EX-10.10 10 dex1010.htm MASTER SERVICES AGREEMENT Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. MASTER SERVICES AGREEMENT
Exhibit 10.10
Confidential Materials omitted and filed separately with the Securities and Exchange Commission.
Asterisks denote omissions.
This Master Services Agreement (“Agreement”) is made between Voyager Pharmaceutical Corporation which has a place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter “Sponsor”), and Quintiles, Inc., a North Carolina corporation having its principal place of business at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter “Quintiles”). When signed by both parties, this Agreement will set forth the terms and conditions under which Quintiles agrees to provide certain services to Sponsor as set forth herein.
A. Sponsor is in the business of developing, manufacturing and/or distributing pharmaceutical products, medical devices and/or biotechnology products. Quintiles is in the business of providing clinical trial services, research, and other services for the pharmaceutical, medical device and biotechnology industries and has made significant, up-front investments in technologies related to those industries, building on important inventions and web-based technologies.
B. Sponsor and Quintiles desire to enter into this Agreement to provide the terms and conditions upon which Sponsor may engage Quintiles from time-to-time to provide services for individual studies or projects by executing individual Work Orders (as defined below) specifying the details of the services and the related terms and conditions.
Agreement:
| 1.0 | Scope of the Agreement; Work Orders; Nature of Services. |
| (a) | Scope of Agreement. As a “master” form of contract, this Agreement allows the parties to contract for multiple projects through the issuance of multiple Work Orders (as discussed in Section 1(b) below), without having to re-negotiate the basic terms and conditions contained herein. This Agreement covers the provision of services by Quintiles and Quintiles’ corporate affiliates (see Section 18) and, accordingly, this Agreement represents a vehicle by which Sponsor can efficiently contract with Quintiles and its corporate affiliates for a broad range of services. |
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will not unreasonably withhold approval of a Change Order, even if it involves a fixed price contract, if the proposed changes in budgets or time lines result from, among other appropriate reasons, forces outside the reasonable control of Quintiles or changes in the assumptions upon which the initial budget or time lines were based, including, but not limited to, the assumptions set forth in the budget or timelines. Quintiles reserves the right to postpone effecting material changes in the Project’s scope until such time as the parties agree to and execute the corresponding Change Order. For any Change Order that affects the scope of the regulatory obligations that have been transferred to Quintiles, Quintiles and Sponsor shall execute a corresponding amendment to the Transfer of Obligations Form. Sponsor shall file such amendment where appropriate, or as required by law or regulation.
The foregoing obligations shall not apply to Confidential Information to the extent that it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party; (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.
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acknowledges that Quintiles possesses certain inventions, processes, know-how, trade secrets, improvements, other intellectual properties and other assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, personnel data, financial information, computer technical expertise and software, which have been independently developed by Quintiles and which relate to its business or operations (collectively “Quintiles’ Property”). Sponsor and Quintiles agree that any Quintiles’ Property or improvements thereto which are used, improved, modified or developed by Quintiles under or during the term of this Agreement are the sole and exclusive property of Quintiles.
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to, investigative sites or third party laboratories), or any Part 11 audits or assessments thereof, unless such applications or systems are owned by Quintiles. Quintiles’ standard operating procedures will be used in performance of the Services, unless otherwise specifically stated in the Work Order. Quintiles certifies that it has not been debarred under the Generic Drug Enforcement Act and that it will not knowingly employ any person or entity that has been so debarred to perform any Services under this Agreement. Sponsor represents and certifies that it will not require Quintiles to perform any assignments or tasks in a manner that would violate any applicable law or regulation. Sponsor further represents that it will cooperate with Quintiles in taking any actions that Quintiles reasonably believes are necessary to comply with the regulatory obligations that have been transferred to Quintiles.
Each party acknowledges that the other party may respond independently to any regulatory correspondence or inquiry in which such party or its affiliates is named. Each party, however, shall: a) notify the other party promptly of any FDA or other governmental or regulatory inspection or inquiry concerning any study or Project of Sponsor in which Quintiles is providing Services, including, but not limited to, inspections of investigational sites or laboratories; b) forward to the other party copies of any correspondence from any regulatory or governmental agency relating to such a study or Project, including, but not limited to, FDA Form 483 notices, and FDA refusal to file, rejection or warning letters, even if they do not specifically mention the other party; and, c) obtain the written consent of the other party, which will not unreasonably be withheld, before referring to the other party or any of its affiliates in any regulatory correspondence.
