Exhibit 10.1
Amendment and Supplement to
Collaborative Research and License Agreement
This Amendment and Supplement dated as of the 19 of November, 1997, made between
Bayer Corporation ("Bayer") an Indiana corporation, having an office at 000
Xxxxxx Xxxx, Xxxx Xxxxx, Xxxxxxxxxxx 00000-0000, and Myriad Genetics, Inc.
("Myriad") a Delaware corporation having an office at 000 Xxxxxx Xxx, Xxxx Xxxx
Xxxx, Xxxx 00000.
WHEREAS, the parties have entered into a Collaborative Research and License
Agreement dated as of September 11, 1995 (the "1995 Agreement"); and
WHEREAS, the parties mutually agree to an amendment and supplement of the
1995 Agreement to add the Depression Field and the Dementia Field (as
hereinafter defined) and to provide for additional funding and an additional
period of time in which to conduct the Research Program relative to the
Depression Field; and additional funding for the Dementia Field.
Now, therefore, in consideration of the premises and for other good and
valuable consideration the receipt of which is hereby acknowledged, the parties
hereby agree as follows:
1. The following amendments are made to Section I of the 1995 Agreement:
(i) Section 1.11 is revised to read as follows:
"Field" means all human therapeutic and prophylactic uses, including but
-----
not limited to, [ ] and [ ] (including [ ]) for any clinical
indication of the genes Discovered under the Research Program involved in
or associated with obesity, asthma, depression (including unipolar major
depressive disorder, and bipolar disorder), dementia and osteoporosis, but
excluding any Discontinued Gene Targets.
1
(ii) The introductory paragraph of Section 1.16 is revised to read
as follows:
"Human Therapeutic Product" means any product for prophylactic or
-------------------------
therapeutic use in the prevention or treatment of any clinical indications
in humans, whether or not for the treatment or prevention of asthma,
obesity, depression, (including unipolar major depressive disorder, and
bipolar disorder), dementia, or osteoporosis, which is, or comprises:
The remainder of Section 1.16 remains unchanged.
(iii) Section 1.22, subparagraph (b) is revised as follows:
(b) any Myriad, University of Utah or other Myriad
collaboration databases of information concerning family
pedigrees and clinical data on such families;
(iv) Section 1.32 is revised as follows:
"Research Term" means the period beginning on the Effective
---------------
Date and ending on the date on which the Research Program
terminates or expires as set forth in Section 2.3 below. The
Research Term shall consist of the "Original Research Term" and
the "Additional Research Term" as defined in Section 2.3.1
below and shall include, for all or any portion of the Research
Program which is extended pursuant to Section 2.3.2, the period
that the Research Term is extended with respect thereto.
(v) Section 1.33 is revised as follows:
"Subfield" means the Asthma Field, the Obesity Field, the
--------
Depression Field, the Dementia Field, or the Osteoporosis
Field.
2
(vi) A new Section 1.36 is added as follows:
1.36 "Depression Field" means that portion of the Field relating to
----------------
the genes Discovered under the Research Program involved with or
associated with depression, including unipolar major depressive
disorder, and bipolar disorder.
(vii) A new Section 1.37 is added as follows:
1.37 "Original Research Field" means that portion of the Field
-------------------------
consisting of the Asthma Field, the Obesity Field and the Osteoporosis
Field.
(viii) New Sections 1.38, 1.39, 1.40, 1.41 and 1.42 are added
as follows:
1.38 "Dementia Field" means that portion of the Field relating to
--------------
genes Discovered under the Research Program involved in or associated
with dementia utilizing the ProNet Technology.
1.39 "Interactive Protein" shall mean a human protein or portion of
-------------------
a human protein which has been identified by means of the ProNet/(TM)/
Technology as a protein which directly, or indirectly through a series
of interactions, interacts with a protein or portion of a protein in
the Dementia Field which was used as a bait in Myriad's high-
throughput yeast two hybrid screen.
