EXCHANGE OF SCIENTIFIC MATERIALS AND DATA AGREEMENT (Materials Are Not for Use in Human Subjects)
Exhibit
10.51
EXCHANGE
OF SCIENTIFIC MATERIALS AND DATA
(Materials
Are
Not
for Use in Human Subjects)
Whereas,
Baylor College of Medicine (“BCM”) located at Xxx Xxxxxx Xxxxx, Xxxxxxx, Xxxxx
00000 and Medgenics,
Inc. (“Medgenics”),
located at Xxxxxxxx Xxxxxxxx Xxxx, X.X. Xxx 00, Xxxxxx 00000, Xxxxxx,
enter into this Agreement for the conduct of the research project entitled
“Helper Dependent Adenoviral Vectors (HDAd) for use in Biopump”
(“ResearchProject”). BCM and Medgenics shall together be referred to as the
“Parties” throughoutthis Agreement. The Parties agree as
follows:
The
capitalized terms as used herein are defined as follows:
“Research Materials” means all
materials used in the carrying out of the Research Project including those
provided by Medgenics, i.e., the plasmid constructs, expression cassettes
including the Factor VIIII gene, and shall not include biopumps or other
Medgenics technology not provided to BCM by Medgenics in connection with the
Research Project. Likewise, Research Materials shall comprise those used by BCM
including the BCM HDAd vector (“BCM Materials”). Research Materials shall also
mean “Combined Materials” which are HDAd Factor VIII, and any sample fluids
derived therefrom by BCM during preparation of the Combined Materials and
transferred to Medgenics.
“Invention”
means any invention or discovery patentable or not arising out of the
Research Project. Notwithstanding, the Combined Materials are not an
Invention.
The
Parties shall exercise reasonable efforts to carry out the activities described
in the work scope provided for in Exhibit 1, which is hereby incorporated into
this Agreement by reference. The Principal Investigator for BCM shall be Xxxxxx
Xx, PhD (“BCM Principal Investigator”). The Principal Investigator for Medgenics
shall be Xxxxxx Xxxxx, PhD (“Medgenics Principal
Investigator”).
BCM shall
provide specifications for the preparation of research grade plasmids containing
the expression constructs for Factor VIII to Medgenics. Medgenics shall prepare
(or have prepared) the plasmids according to the specifications and transfer the
plasmids to BCM. BCM shall insert Factor VIII expression constructs from the
plasmids into appropriate BCM HDAd vectors and verify the identity and titer of
the HDAd–Factor VIII (the “Combined Materials”). BCM shall transfer the Combined
Material and verification information to Medgenics as provided for in the work
scope.
All
Research Materials, including the Combined Material, and unmodified derivatives
thereof will be used only for internal research purposes involved in the
Research Project. Any and all other studies or uses by the Party that does not
own such Research Material are expressly prohibited, including isolating
contaminating helper virus or any other materials from the Combined Material and
the making of any Derivatives, other than as reasonably necessary to perform the
work described in Exhibit 1. “Derivatives” is defined as any
material derived from the Research Materials, including any progeny, any mutant
or other variant thereof (including any genetically engineered variant), any
portion of any such biological, sample, progeny, mutant or variant (such as an
expression product, protein or nucleic acid). It further means any material
derived therefrom (including by chemical modification or physical alteration or
combination), any copy of such nucleic acid or composition, any cell containing
such material, derivative or copy, and any portion of any such cell, as well as
any material derived from any of these. The Research Materials and the Combined
Materials are only to be used in animals and are not to be used, implanted in
humans or used to treat humans. For sake of clarity, Medgenics’s use of the
Research Materials it is providing, or its biopump or other technology, is not
limited by this Agreement.
The
Research Materials will only be used under suitable containment conditions. The
Parties agree to comply with all local, state, and federal laws, rules, and
regulations applicable to the Research Project and the handling of the Research
Material, including, but not
limited to, laws governing the use of hazardous or radioactive materials,
protecting the environment, and the care of laboratory animals.
Medgenics
shall obtain an executed informed consent form for each patient from whom tissue
is obtained for use in the Research Project in a form that complies with all
applicable local and national governmental laws, rules and regulations, and
guidelines.