Each party agrees that, during an inspection by the FDA or other regulatory authority concerning any study or Project of Sponsor in which Quintiles, 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 includes, 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).
During the term of this Agreement, Quintiles will permit Sponsor’s representatives (unless such representatives are competitors of Quintiles) 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. All information disclosed, revealed to or ascertained by Sponsor in connection with any such audit or examination or in connection with any correspondence between Quintiles and any regulatory authorities (including any FDA Form 483 notices) shall be deemed to constitute Quintiles Confidential Information for purposes of this Agreement. Sponsor shall reimburse Quintiles for its time and expenses (including reasonable attorney fees and the costs of responding to findings) associated with any inspection, audit or investigation relating to the Services (“Inspection”) instigated by Sponsor or by a governmental authority, unless such Investigation finds that Quintiles breached this Agreement or any applicable law or regulation.
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If Quintiles will be paying Investigators on behalf of Sponsor, the parties will agree in the applicable Work Orders as to a schedule of amounts to be paid to Investigators. Sponsor acknowledges and agrees Quintiles will only pay Investigators from advances or pre-payments received from Sponsor for Investigators’ services, and that Quintiles will not make payments to Investigators prior to receipt of sufficient funds from Sponsor. Sponsor acknowledges and agrees that Quintiles will not be responsible for delays in a study or Project to the extent that such delays are caused by Sponsor’s failure to make adequate pre-payment for Investigators’ services. Sponsor further acknowledges and agrees that payments for Investigators’ services are pass-through payments to third parties and are separate from payments for Quintiles’ Services. Sponsor agrees that it will not withhold Investigator payments except to the extent that it has reasonable questions about the services performed by a particular Investigator.
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Project , then Sponsor shall provide such indemnification directly to the Third Party. If Sponsor requests Quintiles’ assistance in negotiating the terms of such indemnities, Quintiles shall provide such negotiation services at its standard daily rates, unless otherwise agreed in the Work Order. Quintiles shall not sign such indemnifications on Sponsor’s behalf unless Sponsor has expressly authorized Quintiles to act as its agent for such purpose or has given Quintiles a written power of attorney to sign such indemnifications. In countries in which local laws or local ethics committees require that a local company must sign such indemnifications and Sponsor has no local presence, Quintiles will sign such indemnities only if the parties have entered into an agreement regarding local representative duties containing the terms attached hereto as Attachment B, either as a part of a Work Order or as a separately signed agreement.
If Sponsor requests that Quintiles enter into agreements to retain Third Parties to perform services regarding the Project, such Third Parties shall be independent contractors and shall not be considered the employees, agents, or subcontractors of Quintiles or Sponsor. Sponsor shall pay Quintiles for its reasonable time and expenses in negotiating and administering any such Third Party Agreements.
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attorney fees, court costs, and expenses (collectively “Losses”), joint or several, resulting or arising from any third-party claims, actions, proceedings, investigations or litigation relating to or arising from or in connection with this Agreement, any Work Order, or the Services contemplated herein (including, without limitation, any Losses arising from or in connection with any study, test, device, product or potential product to which this Agreement or any Work Order relates), except to the extent such Losses are determined to have resulted solely from the negligence or intentional misconduct of the Quintiles Indemnified Party seeking indemnity hereunder.
If this Agreement or any Work Order is terminated, Sponsor shall pay Quintiles for all Services performed in accordance with this Agreement and any applicable Work Order and reimburse Quintiles 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. Sponsor shall pay for all the work actually performed in accordance with this Agreement and the applicable Work Order, even if the parties’ original payment schedule spreads-out payments for certain services or defers payments for certain services until the end of the Study. If payments are unit or milestone based, and the Agreement or a Work Order is terminated after costs have been incurred toward achieving portions of one or more incomplete units or milestones, Sponsor will pay Quintiles’ standard fees for actual work performed toward those incomplete units or milestones up to the date of termination, in addition to paying for completed units or
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milestones. Sponsor shall pay for all actual costs, including time spent by Quintiles personnel (which shall be billed at Quintiles’ standard daily rates in effect as of the date of the termination notice), incurred to complete activities associated with the termination and close-out of affected Projects, including the fulfillment of any regulatory requirements.
