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EXHIBIT 10.40
RESEARCH AND CENTER AGREEMENT
BETWEEN
INTRACEL CORPORATION
AND
DUKE UNIVERSITY
DURHAM, NORTH CAROLINA
DECEMBER 28, 1998
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TABLE OF CONTENTS
1. SCOPE OF RESEARCH..................................................1
2. WORKPLAN/PAYMENT...................................................2
3. OPERATION OF THE ONCOVAX CENTER................................... 3
3.1 Operational Policies and Procedures......................... 3
3.2 Personnel................................................... 3
3.3 Designation of Medical Director............................. 3
4. REGULATORY APPROVALS/INTRACEL OVERSIGHT........................... 4
5. TERM & TERMINATION................................................ 4
6. INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE;
SURVIVAL.......................................................... 5
6.1 Hospital Indemnification of Intracel........................ 5
6.2 Intracel Indemnification of Hospital........................ 5
6.3 Notice...................................................... 6
6.4 Third Party Actions......................................... 6
6.5 Other Recoveries............................................ 6
6.6 Limitation of Liability..................................... 7
6.6.1 Limitation of Intracel's Liability.................... 7
6.6.2 Limitation of Hospital's Liability.................... 7
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6.7 Insurance.................................................. 7
6.7.1 Intracel's Obligation to Insure...................... 7
6.7.2 Hospital's Obligation to Insure...................... 8
6.8 Survival................................................... 8
7. MISCELLANEOUS.................................................... 8
7.1 Confidential and Proprietary Information................... 8
7.2 Institutional Review Board Approval........................ 9
7.3 Clinical Data and Reporting................................ 9
7.4 Publication................................................ 9
7.5 Adverse Effects............................................ 10
7.6 Further Assurances......................................... 10
7.7 Assignment; Binding Effect................................. 10
7.8 Governing Law.............................................. 10
7.9 Severability............................................... 10
7.10 Expenses; Attorneys' Fees.................................. 11
7.11 Modification; Waiver....................................... 11
7.12 Notice..................................................... 11
7.13 Benefit of This Agreement.................................. 12
7.14 Complete Agreement......................................... 12
7.15 Contract Modifications for Prospective Legal Events........ 13
7.16 Execution in Counterparts.................................. 13
7.17 Use of a Party's Name...................................... 13
7.18 Independent Contractor..................................... 13
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RESEARCH AND CENTER AGREEMENT
THIS RESEARCH AND CENTER AGREEMENT (this "Agreement") is entered into as of
December 28, 1998, (the "Effective Date") by and between Intracel Corporation
("Intracel"), a Delaware corporation having its principal office at 0000
Xxxxxxx Xxxxx, Xxxxxxxxx, XX 00000, and Duke University ("Hospital"), a North
Carolina non-profit corporation having its principal office at Durnham, North
Carolina.
WHEREAS, Intracel has (i) developed OncoVAXcl(R) ("OncoVAX") to be
utilized in the treatment of colon cancer and (ii) the technical expertise
necessary for the manufacture, production and distribution of OncoVAX and other
drugs to be used in the treatment of cancer and for clinical trials;
WHEREAS, Hospital and its medical staff has the knowledge and expertise,
as well as the facilities reasonably necessary to support the diagnoses and
treatment of certain oncological diseases and the location necessary for the
preparation and delivery of OncoVAX to appropriate patients enrolled in a
clinical research study;
WHEREAS, Intracel desires to utilize Hospital's facilities for preparing
OncoVAX and other materials required for the conduct of certain clinical
research studies;
WHEREAS, Hospital desires to make available certain facilities and
personnel with the requisite skills to Intracel for the establishment of the
Center; and
WHEREAS, the fulfillment of this Agreement is of mutual interest and
benefit to Hospital and Intracel, and will further the instructional and
research objectives of Hospital in a manner consistent with its status as
a non-profit educational health care institution;
NOW THEREFORE, in consideration of the foregoing and of the mutual
covenants and agreements hereinafter set forth, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties hereto hereby agree as follows:
Scope of Operations
1. SCOPE OF RESEARCH
Hospital shall prepare, in compliance with FDA cGMP regulations, OncoVAX
and other materials required for the conduct of clinical research studies as
the parties may mutually agree. Materials prepared by Hospital under this
Agreement shall be used solely for such research purposes; however, Intracel
may recover costs associated with the preparation of such Materials by charging
patients as allowed by, and in strict accordance with, applicable FDA and other
governmental regulations. If Intracel obtains FDA marketing approval for
OncoVAX, Hospital and Intracel agree to use reasonable efforts to permit
Intracel to use facilities controlled by Hospital for
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commercial production on OncoVAX provided that such use is consistent with
Hospital's tax exempt status, applicable Hospital policies and Hospital's own
need for such facility.
