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Exhibit
10.4
LICENSE AND COLLABORATION
AGREEMENT
THIS LICENSE AND
COLLABORATION AGREEMENT (the
“Agreement” ) is entered into as of
November 19, 2003 (the “Effective
Date” ) by and among MAXIM PHARMACEUTICALS,
INC. , a Delaware corporation ( “Maxim
Pharmaceuticals” ), having an address of
8899 University Center Lane, Suite 400, San Diego,
California 92122, and CYTOVIA, INC. , a Delaware corporation
and wholly-owned subsidiary of Maxim Pharmaceuticals (
“Cytovia” ), having an address of
8899 University Center Lane, Suite 400, San Diego,
California 92122 (Maxim Pharmaceuticals and Cytovia are hereinafter
collectively referred to as “Maxim” ),
and MYRIAD GENETICS, INC. , a Delaware corporation, having
an address of 320 Wakara Way, Salt Lake City, Utah 84108 (
“Myriad” ).
RECITALS
WHEREAS, Maxim has
developed expertise and proprietary rights related to its MX90745
series of compounds, including but not limited to MX128495, as more
fully described below;
WHEREAS, Myriad is
engaged in the research, development and commercialization of
pharmaceutical products; and
WHEREAS, Myriad and
Maxim desire to enter into a collaborative relationship to identify
and develop Products (as defined below) for clinical development
and commercialization by Myriad, subject to the terms and
conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
contained herein and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
parties agree as follows:
1. DEFINITIONS
1.1 “Affiliate” shall mean any company
or entity controlled by, controlling, or under common control with
a party hereto and shall include any company more than 50% of whose
voting stock or participating profit interest is owned or
controlled, directly or indirectly, by a party, and any company
which owns or controls, directly or indirectly, more than 50% of
the voting stock of a party.
1.2 “Calendar
Quarter” shall mean each respective period of three
(3) consecutive months ending on March 31, June 30,
September 30 and December 31.
1.3 “Confidential Information” shall
have the meaning provided in Section 10.1.
1.4 “Control” shall mean, with respect
to any Information, Patents or other intellectual property rights,
possession by a party of the right, power and authority (whether by
ownership, license or otherwise) to grant access to, to grant use
of, or to grant a license or a sublicense to such Information,
Patents or intellectual property rights without violating the terms
of any agreement or other arrangement with any Third
Party.
1.5 “FDA” shall mean the United States
Food and Drug Administration, or any successor agency thereto
having the administrative authority to regulate the marketing of
human pharmaceutical products or biological therapeutic products,
delivery systems and devices in the United States of
America.
1.6
“Field” shall mean the treatment and/or
prevention of any disease or disorder.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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1.7 “First
Commercial Sale” shall mean, with respect to any Product,
the first sale for end use or consumption of such Product in a
country after the governing health regulatory authority of such
country has granted Regulatory Approval. Sale to an Affiliate
or Sublicensee shall not constitute a First Commercial Sale unless
the Affiliate or Sublicensee is the end user of the
Product.
1.8 “FTE” shall mean the equivalent of
a full-time scientist’s work time over a 12-month period
(including normal vacations, sick days and holidays). The
portion of an FTE year devoted by a scientist to the Research
Program shall be determined by dividing the number of full working
days during any 12-month period devoted by such scientist to the
Research Program by the total number of working days in such
12-month period. Each party understands and agrees that the
other party retains complete discretion to change the identity of
any individual employee or consultant devoted to the Research
Program and/or the frequency and the time during which such
individual employee’s or consultant’s efforts are
devoted to the Research Program, provided that in any event each
such employee or consultant devoted to the Research Program shall
satisfy the criteria for general experience and qualifications set
forth in the Research Plan.
1.9 “IND” shall mean an Investigational
New Drug Application filed with the FDA, or the equivalent
application or filing filed with any equivalent agency or
governmental authority outside the United States of America
(including any supra-national agency such as in the European Union)
necessary to commence human clinical trials in such
jurisdiction.
