This Standard Service Agreement (the “Agreement”) set forth below govern the performance of services by GenScript Probio USA Inc. and/or its Affiliates ("PROBIO") for you (the "Client").
This Agreement and any work order (including Project Proposal(s) and Quotation(s) therein, collectively, each a “Work Order”) accepted by the Client shall govern the provision of services included in a Work Order by PROBIO to Client (the “Services”). PROBIO’s failure to object to any terms and conditions contained in any purchase order or other document from the Client will neither be construed as PROBIO’S acceptance of such terms and conditions, or a waiver of any terms of this Agreement. To make clarification, this Agreement does not apply to GMP or Non-GMP manufacturing services provided by PROBIO, for which PROBIO and Client will enter into other applicable service agreements.
2. Work Orders.
The specific details of each project under this Agreement (each “Project”) shall be specified in the Work Order. Each Work Order will include, as appropriate, the scope of work, including the specific Services to be provided by PROBIO, time line, deliverables, quality standards, and budget and payment schedule. Each Work Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the applicable Work Order expressly and specifically states an intent to supersede the Agreement on a specific matter.
3. Change Orders.
Any change in the details of a Work Order or the assumptions upon which the Work Order is based (including, but not limited to, changes in an agreed starting date for a Project or suspension of the Project by Client) may require changes in the budget and/or time lines, and shall require a written amendment to the Work Order (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, budget, time line or other matter. No Change Order will be effective until it has been signed by an authorized representative of PROBIO and Client. PROBIO shall be entitled to terminate any Work Order without any liability to Client if no written agreement could be reached by the parties regarding any changes and/or adjustment of compensation and/or costs required by a Change Order requested by Client.
4. Shipment and Acceptance.
All of deliverables of the Services are provided FCA PROBIO’s facility. They are delivered when PROBIO load them on to a commercial carrier. At this point the Client becomes responsible for risk of loss and damage of the deliverables. Client understands that PROBIO shall file several forms to acquire export license or other regulatory approval for the export of deliverables of the Services, any delay arising out of the change of the regulations or requirements of the regulatory authorities or any action of the regulatory authorities shall not be deemed as PROBIO’s breach or default of the obligations or warranties under this Agreement or Work Order. Upon receipt of Services, Client will provide written acknowledgement of receipt in writing or by email within two (2) business days and review the contents of such Service to determine whether they conform substantially to the specifications of the applicable Work Order. Acceptance of Service will occur on the earlier of the date: (a) on which Client indicates in writing to PROBIO acceptable; (b) on which ten (10) business days have passed following Client’s receipt of such Service or work result for acceptance if within that period Client fails to indicate whether they are accepted.
5. Payment and Tax.
Client will pay PROBIO for fees, expenses and pass-through costs in accordance with the budget and payment schedule contained in each Work Order. Unless otherwise agreed in a particular Work Order, the following shall apply: (a) PROBIO will invoice Client for the fees, expenses and pass-through costs incurred in performing the Services according to the Milestone; and, (b) Client shall pay each invoice within seven (7) working days of the date it receives the invoice. If any portion of an invoice is disputed, then Client shall pay the undisputed amounts as set forth in the preceding sentence and the parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. Client shall pay PROBIO interest in an amount equal to one point five percent (1.5%) per month (or the maximum lesser amount permitted by law) of all undisputed amounts owing hereunder and not paid within thirty (30) days of the date of the invoice. Unless otherwise agreed in the applicable Work Order, all taxes arising from the business activities, including but not limited to any use tax, sales tax, excise tax, custom duty, inspection or testing fee, or any other non-income-related taxes, fees, duties or charges imposed by any governmental authority, relating to or measured by the transaction, in addition to the prices quoted or invoiced for each Work Order shall be borne and paid by Client. If PROBIO is required to pay any such taxes (except for any taxes owed for PROBIO income), custom duties, fees or charges, Client shall reimburse PROBIO therefor or provide PROBIO with an exemption certificate or other document acceptable to the authority imposing the taxes, duties, fees, or charges at the time the order is placed.
