Terms

Requester Agreement

Science Exchange, Inc., Requester Agreement

THIS MASTER SERVICE AGREEMENT GOVERNS REQUESTER’S ACQUISITION AND USE OF THE SERVICES AND THE SCIENCE EXCHANGE PLATFORM SERVICES. CAPITALIZED TERMS HAVE THE DEFINITIONS SET FORTH HEREIN, INCLUDING THE SCHEDULES AND EXHIBITS. BY ACCEPTING THIS AGREEMENT, THROUGH (1) CLICKING A BOX INDICATING ACCEPTANCE, (2) ELECTRONIC SIGNATURE, (3) EXECUTING A SCIENCE EXCHANGE SUBSCRIPTION AGREEMENT THAT REFERENCES THIS AGREEMENT, (4) EXECUTION OF A PLATFORM ORDER FORM REFERENCING THIS AGREEMENT, (5) USING THE SCIENCE EXCHANGE PLATFORM, OR (6) THROUGH OTHER MEANS, REQUESTER, ITS AFFILIATES AND SUBSIDIARIES (COLLECTIVELY, “REQUESTER”) AGREE TO THE TERMS OF THIS AGREEMENT. IF THE INDIVIDUAL ACCEPTING THIS AGREEMENT IS ACCEPTING ON BEHALF OF A COMPANY OR OTHER LEGAL ENTITY, SUCH INDIVIDUAL REPRESENTS THAT (A) THEY HAVE THE RIGHT, POWER AND AUTHORITY TO BIND SUCH ENTITY, ITS AFFILIATES, AND SUBSIDIARIES TO THESE TERMS AND CONDITIONS, IN WHICH CASE THE TERM “REQUESTER” SHALL REFER TO SUCH ENTITY, ITS AFFILIATES, AND SUBSIDIARIES; AND THAT (B) THE COMPANY HAS FULL POWER AND AUTHORITY AND ALL NECESSARY AUTHORIZATIONS TO COMPLY WITH THE TERMS OF THE AGREEMENT AND TO PERFORM ITS OBLIGATIONS HEREUNDER.  IF THE INDIVIDUAL ACCEPTING THIS AGREEMENT DOES NOT HAVE SUCH AUTHORITY, OR DOES NOT AGREE WITH THESE TERMS AND CONDITIONS, SUCH INDIVIDUAL MUST NOT ACCEPT THIS AGREEMENT AND MAY NOT USE THE SERVICES. The Services may not be accessed for purposes of monitoring their availability, performance or functionality, or for any other benchmarking or competitive purposes. Science Exchange’s direct competitors are prohibited from accessing the Services, except with Science Exchange’s prior written consent. This Agreement was last updated on August 4, 2021. It is effective between Requester and Science Exchange, Inc. as of the date of Requester accepting it (the “Effective Date”).

RECITALS

Science Exchange has developed a proprietary Platform that enables organizations, like Requester, to search, order, manage and pay for life-sciences related scientific research and development services from its network of service providers;

Requester researches, develops, provides professional consultation services, manufacturers, or distributes pharmaceutical or biotechnology products or services;

Science Exchange wishes to make its Platform available to Requester, and Requester wishes to pay Science Exchange to use its Platform for procurement outsourcing of research and development activities, all in accordance with the terms and conditions set forth below.


The following documents are attached hereto and made a part of the Agreement:

  1. The applicable Science Exchange Subscription Agreement or Platform Order Form
  2. Science Exchange General Terms and Conditions
  3. Schedule A -  Science Exchange Platform Services Terms and Conditions
  4. Schedule B – Science Exchange Research & Development Services Terms and Conditions
  5. Schedule C – Science Exchange Human Clinical Trial Services Terms and Conditions
  6. Schedule D – Science Exchange Terms and Conditions for the Supply of Goods
  7. Exhibit B     – Sample Science Exchange Quote
  8. Exhibit C     – Standard Contractual Clauses and Appendices

The Science Exchange General Terms and Conditions, together with the Schedules, Exhibits, and any other documents incorporated or referenced in a Schedule, constitute the “Agreement”.

Schedule A sets forth specific terms that apply to the Requester’s use of the Platform.  In the event of any conflicting or inconsistent terms in the rest of the Agreement and Schedule A, Schedule A shall govern and control with respect to access to and use of the Platform.

For all research and development related Services, Schedule B shall apply.  In the event of any conflicting or inconsistent terms in the rest of the Agreement and Schedule B, Schedule B shall govern and control with respect to research and development related Services that do not entail human clinical trials.

For human clinical trial related Services, in addition to Schedule B, Schedule C shall apply.  In the event of any conflicting or inconsistent terms in the rest of the Agreement and Schedule C, Schedule C shall govern and control with respect to clinical trial related Services.

For the purchase of goods, in addition to Schedules B and C, Schedule D shall apply.  In the event of any conflicting or inconsistent terms in the rest of the Agreement and Schedule D, Schedule D shall govern and control with respect to the purchase of goods.

This Agreement, applicable Platform Order Form or Science Exchange Subscription Agreement, and any Order are the complete and exclusive agreement between the Parties with respect to the subject matter hereof, superseding and replacing any and all prior and contemporaneous agreements, communications, and understandings (both written and oral) regarding such subject matter.

SCIENCE EXCHANGE GENERAL TERMS AND CONDITIONS

1.          DEFINITIONS

1.1       Affiliate” means any corporation or other business entity controlled by, controlling, or under common control with, a Party. For this purpose, “control” means direct or indirect beneficial ownership of more than fifty percent (50%) of the voting interest in such corporation or other business entity, or otherwise having the power to govern the financial and the operation policies or to appoint the management of an organization.

1.2      AICPA” has the meeting set forth in Section 3.1.

1.3      Applicable Laws” means all statutes, laws, ordinances, regulations, rules, codes, orders, constitutions, treaties, common law, judgments, decrees, other requirements, or rule of law of any federal, state, local or foreign government, or political subdivision thereof, or any arbitrator, court or tribunal of competent jurisdiction, including without limitation the Bribery Act 2010 of the United Kingdom (Bribery Act), the Foreign Corrupt Practices Act 1977 of the United States of America (FCPA), and other applicable anti-corruption legislation, and United States Department of Labor Occupational Safety & Health Administration (“OSHA”) regulations.

1.4      Background IP” means all Intellectual Property Rights owned or controlled by, or licensed to, a Party or the Requester prior to the Effective Date or independently from this Agreement and any Order, including any improvements, enhancements and modifications to, or new uses of, any of the foregoing, even if resulting from the Services, so long as (A) in the case of Requester Background IP, they do not rely on, incorporate or encompass Service Provider Materials or Confidential Information of Service Provider or Science Exchange, (B) in the case of Service Provider Background IP they do not rely on, incorporate or encompass Requester Materials or Confidential Information of a Requester or Science Exchange, and (C) in the case of Science Exchange Background IP, they do not rely on, incorporate or encompass Materials or Confidential Information of Service Provider or Requester.

1.5      Confidential Information” has the meaning provided in Section 6.1 below.

1.6      Data Controller” means the entity or Party which: (A) alone or jointly with others, determines the purposes and means of the processing of Personal Data; and (B) if and as applicable, acts as a Business as defined by Section 1798.140(c) of the California Consumer Privacy Act.

1.7      Data Processor” means the entity or Party which: (A) processes Personal Data on behalf of a Data Controller; and (B) if and as applicable, acts as a Service Provider as defined by Section 1798.140(v) of the California Consumer Privacy Act.

1.8      Deliverable(s)” means any Work Product agreed upon in the applicable Order to be delivered to Requester by Service Provider in accordance with the Order.  Deliverables exclude Service Provider Materials.

1.9      Disaster Recovery and Business Continuity Program” has the meaning set forth in Section 3.6.

1.10      Disclosing Entity” has the meaning set forth in Section 6.1.

1.11       FDA” means the U.S. Food and Drug Administration or any successor agency.

1.12      Fees” mean Order Fees and Platform Fees.

1.13       "Intellectual Property Rights" means all (A) patents, patent disclosures and inventions (whether patentable or not), (B) trademarks, service marks, trade dress, trade names, logos, corporate names and domain names, together with all of the goodwill associated therewith, (C) copyrights and copyrightable works (including computer programs), and rights in data and databases, (D) trade secrets, know-how and other confidential information, and (E) all other intellectual property rights, in each case whether registered or unregistered and including all applications for, and renewals or extensions of, such rights, and all similar or equivalent rights or forms of protection in any part of the world

1.14      Materials” means samples, compounds, research models or any other tangible items provided by or on behalf of Requester to a Service Provider (referred to herein as "Requester Materials") and provided by or on behalf of Service Provider to Requester that are not otherwise Deliverables ("Service Provider Materials"), in order to perform the Services.

1.15      Order” means a Quote for Services that becomes effective (A) when agreed by both Service Provider and Requester and (B) upon the issuance of a Requester purchase order to Science Exchange that references the applicable Quote. To clarify, Requester’s issuance of such a purchase order constitutes Requester’s agreement with the terms of the Order.

1.16      Order Fees” means the fees collected by Science Exchange on behalf of the Service Provider for the Services provided and rendered by such Service Provider.

1.17      Personal Data” means any information relating to an identified or identifiable natural person (the “Data Subject”).  For clarification, an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to their physical, physiological, genetic, mental, economic, cultural or social identity.

1.18      Platform” means the hosted, proprietary platform-as-a-service made available by Science Exchange.

1.19      Platform Fees” means the fees for access to and use of the Platform as specified in a Platform Order Form or Science Exchange Subscription Agreement which are payable to Science Exchange by Requester under this Agreement.

1.20       “Platform Order Form” means an ordering document specifying the Platform Services to be provided hereunder that is entered into between the Requester and Science Exchange, including any addenda and supplements thereto, and which is incorporated by reference and made a part of this Agreement.  By entering into the Platform Order Form hereunder, an Affiliate and/or Subsidiary agree to be bound by the terms of this Agreement as if it were an original party hereto.

1.21       “Platform Services” means the products and services that are ordered by Requester under a Platform Order Form and made available online by Science Exchange.

1.22      Provider Agreement” means the written agreement between the Service Provider and Science Exchange pursuant to which Service Provider performs Services for the Requester, which terms are set forth at www.scienceexchange.com/pages/trust/provider-agreement or are substantially similar thereto.

1.23      Receiving Party” has the meaning set forth in Section 6.1.

1.24      Representatives” means any agent, subcontractor, consultant, or any other third party fulfilling a Party’s or Service Provider’s obligations.

1.25       “Science Exchange Subscription Agreement” means the agreement entered into between Requester and Science Exchange for Platform Services purchased as subscriptions that references this Agreement and that is incorporated by reference and made a part of this Agreement.

1.26      Security Incident” has the meaning set forth in Section 2.1.

1.27      Service(s)” means the scientific research and development goods or services that Requester orders via the Platform to be performed by Service Provider pursuant to a Provider Agreement, and that are explicitly stated in a Quote.

1.28      Service Provider” means a person or entity, including its employees, directors and officers, offering and providing Services via the Platform.

1.29      Subprocessor” has the meaning set forth in Section 2.1.

1.30       "Subscription" means the nontransferable right to on-demand access and use of the Science Exchange Platform, for users affiliated with Requester, during a specified period of time (the "Subscription Period") and subject to and in accordance with this Agreement and relevant Platform Order Form or Science Exchange Subscription Agreement, to the extent not in conflict with this Agreement and relevant Platform Order Form or Science Exchange Subscription Agreement, Science Exchange's Terms of Use, which are available for review on Science Exchange's website at https://www.scienceexchange.com/pages/trust/terms.

1.31      Taxes” has the meaning set forth in Section 4.3.

1.32      Term” has the meaning set forth in Article 5.

1.33      Work Product” shall mean all (A) documents, information, work product, materials, data and results that are (I) delivered to Requester (or its designee) hereunder or (II) prepared by or on behalf of Service Provider in the course of performing the Services, including any items identified as Deliverables, in connection with or arising out of an Order hereunder, including, without limitation, all Intellectual Property Rights, (B) improvements, modifications and enhancements to, and/or new uses of, Requester Materials and/or Requester Confidential Information, and (C) all new Intellectual Property Rights resulting from work under this Agreement or an Order that are not Service Provider Background IP or Science Exchange Background IP.

2.         PERSONAL DATA

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 2 below.

2.1       Handling of Personal Data. To the extent that any Personal Data is transferred to, processed, or accessed by Science Exchange or the Service Provider on behalf of Requester in the course of this Agreement and applicable Platform Order Form(s) or Science Exchange Subscription Agreement or an Order, Science Exchange shall, or Science Exchange shall require that the Service Provider shall, as the case may be, process such Personal Data as a Data Processor with Requester as the Data Controller, and in accordance with the following:

  1. Science Exchange or Service Provider, as the case may be, shall process the Personal Data to provide the Services as set out in this Agreement, or as may otherwise be agreed upon by the Parties, and if applicable Service Provider, in writing.
  2. Science Exchange or Service Provider, as the case may be, will implement and maintain appropriate technical and organizational measures designed to protect the Personal Data it processes against accidental or unlawful destruction, loss, alteration, or unauthorized disclosure or access (each a "Security Incident"), including by compliance with the Information Security Section below.
  3. Science Exchange or Service Provider, as the case may be, shall ensure that any person it authorizes to process the Personal Data shall be subject to a strict duty of confidentiality, whether a contractual or statutory duty.
  4. Where Science Exchange or Service Provider, as the case may be, engages a subcontractor to process the Personal Data (each a “Subprocessor”), Science Exchange or Service Provider, as the case may be, must impose by binding contract data protection obligations upon such Subprocessor that are consistent with those set out in this Agreement and the Provider Agreement, as the case may be. Science Exchange or Service Provider, as the case may be, shall remain fully liable for the Subprocessor’s failure to fulfil its data protection obligations.
  5. Upon becoming aware of any Security Incident, Science Exchange or Service Provider, as the case may be, will without undue delay, notify Requester in writing. Science Exchange or Service Provider, as the case may be, shall provide reasonable assistance to Requester in Requester’s reasonable efforts to remedy or mitigate the effects or damage resulting from the Security Incident as required by Applicable Laws.
  6. Science Exchange or Service Provider, as the case may be, will provide reasonable assistance to Requester with: (I) any Data Subject rights requests Requester receives related to Personal Data processed hereunder (e.g., access, correction, deletion, etc.); and (II) Requester’s obligations under Articles 35 and 36 of the EU General Data Protection Regulation.
  7. Science Exchange or Service Provider, as the case may be, will promptly notify Requester in the event that it receives any inquiry, communication or complaint from a Data Subject, regulator or other person relating to its processing of Personal Data under this Agreement and applicable Platform Order Form or Science Exchange Subscription Agreement or the Order. Science Exchange or the Service Provider, as the case may be, will not respond directly to such enquiry, communication, or complaint without Requester's express prior written consent and shall provide all reasonable and timely assistance in relation to such inquiry, communication or complaint.
  8. In the event of expiry or termination of the Agreement and applicable Platform Order Form or Science Exchange Platform Order Form or an Order, Science Exchange or Service Provider, as the case may be, will, at Requester’s option, delete or return all Personal Data to Requester, save where Science Exchange or the Service Provider, as the case may be, is required to retain copies under Applicable Laws, in which case it will isolate and protect that Personal Data from any further processing except to the extent required by such Applicable Laws.