2. WORKPLAN/PAYMENT
2.1 Each research study to be performed under this Agreement will be
documented in a mutually agreed Workplan which will include, but not be limited
to the study protocol, budget and payment schedule. Each Workplan may be
updated from time to time by mutual agreement between Intracel and Hospital.
Each Workplan will be reviewed on at least a quarterly basis and updated as the
parties may agree.
2.2 The Workplan will include activities to be performed with respect to:
(a) support of Intracel research protocols concerning tumor diagnosis and
treatment including preparation of autologous tumor vaccines,
comprising viable but non-tumorigenic cells from a patient's own
tumor;
(b) numbers and type of personnel required to manage anticipated
activity. Intracel authorizes the retention of two full time
employees at the inception of the Agreement.
(c) Hospital's obligation to conduct work under a particular protocol or
Workplan shall be contingent upon approval of its Institutional
Review Board and such other boards, committees, or officials as may
be required by its policies.
2.3 Payment Terms/Supplies. The parties agree that the Workplan will
include estimates of Hospital's expenses incurred in providing
service under the Agreement. Intracel will pay Hospital on a monthly
basis for these expenses. The aggregate amount will be based on an
estimate of direct employee expenses, supply expenses and an indirect
expense allocation of 28%. Intracel agrees to provide at its own
expense certain critical supplies for the manufacture of OncoVAX
including, but not limited to, Fresh Frozen TICEBCG, Collagenase
Solutions, DNA ase solutions, HBSS, DMSO, HSA in HBSS, and kits and
supplies developed by Intracel. Intracel agrees to pay Hospital for
other expenses including employee transportation costs. Hospital will
invoice Intracel on a monthly basis for total additional costs.
Intracel may audit Hospital's records supporting these other expenses.
2.4 Equipment. Intracel may provide such other equipment as is necessary
for the proper running of the Center. Service and maintenance of this
equipment is Intracel's responsibility. Intracel will retain title to
this equipment and will remove it at the end of this Agreement.
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3. OPERATION OF THE CENTER
3.1 OPERATIONAL POLICIES AND PROCEDURES
Hospital shall adopt and enforce policies and procedures provided by
Intracel for the operation of the operation of the OncoVAX Center. Intracel
shall maintain ultimate responsibility for compliance with all applicable United
States Food And Drug Administration ("FDA") product requirements. Hospital
agrees to conduct all research under this Agreement shall be conducted in
accordance with all applicable federal, state, and local laws and regulations.
3.2 PERSONNEL
(a) All laboratory, clinical and administrative personnel working in
the OncoVAX Center shall be employees of Hospital with the exception of the
Intracel employee described in Section 3.2(b) and subject to Hospital's
personnel policies and procedures. Hospital shall provide the services of a
physician who will, on behalf of Hospital, act as the medical director of the
OncoVAX Center (the "Medical Director"). The Medical Director shall be an
employee of Hospital and provide professional research services as further
described in Section 3.3 below.
(b) Intracel may employ an on-site employee who is responsible for
overseeing the preparation of OncoVAX, and to train and direct the activity of
Hospital employees as it relates to said preparation. Intracel shall be
responsible for all compensation and insurance coverage, including workers'
compensation, for this Intracel employee, and Hospital shall have no obligation
to provide any such compensation or insurance, or any other benefits normally
provided by Hospital to its employees. Intracel agrees to assume all risks
incident to this Intracel's employee's research activity at Hospital (including
the risk of personal injury or property damage) regardless of their causes,
which may include but are not limited to laboratory accidents, and the failure
to supervise any persons, unless due to the negligence or material breach of
Hospital or its agents or employees.