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| If to Quintiles: | If to Sponsor: | |
| Quintiles, Inc. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ATTN: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ | Voyager Pharmaceutical Corporation ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ATTN: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ | |
| With a copy to: | ||
| Quintiles Transnational Legal Department P.O. Box 13979 Research Triangle Park, North Carolina 27709-3979 ATTN: ▇▇▇▇ ▇▇▇▇▇▇▇ |
If Sponsor delivers, ships, or mails materials or documents to Quintiles, or requests that Quintiles deliver, ship, or mail materials or documents to Sponsor or to third parties, then the expense and risk of loss for such deliveries, shipments, or mailings shall be borne by Sponsor. Quintiles disclaims any liability for the actions or omissions of third-party delivery services or carriers. All information transmitted by Quintiles pursuant to this agreement will be sent by the standard transmission method selected by Quintiles (telephone, facsimile, mail, personal delivery or email). Sponsor hereby consents and authorizes Quintiles to send facsimiles relating to the Services, or relating to potential future services, to any office of Sponsor or Sponsor’s affiliates.
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| 27.0 | Choice of Law, Waiver and Enforceability. This Agreement shall be construed, governed, interpreted, and applied in accordance with the laws of the State of North Carolina, exclusive of its conflicts of law provisions. The failure to enforce any right or provision herein shall not constitute a waiver of that right or provision. Any waiver of a |
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breach of a provision shall not constitute a waiver of any subsequent breach of that provision. If any provisions herein are found to be unenforceable on the grounds that they are overly broad or in conflict with applicable laws, it is the intent of the parties that such provisions be replaced, reformed or narrowed so that their original business purpose can be accomplished to the extent permitted by law, and that the remaining provisions shall not in any way be affected or impaired thereby.
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
| QUINTILES, INC. | VOYAGER PHARMACEUTICAL CORPORATION | |||||
| By: | /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ | By: | /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ | |||
| (signature) | (signature) | |||||
| Print Name: | ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ | Print Name: | ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ | |||
| Title: | Vice President | Title: | Executive Vice President & CFO | |||
| Date: | April 1, 2005 | Date: | 3-31-05 | |||
| FEDERAL ID#: ▇▇-▇▇▇▇▇▇▇ |
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EXHIBIT A
SAMPLE WORK ORDER
WORK ORDER
This Work Order (“Work Order”) is between (“Sponsor”) and (“Quintiles”) and relates to the Master Services Agreement dated (the “Master Agreement”), which is incorporated by reference herein. Pursuant to the Master Agreement, Quintiles has agreed to perform certain services in accordance with written work orders, such as this one, entered into from time-to-time.
The parties hereby agree as follows:
| SCOPE OF WORK | ATTACHMENT 1 | |||
| PROJECT BUDGET | ATTACHMENT 2 | |||
| TIMELINE | ATTACHMENT 3 | |||
| PAYMENT SCHEDULE | ATTACHMENT 4 | |||
| TRANSFER OF OBLIGATIONS (if applicable) | ATTACHMENT 5 | |||
| LOCAL REPRESENTATIVE DUTIES (if applicable) | ATTACHMENT 6 |
[Insert names of any subcontractors or consultants, other than Quintiles’ affiliates, that will be used]
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7. Inflation and Cost Adjustment. [Insert cost adjustment provision and inflation provision, if appropriate.]