Medgenics
shall obtain written approval of the protocol establishing the procedure for
obtaining the tissue samples for use in the Research Project from a properly
constituted Institutional Review Board / Ethics Committee prior to the
commencement of the Research Project.
Medgenics
shall perform the Research Project, and all related work, in conformance with
generally accepted standards of good clinical practice, the related protocol and
all applicable local and national governmental laws, regulations, and guidelines
governing the performance of clinical investigations.
The
Parties agree to treat in confidence for a period of three (3) years from the
date of its disclosure by the other party any and all information about the
Research Project and the Research Materials, except for information that was
previously known to the Parties, or is publicly available, or is disclosed after
the date of this Agreement to either party by a third party without breach of an
obligation of confidentiality, or is required to be disclosed due a government
or court request.
Both
Parties may publish/present the results of the Research Project, provided that
such publication/presentation does not violate the obligations of
confidentiality set forth herein, and the Parties agree to acknowledge the other
Party as the source of Research Material and attribute the contributions of each
Party as is scientifically appropriate. Further, Medgenics is to include the
following citations in any abstracts, publications or presentations: Xxxxxx and
Ng, 2003 Mol Ther 8:846; Xxxxxx and Ng, 2004 Mol Ther 10:792. Medgenics shall
also include the following in the acknowledgement section of all public
disclosures regarding the Research Project: “HDAd produced and provided by Dr.
Xxxxxx Xx of Baylor College of Medicine.” Further, BCM is to include in any
resulting publications that the Dermal Biopump is the property of
Medgenics.
The
Research Materials are proprietary to the providing Party. The Parties agree to
retain control over the Research Materials and not to transfer it to third
parties. Third party requests shall be directed to the appropriate providing
Party.
This
Agreement is not to be construed as an assignment or license of either of the
Parties’ interest in the Research Materials or other proprietary rights. BCM
retains the unrestricted right to distribute the BCM HDAd to other commercial or
noncommercial entities. This Agreement in no way alters any rights the U.S.
Government may have in the Research Materials. The Parties agree to promptly
disclose to the other parties all Inventions made through the use of the
Research Materials and each grants to the other a non-exclusive license to use
the same for non-commercial research, educational and patient care
purposes.
The
Parties agree that all profit-making or commercial use of any Invention,
product, or process derived from the Research Materials shall be subject to that
certain Non-Exclusive License Agreement dated January 25, 2007 by and between
the Parties.
All
Research Materials are provided as a service to the Research Community. THEY ARE BEING
SUPPLIED BY THE PARTIES WITH NO WARRANTIES, EXPRESSEDOR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS.
The
Parties make no representations that the use of the Research Materials will not
infringe any patent or proprietary rights of third parties. The Parties accept
the Research Material with the knowledge and understanding that the hazardous
and toxicological properties of the Research Materials have not been completely
investigated and are unknown and that the Research Material should be handled as
if it is hazardous until its properties are fully investigated.
In return
for the performance of BCM’s activities hereunder, Medgenics will pay to Baylor
College of Medicine ten thousand dollars ($10,000 US) for each Combined
Material, and an additional fifty three point five percent (53.5%) in indirect
costs, for a total amount of fifteen thousand three hundred and fifty dollars
($15,350 US) for each Combined Material as described in Exhibit 1, as full
compensation for same under this Agreement. For each such Combined Material as
specified in Exhibit 1, fifty percent (50%) of the respective amount shall be
paid within 10 days from execution of this agreement; and fifty percent (50%)
shall be paid within 10 days from delivery of each Combined Materials. Checks
should be made payable to “Baylor College of Medicine BCM tax
ID number: ###-##-####” and directed to the shipping address provided in
this document for Dr. Xxxxxx Xx.
Medgenics
is responsible for any and all costs associated with any shipping and handling
of the Research Materials and shall provide courier information directly to the
BCM Principal Investigator prior to any shipping. Medgenics agrees to provide,
in completed format, all related export or customs forms regarding shipping or
such information as required to complete them if by law or custom BCM is
required to complete them.
To the
extent allowed by law, each party will indemnify and hold the other party, and
its trustees, officers, agents, employees, students, persons holding academic
appointments with the other party, and the Parties’ affiliated hospitals and
institutions (the “Indemnified Parties”) harmless from and against any and all
claims or lawsuits for personal injury (including death), property damage, and
any other losses of any nature, together with related expenses (including
reasonable attorneys’ fees) made against the Indemnified Parties resulting
directly or indirectly from the use or possession of the Research Materials by
the other party as required by this Research Project or any subsequent research,
clinical use, or application of the results of the Research Project, except for
gross negligence or willful misconduct.
