PROVIDED BY VIROLOGIC TO PROGENICS HEREUNDER INCLUDING TESTS, ASSAYS AND OTHER ACTIVITIES WILL BE PERFORMED FOR “RESEARCH USE ONLY” AND AS SUCH, ARE NOT REPRESENTED TO BE AND SHALL NOT BE REQUIRED TO COMPLY WITH CAP AND/OR CLINICAL LABORATORY IMPROVEMENT ACT REGULATIONS.
6.2 ViroLogic represents and warranties that it is qualified to perform the services required of it hereunder in a competent and professional manner and to satisfy the requirements of Section 6.1 above.
7.1 Progenics agrees to indemnify and hold harmless ViroLogic and its employees, directors, officers and agents from and against any loss, damage, reasonable cost and expense (including reasonable attorneys’ fees and expenses) incurred in connection with any claim proceeding or investigation for bodily injury or death arising out of the clinical study carried out pursuant to the protocol attached hereto in Schedule 1, provided however, that (a) ViroLogic and its employees, directors, officers and agents are shown to have adhered to and complied with their obligations hereunder, the applicable Protocol, all applicable laws, regulations and rules, and all directions and recommendations furnished by Progenics regarding the services to be provided pursuant to this Agreement, and (b) ViroLogic fully cooperates in the handling of any such claim, proceeding or investigation, and, in the event of suit, ViroLogic attends hearings and trials and assists in securing and giving evidence and obtaining attendance of necessary and proper witnesses. At ViroLogic’s request, Progenics will reimburse ViroLogic for all reasonable expenses incurred in connection with item (b) of this subsection 7.1. Progenics at its own expense shall carry out the sole management and defense of such claims or suits, and will provide attorneys of its sole choosing to defend against any such claim, proceeding or investigation. Notwithstanding the foregoing, Progenics shall not be obligated to ViroLogic with respect to any loss, damage, cost and expense relating to any claim, proceeding or investigation which is based upon or the result of the negligence or wrongful conduct of ViroLogic or its employees, directors, officers, agents, or any other third party.
7.2 ViroLogic agrees to indemnify and hold harmless Progenics and its employees, directors, officers and agents from and against any loss, damage, reasonable cost and expense (including reasonable attorneys’ fees and expenses) incurred in connection with any claim, proceeding or investigation arising out of or relating to this Agreement to the extent such claim, proceeding or investigation is based on the negligence or wrongful conduct of ViroLogic, its employees, directors and/or agents with respect to the clinical laboratory testing carried out by ViroLogic pursuant to this Agreement, provided however, that (a) Progenics and its employees, directors, officers and agents are shown to have adhered to and complied with their obligations hereunder, the applicable Protocol, all applicable laws, regulations and rules, and (b) Progenics fully cooperates in the handling of any such claim, proceeding or investigation, and, in the event of suit, Progenics attends hearings and trials and assists in securing and giving evidence and obtaining attendance of necessary and proper witnesses. At Progenics’ request, ViroLogic will reimburse Progenics for all reasonable expenses incurred in connection with item (b) of this subsection 7.2. ViroLogic at its own expense shall carry out the sole management and defense of such claims or suits, and will provide attorneys of its sole choosing to defend against any such claim, proceeding or investigation. Notwithstanding the foregoing, ViroLogic shall not be obligated to Progenics with respect to any loss, damage, cost and expense relating to any claim, proceeding or investigation which is based upon or the result of the negligence or wrongful conduct of Progenics or its employees, directors, officers, agents, or any other third party.
7.3 Any party seeking indemnification pursuant to this Section 7 (the “Indemnitee”) shall notify the party from whom indemnification is sought (the “Indemnitor”) of Indemnitee’s notice of any claim, proceeding or investigation. Such notice shall (i) be in writing, (ii) be delivered to Indemnitor within ten (10) days of the date Indemnitee receives notice of such claim, proceeding or investigation, and (iii) indicate the nature and basis of the claim, proceeding or investigation. The indemnification set forth in Sections 7.1 and 7.2 shall include amounts paid in settlement; provided, however, that no such settlement shall be entered into without the consent of both parties, which consent shall not be unreasonably withheld.