3.3 DESIGNATION OF MEDICAL DIRECTOR
The Medical Director or designee shall serve as Principal Investigator for
each Study and shall exert best efforts to perform the work required under this
Agreement. The Medical Director or designee shall devote a minimum of ten
percent (10%) of his professional time to the performance of the research
contemplated hereunder and shall provide Intracel with a monthly report on the
progress of such research. If the Principal Investigator is unable to continue
to serve in that capacity and a successor acceptable to both DUKE and SPONSOR
is not available, this Agreement will be terminated in accordance with Article
5.3. Intracel shall pay Hospital in compensation for the Medical Director's
effort at the rate of $30,000 for the first year of the subject research
payable in monthly installments of $2,500 per month. The payment shall be made
in arrears at the end of each month. The payment shall be adjusted annually to
reflect changes in Hospital's normal charges for such efforts.
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4. REGULATORY APPROVALS/INTRACEL OVERSIGHT
Hospital shall use reasonable efforts to obtain any authorizations,
consent, and approvals of any federal, state, local, foreign or other
governmental agency, instrumentality, commission, authority, board or body or
other person or entity, including the FDA, for the transactions contemplated
hereunder. Intracel shall cooperate with and assist Hospital in providing
information and other documentation required by such bodies. Hospital agrees to
use its best efforts to cooperate with, and provide support to, Intracel in
complying with current Good Manufacturing Practices ("cGMP"). Intracel shall use
its best efforts to cooperate with, and provide support to, Hospital in
complying with current Good Manufacturing Practices (cGMP) and shall be
responsible for training Hospital employees in such practices. Notwithstanding
anything to the contrary in this Agreement, the parties agree that Intracel
shall have, among others, the following rights: (i) the right to audit the
Center, (ii) the right to close the Center or otherwise stop Hospital from
preparing OncoVAX and other materials required for the research contemplated by
this Agreement if Hospital's facilities are not in compliance with applicable
laws and regulations, (iii) the right to approve all personnel working on the
subject research, and to require removal from the research of any such
personnel, including the Medical Director if they fail in any material way to
comply with applicable laws and regulations, (iv) responsible for any
interaction with the FDA with respect to OncoVAX or any other product agreed to
by the parties, (v) the right to require implementation of any actions or
changes in order to assure full compliance with all applicable FDA requirements,
and (vi) the right to terminate this Agreement should the Hospital not take
actions with respect to the Center, its operations and its employees in order to
comply with all applicable laws and regulations. Intracel shall not make binding
commitments with FDA for Hospital without Hospital's prior written consent which
will not be unreasonably withheld, and Hospital may participate in said
discussions with the FDA as it relates to the Center. Hospital agrees not to
manufacture or use OncoVAX for any purpose without Intracel's prior approval.
5. TERM & TERMINATION
5.1 The term of this Agreement shall commence on the Effective Date and
shall, unless earlier terminated as described in Section 5.2 below, end on the
fourth anniversary of said Effective Date. The parties shall meet prior to each
such anniversary plan to agree on the Workplan as described in Section 2 for the
coming year. If the parties are unable to agree upon a Workplan, this Agreement
shall immediately terminate.
5.2 This Agreement may be terminated at any time by either party by
written notice to the other party in the event that the other party has
materially breached a representation, warranty, covenant or agreement contained
in this Agreement or in any other agreement or document contemplated hereunder
and such breach has not been cured within 30 days of written notice thereof by
the non-breaching party; or
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5.3 EFFECT OF TERMINATION
In the event this Agreement is terminated as provided above,
Hospital will proceed in an orderly fashion to terminate any outstanding
commitments and to stop the work as soon as it is practicable to do so. All
reasonable costs to Hospital associated with termination will be considered
reimbursable costs, including costs incurred prior to the notice of termination
but which have not yet been reimbursed, and commitments existing at the time
the notice of termination is received which cannot be cancelled. Neither of the
parties, nor any of their respective stockholders, directors, officers,
officers or agents shall have any liability to the other party, except for any
deliberate breach or deliberate omission resulting in material breach of any of
the provisions of this Agreement. In such case, the breaching party shall be
liable only for the expenses and costs of the non-breaching party, and in no
event shall either party be liable for anticipated profits or consequential
damages.
