SUBCONTRACT AGREEMENT
Between
BBI BIOTECH RESEARCH LABORATORIES, INC.
(hereinafter referred to as BBI Biotech)
and
VaxGen, INC.
(hereinafter referred to as SUBCONTRACTOR or VaxGen)
Whereas, BBI Biotech has been awarded Contract N01-AI-85341 titled Laboratory
Support for AIDS Vaccine and other Prevention Clinical Trials, ("hereafter, the
"Prime Contract") and whereas the contracting agency, the U.S. Department of
Health and Human Services, National Institutes of Health, National Institute of
Allergy and Infectious Diseases (NIAID), has approved the establishment of a
subcontract between BBI Biotech and VaxGen to facilitate a collaborative
research effort in regards to VaxGen's VAX 004 Phase III Clinical Trial; now
therefore, effective as of May 1, 1999, the parties mutually agree as follows:
PART I
SECTION B - SUPPLIES OR SERVICES AND PRICES
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The Subcontractor shall provide the necessary support, as outlined in the scope
of work and within the constraints of the funding available under this
agreement, to facilitate the collection of specimens at its Phase III Clinical
Trial Study Sites. This shall be referred to in this subcontract as the
"Collaborative Project." The studies to be done with specimens collected under
this subcontract are being performed to facilitate a collaborative ancillary
research effort in regards to VaxGen's VAX 004 Phase III Clinical Trial, which
clinical trial is outside the scope of this Agreement.
ARTICLE B.2. ESTIMATED COST AND PERIOD OF PERFORMANCE
a. In consideration of the Subcontractor's performance on the Collaborative
Project, BBI Biotech shall compensate the Subcontractor on a time and
materials plus other direct cost ("ODC") basis in an amount not to exceed
$1,728,250.
b. It is agreed between the parties that the above referenced sum shall
represent the total amount of this Agreement, except that such amount may
be amended in writing by mutual written agreement of the parties. The
amount set forth is intended to cover all costs of the work as detailed in
the Budget that is attached as part of this document as Section J,
Attachment A. Individual budget items have been provided for guidance only,
the Subcontractor shall be reimbursed based on submitted invoices covering
hours, ODCs and materials. Hourly rates are also provided in Attachment A.
All costs for ODCs must be reasonable, allocable and allowable pursuant to
the Federal Acquisition Regulation ("FAR") Part 31.
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c. This subcontract's period of performance is from May 1, 1999 through
December 31, 2003. The Subcontractor shall be paid for invoices submitted
covering its performance after May 1, 1999 but prior to the date of this
Agreement. Funding for this Agreement shall be available only to the extent
made available by NIAID in the Prime Contract. Total funds currently
available for payment and allotted to this subcontract are $976,250.
ARTICLE B.3. PROVISIONS APPLICABLE TO COSTS
a. Items Unallowable Unless Otherwise Provided
Unless authorized by BBI Biotech in a specific writing, the costs for the
following items are not reimbursable under this subcontract:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value;
(4) Overtime premium;
(5) Consultant fees;
(6) Subcontracts, except that fees for services provided by study sites
shall not be considered to be subcontracts as prohibited herein and
such fees shall be allowable under this subcontract
(7) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years); and "sensitive items (defined and
listed in the Contractor's Guide for Control of Government Property,
1990,) regardless of acquisition value;
(8) Patient care costs;
(9) Travel to general scientific meetings; and
(10) Legal Review costs.
b. Travel Costs
Travel required in the performance of this subcontract shall be considered
an ODC as defined above. The Subcontractor shall invoice and be reimbursed
for all travel costs in accordance with FAR 31.205-46.
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c. The Subcontractor agrees to abide by the terms of FAR 52.247-63, Preference
for U.S.-Flag Air Carriers. This provision states in part that, in
performing work under this contract, the contractor shall utilize U.S. flag
air carriers unless service by those carriers is not available. If U.S.
flag air carriers are not available the Contractor shall so certify in
writing and include that certification/justification in the request for
advance approval of foreign travel. (Cost/lower fares are not acceptable
reasons for proposing to utilize foreign air carriers.)
d. Foreign Travel. Requests for foreign travel must be submitted to BBI
Biotech at least six weeks in advance and shall contain the following: (a)
meeting(s) and place(s) to be visited, with costs and dates; (b) name(s)
and title(s) of Subcontractor personnel to travel and their functions in
the contract project; (c) subcontract purposes to be served by the travel;
(d) how travel of subcontractor personnel will benefit and contribute to
accomplishing the subcontract project, or will otherwise justify the
expenditure of funds for this subcontract; (e) how such advantages justify
the costs for travel and absence from the project of more than one person
if such are suggested; and (f) what additional functions may be performed
by the travelers to accomplish other purposes of the contract and thus
further benefit the project.
e. Government Discount Air Travel Rates. (a) To the maximum extent practicable
consistent with travel requirements, the subcontractor agrees to use the
reduced air transportation rates and services provided through available
Government discount air fares. GSA guidance is provided at URL:
xxxx://xxx.xxx.xxx.xxx/xxxxxxxxx/xxxxxxxxxx00-00.xxx. These fares are
available only for bona-fide employees' travel that is otherwise
reimbursable as a direct cost pursuant to this subcontract. The objective
is to achieve the lowest overall cost to the subcontractor, the prime
contractor, and thus, to the Government. The subcontractor shall submit
written requests to BBI Biotech for authorization to use these rates. The
request shall provide the full name of the traveler(s), the number of the
subcontract for which the travel is being performed, the subcontract
objective that is to be fulfilled and the dates during which the travel is
to occur. BBI Biotech approval, if given, will be on official BBI Biotech
letterhead so that the letter can be presented to the airline as
confirmation of the authorization. (b) Nothing in this clause shall
authorize transportation or services which are not otherwise reimbursable
under this subcontract.. Nothing in this clause requires air carriers to
make available to the subcontractor any government discount airfares.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
a. Indirect Costs
Not applicable.
b. Subcontract
Not applicable.
c. Government Property or Property furnished by BBI Biotech
All equipment purchased by BBI Biotech and placed at the VaxGen Study Sites
will be maintained, kept in a written inventory, and returned to BBI
Biotech (or to a location directed in writing by BBI Biotech) in reasonable
condition, normal wear and tear excepted, at the end of the Collaborative
Project. If such property was government-furnished to BBI Biotech and BBI
Biotech has so
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notified the Subcontractor in writing, VaxGen agrees to comply with the
requirements of the government-furnished property clauses contained in this
subcontract.
d. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated
budget
(1) The Subcontractor shall submit monthly invoices to BBI Biotech. The
Subcontractor agrees to provide a line item invoice, which includes
direct labor costs by salaries and wages paid (or accrued) for direct
performance of the subcontract, materials and supplies purchased, and
other direct costs incurred.. The Subcontractor agrees to immediately
notify BBI Biotech in writing if there is an anticipated overrun of
any amount over the ceiling identified in ARTICLE b. 2, paragraph a.
Monthly invoices must include the current totals and cumulative totals
to date. Invoices are to be submitted to:
BBI Biotech Research Laboratories, Inc. (ATTN Accounts Receivable)
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, XX 00000-0000
(2) Upon approval by the Project Officer the invoice will be forwarded for
payment. The final invoice, clearly marked "Final" shall be filed no
later than sixty days after the last day of the period of performance.