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7.4 ViroLogic agrees to secure and maintain insurance of comprehensive general liability with limits of at least $1,000,000 per occurrence and in the aggregate, workers’ compensation insurance as required by law, and employer’s liability insurance with limits of at least $1,000,000 each accident and a $500,000 disease policy limit.
8. TERM AND TERMINATION
8.1 This Agreement shall become effective when it has been executed by a duly authorized representative of each party, and shall continue in force for a period of three years from the effective date or until terminated in accordance with Section 8.2, whichever occurs earlier, unless extended in writing by the parties.
8.2 This Agreement may be terminated in accordance with the following provisions:
(a) This Agreement may be terminated by either party upon the occurrence of any material default by the other party, provided that the defaulting party shall be given not less than fifteen (15) days prior written notice of such default and the opportunity to cure the default during such period;
(b) This Agreement may be terminated immediately by either party if the other party becomes insolvent, is dissolved or liquidated, makes a general assignment for the benefit of its creditors, or files or has filed against it a petition in bankruptcy or has a receiver appointed for a substantial part of its assets.
8.3. In the event this Agreement is terminated pursuant to Section 8.2, then Progenics, in its sole discretion, may specify in writing, which ViroLogic Services hereunder must be completed by ViroLogic, and the effective date of termination of this Agreement shall be extended only with respect to those ViroLogic Services and corresponding Work Orders specified by Progenics until they are completed. Progenics shall be obligated to pay for the Laboratory Services performed by ViroLogic through the effective date of termination as provided under paragraph 8.5.
8.4 Progenics may terminate any Work Order at any time with or without cause by giving ViroLogic at least thirty (30) days prior written notice. Progenics shall be obligated to pay for the ViroLogic Services performed by ViroLogic through the effective date of termination as provided under paragraph 8.5.
8.5 If this Agreement or any Work Order(s) is terminated pursuant to this Section 8, ViroLogic shall use its best efforts during the period between notice of termination and the effective date of such termination to wind-up all services in accordance with its responsibilities under this Agreement and applicable law and regulation, in order to reduce or eliminate further costs, and to cancel, if permitted under the terms of applicable agreements, any third party obligations. Within thirty (30) days after the completion of wind-up of the terminated ViroLogic Services (which wind-up includes receipt by Progenics of all ViroLogic reports and other deliverables prepared by ViroLogic, if any, prior to the date of termination), ViroLogic shall provide Progenics with a written itemized statement of all work performed by it in connection with the terminated services. Such statement shall include only those ViroLogic Services detailed in the relevant Work Order. ViroLogic shall be entitled to a pro rata payment based on the amount of ViroLogic Services provided by ViroLogic pursuant to the terms of this Agreement through the date of termination. If the amounts paid by Progenics to ViroLogic in connection with such ViroLogic Services exceed such pro rata amount, then ViroLogic shall promptly refund such excess to Progenics, and if such pro rata amount exceeds the amount already paid by Progenics to ViroLogic, then Progenics shall promptly pay the amount of such excess to ViroLogic. Any refund or payment under this Section 8 shall be made within thirty (30) days after Progenics’ receipt of ViroLogic’s itemized statement.
9. NON-ASSIGNABILITY
Neither this Agreement nor any right or interest hereunder may be assigned or transferred by either party without prior written consent of the other party, except this Agreement may be assigned to a party that succeeds to all or substantially all of a party’s business or assets whether by sale, merger, operation of law or otherwise.
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10. NOTICES
Any notice required to be given pursuant to the terms and provisions hereof shall be in writing and shall be sent by overnight courier service or certified or registered mail to ViroLogic at:
ViroLogic, Inc.
