HUMAN TISSUE TRANSFER AND COLLABORATION AGREEMENT
This Agreement is made as of ______________ (“Effective Date”), between The Trustees of the University
of Pennsylvania, a Pennsylvania nonprofit corporation with offices located at Franklin Building, Room P-221, 3451
Walnut Street, Philadelphia, PA 19104-6205 (“Institution”) and ____________________, a corporation organized and
existing under the laws of
("Collaborator"), having a place of business at ____________________________.
BACKGROUND
Institution has collected and will collect biological samples and data from patients suffering from
___________________________________. Institution and Collaborator wish to collaborate on the research set
forth in Exhibit A (“The Research Program”) utilizing the Institution and Collaborator biological samples and data
and Collaborator’s ___________________________. The research program contemplated by this Agreement is of
mutual interest to Institution and Collaborator and furthers the educational, scholarship and research objectives of
Institution as a nonprofit, tax-exempt, educational institution, and may benefit both Collaborator and Institution
through the creation or discovery of new inventions.
NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, Institution and
Collaborator agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meanings indicated:
1.1 “Research Program” shall mean the research set forth in Exhibit A, attached hereto and made a part hereof.
1.2 “Invention” shall mean all patentable inventions conceived and reduced to practice in the conduct of the
Research Program during the term of this Agreement, including any and all patent applications, together with any
patent resulting therefrom, including divisionals, continuations, continuations-in-part, continued prosecution
applications, reissues, extensions of term, substitutions, revalidations, renewals, re-examinations, supplemental
protection certificates, registrations and confirmations thereof which relate to the Inventions.
1.3 “Research Results” shall mean all data and information which are generated in the performance of the Research
Program during the term of this Agreement. Collaborator shall have the right to use Research Results disclosed to
Collaborator in records and reports for any reasonable purpose, provided such use is in accordance with the terms
and conditions of this Agreement, the HIPAA Data Use Agreement and the Human Tissue Biological Materials
Transfer Agreement; provided that Collaborator must obtain a separate license from Institution for any commercial
use that would infringe (i) any patent issued on account of an Institution Invention or (ii) any Institution copyright.
1.4 “Institution Clinical Data” shall mean patient information disclosed by Institution to Collaborator in the
performance of the Research Program and during the term of this Agreement. Institution shall disclose such clinical
data only as a Limited Data Set under the HIPAA Data Use Agreement.
1.5 “Limited Data Set” shall mean any collection of paper records, electronic databases or biological samples
containing Protected Health Information that excludes direct identifiers of the individual or of relatives, employers,
or household members of the individual. To be considered a “limited data set” the information must exclude the
following direct identifiers of the individual or of relatives, employers, or household members of the individual:
Names; Postal address information (other than town or city, State, and zip code); Telephone numbers; Fax numbers;
Electronic mail addresses; Social Security numbers; Medical record numbers; Health plan beneficiary numbers;
Account numbers; Certificate / license numbers; Vehicle identifiers and serial numbers, including license plate
numbers; Device identifiers and serial numbers; Web Universal Resource Locators (URLs); Internet Protocol (IP)
address numbers; any Biometric identifiers, including finger and voice prints; Full face photographic images and
any comparable images.
1.6 “Human Tissue Biological Material Transfer Agreement” shall mean an Agreement substantially in the form
shown in Exhibit Y which governs the transfer and use of specified Institution Material by Collaborator and third
parties. The Human Tissue Biological Material Transfer Agreement may include additional restrictions on transfer
and use of the Institution Material by Collaborator and third parties, as required by Institution's Institutional Review
Board (the "IRB") and Institution after review of the proposed transfer, including but not limited to review of the
specific Institution Material, their proposed use, and the patient consents under which the Institution Material were
obtained.
1.7 “HIPAA Data Use Agreement” shall mean an Agreement substantially in the form shown in Exhibit X which
governs the transfer and use of Institution Clinical Data by Collaborator and third parties. The HIPAA Data Use
Agreement may include additional restrictions on transfer and use of the Institution Clinical Data by Collaborator
and third parties, as required by the IRB and Institution after review of the proposed transfer, including but not
limited to review of the specific Institution Clinical Data, its proposed use, and the patient consents under which the
Institution Clinical Data was obtained.
1.8 “Institution Material” shall mean any biological samples from patients provided by Institution to Collaborator in
the performance of the Research Program and during the term of this Agreement. Institution shall provide such
samples only in accordance with the Human Tissue Biological Material Transfer Agreement and the HIPAA Data
Use Agreement.
1.90 "Protected Health Information" shall mean health information protected under the Health Insurance Portability
and Accountability Act of 1996.
2. RESEARCH PROGRAM
2.1 Research Efforts. Institution and Collaborator shall use reasonable efforts to conduct the tasks assigned to them
as set forth in Exhibit A. Collaborator acknowledges that Institution and the Principal Investigator shall have the
freedom to conduct and supervise the Research Program in a manner consistent with Institution’s educational and
research missions.