1.10 “Information” shall mean all
tangible and intangible (a) techniques, technology, practices,
trade secrets, inventions (whether patentable or not), methods,
knowledge, know-how, skill, experience, test data and results
(including pharmacological, toxicological and clinical test data
and results), analytical and quality control data, results or
descriptions, software and algorithms and (b) compositions of
matter, cells, cell lines, assays, animal models and physical,
biological or chemical material.
1.11 “Inventions” shall have the
meaning provided in Section 8.1.
1.12 “Joint
Inventions” shall have the meaning provided in
Section 8.1.
1.13 “Joint
Patents” shall mean all Patents that claim or disclose a
Joint Invention.
1.14 “Joint
Development Committee” or “JDC” shall
mean the committee formed pursuant to Section 2.1.
1.15 “Major
Market” shall mean [***] .
1.16 “Maxim
Inventions” shall have the meaning provided in
Section 8.1.
1.17 “Maxim
Know-How” shall mean, to the extent useful for purposes
of the Research Program or necessary to develop, make, have made,
use, distribute for sale, promote, market, offer for sale, sell,
have sold, import or export any Product, Information not included
in the Maxim Patents or Joint Patents that Maxim or any of its
Affiliates Controls on the Effective Date or during the Term,
including, without limitation, all such Information that is
conceived or developed by Maxim or any of its Affiliates in the
course and as part of the Research Program, and, in each case, any
replication or any part of such Information.
1.18 “Maxim
Patents” shall mean, to the extent useful or necessary to
develop, make, have made, use, distribute for sale, promote,
market, offer for sale, sell, have sold, import or export any
Product, all Patents that Maxim or any of its Affiliates Controls
as of the Effective Date or during the Term, but excluding the
Joint Patents.
1.19 “Maxim
Technology” shall mean the Maxim Patents and Maxim
Know-How.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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1.20 “MX90745
Series” shall mean the series of compounds described in
[***] .
1.21 “Myriad
Inventions” shall have the meaning provided in
Section 8.1.
1.22 “Myriad
Know-How” shall mean, to the extent useful for purposes
of the Research Program or necessary to develop, make, have made,
use, distribute for sale, promote, market, offer for sale, sell,
have sold, import or export any Product, Information not included
in the Myriad Patents or Joint Patents that Myriad or any of its
Affiliates Controls on the Effective Date or during the Term,
including, without limitation, all such Information that is
conceived or developed by Myriad or any of its Affiliates in the
course and as part of the Research Program, and, in each case, any
replication or any part of such Information.
1.23 “Myriad
Patents” shall mean, to the extent useful for purposes of
the Research Program or necessary to develop, make, have made, use,
distribute for sale, promote, market, offer for sale, sell, have
sold, import or export any Product, all Patents that Myriad or any
of its Affiliates Controls as of the Effective Date or during the
Term, but excluding the Joint Patents.
1.24 “Myriad
Technology” shall mean the Myriad Patents and Myriad
Know-How.
1.25 “NDA” shall mean a New Drug
Application (as more fully defined in 21 C.F.R. 314.5 et
seq. ) and all amendments and supplements thereto filed with
the FDA, or the equivalent application filed with any equivalent
agency or governmental authority outside the United States of
America (including any supra-national agency such as in the
European Union), including all documents, data, and other
information concerning a pharmaceutical product which are necessary
for gaining Regulatory Approval to market and sell such
pharmaceutical product.
1.26 “Net
Sales” shall mean the gross amounts invoiced by Myriad,
its Affiliates and [***] its Sublicensees for sales of
Products to Third Parties that are not Affiliates or Sublicensees
of the selling party (unless such Affiliate or Sublicensee is the
end user of such Product, in which case the amount billed therefor
shall be deemed to be the amount that would be billed to a Third
Party end user in an arm’s-length transaction), less the
following items, as allocable to such Product (if not previously
deducted from the amount invoiced): (i) trade discounts,
credits or allowances; (ii) credits or allowances additionally
granted upon returns, rejections or recalls (except where any such
recall arises out of Myriad’s, its Affiliate’s or
Sublicensee’s gross negligence, willful misconduct or fraud);
(iii) freight, shipping and insurance charges;
(iv) taxes, duties or other governmental tariffs (other than
income taxes); (v) government mandated rebates; and
(vi) all such invoiced amounts that are written off as bad
debt by Myriad, its Affiliates or U.S. Sublicensees (with such bad
debt adjustment to be reduced by invoiced amounts that collected in
the current period that were written off in prior
periods).