Upon request, the Subcontractor hall furnish to BBI Biotech any
necessary documentation supporting invoiced amounts.
e. Intellectual Property, Ownership, and Confidentiality:
1. Definitions:
o "Specimens" means the biological blood samples BBI Biotech will
receive from study sites participating in the Collaborative
Project and process according to the terms and conditions of this
Agreement and any derivative material thereof.
o "Vaccine" means the investigational vaccine against the HIV virus
or its matching placebo developed by VaxGen for clinical testing
pursuant to the Vaccine Trial.
o "Specimen Process" means the process, methods and procedures by
which the Specimens are collected by study sites, and transferred
to and processed at BBI Biotech.
2. Notice of New Inventions, Ownership and Confidentiality:
o Patent Rights: Patent rights shall be subject to the FAR Clause
52.227-11, Patent Rights-Retention by the Contractor (Short Form)
(June 1997, which is incorporated in this subcontract by
reference.. Paragraph (f) is modified to include the requirements
in FAR 27.303(a)(2)(i) through (iv). The frequency of reporting
in (i) is annual.
o Ownership. Subcontractor acknowledges that NIAID is the owner of
the specimens. The parties agree that BBI Biotech shall have no
rights in the specimens, the Vaccine, the Specimen Process, use
of the Vaccine, Confidential Information of VaxGen, Inventions,
or other technology, processes and materials developed, owned,
disclosed or licensed by VaxGen, other than to use the same to
conduct the Collaborative
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Project in accordance with this Agreement. It is understood that
each potential collaborator must submit in writing to the
Scientific Review Committee described in section g below, for
their review and approval, a detailed proposal describing their
intended research project. The decisions (approval or rejection)
of the Scientific Review Committee will be communicated in
writing to the applicant by BBI Biotech who will function as an
Executive Secretary. If approval is given to an investigator for
their proposed research collaboration, BBI Biotech will also
include in their letter a copy of VaxGen's Database License
Agreement ("DLA"). See Attachment E for a copy of this form.
(Note: The Database License Agreement is a model. Investigators
may negotiate with VaxGen and make changes that are mutually
acceptable to the investigators and to VaxGen.) While failure of
an investigator to reach an agreement with VaxGen concerning a
mutually acceptable DLA will not be a condition of award, it will
significantly limit the scope of the investigator's contract.
Investigators are not required to sign a DLA; however, a DLA
needs to be executed before any VaxGen proprietary database
information will be disclosed to that investigator. The following
statement will be included in that form: "No
Collaborative-Project-generated specimen will be moved from
freezers housed at BBI Biotech and given to any individual
without written approval from the Scientific Review Committee",
such Scientific Review Committee being the one referred to in
paragraph g below. Before any interim data are either presented
at a meeting, published in a journal, or otherwise disclosed by
an investigator, all data must first be submitted to the
Scientific Review Committee for their input and VaxGen's review
at least 30 calendar days prior to such disclosure.
o Confidentiality: BBI Biotech agrees that BBI Biotech and all
those involved with BBI Biotech in performing the services
hereunder shall protect VaxGen Property from unauthorized use,
access, duplication, disclosure, loss or damage. In protecting
VaxGen Property, BBI Biotech will take adequate measures,
including but not limited to the following: (1) limit access and
use of VaxGen Property to authorized personnel for whom such
access and use are required for performance of the Specimen
Process; (2) use VaxGen Property only for the purposes described
in the this Agreement or for other purposes as approved by VaxGen
in writing; (3) prevent any unauthorized duplication of VaxGen
Property in written or electronic form and any recompilation or
modification of the Vaccine or the Specimens; (4) use at least
the same degree of care and discretion it uses in maintaining the
confidentiality of its own Confidential Information; and (5)
prevent transfer or disclosure of VaxGen Property to any other
person or entity without joint written approval by VaxGen and
NIAID, until after the Collaborative Project is declared closed
and the data set closed. Aggregate information or summary data
obtained from the Database Materials does not constitute
Confidential Information and can be disclosed for scientific or
public health purposes by the Licensee subject to Article 7.
o BBI Biotech shall not disclose or use for any purpose other than
performance of the Collaborative Project, any trade secret,
privileged record or other confidential or proprietary
information (collectively, the "Confidential Information")
disclosed to or developed by VaxGen, BBI Biotech, or the Sites,
pursuant to this Agreement. BBI Biotech shall cause each staff
member to follow the confidentiality requirements specified in
this agreement. Such Confidential Information shall be disclosed
to BBI
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Biotech by VaxGen hereunder in writing, or if disclosed orally or
in other than documentary form, shall be summarized in writing
within 30 days thereafter. Confidential Information that is not
in oral or written form, with the exception of data related to
Specimens, shall be designated in writing as confidential within
thirty (30) days after disclosure. The obligation of
non-disclosure shall not apply to information that: (i) was known
to BBI Biotech as evidenced by prior written records, prior to
receiving such information either directly or indirectly from
VaxGen, or (ii) is generally known to the public or that becomes
generally known to the public through no act or omission on the
part of BBI Biotech, or (iii) is disclosed to BBI Biotech on a
non-confidential basis at any time by a third party who has not
obtained or disclosed such information through improper or
unlawful means. If BBI Biotech is ordered to provide Confidential
Information by a lawful judicial or government order, BBI Biotech
shall promptly inform VaxGen and shall permit VaxGen to defend
against such order of disclosure and shall assist in such defense
to the extent permitted by law, however BBI Biotech's costs shall
not be charged to the Prime Contract. In no other circumstances
may BBI Biotech disclose information without the consultation and
prior written consent of VaxGen.
f. Scientific Review Committee:
o Under the direction of NIAID, BBI Biotech will establish a Scientific
Review Committee to review scientific projects proposed by
investigators who want to use specimens collected during the
Collaborative Project.
o This Committee will be comprised of representatives from BBI Biotech,
VaxGen and other scientific experts from both the private sector and
government agencies.
o This committee will meet on a quarterly basis or as needed due to the
number of new and/or existing submitted projects and the individual
requests associated with each project.
o Following the review of each proposal, this Committee will notify BBI
Biotech in writing of their decision to approve or disapprove a
potential collaboration. Therefore, under the direction of the
Scientific Review Committee, BBI Biotech will also function as an
Executive Secretary to this committee and in writing will notify
potential collaborators of any decision the committee makes concerning
his/her project.
g. Disclosure to NIAID
The Subcontractor agrees to disclose to NIAID all data in the database that
the Subcontractor has disclosed to investigators under DLAs, provided that
NIAID has signed a DLA with the Subcontractor that is mutually acceptable
to both NIAID and the Subcontractor..
h. The Database
The proprietary VaxGen database, portions of which are to be licensed under
each DLA, shall consist of the following data fields in records pertaining
to all specimens collected under the Collaborative Project:
1. All demographic data (includes age and gender)
2. Treatment assignment (or randomization code identifying which subjects
received vaccine or placebo
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3. Vaccine administration log (when each subject received (or missed) an
immunization)
4. Concomitant medication log (which antiretroviral a subject may have
taken either prophylactically or therapeutically once infected as well
as antimicrobials, other treatments for AIDS and other
immunosuppressive agents)
5. Status Change Form (tracks participation, when and reason why subject
stopped immunizations and/or discontinued from the study).
