1
EXHIBIT 10.39
INITIAL MEDICAL DIRECTOR SERVICES AGREEMENT
This Initial Medical Director Services Agreement (this "AGREEMENT")
is entered into as of December 11, 1998, by and between Intracel Corporation, a
Delaware for-profit corporation ("INTRACEL"), and Lehigh Valley Hospital and
Health Network, a Pennsylvania non-profit corporation ("LEHIGH") (each a
"PARTY", and collectively "PARTIES").
WHEREAS, Intracel Corporation ("INTRACEL") and Lehigh have entered
into a Joint Venture Agreement dated as of December 11, 1998 (the "JOINT VENTURE
AGREEMENT") pursuant to which they intend to form a corporation ("ICC") to
operate a center for the manufacture and provision of OncoVax[cl](R)
("ONCOVAX"), a product developed by Intracel to be utilized in the treatment of
colon cancer and other oncological products as agreed to by Intracel and Lehigh;
WHEREAS, during the period between the Effective Date and the
formation and capitalization of ICC, ICC and Lehigh have entered into an amended
and restated lease with the same effective date as this Agreement (the "AMENDED
AND RESTATED INITIAL ONCOVAX CENTER LEASE") pursuant to which Intracel is
leasing from Lehigh the necessary space and equipment to operate a laboratory
and support area in compliance with current Good Manufacturing Practices to
manufacture and provide OncoVax and other oncological products as agreed to by
Intracel and Lehigh (the "ONCOVAX CENTER");
WHEREAS, Xxxxxxx X. Xxxxxx, Xx., M.D. is a physician employed by
Lehigh Valley Physician Group, which is a Pennsylvania non-profit corporation
and wholly-owned subsidiary of Lehigh;
WHEREAS, Xxxxxxx X. Xxxxxx, Xx., M.D. serves as the Chair of Surgery
for Lehigh pursuant to an agreement between Lehigh Valley Physician Group and
Lehigh;
WHEREAS, Intracel desires to obtain the services of Xxxxxxx X.
Xxxxxx, Xx., M.D. ("MEDICAL DIRECTOR") or his designee on an initial part-time,
independent contractor basis from Lehigh for the provision of certain Medical
Director services at the OncoVax Center as set forth more fully in Section 1.1
("SERVICES");
WHEREAS, pursuant to the Joint Venture Agreement, Lehigh has agreed
to provide the Services of the Medical Director on an initial part-time,
independent contractor basis to Intracel for Intracel's Service Fee (as defined
below) to Lehigh; and
WHEREAS, the Parties desire to enter into this Agreement to set forth
the terms and conditions under which Lehigh will provide the Services to
Intracel, and Intracel will compensate Lehigh for such Services.
2
NOW, THEREFORE, in consideration of the foregoing and for other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
1. MEDICAL DIRECTOR SERVICES
1.1 GENERAL DESCRIPTION OF SERVICES
During the Term (as defined in Section 6), Lehigh shall provide the
Services to Intracel through Medical Director, or as described in Section 1.9
below, through the Medical Director's designee. The Services shall include: (a)
assisting Intracel in establishing and enhancing the OncoVax Center, including
assisting with the clinical design of the center and the establishment of
protocols and systems; and (b) serving the OncoVax Center once it is operational
as a medical director, including (1) participating in administrative meetings
and performing other administrative duties as requested by Intracel, (2)
recommending rules and policies for the operation of the center, (3) serving as
a liaison with Lehigh and Lehigh physicians, and (4) assisting in the assessment
of outcomes and other clinical data with respect to OncoVax and other Intracel
products. Medical Director and Lehigh acknowledge and agree that, depending upon
certain development decisions and other circumstances, some details of Medical
Director's duties may change over time. This Agreement shall remain in effect
notwithstanding such changes. Intracel agrees to discuss any such changes with
Medical Director and to consider his input in these decisions. No activities or
services performed by Medical Director pursuant to this Agreement shall
constitute the practice of medicine. Any evaluations, diagnoses, treatments,
procedures or other professional health care services furnished to patients by
Medical Director will be provided in his individual capacity as a practicing
physician or employee of Lehigh or other entity, and will not be provided by
Medical Director in his capacity as an independent contractor to Intracel
pursuant to this Agreement.