2.2       Standard Contractual Clauses. If Personal Data originating in the European Economic Area, Switzerland, and/or the United Kingdom is transferred by Requester to Science Exchange or the Service Provider, as the case may be, in a country that has not been found to provide an adequate level of data protection under Applicable Laws, the Parties agree that the terms of the transfer shall be governed by the Standard Contractual Clauses attached hereto as Exhibit C. The audits described in Clause 5(f) and Clause 12(2) of the Standard Contractual Clauses shall be carried out in accordance with Section 2.2 of the Science Exchange General Terms and Conditions. Pursuant to Clause 5(h) and Clause 11 of the Standard Contractual Clauses, Science Exchange or Service Provider, as the case may be, may engage new subprocessors in accordance with Section 2.1(D) of the Science Exchange General Terms and Conditions; and (iii) the subprocessor agreements referenced in Clause 5(j) and certification of deletion referenced in Clause 12(1) of the Standard Contractual Clauses shall be provided only upon Requester’s written request. Each Party’s signature to the Agreement shall be considered a signature to the Standard Contractual Clauses to the extent that the Standard Contractual Clauses apply hereunder and thereunder as applicable. Notwithstanding anything to the contrary, this Section 2.2 and Exhibit C may be amended by Science Exchange to address changes in Applicable Laws with fifteen (15) days’ written notice to Requester.

2.3       Personal Data Audits. Upon request, Science Exchange or Service Provider, as the case may be, will make available to Requester reasonable information necessary to demonstrate compliance with the obligations set forth in this Article 2 (Personal Data). In addition, not more than once per year, Science Exchange or the Service Provider, as the case may be, shall permit Requester to audit its policies, procedures, and records relevant to compliance with this Article 2 (Personal Data) upon reasonable notice, during regular business hours, and subject to reasonable confidentiality procedures.

3.         INFORMATION SECURITY

3.1       Information Security. Science Exchange shall implement, and warrants that it will maintain throughout the term of the Agreement, an information security program that is designed to meet the American Institute of Certified Public Accountants (“AICPA”) Trust Services Principles, Criteria and Illustrations, and more specifically SOC 2.

3.2       Data Security. Science Exchange shall encrypt all information on the Platform it transmits between Science Exchange and Requester, and between Science Exchange and all Service Providers and/or Representatives. Encryption will utilize industry standard algorithms with a minimal key length of 128 bit.

3.3       Access Control. Science Exchange shall maintain controls designed to prohibit third parties (other than its service providers or Representatives and Service Providers, who, pursuant to the terms of the Agreement, are permitted access) from accessing Requester Confidential Information. Science Exchange shall use authentication and authorization technologies for service, user and administrator level accounts in accordance with AICPA. Science Exchange shall ensure procedures exist designed for prompt modification or termination of access or rights in response to organizational changes. Science Exchange shall ensure procedures exist designed for provisioning accounts with privileged access rights (e.g., system administration privileges). Science Exchange shall periodically review the necessity of privileged access accounts.

3.4       Physical Security. Science Exchange shall ensure that it has adequate processes in place designed to protect its devices and terminals used to support the Services hereunder from fire, theft, acts of God, or other damages whether it be by accident or deliberate means.

3.5       Risk Assessment. Upon written request by Requester, Science Exchange shall, no more than once per calendar year, subject itself to a risk assessment in accordance with Requester guidelines and/or Applicable Laws. The risk assessment shall be provided to Science Exchange by Requester and shall be returned within forty-five (45) days after receipt.

3.6       Disaster Recovery and Business Continuity Plan. During the Term of this Agreement, Science Exchange will maintain and adequately support a disaster recovery and business continuity program ("Disaster Recovery and Business Continuity Program") that is designed to ensure the continuous operation and, in the event of an interruption, the recovery of all material business functions needed to meet Science Exchange's obligations under this Agreement. The Disaster Recovery and Business Continuity Program will include at a minimum a detailed disaster recovery plan, which describes the management methodology, management team, emergency contact persons, and specific plans for potential risks that may disrupt Science Exchange’s operations. The plan shall meet and be consistent with generally accepted industry standards. Upon demand, Science Exchange will provide a Requester-facing version of the plan and overview of the plan to Requester. For the avoidance of doubt, Disaster Recovery and Business Continuity Program shall be considered Science Exchange Confidential Information and subject to confidentiality obligations under this Agreement.

4.         COMPENSATION, PAYMENT OF FEES, AND TAXES

4.1       Compensation. In consideration for Science Exchange making the Platform available in its performance of this Agreement, Requester shall also pay Science Exchange (A) any Platform Fees set forth on a relevant Platform Order Form or Science Exchange Subscription Agreement and (B) the Order Fees for the Services as set forth in each Order. Requester shall make no payments directly to the Service Provider.

4.2       Late Payments. Late payments will bear interest at a monthly rate of 1.5% or the maximum rate permitted by law, whichever is less, calculated from the date such amount was due until the date the payment is received by Science Exchange.

4.3       Taxes. All Fees payable under this Agreement exclude all applicable sales, use, VAT and other taxes and all applicable export and import fees, customs duties and similar charges (“Taxes”). Requester will be responsible for payment of all such Taxes (other than taxes based on Science Exchange’s net income), duties and charges, and any related penalties and interest, arising from the payment of any Fees under this Agreement or the delivery of any Services under this Agreement including any Taxes owed to the United States Federal Government and the State of California. Any such Taxes paid by Science Exchange for Requester, as a matter of convenience to Requester, which are the obligation of Requester, will be added to charges due by Requester hereunder.

5.         TERM AND TERMINATION

This Agreement commences on the Effective Date and will terminate when either Party gives notice of termination as provided herein (the “Term”).  Either Party may terminate the Agreement at any time by providing thirty (30) days prior written notice to the other Party to terminate the Agreement.  Either Party may terminate the Agreement if the other Party breaches any material term or condition of this Agreement and fails to cure such breach within thirty (30) days after written notice, or if the other Party becomes the subject of a voluntary or involuntary petition in bankruptcy or any voluntary or involuntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors (provided that such petition or proceeding is not dismissed within sixty (60) days of filing).  A termination of this Agreement for a voluntary or involuntary petition in bankruptcy or any voluntary or involuntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors (provided that such petition or proceeding is not dismissed within sixty (60) days of filing) will also terminate any Order then in force.

6.         CONFIDENTIALITY

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 6 below.

6.1       Confidential Information. The Confidential Information of each Party includes any and all Platform Order Forms (including pricing) or Science Exchange Subscription Agreement (including pricing), as well as any and all information, including but not limited to, know-how, intellectual property, plans, documents, financial information, formulas, designs, calculations, facilities, reports, models, agreements, methods, inventions, discoveries, research concepts, patents, technology, products, chemical compounds and compositions, molecules, precursors, concepts, ideas, plans, processes, specifications, characteristics, techniques, and assays; clinical information such as raw data, scientific preclinical or clinical data, observations, records, databases, dosing regimens, clinical studies or protocols, posters, presentations and abstracts, product pipelines, timelines and schedules; business information such as development, marketing, sales, customer lists, suppliers, consulting relationships, performance and cost structures, pricing and commercialization plans, forecasts, proposals, and any other non-public information or other trade secrets, whether scientific, clinical or financial in nature, however recorded or preserved, that is provided or disclosed by or on behalf of (A) a Service Provider to Requester or its Representatives, (B) Requester to Service Provider or its Representatives, or (C) one Party or its Representatives to the other Party or its Representatives (in each case, (A), (B), or (C), the entity causing the information to be disclosed or provided is referred to herein as the "Disclosing Entity") in the performance or contemplation of an Order, via the Platform or by any other means, whether in writing, orally, pictorially or through other tangible materials ("Confidential Information") shall be the Confidential Information of the Disclosing Entity. A Party in receipt of Confidential Information from a Disclosing Entity is a "Receiving Party" with respect to such Confidential Information. Notwithstanding the foregoing, any Work Product and Deliverables shall be considered Requester’s Confidential Information, except to the extent any non-exclusively licensed Service Provider Background IP is incorporated therein. For the avoidance of doubt, as between the Parties, information regarding the Platform shall be considered Science Exchange’s Confidential Information.

6.2       Treatment. Each Party and Service Provider shall maintain all Confidential Information of Disclosing Entity as such, using at least the same standard of care that the Receiving Party uses in protecting its own Confidential Information of a similar nature, which will in no event be less than reasonable care.

6.3       Exclusions. Confidential Information will not include any information that: (A) is now or hereafter becomes generally known or available to the public through no act or omission on the part of the Receiving Party in breach of this Agreement; (B) can be proven by written record was in Receiving Party’s possession prior to receiving such information from the Disclosing Entity; (C) is rightfully acquired by the Receiving Party from a third party who did not obtain it directly or indirectly from the Disclosing Entity and who has the right to disclose it to the Receiving Party; or (D) can be proven by written record is independently developed by the Receiving Party without access to any Confidential Information of the Disclosing Entity.

  1. Notwithstanding the foregoing, the following shall in any event be deemed the Requester’s Confidential Information: (A) the Requester Materials and all information relating to the Requester Materials, including, but not limited to, their identity, characteristics, past and potential uses, and other activities; (B) Work Product (C) Requester's Background IP; and (D) any Deliverables.
  2. Notwithstanding the foregoing, the following shall be deemed the Service Provider’s Confidential Information: (A) the Service Provider Materials and all information relating to the Service Provider Materials, including, but not limited to, their identity, characteristics, past and potential uses, and other activities; and (B) Service Provider's Background IP.

6.4       Restrictions. Each Party and Service Provider shall: (A) not disclose Confidential Information of the Disclosing Entity to any third parties without first obtaining the Disclosing Entity’s prior written consent to such disclosure; (B) in the case of Science Exchange as the Receiving Party, not use Confidential Information of Requester for any purpose except to perform or enforce the terms of this Agreement; (C) maintain reasonable security measures to protect the Disclosing Entity’s Confidential Information against loss, theft or destruction; and (D) return or (at the Disclosing Entity’s direction) destroy all Confidential Information of the Disclosing Entity (including the Disclosing Entity's Materials or modified versions or derivatives thereof) upon completion or abandonment of the Order or the termination of this Agreement; provided that the Receiving Party may retain a copy of the Disclosing Entity’s Confidential Information solely to monitor its ongoing obligations or enforce its rights under this Agreement or the Order and as needed to comply with Applicable Law. A Party or Service Provider may disclose Confidential Information to its Representatives who have a bona fide need to know such information in order to perform the Order or  this Agreement, provided, however, that such Party or Service Provider has entered into agreements that are substantially similar to the confidentiality provisions of this Agreement.

6.5       Unauthorized Use/Disclosure. Receiving Party will notify the Disclosing Entity of any unauthorized transfer, disclosure, loss, or use of any Confidential Information of the Disclosing Entity.

6.6       Release by Judicial Order. If the Receiving Party is required or requested to disclose Confidential Information by judicial or administrative process or as otherwise required by Applicable Laws, to the extent legally permitted and practicable it shall promptly notify the Disclosing Entity and allow the Disclosing Entity a reasonable amount of time and opportunity to oppose such process and/or seek a protective order. The Receiving Party shall disclose only the minimum Information required to be disclosed in order to comply, whether or not Disclosing Entity obtains a protective order or other similar order. Notwithstanding anything in this Agreement to the contrary, the Parties and Service Provider shall have the right to disclose any Confidential Information to a regulatory agency to the extent required or requested by such agency in connection with any regulatory filing, inspection or otherwise.

6.7       Irreparable Injury. Any violation of the terms of the Agreement relating to the disclosure or use of Confidential Information may result in irreparable injury and damage to the Disclosing Entity not adequately compensable in money damages, and for which Disclosing Entity may have no adequate remedy at law.  In the case of breach or threatened breach of the disclosure and non-use terms herein, Disclosing Entity shall have the right to injunctions, orders, decrees and other equitable remedies in order to protect the Confidential Information and will be entitled to do so without having to post a bond or other security or show monetary damages.

7.         INDEPENDENT CONTRACTORS

Science Exchange is an independent contractor of Requester, and nothing in this Agreement will be construed as creating an employer-employee relationship, a partnership, or a joint venture between the Parties. Nothing in this Agreement will be construed or interpreted so as to prohibit Science Exchange from entering into similar agreements with any third parties concerning similar deliverables or services so long as Science Exchange complies with its obligations hereunder, including without limitation with respect to confidentiality and ownership of intellectual property. Neither Party will have, nor represent to any third party that it does have, any power or authority to bind the Party or incur any obligations on the other Party’s behalf. Science Exchange’s employees will not be entitled to any of the benefits that Requester may make available to Requester employees, including without limitation, group insurance, profit-sharing or retirement benefits.

8.         USE OF NAME

Either Party may publicly identify the other Party as a customer or vendor, as applicable, using the other Party's name and logo.

9.         THIRD-PARTY BENEFICIARIES

Except as expressly provided herein, no provisions of this Agreement, express or implied, are intended or will be construed to confer rights, remedies or other benefits to any third party under or by reason of this Agreement.  Notwithstanding the foregoing, with regard to any Order with a specific Service Provider, Requester shall have the right to enforce any of the provisions of the applicable Provider Agreement as an express intended third party beneficiary.