2.2 Principal Investigator. The portion of the Research Program to be performed at Institution shall be under the
direction of _________________________, (“Principal Investigator’) as set forth in Exhibit A. If the services of the
Principal Investigator become unavailable to Institution for any reason, Institution shall be entitled to designate
another member of its faculty who is acceptable to Collaborator to serve as the Principal Investigator of the
Research Program. If a substitute Principal Investigator has not been designated within sixty (60) days after the
original Principal Investigator ceases his or her services under this Agreement, either party may terminate this
Agreement upon written notice thereof to the other party, subject to the provisions of Section 11.
2.3 Collaborator’s Representative. Collaborator’s designated representative (“Collaborator Investigator”) for
consultation and communications with the Principle Investigator shall be _________________or such other person
as Collaborator may from time to time designate in writing to Institution and the Principal Investigator.
2.4 Reporting. Principal Investigator and Collaborator Investigator shall maintain records of the Research Results
and shall provide each other from time to time with reports describing the progress made on the Research Program.
3. DELIVERY AND USE OF MATERIAL AND CLINICAL DATA
3.1
Institution Material and Institution Clinical Data. Within fourteen (14) days following the Effective Date,
or as early as is reasonably practicable, Institution shall use reasonable efforts to provide Collaborator with sufficient
amounts of Institution Material and/or Institution Clinical Data, as available, for Collaborator to conduct its portion
of the Research Program. The amount and sufficiency of Institution Material provided can not be guaranteed.
Collaborator shall not use Institution Material or Institution Clinical Data for any other purpose except to perform
the research experiments specified in the Research Program in strict accordance with the terms of the Human Tissue
Biological Material Transfer Agreement and the HIPAA Data Use Agreement.
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3.2
Delivery. Institution Material, Institution Clinical Data and related Confidential Information shall be
directed to the attention of ______________________or such person as Collaborator shall designate in writing to
the Institution.
3.3
IRB approval. Collaborator understands and agrees that no transfer or use may be made of specific
Institution Material or Institution Clinical Data without IRB approval. Furthermore, Patient participation and the use
of Institution Clinical Data and Institution Material will be governed by the IRB and subject to all policies of
Institution relating to clinical trials and any applicable Federal, state, or local laws and regulations. Institution shall
use reasonable efforts to obtain any required approvals from the IRB relating to the collection, sharing and use of
any requested Institution Material and Institution Clinical Data for the purpose of performing the Research Program.
However, Institution can not guarantee IRB approval for the collection, transfer or use of any given Institution
Clinical Data or Institution Material.
4. BUDGET
Collaborator and Institution shall be responsible for their own costs and expenses incurred in performing the
Research Program.
5. CONFIDENTIAL INFORMATION
5.1 Confidential Information. Confidential information shall mean confidential scientific, business, or financial
information disclosed by one party to the other for purposes of conducting the Research Program, provided that such
information:
5.1.1
is not publicly known or available from other sources that are not under a confidentiality
obligation to the source of the information;
5.1.2
has not been made available by its owners to others without a confidentiality obligation;
5.1.3
is not already known by or available to the receiving party without a confidentiality
obligation;
5.1.4
is not independently developed by the receiving party;
5.1.5
is not required to be disclosed by law or regulation.
Notwithstanding the above, Confidential Information shall not include Institution Clinical Data or Institution
Material. Any use of Institution Clinical Data or Institution Material by Collaborator or third parties will be in strict
compliance with the Human Tissue Biological Material Transfer Agreement and the HIPAA Data Use Agreement.
Institution shall not be obligated to accept any confidential information from Collaborator, except as required under
Section 7.5, herein. If Collaborator desires to furnish any confidential information to the Principal Investigator,
Collaborator may request the Principal Investigator and any other individuals at Institution involved in the Research
Program who will receive the confidential information to sign the “Agreement between Collaborator and Principal
Investigator concerning Collaborator’s Confidential Information” that is attached as Exhibit Z. Institution bears no
responsibility for maintaining the confidentiality of any confidential information of Collaborator provided under
such agreement.
5.2 Either party’s acceptance and use of any Confidential Information which may be supplied by the other party in
the course of the Research Program shall be subject to the following;
5.2.1
To be considered Confidential Information, all written information must be marked or
designated in writing as CONFIDENTIAL, and oral communications must be reduced to writing
within thirty (30) days of the initial communication of the information and such writing must be
marked or designated in writing as CONFIDENTIAL.
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5.2.2
The receiving party’s obligation to hold Confidential Information in confidence expires
two (2) years after the termination or expiration of this Agreement, two (2) years after the
completion of the Research Program, or three (3) years from the Effective Date, whichever occurs
last. Notwithstanding the foregoing, such obligation of confidentiality shall not exceed five (5)
years from the date of receipt by the receiving party.