Client represents and warrants that to its knowledge, Client’s instruction, specification, process, materials, including materials supplied or designated by Client, do not and will not violate or infringe the Intellectual Property Right of any third party, except to the extent that such infringement arises as a result of PROBIO’s breach of its representations or warranties as set forth below.
7. Ownership and Inventions.
7.1 All data and information derived by PROBIO as the result of Services performed by PROBIO under this Agreement (“Results”) shall be and remain the exclusive property of Client. Any inventions that may evolve from the Results described above or otherwise as the result of Services performed by PROBIO under this Agreement, including but not limited to discoveries, improvements, ideas, processes, formulations, products, computer programs, works of authorship, databases, trade secrets, know-how, information, data, documentation, reports, research, creations and all other products and/or materials arising from or made in the performance of Services (“Project Inventions”), shall belong to Client and PROBIO agrees to, and does hereby, assign its rights and interest in and to all such Results and Project Inventions and/or related intellectual property and/or other proprietary rights to Client, such assignment to automatically become effective upon Client’s full payment of service fee. PRIOBIO further acknowledges and agrees that such assignments may include rights and inventions not yet in existence, and agrees to take further actions, including executing additional documents, at Client’s reasonable expense, to further evidence or record such assignments.
7.2 Notwithstanding the foregoing, Client acknowledges that PROBIO possesses certain inventions, processes, know-how, trade secrets, template, methodologies, improvements, other intellectual properties and other assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, cell lines, plasmids, personnel data, financial information, computer technical expertise and software, which have been independently developed by PROBIO prior to the Effective Date of this Agreement and which relate to its business or operations (collectively “PROBIO’s Property”). Client and PROBIO agree that any PROBIO’s Property and improvements thereto which are (a) used, improved, modified or developed by PROBIO under or during the term of this Agreement and (b) do not arise from or include any Client Confidential Information or materials, are the sole and exclusive property of PROBIO.
8.1 It is understood that during the course of this Agreement, PROBIO and its employees may be exposed to data and information that are confidential and proprietary to Client. All such data and information (hereinafter “Client Confidential Information”) written or verbal, tangible or intangible, made available, disclosed, or otherwise made known to PROBIO and its employees as a result of Services under this Agreement shall be considered confidential and shall be considered the sole property of Client.
8.2 All information regarding PROBIO’ operations, methods, and pricing and all PROBIO’ Property (as defined in Section 7.2), disclosed by PROBIO to Client in connection with this Agreement is proprietary, confidential information belonging to PROBIO (the “PROBIO Confidential Information”, and together with the Client Confidential Information, the “Confidential Information”).
8.3 The Confidential Information shall be used by the receiving party and its employees only for purposes of performing the receiving party’s obligations hereunder. Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without the prior written consent of the disclosing party. Each party agrees that it will not disclose the terms of this Agreement or any Work Order to any third party without the written consent of the other party, which shall not unreasonably be withheld.
8.4 These obligations of confidentiality and nondisclosure shall remain in effect for a period of ten (10) years after the completion or termination of this Agreement except such Confidential Information are trade secrets which shall be treated confidential permanently until the disclosing party no longer treat such Confidential Information as a trade secret.
8.5 The foregoing obligations shall not apply to Confidential Information to the extent that a receiving party can demonstrate it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party or its Affiliates or personnel; (b) becomes available to the receiving party on a non-confidential basis from a source which is not prohibited from disclosing such information; (c) was developed independently of any disclosure by the disclosing party or was known to the receiving party prior to its receipt from the disclosing party, as shown by contemporaneous written evidence; or, (d) is required by law or regulation to be disclosed.