10.       FORCE MAJEURE

Neither Party nor the Service Provider will be liable for any delay or failure of its performance in connection with this Agreement due to events beyond its reasonable control, including acts of God, acts of government, flood, fire, earthquakes, Internet service provider failure or delay, pandemic, epidemic, non-Science Exchange software application, or denial-of-service attack, civil unrest, and acts of terror, provided that such Party or the Service Provider, as the case may be, provides prompt written notice of the event and uses its diligent efforts to resume performance. Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 10 above.

11.       NO ASSIGNMENT

Neither Party may assign or delegate this Agreement without the other Party’s prior written consent, and any such purported assignment or delegation shall be void, except that either Party may assign this Agreement, without the other Party’s consent, to an Affiliate or to a successor or acquirer, as the case may be, in connection with a merger or acquisition, or the sale of all or substantially all of such Party’s assets to which this Agreement relates. Subject to the foregoing, this Agreement will bind and inure to the benefit of the Parties’ permitted successors and assigns.

12.       WAIVER, AMENDMENTS AND MODIFICATIONS

Failure by either Party to enforce any provision of this Agreement will not be deemed a waiver of future enforcement of that or any other provision. Any waiver, amendment or other modification of any provision of this Agreement or any Platform Order Form, or Science Exchange Subscription Agreement, will be effective only if in writing and signed by duly authorized representatives of the Parties.

13.       NOTICES

All notices under this Agreement will be written in English, will reference this Agreement and will be sent to (other than electronic notices permitted under this Agreement to be provided via the Platform):

Science Exchange Attn: Legal Department
555 Bryant Street, Suite 939 Palo Alto, CA 94301
cc:legal@scienceexchange.com

14.       SEVERABILITY

If for any reason a court of competent jurisdiction finds any provision of this Agreement invalid or unenforceable, the remaining provisions of the Agreement will remain in full force and effect, and the invalid or unenforceable provision will be enforced as nearly as possible in accordance with the stated intention of the Parties. To the extent that any provision cannot be enforced in accordance with the stated intentions of the Parties, such provision will be deemed not to be a part of this Agreement but otherwise this Agreement and all Orders will continue in full force and effect.

15.       GOVERNING LAW AND JURISDICTION

This Agreement will be governed by and construed in accordance with the laws of the State of Delaware, excluding any conflicts of law principles that would otherwise apply the law of any other jurisdiction. Any legal suit, action or proceeding arising out of or related to this Agreement or the Services provided hereunder shall be brought exclusively in the federal and state courts located in the State of Delaware (and the appropriate appellate courts therefrom), and each Party irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action or proceeding, and irrevocably waives any objection based on inconvenient forum or lack of personal jurisdiction.

16.       SURVIVAL

Any terms of this Agreement, which by their nature extend beyond the termination of this Agreement, will survive the termination of this Agreement to the extent necessary to effectuate the intent of the Parties. This includes, without limitation, the confidentiality, personal data, intellectual property, indemnification, limitation of liability, governing law, submission to jurisdiction, notice provisions and this survival provision.

SCHEDULE A
SCIENCE EXCHANGE PLATFORM SERVICES

1.         DEFINITIONS

1.1       “Requester Data” shall mean electronic data and information submitted by or for Requester to the Platform.

1.2       "SE Indemnified Parties" shall have the meaning set forth in Article 4 below.

2.         PROVISION OF PLATFORM SERVICES

Science Exchange will make the Platform available to Requester for use according to this Schedule A and to the extent not in conflict with this Schedule A, Science Exchange’s Terms of Use available at www.scienceexchange.com/pages/trust/terms, which are incorporated herein by reference. Science Exchange shall use commercially reasonable efforts to make the online Platform available 24 hours a day, 7 days a week, except for: (A) scheduled maintenance of which Science Exchange provides reasonable advance electronic notices via the Platform and unscheduled maintenance; and (B) any unavailability due to force majeure events or other circumstances beyond Science Exchange’s reasonable control, including acts or omissions of the Requester or any Service Provider.

3.         FEES

Platform access is purchased on a subscription, access or transaction pricing basis.  Requester shall pay Science Exchange the Platform Fees for Platform access in accordance with this Schedule A and the provisions of the relevant Platform Order Form or Science Exchange Subscription Agreement.  In the event of a conflict in the payment terms of this Schedule A and the payment terms of a Platform Order Form or Science Exchange Subscription Agreement, the payment terms of the applicable Platform Order Form or Science Exchange Subscription Agreement shall control.

4.         TERM OF SUBSCRIPTIONS

The term of each subscription shall be as specified in the applicable Platform Order Form or Science Exchange Subscription Agreement.

5.         INDEMNIFICATION

Requester shall defend, indemnify, and hold harmless Science Exchange, its Affiliates, and its and their respective officers, directors, employees, agents, and representatives (collectively "SE Indemnified Parties") from, and defend the SE Indemnified Parties against, all claims, suits, judgments, demands, losses, fines, penalties, costs, expenses, and other liabilities, including attorneys’ fees and court costs, arising out of or relating to Requester’s breach of its obligations under this Schedule A and/or Science Exchange’s Terms of Use available at www.scienceexchange.com/pages/trust/terms.

6.         PROPRIETARY RIGHTS AND LICENSES

6.1       Reservation of Rights.  Subject to the limited rights expressly granted hereunder, Science Exchange reserves all right, title and interest in and to the Platform (and all improvements thereto and new uses thereof), including all related intellectual property rights.  No rights are granted to Requester hereunder regarding the Platform other than as expressly set forth herein.

6.2       License by Requester to Host Your Data.  Requester grants Science Exchange and its hosting providers a worldwide, limited-term license to host, copy, transmit and display Requester’s Data, non-Science Exchange software applications or program code.

6.3       3. License by Requester to Use Feedback.  Requester grants Science Exchange a worldwide, perpetual, irrevocable, royalty-free license to use and incorporate into the Platform any suggestion, enhancement request, recommendation, correction or other feedback.

 

SCHEDULE B
SCIENCE EXCHANGE RESEARCH & DEVELOPMENT SERVICES TERMS AND CONDITIONS

1.         DEFINITIONS

1.1      Change Order” means a written modification to an Order signed by the Requester and the Service Provider.

1.2      Debarred” has the meaning set forth in Section 3.4.

1.3      Disqualified” has the meaning set forth in Section 3.4.

1.4      Excluded” has the meaning set forth in Section 3.4.

1.5      Good Laboratory Practices” or “GLP” means then-current standards, practices and procedures promulgated or endorsed by (A) the European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices as well as “The rules governing medicinal products in the European Union,” Volume 3, Scientific guidelines for medicinal products for human use (ex - OECD principles of GLP), (B) the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and (C) the equivalent laws in any relevant country, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.

1.6      Good Manufacturing Practices” means the then-current good manufacturing practices required by (A) the FDA, as set forth in the Food Drug &Cosmetic Act and the regulations promulgated thereunder, for the manufacture and testing of Federal  pharmaceutical materials, including the provisions of 21 C.F.R. Parts 210 and 211, (B) European Commission Directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively, as well as “The rules governing medicinal products in the European Union,” Volume 4, Guidelines for good manufacturing practices for medicinal products for human and veterinary use, and (C) the principles detailed in the ICH Q7A guidelines, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.

1.7      Human Substances” has the meaning set forth in Section 7.3.

1.8      Indemnified Party" has the meaning set forth in Section 10.2.

1.9      Indemnifying Party" has the meaning set forth in Section 10.2.

1.10      Milestone" means a Service or Deliverable, or a set thereof, described in the Order that upon its completion triggers an invoice and a non-refundable payment of a specific amount less than the value of the entire Order.

1.11      Preferred Provider” means any Provider that has an established collaboration or establishes a collaboration directly with Requester prior to or during the term of this Agreement.

1.12      Quote(s)” means Service Provider’s written, itemized, descriptive list of Services and their associated fees therefor.

1.13      Record” means those specific records, notes, documents, data and the like that are specific to a business process (as opposed to any particular Order or Requester’s Confidential Information) that are regularly kept in the ordinary course of the business and/or are required to be owned and maintained by a Service Provider for legal or regulatory reasons, such as, but not limited to, medical records, source documents, written policies and procedures, standard operating procedures, time sheets, third party invoices, system validation, maintenance tests of equipment, and financial reports.

1.14      Request” means a request for a Quote for Services.

1.15      Separate Agreement” has the meaning set forth in Section 2.6.

1.16      Statement of Work” means a detailed written description of the specific Services and/or Deliverables to be completed under an Order and may include the designation of Milestones.

1.17      Third Party Claim” has the meaning set forth in Section 10.1.

2.         SCOPE OF WORK, ORDERING, PREFERRED PROVIDERS

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 2 below.

2.1       Scope of Work. Service Provider will perform the Services ordered by Requester and create and deliver any specified Deliverables, as detailed in the Order, including any Statement of Work attached thereto or incorporated therein by reference.

2.2       Ordering Process. (A) Requester will order any Services by submitting a Request to Science Exchange via the Platform. Requester will ensure that each Request includes any information (e.g. a Statement of Work, protocols, specifications, etc.) reasonably necessary to describe the Services to be performed such that a Service Provider can respond with an accurate Quote. Once a Requester receives a Quote that meets its needs, Requester will accept the Quote on the Platform and such Quote will then become an Order; or, (B) alternatively, Service Provider will submit a Quote via the Platform to Requester and Requester will accept the Quote on the Platform and such Quote will then become an Order.

2.3       Change Orders. After placement of an Order, should a Change Order be needed, such Change Order must be documented and agreed upon by the Service Provider and Requester. Requester shall ensure that each Change Order identifies all applicable changes.

2.4       Milestone and Order Completion. After performing a Milestone or Order, Service Provider will so indicate via the Platform. Requester shall promptly, upon receipt of the Deliverables, confirm or deny that the Milestone or Order, as applicable, has been performed in conformance with the applicable Order, including any Statement of Work attached thereto or incorporated therein by reference. Requester may do so regarding a Milestone or Order via the appropriate Platform product feature or, in respect to Milestones, by paying Science Exchange after the completion of the Milestone. For the sake of clarity, prepayments made by Requester pursuant to an invoice identifying them as such shall not be construed as confirmation of completion of a Milestone via payment. In the event that Requester denies that the Milestone or Order has been properly completed, Requester shall promptly provide Science Exchange and Service Provider with an explanation of the nonconformance. The Parties agree that performance of a Milestone or Order shall be deemed complete upon the earliest of Requester's (A) communication via the Platform confirming completion, (B) payment for the Milestone or Order, excluding pre-payments, or (C) two (2) weeks from the date upon which the Service Provider indicates the Milestone or Order is complete, provided that Requester communicates no objection.

2.5       Conflict. Except as otherwise expressly set forth herein, in the event of any conflict or inconsistency between the terms of this Agreement and any Order, the terms of this Agreement will prevail. Any additional or inconsistent terms in any purchase order, quotation, acknowledgment, or other documentation of Requester are hereby rejected and shall not be part of any agreement between Requester and Science Exchange or any Order unless, in the case of additional terms applicable to an Order, they specifically are agreed to pursuant to Section 2.7 hereof.

2.6       Preferred Provider(s). If Requester chooses to use the Platform to order Services from its Preferred Providers using an existing agreement directly with such Preferred Provider (each a “Separate Agreement”), then such Separate Agreement shall govern the Services ordered via the Platform. In such instance, Science Exchange’s sole responsibility with regard to the Services is to act as the billing/payment entity and purchase order processor; and Science Exchange disclaims all contractual liability as it relates to Services under any such Separate Agreement and any disputes arising out of such Services shall be resolved in accordance with the Separate Agreement between Requester and Preferred Provider. Furthermore, it is understood and agreed between the Parties that Requester will take all necessary actions to ensure the language within quotations in Section 5.4 of this Schedule B, or language of the same legal effect, shall supersede the applicable section(s) of the Separate Agreement between Requester and Provider. Requester hereby agrees and covenants to first gain Provider’s written assent prior to using the Separate Agreement for any particular Order. The Parties acknowledge that where a Separate Agreement is utilized for an Order, Science Exchange's applicable Terms of Use and Privacy Policy shall still apply to Requester and its Preferred Provider(s) with regard to their use of the Platform for processing of such Order.

2.7       Additional Terms. It is the intent of the Science Exchange and Requester to include in this Agreement any and all applicable terms and conditions for the provision of Services required by Requester. However, in the event Requester requires the Service Provider to agree to additional terms beyond those contained within the Provider Agreement, Requester shall have the right to add such terms to the respective Quote, provided that the additional terms are agreed upon in writing by the Service Provider prior to commencement of the Services, but only to the extent that such additional terms explicitly reference this Section 2.7.

3.         PERFORMANCE OF THE SERVICES

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 3 below.

3.1       Service Providers. Requester acknowledges that the Services are not performed by Science Exchange but rather by one or more Service Providers pursuant to the applicable Provider Agreement, which has terms consistent in all material respects with this Agreement. Science Exchange shall require each Service Provider, to the extent of the Services to be performed by Service Providers, to be bound to Science Exchange by terms of the contract documents and to assume towards Science Exchange all obligations and responsibilities which Science Exchange by the contract documents assumes towards the Requester under this Agreement. Service Providers are independent contractors, free to determine the manner in which the Services are performed.  Science Exchange is only responsible for (A) determining which Service Providers will be entitled to offer Services through  the Platform and (B) payment of the fees due to any Service Providers. Each Service Provider shall perform the Services outlined in the Order in accordance with the Provider Agreement.

3.2       Standards. Service Provider will perform Services in a thorough, timely and professional manner, consistent with prevailing scientific, professional and industry standards by individuals with the requisite training, background, experience, technical knowledge and skills to perform the Services, in accordance with the applicable Order and in compliance with all Applicable Laws, including, to the extent applicable, as specified in the applicable Order Good Laboratory Practices or Good Manufacturing Practices .

3.3       Animal Services. If Services under an Order involve the use of animals, Service Provider will care for and use the animals in accordance with all Applicable Laws, including applicable NIH guidelines, ILAR Guide for the Care and Use of Laboratory Animals, Animal Welfare Act, and AAALAC International. Service Providers will be responsible for the care and treatment of any animals involved in the Services, including seeking any necessary veterinary care.

