Transgenic and Gene Targeting Core
Transgenic or Gene Targeted Animal Development Disclaimer
I.
THE PROJECT:
This Agreement is made between the Transgenic and Gene Targeting Core at UCD (herein, "TGTC") and
the requesting Investigator for the purposes of the development of transgenic or gene targeted mice.
II.
RESPONSIBILITIES:
A.
TGTC RESPONSIBILITIES
We will use all reasonable efforts to create founder transgenic or gene targeted mice through the
microinjection of the Investigator’s DNA construct into fertilized one cell mouse embryos or the
injection of targeted ES cells into blastocyst stage embryos, respectively.
INVESTIGATOR RESPONSIBILITIES:
Investigator agrees and acknowledges:
a) to provide the DNA construct or cell lines as well as all disclosures and approvals
required under this agreement.
b) that no guarantees, either implied or expressed, are issued within this contract regarding the
production of construct positive transgenic animals.
c) that production of a minimum of two construct positive transgenic animals or 2 male chimeras
will constitute a successful injection series.
B.
III.
DISCLOSURE OF THE DNA CONSTRUCT OR CELL LINES, INSTITUTIONAL APPROVALS,
RESTRICTED GENETIC MATERIALS AND CONDITION OF GENETIC MATERIALS:
A.
Investigator will provide the TGTC with a full written disclosure of the nature of the DNA construct
or cell lines, including a restriction map and original published references if available.
Investigator shall provide to the TGTC, copies of approved UC Denver Institutional Animal Care
and Use Committee protocol for the following:
a) IACUC “Production of Transgenic Mice by DNA or Stem Cell Injection Into Mouse Embryos”
standardized form and
b) Investigator’s applicable IACUC protocol (“Experimental Protocol”) which provides for the
utilization of the transgenic animals following their development by the TGTC (UC Denver CCMhoused animals only).
Investigator hereby represents and warrants that the DNA construct(s) or cell line(s) will not
produce any infectious condition that may be harmful to other animals, humans or the
environment and that experimentation does not require containment conditions greater than those
required under NIH RAC BL-2 standards.
2.
3.
D.
The TGTC shall be entitled to
a) not commence its duties under Section II.A until such time as it receives the written
documentation required under Sections III.A., III.B. and III.C. and initial fees or
requisitions as required under Section IV.A. and
b) terminate this Agreement and the duties and responsibilities if found that
(1) a DNA construct or mouse cell line consists of or contains, in whole or in part,
a replication competent virus or recombinant DNA requiring containment in
excess of NIH RAC BL-2 containment or
(2) for microinjection experiments the TGTC finds that Investigator's DNA
construct has not been appropriately prepared according to the outlined
guidelines or does not meet the stated requirements for microinjection.
1
IV. FEE, PAYMENT SCHEDULE, TERMS AND CONDITIONS:
1.
Fee for production of transgenic animals using the stated construct shall be no more than stated
in current published TGTC price schedule per injection day. Covered services and procedures
are set forth in the current TGTC price schedule as published on the Transgenic Web Site.
a) Investigator shall be billed incrementally by the TGTC each month through the Center for
Comparative Medicine for procedures begun for creating the transgenic animals during that billing
period.
(b) Procedures performed by ES Cell Services laboratory will be billed fully at the end of the
monthly billing cycle.
(c) Billing generated during the production of transgenic animals by the TGTC shall cease upon
weaning of the putative founder animals and delivery of the tissue samples to Investigator for
analysis.
2.
Investigator shall use the genetically altered mice provided under this contract solely for purposes
of non-commercial research. Investigator shall not use the transgenic mice other than as
provided herein and shall not sell, lease, rent, barter away or otherwise transfer the transgenic
mice or any interest therein, except that transgenic mice may be transferred to a third party for
purposes of having the third party breed the transgenic mice solely for use by Investigator and,
except that transgenic mice may be provided to other institutions for research purposes in
accordance with UCD policies.
3.
V. CONFIDENTIALITY:
1.
The TGTC will hold in confidence the identity and nature of Investigator's projects and will limit
disclosure of such matters to only those of its employees who will work directly on, and therefore
need to know such information to accomplish the Project, provided however, that such
confidentiality obligation does not apply to
a) information that is known to the TGTC on the date hereof or becomes known to the
TGTC from a third party; or
b) information that is required to be disclosed by applicable law or a governmental
authority having jurisdiction.
B.
Upon completion or termination of the TGTC's duties and obligations hereunder, the TGTC shall
retain an appropriate sample of the Investigator's provided materials and shall, if requested by
Investigator, return any other remaining materials, proprietary information, cell lines or DNA
constructs supplied by the Investigator.
VI.
MISCELLANEOUS:
A.
Upon Investigator's receipt of any mice from the TGTC, Investigator agrees to assume full
responsibility for such mice and all risks of harm they may cause including, but not limited to, any
injury resulting from the handling of the mice.
B.
Investigator's construct(s) must be linear, clean and free from any contaminants such as agarose,
residual salts, ethanol or extraneous (e.g. prokaryotic) sequences. (See DNA preparation
protocols published on the TGTC web site.)
C.
Investigator agrees to assume responsibility for any claims of third parties based on or arising out
of:
a) a breach of Investigator's agreements, obligations, representations, or warranties
made hereunder or pursuant hereto,
2
b) any patent or other proprietary right infringement claim which is brought with respect to
the DNA construct, targeted embryonic stem (ES) cells or the TGTC's use of said
materials as contemplated herein or the use of any pronuclear transgenic mice by
Investigator or by any third party who obtains such pronuclear transgenic mice from
Investigator or
c) the use, storage, handling, distribution, or disposal of any pronuclear transgenic mice
by Investigator or by any third party who obtains such pronuclear transgenic mice from
Investigator, to the extent provided under the Federal Tort Claims Act or other applicable
Federal Statute.
D.
Investigator hereby agrees that any scientific publications involving transgenic mice provided
hereunder shall acknowledge the TGTC as the source of the transgenic mice. Investigator shall
promptly provide copies of all such publications to the TGTC.
E.
Investigator hereby acknowledges that although the TGTC will use all reasonable efforts to
produce transgenic mice, it is not possible for the TGTC to guarantee the successful production
of transgenic/chimeric mice and that the TGTC has made no representation or warranty to that
effect.
F.
TGTC will, however, produce a minimum per injection day, of either:
Pronuclear Injection
a) twenty (20) putative F0 founders or
b) generation of a minimum of two (2) construct integration positive
founders. Gene expression is neither implied nor guaranteed.
Blastocyst Injection
a) two male chimeras
In the event that neither of the foregoing conditions is met, the TGTC will perform a second
injection day with no additional charge to investigator except for purchase of additional embryo
donors and the per diem for recipient animals.
G.
3
This Agreement shall be construed, interpreted, and applied in accordance with the laws
of:
(1) the State of Colorado and
(2) regulations of the University of Colorado Denver.