345 Oyster Point Blvd.
South San Francisco, CA 94080
Attention: Chief Executive Officer,
and with copies to:
Vice President, Clinical Research
Vice President and General Counsel
and to Progenics at:777 Old Saw Mill River Road
Tarrytown, New York 10591
and with copies to:William Olsen, Vice President of Research and Development
Phillip Yachmetz, Vice President and General Counsel
11. INDEPENDENT RELATIONSHIP
For purposes of this Agreement, ViroLogic, its employees and any other individuals assigned by them to perform services under this Agreement (“Staff Members”) shall not be deemed agents, servants, partners, joint venturers or employees of Progenics. Thus, they do not have the authority to take action on Progenics’ behalf or to bind Progenics without Progenics’ prior written consent. ViroLogic and its Staff Members are acting in the capacity of independent contractors of Progenics. Progenics is not responsible for withholding, and shall not withhold, taxes of any kind from any payments it owes to ViroLogic. ViroLogic is responsible to provide any and all compensation, benefits and/or insurance to its Staff Members. It is also understood and expressly acknowledged that neither ViroLogic nor its Staff Members are eligible to participate in, nor are they eligible for coverage under, any of Progenics’ benefit plans, programs, employment policies, procedures or workers’ compensation insurance. In consideration of Progenics’ performance hereunder, Progenics shall be released from any liability arising from Progenics’ failure to provide such plans, programs, policies, procedures and workers’ compensation insurance.
12. DELAYS
12.1 Neither party shall be liable for the failure to perform its obligations under this Agreement if such failure is occasioned by a contingency beyond such party’s reasonable control, including but not limited to strikes or other labor disturbances, lockouts, riots, wars, earthquakes, fires, floods or storms. A party claiming a right to excused performance under this Section 12 shall immediately notify the other party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control that prevents such performance,12.2 If Progenics determines and acknowledges in writing that ViroLogic Services will be delayed for unavoidable justified reasons, ViroLogic will be obligated to complete its duties and obligations hereunder by that extended date.
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13. BENEFIT
This Agreement is intended to inure only to the benefit of ViroLogic and Progenics. This Agreement is not intended to create, nor shall be deemed or construed to create, any rights in any third parties.
14. HEADINGS
The headings appearing in this Agreement are for convenience and reference only and are not intended to and shall not, define or limit the scope of the provisions to which they relate.
15. ENFORCEABILITY/SEVERANCE CLAUSE
The invalidity or unenforceability of any terms or provisions hereto in any jurisdiction shall in no way affect the validity or enforceability of any of the other Terms or provisions in that jurisdiction, or of the entire Agreement in any other jurisdiction.
16. INTEGRATION
This Agreement constitutes the entire agreement between the parties on the subject matter hereof and supersedes all prior contracts, agreements, and understandings relating to the same subject matter between the parties.
17. WAIVER
No course of dealing between the parties or any delay on the part of either party in exercising any rights it may have under this Agreement shall operate as a waiver of any of the rights of such hereunder.
19. MODIFICATION
Except for the Protocol and/or Study Schedule(s) which may be modified in accordance with Section 2.2, this Agreement may not be modified except in a writing signed by an authorized representative of each party.
20. SURVIVAL OF PROVISIONS
Sections 3, 4, 5, 7, 8, 10, 11, 18, 20 and 21 hereof shall survive termination of this Agreement.
21. APPLICABLE LAW
This Agreement shall be construed under, and the rights of the parties hereto shall be governed under the laws of the State of Delaware without giving effect to its choice of law principles.
22. EXECUTION
This Agreement may be executed by way of faxed signatures exchanged between the parties. If the parties choose to execute via faxed signatures, the Agreement shall be fully executed and effective upon the receipt by both parties of a faxed signature from the other upon a complete copy of this Agreement. The parties may then also exchange hard signature copies, but any failure to do so shall not affect the execution or effectiveness of this Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in their names as their official acts by their respective representatives, each of whom is duly authorized to execute the same.