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
| [Quintiles] | [Sponsor] | |||||
| By: |
| By: | ||||
| Title: |
| Title: | ||||
| Date: |
| Date: |
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EXHIBIT B
SAMPLE LOCAL REPRESENTATIVE DUTIES ATTACHMENT
LOCAL REPRESENTATIVE DUTIES
NOW THEREFORE, as part of the attached Agreement, the parties hereby agree as follows:
1) Quintiles agrees that it will act as Sponsor’s Local Representative for the Clinical Trials in the following country or countries that require that local sponsors or representatives must sign the indemnifications to sites or other entities: [insert applicable countries, e.g., Australia, China, Denmark, Mexico or Singapore]; provided, however, that the following special requirements must be met:
a) Sponsor shall make Quintiles and its affiliates an additional insured on insurance policies covering the Clinical Trials that are valid in each such country and that contain, at a minimum, the following types and amounts of insurance with an insurance company that is rated at least B, XXI by A.M. Best (or of an analogous rating by a similar organization if Sponsor is not a United States company): Products liability insurance and professional liability insurance, having an aggregate coverage and per occurrence limit of not less than US$[**]. : 1) Professional Liability and Product Liability with aggregate and per occurrence limits of at least US$[**]; 2) General Liability in amounts of at least US$5,000,000.00; 3) Workers compensation or foreign employer liability in amounts in accordance with local and national statute; and 4) Property in an amount of at least US$500,000.00 in accordance with local and national statute. All insurance amounts may be obtained by full, individual primary policy amount; a primary amount of less than minimum requirement enhanced by a blanket excess umbrella policy; or a combination of either. Such insurance will remain in effect during the entire period of the Clinical Trials and for at least four years thereafter in either the form of a primary policy or an extended reporting period endorsement. Said policies shall not be canceled or otherwise materially changed during that period without thirty (30) days prior written notice to Quintiles. Sponsor agrees to provide a certificate of insurance for the above-referenced insurance within 10 days of the execution of this agreement to the Quintiles Project Manager for the Clinical Trials, with a copy to the following address: Quintiles Transnational Risk Management, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇, Attention, ▇▇▇▇▇▇▇ ▇▇▇▇▇.
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b) Quintiles shall perform all the monitoring for the Clinical Trials in countries with such indemnification requirements, and Sponsor shall not use any other contract research organization in those countries to perform any duties or tasks for which Quintiles may be held responsible as Local Representative.
c) (This sub-section is applicable only if the Study Drug has never before been tested in humans, or if the Clinical Trials involve testing on pregnant women, introduction of a live virus into humans who do not already have a terminal illness, or medical devices subject to tracking pursuant to 21 CFR Part 821, or if Quintiles has notified Sponsor in writing prior to the signing of the attached Agreement that Quintiles reasonably believes the Clinical Trials involve an unusually high degree of risk). Sponsor shall provide to Quintiles, within 10 days of the execution of the Agreement, a summary of the safety history and issues involving that drug, device or product, and will provide, within ten days of any such request, any additional safety or manufacturing information reasonably requested by Quintiles. Upon receipt of such safety materials, Quintiles will assess the seriousness of the safety issues, the specific legal risks and obligations assumed by Quintiles in the country at issue, and the potential revenue and other benefits to Quintiles in performing the Clinical Trials, and Quintiles shall have the option of notifying Sponsor, within 10 days of receipt of all the requested safety information, that it declines to enter into the indemnification agreements for a specific country or countries.
2) Sponsor agrees that Quintiles will be Sponsor’s authorized agent solely for the purpose of serving as Sponsor’s Local Representative in the above-listed countries and performing the duties and obligations that Quintiles and Sponsor agree in writing that Quintiles will perform. If a local governmental authority instructs Quintiles, in its capacity as Local Representative, to fulfill duties or tasks that Sponsor and Quintiles have not agreed that Quintiles will perform, then Quintiles shall inform Sponsor of the authority’s instructions, and either Sponsor shall perform the required duties or tasks, or Quintiles shall perform the required duties and tasks, and Sponsor shall pay for Quintiles’ time (at its standard daily rates) and expenses in performing such duties and tasks. Sponsor hereby expressly acknowledges and agrees that the indemnification included in the attached Agreement applies to any and all claims, damages, costs, liabilities and expenses (including reasonable attorney’s fees and court costs) of any type (“Losses”) arising from or in connection with Quintiles’ services as Local Representative for the Clinical Trials, including, but not limited to, any and all Losses incurred due to any indemnifications entered into by Quintiles pursuant to Section 1 above.