6. HIV-1 Infection (laboratory data that confirms infection and indicates
the date of the diagnosis.)
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK
ARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government or BBI Biotech, the
subcontractor shall make all reasonable efforts to furnish all the required
services, within the constraints of the funding provided, to perform the
Statement of Work, SECTION J, ATTACHMENT B, attached hereto and made a part of
this subcontract.
ARTICLE C.2. REPORTING REQUIREMENTS, OTHER DELIVERABLES & BIOLOGICAL SPECIMENS
VaxGen shall cooperate, as requested by BBI Biotech, in furnishing input for all
reports set forth in BBI Biotech's prime contract, which include: quarterly
progress report, an annual report, interim reports, a final report and
compliance-relevant enrollment data files.
At the conclusion of the trial, or the completion of this subcontract, whichever
shall occur first, VaxGen shall provide information on vaccine efficacy to
NIAID.
By the completion date of this Subcontract, VaxGen, when instructed by BBI
Biotech, shall deliver to BBI Biotech (or its designee) stored volunteer
specimens and material derived from volunteer specimens (peripheral blood
mononuclear cells and seminal plasma).
At the conclusion of the Collaborative Project, or upon the full execution or
termination of this Subcontract (whichever occurs first), the disposition of all
biological specimens used in the Collaborative Project shall be as directed by
NIAID.
ARTICLE C.3. INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR clause 52.227-11, incorporated by
reference in this Subcontract, shall be furnished to BBI Biotech as required by
the clause.
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this Subcontract shall be packaged, marked and
shipped in accordance with Government-supplied specifications. The Subcontractor
warrants that all required materials shall be delivered in immediately usable
and acceptable condition.
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SECTION E - INSPECTION AND ACCEPTANCE
BBI Biotech or its duly authorized representative will perform inspection and
acceptance of materials and services to be provided. This Subcontract
incorporates the following clause by reference, appropriately modified: FAR
52.249-6, Inspection of Research and Development (Short Form) (April 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1 . DELIVERIES
Not Applicable, except as specified above under Reporting Requirements and Other
Deliverables.
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE , FAR 52.252-2 (FEBRUARY 1998)
This subcontract incorporates FAR clauses by reference, with the same force and
effect as if they were given in full text. The full text of a clause may be
accessed electronically at this address: xxxx://xxx.xxxxx.xxx/xxx/. In each
clause, substitute the term "VaxGen" for "Contractor," and BBI Biotech for
"Government" or "Contracting Officer" as required by the text of the clause.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
Xx. Xxxx Xxxxxxxxx of BBI Biotech.
ARTICLE G.2. CONTRACT PERSONNEL
Xx. Xxxxxxx Xxxxxxx shall represent the Subcontractor and shall be responsible
for the technical matters related to the Statement of Work.
ARTICLE G.3 .INVOICE SUBMISSION
Invoices are to be submitted to:
BBI Biotech Research Laboratories, Inc. (ATTN: Accounts Payable)
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, XX 00000-0000
ARTICLE G.4. GOVERNMENT PROPERTY
In addition to the requirements of the clause Government Property incorporated
in this Subcontract, the
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Subcontractor shall comply with the provisions of DHHS Publication, Contractor's
Guide for Control of Government Property, 1990, which is incorporated by
reference. BBI Biotech will provide a copy upon request.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS
The primary purpose of the Public Health Service (PHS) is to support and advance
independent research within the scientific community. This support is provided
in the form of contracts and grants totaling approximately 7 billion dollars
annually. PHS has established effective, time tested and well recognized
procedures for stimulating and supporting this independent research by selecting
from multitudes of applications those research projects most worthy of support
within the constraints of its appropriations. The reimbursement through the
indirect cost mechanism of independent research and development costs not
incidental to product improvement would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
ARTICLE H.2. HUMAN SUBJECTS
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this Subcontract, and that no material developed,
modified, or delivered by or to the Government or to BBI-Biotech under this
Subcontract, or any subsequent modification of such material, will be used by
the Subcontractor or made available by the Subcontractor for use by anyone other
than the Government, for experimental or therapeutic use involving humans
without the prior written approval of BBI-Biotech, which approval shall not be
granted without the approval of the Contracting Officer responsible for
BBI-Biotech's prime contract.
ARTICLE H.3. HUMAN MATERIALS/ASSURANCE
It is understood that the acquisition and supply of all human specimen material
(including fetal material) used under this contract shall be obtained by the
Contractor in full compliance with applicable State and Local laws and the
provisions of the Uniform Anatomical Gift Act in the United States and that no
undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.
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The Subontractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
subcontract, by collaborating sites, or by subcontractors identified under this
subcontract, were obtained with prior approval by the Office for Human Research
Protections (OHRP)of an assurance to comply with the requirements of 45 CFR 46
to protect human research subjects. This restriction applies to all
collaborating sites without OHRP-approved assurances, whether domestic or
foreign, and compliance must be ensured by the Subcontractor.
The Subcontractor shall provide to BBI-Biotech a properly completed Optional
Form 310 certifying IRB review and approval of the protocol from which the human
materials were obtained. The human subject certification can be met by
submission of a self designated form, provided that it contains the information
required by the Optional Form 310.
ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO
a. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract funds
may not be used for (1) the creation of a human embryo or embryos for research
purposes; or (2) research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human
embryo or embryos" includes any organism, not protected as a human subject under
45 CFR 46 as of the date of the enactment of this Act, that is derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
b. Public Law and Section No. Fiscal Year
Period Covered
105-227, Section 510 1999
10/01/98 - 09/30/99
106-113, Section 510 2000
10/01/99 - 09/30/00
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds may be used to pay the direct salary of an individual through this
contract at a rate in excess of applicable amount shown for the fiscal year
covered. Direct salary is exclusive of overhead, fringe benefits and general and
administrative expenses. The per year salary rate limit also applies to
individuals proposed under subcontracts. If this is a
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multiple year contract, it may be subject to unilateral modifications by the
Government if an individual's salary rate exceeds any salary rate ceiling
established in future DHHS appropriation acts.
Dollar Amount of
b. Public Law No. Fiscal Year Salary
Limitation
105-277 FY-99 Executive
Level III*
106-113 FY-00 Executive
Level II**
c. Direct salaries which will be paid with FY-99 funds are limited to the
Executive Level III rate which was in effect on the date(s) the expense was
incurred. Direct salaries which will be paid with FY-00 funds are limited to the
Executive Level II rate which was in effect on the date(s) the expense was
incurred.
* For contract expenditures using FY 99 funds, for the period 10/1/98-12/31/99,
this amount is $125,900. Effective 1/1/00 , for contract expenditures using FY
99 funds, this amount is increased to $130,200 and will remain at this level
until such time as the Executive Level III is increased. See the web sites
listed below for Executive Level III rates of pay.
** For contract expenditures using FY 00 funds, for the period 10/1/99 -
12/31/99, this amount is $136,700. Effective 1/1/00, for contract expenditures
using FY 00 funds, this amount is increased to $141,300 and will remain at this
level until such time as the Executive Level II is increased. See the web sites
listed below for Executive Level II rates of pay.