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| PROGENICS PHARMACEUTICALS, INC. | VIROLOGIC, INC. |
| | |
| By: /s/ Philip K. Yachmetz | By: /s/ William D. Young |
| | |
| Printed Name: Philip K. Yachmetz | Printed Name: William D. Young |
| | |
| Title: Vice President and General Counsel | Title: Chairman & CEO |
| | |
| Date: June 4, 2002 | Date: 5/23/02 |
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EXHIBIT A
SAMPLE FORMAT FOR WORK ORDERS
This Work Order is issued pursuant to the Master ViroLogic Services Agreement, dated as of __________, between PROGENICS PHARMACEUTICALS with an office located at 209 Perry Parkway, Gaithersburg, MD 20877 (“Progenics”) and VIROLOGIC, INC. with its office and place of business located at 345 Oyster Point Blvd, South San Francisco, CA 94080 (“ViroLogic”) (the “Agreement”), and incorporates all of the terms and conditions therein. The parties agree that ViroLogic shall perform the services in accordance with this Work Order using, if applicable, the Material provided by Progenics hereunder, subject to all of the terms and conditions of the Laboratory Service Agreement effective January 10, 2002 between the parties. The Work Order is incorporated in and made a part of the Laboratory Service Agreement.
| Work Order Number: ______ | Study Number: ________________________ |
| | |
| Name of ViroLogic Project Manager: ________________________________________________________________________ |
| | Phone: ______________________________ |
| | Facsimile: ____________________________ |
| | Email: _______________________________ |
Materials Supplied:
_______________________________
ViroLogic Services (Scope of Work)
ViroLogic shall provide those ViroLogic Services listed herein. ViroLogic acknowledges and agrees that the ViroLogic Services listed herein are customarily offered by ViroLogic and ViroLogic is capable of performing same in accordance with the terms of the Agreement.
_____________________ Clinical Leader:
Correspondence and testing results will be addressed to ___________________ ’ Clinical Leader.
Name ____________________________________________
Title, Department____________________________________
Address __________________________________________
City State ZIP ______________________________________
Tel: ____________________________
Fax: __________________ Progenics ___________________
Email: ____________________________________________
Compensation:
ViroLogic shall charge fees for the ViroLogic Services provided pursuant to the Work Order in the amounts set forth in Schedule 2, or for an amount as agreed upon by both parties.
__________________ shall pay ViroLogic, Inc. in consideration for the performance of the testing services described above in Services, as acceptable according to the terms of the Laboratory Services Agreement and corresponding work order for each project. Additional fees for electronic data delivery or other project management and
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programming services will be determined according to the fee schedule as set forth in the Laboratory Services Agreement.
For Work Orders between ViroLogic and Progenics, ______________________ agrees to pay any undisputed amounts specified in the monthly statement referred to in Section 2.1 of the Agreement within thirty (30) days after ________________________receipt of such statement.
Payment as set forth in this Work Order shall constitute full payment for the Study and the ViroLogic Services provided hereunder, and Progenics shall have no other payment obligations hereunder to ViroLogic or any other third party.
I. All invoices to ______________________ shall be sent at the attention of:
Name: _______________________________________Address: ____________________________________
The name and address of the payee for all payments due to ViroLogic hereunder is:
Attn: Billing Department
ViroLogic, Inc.
345 Oyster Point Blvd.
South San Francisco, CA 94080
Tax ID Number of the payee: 94-3234479________________________________
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2. Site mailing address for correspondence.
_____________________________________
_____________________________________
_____________________________________
_____________________________________
This Work Order is entered into and made effective as of _____________________________ .