1.2 BEST EFFORTS
Medical Director shall devote his best efforts to performing the
Services. In doing so, Medical Director shall use his full education, skills,
and professional energy, consistent with his training and experience, to advance
the business interests of Intracel. During the Term of this Agreement, Medical
Director shall not engage in any other activity or occupation for compensation,
or any non-compensated activity, that in Intracel's reasonable opinion is
competitive with or adverse to the interests of Intracel, without the prior
written consent of Intracel. Notwithstanding the foregoing, nothing in this
Section 1.2 or elsewhere in this Agreement shall prevent Medical Director,
during the time not required for the performance of the Services, from
maintaining his individual medical practice or performing his duties as the
Chair of Surgery for Lehigh or an employee of Lehigh Valley Physician Group.
2
3
1.3 HOURS AND RECORDS
Notwithstanding any other provision of this Agreement, Medical Director
shall not spend less than 15 hours per month or be required to spend more than
25 hours per month, on average, performing the Services. The Parties agree that
these minimum and maximum numbers are annual averages, and that Medical Director
may spend less than 15 hours or more than 25 hours in any particular month
depending on Intracel's needs and Medical Director's availability. Within ten
(10) days following the end of each calendar month during the Term of this
Agreement, Lehigh shall provide Intracel with a record of time Medical Director
spent performing the Services in the previous month. Such accounting shall
include the dates on which Medical Director performed Services, a description of
the Services performed on each date, and the amount of time spent performing
those Services.
1.4 REPORTING TO INTRACEL
Lehigh and/or Medical Director shall notify Intracel in writing within
one working day of the occurrence of any of the following: (a) Medical
Director's being notified that any written complaint or report concerning him
has been filed with the Pennsylvania state medical board or the National
Practitioner Data Bank; (b) Medical Director's being notified that any written
complaint has been filed against him, or any adverse action has been proposed
(whether final or not), at any hospital, other health care facility, health
maintenance organization, preferred provider organization, insurer or health
plan, professional review organization, professional association or governmental
body; (c) Medical Director's receiving a summons and complaint or a subpoena
relating to his professional practice; (d) Medical Director's being charged with
any crime (excluding minor traffic violations); (e) any other event which
reasonably might be anticipated to expose Intracel to a legal claim or adverse
publicity, or interfere with Medical Director's discharging his responsibilities
under this Agreement; or (f) any other disciplinary or professional liability
actions initiated against Medical Director. Medical Director acknowledges and
agrees that Intracel may inform malpractice carriers or other appropriate
parties of any such occurrence.
1.5 COMPLIANCE WITH LAW
Lehigh and Medical Director shall perform the Services faithfully,
diligently, ethically, in a professional manner and in accordance with all
applicable laws, regulations and currently recognized professional standards.
1.6 COMPLIANCE WITH INTRACEL RULES
Lehigh and Medical Director shall comply in all material respects with
the reasonable rules and policies of Intracel and the OncoVax Center, as they
now exist or as they may from time to time be amended, including rules and
policies governing the
3
4
provision of services, billing, records, and relationships with OncoVax Center
employees.
1.7 COOPERATION IN PROCEEDINGS
During and after the Term (and notwithstanding expiration or termination
of this Agreement for whatever reason), Lehigh and Medical Director shall,
without additional compensation, provide all reasonable assistance requested by
Intracel in order to (a) assert Intracel's rights under any insurance policies;
or (b) assist Intracel in defense of professional liability or other actions.
1.8 PROFESSIONAL LIABILITY INSURANCE
Lehigh covenants that the Medical Director shall at all times during the
Term be covered by professional liability insurance that meets all requirements
of the Pennsylvania Healthcare Malpractice Act, as amended, and that such
coverage will be provided at Lehigh's cost.