3.4       Debarment. Science Exchange represents and warrants that neither Science Exchange, nor any Service Providers used in connection with the Services, nor their Representatives are debarred pursuant to the United States Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335(a)), as amended, or any similar Applicable Laws (collectively “Debarred”), excluded by any government agency from participation in any government healthcare program (collectively “Excluded”) or otherwise disqualified or restricted by the FDA or any other regulatory authority (collectively “Disqualified”). Science Exchange represents and warrants that to its knowledge neither Science Exchange, nor any Service Providers used in connection with the Services, nor its nor their Representatives are under investigation or there are any circumstances which may result in being Debarred, Excluded or Disqualified. In the event of any pending proceeding or threatened action that may lead to Science Exchange, Service Provider, or its or their Representatives being Debarred, Excluded, or Disqualified, to the extent legally permitted Science Exchange covenants that it shall promptly notify Requester in writing pursuant to the notice provisions provided herein.

3.5       Records. Service Provider will prepare and maintain complete and accurate records of Work Product and the Services. All Records and accounts relating to financial matters must be in a format consistent with U.S. Generally Accepted Accounting Principles (GAAP).

3.6       Inspections. Upon reasonable notice, but not more than once annually, (A) Requester and its Representatives may visit Service Provider’s facilities at mutually agreeable times during normal business hours to observe the progress of the Services. Science Exchange may assist Requester in scheduling such visits, and (B) Science Exchange will make available to Requester or its Representatives during normal business hours, data and records that Science Exchange compiles in the course of the Services. During these visits, Requester’s Representatives may examine the reports containing the results of all quality assurance inspections performed by Science Exchange with respect to any Services and to examine the controls and procedures used by Science Exchange in the performance of such quality assurance inspections. Requester and its Representatives shall at all times while present on Service Provider or Science Exchange premises comply with all Service Provider or Science Exchange rules, regulations, policies and standard operating procedures; failure to do so is grounds for immediate removal.

3.7       Regulatory Inspections. If any governmental or regulatory authority of appropriate jurisdiction conducts, or gives notice of intent to conduct, an inspection of the records of a Service Provider related to an Order or any facility of a Service Provider where Services are performed, to the extent legally permitted the Service Provider shall as soon as practicable, and in no event less than one (1) business day from receipt of notice from such authority, provide Requester with notice thereof. If the inspection relates to or impacts Services performed for Requester, to the extent legally permitted the Service Provider will furnish Requester with copies of any documents provided to such authority and copies of any written communications received from such authority pertinent to such inspection and, further, Requester shall have the right to be present at any such inspection, unless legally prohibited from attending. Such Service Provider shall cause its Affiliates and Representatives involved in the performance of the Services which are the subject of such governmental inspection or who are performing the Services at the facility that is the subject of such government inspection to cooperate with such inspection. The Service Provider and its Affiliates shall promptly take all steps necessary to correct any deficiencies noted by such inspecting authority during the inspection. The Service Provider shall give Science Exchange and Requester at least five (5) business days to review any response to a regulatory authority that is in response to a notice to inspect or other regulatory action or proposed regulatory action before it is forwarded to such regulatory authority.

3.8       Records related to Costs. In no event will Requester have access to either a Service Provider's or Science Exchange’s records with regards to its confidential and proprietary pricing structure or the make-up and application of its indirect rates/costs.

3.9       Non-Conforming Services. In the event Services rendered by a Service Provider do not meet the specifications as set forth in the applicable Order, at Requester’s option, the Service Provider shall, after receiving notice from Requester of such non-conforming Services, either (A) re-perform the non-conforming Services at its own cost within thirty (30) days or, if performance of the Services within that period of time is impossible, then within the same amount of time initially provided for performance in the applicable Order; or (B) reimburse Requester any amounts paid for such Services and compensate Requester for the cost of Requester Materials used in the performance of the Services. In the event that any animal involved in the Services becomes moribund or seriously ill (except for illness or death due to treatment with the Requester Material), Service Provider shall be required to replace such animal at Service Provider’s expense upon request by Requester or Science Exchange.

4.         MATERIALS

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 4 below.

4.1       Ownership of Materials. To the extent that any Order provides that Requester supply (or has a third- party supply) Service Provider with certain Requester Materials as described in the applicable Order or that a Service Provider supply Service Provider Materials (such as samples which are subsequently prepared by Requester and returned to Service Provider for analysis) to Requester in order to effectuate the performance of Services under an Order, Requester shall retain all right, title, and interest to all Requester Materials and any intellectual property rights therein and Service Provider shall retain all right, title, and interest to all Service Provider Materials and any intellectual property rights therein, such that all rights to Materials remain with the party from which the Materials originated. Nothing in this Agreement or any Order grants to a Party or Service Provider any rights in or to Materials, except the limited right to use such Materials as necessary for the corresponding Order to be performed.

4.2       Materials Warranty. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN ALL SUCH REQUESTER MATERIALS ARE PROVIDED “AS IS” WITH NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. REQUESTER DOES NOT WARRANT OR MAKE ANY REPRESENTATION REGARDING THE USE, RESULTS, OR APPROPRIATENESS OF THE USE OF THE REQUESTER MATERIALS IN ACCORDANCE WITH AN ORDER. REQUESTER WARRANTS TO SCIENCE EXCHANGE AND THE SERVICE PROVIDER THAT USE OF THE REQUESTER MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY. REQUESTER ACKNOWLEDGES THAT FAILURE TO USE OR HANDLE SERVICE PROVIDER MATERIALS IN ACCORDANCE WITH APPLICABLE SERVICE PROVIDER INSTRUCTIONS MAY IMPACT THE RESULTS ASSOCIATED WITH AN ORDER.

4.3       Use of Materials. With respect to another's Materials, each Party and the Service Provider, as the case may be, will (A) use the Requester Materials or Service Provider Materials provided to it hereunder, as applicable, solely in furtherance of the performance of the corresponding Order as set forth in the applicable Order and not for any other purpose; (B) store, handle and maintain the applicable Materials in accordance with the applicable Order, any instructions provided in regard to appropriate use of the Materials, prevailing industry practices, and any Applicable Laws; and (C) not use the Materials for any experiments on human subjects, clinical trials, or diagnostic purposes involving human subjects.

4.4       Distribution of Materials. With respect to another's Materials, each Party and the Service Provider will ensure that, except as otherwise provided in the applicable Order (including any Statement of Work attached thereto or incorporated therein by reference), it and its Representatives shall not (A) provide or describe the Materials to any third-parties other than as necessary to further performance of the Order or comply with Applicable Laws; (B) attempt to reverse engineer any of the Materials; (C) perform any studies to determine the structure, chemical composition, or other makeup of the Material; or (D) make any derivatives or progeny of the Materials.

5.         PAYMENTS

5.1       Payment of Order Fees

5.1.1. Invoices.

Science Exchange will invoice Requester for Order Fees via the Platform and Requester shall pay the Order Fees therefore in accordance with the terms provided in Section 5.1.2. below.

5.1.2. Payment Terms.

  1. Requester will pay the invoiced amounts with reference to the specific Order and otherwise due in connection with this Agreement within thirty (30) days from the date of receipt of the invoice. Requester may withhold payment of invoiced amounts which are disputed in good faith pending the resolution of such dispute, provided that: (I) Requester notifies Science Exchange of any dispute in writing within ten (10) days after receipt of the invoice that pertains to the dispute; (II) the notice provides reasonable explanation as to which amounts are being disputed and the nature of the dispute; and (III) Requester pays any undisputed amounts upon receipt of an updated invoice to reflect the undisputed portion.
  2. Upfront Payments. Notwithstanding the foregoing, from time to time Service Provider may require upfront payments in order to procure animals or other items in furtherance of the Services. Requester will make any such upfront payments upon receipt of the applicable invoice. Requester agrees to make timely upfront payments and Milestone payments to the extent necessary for a Service, which will be confirmed in each Order.

5.2       Fair Market Value. Requester and Science Exchange acknowledge and agree that Requester's payments to Science Exchange under this Agreement constitute fair market value for the Services performed hereunder and are not being given, directly or indirectly, as an inducement or reward with respect to the formulary placement of any Requester product.  Further, the Parties acknowledge and agree that Science Exchange is not (and any Service Providers are not) required to purchase, order or recommend to any patients any products manufactured or available through Requester.

5.3       Payments to Covered Entities. In the event that Science Exchange utilizes a U.S. teaching hospital or a U.S. physician to perform any of its obligations hereunder, payments made by or on behalf of Science Exchange to each such Covered Entity or other compensation or consideration received by each such Covered Entity on account of its contributions to or performance of any of Science Exchange obligations hereunder shall represent fair market value and comply with Applicable Laws. Additionally, Science Exchange shall inform Requester of any such payments to a Covered Entity to comply with Applicable Laws such as the Physician Open Payments Program or its foreign equivalent.

5.4       Separate Agreement Payments. The Parties agree that the following language in Quotes will supersede any conflicting language in a Separate Agreement:

"The party to this Agreement providing scientific services through Science Exchange (the “Provider”, which is providing “Services”) has authorized Science Exchange or Science Exchange’s third-party payment processor to collect the total cost of performance of those Services, as determined by Provider in compliance with any pricing set for in this Agreement, from the party to this Agreement making the request (the “Requester”). Requester has agreed to and shall pay Science Exchange the amount it is invoiced by Science Exchange for such Services and Science Exchange has agreed to pay Provider’s indicated payment account in accordance with the payment terms set forth in the purchase order issued by Science Exchange to Provider following Requester’s indication on the Platform that they are complete and have been performed in compliance with the applicable agreement and any additional terms as set forth in the accepted quote. If Science Exchange receives no communication from a Requester within two (2) weeks of the Providers indication that the Services are complete, Science Exchange may indicate they are complete and pay the Provider accordingly. Each Party is solely responsible, as applicable, for all costs incurred in using the Science Exchange proprietary hosted platform, performing Services and determining, collecting, reporting and paying all applicable state and federal sales, income, and other taxes. After the commencement of the Services, should changes be needed, such changes shall be documented and agreed to between the Provider and Requester (via the Science Exchange Platform) in the form of a “Change Order”. In such instance, Science Exchange on behalf of Requester shall ensure that each Change Order identifies all applicable changes.  Requester will pay the invoiced amount by Science Exchange within the time stated in the invoice.  If any amounts of an invoice are disputed, Requester has agreed to, and shall, promptly discuss such amounts with Science Exchange to come to a resolution.  Notwithstanding the foregoing, from time to time Provider may require upfront payments in order to procure animals or other items in furtherance of the Service.  Requester has agreed to make upfront payments and milestone payments to the extent necessary for a Service, which the Parties will confirm in each accepted quote."

6.         ORDER TERMINATION

6.1       Termination.  Requester may terminate any Order by written notice at any time by providing ten (10) days prior written notice to the other Party to terminate an Order, provided that Requester pays all applicable Fees due for Services performed through the effective date of termination, unless otherwise agreed in writing by the Parties.

6.2       Effect of Termination.  Termination of an Order alone in accordance with Section 6.1 above will not terminate this Agreement.  If at the end of the Term, or termination of this Agreement upon 30 days written notice as permitted under the Science Exchange General Terms and Conditions, the Services under an Order then in force are not yet completed, this Agreement will remain in full force and effect solely with respect to such Order(s) until the earlier of either: (A) the completion of such Services or (B) the termination of such Order(s) in accordance with Section 6.1 above.

7.         HUMAN SUBSTANCES

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 7 below.

7.1       Human Subject Consent. To the extent the Order requires Requester to be provided with cells, tissue, blood, or any other bodily fluids collected from human subjects as well as any derivatives thereof (collectively “Human Substances”), and to the extent any consent or authorization is required by Applicable Laws, applicable policy, or other approval authority, to be obtained from an individual in connection with the collection, maintenance, or transfer of the Human Substances, such informed consent or authorization was or will be obtained by Service Provider on behalf of the Requester prior to providing such Human Substances and that the collection and transfer of the Human Substances is in compliance with Applicable Laws. Any consent forms shall be provided to Requester upon request.

7.2       Transfer of Human Substances. Requester represents and warrants that it will maintain control over the Human Substances received from the Service Provider and agrees that such Human Substances will not be distributed for commercial purposes or otherwise transferred, given or sold by Requester (excluding an Affiliate or Representative thereof) to any third party for any purpose(s) whatsoever without the prior written consent of the Service Provider.

7.3       Use. Requester acknowledges that the Human Substances are intended for research use only and are not to be used for any other purposes including, but not limited to, unauthorized commercial purposes, in vitro diagnostic purposes, ex vivo or in vivo therapeutic purposes, or for consumption by, or use in connection with administration or application to humans or animals. From the point of delivery of the Human Substances, the custody control and risk for the Human Substances shall pass to the Requester. The Requester shall be wholly responsible for the safe use and disposal of the Human Substances and all, if any, substance being derived from the Human Substances while in its possession and control and for that purpose it shall be the Requester’s obligation to comply with all Applicable Laws, in whatever jurisdiction, affecting such use, possession control or disposal. The Requester shall carry out disposal of the Human Substances in a controlled respectful manner and in line with Applicable Laws. The Requester must on disposal of any Human Substances, provide to Science Exchange a written confirmation of its disposal. Additionally, upon receipt of Human Substances, Requester shall provide Science Exchange contact information for the person responsible for the care of Human Substances delivered to Requester.

7.4       HAZARDOUS AGENTS. REQUESTER AGREES THAT HUMAN SUBSTANCES MAY CONTAIN INFECTIOUS AND/OR POTENTIALLY HAZARDOUS AGENTS.

7.5       Warranty. Service Provider warrants (based on the representations from the sites providing Human Substances and review of the applicable clinical records) that it will not provide Human Substances from individuals believed to be Hep-B/C and HIV 1/2 positive at the time of procurement (unless otherwise requested in the Order). Service Provider shall notify Requester immediately upon learning that Human Substances delivered to Requester were obtained from a patient who was infected with Hep-B/C, HIV 1/2, syphilis, or any other infectious disease that should have been disclosed to anyone handling such Human Substances pursuant to industry standards.

7.6       ISO Certification. Service Provider shall comply with the general requirements for biobanking set forth in ISO 20837:2018.

8.         INTELLECTUAL PROPERTY

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 8 below.