FOR FY-99 EXECUTIVE LEVEL SALARIES:
xxxx://xxx.xxx.xxx/xxx/00xxxxxx/XXXXxxx/xxxx/00xxxxxx.xxx
FOR FY-00 EXECUTIVE LEVEL SALARIES:
xxxx://xxx.xxx.xxx/xxx/0000xxxx/Xxxxxxx/xxxx/xxxxxxxx.xxx
The direct salaries paid under the rate structure set forth in Attachment E to
this Subcontract comply with the above limitations.
ARTICLE H.6. EPA ENERGY STAR REQUIREMENTS
In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment) all microcomputers, including personal computers,
monitors, and printers that are deliverables under the procurement or are
purchased by the subcontractor using Government funds in performance of a
contract shall be equipped with or meet the energy efficient low-power standby
feature
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as defined by the EPA Energy Star program unless the equipment always meets EPA
Energy Star efficiency levels. The microcomputer, as configured with all
components, must be Energy Star compliant.
This low-power feature must already be activated when the computer equipment is
delivered to BBI Biotech and be of equivalent functionality of similar power
managed models. If the equipment will be used on a local area network, the
vendor must provide equipment that is fully compatible with the network
environment. In addition, the equipment will run commercial off-the-shelf
software both before and after recovery from its energy conservation mode.
ARTICLE H.7. PUBLICATION AND PUBLICITY
The subcontractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, under Contract No. NO1-AI-85341."
ARTICLE H.8. PRESS RELEASES AND OTHER PUBLIC STATEMENTS
a. Subcontractor agrees that it shall not issue press releases or other public
statements relating to the work performed under this Agreement without
submitting such statements to NIAID at least 10 (ten) working days in advance of
any release. Pursuant to Public Law(s) cited in paragraph b., below, the
contractor shall clearly state, when issuing statements, press releases,
requests for proposals, bid solicitations and other documents describing
projects or programs funded in whole or in part with Federal money: (1) the
percentage of the total costs of the program or project which will be financed
with Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of the
project or program that will be financed by nongovernmental sources.
b. Public Law and Section No. Fiscal Year
Period Covered
105-227, Section 507 1999
10/01/98 - 09/30/99
106-113, Section 507 2000
10/01/99 - 09/30/00
ARTICLE H.9. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall
not be used to carry out any program of distributing sterile needles or syringes
for the hypodermic injection of any illegal drug.
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b. Public Law and Section No. Fiscal Year
Period Covered
105-227, Section 505 1999
10/01/98 - 09/30/99
106-113, Section 505 2000
10/01/99 - 09/30/00
ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 0-000-XXX-XXXX (0-000-000-0000). All telephone calls will be
handled confidentially. The e-mail address is Xxxxx@xx.xxxx.xxx and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
X.X. Xxx 00000
Xxxxxxxxxx, X.X. 00000
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (xxxx://xxx0.xx.xxx.xxx/xxx/xxx.xxx)
ARTICLE H.11. YEAR 2000 COMPLIANCE
In accordance with FAR 39.106, Information Technology acquired under this
subcontract must be Year 2000 compliant as set forth in the following clause(s):
1. Service Involving the Use of Information Technology
YEAR 2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
The Subcontractor agrees that each item of hardware, software, and firmware
used under this contract shall be able to accurately process date data
(including, but not limited to, calculating, comparing and sequencing)
from, into and between the twentieth and twenty-first centuries and the
Year 1999 and the Year 2000 and leap year calculations.
(End of Clause)
2. Noncommercial Supply Items Warranty
YEAR 2000 WARRANTY--NONCOMMERCIAL SUPPLY ITEMS
13
The Subcontractor warrants that each noncommercial item of hardware,
software, and firmware delivered or developed under this contract and
listed below shall be able to accurately process date data (including, but
not limited to, calculating, comparing and sequencing) from, into and
between the twentieth and twenty-first centuries and the Year 1999 and the
Year 2000 and leap year calculations, when used in accordance with the item
documentation provided by the subcontractor, provided that all listed or
unlisted items (e.g., hardware, software and firmware) used in combination
with such listed item properly exchange date data with it. If the contract
requires that specific listed items must perform as a system in accordance
with the foregoing warranty, then that warranty shall apply to those listed
items as a system. The duration of this warranty and the remedies available
to the Government for breach of this warranty shall be as defined in, and
subject to, the terms and limitations of any general warranty provisions of
this contract provided that notwithstanding any provision to the contrary
in such warranty provision(s), or in the absence of any such warranty
provision(s), the remedies available to the Government under this warranty
shall include repair or replacement of any listed item whose noncompliance
is discovered and made known to the contractor in writing within ninety
(90) days after acceptance. Nothing in this warranty shall be construed to
limit any rights or remedies the Government may otherwise have under this
contract with respect to defects other than Year 2000 performance.
YEAR 2000 COMPLIANT ITEMS
(end of clause)
3. Commercial Supply Products Warranty
YEAR 2000 WARRANTY--COMMERCIAL SUPPLY ITEMS
The Subcontractor warrants that each hardware, software and firmware
product delivered under this subcontract and listed below shall be able to
accurately process date data (including, but not limited to, calculating,
comparing, and sequencing) from, into, and between the twentieth and
twenty-first centuries and the Year 1999 and the Year 2000 and leap year
calculations, when used in accordance with the product documentation
provided by the contractor, provided that all listed or unlisted products
(e.g., hardware, software, firmware) used in combination with such listed
product properly exchange date data with it. If the contract requires that
specific listed products must perform as a system in accordance with the
foregoing warranty, then that warranty shall apply to those listed products
as a system. The duration of this warranty and the remedies available to
the Government for breach of this warranty shall be as defined in, and
subject to, the terms and limitations of the contractor's standard
commercial warranty or warranties contained in this contract, provided that
notwithstanding any provision to the contrary in such commercial warranty
or warranties, the remedies available to the Government under this warranty
shall include repair or replacement of any listed product whose
non-compliance is discovered and made known to the contractor in writing
within ninety (90) days after acceptance. Nothing in this warranty shall be
construed to limit any rights or remedies the Government may otherwise have
under this contract with respect to defects other than Year 2000
performance.
YEAR 2000 COMPLIANT ITEMS
(end of clause)
14
ARTICLE H12. COMPLIANCE WITH PUBLIC LAWS
VaxGen will assure that all federal regulations regarding research on human
subjects and linked specimens are adhered to including those on which the
successful performance of this subcontract depend. Upon BBI Biotech's request
VaxGen will supply access to the documentation of this compliance (eg. informed
consent forms, IRB approvals).