6. PUBLICATION
6.1
Publications. Notwithstanding Section 5, Collaborator acknowledges that Institution is an academic
institution and that its investigators and their collaborators shall be free to publish the results of their research
without undue restraint. In the event a publication is the result of collaborative work, which will acknowledge
authorship from the staff of Collaborator and faculty of Institution, the traditional system for determining authorship
and authorship order shall preside as determined by the principal scientist who initiated and is responsible for the
scientific collaboration. In order to avoid possible loss of patent rights as a result of public disclosure of patentable
information or unauthorized public disclosure of Confidential Information, Institution and Collaborator each shall
submit to the other any materials relating to a planned written publication or other disclosure for review at least
thirty (30) days prior to the date of the planned submission for publication or other disclosure. Disclosure of
Collaborator materials to Institution and the determination of whether it is desirable to file patent applications on any
inventions contained in the materials shall be pursuant to Section 7, hereof. In the case of materials disclosed by
Institution, Collaborator shall notify Institution within twenty (20) days of receipt of such materials whether it is
desirable to file patent applications on any inventions contained in the materials. Written publication or other
disclosure may be deferred at the request of Collaborator, to permit the filing of any desired patent applications;
provided, however, that said deferral shall in no event exceed sixty (60) days from the date of receipt by
Collaborator of the materials.
6.2
In order to preserve the patentability of any Institution Invention, Collaborator Invention or Joint Invention,
each party shall maintain any Institution Invention, Collaborator Invention or Joint Invention and information
provided pursuant to the Research Program (whether oral or written) as confidential. No disclosure of such
information to any third party shall occur until written verification that all desirable patentable inventions have been
protected has been provided to the parties.
7. INTELLECTUAL PROPERTY RIGHTS
7.1
Ownership of Inventions. Inventions conceived and first reduced to practice solely by Institution, or its
employees or agents shall be owned by Institution and shall be known as “Institution Inventions.” Inventions
conceived and first reduced to practice solely by Collaborator, or its employees, or agents, shall be owned by
Collaborator and shall be known as “Collaborator Inventions.” Inventions conceived and first reduced to practice by
at least one employee or agent of each of Institution and Collaborator, shall be jointly owned by Institution and
Collaborator and shall be known as “Joint Inventions.”
7.2
Patent Prosecution and Expenses. Principal Investigator shall provide Institution and Collaborator a written
disclosure of any Institution Inventions or Joint Inventions reasonably considered patentable. Collaborator shall
advise Institution in writing, no later than thirty (30) days after receipt of such disclosure, whether it requests
Institution to file and prosecute patent applications related to such Institution Inventions. If Collaborator does not
request Institution to file and prosecute such patent applications, Institution may proceed with such preparation and
prosecution at its own cost and expense; but such patent applications shall be excluded from Collaborator's option
under Section 8.1 hereof.
7.3
Institution shall control and be responsible for the preparation, filing, prosecution, and maintenance of
appropriate United States and foreign patent applications of all Institution Inventions. With regard to any patent
applications filed at the request and expense of Collaborator, Institution will consult with Collaborator on patent
prosecution. Collaborator shall reimburse Institution upon receipt of invoice for all documented expenses incurred
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in connection with the filing and prosecution of the patent applications and maintenance of the patents that
Collaborator has requested Institution to prosecute under Section 7.2 hereof.
7.4
Collaborator shall promptly disclose to Institution’s Center for Technology Transfer any Inventions
conceived and reduced to practice in the conduct of the Research Program during the term of this Agreement.
Institution, acting through its Center for Technology Transfer, will use reasonable efforts not to disclose to any third
party outside of Institution any confidential information disclosed pursuant to this Section 7.4. The parties will
confer in good faith to determine whether such Invention is a Collaborator Invention or a Joint Invention.
Collaborator shall be responsible for preparing, filing, prosecuting, and maintaining appropriate United States and
foreign patent applications of Collaborator Inventions.
7.5
Collaborator shall control and be responsible for the preparation, filing, prosecution, and maintenance of
appropriate United States and foreign patent applications of Joint Inventions. Collaborator shall give Institution an
opportunity to review the text of the application before filing, shall consult with Institution with respect thereto, and
shall supply Institution with a copy of the application as filed, together with notice of its filing date and serial
number. Collaborator shall keep Institution advised of the status of the actual and prospective patent filings and
provide advance copies of any papers related to the filing, prosecution and maintenance of such patent filings for
Institution’s review and comment. With respect to all filings hereunder, Collaborator shall be responsible for
payment for all costs and expenses related to such filings. If Collaborator elects not to pay for: (i) the filing of a
patent application in any country on any such Joint Invention, or (ii) the further prosecution or maintenance of any
such application in any country, or (iii) the filing of any divisional or continuing patent application based on any
such application in any country, Collaborator shall notify Institution at least fourteen (14) days prior to the deadline
by which such application must be filed, and Institution may do so at its own expense. In such event, Institution’s
undivided interest in such Joint Invention shall be excluded from Collaborator's option under Section 8.1 hereof.