8.1       Background IP. This Agreement does not transfer ownership or title of any Background IP.

8.2       Deliverables. Without limiting any other remedies available in law or equity, all right, title and interest in and to any Deliverables, including without limitation any and all intellectual property therein, shall be the sole property of Requester whether the Services to be performed are completed or not. Service Provider is obligated to assign to Requester all of Service Provider’s right, title and interest in any Deliverables. Service Provider and its Representatives that contribute to any Deliverables have agreed in advance in writing that all right, title and interest in such contributions is assigned to Service Provider or directly to Requester, and that to the extent legally permissible they waive any droit moral or similar rights to object to modifications, adjustments or additions to their contributions. All Deliverables and any reproductions thereof are required to be surrendered to Requester by Service Provider upon completion of the related Order, or termination of an Order, whichever occurs first. Deliverables may be used by Requester without restriction and may not be used by Science Exchange, Service Provider or their Representatives, if any, without Requester’s prior written consent.

8.3       Cooperation. Requester will have the sole right to determine the treatment of any Deliverables, including with respect to intellectual property or proprietary rights therein, to file and execute patent applications, to use and disclose them, or to take any other action that Requester deems appropriate. Service Provider is required to reasonably cooperate with Requester, at Requester's expense, during and after the term of this Agreement to apply for, and to execute any applications, assignments, or other documents reasonably necessary to obtain, protect, or evidence any intellectual property rights or other statutory protection for the Deliverables, as Requester deems appropriate.

8.4       License. If, in the course of performing the Services, Service Provider incorporates into any Deliverable or utilizes in the performance of the Services any Background IP, Service Provider is required to grant to Requester, and ensure its Representatives grant to Requester, a nonexclusive, royalty-free, perpetual, irrevocable, transferable, worldwide license (with the right to grant and authorize sublicenses) under such Background IP to make, have made, use, import, offer for sale, sell, reproduce, distribute, modify, adapt, prepare derivative works of, display, perform, and otherwise exploit the Deliverables. Service Provider will not, and shall ensure its Representatives will not, knowingly incorporate any invention, improvement, development, concept, discovery, work of authorship or other proprietary information owned by any third party into any Work Product or Deliverables without Requester’s prior written authorization and only after receiving the required approval from such third party.

9.         WARRANTIES AND REPRESENTATIONS

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 9 below.

9.1       Mutual. Each Party represents and warrants to the other that it has the full power, right and authority to enter into this Agreement, to carry out its obligations under this Agreement, and to assign and grant the rights pursuant to this Agreement. In addition, each Party represents and warrants to the other that it will comply with Applicable Laws.

9.2       Services. Service Provider warrants that the Services will be performed in a good and professional manner and in accordance with terms consistent with Article 3 of this Schedule B. Without limiting other remedies available at law or in equity, in the event of a breach of this warranty, Service Provider is obligated to follow the re- performance or refund procedures consistent with those provided in Section 3.9 of this Schedule B.

9.3       ISO 9001. Service Provider represents and warrants that is has and will maintain throughout the term of this Agreement a quality management system pursuant to the standards set forth in ISO 9001-2015. Upon written request, Science Exchange shall make available to Requester any and all documentation required to corroborate its adherence to this Section 9.3.

9.4       Resources; Permitting. Service Provider represents and warrants to Requester that (A) Service Provider possesses the business, professional and technical expertise and the resources, including without limitation equipment, facilities and employees to perform the Services; and (B) Service Provider has been issued, as of the date of this Order, and shall maintain in effect for the term of the Order, all permits, licenses, certificates or approvals required by Applicable Laws to perform the Services. Service Provider is obligated to notify Requester and Science Exchange promptly in the event its permits, licenses, certificates or approvals to perform the Services are modified, revoked, suspended, transferred or otherwise changes such that there is a material adverse effect upon the Services.

9.5       Research Use Only. Requester acknowledges and understands that any Work Product delivered by Service Provider as it pertains to this Agreement will be used for research purposes and, unless otherwise agreed upon by the Parties and Service Provider, will not be used in human subjects, or for administration in clinical trials, or any other purpose that is not contemplated herein or in the Order.

9.6       Research Nature. Requester acknowledges and understands that Services contemplated herein are of a research nature and by that effect, neither Science Exchange nor Service Provider represent or warrant that Service Provider will achieve the results desired by Requester.

9.7       Disclaimer. OTHER THAN THOSE WARRANTIES EXPRESSLY SET FORTH HEREIN, SCIENCE EXCHANGE SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND/OR QUALITY.

10.       INDEMNIFICATION

10.1       Indemnification. Each Party will, at its expense, indemnify, defend and hold harmless the other Party, its officers, directors, employees, and Representatives, against any liabilities, losses, damages, judgements, expenses, fines, penalties, charges and fees (including reasonable attorneys’ fees) resulting from any claim, suit, action, demand or proceedings or allegations brought against an indemnitee by a third party (each a “Third Party Claim”) to the extent arising out of or attributable to: (A) any breach of this Agreement by the Indemnifying Party, (B) any negligence or willful misconduct of the Indemnifying Party in the performance of this Agreement, or (C) where Requestor is the Indemnifying Party, misappropriation or infringement of intellectual property rights regarded as being caused by Requester-supplied designs or specifications, or Requester Materials or Requester Confidential Information.

10.2       Indemnification Procedure.

10.2.1   Notice. In the event any Third Party Claim contemplated in Section 10.1 (Indemnification) of this  Schedule B is made, or action initiated, the Party seeking indemnification hereunder (the “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in writing of such actual or threatened Third Party Claim to enable the Indemnifying Party to arrange for the defense of such Third Party Claim, provided, however that failure to give prompt written notice shall not limit the rights to indemnification hereunder except to the extent that the Indemnifying Party is materially prejudiced by such failure.

10.2.2   Cooperation. The Indemnified Party shall cooperate with the Indemnifying Party in the investigation, defense and settlement of any Third Party Claims when the Indemnifying Party controls the defense of any such Third Party Claims. The Indemnifying Party shall provide a diligent defense against and/or final settlement of any Third Party Claims brought or actions filed for the loss which is the subject of the foregoing indemnity.

10.2.3   Control of Defense. The Indemnifying Party shall have sole control over the defense and the right to enter into a full and final monetary settlement of the Third Party Claims, at the Indemnifying Party’s sole expense and discretion, provided that the Indemnifying Party shall not agree to any settlement which imposes injunctive relief on, requires an admission of fault by, or does not include a complete release of the Indemnified Party without the consent of the Indemnified Party. In any such proceeding, the Indemnified Party shall have the right to retain its own counsel and participate in the defense of the Third Party Claims, at the Indemnified Party’s expense, provided that the Indemnified Party shall not consent to the entry of any judgment or enter into any settlement with respect to the claims without the prior written consent of the Indemnifying Party, which consent must not be unreasonably withheld.

10.2.4   Non-exclusivity. The indemnification provided by this Agreement shall not be deemed exclusive of any other rights to which the Indemnified Party may be entitled to under this Agreement, any other agreement, applicable law, or otherwise.

11.       LIMITATION OF LIABILITY & INSURANCE

11.1       SUBJECT TO SECTION 11.2 BELOW, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY FORM OF SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR LOSS OF PROFIT, REGARDLESS OF WHETHER THE CAUSE OF ACTION IS BASED ON CONTRACT, TORT, STRICT LIABILITY OR ANY OTHER LEGAL THEORY, EVEN IF INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES. SUBJECT TO SECTION 11.2 BELOW, IN NO EVENT WILL THE AGGREGATE LIABILITY OF SCIENCE EXCHANGE EXCEED THE LESSER OF (A) ONE MILLION DOLLARS ($1,000,000) OR (B) THE TOTAL AMOUNTS DUE UNDER THE ORDER WHERE SUCH DAMAGES AROSE.

11.2       Exceptions. THE LIMITATIONS OF LIABILITY SET FORTH IN THIS ARTICLE 11 SHALL NOT APPLY TO (A) REQUESTER’S BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS SET FORTH IN THE SCIENCE EXCHANGE GENERAL TERMS AMD CONDITIONS; (B) REQUESTER’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 10 OF THIS SCHEDULE B; (C) ANY DAMAGE OR LIABILITY RESULTING FROM REQUESTER’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; (D) REQUESTER’S INFRINGEMENT OR MISAPPROPRIATION OF INTELLECTUAL PROPERTY RIGHTS; OR (E) REQUESTER’S OBLIGATION TO PAY FEES HEREUNDER.

11.3       Insurance. Science Exchange will carry, with financially sound and reputable insurers, commercially reasonable  amounts and types of insurance coverage (including, but not limited to, comprehensive general liability and workers' compensation) to secure the performance of its obligations under this Agreement. Upon request, Science Exchange will provide Requester with certificates of insurance evidencing such coverage.

SCHEDULE C
SCIENCE EXCHANGE CLINICAL TRIAL SERVICES SCHEDULE

1.       DEFINITIONS.

1.1      Case Report Form” or “CRF” means the case report form (paper or electronic) to be used by Service Provider to record all of the Protocol-required information to be reported to Requester on each Study Subject.

1.2      Confidential Information: means, in addition to Confidential Information as defined in the Science Exchange General Terms and Conditions,  (A) the following information disclosed by or on behalf of Requester to Service Provider, or Service Provider personnel: the Investigational Product, technical information relating to the Investigational Product, and the Protocol; (B) Study enrollment information, information pertaining to the status of the Study, communications to and from regulatory authorities, information relating to the regulatory status of the Investigational Product, and Study Data; (C) the Investigators’ Drug Brochure, information contained in or comprised of Investigational Product or other materials provided by or on behalf of Requester; (D) all approvals and correspondence with or from an IRB or other entities with oversight responsibilities for the Study, including ethics committees or data safety monitoring committees, all Study correspondence, all Investigational Product accountability forms, all CRFs and all other information generated by Service Provider, Investigator or Study Staff  in connection with the Study; (E) patent applications, technology, business plans, the Protocol and all information relating thereto; and (F) all proprietary biological, chemical or other materials; applications, formulas, manufacturing processes, basic scientific data, Study Data, prior clinical data and formulation information.

1.3      Good Clinical Practices” means the then-current standards, practices and procedures promulgated or endorsed by (A) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (B) the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA, and (C) the equivalent Applicable Laws in any relevant country, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.

1.4      IEC” has the meaning set forth in Section 2.2.

1.5      Investigational Product” means the compound/medical device identified in the Protocol that is being tested in the Study.

1.6      Investigator” means a qualified employee of, or contractor to, Service Provider experienced in the conduct of clinical studies in humans.

1.7      IRB” has the meaning set forth in Section 2.2.

1.8      Item(s) of Value” includes any payment or transfer of value as defined in the U.S. Physician Payment Sunshine Act (42 USC 1320(e)(10)), and implementing regulations (42 CFR 403.900 et seq). The term “Item(s) of Value” should be interpreted broadly and may include, but is not limited to, money or payments or equivalents, such as gift certificates; gifts or free goods; meals, entertainment, or hospitality; travel or payment of expenses; provision of services, including medical writing and publications assistance; purchase of property or services at inflated prices; assumption or forgiveness of indebtedness; intangible benefits, such as enhanced social or business standing (e.g., making donations to government official’s favored charity); and/or benefits to third persons related to government officials (e.g., close family members).

1.9      Medical Records” means the Study Subjects’ primary medical records kept by the Service Provider on behalf of the Investigator, including, without limitation, treatment entries, x-rays, biopsy reports, ultrasound photographs and other diagnostic images.

1.10      Protocol” means the written clinical protocol referenced in each Order, as such protocol may be modified from time to time by the Requester.

1.11      Study” means the human clinical trial that is to be performed in accordance with the Agreement and the Protocol for purposes of gathering information about the Investigational Product identified in the Protocol.

1.12      Study Data” means all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Requester pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product.

1.13      Study Facilities” means clinical facilities at which the Service Provider will perform such Study.

1.14      Study Staff” means the individuals involved in conducting the Study under the direction of the Investigator.

1.15      Study Subject” means an individual who participates in the Study, either as a recipient of the Investigational Product or as a control.

2.       CONDUCT OF THE STUDY

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 2 below.

2.1       Compliance with Laws, Regulations, and Good Clinical Practices
Service Provider, Investigator and Study Staff shall perform the Study in strict accordance with the Agreement (including this Schedule), the Protocol, any and all Applicable Laws.

2.2       Informed Consent Form
Service Provider shall use an informed consent form that has been approved by Requester and is in accordance with applicable regulations and the requirements of the Service Provider institutional review board (“IRB”) or independent ethics committee (“IEC”) that is responsible for reviewing the Study. Pursuant to the Service Provider Agreement, Service Provider shall obtain the prior written informed consent of each Study Subject.

2.3       Medical Records and Study Data

2.3.1 Collection, Storage and Destruction:  Service Provider shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records and Study Data.

Service Provider shall:

  1. maintain and store Medical Records and Study Data in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws;
  2. protect the Medical Records and Study Data from unauthorized use, access, duplication, and disclosure;
  3. if directed by Requester or Science Exchange, submit Study Data using the electronic system provided by Requester or Science Exchange or their designated representative and in accordance with Requester’s instructions for electronic data entry;
  4. prevent unauthorized access to the Study Data by maintaining physical security of the electronic system and ensuring that Investigator and Study Staff maintain the confidentiality of their passwords and ensure that Investigator collects all Study Data in Medical Records prior to entering it into the CRF. Service Provider shall ensure the prompt submission of CRFs;
  5. take measures to prevent accidental or premature destruction or damage of these documents, for as long as required by Applicable Laws; and
  6. not, and ensure that Investigator shall not, destroy or permit the destruction of any Medical Records or Study Data without prior written notification to the Requester, and continue to store Medical Records and Study Data, at the Requester’s expense, for any period that the Requester may request in writing after retention is no longer required by any Applicable Law.

If the Investigator is no longer employed or engaged by Service Provider, then responsibility for maintaining Medical Records and Study Data shall be determined in accordance with Applicable Law but Service Provider will not in any case be relieved of its obligations under the Agreement for maintaining the Medical Records and Study Data.

2.3.2 Ownership.  Service Provider shall retain ownership of Medical Records. Service Provider shall assign and shall ensure that Investigator assigns to Requester all of their rights, title and interest, including intellectual property rights, to all Study Data and other Confidential Information of Requester generated by or on behalf of Service Provider in connection with the Study. Without Requester's prior express written consent, neither Service Provider nor the Investigator will analyze or have Study Data analyzed, or make the Study Data available to third parties. Study Data and the results of any use, processing, evaluation, or analysis of the Study Data will be Confidential Information of the Requester.