PART II - SUBCONTRACT CLAUSES
SECTION I - SUBCONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A TIME AND MATERIAL OR A LABOR HOUR SUBCONTRACT
- FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates one or more clauses by reference, with the same force
and effect, as if they were given in full text. Upon request, BBI Biotech will
make their full text available. Also, the full text of a clause may be accessed
electronically at this address: xxxx://xxx.xxxxx.xxx/xxx/. In each clause,
substitute the term "VaxGen" for "Contractor," and substitute BBI Biotech for
"Government" or "Contracting Officer" as required by the text of the clause.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES
FAR
CLAUSE
NO. DATE TITLE
--- ---- -----
52.202-1 Oct 1995 Definitions
52.203-3 Apr 1984 Gratuities (Over $100,000)
52.203-5 Apr 1984 Covenant Against Contingent Fees (Over
$100,000)
52.203-6 Jul 1995 Restrictions on Subcontractor Sales to
the Government (Over $100,000)
52.203-7 Jul 1995 Anti-Kickback Procedures(Over $100,000)
52.203-8 Jan 1997 Cancellation, Recission, and Recovery of
Funds for Illegal or Improper Activity
(Over $100,000)
15
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or
Improper Activity (Over $100,000)
52.203-12 Jun 1997 Limitation on Payments to Influence
Certain Federal Transactions (Over
$100,000)
52.215-2 Jun 1999 Audit and Records - Negotiation (Over
$100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract
Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or
Pricing Data
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over
$500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
52.215-15 Dec 1998 Pension Adjustments and Asset Reversions
52.215-18 Oct 1997 Reversion or Adjustment of Plans for
Post-Retirement Benefits (PRB) other
than Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
52.215-21 Oct 1997 Requirements for Cost or Pricing Data or
Information Other Than Cost or Pricing
Data - Modifications
52.219-8 Oct 1999 Utilization of Small Business Concerns
(Over $100,000)
52.222-26 Feb 1999 Equal Opportunity
52.222-35 Apr 1998 Affirmative Action for Disabled Veterans
and Veterans of the Vietnam Era
52.222-36 Jun 1998 Affirmative Action for Workers with
Disabilities
52.222-37 Jan 1999 Employment Reports on Disabled Veterans
and Veterans of the Vietnam Era
52.223-14 Oct 1996 Toxic Chemical Release Reporting
52.225-13 Aug 1998 Restrictions on Certain Foreign
Purchases
16
52.227-1 Jul 1995 Authorization and Consent
52.227-11 June 1997 Patent Rights-Retention by the
Contractor (Short Form). Paragraph (f)
is modified to include the requirements
in FAR 27.303(a)(2)(i) through (iv). The
frequency of reporting in (i) is annual
52.227-2 Aug 1996 Notice and Assistance Regarding Patent
and Copyright Infringement (Over
$100,000)
52.232-7 Feb 1997 Payments under Time-and-Materials and
Labor-Hour Contracts
52.232-17 Jun 1996 Interest (Over $100,000)
52.232-25 Jun 1997 Prompt Payment
52.243-3 Aug 1987 Changes - Time-and-Materials and
Labor-Hours; provided however that the
parties agree that BBI Biotech may make
changes only to the extent such changes
are required by change orders from NIAID
pursuant to the Prime Contract.
52.245-5 Jan 1986 Government Property (Cost-Reimbursement,
Time and Material, or Labor-Hour
Contract)
52.249-6 Sep 1996 Termination (Cost-Reimbursement),
Alternate IV (Sep 1996); provided
however, that BBI Biotech may invoke
this clause only if the Government
exercises its termination rights under
the Prime Contract; and such exercise by
BBI Biotech shall only be to the same
extent that the Government exercises its
rights.
52.249-14 Apr 1984 Excusable Delays
17
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES
HHSAR
CLAUSE NO. DATE TITLE
---------- ---- -----
352.202-1 Apr 1984 Definitions
352.228-7 Dec 1991 Insurance - Liability to Third Persons
352.232-9 Apr 1984 Withholding of Contract Payments
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
Not Applicable
ARTICLE I.3. ADDITIONAL SUBCONTRACT CLAUSES
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
FAR 52.227-14, Rights in Data-General (June 1987) AND FAR 52.227-16,
Additional Data Requirements (June 1987), PROVIDED, however, that data
subject to these clauses shall be limited to the Database, as defined
previously in this Agreement in Article B.4.i.
FAR 52.251-1, Government Supply Sources (APRIL 1984).
ARTICLE I.4. ADDITIONAL FAR SUBCONTRACT CLAUSES INCLUDED IN FULL TEXT
Note: Substitute "VaxGen" wherever the term "Contractor" appears, and substitute
BBI Biotech wherever the term "Contracting Officer" or "Government" appears, as
required by the text.
FAR Clause 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (APRIL 1998)
(a) Definition.
Commercial item, as used in this clause, has the meaning contained in
the clause at 52.202-1, Definitions.
18
Subcontract, as used in this clause, includes a transfer of commercial
items between divisions, subsidiaries, or affiliates of the Contractor
or subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate,
and require its subcontractors at all tiers to incorporate, commercial
items or non developmental items as components of items to be supplied
under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is
not required to include any FAR provision or clause, other than those
listed below to the extent they are applicable and as may be required
to establish the reasonableness of prices under Part 15, in a
subcontract at any tier for commercial items or commercial components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Disabled Veterans and Veterans
of the Vietnam Era (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Handicapped Workers (29 U.S.C.
793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged Commercial
Vessels (46 U.S.C. 1241) (flow down not required for subcontracts
awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including this
paragraph (d), in subcontracts awarded under this contract.
ARTICLE I.5 DISPUTES
Except as set forth below, any dispute arising under this Subcontract which
is not settled by agreement of the parties shall be submitted by the
parties to binding arbitration under the auspices of the American
Arbitration Association in accordance with its commercial arbitration
rules, and judgement upon any determination, which may include an award of
damages, may be entered by the highest State or Federal court having
jurisdiction. Pending any decision, appeal or judgement referred to in this
clause or the settlement of any disputes arising under this Subcontract,
Subcontractor shall diligently continue with the performance of this
Subcontract while disputes are arbitrated.
Not covered under the above arbitration clause are efforts by Subcontractor
to protect its intellectual property from misappropriation or copyright or
patent infringement. Such legal action may be brought in any court of
competent jurisdiction at Subcontractor's discretion.
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this subcontract:
Budget, Statement of Work ATTACHMENT A, including VaxGen Hourly billing rates, 2
pages.
Statement of Work ATTACHMENT B, 1 page.
19
Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97), ATTACHMENT C, 1
page.
Procurement of Certain Equipment. Procurement of Certain Equipment, NIH(RC)-7,
4/1/84, ATTACHMENT D, 1 page.
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
Not applicable.
In witness whereof, the parties have caused this Agreement to be executed as of
the date written by their duly authorized representatives, and this Agreement
shall be effective as of May 1, 1999:
FOR: BBI BIOTECH RESEARCH LABORATORIES INC.
----------------------------
Xxxx Xxxxx,
Vice President and General Manager
-----------------------------
Date
FOR: VaxGen, Inc..
-----------------------------
-----------------------------
Date
END of the SCHEDULE
(CONTRACT)
20
ATTACHEMENT A BUDGET
----------------------------------------------------------------------------------------------------------------------------------
Year Year Year Year Year Year Year
Line Item Description 1 2 3 4 5 6 7 Total
----------------------------------------------------------------------------------------------------------------------------------
VaxGen Costs
Contract Amendments
$ 204,750 -- -- -- -- -- $ 204,750
Protocol Amendments
-- 25,000 -- -- -- -- -- 25,000
Project Management - Step A
Uninfected -- 5,500 4,000 4,000 4,000 -- -- 17,500
Project Management - Step B
Infected -- 5,500 4,000 4,000 4,000 -- -- 17,500
Site Management - Steps A&B
-- 48,000 48,000 50,000 46,500 -- -- 192,500
Data Management - Steps A&B
-- -- -- -- 31,500 -- -- 31,500
Vax Gen Subtotal
-- 288,750 56,000 58,000 86,000 -- -- 488,750
Pass Through Costs to Sites
IRB Submission
39,500 -- -- -- -- -- 39,500
Site Reimbursements - Step A
Uninfected -- 150,000 350,000 300,000 200,000 -- -- 1,000,000
Site Reimbursements - Step B
Infected -- 28,500 40,500 40,500 40,500 -- -- 150,000
Site Reimbursements - Step B
Infected 9,500 13,500 13,500 13,500 -- -- 50,000
Subtotal Study Sites
-- 227,500 404,000 354,000 254,000 -- -- 1,239500
----------------------------------------------------------------------------------------------------------------------------------
Total $0 $ 516,250 $460,000 $412,000 $340,000 $0 $0 $ 1,728,250
----------------------------------------------------------------------------------------------------------------------------------
21
VaxGen, Inc.