Institution agrees to cooperate with Collaborator to execute all lawful papers and instruments, to make all rightful
oaths and declarations and to provide consultation and assistance as may be necessary in the preparation,
prosecution, maintenance, and enforcement of all such patents. If Collaborator chooses not to file and prosecute
patent applications to Joint Inventions, Institution may proceed with such preparation and prosecution at its own cost
and expense; but such patent applications shall be excluded from Collaborator's option under Section 8.1 hereof.
8. Grant of Rights
8.1
Option for Invention Rights. In consideration of Collaborator’s participation in the Research Program and
payment for intellectual property expenses as provided for in Sections 7.2 and 7.5, Institution grants Collaborator a
first option to negotiate to acquire an exclusive license on commercially reasonable terms to practice Institution
Inventions and/or Institution’s interest in Joint Inventions. Institution and Collaborator will negotiate in good faith
to determine the terms of a license agreement as to each item of Institution Inventions or Joint Inventions for which
Collaborator has agreed to make payment for intellectual property expenses as provided for in Section 7.2, if any. If
Collaborator and Institution fail to execute a license agreement within six (6) months after disclosure of the
Institution Invention or Joint Invention to Collaborator or if Collaborator fails to make payment for intellectual
property expenses as provided for in Section 7.2, Institution shall be free to license the Institution Invention or
Institution’s interest in the Joint Invention to any party without any further obligation to Collaborator.
8.2
Retained Rights. Institution shall have the right to use, free of cost and without limitation, all Institution
Inventions and Joint Inventions licensed to Collaborator hereunder, for its ordinary course of business and for
education and non-commercial research purposes and, if applicable, to the rights of the United States government
reserved under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued
thereunder.
8.3
Joint Inventions Not Exclusively Licensed. In the event that Collaborator does not obtain an exclusive
commercialization license to Institution’s rights in Joint Inventions described in Section 8.1, then each party shall
have the right to use the Joint Invention and to license its use to others on a non-exclusive basis. The parties may
agree to a joint licensing approach for such Joint Inventions.
9. REPRESENTATIONS AND WARRANTIES
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9.1
NO WARRANTIES. THE PARTIES MAKE NO WARRANTIES, EXPRESS OR IMPLIED, AS TO
ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, WARRANTIES WITH RESPECT
TO THE CONDUCT, COMPLETION, SUCCESS OR PARTICULAR RESULTS OF THE RESEARCH
PROGRAM, OR THE CONDITION, OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE OF ANY INTELLECTUAL PROPERTY, CLINICAL DATA, MATERIALS OR
RESEARCH RESULTS OR THAT THE USE OF THE INTELLECTUAL PROPERTY, CLINICAL DATA,
MATERIALS OR RESEARCH RESULTS WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK OR OTHER INTELLECTUAL PROPERTY RIGHT OF A THIRD PARTY.
INSTITUTION SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, PUNITIVE OR
OTHER DAMAGES SUFFERED BY COLLABORATOR OR ANY OTHER PERSON RESULTING FROM THE
RESEARCH PROGRAM OR THE USE OF ANY INSTITUTION INTELLECTUAL PROPERTY, JOINT
INTELLECTUAL PROPERTY, CLINICAL DATA, MATERIALS OR ANY RESEARCH RESULTS OR ANY
PRODUCTS RESULTING THEREFROM.
10. INDEMNIFICATION
10.1
Collaborator shall defend, indemnify and hold harmless Institution, the Principal Investigator and any of
Institution's faculty, students, employees, trustees, officers, affiliates and agents (hereinafter referred to collectively
as the "Indemnified Persons") from and against any and all liability, claims, lawsuits, losses, damages, costs or
expenses (including attorneys' fees), which the Indemnified Persons may hereafter incur, or be required to pay as a
result of Collaborator's use of the results of the Research Program or any Institution Invention, Joint Invention,
Institution Clinical Data, Institution Materials or Research Results or as a result of any breach of this Agreement,
including but not limited to the Human Tissue Biological Material Transfer Agreement and the HIPAA Data Use
Agreement, or any act or omission of Collaborator, its employees, affiliates, contractors, licensees or agents.
Institution shall notify Collaborator upon learning of the institution or threatened institution of any such liability,
claims, lawsuits, losses, damages, costs and expenses and Institution shall cooperate with Collaborator in every
proper way in the defense or settlement thereof at Collaborator's request and expense.
10.2
In no event shall Collaborator be obligated to defend, indemnify, and hold harmless an Indemnified Person
from any claim directly resulting from the gross negligence or willful misconduct of Institution or any of its
Indemnified Persons, or from Institution’s or any of its Indemnified Persons’ improperly following directions
provided by Collaborator (including but not limited to any research protocol approved by Collaborator).