2.3.3 Access, Use, Monitoring and Inspection.  Service Provider shall provide original or copies (as the case may be) of all Study Data to Science Exchange and Requester for Requester’s use. Service Provider shall afford Requester and Science Exchange and their representatives and designees reasonable access to Service Provider’s facilities, including Study Facilities, and to Medical Records and Study Data so as to permit Requester and Science Exchange and their representatives and designees to monitor the Study.

Without limiting the foregoing, Science Exchange, Requester or their respective representatives shall be entitled to visit or meet with Service Provider, Investigator and sub-investigators and examine, audit and inspect Service Provider facilities, including Study Facilities, upon reasonable advance notice and with reasonable frequency during normal business hours to observe the progress of the Study and review and copy documents, records, data, information, and materials relating to the Study.  Service Provider shall assist and shall ensure that Investigator assist Requester and Science Exchange in scheduling such visits and in providing adequate workspace, cooperate with the Requester or Science Exchange, comply with the legitimate requirements of the visit or inspection, and make appropriate Study Staff available to explain and discuss records and documentations related to the Study.  For Science Exchange or Requester inspections of Service Provider, Service Provider shall submit a written response to Requester for all non-conformances within fifteen (15) days after receipt of the inspection report.  Service Provider’s written response shall include the cause of each non-conformance, the underlying source of the cause, and a corrective action plan for each non-conformance.  Service Provider will complete all corrective actions for each non-conformance within ninety (90) days after the receipt of the inspection report.

Service Provider shall afford regulatory authorities reasonable access to Service Provider’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data.

Service Provider shall immediately notify Science Exchange and Requester of, and provide Science Exchange and Requester copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Service Provider’s facilities, and the Service Provider shall permit Science Exchange and Requester to attend any such inspections. Service Provider will make reasonable efforts to separate, and not disclose, Confidential Information that is not required to be disclosed during such inspections.

Service Provider shall promptly notify Science Exchange and Requester of any inspection of its facilities or operations relating to the Study, cooperate with the regulatory authorities, comply with the legitimate requirements of the audit, and make appropriate Study Staff available to explain and discuss records and documentations related to the Study.  Requester shall have the right to be present at inspections of the Service Provider’s facilities or operations or of the facilities, including those where the Study is conducted, and shall have the opportunity to provide review and comment on any responses that may be required.

Service Provider agrees to cooperate with the representatives of Science Exchange and Requester, and the Service Provider agrees to ensure that the employees, agents and representatives of the Service Provider do not harass, or otherwise create a hostile working environment for such representatives of Science Exchange and Requester.

2.3.4 Survival.  This Section 2.3 (“Medical Records and Study Data”) shall survive termination or expiration of the Agreement.

2.4       Duties of Investigator
Service Provider shall ensure that Investigator is responsible for the conduct of the Study at Service Provider and for supervising any individual or party to whom the Investigator delegates Study-related duties and functions. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions, to ensure that all informed consent requirements are met, to ensure that all required reviews and approvals by applicable regulatory authorities and IRBs or IECs are obtained, and to review all CRFs to ensure their accuracy and completeness.

If Service Provider retains the services of any individual or third party to perform Study-related duties and functions, the Service Provider shall ensure this individual or third party is qualified to perform those Study-related duties and functions and shall implement procedures to ensure the integrity of the Study-related duties and functions performed and any data generated.

Service Provider shall ensure that Investigator agrees to provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product.

Service Provider shall ensure that Investigator agrees to provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Service Provider in connection with the conduct of the Study and the Investigational Product.

Service Provider agrees to provide prompt advance notice to Requester and Science Exchange if Investigator will be leaving the Service Provider or is otherwise no longer able to perform the Study.  The appointment of a new Investigator must have the prior approval of Requester and Science Exchange.

2.5       Adverse Events
Service Provider shall report adverse events and serious adverse events as directed in the Protocol and by Applicable Laws.  The Service Provider shall cooperate with Requester in its efforts to follow-up on any adverse events. Service Provider shall comply with its IRB/IEC reporting obligations.

Requester shall promptly report to the Service Provider, the Service Provider’s IRB/IEC, and Science Exchange, any finding that could affect the safety of Study Subjects or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Service Provider’s IRB/IEC approval to continue the Study.

Deviations from the Protocol are not permitted except when necessary to protect the safety, rights or welfare of the Study Subjects. Service Provider and/or Investigator will, within one (1) business day from occurrence, or as specified in the Protocol, notify Science Exchange and Requester of any (A) deviation from the Protocol, including any deviations necessary to protect the safety, rights or welfare of the Study Subjects, (B) serious adverse event (as defined in the Protocol) which occurs to a Study Subject, or (C) communication with a regulatory agency concerning (I) the Study, including any requests to inspect, examine, copy or remove records of the Study, (II) another study which might have an impact on the Study, or (III) the qualification of Service Provider or Investigator to perform the Study.  In addition, Service Provider and/or Investigator will promptly report to Science Exchange and Requester any adverse event (as defined in the Protocol) which occurs to a Study Subject. Service Provider will not delay the report to Science Exchange and Requester of an adverse event because of incomplete information, which can be supplied later. None of Service Provider, the Investigator, or any Study Staff will report adverse events directly to regulatory authorities, except (X) with five (5) days prior notice to Science Exchange and Requester, (Y) to protect public safety and welfare, and (Z) if Service Provider reasonably believes Science Exchange or Requester is not reporting adverse events according to regulatory requirements.

2.6       Use and Return of Investigational Product and Equipment
Requester or a duly authorized agent of Requester shall supply Service Provider with sufficient amount of Investigational Product as described in the Protocol.

Service Provider shall maintain exclusive control of the Investigational Product (and shall under no circumstance transfer the Investigational Product to any third party), use the Investigational Product and any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and shall handle, store and maintain the Investigational Product as specified by Requester and the Protocol and according to Applicable Laws, including storage in a locked, secured area at all times.

Service Provider shall: (A) verify receipt of the Investigational Product by signing the appropriate documentation provided by Requester or Science Exchange; (B) store all Investigational Product securely as designated in the Protocol; (C) document the administration of the Investigational Product to Study Subjects; and (D) only dispense the Investigational Product to Study Subjects in accordance with the Protocol.

Upon completion or termination of the Study, Service Provider shall return or destroy, at Requester’s option, the Investigational Product, comparator products, and materials and all Confidential Information of Requester at Requester’s sole expense.

Service Provider shall comply with all Applicable Laws governing the disposition or destruction of Investigational Product and any instructions from Requester or Science Exchange that are not inconsistent with such Applicable Laws.

Service Provider shall return any equipment or materials provided by Requester for use in the Study unless Requester and Service Provider have a written agreement for Service Provider to acquire the equipment.

2.7       Key Enrolment Date
Service Provider understands and agrees that if Service Provider has not enrolled at least one (1) Study Subject by the key enrollment date set forth in the Protocol, then Requester and Science Exchange may terminate the applicable Order in accordance with Article 8 below (“Study Termination”). Requester/Science Exchange has the right to limit enrollment at any time.

2.8       Conduct of Study; Suspension.
Service Provider agrees to conduct the Study solely at the Study Facilities.  The Study Facilities may not be changed without Science Exchange’s or Requester’s prior written consent.  The Study shall commence as soon as possible following receipt of IRB/IEC written approval, or as otherwise agreed upon in writing with Science Exchange or Requester.  Requester or Science Exchange may suspend the entire Study (or a portion of the Study) at any time for any reason.  Service Provider may suspend the Study, if, using good medical judgment, Service Provider determines it is appropriate to do so for the medical benefit of the Study Subject participating in the Study. The suspension of the Study by Requester, Science Exchange, or Service Provider in accordance with this Section shall not be deemed a material breach of the Agreement. Service Provider will conduct the Study only at Study Facilities that are found to be adequate by Science Exchange or Requester. Service Provider will ensure that they remain adequate during the Study. Adequate Study Facilities, at minimum, are safe, secure, hygienic, include adequately-maintained and calibrated equipment, and provide for secure and accessible storage of the Investigational Product and other materials supplied by Requester and/or the Science Exchange hereunder and records. Service Provider will notify Science Exchange and Requester promptly of any detrimental change in its Study Facilities’ adequacy

3.       PAYMENT

In consideration for the proper performance of the Study by Service Provider in compliance with the terms and conditions of the Agreement (including this Schedule C), payments shall be made in accordance with the provisions set forth in the applicable Order, with the last payment being made after the Service Provider completes all its obligations hereunder, and Science Exchange or Requester has received all properly completed CRFs and, if Science Exchange or Requester requests, all other Confidential Information of Requester.

4.       CONFIDENTIALITY

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 4 below. In addition to the other obligations set forth in the Agreement regarding Confidential Information, Service Provider and Service Provider’s personnel, including the Investigator and Study Staff, shall not with respect to Requester Confidential Information disclosed or generated in connection with an Order for a Study use such Confidential Information for any purpose other than the performance of the Study. To protect Requester Confidential Information disclosed or generated in connection with an Order for a Study, Service Provider agrees to:

  1. limit dissemination of such Confidential Information to only the Investigator and those Study Staff having a need to know for purposes of performing the Study;
  2. advise the Investigator and all Study Staff who receive such Confidential Information of the confidential nature of such information; and
  3. use reasonable measures to protect such Confidential Information from disclosure and enter into written agreements with the Investigator and Study Staff with binding obligations of confidentiality and non-use no less stringent than those contained in the Agreement.

5.       PERSONAL DATA

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 5 below.

5.1       Personal Data
Both prior to and during the course of the Study, the Investigator and his/her teams may be called upon to provide personal data. This data falls within the scope of the law and regulations relating to the protection of personal data and may be used by Science Exchange, Requester, and their Affiliates in compliance with Applicable Law, including as set forth below and for the length of time reasonably necessary for the purposes below.

For the Investigator, this personal data may include names, contact information, work experience and professional qualifications, publications, resumes, educational background and information related to financial disclosures or other potential conflict of interest, and payments made to payee(s) under the Agreement for the following purposes:

  1. the conduct of clinical trials and/or statistical analysis;
  2. verification by governmental or regulatory agencies, the Requester, Science Exchange, and their agents and affiliates;
  3. compliance with legal and regulatory requirements;
  4. publication on www.clinicaltrials.gov and websites and databases that serve a comparable purpose;
  5. storage in databases to facilitate the selection of investigators for future clinical trials or other business; and
  6. anti-corruption compliance.

Investigator’s personal data may be transferred to countries outside of Investigator’s country, which may not provide for the same level of protection as is applicable in Investigator’s country. In such event, Science Exchange or Requester, as applicable, will make sure that appropriate safeguards are secured in advance of any transfer in accordance with Science Exchange’s or Requester’s, as applicable, legal obligations to ensure the protection of Investigator’s personal data according to the data protection laws and regulations applicable in Investigator’s country.

Names of members of Study Staff may be processed in Science Exchange’s and Requester’s study contacts database for study-related purposes only.

5.2       Study Subject Personal Data
The Service Provider shall obtain Study Subject written consent for the collection and use of Study Subject personal data for Study purposes, including the disclosure, transfer and processing of data collected in accordance with the Protocol, in compliance with applicable data protection provisions.

5.3       Patient Protection and Affordable Care Act
Service Provider acknowledges that, pursuant to the Patient Protection and Affordable Care Act (2010), Requester will make reports to the United States government disclosing information associated with transfers of value to Service Provider, including but not limited to payments and other transfers under the Agreement, which will be published by the government on a public website.

5.4       Survival
This Article 5 (“Personal Data”) shall survive termination or expiration of the Agreement.

6.       STUDY SUBJECT INJURY

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 6 below.

The Service Provider shall promptly notify Science Exchange and Requester in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Requester in the handling of the adverse event.

Requester shall reimburse Service Provider for the direct, reasonable and necessary medical expenses incurred by Service Provider for the treatment of any adverse event experienced by, illness of or bodily injury to a Study Subject that is caused by treatment of the Study Subject in accordance with the Protocol, except to the extent that such adverse event, illness or personal injury is caused by:

  1. failure by Service Provider, or any of their respective personnel to comply with the Agreement (including this Schedule), the Protocol, any written instructions of Requester concerning the Study, or any Applicable Law, including GCPs,, or
  2. negligence or willful misconduct by Investigator, Service Provider or any of its personnel,
  3. failure of the Study Subject to follow the reasonable instructions of the Investigator or Service Provider relating to the requirements of the Study,
  4. natural disease progression of any pre-existing disease or any underlying illness whether or not previously diagnosed, or
  5. Protocol procedures that are also standard of care (i.e., where the Study Subject would have undergone such procedures for the treatment of the underlying disease even if not participating in the Study).

This Article 6 (“Study Subject Injury”) shall survive termination or expiration of the Agreement.

7.       SCIENCE EXCHANGE DISCLAIMER

Science Exchange expressly disclaims any liability in connection with the Investigational Product, including any liability for any claim arising out of a condition caused by or allegedly caused by any Study procedures associated with such product except to the extent that such liability is caused by the negligence, willful misconduct or breach of the Agreement by Science Exchange.

This Article 7 (“Science Exchange Disclaimer”) shall survive termination or expiration of the Agreement.

8.       STUDY TERMINATION

Pursuant to the Provider Agreement, each Service Provider has agreed to comply with the terms applicable to it set forth in this Article 8 below.

Science Exchange or Requester may terminate an Order for a Study for any reason effective immediately upon written notice to the Service Provider.  The Service Provider may terminate an Order for a Study upon written notice if circumstances beyond the Service Provider’s reasonable control prevent completion of the Study, or if it reasonably determines that it is unsafe to continue the Study.  Upon receipt of notice of termination of an Order for a Study, the Service Provider shall immediately cease any Study Subject recruitment, follow the specified termination procedures, ensure that any required Study Subject follow-up procedures are completed, and make all reasonable efforts to minimize further costs, and Science Exchange shall make a final payment for visits or milestones properly performed pursuant to the Order for the Study in the amounts specified in applicable Order; provided, however, that ten percent (10%) of this final payment will be withheld until final acceptance by Requester of all CRF pages and all data clarifications issued and satisfaction of all other applicable conditions set forth herein.  If a material breach of the Agreement appears to have occurred and termination of an Order for a Study may be required, then, except to the extent that Study Subject safety may be jeopardized, Science Exchange or Requester may suspend performance of all or part of the Order, including, but not limited to, Study Subject enrollment.

SCHEDULE D
SCIENCE EXCHANGE TERMS AND CONDITIONS FOR THE SUPPLY OF GOODS

1.         DEFINITIONS.

1.1      CRO” means a for-profit or non-profit organization that performs scientific and research services on a fee-for-service basis for the benefit of a third-party customer.