1.27 “Patents” shall mean
(a) United States patents, re-examinations, reissues,
renewals, extensions and term restorations, and foreign
counterparts thereof, and (b) pending applications for United
States patents, including, without limitation, provisional
applications, continuations, continuations-in-part, divisional and
substitute applications, including, without limitation,
inventors’ certificates, and foreign counterparts
thereof.
1.28 “Percentage-Based Payments” shall
have the meaning provided in Section 6.6.
1.29 “Phase 1
Clinical Trial” shall mean a human clinical trial that
would satisfy the requirements for a Phase 1 study as defined
in 21 C.F.R. 312.21(a) (or its successor regulation).
1.30 “Phase 2
Clinical Trial” shall mean a human clinical trial that
would satisfy the requirements for a Phase 2 study as defined
in 21 C.F.R. 312.21(b) (or its successor regulation).
1.31 “Phase 3
Clinical Trials” shall mean a human clinical trial that
would satisfy the requirements for a Phase 3 study as defined
in 21 C.F.R. 312.21(c) (or its successor regulation).
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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1.32 “Product” shall mean a product
that contains any composition of matter in the MX90745 Series, or
any analog, homolog, derivative or isomer of any composition of
matter in the MX90745 Series, including, in each case, all
formulations, line extensions and modes of administration
thereof. Product shall also mean any product developed in the
Research Program.
1.33 “Regulatory Approval” shall mean
any and all approvals (including price and reimbursement approvals,
if required), licenses, registrations, or authorizations of any
country, federal, supranational, state or local regulatory agency,
department, bureau or other government entity that are necessary
for the manufacture, use, storage, import, transport and/or sale of
a Product in such jurisdiction.
1.34 “Research
Plan” shall mean the plan for conducting the Research
Program, as amended from time to time by the JDC. The initial
Research Plan has been agreed upon by the parties in writing as of
the Effective Date and is attached hereto as Exhibit A.
1.35 “Research
Program” shall mean a research program carried out by
Maxim during the Research Term pursuant to Articles 2 and 3
hereof, as more fully described in the Research Plan.
1.36 “Research
Term” shall mean the period beginning on the Effective
Date and ending on the first (1 st ) anniversary of the Effective Date, subject to extension
for one (1) additional year in accordance with
Section 3.4 and to termination in accordance with
Article 11.
1.37 “Royalty
Term” shall mean, in the case of any Product, in any
country, the period of time commencing on the First Commercial Sale
in such country and ending upon the later of (a) ten
(10) years after the date of First Commercial Sale in such
country, and (b) the expiration of the last to expire of the
Maxim Patents or Joint Patents containing a Valid Claim claiming
the manufacture, use or sale of such Product in such
country.
1.38 “Sublicensee” shall mean a Third
Party to whom Myriad or any of its Affiliates has granted a license
or sublicense of the right to develop, make, have made, use,
distribute for sale, promote, market, offer for sale, sell, have
sold, import or export Products, beyond the mere right to purchase
Product from Myriad or its Affiliates.