Hourly Xxxx Rates
1999 2000
Government Government
Department / Position Rate* Rate**
--------------------------------------------------------------------------------
Administration
------------------------------------
Executive Management 125.00 117.00
Senior Director 125.00 105.00
Director 110.00 80.00
Associate Director 100.00 75.00
Administrative / Staff Support II 80.00 65.00
Administrative / Staff Support I 65.00 50.00
Clinical
------------------------------------
Executive Management 165.00 117.00
Director 165.00 115.00
Associate Director 155.00 100.00
Clinical Program Manager 145.00 95.00
Senior Clinical Research Associate 135.00 85.00
Clinical Research Associate 125.00 75.00
Administrative / Staff Support I 115.00 65.00
Data Management / Biostatistics
------------------------------------
Director 170.00 110.00
Associate Director 150.00 105.00
Senior Analyst 135.00 90.00
Analyst 120.00 80.00
Data Manager 120.00 75.00
Clinical Data Associate 110.00 65.00
Laboratory
------------------------------------
Executive Management 185.00 170.00
Director 175.00 135.00
Associate Director 165.00 125.00
Senior Research Associate 150.00 115.00
Research Associate 135.00 105.00
Administrative / Staff Support II 125.00 115.00
Administrative / Staff Support I 115.00 100.00
* 1999 salaries capped at $125,900
** 2000 salaries capped at $141,300
22
ATTACHMENT B STATEMENT OF WORK
Contract N01-AI-85341entitled "Laboratory Support for AIDS Vaccine and Other
Prevention Clinical Trials" which was awarded to BBI Biotech has a need to
establish a subcontract with VaxGen. The purpose of this subcontract is to
facilitate a four year collaborative research project in conjunction with
VaxGen's VAX 004 Phase III Clinical Trial but does not alter in any manner
VaxGen's sole responsibility for VAX 004 design, conduct, analysis and
reporting. The specimens associated with this subcontract will be housed at BBI
Biotech's repository and will not be given to any investigator during the period
of this contract except as provided in this Subcontract.
Specifically, VaxGen agrees to do the following for this Collaborative Project:
o Coordinate and oversee all activities at the clinical sites.
o Submit protocol changes to clinical sites for IRB submissions.
o Act as a communication link between any clinical site and BBI Biotech.
o Review and oversee sample processing and storage Standard Operating
Procedures (SOPs) and Quality Assurance (QA)-related tasks performed
at BBI Biotech for this study as related to peripheral blood
mononuclear cells and seminal plasma.
o Approve format and information field design of specimen inventory
system called Biological Specimen Inventory System version.
o Be involved in and ultimately approve the resolution of any sample or
sample related data discrepancy.
o Provide BBI Biotech for BBI Biotech's approval, a copy of a standard
"Scientific Collaborator Agreement" that protects VaxGen's
intellectual property rights".
o All other activities necessary for successful completion of this
Subcontract Agreement, subject to the funding limitations stated in
this Subcontract.
23
ATTACHMENT C PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(a) To help ensure the protection of the life and health of all persons, and to
help prevent damage to property, the Subcontractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Subcontractor shall take or cause to be taken additional
safety measures as the Contracting Officer in conjunction with the project
or other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.
(c) The Subcontractor shall maintain an accurate record of, and promptly report
to the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Subcontractor fails or refuses to comply promptly with the Federal,
State or local regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.
(e) The Subcontractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or operations.
Compliance with the provisions of this clause by subcontractors will be the
responsibility of the Contractor.
(End of clause)
24
ATTACHMENT D PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the subontractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and Support
(Excluding 7045-ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
25
ATTACHMENT E - DATABASE LICENSE AGREEMENT
This database licensing agreement is a model. Investigators may negotiate with
VaxGen and make changes that are mutually acceptable to the investigators and to
VaxGen.
DATABASE LICENSE AGREEMENT
THIS DATABASE LICENSE AGREEMENT ("Agreement") is made , 2000 ("Effective Date"),
by and between VaxGen, Inc., a California corporation located at 0000 Xxxxxx
Xxxx., Xxxxxxxx, XX 00000-0000 ("VaxGen"), and ________________, a
________________ corporation with offices at _________________________
("Licensee").
RECITALS
WHEREAS, VaxGen has developed a proprietary database pertaining to clinical
trials related to a vaccine for prevention of Acquired Immune Deficiency
Syndrome ("AIDS") and supporting information as further described in Exhibit A,
a portion of which VaxGen desires to license to Licensee (the "Database");
WHEREAS, Licensee desires to perform research pertaining to an AIDS vaccine
under a subcontract funded by the National Institute of Allergy and Immune
Deficiencies ("NIAID);
WHEREAS, VaxGen desires to grant, and Licensee desires to obtain, the
necessary rights and license to use the Database to conduct said research in
accordance with the terms and conditions set forth in this Agreement; and
NOW, THEREFORE, in consideration of the foregoing premises, the mutual
covenants and agreements contained herein, and other good and valuable
consideration the receipt and sufficiency of which is hereby acknowledged, the
parties hereto agree as follows:
1. LICENSE. Subject to the terms and conditions of this Agreement, VaxGen hereby
grants Licensee a nonexclusive, nontransferable license, without right to
sublicense, license to use, and copy for internal use only, the VaxGen Database.
The license granted to Licensee under this Agreement is solely for the purposes
set forth in Exhibit B (the "Licensed Purposes").
2. UNAUTHORIZED USE.
2.1 Any use, copying, disclosure, or distribution of the Database not expressly
authorized in this Agreement is strictly prohibited. Without limiting the
generality of the foregoing, Licensee is expressly prohibited from (i)
sublicensing or reselling all or any portion of the Database; (ii) using or
allowing third parties to use the Database for the purpose of compiling,
enhancing, verifying, supplementing, adding to or deleting from any mailing
list, geographic or trade directories, business directories, classified
directories, classified advertising, or other compilation of information which
is sold, rented, published, furnished or in any manner provided to a third
party; (iii) using the Database in any service or product not specifically
authorized in this Agreement or offering it through any third party; or (iv)
modifying or otherwise altering the Database or any part thereof without
VaxGen's prior written consent, such consent may be withheld in VaxGen's sole
discretion.
2.2 Licensee will protect all data in the Database in a secure location and make
its best effort to prevent unauthorized usage or copying of the Database.
Without limiting the foregoing Licensee will implement a system of controls
designed to: a) protect the integrity of the Database; b) control access to the
VaxGen Database; and, if applicable c) reasonably ensure that the amount of
usage of the VaxGen Database is accurately recorded.