1.9 MEDICAL DIRECTOR'S DESIGNEE
The Parties agree that Medical Director may delegate the provision of
Services to a designee, which designee shall be Xxxxx Xxxxxxx, M.D. unless the
Parties mutually agree on another designee. Notwithstanding anything in Section
1.3 to the contrary, Medical Director's designee shall devote a minimum of fifty
percent (50%) of her professional time to the performance of the Services. In
the event of such delegation, Medical Director's designee shall be subject to
all the terms and conditions under this Agreement which are applicable to
Medical Director as if a reference to such designee was expressly set forth in
each provision applicable to Medical Director. Any breach of any term or
condition as applied to any designee shall be a breach thereof in the same
manner as if applied to Medical Director himself.
2. REPRESENTATION AND WARRANTIES OF LEHIGH
2.1 GENERAL REPRESENTATIONS AND WARRANTIES
Lehigh hereby represents and warrants that (a) Medical Director
possesses and throughout the Term shall maintain, a current, valid, and
unencumbered license to practice medicine in the State of Pennsylvania; (b)
Medical Director either (1) is not subject to any actual or threatened
investigation, disciplinary proceeding, ethics action, public or private suit or
claim as to malpractice or professional misconduct, and his performance in his
job functions is not impaired due to a physical or mental condition or substance
abuse, or (2) as to any such matter to which Medical Director is subject, full
information has been disclosed in writing to Intracel; (c) Medical
4
5
Director either (1) knows of no existing circumstances that would provide a
basis for revoking or suspending his medical license, or subjecting him to suit,
or which would be harmful to Intracel in engaging Medical Director, or (2) has
disclosed the same in writing to Intracel; (d) Medical Director has adequate
malpractice "occurrence" coverage or "tail" coverage under existing insurance
with limits of liability of not less than $1 million per occurrence and $3
million in the aggregate, covering any claims relating to activities in his
private medical practice, and Lehigh shall indemnify and hold harmless Intracel
from and against any claims, costs or expenses arising from such activities; and
(e) execution and performance of this Agreement does not violate any contract,
agreement, regulatory ruling or judicial order to which Lehigh or Medical
Director is subject (including both the Medical Director's employment agreement
and Lehigh's agreement with Lehigh Valley Physician Group), or to the best of
Lehigh's knowledge, violate any law.
2.2 EFFECT OF INACCURATE REPRESENTATIONS OR WARRANTIES
The Parties acknowledge and agree that if any representation or warranty
contained in this Section 2 is untrue or becomes untrue during the Term of this
Agreement, such untrue representation or warranty shall be deemed to be a
material misrepresentation by Medical Director and Intracel shall have the right
to terminate this Agreement pursuant to Section 6.
3. RESPONSIBILITIES OF INTRACEL
3.1 INTRACEL FACILITIES
Throughout the Term of this Agreement, Intracel shall provide clerical
and other administrative support, to the extent Intracel deems reasonable, to
help facilitate Medical Director's performance of the Services.
3.2 BUSINESS AND PROPERTY LIABILITY INSURANCE
Intracel shall maintain general business and property liability
insurance for claims arising from (a) the occupancy of Intracel offices by
Medical Director; and (b) the performance by Medical Director of the Services in
accordance with the terms of this Agreement.
4. REPRESENTATIONS AND WARRANTIES OF INTRACEL
Intracel hereby represents and warrants that (a) it is a corporation
duly organized and validly existing; (b) this Agreement has been duly executed
on behalf of Intracel; (c) this Agreement is a legal, valid and binding
obligation of Intracel; and (d) execution and performance of this Agreement does
not violate any contract,
5
6
agreement, regulatory ruling, or judicial order to which Intracel is subject, or
to the best of Intracel's knowledge, violate any law.