5.4 GENERALLY
After termination, each party shall keep confidential all information
provided by the other pursuant to this Agreement which is not in the public
domain, shall exercise the same degree of care in handling such information as
it would exercise with similar confidential information of its own, and shall
return any such information upon the other party's request.
6. INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE; SURVIVAL
6.1 HOSPITAL INDEMNIFICATION OF INTRACEL
Hospital will indemnify, defend and hold harmless Intracel and
Intracel's successors and assigns from and against any and all actual and
direct claims, damages, losses and liabilities (including reasonable attorneys'
fees) ("Losses") which may at any time be asserted against or suffered by
Intracel as a result of or on account of any material breach of any
representation, warranty or covenant on the part of Hospital made herein or in
any instrument or document delivered pursuant hereto.
6.2 INTRACEL INDEMNIFICATION OF HOSPITAL
Intracel will indemnify, defend and hold harmless Hospital and
Hospital's successors and assigns from and against any and all Losses which may
at any time be asserted against or suffered by Hospital as a result of or on
account of any breach of any representation, warranty or covenant on the part
of Intracel made herein or in any instrument or document delivered pursuant
hereto. In addition, Intracel agrees to indemnify, hold harmless and defend
Hospital, its trustees, officers, employees, and agents from and against any
and all claims, suits, losses, damages, costs, fees, expenses (including
reasonable attorneys' fees), and other liabilities asserted by third parties,
both government and non-government, resulting from or arising out of the
clinical study and research program carried out pursuant to this Agreement;
provided,
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however, that Intracel shall not be liable for DUKE's negligence, intentional
wrongdoing, or its failure to follow a mutually agreed protocol.
6.3 NOTICE
A party (an "Indemnified Party") shall give prompt written notice to
an indemnifying party (the "Indemnifying Party") of any payments, demands,
claims, suits, judgments, liabilities, losses, costs, damages or expenses (a
"Claim") in respect of which such Indemnifying Party has a duty to provide
indemnity to such Indemnified Party under this Section 6.3, except that any
delay or failure to notify the Indemnifying Party only shall relieve the
Indemnifying Party of its obligations hereunder to the extent, if at all, that
it is prejudiced by reason of such delay or failure.
6.4 THIRD PARTY ACTIONS
In the event any claim is made, suit is brought, or other proceeding
instituted against a party to this Agreement which involves or appears
reasonably likely to involve a Loss, the Indemnified Party will, within 10 days
after receipt of notice of any such claim, suit, or proceeding for which
indemnification may be sought, notify the Indemnifying Party in writing of the
commencement thereof; provided, however, that failure to give such notification
shall not affect the indemnification provided hereunder except to the extent the
Indemnifying Party can demonstrate actual monetary prejudice as a direct or
indirect result of such failure.
The Indemnified Party may elect, within 30 days after the
Indemnifying Party's receipt of such notice, or five days before the return date
required by any citation, claim, or other statute, whichever occurs earlier, to
contest or defend against such claim at the Indemnifying Party's expense, and
shall give written notice to the Indemnifying Party of the commencement of such
defense. The Indemnifying Party, its subsidiaries, successors, and assigns shall
be entitled to participate with the Indemnified Party in such event (at the
Indemnifying Party's cost and expense). In the event that the Indemnified Party
does not elect to contest, defend, settle, or pay the claim as provided above,
the Indemnifying Party, its subsidiaries, successors, or assigns shall have the
exclusive right to prosecute, defend, compromise, settle, or pay the claim in
its sole discretion and pursue its rights under this Agreement but shall not be
entitled in any way to release, waive, settle, modify, or pay such claim without
the consent of the Indemnified Party. Each party, its subsidiaries, successors,
and assigns shall cooperate in the defense of such action and the records of
each shall be available to the other with respect to such defense.