26
2.3 Licensee acknowledges that any unauthorized use distribution or disclosure
of the Database will cause irreparable harm and injury to VaxGen for which there
is no adequate remedy at law. In addition to all other remedies available under
this Agreement, at law or in equity, Licensee further agrees that VaxGen shall
be entitled to injunctive relief in the event Licensee uses distributes or
discloses all or a portion of the Database in violation of the limited license
granted hereunder.
3. LICENSE FEES AND ROYALTIES.
3.1 Licensee shall not be required to pay license fees to VaxGen.
4 DELIVERY.
4.1 VaxGen will provide Licensee with the Database and at VaxGen's sole
discretion, updates thereto.
4.2 If Licensee should be in default of the Agreement VaxGen may, among other
actions, and in its sole discretion, withhold updates of the VaxGen Database.
5 TERMINATION.
5.1 Either party may terminate this Agreement if the other party: (a) materially
breaches any term or condition of this Agreement (except as otherwise provided
in paragraph 5.2 of this Agreement) and fails to remedy such breach within
thirty (30) days after written notice of such breach; or (b) becomes subject to
any receivership, insolvency, bankruptcy, moratorium or similar proceeding for
more than thirty (30) days.
5.2 VaxGen may terminate this Agreement immediately if (a) Licensee participates
in any unauthorized use of the VaxGen Database (including, without limitation,
participating in or allowing an unauthorized third party's use thereof or access
to or failing to maintain controls as outlined in paragraph 2.2 above) (b) all
or substantially all of the assets of Licensee are sold, assigned or otherwise
transferred to any direct competitor of VaxGen (c) 50% or more of the equity
securities or voting interests of Licensee or the ultimate parent of Licensee is
sold, assigned or otherwise transferred in a single transaction or a series of
related transactions to a direct competitor of VaxGen; or (d) Licensee or its
ultimate parent is a party to a merger, consolidation or other similar
transaction with a direct competitor of VaxGen.
5.3 Upon termination or expiration of this Agreement for any reason, Licensee
shall (i) ensure that all copies of the Database and any related data and
information is deleted from its computers and the computers of any service
provider or other third party who processed the VaxGen Database for the
Licensee; (ii) cease any and all use of the VaxGen Database; (iii) return all
copies, whether in print, tape or other media, of all or any part of the VaxGen
Database to VaxGen no later than ten (10) days after termination of this
Agreement; and, (iv) certify in writing within twenty (20) days after
termination of this Agreement that Licensee and its service providers have
deleted or returned to VaxGen all copies of the VaxGen Database.
5.4 Except as otherwise provided in this Agreement, the remedies contained in
this Agreement are in addition to all other remedies available to either party
at law or in equity.
6. PROPRIETARY RIGHTS. Licensee acknowledges that all rights, title and interest
to the Database, regardless of the form of media in which it is contained, shall
be and are retained by VaxGen,
27
subject to the license granted to Licensee under this Agreement. Nothing in this
Agreement shall be construed as granting VaxGen any rights in software,
services, technology, or information created by outside of this Agreement, which
shall at all times remain the sole property of Licensee.
7. INVENTIONS.
7.1 If Licensee conceives or reduces to practice an invention arising from or in
connection with the subject matter of this Agreement during the Term,
(hereinafter a "Subject Invention") Licensee agrees to grant VaxGen the
exclusive option for an exclusive license subject to the nonexclusive rights of
the U.S. Agreement, on reasonable terms, to practice the invention in the field
of AIDS treatment. The terms of such license will be subject to negotiation by
the parties. During the first six (6) months after notice election to take an
exclusive offer by VaxGen, the parties shall in good faith negotiate the terms
of such license. During this time, Licensee will not negotiate or grant any
license to the invention to any other party or practice the invention itself for
commercial purposes. If, after six (6) months, the parties have failed to agree
on terms, the parties will engage in nonbinding mediation. Thereafter, VaxGen
shall have a right of first refusal over any license purposed to be granted by
Licensee.
7.2 Licensee shall fully disclose to VaxGen in writing all Subject Inventions
within ninety (90) days after the conception or reduction to practice of any
such invention, whichever occurs first. Neither Licensee nor VaxGen shall make
any disclosure regarding or related to a Subject Invention to any third party,
except the U.S. Government, until VaxGen or Licensee, as the parties may agree,
shall have at least ninety (90) days after such agreement, to complete
appropriate patent or FDA filings, or both.
7.3 All proposed publications or other disclosures of Licensee pertaining to its
research on AIDS vaccines sponsored by NIAID which shall have relied in any way
on data licensed to it hereunder by VaxGen, shall be submitted to VaxGen for
comment at least thirty (30) days prior to such publication or other disclosure.
The purpose of such comment period shall be to afford VaxGen the opportunity to
protect its intellectual property rights in the Database.
8. CONFIDENTIALITY.
8.1 Confidential Information. As used herein, "Confidential Information" means
(i) any business or technical information of a party, including but not limited
to, the Database Materials, information relating to a party's product plans,
designs, costs, product prices and names, finances, marketing plans, business
opportunities, personnel, research, development or know-how; (ii) any
information identified in writing by a party as "confidential" or "proprietary"
or which, under the circumstances taken as a whole, would reasonably be
understood to be confidential; and (iii) the terms and conditions (but not the
existence) of this Agreement, other than this Section 8. Aggregate information
or summary data obtained from the Database Materials does not constitute
Confidential Information and can be disclosed for scientific or public health
purposes by the Licensee subject to Article 7.
8.2 Conditions. Except to the extent permitted by this Agreement or as otherwise
agreed by the parties in writing, the parties agree that the party receiving
Confidential Information hereunder (the "Receiving Party") shall keep completely
confidential, shall not publish or otherwise disclose and shall not use directly
or indirectly for any purpose any Confidential Information furnished to it by
the other party (the "Disclosing Party") pursuant to this Agreement or otherwise
relating to any transaction contemplated hereby, including information
heretofore furnished to it, except to the extent that the Receiving Party can
establish by competent proof that such information: (a) was already known to the
Receiving Party, other than under an obligation of confidentiality, at the time
of disclosure by the
28
Disclosing Party, as evidenced by the Receiving Party's prior written and dated
records; (b) was known to the public at the time of its disclosure by the
Disclosing Party in substantially the same usable form; (c) became known to the
public in substantially the same usable form after its disclosure by the
Disclosing Party, other than through any act or omission of the Receiving Party
in breach of this Agreement; or (d) was disclosed to the Receiving Party by a
third party who was rightfully in possession of such information and had no
obligation not to disclose such information to others.
8.3 Authorized Disclosure. Each party may disclose Confidential Information
received from another party only to the extent that such disclosure is
reasonably necessary in complying with applicable government laws, rules or
regulations or judicial orders or decrees, provided that if a Receiving Party
intends to make any such disclosure, it shall give reasonable advance written
notice to the Disclosing Party of such intention. Furthermore, nothing in this
Section 8 shall be construed to preclude a party from disclosing such
information to such third parties as may be necessary in connection with the
transactions contemplated by this Agreement, provided that the Receiving Party
in question shall in each case obtain from the proposed third party recipient a
written confidentiality undertaking containing confidentiality obligations no
less restrictive than those set forth in this Section 8.