5. PAYMENT FOR SERVICES
5.1 SERVICE FEE
In return for the Services, Intracel shall pay to Lehigh a monthly
service fee ("SERVICE FEE") payable in arrears at the end of each month during
the Term. The Service Fee shall be $6,250 per month. The Parties agree (i) that
the Service Fee reflects the fair market value for the Services, and (ii) that
Intracel shall annually adjust the Service Fee to reflect the fair market value
of the Services.
5.2 EXPENSES
Subject to reasonable Intracel policies, including advance approval by
Intracel, and up to the reasonable dollar limits specified from time to time by
Intracel, Lehigh shall be entitled to reimbursement by Intracel for reasonable
expenses (including but not limited to reasonable travel expenses) incurred by
Medical Director during the Term of this Agreement in performance of the
Services and upon the presentation of appropriate documentation. It is intended
that all expenses incurred pursuant to this Section 5.2 are to be ordinary and
necessary business expenses. It is therefore agreed that if any expense paid
for, or reimbursed to, Lehigh is disallowed by the Internal Revenue Service as a
federal income tax deduction of Intracel, (1) Intracel shall not be obliged to
contest such ruling, and (2) Lehigh shall reimburse Intracel for such disallowed
expense within sixty (60) days after the final determination of such
disallowance.
6. TERM AND TERMINATION
6.1 TERM
The term of this Agreement (the "TERM") shall commence on the Initial
Closing Date, as that term is defined in the Joint Venture Agreement (the
"EFFECTIVE DATE") and shall end, unless earlier terminated in accordance with
this Section 6, on the Final Closing Date, as that term is defined in the Joint
Venture Agreement.
6.2 TERMINATION BY INTRACEL
Intracel may terminate this Agreement for Cause at any time during the
Term of this Agreement by giving Lehigh written notice at least thirty (30) days
in advance (the "NOTICE PERIOD") of the effective date of such termination (the
"TERMINATION
6
7
DATE"). Intracel may (without alteration of payment obligations under this
Agreement during the Notice Period) require that Medical Director cease his
performance of the Services at any time during the Notice Period. The following
shall be Cause for termination pursuant to this Section 6.2 (i) Lehigh itself,
or through Medical Director, breaches or fails to perform a material obligation
under this Agreement and that breach or failure is not cured to the reasonable
satisfaction of Intracel within the Notice Period; (ii) any act or omission
constituting fraud or material misrepresentation by Lehigh or Medical Director
in dealing with Intracel or the OncoVax Center; (iii) Medical Director's license
to practice medicine is suspended, limited or revoked, irrespective of other
proceedings, or Medical Director's DEA license to prescribe controlled
substances is revoked, limited or suspended; (iv) Medical Director is suspended
or barred from participation in Medicare; (v) Xxxxxxx X. Xxxxxx, Xx. is no
longer the Medical Director performing the Services on behalf of Lehigh, or he
becomes disabled to the extent that he is unable to perform the Services; (vi)
Medical Director becomes ineligible for professional liability coverage on
commercially reasonable terms; (vii) Lehigh is adjudged insolvent or bankrupt or
makes a general assignment for the benefit of creditors; or (viii) Medical
Director is convicted of a crime bearing on the practice of medicine, any crime
involving moral turpitude or fraud, or Medical Director is convicted of any
felony.
6.3 TERMINATION BY LEHIGH
Lehigh may terminate this Agreement for Cause at any time during the
Term of the Agreement by giving Intracel written notice at least thirty (30)
days in advance (the "NOTICE PERIOD") of the effective date of such termination
(the "TERMINATION DATE"). The following shall be Cause for termination pursuant
to this Section 6.3 (i) Intracel becomes insolvent or bankrupt or makes a
general assignment for the benefit of creditors; (ii) Intracel breaches or fails
to perform any material obligation under this Agreement, and such breach or
failure is not cured to the reasonable satisfaction of Lehigh within the Notice
Period; or (iii) Intracel commits fraud or material misrepresentation in its
dealings with Lehigh or Medical Director.
