defined below. Cancer Insight hereby accepts such engagement and shall perform the Services pursuant to the terms and conditions set forth in this Agreement. 3. Services. In fulfillment of this Agreement, Cancer Insight shall perform the services as more fully described in the Work Orders, to be appended hereto and incorporated herein by reference (the “Services”). In providing the Services, Cancer Insight shall devote its best efforts to the performance of its duties hereunder, and shall diligently and competently perform its duties under this Agreement in accordance with any schedule set forth in the Work Orders. In the event that Cancer Insight fails to reasonably perform any Services in accordance with the applicable Work Order, then Cancer Insight shall within thirty (30) days of written notice thereof, at Cancer Insight’s option, (a) re-perform such Services at Cancer Insight’s cost, or (b) refund to Sponsor all amounts paid in connection with such Services that were not performed in accordance with the applicable Work Order. In the event that a material change to the Services becomes necessary, any such change shall be mutually agreed upon in writing in a change order (“Change Order”) by the Parties.
8.3. Effect of Termination and Final Invoice. As soon as practicable after receipt of a termination notice by one Party, the Parties shall cooperate in good faith to expeditiously wind down and conclude activities under any uncompleted Work Order. Cancer Insight shall prepare and submit to Sponsor within thirty (30) days of termination a final invoice for Services performed through the effective date of such termination, provided that Cancer Insight has submitted all Research Results and work product related to such Services to Sponsor. Sponsor shall pay to Cancer Insight all undisputed amounts due and owing for all such Services performed and any non-cancellable expenses incurred by Cancer Insight hereunder within thirty (30) days of receipt of the final invoice. 8.4. Return of Products upon Termination. Upon termination of this Agreement for any reason, Cancer Insight shall promptly deliver to Sponsor or destroy all of Sponsor’s materials, at Sponsor’s option, including all Products, Confidential Information, and Research Results, in whatever form (including any reproductions of same) of any nature which are in Cancer Insight’s possession or control; provided however, that Cancer Insight may retain one copy of Confidential Information solely for ensuring compliance with its obligations under this Agreement. 8.5. Survival. Notwithstanding anything to the contrary that may be contained herein, in the event of termination of this Agreement, the provisions of the Agreement under the headings Confidentiality, Intellectual Property, Insurance, Publication, Publicity, Injunctive Relief, Indemnity, Limitation of Liability, and Governing Law, and any other provisions which by their terms are to be performed or complied with subsequent to the termination of this Agreement shall survive and continue in full force and effect. The termination of this Agreement for any reason shall be without prejudice to, and shall not affect, the right of either Party to recover from the other any and all damages to which either may be entitled therefore, or any other rights of either in connection therewith, and all such rights of both shall survive such termination.