3) If the attached Agreement is terminated, then Quintiles will cease acting as Local Representative, will terminate any indemnifications it has entered into as Local Representative, and will assign to Sponsor or Sponsor’s designate any investigator agreements relating to the Clinical Trials that have been executed by Quintiles. In addition, Quintiles may cease acting as Local Representative and terminate any existing indemnifications if: a) Sponsor fails to maintain the insurance required in Section 1; b) Quintiles is no longer providing all the monitoring in the countries listed above due to a modification of the attached Agreement; or, c) one or more serious adverse events occur such Quintiles reasonably believes that subjects or patients will be
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subjected to unacceptable safety risks. Sponsor agrees that Quintiles shall have no liability to Sponsor for any cessation of its Local Representative Duties or termination of indemnifications pursuant to this Section.
4) If Sponsor requests that Quintiles act as its Local Representative for the Clinical Trials in any additional country not currently listed herein, and Quintiles agrees to act as the Local Representative in such country, then the terms of this Attachment shall apply to Quintiles’ services as Local Representative in that country.
5) The terms of this Attachment shall form an integral part of, and are incorporated into, the attached Agreement.
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EXHIBIT C
SAMPLE CLINICAL TRIAL AGREEMENT FORM
CLINICAL TRIAL AGREEMENT
Made between «INVNAME», having a place of business at «INVADD1», «INVADD2», «INVADD3»,, «INVADD4» (the “Investigator”), «SITENAME», having a place of business at «SITEADD1», «SITEADD2», «SITEADD3», «SITEADD4» (the “Institution”), [if applicable, add <<Research Company>> at <<RCADD>>] (the “Research Company”) and [insert name of Quintiles entity], having a place of business at [insert address] (“Quintiles”) representing the interests of [SPONSOR LEGAL NAME] (the “Sponsor”).
| PROTOCOL NUMBER: | ||
| PROTOCOL TITLE: | ||
| PROTOCOL DATE: | ||
| SPONSOR: | ||
| PRINCIPAL INVESTIGATOR: | «INVNAME» Note: If Investigator is not a party to the Agreement, then Investigator must be an actual employee of the Institution, and the following language must be included after the Investigator’s name: “an employee of Institution” |
NOW THEREFORE, the following is agreed:
| 1. | Quintiles hereby appoints the Site to conduct the Study, and the Site agrees to ensure that the Site and the Site’s employees, agents, and staff will conduct the Study in accordance with the Protocol, the terms of this agreement, including the Terms and Conditions attached as Attachment A, the Payment Schedule and Budget attached as Attachment B, and any other the attachments hereto, which all are incorporated by reference herein (the “Agreement”), good clinical practices, and all applicable laws and regulations. The Site hereby confirms that it has enough time and resources to perform the Study according to the highest quality standards. |
| 2. | Payments shall be made in accordance with the provisions set forth in Attachment B, with the last payment being made after the Site completes all its obligations hereunder, and Quintiles has received all completed case report forms (“CRFs”) and, if Quintiles requests, all other Confidential Information as defined in Attachment A, Section 2 (Confidential and Proprietary Information). The Site will act as an independent |
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contractor, and shall not be considered the employee or agent of Quintiles or Sponsor. Neither Quintiles nor Sponsor shall be responsible for any employee benefits, pensions, workers’ compensation, withholding, or employment-related taxes as to the Site. The Site acknowledges and agrees that Investigator’s judgment with respect to Investigator’s advice to and care of each subject is not affected by the compensation Site receives hereunder. The parties agree that the payee designated below is the proper payee for this Agreement, and that payments under this Agreement will be made only to the following payee (the “Payee”):
| PAYEE NAME: Please note: This should be a business name and must match the business name used to file for your tax EIN or other tax ID number | «PayeeName» | |
| PAYEE ADDRESS: Please Note: this should be street address, not a PO Box | «Payee Address»
| |
| «PayeeAddress2»
| ||
| «Payee City», «Payee State» «PayeePostal_Code» | ||
| THE TAX ID MUST EXACTLY MATCH THE PAYEE NAME INDICATED ABOVE | ||
| TAX ID NUMBER [For Canada,Insert: GST & PROVINCIAL TAX IF APPLICABLE] |
| |
| For Canada: GST tax number or applicable provincial tax number | ||
|
| ||
| or Tax exempt |
If the Payee is in the United States of America (“U.S.”), the Payee’s 9 Digit Tax Identification Number and SSN/EIN designation will be required before any payments can be made under this Agreement.