10.3
The indemnities set forth in this Section 10 are subject to the condition that the Indemnified Persons shall
notify Collaborator as soon as they become aware of any suit, action or claim and cooperate with and authorize
Collaborator to carry out the sole management and defense of any such suit, claim or action. Collaborator agrees, at
its own expense, to provide attorneys to defend against any actions brought or filed against the Indemnified Persons
with respect to the indemnity contained herein, whether or not such suits, claims or actions are rightfully brought or
filed, and each Indemnified Person shall have the right to approve the selection of such attorney(s) provided by
Collaborator, which approval shall not unreasonably be withheld. Collaborator shall not dispose or settle any claim
that (i) admits liability on the part of the Indemnified Persons or (ii) imposes obligations on the part of the
Indemnified Persons, without such Indemnified Persons’ prior consent. If Collaborator fails or declines to assume
the defense of any such suit, action, or claim within thirty (30) days after notice thereof, an Indemnified Person may
assume the defense of such suit, action, or claim, at Collaborator’s sole expense (including, without limitation,
attorney’s fees and expenses).
11. TERM AND TERMINATION
11.1
Term. This Agreement shall terminate after ________ years from the Effective Date, unless sooner
terminated in accordance with the provisions of this Agreement.
11.2
Termination Without Cause. Either party may unilaterally terminate this Agreement, with or without
cause, by delivering at least ninety (90) days advance written notice to the other party hereto.
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11.3
Termination with Cause. In the event that either party shall be in default of any of its obligations under this
Agreement, including the attached HIPAA Data Use Agreement (Exhibit X), Human Tissue Biological Material
Transfer Agreement (Exhibit Y) and Agreement between Collaborator and Principal Investigator concerning
Collaborator’s Confidential Information (Exhibit Z), and shall fail to remedy such default within thirty (30) days
after receipt of written notice thereof, the non-defaulting party shall have the option of terminating this Agreement
by giving written notice thereof in accordance with Section 12.3.
11.4
Force Majeure Event. In the event of the occurrence of a force majeure event, the party unable to perform
shall promptly notify the other party pursuant to Section 12.3. It shall further use reasonable efforts to resume
performance as quickly as possible and shall suspend performance only for such period of time as is necessary as a
result of the force majeure event. In the event that performance is suspended indefinitely as a result of the force
majeure event, the other party shall have the option of terminating this Agreement by giving written notice thereof in
accordance with Section 12.3. Neither party shall be liable for any termination resulting from a force majeure event.
For purposes of this Section 11.4, a "force majeure event" shall be any unforeseeable event beyond a party's
reasonable control not caused by the fault or negligence of such party, which causes such party to be unable to
perform its obligations under this Agreement and which it has been unable to overcome by the exercise of due
diligence, including, but not limited to the inability to obtain IRB approval.
11.5
Effects of Termination. Termination of this Agreement shall not affect the obligations of the parties
accrued prior to termination.
11.6
Survival. The provisions of articles 5, 6, 7, 9, 10, and 11 shall survive any expiration or termination of this
Agreement.
12. GENERAL
12.1
Binding Effect: Assignment. This Agreement shall be binding upon and shall inure to the benefit of the
parties hereto and their respective transferees, successors and assigns, except that neither party shall have the right to
assign this Agreement or its right and obligations hereunder, without the prior written consent of the other party
thereto.
12.2
Entire Agreement. This Agreement, including the attached HIPAA Data Use Agreement (Exhibit X),
Human Tissue Biological Material Transfer Agreement (Exhibit Y) and Collaborator Confidential Information
Agreement between the Principal Investigator and Collaborator concerning Collaborator’s Confidential Information
(Exhibit Z), constitutes the entire and only agreement between the parties relating to the Research Program, and all
prior negotiations, representations, agreements and understandings are superseded hereby. No agreements
amending, altering or supplementing the terms hereof may be made except by means of a written document signed
by the duly authorized representatives of the parties.
12.3
Notices. Any notice or communication required or permitted to be given hereunder shall be in writing and,
except as otherwise expressly provided in this Agreement, shall be deemed given and effective (i) when delivered
personally, by telex or telecopier or (ii) when received if sent by overnight express or mailed by certified, registered
or regular mail, postage prepaid, addressed to a party at its address set forth below (or to such other address as such
party may designate by written notice in accordance with the provisions of this Section 12.3), said notice being
deemed given as of the date of mailing:
To INSTITUTION:
Copy to Principal Investigator:
___________________
___________________
___________________
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Copy to:
Office of Research Services
University of Pennsylvania
P-221 Franklin Building
3451 Walnut Street
Philadelphia, PA. 19104-6205
Attention: Executive Director
To Collaborator:
__________________
__________________
__________________
Copy to:
___________________
___________________
___________________
12.4 Applicable Law. This Agreement shall be construed and enforced in accordance with the laws of the
Commonwealth of Pennsylvania without regard to any choice or conflict or laws. In the event that a party to this
Agreement perceives the existence of a dispute with the other party concerning any right or duty provided for herein,
the parties will, as soon as practicable, confer in an attempt to resolve the dispute. If the parties are unable to resolve
such dispute amicably, then the parties hereby submit to the exclusive jurisdiction of and venue in the United States
federal courts located in the Eastern District of the Commonwealth of Pennsylvania with respect to any and all
disputes concerning the subject of this Agreement.