6.5 OTHER RECOVERIES
The amount of any Losses recoverable by an Indemnified Party
hereunder shall be reduced by the amount, if any, of the recovery (net of
reasonable expenses incurred in obtaining said recovery) the Indemnified Party
hereunder shall have received with respect thereto from any other party, person,
or entity, other than an insurer of the Indemnified Party unless such insurer
has expressly waived all rights of subrogation with respect to such recovery. In
the event such a recovery is made by an Indemnified
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Party after it receives payment or other credit hereunder with respect to any
Losses, then a refund equal to aggregate amount to the recovery, net of
reasonable expenses incurred in obtaining that recovery, shall be made promptly
to the Indemnifying Party making such payment. Without limiting the foregoing,
in the event that a claim or benefit is created in connection with the
occurrence of any Losses which have not been collected by the Indemnified Party
at the time payment with respect to such Losses is made by the Indemnifying
Party, the Indemnified Party shall assign such benefit or claim to the
Indemnifying Party as a condition to the payment by the Indemnifying Party and
shall cooperate with the Indemnifying Party in its efforts to collect any such
benefit or claim. If such claim or benefit is not assignable under applicable
laws, the Indemnified Party shall cooperate in good faith with the Indemnifying
Party's efforts to collect such claim or benefit.
6.6 LIMITATION OF LIABILITY
6.6.1 LIMITATION OF INTRACEL'S LIABILITY
Notwithstanding any other provision contained in this
Agreement, Intracel's liability under this Agreement shall be limited to actual
and direct losses suffered by Hospital arising as a result of Intracel's
negligent failure to perform its obligations under this Agreement. Hospital
acknowledges and agrees that Intracel shall not be liable for any lost
reimbursement or loss of data, earnings, profits or goodwill or any other
indirect, consequential, incidental, exemplary or punitive damages suffered by
any person or entity, including Hospital, caused directly or indirectly by the
acts or omissions of Intracel, its employees or agents in the course of
performing services or functions contemplated under or related in any way to
this Agreement (including, without limitation, any breach by Intracel of its
obligations under this Agreement).
6.6.2 LIMITATION OF HOSPITAL'S LIABILITY
Notwithstanding any other provision contained in this
Agreement, Hospital's liability under this Agreement shall be limited to actual
and direct losses suffered by Intracel arising as a result of Hospital's
negligent failure to perform its obligations under this Agreement. Intracel
acknowledges and agrees that Hospital shall not be liable for any lost
reimbursement or loss of data, earnings, profits or goodwill or any other
indirect, consequential, incidental, exemplary or punitive damages suffered by
any person or entity, including Intracel, caused directly or indirectly by the
acts or omissions of Hospital, its employees or agents in the course of
performing obligations or functions contemplated under or related in any way to
this Agreement (including, without limitation, any breach by Hospital of its
obligations under this Agreement).
6.7 INSURANCE
6.7.1 INTRACEL'S OBLIGATION TO INSURE
Intracel shall obtain and maintain in effect at all times
during the term of this Agreement insurance as set forth in Schedule 6.7.1.
Such insurance policies shall name Hospital as an additional insured and
Intracel shall provide such
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restrictions with respect to information furnished to one party by the other
shall not apply to any such information which the receiving party demonstrates
(i) is on the date hereof, or hereafter becomes, generally available to the
public other than as a result of a disclosure, directly or indirectly, by the
receiving party or (ii) was available or becomes available to the receiving
party on a confidential or non-confidential basis from a source other than the
other party hereto, which source was not itself bound by a confidentiality
agreement with such other party and did not receive such information, directly
or indirectly, from a person or entity so bound, (iii) is independently
developed by personnel of the receiving party without use or reliance upon
Confidential Information provided under this Agreement; or (e) is disclosed
pursuant to any judicial or governmental request, requirement or order,
provided that the disclosing party takes reasonable steps to provide the other
party with sufficient prior notice in order to allow the other party to contest
such request, requirement or order. Intracel shall be provided with patient
information as required by mutually agreed protocols and as allowed by law, and
will maintain the confidentiality of all such patient information in accordance
with all applicable laws and regulations.
7.2 INSTITUTIONAL REVIEW BOARD APPROVAL
Intracel shall cooperate with Medical Director in preparing and
filing research protocols, informed consent form, and other information with
Hospital's Institutional Review Board ("IRB"). Medical Director shall apply for
approval to conduct the research protocol with the IRB.