1.39 “Sublicensing Revenues” shall mean
the amount actually received by Myriad or an Affiliate of Myriad
from any and all Sublicensees arising from the license or
sublicense of the right to develop, make, have made, use,
distribute for sale, promote, market, offer for sale, sell, have
sold, import or export Products [***] . Sublicensing
Revenues shall include up-front or license fees, milestone
payments, royalties paid to Myriad or any of its Affiliates by a
Sublicensee based on such Sublicensee’s sale of Products,
premiums above the fair market value on sales of securities, annual
maintenance fees and any other payments in respect of the grant to
such Sublicensee of a license or sublicense of the right to
develop, make, have made, use, distribute for sale, promote,
market, offer for sale, sell, have sold, import or export Products
[***] (with any of the foregoing consideration received by
Myriad or its Affiliate other than in the form of cash to be valued
at its fair market value as of the date of receipt); provided,
however, that Sublicensing Revenues shall not include any
payments tied directly to the provision of goods and services by
Myriad or its Affiliate to such Sublicensee (including research and
development and manufacturing) to compensate Myriad or its
Affiliate for the fair market value of the provision of such goods
and services, reimbursement to Myriad by Maxim or a Third Party for
costs or expenses incurred by Myriad in the performance of its
obligations under this Agreement (including reimbursement for
patent and trademark costs but excluding costs or expenses
associated with the development and pursuit of Regulatory Approval
for any Product), or payments for securities (other than premiums
above the fair market value of such securities).
1.40 “Term” shall have the meaning
provided in Section 11.1.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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1.41 “Third
Party” shall mean any entity other than Maxim or Myriad
or an Affiliate of Maxim or Myriad.
1.42 “Valid
Claim” shall mean (a) an unexpired claim of an
issued patent within the Maxim Patents or Joint Patents which has
not been found to be unpatentable, invalid or unenforceable by a
court or other authority in the subject country, from which
decision no appeal is taken or can be taken; or (b) a claim of
a pending application within the Maxim Patents or Joint Patents,
which application claims a first priority no more than five
(5) years prior to the date upon which pendency is
determined.
2. RESEARCH PROGRAM
GOVERNANCE
2.1 Joint Development
Committee. Promptly after the Effective Date, the parties
will form a Joint Development Committee (the
“JDC” ) comprised of three
(3) representatives of each of Myriad and Maxim. One
(1) member of the JDC shall be selected to act as the
chairperson of the JDC, with each chairperson acting for a term of
twelve (12) months. The chairperson shall be selected
alternately by Maxim and Myriad, and Myriad shall designate the
first chairperson. The JDC shall meet at least four
(4) times per year during the Research Term or at such greater
frequency as the JDC agrees. Such meetings may be conducted by
videoconference, teleconference or in person, as agreed by the
parties, and the parties shall agree upon the time of
meetings. Within 30 days after each meeting, the JDC
chairperson will provide the parties with a written report
describing, in reasonable detail, the status of the Research
Program, a summary of the results and progress to date, the issues
requiring resolution, and the agreed resolution of previously
reported issues. A reasonable number of additional
representatives of a party may attend meetings of the JDC in a
non-voting capacity.
2.2 Joint Development
Committee Functions and Powers. The responsibilities of
the JDC shall be as follows:
(a) encouraging
and facilitating communication between the parties with respect to
the Research Program;
(b)
establishing, updating, reviewing and approving the Research Plan
and other plans for accomplishing the goals of the Research
Program;
(c) overseeing
development and regulatory strategies for Products;
(d) monitoring
progress of the Research Program and Maxim’s diligence in
carrying out its responsibilities thereunder; and
(e) carrying out
the other duties and responsibilities described for it in this
Agreement.
2.3 JDC
Decision-Making. Decisions of the JDC shall be made by
unanimous vote, with each party having one (1) vote. No
vote of the JDC may be taken unless at least two (2) of each
party’s representatives on the JDC vote. If the JDC is
unable to reach a unanimous vote on any matter, then the matter
shall be referred to the Chief Executive Officer of Maxim and the
Chief Executive Officer of Myriad for further discussion and
resolution. These individuals shall as soon as practicable
attempt in good faith to resolve the matter and thereby make the
decision on behalf of the JDC. These individuals may obtain
the advice of other employees or consultants as they deem necessary
or advisable in order to make the decision. In the event that
these individuals are unable to resolve the matter within
30 days of commencing such discussions, the [***] ;
provided, however, that [***] be construed to permit
[***] to, and neither [***] shall have the right to:
(a) [***] ; (b) [***] ; (c)
[***] .