[For Canada include “If the Payee is in Canada the Payee’s applicable tax numbers or Tax exempt status designation will be required before any payment can be made under this Agreement.”]
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Site will have thirty (30) days from the receipt of final payment to dispute any payment discrepancies during the course of the Study.
The parties acknowledge that the designated Payee is authorized to receive all of the payments for the services performed under this Agreement. If the Investigator is not the Payee, then the Payee’s obligation to reimburse the Investigator will be determined by a separate agreement between Investigator and Payee, which may involve different payment amounts and different payment intervals than the payments made by Quintiles to the Payee. Investigator acknowledges that if Investigator is not the Payee, Quintiles will not pay Investigator even if the Payee fails to reimburse Investigator.
| 3. | This Agreement will become effective on the date on which it is last signed by the parties and shall continue until completion or until terminated in accordance with the provision in Attachment A. In the event of a conflict between the Protocol and this Agreement, the terms of the Agreement will govern. |
| 4. | [INSERT ANY SPECIAL COUNTRY REQUIREMENTS, IF APPLICABLE] [For Sites in the European Union, the following language must be included due to Data Privacy laws and regulations: Prior to and during the course of the Study, the Site and Site staff may provide personal data relating to its investigators, Site staff or other personnel, which may be subject to data privacy laws or regulations. Such personal data may include names, contact information, work experience, qualifications, publications, resumes, educational background, performance information, facilities, staff capabilities, and other information relating to the Site’s conduct of clinical trials. If the Site is in the European Union, the Sponsor would be the data controller for such personal data. The Site hereby consents to the use and processing of its personal data and the personal data of its investigators, staff and personnel for the following purposes: a) the conduct of the Study; b) review by governmental or regulatory agencies, Sponsor, Quintiles, and their agents, and affiliates; c) satisfying legal or regulatory requirements; and, d) storage in databases for use in selecting sites in future clinical trials. The Site further consents to the transfer of such data to countries other than the Site’s own country, even though data protection may not exist or be as developed in those countries as in the Site’s own country. The Site agrees to ensure that its staff and personnel are aware that their personal data will be used, processed and stored for above-stated purposes and may potentially be transferred to other countries and that they consent to such use, storage and transfer.” |
ACKNOWLEDGED AND AGREED BY [Insert legal name of Quintiles entity]
| By: |
| |
| Title: |
| |
| Date: |
|
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ACKNOWLEDGED AND AGREED BY THE PRINCIPAL INVESTIGATOR:
|
| ||
| <<INVNAME>> | ||
| Date: |
|
| ACKNOWLEDGED AND AGREED BY [Insert legal name of Institution], if applicable: | ||||
| By: |
| |||
| Title (must be authorized to sign on Institution’s behalf): | ||||
| Date: |
|
ACKNOWLEDGED AND AGREED BY [Insert legal name of Research Company], if applicable:
| By: |
| |
| Title (must be authorized to sign on Research Company’s behalf): | ||
| Date: |
|
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ATTACHMENT A
TERMS AND CONDITIONS
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otherwise protect Sponsor’s interests in such inventions or discoveries. The Site agrees to comply with any applicable data privacy or data protection legislation of the country in which the data originated.
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however, that ten percent (10%) of this final payment will be withheld until final acceptance by Sponsor of all subject CRF pages and all data clarifications issued and satisfaction of all other applicable conditions set forth in the Agreement. Neither Quintiles nor Sponsor shall be responsible to the Site for any lost profits, lost opportunities, or other consequential damages. If a material breach of this Agreement appears to have occurred and termination may be required, then, except to the extent that subject safety may be jeopardized, Quintiles may suspend performance of all or part of this Agreement, including, but not limited to, subject enrollment.
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ATTACHMENT B
NAME COMPANY, NAME PROTOCOL
BUDGET AND PAYMENT SCHEDULE
A. PAYMENT TERMS
Quintiles will reimburse the Payee monthly, on a completed visit per subject basis in accordance with the attached budget. Ninety percent (90%) of each payment due, including any Screening Failure that may be payable under the terms of this Agreement, will be made based upon prior month enrollment data confirmed by subject Case Report Forms (“CRFs”) received from the Site supporting subject visitation. The balance of monies earned, up to ten percent (10%), will be pro-rated upon verification of actual subject visits, and will be paid by Quintiles to the Payee upon final acceptance by Sponsor of all CRFs pages, all data clarifications issued, the receipt and approval of any outstanding regulatory documents as required by Quintiles and/or Sponsor, the return of all unused supplies to Quintiles, and upon satisfaction of all other applicable conditions set forth in the Agreement.