1.39(a) "Interactions" means contact between proteins that is
------------
sufficiently stable to allow the yeast two hybrid system to function
resulting in the identification of Interactive Proteins.
1.40 "Pathway" shall mean a series comprising up to ten (10) genes
-------
that interact with one another as defined by the ProNet
3
Technology and interact directly with an Interactive Protein as
defined by the ProNet Technology and includes the related
Interactions.
1.41 "ProNet Database" shall mean Myriad's proprietary compilation of
---------------
protein-protein interaction data for the human genome which is
generally accessible to Myriad's ProNet collaborators.
1.42 "ProNet(TM) Technology" shall mean the proprietary tools
---------------------
(robotics, plastics, software, etc.), proprietary methods (protocols,
processes, etc.) and proprietary reagents (vectors, strains, buffers
and solutions, etc.) used by Myriad to carry out the yeast two hybrid
protein-protein interaction studies.
1.43 "Selection Period" shall mean a period during which the
----------------
expression profile of an Interactive Protein is studied to gain an
understanding of its potential function.
2. Section 2.1.3 is revised as follows:
"Staffing and Resources." For the Original Research Term, Myriad will
----------------------
provide for use in the Research Program at least [ ] full-time
equivalent employees (FTEs) per year. For the Additional Research
Term, Myriad will provide [ ] FTEs for years 1, 4 and 5 for the
Depression Field and [ ] FTEs for year 1 and [ ] FTEs for years
2 & 3 for the Dementia Field. Appendix I attached hereto sets forth
the average staffing levels to be provided by Myriad for the Original
Research Term (as defined in Section 2.3.1) and the Additional
Research Term (as defined in Section 2.3.1). Should the Research
Program terminate for any reason prior to completion of the Original
Research Term or the Additional Research Term, as the case may be,
Myriad will not be in default if it shall have provided less than
[ ] full time equivalent employees per
4
year for the Original Research Term or less than [ ] full time
equivalent employees per year for research in the Depression Field or
Dementia Field through the date of termination.
The remainder of Section 2.1.3 remains unchanged, except that the
words "Research Term" in the third sentence of such section shall be
replaced with the words "Original Research Term".
3. The following sentence shall be added at the end of Section 2.1.4:
The parties shall mutually agree upon a schedule for completing the
Annual Research Plan related to the Depression Field and the Dementia
Field, with the goal of efficient incorporation of such planning
process into the ongoing work of the RSC.
4. The following sentence shall be added at the end of Section 2.1.5.
Myriad and its Affiliates will not, except under the Research Program,
perform sponsored research for any other company or other institution
with respect to genes within the Dementia Field, however nothing
herein will prevent Myriad from entering into non-exclusive licenses
for access to its ProNet Database or the licensing of rights with
respect to intellectual property therein.
5. The final sentence of Section 2.2.1 is replaced with the following
sentence:
If the Annual Research Plans for any Subfield in the Original Research
Field allocate less than [ ] to the Research Program for such
Subfield for more than one year, then Myriad may, at its option, elect
to cause all genes in such Subfield to be Discontinued Target Genes
under Section 2.28 hereof.