In no
event shall either party or such Parties’ trustees, officers, agents and
employees be liable for any use by the other party of any Invention, results of
the Research Project, or for any claim, liability, cost, expense, damage,
deficiency, loss or obligation, of any kind or nature (including, without
limitation, reasonable attorneys’ fees and other costs and expenses of defense),
that may arise from or in connection with this Agreement or the use, handling,
storage, or disposition of an Invention or the Research Materials by the other
party, or others who possess the Research Materials through a chain of
possession leading back, directly or indirectly, to the other party
(collectively, “Claims”). The Parties agree to indemnify, defend and hold
harmless the other Party and its respective trustees, officers, agents, and
employees from any and all Claims. The Parties shall have no obligation to
indemnify, defend or hold harmless a party identified in the foregoing sentence
if it is determined with finality by a court of competent jurisdiction that the
relevant Claim resulted solely from such party’s own negligence or willful
misconduct. This paragraph shall survive termination of the
Agreement.
The term
of this Agreement shall commence on the last day of the signing of this
Agreement
and shall continue for a period of 18 months.
Approved:
Agreed to this 25 day of January, 2010.
BAYLOR
COLLEGE OF MEDICINE
|
MEDGENICS
|
|
AUTHORIZED
SIGNATORY:
|
AUTHORIZED
SIGNATORY:
|
|
/s/
Xxxxx Xxxxxxxx
|
/s/
Xxxxxxx Xxxxxxx
|
|
Xxxxx
Xxxxxxxx
|
Signature
of Recipient Official
|
|
Executive
Director, Office of Research
|
||
|
Xxxxxxx
Xxxxxxx
|
|
Typed
Name
|
||
COO
|
||
Title
|
||
1/25/10
|
January
26, 2010
|
|
Date
|
Date
|
|
/s/ Xxxxxx Xx | /s/ Xxxxxx Xxxxx | |
BCM
Laboratory Director
|
Medgenics
Principal Investigator
|
|
Xxxxxx
Xx, Ph.D.
|
Xxxxxx
Xxxxx, Ph.D.
|
BCM
Shipping Address
|
Medgenics
Shipping Address
|
Xxxxxx
Xx, Ph.D.
|
Xxxxxx
Xxxxx, Ph.D.
|
Assistant
Professor
|
|
Department
of Molecular and Human Genetics
|
Misgav
Business Park
|
Baylor
College of Medicine
|
X.X.
Xxx 00
|
Xxx
Xxxxxx Xxxxx, X000
|
Xxxxxx
00000
|
Xxxxxxx,
XX 00000
|
Israel |
EXHIBIT
1
BCM
Activities
For each
of the Factor VIII constructs provided by Medgenics:
1. Xx.
Xx’x group will produce an HDAd bearing the Factor VIII expression cassette and
provide approximately 3x1012
viral particles in approximately 3 months. If it becomes possible to provide
them significantly sooner than 3 months BCM will endeavor to do so.
2. Xx.
Xx’x group will verify the identity of the HDAd bearing the Factor VIII
expression cassette by ethidum bromide staining following restriction enzyme
digestion and agarose gel electrophoresis.
3. Xx.
Xx’x group will determine physical titer (viral particles per milliliter) of the
HDAd bearing the Factor VIII expression cassette by absorbance at 260
nm.
Methodolgy
employed by Xx. Xx’x group will follow that of “Xxxxxx and Ng, 2003 Mol Ther
8:846” which typically yields a helper virus contamination of 0.02%. Medgenics
agrees that it will be responsible for any such testing beyond that undertaken
in 3. above to confirm such levels.
Medgenics
Activities
1. Medgenics
will provide 3 constructs containing Factor VIII gene as listed
below:
1. HDAd-CAG-wtFVIII
2. HDAd-CAG-optFVIII
3. HDAd-CAG-MAR-optFVIII
2. Medgenics
will use HDAd with the Factor VIII constructs, to transduce human dermal micro
organs to test for sustained high level Factor VIII secretion from Biopumps both
in vitro and in mice models.