6.4 TERMINATION BY EVENT
Unless the Parties agree in writing to continue this Agreement, this
Agreement shall automatically terminate upon the occurrence, at any time, of any
of the following events: (i) the termination for any reason of the Joint Venture
Agreement, or (ii) in accordance with and only in accordance with the provisions
of Section 8.5, in the event this Agreement is deemed in the reasonable opinion
of either Party to violate law and be incapable of amendment.
7
8
6.5 COOPERATION
In the event of the expiration or termination of this Agreement for any
reason, Lehigh and Medical Director shall, without further compensation, if so
requested by Intracel, thereafter, promptly (a) respond to requests for
information as reasonably may be necessary to ensure appropriate transfer of
their responsibilities; and (b) advise Intracel if either receives a complaint,
summons, subpoena, or similar court order for records or testimony relating to
performance of the Services.
7. CONFIDENTIALITY
7.1 CONFIDENTIALITY
During the course of Lehigh's performance of the Services, Lehigh and/or
Medical Director may come to know certain confidential and proprietary business
or medical information of or about Intracel, the OncoVax Center, and/or Intracel
affiliates and joint venture partners (collectively, "ENTITIES"), including but
not limited to information concerning (a) business, affairs or operations of the
Entities or their customers, (b) Entity trade secrets, new product developments,
special or unique processes, protocols, or methods, (c) Entity marketing, sales,
advertising or other concepts or plans, (d) Entity fees and billing
arrangements, (e) Entity finances, (f) Entity management systems, or (g) Entity
business plans or prospects ("CONFIDENTIAL INFORMATION"). The term "Confidential
Information" shall exclude any information that is a matter of public knowledge
(except if such public knowledge resulted from an improper act of Medical
Director or Lehigh). Lehigh agrees that both during the Term of this Agreement
and after the expiration or termination of this Agreement for whatever reason,
Lehigh shall hold all such Confidential Information in the strictest confidence,
and shall not disclose, use, display, transfer, sell, publish, or otherwise make
available to any other person or entity, any such Confidential Information
without the prior written consent of Intracel, except as may be specifically
required by law. Lehigh shall protect such Confidential Information in a manner
consistent with the usual manner in which the most confidential business and
professional information is protected. Lehigh shall ensure that Medical Director
complies with the provisions of this Section 7.1.
7.2 ENFORCEMENT OF CONFIDENTIALITY REQUIREMENTS
Lehigh agrees that the restrictions contained in Section 7.1 are
part of the consideration for inducing Intracel to contract with Lehigh to
provide the Services for the fees provided for in this Agreement; that such
restrictions are reasonable and necessary to protect the business interests of
Intracel and the OncoVax Center; and that any violation of such restrictions
will cause substantial and irreparable injury to the Intracel and/or the OncoVax
Center. These restrictions shall be effective and enforceable upon the execution
of this Agreement by Lehigh, irrespective of the
8
9
length of its Term. The Parties agree that Intracel and the OncoVax Center each
are entitled, in addition to any and all other remedies available at law or in
equity, to a restraining order, preliminary and permanent injunctive relief and
specific performance to prevent a breach or contemplated breach of these
restrictions, without the necessity of proving actual damages. In the event of a
breach of these provisions, Lehigh shall be obligated to pay all costs and
expenses, including reasonable attorneys' fees, incurred by Intracel or the
OncoVax Center due to such breach or threatened breach.
7.3 NO ACQUIRED INTERESTS
Lehigh and Medical Director agree that upon termination or
expiration of this Agreement, all proprietary interest of Intracel or the
OncoVax Center in OncoVax or its other products, in customer accounts, lists,
copyrighted items, trade secrets, proprietary information, including all
intellectual property rights in any materials, documents, protocols, systems,
reports, or inventions, and all business assets, tangible or intangible
(collectively "PROPRIETARY INTERESTS"), with which Lehigh or Medical Director
deals or has access to, or that are developed or improved in whole or in part by
Lehigh or Medical Director in performing the Services during the Term of this
Agreement, shall remain the sole and exclusive property of Intracel and/or the
OncoVax Center, and in no event shall Lehigh or Medical Director, by virtue of
performing the Services, acquire any personal interest in the Proprietary
Interests or any right to use the Proprietary Interests except as specifically
set forth in a license agreement or other agreement executed by the Parties.