9. Records and Materials.
At the completion of the Services by PROBIO, all materials, information and all other data owned by Client, regardless of the method of storage or retrieval, shall be delivered to Client in such form as is then currently in the possession of PROBIO, subject to the payment obligations set forth in Section 5 herein. Alternatively, at Client’s written request, such materials and data may be retained by PROBIO for Client for an agreed-upon time period, or disposed of pursuant to the written directions of Client. Client shall pay the costs associated with any of the above options and shall pay a to-be-determined fee (or the fee set forth in the applicable Work Order) for storage by PROBIO of records and materials after completion or termination of the Services. PROBIO, however, reserves the right to retain, at its own cost and subject to the confidentiality provisions herein, the original documents, information, data and all materials (if any) that may be needed to satisfy regulatory requirements, self-archiving policy or to resolve disputes regarding the Services.
10. Regulatory Compliance; Inspections.
10.1 PROBIO agrees that its Services will be conducted in full compliance with all applicable laws, rules and regulations, and with the standard of care customary in the contract research organization industry. PROBIO shall not be liable for any adverse events or other problems occurring during clinical trials performed, directed or sponsored by Client related to deliverables of Services provided by PROBIO pursuant to applicable Work Order.
10.2 PROBIO’ standard operating procedures will be used in performance of the Services, unless otherwise specifically stated in the Work Order. PROBIO certifies that it has not been debarred and that it will not knowingly employ any person or entity that has been so debarred to perform any Services under this Agreement. Client represents and certifies that it will not require PROBIO to perform any assignments or tasks in a manner that Client’s knows or should know would violate any applicable law or regulation. Client further represents that it will reasonably cooperate with PROBIO in taking any actions that PROBIO reasonably believes are necessary to comply with the regulatory obligations that have been transferred to PROBIO.
10.3 Each party agrees that, during an inspection by the NMPA, FDA, EMA or other regulatory authority concerning any study or Project of Client in which PROBIO is providing Services, it will not disclose information and materials that are not required to be disclosed to such agency, without the prior consent of the other party, which shall not unreasonably be withheld. Such information and materials include, but are not limited to, the following: 1) financial data and pricing data (including, but not limited to, the budget and payment sections of the Work Order); 2) sales data (other than shipment data); and 3) personnel data (other than data as to qualification of technical and professional persons performing functions subject to regulatory requirements). Client shall reimburse PROBIO for its time and expenses (including reasonable attorney fees and the costs of responding to findings) associated with any inspection instigated by a governmental authority.
10.4 During the term of this Agreement, PROBIO will permit Client’s representatives (unless such representatives are competitors of PROBIO) to examine or audit the work performed hereunder and the facilities at which the work is conducted upon reasonable advance notice during regular business hours to determine that the Project assignment is being conducted in accordance with the agreed task and that the facilities are adequate. The audit, if without cause, shall be no more than once per Project, or per annual year, which is less.
10.5 All information disclosed, revealed to or ascertained by Client in connection with any such audit or examination or in connection with any correspondence between PROBIO and any regulatory authorities shall be deemed to constitute PROBIO Confidential Information for purposes of this Agreement.
11. Indemnification and Limitation of Liability.
11.1 Client shall indemnify, defend and hold harmless PROBIO and its Affiliates, and its and their directors, officers, employees and agents (each, a “PROBIO Indemnified Party”), from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively “Losses”), joint or several, resulting or arising from any third-party claims, actions, proceedings, investigations or litigation to the extent relating to or arising from or in connection with a breach by Client of this Agreement, any Work Order, including Client’s representations and warranties, except to the extent such Losses (i) are covered by PROBIO’s indemnification obligations set forth in Section 11.2 below, or (ii)result from the negligence or intentional misconduct of the PROBIO Indemnified Party seeking indemnity hereunder.
11.2 PROBIO shall indemnify, defend and hold harmless Client and its Affiliates, and its and their directors, officers, employees and agents (each, a “Client Indemnified Party”), from and against any and all Losses, joint or several, resulting or arising from any third-party claims, actions, proceedings, investigations or litigation to the extent relating to or arising from or in connection with a breach of this Agreement, any Work Order, or the performance of Services contemplated herein, including PROBIO’s representations and warranties, except to the extent such Losses (i) are covered by Client’s indemnification obligations set forth in Section 11.1 above; or (ii) result from the negligence or intentional misconduct of the Client Indemnified Party seeking indemnity hereunder.