5
6. Section 2.3.1 is revised as follows:
2.3.1 The Research Term with respect to that portion of the Research
Program related to the Original Research Field ("the Original Research
Term") shall commence on the Effective Date and terminate five (5)
years after the Effective Date unless extended as provided below or
unless earlier terminated by either party pursuant to the termination
provisions below. [ ]. The Research Term with respect to that
portion of the Research Program related to the Depression Field (the
"Additional Research Term") shall commence as of the effective date of
this Amendment and shall terminate on September 10, 2002, unless
extended as provided below or unless earlier terminated by either
party pursuant to the termination provisions below. The term for the
Dementia Field shall commence as of the effective date of this
Amendment and terminate on December 31, 2000 unless extended by the
agreement of both parties. Bayer shall have the exclusive option, in
its discretion, to extend the term for the Dementia Field in one year
increments provided that Bayer funds the Dementia Field for each such
extension at funding levels to be negotiated in good faith by Bayer
and Myriad, but in no event less than [ ] per year during any
extension. For purposes of Section 2.3.2 below, (i) "Research Term"
shall mean the Original Research Term or the Additional Research Term,
as the case may be, and (ii) "Field" shall mean the Original Research
Field or the Depression Field, or the Dementia Field as the case may
be, such that the provisions of Section 2.3.2, governing the extension
of the Research Program, shall apply separately to the Original
Research Term and the Additional Research Term. By way of example, the
extension of the Original Research Term for an additional year beyond
September 10, 2000 will require Bayer to provide at least [ ] of
funding for ongoing research in the Original Research Field, while
Bayer shall continue to provide a total of [ ] per year for
research in the Depression Field and the Dementia Field during the
Additional Research
6
Term.
7. Add a new Section 16 as follows:
16. OPTION PERIOD FOR INTERACTIVE PROTEINS
16.1 Option for Interactive Proteins. Bayer, with Myriad's consultation,
-------------------------------
shall identify the initial baits for use in Myriad's high-throughput yeast
two hybrid screen and select the subset of Interactive Proteins for the
successive yeast two hybrid analysis. Upon the identification of an initial
Interactive Protein (P\\o\\), the Selection Period will begin for that
Interactive Protein. During the Selection Period, Bayer and Myriad will
further evaluate the Interactive Protein which has been identified. Upon
the earlier of either: (a) the identification of a second Interactive
Protein (P\\1\\) which interacts with the initial Interactive Protein
\\Po\\; or (b) the expiration of a period of [ ] from the identification of
the initial Interactive Protein P\\o\\ in the event identification of a
second Interactive Protein P\\1\\ is not underway within [ ] of
identification of the initial Interactive Protein P\\o\\, Bayer shall have
a period of [ ] (the "Exercise Period") to exercise an option for a period
of [ ] ("Option Period") to obtain an exclusive world-wide License (as
defined in Section 7.1 of the 1995 Agreement) including but not limited to
interactive proteins, Interactions, genes encoding them, the use of these
genes in research and drug screening, and transgenic cell lines and animals
containing these genes, Human Therapeutic Products which are comprised or
derived of any Interactive Protein within the Pathway. Prior to the end of
the Option Period, Bayer may exercise its right to acquire an exclusive
world-wide License to the Interactive Protein upon the payment by Bayer to
Myriad of [ ]. In addition, Bayer may extend the Option Period for any
specific Interactive Protein for an additional [ ] upon the payment of [ ]
Option Extension Fee per Interactive Protein. The License will contain a
milestone payment of [ ] at Decision Point No.1 which is defined as the
point at which a compound is considered to be characterized pursuant to the
1995 Agreement and is accepted by Bayer as a candidate for clinical
development and in addition, the milestone payment obligations numbered 3
through 6 as
7
set forth in Section 3.2 (Milestone Payments), as well as the royalty rates
and other terms and conditions contained in said Section 3.2 and Article 7
of the 1995 Agreement.
16.1.1 If Bayer has not exercised its option prior to the end of the
Exercise Period, Myriad shall retain all rights to the Interactive
Protein(s) and may place the Interactive Protein(s) into the ProNet
Database. Thereafter, Bayer will have the right to seek a license from
Myriad at any time, provided that Myriad has not licensed the rights to the
Interactive Protein(s) to another party.
16.1.2 If Bayer has not exercised its right to acquire a License prior
to the end of the Option Period, Myriad shall retain all rights to all
Interactive Proteins and may place all Interactive Protein(s) into the
ProNet Database. Thereafter, Bayer will have the right to seek a License
from Myriad at any time, provided that Myriad has not licensed the rights
to the Interactive Protein(s) to another party.