3. CONDUCT OF THE RESEARCH
PROGRAM
3.1 Objectives;
Responsibilities. The parties hereby agree to establish
the Research Program, to be conducted by Maxim during the Research
Term in accordance with the Research Plan and with the terms of
this Agreement, with the goal of discovering and
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
5
developing one or more Products for
development and commercialization by Myriad. Any amendments or
revisions to the Research Plan shall be in writing and shall
require unanimous approval of the JDC. Myriad shall be
responsible for development and Regulatory Approval of Products, as
more fully described in Article 4, and Maxim shall assist
Myriad in Myriad’s development efforts through Maxim’s
performance of its obligations under the Research Plan. In
addition, at Myriad’s request, Maxim will contribute
high-level support in the areas of clinical development and
regulatory strategy to support Myriad’s development of
Products.
3.2 Technology
Transfer. Commencing promptly after the Effective Date
and from time to time thereafter during the Research Term, Maxim
shall disclose to Myriad the Maxim Technology to the extent
necessary to enable Myriad to exercise fully the licenses granted
to Myriad under Article 5 hereof. Commencing promptly
after the Effective Date and from time to time thereafter during
the Research Term, Myriad will disclose to Maxim such Myriad
Technology as is reasonably necessary to enable Maxim to perform
its Research Program activities hereunder in accordance with the
Research Plan and otherwise to exercise fully the licenses granted
to Maxim under Article 5 hereof. During the Research
Term, Maxim will provide Myriad with reasonable technical
assistance relating to the use of the Maxim Technology by Myriad
solely to the extent permitted under the license granted to Myriad
under Article 5. During the Research Term, Myriad will
provide Maxim with reasonable technical assistance relating to the
use of the Myriad Technology by Maxim solely to the extent
permitted under the license granted to Maxim under
Article 5.
3.3 Performance
Standards. Maxim shall conduct its activities under the
Research Program in good scientific manner, and in compliance in
all material respects with the requirements of applicable laws and
regulations and with applicable good laboratory practices, to
attempt to achieve its objectives efficiently and
expeditiously. Maxim shall maintain laboratories, offices and
all other facilities reasonably necessary to carry out the
activities to be performed pursuant to the Research Plan. In
conformity with standard pharmaceutical and biotechnology industry
practices and the terms and conditions of this Agreement, Maxim
shall prepare and maintain, or shall cause to be prepared and
maintained, complete and accurate written records, accounts, notes,
reports and data with respect to activities conducted pursuant to
the Research Plan and, upon Myriad’s written request, shall
send legible copies of the aforesaid to Myriad. Upon
reasonable advance notice, Maxim agrees to make its employees and
non-employee consultants reasonably available at their respective
places of employment to consult with Myriad on issues arising
during the Term and in connection with any request from any
regulatory agency, including, without limitation, regulatory,
scientific, technical and clinical testing issues.
3.4 Research
Commitment; Research Term Extension. During the Research
Term, Maxim shall use its commercially reasonable efforts to
conduct the Research Program in accordance with the Research Plan,
as revised from time to time by the JDC. Without limiting the
generality of the foregoing, and subject to Myriad’s
compliance with its funding obligations under Section 6.2
hereof, Maxim shall devote to the Research Program [***]
FTEs during the one (1) year period following the Effective
Date. At Myriad’s option, exercisable by written notice
to Maxim given no less than 60 days prior to the first (1
st
) anniversary of the
Effective Date, Myriad may extend the Research Term until the
second (2 nd ) anniversary of the Effective Date. In the event of
such extension, Maxim shall devote to the Research Program up to
[***] FTEs during such additional year of the Research Term,
subject to Myriad’s compliance with its funding obligations
under Section 6.2 hereof.