11.3 LIMITATION OF LIABILITY. EXCEPT WITH RESPECT TO LIABILITIES ARISING FOR A PARTY PURSUANT TO A BREACH OF ITS CONFIDENTIALITY OBLIGATIONS (SECTION 8) OR ITS THIRD PARTY IP INDEMNIFICATION OBLIGATIONS (SECTION 11): (A) NEITHER PARTY, NOR ITS AFFILIATES, NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, SUBCONTRACTORS OR AGENTS SHALL HAVE ANY LIABILITY OF ANY TYPE (INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE, AND TORT LIABILITY), FOR ANY LOSS OF PROFITS, OPPORTUNITY OR GOODWILL, OR ANY TYPE OF SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGE OR LOSS IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT, ANY WORK ORDER, OR THE SERVICES PERFORMED BY PROBIO HEREUNDER; AND (B) IN NO EVENT SHALL THE COLLECTIVE, AGGREGATE LIABILITY (INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE AND TORT LIABILITY) OF EITHER PARTY, ITS AFFILIATES, OR THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, SUBCONTRACTORS AND AGENTS, UNDER THIS AGREEMENT OR ANY WORK ORDER HEREUNDER EXCEED THE AMOUNT OF FEES ACTUALLY RECEIVED BY PROBIO FROM CLIENT FOR THE ASSIGNMENT OR TASK FROM WHICH SUCH LIABILITY AROSE.
Generally, both parties are not allowed to terminate the specific Work Order. In case Client plans to terminate or suspend Work Order, it shall notify PROBIO upon prior written notice. PROBIO will evaluate the potential effects and consequences for such requests within thirty (30) days after receiving the notice. It’s on PROBIO’s sole discretion whether or not accept such termination or suspension while PROBIO will not unreasonably withhold the response to Client’s request. Once PROBIO agrees to terminate or suspend the specific Work Order, Client shall pay PROBIO for all Services performed in accordance with the Work Order and reimburse PROBIO for all costs and expenses incurred in performing those Services, including all non-cancelable costs incurred prior to termination but paid after the termination date, such as material, equipment, outsourced costs incurred to complete activities associated with the termination as well as any loss, damage or claims due to such termination up to the date of termination. Payment made prior to termination is non-refundable. In the event that Client does not notify PROBIO to initiate the Project within sixty (60) days after the scheduled initiate date, PROBIO shall have the right to deem the Work Order is terminated by Client.
Client agrees that PROBIO may use its corporate Affiliates to fulfill PROBIO’s obligations under this Agreement and any Work Order. Any Affiliate so used shall be subject to all of the terms and conditions applicable to PROBIO under this Agreement or any Work Order, and entitled to all rights and protections afforded PROBIO under this Agreement and any Work Order, provided that PROBIO shall remain liable to Client for any such Affiliates’ compliance with the terms and conditions of this Agreement and any applicable Work Order(s). The term “Affiliate” shall mean all entities controlling, controlled by or under common control with PROBIO, as the case may be. The term “control” shall mean the ownership, directly or indirectly, in the aggregate of fifty percent (50%) or more of the voting securities of any entity or otherwise having the ability to influence and direct the polices and direction of an entity.
14. Cooperation; Client Delays.
Client shall forward to PROBIO in a timely manner all documents, materials as well as comprehensive data or information concerning the stability, storage and safety requirements of such materials in Client’s possession or control necessary for PROBIO to conduct the Services. PROBIO shall not be liable to Client nor be deemed to have breached this Agreement for errors, delays or other consequences to the extent arising from Client’s failure to timely provide documents, materials or information or to otherwise cooperate with PROBIO in order for PROBIO to timely and properly perform its obligations, and any such failure by Client shall automatically extend any timelines affected by a time period reasonably commensurate to take into account such failure. In addition, Client will pay all non-cancelable costs and expenses incurred by PROBIO due to the delay and will adjust all timelines to reflect additional time required due to the delay.