Lehigh and Medical Director each hereby assign to Intracel all of Lehigh's or
Medical Director's right, title and interest, including all intellectual
property rights, if any, in any Proprietary Interests developed in whole or in
part by Lehigh or by Medical Director in performance of the Services, which
Proprietary Interests all shall be considered works made for hire. Lehigh and
Medical Director agree that upon termination or expiration of this Agreement
each shall promptly return to Intracel all business, corporate, medical or
financial records, documents, forms, contracts, lists and completed work or work
in progress relating to the affairs of Intracel or the OncoVax Center and any
personal property of Intracel or the OncoVax Center in their possession at the
time of termination or expiration.
8. GENERAL PROVISIONS
8.1 NOTICES
All notices and other communications under this Agreement shall
be in writing and shall be deemed given when delivered personally, sent by
federal express or other recognized overnight delivery service or mailed by
registered or certified mail, return receipt requested, to the Parties as
follows or to such other addressee as a party may in writing designate.
9
10
If to Lehigh:
Lehigh Valley Hospital and Health Network
Xxxxx Xxxxx & X-00
X.X. Xxx 000
Xxxxxxxxx, Xxxxxxxxxxxx 00000-0000
Attn: Xxxxx X. Xxxxxxxxx
Facsimile: (000) 000-0000
with a copy to:
Xxxxxxx, Xxxxxxx & Xxxxxxxxxx
The Paragon Centre
0000 Xxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxxxxxxx, Esq.
Facsimile: (000) 000-0000
If to Intracel or OncoVax Center:
Intracel Corporation
0000 Xxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxx X. Xxxxx
Facsimile: (000) 000-0000
with a copy to:
Xxxxx Xxxxxxx, Esq.
Xxxxx & Xxxxxxx, L.L.P.
000 00xx Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000
Facsimile: (000) 000-0000
Each notice, demand, request or communication that shall be given or
made in the manner described in this Section 8.1 shall be deemed sufficiently
given or made for all purposes at such time as it is delivered to the addressee
(with the return receipt, the delivery receipt, or the affidavit of messenger
being deemed conclusive but not exclusive evidence of such delivery) or at such
time as delivery is refused by the addressee upon presentation. This Section 8.1
shall survive termination of this Agreement.
10
11
8.2 ENTIRE AGREEMENT; AMENDMENTS
This Agreement sets forth the entire understanding and agreement between
the parties with respect to the subject matter of this Agreement, and supersedes
all prior undertakings of any kind, whether written or oral. No terms,
conditions, or warranties, other than those contained in this Agreement, and no
amendments or modifications to this Agreement, shall be valid unless made in
writing and signed by the Parties.
8.3 EFFECT AND BENEFIT OF AGREEMENT
This Agreement shall be binding upon and inure to the benefit of the
Parties and their respective successors and permitted assigns. The covenants,
undertakings, and agreements set forth in this Agreement shall be solely for the
benefit of, and shall be enforceable only by, the Parties and their permitted
assigns, respective heirs, successors or legal representatives. Nothing in this
Agreement is intended to or shall be construed to, confer upon any person or
entity not a Party to this Agreement, any rights or benefits under this
Agreement.
8.4 ASSIGNMENT
This Agreement and its performance shall not be assigned, sublet,
delegated or transferred by either Party in whole or in part without the prior
written consent of the other party, except that Intracel shall have the right to
assign or delegate its rights and responsibilities under this Agreement, in
whole or in part, without Lehigh's consent, to the OncoVax Center (or a
successor entity) or to any affiliate or subsidiary of, or successor entity to,
Intracel.