Accepted and Agreed to by:
| PROGENICS PHARMACEUTICALS, INC. | VIROLOGIC, INC. |
| | |
| By: /s/ Philip K. Yachmetz | By: /s/ William D. Young |
| | |
| Printed Name: Philip K. Yachmetz | Printed Name: William D. Young |
| | |
| Title: Vice President and General Counsel | Title: Chairman & CEO |
| | |
| Date: June 4, 2002 | Date: 5/23/02 |
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SCIEDULE 1 to work Order # _____
STUDY PROTOCOL
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SCHEDULE 2 to WORK ORDER # ____
FEE SCHEDULE
| Phenotypic Testing Fee Summarv | |
| | |
Entry Assay (up to six drugs) | $1,000.00 |
| | |
Standard PhenoSense™ HIV Select Panel*
For Protease and RT Drugs | $775.00 |
| | |
Standard PhenoSense™ HIV Comprehensive Panel*
For Protease and RT Drugs | $955.00 |
| | |
Custom PhenoSense™ HIV Panels
For Protease and RT Drugs
| |
| • | From 1 to 6 drugs in panel* * | $600.00 |
| | • | 7-12 drugs in panel** | $775.00 |
| | • | Each additional drug above 12 drugs** | $60.00 |
| | • | **Additional cost for any novel drug included in panel | $300.00/per drug, per test |
| | | | |
| Repeat testing of cell assay portion of PhenoSense using previously created plasnaid | |
| | • | One drug** | $250.00 |
| | • | Two drug** | $450.00 |
| | • | Three to six drugs** | $600.00 |
| | • | Seven to twelve drugs** | $775,00 |
| | • | Each additional drug above 12 drugs** | $60.00 |
| | • | **Additional cost for any novel drug included in tested drugs | $300.00/per drug, per test |
| | | | |
| Additional Costs for Custom Test Requests | |
| | | One time set-up/automation fee for novel drug | $5,000.00/drug |
| | | Use of library specimen from ViroLogic’s library | $1,000.00/specimen |
| | | (clinical sample or site-directed mutant) | |
| | | One time design and development fee for novel site-directed mutant | $5,000.00/SDM |
| | | | |
| Genotypic Testing Fee Schedule | |
| | | | |
| | • | Standard GeneSeg™ HIV Assay* | $495.00 |
| | | For Protease and RT Drugs | |
* Standard Panels refer to the drugs available in each assay as sold and marketed by ViroLogic for the patient testing market at the time of the study.
* The costs for providing testing results by overnight mail shall be borne by Customer, if such delivery is requested by Customer
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| Viral Load Testing Fee Schedule | |
| | |
| | • | Amplicor HIV-1 Monitor- Extended Range | $200.00 |
| | • | Amplicor HIV-1 Monitor- Ultrasensitive | $235.00 |
* Standard Panels refer to the drugs available in each assay as sold and marketed by ViroLogic for the patient testing market at the time of the study.
* The costs for providing testing results by overnight mail shall be borne by Customer, if such delivery is requested by Customer
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| Other Testing Fees |
| | | |
| | • | Partial fee for un-acceptable samples. A fee will be charged by ViroLogic in the event that a testing result is not obtained due to low viral load (<500 copies/mil) or improperly collected and handled specimens. |
| | | • | $500.00 if phenotype and genotype or phenotype alone ordered | |
| | | • | $250.00 if genotype only ordered | |
| | | | | |
| | • | Additional Patient Reports | $25.00 per report |
| | | One copy of the paper patient report is included in testing fee. There will be a charge for each additional copy to be reported out. |
| | | | | |
| Programming and Project Management Services | |
| | | | | |
| Customization of data management, data analysis, data reporting and other such services. | |
| | | | | |
| | • | Programming | $100.00 per hour |
| | • | Electronic Data Deliverable (EDD) | $200.00 per file |
| | • | Other Services | $100.00 per hour |
Formal Study Report
The basic fee for a formal written study report, if requested, is $ 5000, plus additional time or services as may be required to prepare report in a format to be defined jointly by Pro genics and VIROLOGIC.
All drugs manufactured, marketed or under development by _Progenics_ to be used and tested in PhenoSense™ HIV will be supplied to ViroLogic at no charge.
Virologic, Inc. and Progenics will develop and agree to project plans that describe the scope of work, including Programming and Project Management Services, for each study.