12.5
Heading. Headings included herein are for convenience only, and shall not be used to construe this
Agreement.
12.6
Relationship of Parties. For the purposes of this Agreement and all services to be provided hereunder, each
party shall be, and shall be deemed to be, an independent contractor and not any agent or employee of the other
party. Neither party shall have authority to make any statements, representations or commitments of any kind, or to
take any action which shall be binding on the other parties, except as may be explicitly provided for herein or
authorized in writing.
12.7
Severability. If any provision of this Agreement shall be found by a court of competent jurisdiction to be
void, invalid or unenforceable, the same shall either be reformed to comply with applicable law or stricken if not so
conformable, so as not to affect validity or enforceability of this Agreement.
12.8
Waivers. No delay or omission on the part of either party to enforce or exercise any right under this
Agreement shall operate as a waiver of that right or any other right hereunder, or the ability to later assert that right
relative to the particular situation involved or to terminate this Agreement arising out of any subsequent default or
breach.
12.9
Counterparts. This Agreement may be executed in any number of counterparts, each of which shall
constitute an original document, but all of which shall constitute the same agreement.
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12.10 Use of Name.
Institution shall not use Collaborator's name without Collaborator's prior written consent
except that Institution may acknowledge Collaborator's participation in this Research Program and any scientific
contributions in scientific publications and in listings of sponsored research projects. Collaborator shall not use
Institution's name, or the name of any trustee, officer, faculty member, student or employee thereof, without
Institution's prior written consent, except to the extent that disclosure of such name(s) may be required by law (i) for
securing license or marketing approval necessary as a prerequisite for marketing a Collaborator Invention or a Joint
Invention in a particular country or (ii) in connection with any filings made by the Securities and Exchange
Commission or similar non-U.S. regulatory authorities or by the disclosure policies of a major stock exchange.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized
representatives as of the date first written above.
THE TRUSTEES OF THE
UNIVERSITY OF PENNSYLVANIA
COLLABORATOR
By:
Name:
Title:
By:__________________________
Name:
Title:
I, ____________________, named as Principal Investigator in this Agreement, acknowledge that I have read this
Agreement in its entirety and that I shall use reasonable efforts to fulfill my individual obligations and
responsibilities as set forth herein.
By:
Name:
Title:
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EXHIBIT A
RESEARCH WORKPLAN
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EXHIBIT X
UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM &
UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE
HIPAA DATA USE AGREEMENT
This Data Use Agreement (“Agreement”) is made and entered into as of this ________________ day of
____________, 20__ by and between The Trustees of the University of Pennsylvania, owner and operator of the
University of Pennsylvania Health System (UPHS) and the University of Pennsylvania School of Medicine (SOM)
(UPHS and SOM shall be defined collectively as the “Covered Entity”) and ___________________(“Data
Recipient”).
1.
This Agreement sets forth the terms and conditions pursuant to which Covered Entity will Disclose certain
Protected Health Information (PHI) to the Data Recipient as described below (insert a meaningful
description of the data set):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
2.
Except as otherwise specified herein, Data Recipient may make Uses and Disclosures of the Limited Data
Set consistent with the purpose of the research as described in the research application and in strict
compliance with the following restrictions:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
3.
The title of the research project has been provided below:
Discovery, validation, and characterization of novel biomarkers for diagnostic, therapeutic and/or
prophylactic uses in the treatment of ectopic pregnancy.
4.
In addition to the Data Recipient, the individuals, or classes of individuals, who are permitted to Use or
receive the Limited Data Set for purposes of the Research Project, include:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
5.
Data Recipient agrees to not Use or Disclose the Limited Data Set for any purpose other than the Research
Project or as required by law.
6.
Data Recipient agrees to use appropriate safeguards to prevent Use or Disclosure of the Limited Data Set
other than as provided for by this Agreement.
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7.
Data Recipient agrees to report to the Covered Entity any Use or Disclosure of the Limited Data Set not
provided for by this Agreement, of which it becomes aware, including without limitation, any Disclosure of
PHI to an unauthorized subcontractor, within ten (10) days of its discovery.
8.
Data Recipient agrees to ensure that any agent, including a subcontractor, to whom it provides the Limited
Data Set, agrees in writing to the same restrictions and conditions that apply through this Agreement to the
Data Recipient with respect to such information.
9.
Data Recipient agrees not to identify the information contained in the Limited Data Set or contact the
individuals.
10.
Indemnification:
The Data Recipient agrees to assume all risks and responsibility in connection with its receipt, handling,
storage, use or disclosure of Limited Data Set or any derivative received from Covered Entity or any of
Covered Entity’s affiliates and their respective trustees, officers, directors, employees and agents. The
undersigned warrant that they have the authority to execute this agreement on behalf of the Data Recipient.