7.3 CLINICAL DATA AND REPORTING
All clinical data, including case report forms and other relevant
information generated during performance under the Agreement will be promptly
and fully disclosed to Intracel, and shall be freely usable by Intracel
consistent with good business judgment. Hospital will submit a complete written
progress report after the Agreement is completed. Hospital shall also submit
interim progress reports.
7.4 PUBLICATION
Hospital shall be free to use the results of the research and
clinical study for its own teaching, research, education, clinical and
publication purposes without the payment of royalties or other fees. Hospital
shall submit to Intracel for its review, a copy of any proposed publication
resulting from the research at least thirty (30) days prior to the estimated
date of publication and if no response is received within thirty (30) days of
the date submitted to Intracel, it will be conclusively presumed that the
publication may proceed without delay. If Intracel determines that the proposed
publication contains patentable subject matter which requires protection,
Intracel may require the delay of publication for a period of time not to
exceed sixty (60) days for the purpose of filing patent applications.
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7.5 ADVERSE EFFECTS
Intracel will reimburse Hospital and/or the patient for the
reasonable costs and expenses incurred in diagnosing and treating unanticipated
adverse effects, injuries, illnesses, or reactions that result from the use or
application of Intracel's investigational drug or device in the course of the
Agreement.
7.6 FURTHER ASSURANCES
The parties hereby agree to take whatever further actions or to
execute and deliver whatever further documents or instruments or make whatever
further filings as may be reasonably necessary or desirable to effectuate the
express provisions or the intent of this Agreement.
7.7 ASSIGNMENT; BINDING EFFECT
This Agreement, and the rights and obligations of the parties created
hereunder, shall not be assigned or delegated by either Hospital or Intracel
without the prior written consent of all parties, and any purported or
attempted assignment or delegation without such consent shall be void and
without effect, except that (i) Intracel may assign or delegate its rights and
obligations under this Agreement to any successor to Intracel in the event of a
merger or consolidation of Intracel with another entity, or to any purchaser of
all or substantially all of the assets or business of Intracel, and (ii) either
party may assign or delegate its rights and obligations under this Agreement to
an Affiliate (as defined below) in which case the assigning or delegating party
shall not be relieved of their obligations hereunder. For purposes of this
Section 7.3, an Affiliate shall mean, as to any party hereto, any corporation
or other entity which, directly or indirectly, through one or more
intermediaries, controls (i.e., possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of an entity,
whether through ownership of voting securities, by contract, or otherwise) is
controlled by, or is under common control with such party. Subject to the
foregoing, this Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective successors, assigns, heirs, executors,
administrators, and/or personal representatives.
7.8 GOVERNING LAW
This Agreement and the rights and obligations of the parties hereto
shall be governed by and construed and enforced in accordance with the laws of
the North Carolina (excluding the choice of law rules thereof).
7.9 SEVERABILITY
In the event that a court of competent jurisdiction holds that a
particular provision or requirement of this Agreement is in violation of any
applicable law, each such provision or requirement shall be enforced only to
the extent it is not in violation of such law or is not otherwise unenforceable
and all other provisions and requirements of this Agreement shall remain in
full force and effect.
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7.10 EXPENSES; ATTORNEYS' FEES
The parties shall pay their own respective expenses (including,
without limitation, the fees, disbursements and expenses of their attorneys,
accountants, actuaries, and financial and other advisors) in connection with
the negotiation and preparation of this Agreement and the transactions
contemplated hereby. If any party is required to institute legal action or
arbitration against another party to enforce the provisions of this Agreement,
the court or arbitration panel may award costs of litigation, including, but
without limitation, reasonable attorneys' fees.
7.11 MODIFICATION; WAIVER
This Agreement shall not be modified or amended except by an
instrument in writing signed by Hospital and Intracel. No delay or failure on
the part of any party hereto in exercising any right, power, or privilege under
this Agreement or any other instruments executed and delivered in connection
with or pursuant to this Agreement, shall impair any such right, power, or
privilege or be construed as a waiver of any default hereunder or any
acquiescence therein. No single or partial exercise of any such right, power,
or privilege shall preclude the further exercise of such right, power, or
privilege, or the exercise of any other right, power or privilege. No waiver
shall be valid against any party hereto unless made in writing and signed by
the party against whom enforcement of such waiver is sought and then only to
the extent expressly specified therein.