1.2      Custom-Manufactured Products” mean non-off-the-shelf Products supplied hereunder to fit specific Requester-designed functions or requirements.

1.3      DMFs” has the meaning provided in Section 2.9 below.

1.4       “Mice” means mouse strains supplied by Service Provider, their unmodified progeny or descendants of any kind and biological materials derived therefrom, including, but not limited to, cells, tissues, gametes and embryonic stem cells.  Mice also includes any progeny resulting from cross-breeding of two or more Mice strains together as well as their unmodified descendants and any biological materials derived therefrom. Service Provider Materials shall include Mice.

1.5       “Modified Mice” means mouse strains produced by (A) breeding Mice with mouse strains other than Mice, or (B) otherwise introducing into Mice one or more heritable genetic mutations through genetic engineering of any kind resulting in a measurable or observable phenotypic change, as well as their progeny, descendants and any biological materials derived therefrom including, but not limited to, cells, tissues, gametes and embryonic stem cells, or (C) modifications through use of somatic transgenesis resulting in a measurable or observable phenotypic change. Requester Materials shall include Modified Mice.

1.6      Pre-Shipment Sample” has the meaning provided in Section 3.3 below.

1.7      Product” means the product or products described in the applicable Order. Products may include, without limitation, reagents, cell culture and other media, laboratory equipment and supplies, machinery, and other “goods” as defined in the Uniform Commercial Code and similar foreign laws and statutes.

1.8      Product Quality Agreement” means the written quality technical agreement between the Parties that describes the Parties’ quality control, technical, quality assurance and regulatory responsibilities relating to the manufacture and release of Product.  Additional provisions to be covered in the Product Quality Agreement may include annual product reviews, returned goods, complaints, compliance with Product specific GMPs and relevant manufacturing regulations, and such other quality related concerns as deemed necessary.

1.9      Product Specifications” means the specifications or similar requirements for each Product set forth in the applicable Order.

1.10      Product Warranty” has the meaning provided in Article 4 below.

1.11      Rejected Products” have the meaning provided in Section 3.5 below.

1.12      Rolling Forecast” has the meaning provided in Section 2.2 below.

1.13      Shortage of Supply” has the meaning provided in Section 2.7 below.

2.         PRODUCT SUPPLY.

Pursuant to the Provider Agreement, Service Provider agrees to comply with the terms applicable to it set forth in this Article 2 below.

2.1       Supply.  Subject to the terms and conditions of this Agreement and the applicable Order, Service Provider shall supply Products to Requester or its Affiliate(s).  Unless otherwise agreed in the Order, Service Provider will supply all equipment or machinery used by Service Provider in the manufacturing, holding, processing, testing and release of Products to the extent necessary to perform Service Provider’s obligations with regard to the supply of Products hereunder and the applicable Order.

2.2       Forecasts.  If so specified, and on the schedule set forth, in the applicable Order, Requester shall provide Service Provider with a written forecast of Requester’s estimated Product supply requirements for the period specified in the Order (each, a “Rolling Forecast”).  The Rolling Forecast will be non-binding and serve only as a good-faith estimate to facilitate Service Provider’s production scheduling.  Service Provider shall notify Requester within twenty (20) days (or such other time period as set forth in the Order) of receipt of each Rolling Forecast whether or not Service Provider can supply the amount of Products set forth therein.

2.3       Minimum Capacity.  If so specified in the applicable Order, at all times Service Provider shall reserve and maintain sufficient capacity, raw materials and other resources to manufacture and supply at least one hundred percent (100%) (or such other amount as set forth in the Order) of the quantities of Products set forth in the Rolling Forecasts.  At Requester’s reasonable request, Service Provider will discuss with such Requester current and projected capacity to manufacture and supply the Products.

2.4       Product Orders.   Each Order for Products will specify the price and quantity of each Product to be delivered as well as the delivery destination(s) and delivery date(s).

2.5       Cancellations. Except as specified in this Section 2.5 or as otherwise provided for in the Order, Orders for Product may be cancelled by Requester at any time and for any reason prior to shipment without additional charge.  Orders for Custom-Manufactured Products may be cancelled by Requester at any time for any reason, and shall be without charge if cancellation occurs within sufficient time to enable Service Provider to cancel without incurring any significant cost. In the event that Requester fails to cancel an Order for any Custom-Manufactured Product within the time period set forth in the immediately preceding sentence, Requester shall be responsible for Service Provider’s reasonable out-of-pocket costs actually incurred to manufacture such ordered Custom-Manufactured Products through the date of notice of cancellation (including costs of raw materials and labor), as evidenced by detailed written documentation. Service Provider will use its reasonable efforts to mitigate and minimize such costs.

2.6       Shipping.  Unless otherwise provided for in the Order, Service Provider shall deliver the Products ordered by Requester in accordance with Section 2.5 to the location specified in the applicable Order no earlier or later than fifteen (15) days of the delivery dates specified in the applicable Order.  Service Provider shall make all arrangements and payments for delivery. Except as may otherwise be set forth in the Order, all shipments will be FCA (Incoterms 2020), Service Provider’s loading dock.  Title to Products and risk of loss or damage thereto will pass to Requester at the time such Products are delivered to the common carrier. Service Provider shall ship Products in accordance with any agreed-upon shipment specifications or as otherwise agreed in writing by the Service Provider and the Requester and in accordance with this Agreement and the applicable Order.  Service Provider shall package and ship all Products in accordance with standard industry practices that meet or exceed Applicable Laws, including the U.S. Department of Transportation and the International Air Transport Association requirements, at no additional charge. Service Provider is solely responsible for any damage to or loss of Product resulting from defective packaging, improper packing or marking, or other failure to deliver Product in accordance with this Agreement.

2.7       Shortage of Supply; Safety Stock.  If Service Provider anticipates for any reason that it will not be able to manufacture and supply to Requester the quantities of Products in the required time frames (“Shortage of Supply”), Service Provider shall promptly notify Requester in writing, which notice shall include a detailed explanation of the reason for such inability.  Without limiting Service Provider’s obligations to supply the required quantities of Products in a timely manner, in the event of a Shortage of Supply or any scarcity of capacity, raw materials, or other resources that restricts Service Provider’s ability to manufacture and supply Products, Service Provider shall ensure that Requester receives at least its pro rata share of Products (during shortage and ramp up periods).  To help ensure continuity of supply, if and only to the extent set forth in the applicable Order, Service Provider will hold safety stock of Products sufficient for one (1) year of demand by Requester (as set forth in the then-current Rolling Forecast) or such other period of time as may be specified in the Order.

2.8       Right of Reference. Requester and its Affiliates shall have a right of reference to Service Provider drug master files (“DMFs”) and other regulatory documents for Products to the extent necessary or reasonably useful for Requester’s regulatory requirements for its products incorporating or made using Product. Service Provider shall provide to Requester upon request, a cross-reference letter or similar communication to the applicable regulatory authority to effectuate the right of reference for Product. If Service Provider has not filed a DMF in any jurisdiction or has not or cannot give Requester, its Affiliates a right of access to any manufacturing know-how required to be included in any regulatory filing, Service Provider will provide such know-how to such Party’s regulatory group for the sole purpose of preparing and filing applications for and maintaining regulatory approvals. Service Provider will not terminate or allow any DMF to expire without first obtaining Requester’s prior written consent.

2.9       Price.  Except as otherwise specified in the applicable Order, all prices for Product include, and Service Provider is solely responsible for, all costs and expenses relating to packing, crating, boxing, transporting, loading and unloading, customs, tariffs and duties, insurance, and any other similar financial contributions or obligations relating to the production, manufacture, sale, and delivery of the Products. Unless otherwise specified in the applicable Order, all amounts payable for Product shall be in U.S. Dollars.

2.10       Mice and Modified Mice. Requester and its Affiliates shall not use Mice or Modified Mice for (A) the development of a library of mouse embryonic stem cells; (B) the commercial sale or lease of any Mice or Modified Mice; (C) use of any Mice or Modified Mice or in the performance of fee-for-service contract research or development services for a third party, including but not limited to use in contract testing services; or (D) the generation, development, manufacture or importation of any Mice or Modified Mice for any of the foregoing. Subject to the foregoing limitations, any Mice and Modified Mice that are a Deliverable will be used solely for internal research, which may include: (1) breeding of Mice, or crossbreeding or genetic engineering of any kind leading to Modified Mice, provided that any resulting strain shall be subject to this Agreement; (2) transfer of Modified Mice to a CRO to provide services, including breeding or crossbreeding services, solely for the benefit of Requester or its Affiliates; (3) transfer of Modified Mice to a non-CRO research collaborator or other recipient for the research collaborator’s or other recipient’s internal research use; or (4) transfer of Mice to a CRO to provide services other than breeding or crossbreeding solely for the benefit of Requester or its Affiliates. To the extent that Service Provider owns or controls (with the right to sublicense) Intellectual Property Rights applicable to the Mice and Modified Mice, these rights are licensed to Requester and its Affiliates on a non-exclusive, royalty-free, fully paid-up, perpetual, non-transferable, and non-sublicensable (except as permitted above) basis for Requester and its Affiliates internal research use on the terms set forth above in this Section 2.10.

3.         PRODUCT QUALITY; ACCEPTANCE AND REJECTION.

Pursuant to the Provider Agreement, Provider agrees to comply with the terms applicable to it set forth in this Article 3 below.

3.1       Quality Systems and Assurance.  The quality management system and standards employed by Service Provider to manage and monitor Product quality shall be based upon and in accordance with Applicable Laws, and as set forth in the Product Quality Agreement if one is in place.  Prior to each shipment of Product, Service Provider shall perform quality control procedures reasonably necessary to ensure that the Product to be shipped conforms fully to the Product Specifications and other warranties set forth herein.  Each shipment of Product must be accompanied by reasonable documentation identifying the Product lot number(s) and describing all current requirements of the applicable Product Specifications and results of tests performed certifying that the quantities of each Product supplied have been manufactured, controlled and released according to the applicable Product Specifications.

3.       Product Quality Agreement.  If so reasonably requested by the Requester, Service Provider and Requester shall execute a mutually agreeable Product Quality Agreement, which, upon execution, will also govern quality aspects of the Orders for Products, provided that such Product Quality Agreement shall not be deemed to have changed or modified any of the terms and conditions of this Agreement.

3.3       Pre-Shipment Sample. Unless otherwise provided for in the applicable Order, upon Requester’s reasonable written request Service Provider will provide Requester with a sample of a manufactured lot of Product (a “Pre-Shipment Sample”) for the purpose of determining whether such sample conforms to the Product Specifications.  Unless otherwise provided for in the applicable Order, within thirty (30) days of receiving such Pre-Shipment Sample, Requester shall notify Service Provider in writing as to whether or not the Pre-Shipment Sample conforms to the Product Specifications. If the Pre-Shipment Sample conforms to the Product Specifications or Requester fails to notify Service Provider in writing within the thirty (30) day (or other) period that it does not conform, Service Provider shall deliver to Requester the Products in accordance with the terms of this Agreement. If Requester submits a notice of non-conformity, it shall also describe the specific reasons that the Pre-Shipment Sample does not conform and, upon Service Provider's written request, Requester shall return such Pre-Shipment Sample to Service Provider within seven (7) days or such other period provided for in the applicable Order. Requester shall cooperate with Service Provider in determining the basis of non-conformance. Unless otherwise provided for in the applicable Order, within thirty (30) days of receiving the notice of non-conformance and Service Provider's confirmation that the Pre-Shipment Sample does not comply with the Product Specifications, Service Provider shall have at its option, the right to rectify the reason for non-conformance or send a replacement Pre-Shipment Sample to Requester.

3.4       Inspection of Product by Requester. Upon Requester’s or its Affiliates’ receipt of Products, Requester or its Affiliates shall visually inspect the Products and notify Service Provider within thirty (30) days (or such other time period set forth in the applicable Order) after receipt of any claims for visible shortages or excess, defects or damages.

3.5       Returns; Non-Conforming Products.  Requester or its Affiliates, as the case may be, shall have the right at their sole discretion to return any Products for any reason whatsoever and without charge to it within thirty (30) days of receiving such Products (or such other time period set forth in the applicable Order).  Requester or its Affiliates, as the case may be, may reject any Product(s) that do not conform to Product Specifications (“Rejected Products”) (A) for “patent defects”, meaning those non-conformities that are capable of detection upon a reasonable visual inspection, within thirty (30) days after receipt of the Products (or such other time period set forth in the applicable Order); or (B) for “latent defects”, meaning those that are not capable of detection upon a reasonable visual inspection, within sixty (60) days from the date of discovery of such non-conformity (or such other time period set forth in the applicable Order). Requester or its Affiliates shall inform Service Provider of such rejection by providing written notice and shall return the Rejected Product to Service Provider in accordance with Service Provider's instructions at Service Provider’s cost. Service Provider shall not replace Rejected Products without the written consent of Requester or its Affiliates, as the case may be.

3.6       Testing of Products. Payment for or usage of Products for the purpose of testing such Products shall not constitute acceptance of such Products by Requester. Requester shall have no obligation to test or reject any Product, and Requester’s inspection of, or failure to inspect or reject, any Product shall not affect any rights of Requester under this Agreement and the applicable Order.

3.7       Recall. If Service Provider reasonably believes a recall may be necessary with respect to any Product provided under this Agreement, Service Provider shall promptly, and in all events within two (2) business days of such determination, notify Requester in writing. Requester shall have sole discretion, unless otherwise required by a regulatory authority, over whether and under what circumstances to require the recall or withdrawal of any product containing the Product. Service Provider shall provide reasonable assistance to Requester in conducting a recall or withdrawal, including providing Requester with all reasonably pertinent records and information.  Service Provider shall be responsible for all costs and expenses in connection with the recall of any Requester product which contains non-conforming Product, including expenses and other costs or obligations owed to third parties (for example, costs imposed by distributors), the cost and expense of notifying customers, the cost and expense associated with shipment of such recalled Requester product, and the cost and expense of replacing and destroying such Requester product that is removed from the market, if necessary.

3.8       Change Notice. Unless otherwise provided for in the applicable Order, Service Provider shall provide Requester with at least ninety (90) days’ prior written notice of any proposed change to the Product Specifications.  Unless otherwise provided for in the applicable Order, within thirty (30) days after sending such notice to Requester, Service Provider shall send Requester samples of such Product manufactured in accordance with such proposed modified Product Specifications.