Major, disqualifying Protocol violations are not payable under this Agreement
B. ADVANCE PAYMENT:
Upon completion and receipt by Quintiles of all original contractual and regulatory documentation, Quintiles will pre-pay a portion of the monies that Site will be entitled, under Section A of this Budget and Payment Schedule, to receive as it performs subject activities covered by such Section (the “Advance”). Consequently, as it performs these subject activities, Site will not receive payment for them from Quintiles under such Section, but will instead incrementally earn the Advance. Once Site has earned the entire Advance, payments from Quintiles under such Section will resume for subsequent subject activities covered by such Section that are performed by Site. If, upon completion or termination of this Agreement, the amount of the Advance exceeds the amount that Site is entitled to receive under such Section for all the subject activities covered by such Section that it performed up to that time, then Site shall promptly remit the difference to Quintiles. The amount of the Advance is XXXXX Thousand Dollars ($XXXX).
Any expense or cost incurred by Site in performing this Agreement that is not specifically designated as reimbursable by Quintiles or Sponsor under the Agreement (including this Budget and Payment Schedule) is Site’s sole responsibility.
C. SCREENING FAILURE PAYMENTS: [If screen failure payments will not be made, be sure it’s stated explicitly]
Reimbursement for screen failures will be at the amount indicated on the screening visit of the attached budget, not to exceed XXX (X) screen failure paid to XXX (X) subject randomized. To be eligible for reimbursement of screening visit, completed screening CRF pages must be submitted to Quintiles and any additional information, which may be requested by Quintiles to appropriately document the subject screening procedures.
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D. DISCONTINUED OR EARLY TERMINATION PAYMENTS:
Reimbursement for discontinued or early termination subjects will be prorated based on the number of confirmed completed visits.
Original Invoices pertaining to this Study for the following items must be submitted to Quintiles for reimbursement at the following address:
Quintiles, Inc.
Attn: Name of Payments Analyst
Investigator Payment Administration Department
{Insert appropriate address}
Phone Number of Payments Analyst
▇-▇▇▇-▇▇▇-▇▇▇▇
Please note that invoices will not be processed unless they reference the Sponsor name, Protocol number and Investigator and will be included with the regular payments. After receipt and verification, reimbursement for invoices will be included with the next regularly scheduled payment for subject activity.
| • | Subject Recruitment/Advertising |
Advertising (e.g., newspapers, radio stations etc.) will be reimbursed for actual costs paid by the Site on a pass-through basis upon receipt of original supporting invoices from third party vendors. Reimbursement will only be made if the advertisement(s) were previously approved by Quintiles, the Sponsor and the IRB/IEC. The reimbursement will NOT include overhead and will not exceed XXX Hundred Dollars ($XXX) per randomized subject [or overall maximum amount]. Said invoices should be directed as instructed in this Attachment.
| • | Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) Payments |
IRB/IEC costs will be reimbursed on a pass-through basis and are not included in the attached Budget. Any subsequent re-submissions or renewals, upon approval by Quintiles and Sponsor, will be reimbursed upon receipt of appropriate documentation.
NO OTHER ADDITIONAL FUNDING REQUESTS WILL BE CONSIDERED
The Budget is as follows:
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EXHIBIT *
DESIGNATION OF LOCAL REPRESENTATIVE FOR DATA PROTECTION PURPOSES [For use only if personal data will be collected or processed in the EEA and Sponsor is not located in the EEA]
Pursuant to the European Union Data Protection Directive, Sponsor, which is not located in the European Economic Area (“EEA”), hereby designates the following company to serve as its agent and representative for data protection purposes in the EEA (“Data Protection Representative”);
| Name | Date |
If the designated Data Protection Representative is Quintiles or a Quintiles Affiliate, the parties shall mutually agree upon a fee per country for each EEA country from which personal data will be exported to a location outside of the EEA pursuant to this Agreement.
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