8.5 INVALID PROVISIONS
If any provision of this Agreement or other document contemplated in
this Agreement is held to be illegal, invalid, or unenforceable under present or
future laws, such provisions shall be fully severable: (a) the appropriate
documents shall be construed and enforced as if such illegal, invalid, or
unenforceable provision had never comprised a part of the Agreement; (b) the
remaining provisions shall remain in full force and effect and shall not be
affected by the illegal, invalid or unenforceable provision; and (c) the Parties
shall in good faith negotiate and substitute a provision as similar in terms to
such illegal, invalid, or unenforceable provision as may be possible and still
be legal, valid and enforceable, unless the effect of such severance and
substitution would be to deprive a Party substantially of the benefits
contemplated under this Agreement, in which case either Party may terminate this
Agreement upon thirty days written notice to the other Party.
11
12
8.6 INDEPENDENT CONTRACTORS
The Parties acknowledge and agree that, with respect to this Agreement
and the arrangements set forth in this Agreement, they are independent
contractors and that except as provided in this Agreement, neither Party has the
right to obligate or bind the other Party in any manner whatsoever. Nothing in
this Agreement shall be interpreted, or is intended, to constitute either Party
as the employee or employer, joint venturer, or partner of the other Party. The
Parties understand and agree that (a) Intracel will not withhold on behalf of
Medical Director any sum for income tax, unemployment insurance, social security
or any other withholding applicable to employees, and Intracel will not provide
Medical Director with any of the benefits provided to employees of Intracel or
its affiliates; (b) as between Intracel and Lehigh, all such payments,
withholdings and benefits, if any, shall be the sole responsibility of Lehigh;
and (c) Lehigh will indemnify and hold Intracel harmless from any and all loss
or liability, cost or expense arising with respect to any such payments,
withholds, and benefits.
8.7 ACCESS TO BOOKS AND RECORDS
Until the expiration of six (6) years after expiration or termination of
this Agreement, Intracel and Medical Director each shall make available to the
Secretary, U.S. Department of Health and Human Services, the U.S. Comptroller
General and their representatives, this Agreement and all books, documents and
records necessary to certify the nature and extent of the costs of the services
furnished hereunder and will provide such additional documentation as they
reasonably require. If Medical Director carries out any of the duties of this
Agreement through a subcontract worth ten thousand dollars ($10,000) or more
over a twelve month period with a related organization, the subcontract will
also contain a clause to permit access by the Secretary, Comptroller General,
and their representatives to the related organization's books and records. This
Section 8.7 shall survive termination of this Agreement.
8.8 REMEDIES
Any remedies the Parties may have pursuant to this Agreement or by law
shall be cumulative.
8.9 NO WAIVER
The waiver by either Party of any breach of any provision of this
Agreement shall not be construed as a waiver of any subsequent breach of the
same or another provision. The failure to exercise any right under this
Agreement shall not operate as a waiver of such right. Any waiver must be in
writing and signed by the Party to be charged.
12
13
8.10 GOVERNING LAW
This Agreement, to the extent any particular issue is controlled by
state law, shall be governed by and construed in accordance with the laws of the
State of Maryland (but not including choice of law rules thereof).
8.11 COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but which together shall constitute one and
the same Agreement.
13
14
IN WITNESS WHEREOF, each of the Parties intending to be legally
bound has caused this Agreement to be duly executed and delivered in its name
and on its behalf as of the date first set forth above.
INTRACEL CORPORATION
By:
--------------------------------------
Name:
------------------------------------
Title:
-----------------------------------
LEHIGH VALLEY HOSPITAL AND HEALTH NETWORK
By:
--------------------------------------
Name:
------------------------------------
Title:
-----------------------------------
ACKNOWLEDGED AND AGREED:
XXXXXXX X. XXXXXX, XX., M.D.
By:
--------------------------------------
ACKNOWLEDGED AND AGREED:
XXXXX XXXXXXX, M.D.
By:
--------------------------------------
14