3.9       Waste Disposal. The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated in connection with the manufacture and supply of Product hereunder will be the responsibility of Service Provider at Service Provider’s sole cost and expense. Without limiting other applicable requirements, Service Provider will prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Law.

3.10       Safety Procedures. Service Provider will be solely responsible for implementing and maintaining health and safety procedures in connection with the manufacture and supply of Product hereunder and for the handling of any materials or hazardous waste used in or generated in connection therewith. Requester will have no responsibility for Service Provider’s health and safety program.

3.11       Permits and Approvals.  Service Provider will ensure that any and all permits, licenses, registrations, and approvals required by Applicable Law have been obtained in connection with each facility used in connection with the manufacture or supply of Products.  Service Provider will maintain each such facility in a state of repair and operating efficiency consistent with prevailing industry practices and all Applicable Law. Service Provider will only use disposal services or sites that have appropriate environmental permits and are in compliance with Applicable Law.

4.         Product Warranty.

In addition to all other representations and warranties in the Agreement, Service Provider warrants that all Products delivered to Requester at the time of delivery (A) will have been manufactured in accordance with Applicable Law (including GMP if applicable), the terms of this Agreement, the Order and the terms of the Product Quality Agreement, (B) will be delivered with full title, free and clear of any liens or encumbrances or security interests, (C) conform to the applicable Product Specifications from the date that Service Provider delivers the Product to Requester until the end of the shelf life of such Product (or such other period as specified in the applicable Order) (the “Product Warranty”).  In the event that Product does not conform with the Product Warranty, Requester or the Affiliates, as the case may be, shall notify Service Provider and Service Provider shall, if so requested by Requester or the Affiliates, replace all rejected Product within the shortest commercially reasonable time possible at no additional cost to Requester or the Affiliates (including transportation costs). If Service Provider does not provide replacement Product immediately that conforms with the Product Warranty or Requester or the Affiliates does not ask for a replacement, Service Provider shall refund any amounts paid by Requester or the Affiliates to Service Provider for such Product.  Upon the written request of Requester or the Affiliates, unless otherwise specified in the applicable Order Service Provider shall (X) pass through any applicable third-party manufacturer’s warranty or assign its warranty rights to Requester or its Affiliates to the extent permitted by such Product manufacturer's warranty and (Y) provide to Requester or the Affiliates a copy of such manufacturer’s warranty.

EXHIBIT B

Graphical user interface, text, application, email

EXHIBIT C

Standard Contractual Clauses (Processors)

For the purposes of Article 26(2) of Directive 95/46/EC for the transfer of personal data to processors established in third countries which do not ensure an adequate level of data protection.

Name of the data exporting organisation: Requester.

(the data exporter)

And

Name of the data importing organisation: Science Exchange.

(the data importer)

each a “party”; together “the parties”,

HAVE AGREED on the following Contractual Clauses (the Clauses) in order to adduce adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals for the transfer by the data exporter to the data importer of the personal data specified in Appendix 1.

Clause 1
Definitions

For the purposes of the Clauses:

  1. 'personal data', 'special categories of data', 'process/processing', 'controller', 'processor', 'data subject' and 'supervisory authority' shall have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data;
  2. 'the data exporter' means the controller who transfers the personal data;
  3. 'the data importer' means the processor who agrees to receive from the data exporter personal data intended for processing on his behalf after the transfer in accordance with his instructions and the terms of the Clauses and who is not subject to a third country's system ensuring adequate protection within the meaning of Article 25(1) of Directive 95/46/EC;
  4. 'the subprocessor' means any processor engaged by the data importer or by any other subprocessor of the data importer who agrees to receive from the data importer or from any other subprocessor of the data importer personal data exclusively intended for processing activities to be carried out on behalf of the data exporter after the transfer in accordance with his instructions, the terms of the Clauses and the terms of the written subcontract;
  5. 'the applicable data protection law' means the legislation protecting the fundamental rights and freedoms of individuals and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established;
  6. 'technical and organisational security measures' means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing.

Clause 2
Details of the transfer

The details of the transfer and in particular the special categories of personal data where applicable are specified in Appendix 1 which forms an integral part of the Clauses.

Clause 3
Third-party beneficiary clause

  1. The data subject can enforce against the data exporter this Clause, Clause 4(b) to (i), Clause 5(a) to (e), and (g) to (j), Clause 6(1) and (2), Clause 7, Clause 8(2), and Clauses 9 to 12 as third-party beneficiary.
  2. The data subject can enforce against the data importer this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where the data exporter has factually disappeared or has ceased to exist in law unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law, as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity.
  3. The data subject can enforce against the subprocessor this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity. Such third-party liability of the subprocessor shall be limited to its own processing operations under the Clauses.
  4. The parties do not object to a data subject being represented by an association or other body if the data subject so expressly wishes and if permitted by national law.

Clause 4
Obligations of the data exporter

The data exporter agrees and warrants:

  1. that the processing, including the transfer itself, of the personal data has been and will continue to be carried out in accordance with the relevant provisions of the applicable data protection law (and, where applicable, has been notified to the relevant authorities of the Member State where the data exporter is established) and does not violate the relevant provisions of that State;
  2. that it has instructed and throughout the duration of the personal data processing services will instruct the data importer to process the personal data transferred only on the data exporter's behalf and in accordance with the applicable data protection law and the Clauses;
  3. that the data importer will provide sufficient guarantees in respect of the technical and organisational security measures specified in Appendix 2 to this contract;
  4. that after assessment of the requirements of the applicable data protection law, the security measures are appropriate to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing, and that these measures ensure a level of security appropriate to the risks presented by the processing and the nature of the data to be protected having regard to the state of the art and the cost of their implementation;
  5. that it will ensure compliance with the security measures;
  6. that, if the transfer involves special categories of data, the data subject has been informed or will be informed before, or as soon as possible after, the transfer that its data could be transmitted to a third country not providing adequate protection within the meaning of Directive 95/46/EC;
  7. to forward any notification received from the data importer or any subprocessor pursuant to Clause 5(b) and Clause 8(3) to the data protection supervisory authority if the data exporter decides to continue the transfer or to lift the suspension;
  8. to make available to the data subjects upon request a copy of the Clauses, with the exception of Appendix 2, and a summary description of the security measures, as well as a copy of any contract for subprocessing services which has to be made in accordance with the Clauses, unless the Clauses or the contract contain commercial information, in which case it may remove such commercial information;
  9. that, in the event of subprocessing, the processing activity is carried out in accordance with Clause 11 by a subprocessor providing at least the same level of protection for the personal data and the rights of data subject as the data importer under the Clauses; and
  10. that it will ensure compliance with Clause 4(a) to (i).

Clause 5
Obligations of the data importer

The data importer agrees and warrants:

  1. to process the personal data only on behalf of the data exporter and in compliance with its instructions and the Clauses; if it cannot provide such compliance for whatever reasons, it agrees to inform promptly the data exporter of its inability to comply, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract;
  2. that it has no reason to believe that the legislation applicable to it prevents it from fulfilling the instructions received from the data exporter and its obligations under the contract and that in the event of a change in this legislation which is likely to have a substantial adverse effect on the warranties and obligations provided by the Clauses, it will promptly notify the change to the data exporter as soon as it is aware, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract;
  3. that it has implemented the technical and organisational security measures specified in Appendix 2 before processing the personal data transferred;
  4. that it will promptly notify the data exporter about:
    1. any legally binding request for disclosure of the personal data by a law enforcement authority unless otherwise prohibited, such as a prohibition under criminal law to preserve the confidentiality of a law enforcement investigation,
    2. any accidental or unauthorised access, and
    3. any request received directly from the data subjects without responding to that request, unless it has been otherwise authorised to do so;
  5. to deal promptly and properly with all inquiries from the data exporter relating to its processing of the personal data subject to the transfer and to abide by the advice of the supervisory authority with regard to the processing of the data transferred;
  6. at the request of the data exporter to submit its data processing facilities for audit of the processing activities covered by the Clauses which shall be carried out by the data exporter or an inspection body composed of independent members and in possession of the required professional qualifications bound by a duty of confidentiality, selected by the data exporter, where applicable, in agreement with the supervisory authority;
  7. to make available to the data subject upon request a copy of the Clauses, or any existing contract for subprocessing, unless the Clauses or contract contain commercial information, in which case it may remove such commercial information, with the exception of Appendix 2 which shall be replaced by a summary description of the security measures in those cases where the data subject is unable to obtain a copy from the data exporter;
  8. that, in the event of subprocessing, it has previously informed the data exporter and obtained its prior written consent;
  9. that the processing services by the subprocessor will be carried out in accordance with Clause 11;
  10. to send promptly a copy of any subprocessor agreement it concludes under the Clauses to the data exporter.

Clause 6
Liability

  1. The parties agree that any data subject, who has suffered damage as a result of any breach of the obligations referred to in Clause 3 or in Clause 11 by any party or subprocessor is entitled to receive compensation from the data exporter for the damage suffered.
  2. If a data subject is not able to bring a claim for compensation in accordance with paragraph 1 against the data exporter, arising out of a breach by the data importer or his subprocessor of any of their obligations referred to in Clause 3 or in Clause 11, because the data exporter has factually disappeared or ceased to exist in law or has become insolvent, the data importer agrees that the data subject may issue a claim against the data importer as if it were the data exporter, unless any successor entity has assumed the entire legal obligations of the data exporter by contract of by operation of law, in which case the data subject can enforce its rights against such entity.
     
    The data importer may not rely on a breach by a subprocessor of its obligations in order to avoid its own liabilities.
  3. If a data subject is not able to bring a claim against the data exporter or the data importer referred to in paragraphs 1 and 2, arising out of a breach by the subprocessor of any of their obligations referred to in Clause 3 or in Clause 11 because both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, the subprocessor agrees that the data subject may issue a claim against the data subprocessor with regard to its own processing operations under the Clauses as if it were the data exporter or the data importer, unless any successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law, in which case the data subject can enforce its rights against such entity. The liability of the subprocessor shall be limited to its own processing operations under the Clauses.

Clause 7
Mediation and jurisdiction

  1. The data importer agrees that if the data subject invokes against it third-party beneficiary rights and/or claims compensation for damages under the Clauses, the data importer will accept the decision of the data subject:
    1. to refer the dispute to mediation, by an independent person or, where applicable, by the supervisory authority;
    2. to refer the dispute to the courts in the Member State in which the data exporter is established.
  2. The parties agree that the choice made by the data subject will not prejudice its substantive or procedural rights to seek remedies in accordance with other provisions of national or international law.

Clause 8
Cooperation with supervisory authorities

  1. The data exporter agrees to deposit a copy of this contract with the supervisory authority if it so requests or if such deposit is required under the applicable data protection law.
  2. The parties agree that the supervisory authority has the right to conduct an audit of the data importer, and of any subprocessor, which has the same scope and is subject to the same conditions as would apply to an audit of the data exporter under the applicable data protection law.
  3. The data importer shall promptly inform the data exporter about the existence of legislation applicable to it or any subprocessor preventing the conduct of an audit of the data importer, or any subprocessor, pursuant to paragraph 2. In such a case the data exporter shall be entitled to take the measures foreseen in Clause 5 (b).

Clause 9
Governing Law

The Clauses shall be governed by the law of the Member State in which the data exporter is established.

Clause 10
Variation of the contract

The parties undertake not to vary or modify the Clauses. This does not preclude the parties from adding clauses on business related issues where required as long as they do not contradict the Clause.

Clause 11
Subprocessing

  1. The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the subprocessor which imposes the same obligations on the subprocessor as are imposed on the data importer under the Clauses. Where the subprocessor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the subprocessor's obligations under such agreement.
  2. The prior written contract between the data importer and the subprocessor shall also provide for a third- party beneficiary clause as laid down in Clause 3 for cases where the data subject is not able to bring the claim for compensation referred to in paragraph 1 of Clause 6 against the data exporter or the data importer because they have factually disappeared or have ceased to exist in law or have become insolvent and no successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law. Such third-party liability of the subprocessor shall be limited to its own processing operations under the Clauses.
  3. The provisions relating to data protection aspects for subprocessing of the contract referred to in paragraph 1 shall be governed by the law of the Member State in which the data exporter is established.
  4. The data exporter shall keep a list of subprocessing agreements concluded under the Clauses and notified by the data importer pursuant to Clause 5 (j), which shall be updated at least once a year. The list shall be available to the data exporter's data protection supervisory authority.

Clause 12
Obligation after the termination of personal data processing services

  1. The parties agree that on the termination of the provision of data processing services, the data importer and the subprocessor shall, at the choice of the data exporter, return all the personal data transferred and the copies thereof to the data exporter or shall destroy all the personal data and certify to the data exporter that it has done so, unless legislation imposed upon the data importer prevents it from returning or destroying all or part of the personal data transferred. In that case, the data importer warrants that it will guarantee the confidentiality of the personal data transferred and will not actively process the personal data transferred anymore.
  2. The data importer and the subprocessor warrant that upon request of the data exporter and/or of the supervisory authority, it will submit its data processing facilities for an audit of the measures referred to in paragraph 1.

APPENDIX 1 TO THE STANDARD CONTRACTUAL CLAUSES

This Appendix forms part of the Clauses and must be completed by the parties.

The Member States may complete or specify, according to their national procedures, any additional necessary information to be contained in this Appendix.

Data exporter
The data exporter is: Requester.

Data importer
The data importer is: Science Exchange.

Data subjects The personal data transferred concern the following categories of data subjects: Data Subjects whose Personal Data is processed pursuant to the Agreement.

Categories of data The personal data transferred concern the following categories of data: Personal Data that is processed pursuant to the Agreement.

Special categories of data (if appropriate) The personal data transferred concern the following special categories of data: Personal Data that is considered a special category of personal data under Applicable Laws and processed pursuant to the Agreement.

Processing operations The personal data transferred will be subject to the following basic processing activities: Processing to provide the Services in accordance with the Agreement.

APPENDIX 2 TO THE STANDARD CONTRACTUAL CLAUSES

This Appendix forms part of the Clauses and must be completed by the parties.

Description of the technical and organisational security measures implemented by the data importer in accordance with Clauses 4(d) and 5(c):

Science Exchange will implement and maintain appropriate technical and organisational measures designed to protect Personal Data in accordance with the Agreement.