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Exhibit B
TASK CHANGE FORM
| Study Name: | Protocol Number: |
| | |
_____________________ Contact:
Name:___________________________________ | ViroLogic Contact:
Name:__________________________________ |
| | |
| Title: _______________________________ | Title: _____________________________ |
| | |
| Telephone No. ________________________ | Telephone No. _______________________ |
| | |
| FAX No. ____________________________ | FAX No. ___________________________ |
| | |
|
|
| Change Order (describe all tasks and services, associated timelines) and responsible person(s)/party): |
| |
| Task Description | | Cost |
| | | |
| |
|
| | | |
| |
|
| | | |
| |
|
| | | |
| |
|
| | | |
| |
|
| | | |
| |
|
| | | |
| |
|
| | | |
For additional space, use separate page.
|
| |
|
|
|
| | | |
| Authorized and Agreed: | |
| | |
| By: ____________________________ | By: ____________________________ |
| | |
| Title: ___________________________ | Title: ___________________________ |
| | |
| Date: ___________________________ | Date: ___________________________ |
| | |
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Attachment A
Drug Susceptibility Panels
| Select Panel (12 drugs) | Comprehensive Panel (16 drugs) |
| | |
| NRTI | NRTI |
| Abacavir - - ABC | Abacavir - - ABC |
| | |
| Didanosine – ddI | Didanosine - - ddI |
| | |
| Lamivudine - - 3TC | Lamivudine - - 3TC |
| | |
| Stavudine - - d4T | Stavudine - - d4T |
| | |
| Zidovudine - - ZDV | Zalcitabine - - ddC |
| | |
| | Zidovudine - - ZDV |
| | |
| | Tenofovir - TFV |
| | |
| NNRTI | NNRTI |
| Efavirenz – EFV | Delavirdine - DLV |
| | |
| Nevirapine - NVP | Efavirenz - EFV |
| | |
| | Nevirapine - NVP |
| | |
| PRI | PRI |
| Amprenavir – AMP | Amprenavir - AMP |
| | |
| Indinavir – IDV | Indinavir - IDV |
| | |
| Nelfinavir – NFV | Lopinavir - LPV |
| | |
| Ritonavir – RTV | Nelfinavir - NFV |
| | |
| Saquinavir – SQV | Ritonavir - RTV |
| | |
| | Saquinavir - - SQV |
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Attachment B
Procedure for the Collection, Handling and Shipment of Specimens to ViroLogic, Inc. for Clinical Research Testing
This document describes the requirements for collection, handling, and shipment of blood samples prior to testing in the Phenogense™ HIV and GeneSeg™ MV assays. The PhenoSense™ HIV assay is intended for use in the evaluation of the phenotypic susceptibility of HIV-1 in plasma to antiviral drugs. The GeneSeq™ HIV assay is intended for use in identifying specific genetic mutations in HIV-1 that have been associated with antiviral drug resistance.
HIV RNA is especially vulnerable to degradation, therefore proper collection and handling of blood specimens is essential for successful performance of these assays.
Specimen Collection:
Whole blood should be collected in sterile tubes containing EDTA as the anticoagulant (lavender top or PPT).
Specimen Volume Required for Testing:
| • | 3 mL of plasma is requested for optimal performance of these assays. |
| | Minimum volume accepted: 1.5 – 2.0 mL |
| | |
| Specimen Processing: |
| | |
| • | Draw blood in a sterile tube containing EDTA anticoagulant (lavender top or PPT). |
| | |
| • | Centrifuge blood within 6 hours of collection. Centrifuge whole blood at 1000-1200 x g at room temperature for 10-15 minutes. |
| | |
| • | Immediately after centrifugation remove plasma from cells and transfer to a screw cap top tube. |
| | |
| • | Immediately freeze plasma sample at or below -20°C in a standard laboratory freezer. |
| | |
| • | DO NOT THAW SAMPLE AFTER FREEZING! |
| | |
| Specimen Packaging: |
| | |
| • | Transportation of whole blood or plasma must comply with country, federal, state and local regulations for the transport of infectious agents. |
| | |
| • | Plasma must be transported frozen on dry ice. |
| | |
| • | Properly package specimens to ensure safe arrival to ViroLogic. |
| | |
| • | Enclose a completed [Test Requisition Form) or [Spreadsheet] with each shipment. |
| | |
| • | E-mail ViroLogic (receiving@virologic.com) the following information prior to each shipment: |
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