8.4 Notification. The Receiving Party shall notify the Disclosing Party
immediately, and cooperate with the Disclosing Party as the Disclosing Party may
reasonably request, upon the Receiving Party's discovery of any loss or
compromise of the Disclosing Party's Confidential Information.
8.5 Remedies. Each party agrees that the unauthorized use or disclosure of any
material or Confidential Information by the Receiving Party in violation of this
Agreement shall be a material breach of this Agreement and will cause
irreparable harm to the Disclosing Party. In the event of any violation of this
Section 8, the Receiving Party agrees that the Disclosing Party shall be
authorized and entitled to obtain from any court of competent jurisdiction
injunctive relief, whether preliminary or permanent, as well as any other relief
permitted by applicable law. The Receiving Party agrees to waive any requirement
that the Disclosing Party post bond as a condition for obtaining any such
relief.
9. DISCLAIMER OF WARRANTY, LIMITATION OF REMEDY, AND LIMITATION OF LIABILITY.
9.1 The Database is licensed on an "AS IS" basis without guarantee. VaxGen does
not guarantee that the VaxGen Database will meet the Licensee's requirements;
that it will operate in the combinations, or in the equipment, selected by the
Licensee or that its operation will be error-free or without interruption.
Licensee assumes sole responsibility for results obtained from the use of the
Database by Licensee and for conclusions drawn from such use.
9.2 VAXGEN MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS
FOR A PARTICULAR PURPOSE. NO REPRESENTATION OR STATEMENT SHALL BE BINDING UPON
VAXGEN AS A WARRANTY OR OTHERWISE UNLESS EXPRESSLY CONTAINED IN THIS AGREEMENT.
9.3 NOTWITHSTANDING PARAGRAPHS 9.1 AND 9.2 ABOVE, IF FOUND LIABLE VAXGEN'S
ENTIRE LIABILITY FOR DAMAGES IN CONNECTION WITH THE USE OF THE VAXGEN DATABASE
PROVIDED TO LICENSEE OR PROVIDED BY LICENSEE TO USERS (WHETHER BASED IN
CONTRACT, TORT OR OTHERWISE), WILL IN NO EVENT EXCEED $10,000.
29
9.4 VAXGEN SHALL NOT BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES OR FOR
ANY LOST PROFITS OR ANY CLAIM OR DEMAND OF A SIMILAR NATURE OR KIND, WHETHER
ASSERTED BY LICENSEE AGAINST VAXGEN OR AGAINST LICENSEE BY ANY OTHER PARTY, EVEN
IF VAXGEN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
10. INDEMNIFICATION. Licensee agrees to defend, indemnify and hold harmless
VaxGen, its officers, directors, employees, agents, and affiliates from any and
all claims, actions, demands, or liability to third parties that arise from or
in connection with Licensee's use of the VaxGen Database.
11. FORCE MAJEURE. Except for payment of money, neither party shall be
responsible for delays or failures in performance resulting from acts beyond the
reasonable control of such party. Such acts shall include but not be limited to
acts of God, riots, acts of war, and other disasters. In the event such an act
occurs, the party whose performance is delayed or affected will give prompt
notice to the other party, stating the period of time the delay or failure is
expected to continue.
12. ASSIGNMENTS. Licensee shall not assign or transfer this Agreement (directly
or indirectly) without the prior written consent of VaxGen. Any attempted
assignment to transfer in violation of this section shall be void.
13. MODIFICATION. No modification of this Agreement shall be binding upon the
Licensee and VaxGen unless made in writing and signed by duly authorized
officers of both parties.
14. NOTICES. All correspondence required by this Agreement shall be addressed to
the individuals listed below. Any notice required shall be given in writing and
shall be deemed effectively given upon personal delivery, deposit in the U.S.
post office as certified or registered mail or deposited in a private next day
delivery service.
Licensee
____________________
____________________
____________________
____________________
VaxGen, Inc.
Xx. Xxxxxxx Xxxxxxx
Xx. Director, Corporate Development
VaxGen, Inc
0000 Xxxxxx Xxxx.
Xxxxxxxx, XX 00000
15. WAIVERS. The failure of either party to require the performance of any term
or condition of this Agreement shall not prevent any subsequent enforcement of
this term or condition, nor shall it be deemed a wavier of any subsequent
breach.
30
16. GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard to its
conflicts of laws principles and both parties consent to the exclusive
jurisdiction of the state or federal courts located in ________________.
17. SEVERABILITY. A decision by any court of competent jurisdiction invalidating
or holding unenforceable any part of this Agreement will not affect the validity
and enforceability of any other part of this Agreement.
18. NO THIRD PARTY BENEFICIARIES. This Agreement is made solely and specifically
between and for the benefit of the parties signatory hereto, and no other person
or entity whatsoever shall have any rights, interests or claims hereunder or be
entitled to any benefits under or on account of this Agreement as a third party
beneficiary or otherwise.
19. RELATIONSHIP OF PARTIES. This Agreement does not create a joint venture or
partnership between VaxGen and the Licensee, and each will act independently of
the other. Neither party is empowered to bind or commit the other to any
contract or other obligation.
20. COMPLIANCE. Licensee shall use, and shall ensure that its Users use, the
VaxGen Database in strict compliance with all applicable federal, state and
local laws, rules and regulations, including but not limited to those concerning
fax and/or e-mail transmissions, direct marketing, and any third-party's patent,
copyright or other intellectual property rights and interests. Licensee further
acknowledges that Licensee is aware that certain states have enacted
restrictions regarding promotional mailings, and that Licensee or its customer
should consult with legal counsel regarding state statutes before initiating a
promotional mailing.
21. TAXES. Licensee shall be responsible to pay all taxes of any type, nature or
description (including, but not limited to, sale, use, gross receipts, excise,
import, export, income and employment taxes); provided, however, Licensee shall
not be responsible for any income taxes imposed upon VaxGen by any taxing
jurisdiction, arising by virtue of the performance of this Agreement.
22. ENTIRE AGREEMENT. This Agreement constitutes the entire Agreement between
the Parties and merges all prior and contemporaneous communications.
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the
duly authorized officers of the parties hereto on the date first above written.
LICENSEE VAXGEN, INC.
By:__________________________ By:______________________________
Name:________________________ Name_____________________________
Title:_______________________ Title:___________________________
E-mail_______________________ E-mail:__________________________
Fax:_________________________ Fax:_____________________________
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EXHIBIT A
DATABASE DESCRIPTION AND SPECIFICATIONS
Definition of Database: "Database" shall mean the following data fields in each
and every record pertaining to specimens collected under
the Collaborative Project.
1. All demographic data (includes age and gender).
2. Treatment assignment (or randomization code identifying which subjects
received vaccine or placebo).
3. Vaccine administration log (when each subject received (or missed) an
immunization).
4. Concomitant medication log (which antiretroviral a subject may have
taken either prophylactically or therapeutically once infected as well
as antimicrobials, other treatments for AIDS and other
immunosuppressive agents).
5. Status Change Form (tracks participation, when and reason why subject
stopped immunizations and/or discontinued from the study).
6. HIV-1 Infection (laboratory data that confirms infection and indicates
the date of the diagnosis).
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EXHIBIT B
LICENSED PURPOSES
Evaluation of the cellular immune response and cellular factors of AIDSVAX
recipients in VAX004.
33