15. Conflict of Agreements.
PROBIO represents to Client that it is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement and that during the term of this Agreement, PROBIO agrees that it will not enter into any agreement to provide services which would in any way prevent it from providing the services contemplated under this Agreement. Client agrees that it will not enter into an agreement with a third party that would alter or affect the regulatory obligations delegated to PROBIO in any study or Project without the written consent of PROBIO, which will not be unreasonably withheld.
Each party acknowledges and agrees that all results resulting from this Agreement are subject to the export control laws and regulations of the competent jurisdiction. Client especially agrees that all exports related to this agreement will be in compliance with such laws and regulations.
17. Force Majeure.
In the event either party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, inability to procure materials or services, failure of power or restrictive government or judicial orders, or decrees, riots, insurrection, war, Acts of God, inclement weather or other reason or cause beyond that party’s control, then performance of such act (except for the payment of money owed) shall be excused for the period of such delay.
During the term of this Agreement, the Client shall not, without the prior written consent of PROBIO, solicit or entice away any employee of PROBIO who performed (or is performing) material obligations under any applicable Work Order (excluding administrative, secretarial, or other back-office functions), other than by means of a national advertising campaign open to all-comers and not specifically targeted at employees of PROBIO. If the restriction set forth in this Section is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area for which it may be enforceable. If the Client breaches this Section, it shall pay PROBIO an amount equal to the last twenty-four (24) months’ salary of the applicable individual in recognition of the value of the individual to PROBIO and cost of recruiting and training a replacement. The parties agree that this sum is a genuine pre-estimate of the loss likely to be suffered by PROBIO in these circumstances and not a penalty.
19. Independent Contractor Relationship.
For the purposes of this Agreement, the parties hereto are independent contractors and nothing contained in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint ventures.
Neither Project Inventions nor any Results may be published or referred to, in whole or in part, by PROBIO or its Affiliates without the prior expressed written consent of Client. Neither party will use the other party’s name in connection with any publication or promotion without the other party’s prior, written consent.
21. Binding Agreement and Assignment.
This Agreement shall be binding upon and inure to the benefit of Client and PROBIO and their respective successors and permitted assigns. Except as stated above in Section 13, neither party may assign any of its rights or obligations under this Agreement to any party without the express, written consent of the other party, provided that either party may assign its rights without the prior written consent of the other party to (a) any such party’s Affiliate; or (b) a third party who purchases or otherwise acquires all or substantially all of such party’s assets associated with the subject matter of this Agreement. Any purported assignment in violation of this Section shall be void ab initio. Any assignment or other transfer permitted under this Section shall not in any manner relieve the assigning or transferring party from its liability for the performance of this Agreement by its assignee or transferee.
22. Governing Law and Dispute Resolution.
This Agreement shall be construed, governed, interpreted, and applied in accordance with the laws of the State of Delaware exclusive of its conflicts of law provisions. The parties’ consent to the exclusive jurisdiction of the state or federal courts located in the State of Delaware for any dispute arising out of, or in any way relating to, the Agreement.
The rights and obligations of Client and PROBIO, which by intent or meaning have validity beyond such termination (including, but not limited to, rights with respect to inventions, confidentiality, discoveries and improvements, indemnification and liability limitations) shall survive the termination of this Agreement or any Work Order.
24. Entire Agreement, Headings and Modification.
This Agreement, together with the applicable Work Orders, contains the entire understandings of the parties with respect to the Project herein, and supersedes all previous agreements (oral and written), negotiations and discussions. The descriptive headings of the sections of this Agreement are inserted for convenience only and shall not control or affect the meaning or construction of any provision hereof. Any modifications to the provisions herein must be agreed by both parties and executed as addendum in writing.