7.12 NOTICE
All notices, demands, requests or other communications which may be
or are required to be given, served or sent by any party to any other party
pursuant to this Agreement shall be in writing and shall be hand delivered
(including delivery by courier), sent by Federal Express or by other recognized
overnight delivery service, mailed by first-class, registered or certified
mail, return receipt requested, postage prepaid, or sent by telegram, telex, or
facsimile transmission, addressed as follows:
If to Intracel:
Intracel Corporation
0000 Xxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx
FAX 000-000-0000
and
Intracel Corporation
0000 Xxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: Xxxxx Xxxxx, CFO
FAX 000-000-0000
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if to Hospital:
Duke University Medical Center
Office of Grants and COntracts
Duke University Medical Center
107 Xxxxxx X. Xxxx Building - Box 3001
Xxxxxx, Xxxxx Xxxxxxxx 00000
with a copy (which shall not constitute notice) to:
Office of Counsel
Duke University
0000 Xxxxx Xx. Xxxxx 0000
DUMC Box 3024
Xxxxxx, Xxxxx Xxxxxxxx 00000
Each party may designate by notice in writing a new address to
which any notice, demand, request or communication may thereafter be so given,
served, or sent. Each notice, demand, request, or communication which shall be
mailed, delivered, or transmitted in the manner described above shall be deemed
sufficiently given, served, sent, or received for all purposes at such time as
it is delivered to the addressee (with the return receipt, the delivery
receipt, the affidavit of messenger, or (with respect to a telex or facsimile)
the answer back being deemed conclusive, but not exclusive, evidence of such
delivery) or at such time as delivery is refused by the addressee upon
presentation.
7.13 BENEFIT OF THIS AGREEMENT
It is the explicit intention of the parties hereto that except as
set forth below no person or entity other than a party hereto is or shall be
entitled to bring any action to enforce any provision of this Agreement against
any of the parties hereto, and that 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 hereto or their respective successors and
assigns as permitted hereunder. Notwithstanding the foregoing, ICC shall be a
third party beneficiary hereto with respect to the enforcement of, and only to
the extent of, any rights it may have hereunder.
7.14 COMPLETE AGREEMENT
This Agreement sets forth the entire agreement of the parties
hereto with respect to its subject matter and any all prior agreements, whether
oral or written, between or among the parties hereto and relating to the
subject matter hereof are superseded hereby.
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7.15 CONTRACT MODIFICATIONS FOR PROSPECTIVE LEGAL EVENTS
In the event any state or federal laws or regulations, now existing or
enacted or promulgated after the date hereof, are interpreted by judicial
decision, a regulatory agency or legal counsel in such manner as to indicate
that this Agreement or any provision hereof may be in violation of such laws or
regulations, Intracel and Hospital shall amend this Agreement as necessary to
preserve the underlying economic and financial arrangements between Intracel and
Hospital and without substantial economic detriment to either party. Neither
party shall claim or assert illegality as a defense to the enforcement of this
Agreement or any provision hereof; instead any such purported illegality shall
be resolved pursuant to the terms of this Section 7.11.
7.16 EXECUTION IN COUNTERPARTS
This Agreement may be executed in counterparts, each of which shall
constitute an original hereof for all purposes.
7.17 USE OF A PARTY'S NAME
Neither party will, without the prior written consent of the other
party, use in advertising, publicity, or otherwise, the name, trademark, logo,
symbol, or other image of the other party or that party's employee or agent.
7.18 INDEPENDENT CONTRACTOR
Hospital's and the Principal Investigator's relationship to Intracel
under this Agreement shall be that of an independent contractor and not an
agent, joint venturer, or partner of Intracel.
13
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IN WITNESS WHEREOF, each of the parties has duly caused this OncoVAX
Center Agreement to be duly executed in its name and on its behalf, as of the
date first written above.
INTRACEL CORPORATION
By:
-----------------------------
Name:
---------------------------
Title:
--------------------------
DUKE UNIVERSITY MEDICAL CENTER
By:
-----------------------------
Name:
---------------------------
Title:
--------------------------
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