16.2 Successive Interactive Proteins. The identification of each
-------------------------------
successive Interactive Protein will begin a new Selection Period for each
successive Interactive Protein. For example, the identification of a
second Interactive Protein P\\1\\ which interacts with the initial
Interactive Protein P\\O\\ will begin the Selection Period for Interactive
Protein P\\1\\. The identification of a third Interactive Protein (P\\2\\)
which interacts with the second Interactive Protein P\\1\\ will begin a new
Selection Period for Interactive Protein P\\2\\.
16.3 Number of Option Rights. During the term of this Agreement, Bayer
-----------------------
can exercise its option on a maximum of [ ] Interactive Proteins and
their Pathways identified through the use of the ProNet Technology.
8. Funding: In accordance will Appendix II Bayer will pay Myriad [ ]
-------
in 1998 in addition to the funding in the original contract, to be used by
Myriad in carrying out research in the Depression and Dementia Fields. In
1999 and 2000, Myriad will perform research into the
8
Depression Field [ ] using the funds in the original contract, and Bayer
will pay an additional [ ] in each of these years, to be used by Myriad
in carrying out research in the Dementia Field. In the years 2001 and 2002
Bayer will pay Myriad [ ] each year, to be used by Myriad in carrying
out research in the Depression Field. During 1998, such funding shall be
payable in advance in equal installments of [ ] commencing on January 1,
1998 and continuing on April 1, 1998, July 1, 1998 and October 1, 1998.
Thereafter, during 1999, 2000, 2001 and 2002, such funding shall be payable
in advance in equal installments of [ ] commencing on January 1, 1999
and continuing on each April 1, July 1, and October 1 thereafter during the
Additional Research Term. On or about January 1, 1998, Bayer will make an
additional one time payment of [ ] to Myriad to be used exclusively in
carrying out the Research Program in the Depression Field. All funding
paid to Myriad under this Amendment and Supplement shall be used by Myriad
solely to fund the costs (including overhead) incurred by it in carrying
out the Depression Field portion and the Dementia Field portion of the
Research Program. Milestone payments and payment of Royalties under this
Amendment and Supplement shall be as provided in Sections 3.2 and 7.4,
respectively, of the 1995 Agreement.
9. Myriad and Bayer hereby agree to expand the Research Committee to
include up to six (6) members appointed by Bayer and six (6) members
appointed by Myriad. In accordance with Section 2.2.2 of the 1995
Agreement, Bayer hereby appoints the following members to the Research
Steering Committee [ ].
10. The provisions of Section 4.3 of the 1995 Agreement shall apply to the
disclosures by the parties with respect to this Amendment and Supplement.
11. All other provisions of the 1995 Agreement shall continue in full
force and effect.
IN WITNESS WHEREOF, the parties have caused this Amendment and Supplement to be
executed by their duly authorized representatives.
9
BAYER CORPORATION
By: /s/ R. Xxxxxxxxxxx Xxxxxx
-------------------------
R. Xxxxxxxxxxx Xxxxxx
Title: Vice President
-------------------------
Date: November 19, 1997
-------------------------
MYRIAD GENETICS, INC.
By: /s/ Xxxxx X. Xxxxxxx
-------------------------
Xxxxx X. Xxxxxxx
Title:
-------------------------
President and CEO
Date: November 19, 1997
-------------------------
November 18, 1997
10
APPENDIX I
FTE allocations
[ ]
Allocation of FTE's flexible and controlled by joint research committee
11
APPENDIX II
Overview - CNS collaboration payments
[ ]
Payments highlighted are our pre-existing obligations under current contract.
12
BAYER - MYRIAD JOINT RESEARCH PROGRAM IN CNS
DEPRESSION - [ ]
[ ]
DEMENTIA - [ ]
Goals
[ ]
Research Outline
MYRIAD
Library Construction
[ ]
ProNet Analysis
[ ]
Analysis of Selected Genes
[ ]
13