11.
This Data Use Agreement will terminate as of_____________________. At the Termination of this
agreement the Data Recipient will return the Limited Data Set to Covered Entity and will make no further
use of the Limited Data Set or will destroy the Limited Data Set at the request of Entity.
12.
The terms of this agreement can be changed only by written modification signed by both parties.
13.
Parties agree that UPHS/SOM retains all ownership rights to the information contained in the Limited Data
Set, and that the Data Recipient does not obtain any right, title or interest in any of the data provided by
UPHS/SOM, except as permitted under the Collaboration Agreement by and between The Trustees of the
University of Pennsylvania and the Data Recipient dated as of ________________.
THE TRUSTEES OF THE UNIVERSITY OF
PENNSYLVANIA, OWNER AND OPERATOR OF THE
UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM
AND UNIVERSITY OF PENNSYLVANIA
SCHOOL OF MEDICINE
DATA RECIPIENT
Name:
Name:
Title:
Title:
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EXHIBIT Y
HUMAN TISSUE BIOLOGICAL MATERIALS TRANSFER AGREEMENT
This Materials Human Tissue Transfer Agreement is made this
day of _________, 200_, by and
between The Trustees of the University of Pennsylvania (“Institution”), and_________________, (“Collaborator”).
Institution is or may be in possession of certain human tissues described in Attachment A (“Tissue”); and
Whereas, Collaborator has approached Institution and has asked that such Tissue be transferred to
Collaborator for the advancement of biomedical research and Institution is amenable to such Transfer; and
Whereas, use of the Tissue would promote research that could benefit the public;
Now, therefore, intending to be legally bound by the terms hereof, the parties hereto agree to the following:
(1)
During the term of this Agreement and pursuant to the terms and conditions hereinafter set forth, Institution
agrees to use reasonable efforts to supply Collaborator with Tissue in the amounts specified in Attachment
A. If this transfer contemplates ongoing collection of Tissue, Institution can not guarantee the actual
amount of Tissue that will be supplied to Collaborator.
(2)
Pursuant to the requirements for approval of this transfer by Institution’s Institutional Review Board,
Collaborator agrees to the following restrictions on its use of the Tissue:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
(3)
To the extent applicable, Collaborator shall reimburse Institution for all reasonable sums associated with
the procurement, processing, storage and transportation of Tissue supplied to it hereunder. Such costs must
be incurred after the effective date of this agreement, and be the result of actions requested by Collaborator.
Collaborator shall not be responsible for such costs if they are covered or reimbursed by federal grants
made to Institution on which Collaborator is named as a collaborator.
(4)
Collaborator acknowledges and accepts that, except for conditions noted in Paragraph (2) above, this
Tissue is being supplied to Collaborator “as is” with no representations or warranties, express or implied,
including any warranty of merchantability or fitness for a particular purpose. Additionally, Collaborator
acknowledges and accepts that Institution has no ownership or proprietary rights in the Tissue being
supplied hereunder.
(5)
Collaborator agrees to defend, indemnify, and hold harmless Institution, its faculty, students, employees,
trustees, officers, affiliates and agents (hereinafter referred to collectively as the “Indemnified Persons”)
from and against any and all liability, claims, lawsuits, losses, damages, costs or expenses (including
attorneys’ fees), which the Indemnified Persons may hereafter incur, or be required to pay that results from
or arises out of: (i) the development, use, conversion, manufacture, promotion, sale or other disposition of
the Tissue or any products or derivatives generated from the materials; and (ii) any breach by Collaborator
of this Agreement as provided in Section 10 of the research Collaboration Agreement between parties dated
___________which provision shall be deemed incorporated as part of this Agreement.
(6)
Collaborator acknowledges that the Tissue being supplied may have unknown characteristics and may
potentially carry infectious agents. Collaborator warrants that it has the knowledge and ability to safely
handle any Tissue supplied to it and agrees to use prudence and care in the handling, storage, transportation
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and containment of the Tissue and all derivatives thereof. All costs and expenses associated with such
protective measures shall be borne by Collaborator.
(7)
Collaborator shall use the Tissue solely for research purposes. Collaborator shall not use the Tissue in
humans, nor will any products or derivatives generated from the Tissue, nor will cells or substances in
contact with the Tissue, be infused into humans. Collaborator shall use the Tissue in compliance with all
applicable federal, state and local laws and regulations. Collaborator shall not transfer the Tissue to any
facility not under the control of Collaborator, nor transfer the Tissue to any person who is not under the
immediate and direct supervision of Collaborator, and Collaborator shall assure that any such transfers shall
comply with the terms of this Agreement.
(8)
Collaborator agrees to dispose of the used and unused Tissue, and the derivatives, according to all
applicable federal, state and local regulations.
(9)
This Agreement shall be effective as of the last date signed by the parties below and shall be deemed
terminated as of the same date as the expiration or termination of the Collaboration Agreement, unless this
Agreement is earlier terminated at any time by either party upon ten (10) days written notice.
(10)
This Agreement may not be amended without the prior written consent of both parties hereto.
(11)
This Agreement constitutes the entire agreement between the parties hereto relating to the subject matter
thereof, and supercedes any prior agreements, written or oral, regarding the subject matter hereof. Sections
3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 shall survive the termination or expiration of this Agreement.
(12)
This Agreement shall be construed and interpreted in accordance with the laws of the Commonwealth of
Pennsylvania, without giving effect to its principles of conflict of law.
The Trustees of the University of Pennsylvania
Collaborator
By:
By:
Title:
Title:
Date:
Date:
14
ATTACHMENT A
(Description of Human Tissue to be Transferred)
15
EXHIBIT Z
COLLABORATOR CONFIDENTIAL INFORMATION
The free publication and dissemination of research results and information is an essential and long-standing
policy of the University of Pennsylvania. Because of the negative impact confidentiality obligations can have on the
educational mission of the University and the free communication of research results, the University of
Pennsylvania does not undertake to keep proprietary information provided by a commercial company confidential.
Under certain circumstances, however, the University of Pennsylvania recognizes that a University of Pennsylvania
principal investigator during a collaborative research program may desire to receive confidential and proprietary
information of the commercial collaborator that the principal investigator considers essential for the conduct of the
research program. Accordingly, the University of Pennsylvania will permit the principal investigator to accept
confidential information of a collaborator under the terms and conditions of the agreement between the collaborator
and principal investigator stated below.
Agreement between Collaborator and Principal Investigator
Concerning Collaborator Confidential Information
In connection with research to be conducted at the University of Pennsylvania (“Institution”) in participation with
_________________________ (“Collaborator”) and relating to_________________________, (the “Research
Program”), Collaborator desires to provide ________________________ (“Principal Investigator”) with certain
information that Collaborator considers confidential.
1.
For purposes of this Agreement, “Confidential Information” means only confidential information of
Collaborator related to the Research Program that is disclosed to the Principal Investigator by Collaborator
in writing and conspicuously marked as confidential and proprietary at the time of disclosure, or, if
disclosed visually or orally, is stated to be confidential and proprietary at the time of disclosure and
confirmed by a written summary describing the information in reasonable detail delivered by Collaborator
to Principal Investigator within seven (7) days after disclosure. Notwithstanding anything to the contrary
contained in this Agreement or the markings on any document disclosed by Collaborator, Confidential
Information does not include:
(a)
information that is in the public domain at the time Collaborator discloses it to Principal
Investigator or that thereafter enters the public domain through no fault of Principal Investigator;
(b)
information that was known to Principal Investigator or to Institution before the date Collaborator
discloses it to Principal Investigator, or that becomes known to Principal Investigator or Institution
through a third party having an apparent bona fide right to disclose the information;
(c)
information that is independently developed by Institution personnel;
(d)
information that is disclosed by Principal Investigator or Institution in accordance with the terms
of Collaborator’s written approval;
(e)
information that is required to be disclosed for compliance with any Federal, state or local law or
regulation, or required to be disclosed by a court of law or governmental authority.
2.
The Principal Investigator retains the right to refuse to accept any Confidential Information that
the Principal Investigator does not consider to be essential to the performance of the Research Program or that the
Principal Investigator believes to be improperly designated as Confidential Information.
3.
In the event the Investigator does accept any Confidential Information, for a period of three (3)
years after Principal Investigator’s acceptance of Confidential Information, Principal Investigator agrees to use
efforts no less than those Principal Investigator employs with respect to Principal Investigator’s own confidential
information:
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(a)
not to disclose the Confidential Information to third parties (including other academic assistants
and collaborators) without Collaborator’s consent to such disclosure (which consent shall require
that such third party also agree to be bound by the terms of this Agreement); and
(b)
to use the Confidential Information only in furtherance of the Research Program.
4.
Collaborator specifically acknowledges its understanding that the Principal Investigator's efforts
hereunder will not necessarily conform to prevailing commercial standards for the protection of confidential and
proprietary information. Collaborator expressly agrees that Institution shall not be liable for any disclosure of
Collaborator’s Confidential Information.
5.
This Agreement sets forth the entire understanding of Collaborator and Principal Investigator with
respect to the subject matter hereof, supersedes any prior agreement between Collaborator and Principal
Investigator, and there are no other understandings or agreements, written or oral, between them relating to such
subject matter. The Agreement may not be changed or supplemented in any way except by a written agreement duly
executed by both Collaborator and Principal Investigator and approved by Collaborator. This Agreement shall be
governed by, enforced, and interpreted in accordance with the laws of the Commonwealth of Pennsylvania, without
giving effect to its principles of conflict of laws.
Collaborator
Principal Investigator
______________________
______________________
Date: ___________________
Date: __________________
17