3.5 Research
Reports. Maxim shall keep Myriad fully informed as to all
discoveries and technical developments (including, without
limitation, any Inventions) made in the course of performing
activities under the Research Program. In particular, Maxim
shall prepare, and distribute to all members of the JDC no later
than five days prior to the next JDC meeting, a reasonably
detailed written summary report, in such form and format and
setting forth such information regarding the results and progress
of performance of the Research Program as determined from time to
time by the JDC.
3.6 Subcontracts. Maxim may perform some of
its obligations under the Research Plan through one (1) or
more subcontractors, provided that (a) none of the rights of
either party hereunder are diminished or otherwise adversely
affected as a result of such
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
6
subcontracting, and (b) the
subcontractor undertakes in writing obligations of confidentiality
and non-use regarding Confidential Information which are
substantially the same as those undertaken by the parties pursuant
to Article 10 hereof. In the event Maxim performs any of
its obligations under the Research Plan through a subcontractor,
then Maxim will at all times be responsible for the performance and
payment of such subcontractor. Additionally, all such
subcontractors shall be obligated to enter into a written agreement
to assign all of Subcontractor’s intellectual property rights
for any work performed under the Research Program to
Maxim.
3.7 Materials
Transfer. In order to facilitate the Research Program,
either party may provide to the other party certain biological
materials or chemical compounds Controlled by the supplying party,
including, but not limited to, compounds from the MX90745 Series or
analogs, homologs, derivatives or isomers thereof (collectively,
“Materials” ) for use by the other party
in furtherance of the Research Program. Except as otherwise
provided under this Agreement, all such Materials delivered to the
other party will remain the sole property of the supplying party,
will be used only in furtherance of the Research Program in
accordance with this Agreement, and will be used in compliance with
all applicable laws, rules and regulations. The Materials
supplied under this Agreement must be used with prudence and
appropriate caution in any experimental work because not all of
their characteristics may be known. Except as expressly set
forth herein, THE MATERIALS ARE PROVIDED “AS IS” AND
WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY
WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE
ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD
PARTY.
4. DEVELOPMENT AND
COMMERCIALIZATION OF PRODUCTS
4.1 Development and
Commercialization of Products. Subject to the terms and
conditions of this Agreement (including, without limitation,
Section 5.2), Myriad shall control the worldwide development
and commercialization of Products, including, but not limited to,
the worldwide supply of Products for use in development and
commercialization activities.
4.2 Disclosure
Regarding Myriad Efforts. Myriad will keep Maxim
appropriately informed about Myriad’s research, development,
clinical trial progress and commercialization efforts with respect
to Products. Without limiting the generality of the foregoing,
Myriad shall provide Maxim with written notice of the
following:
(a)
identification or generation of any Product by or on behalf of
Myriad or any of its Affiliates outside of the Research Program or
after the Research Term for which IND-enabling non-clinical studies
are commenced;
(b) filing of an
IND or NDA with respect to any Product in any
jurisdiction;
(c) initiation
of Phase I Clinical Trials, Phase II Clinical Trials and
Phase III Clinical Trials, and Regulatory Approval, with
respect to any Product in any jurisdiction; and
(d) clinical
trial progress and commercialization plans, activities and results
with respect to Products in any jurisdiction.
With respect to clause (a) of this
Section 4.2, Myriad shall disclose to Maxim any such Products
generated by or on behalf of Myriad or any of its Affiliates during
any Calendar Quarter within 30 days of the end of such
Calendar Quarter. With respect to clauses (b) and
(c) of this Section 4.2, Myriad will provide such notice
promptly (and in any event within 10 days) following the
occurrence of the applicable event. With respect to
clause (d) of this Section 4.2, such notice shall be
provided to Maxim as regularly as appropriate to keep Maxim
reasonably informed, and, in any event, Myriad shall provide Maxim
with annual written reports summarizing in reasonable detail any
such events that have occurred during the applicable twelve
(12) month period. The provisions of this
Section 4.2 shall survive expiration or termination of the
Research Term for so long as Myriad has a license hereunder
pursuant to Section 11.3.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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5. LICENSES
5.1 License
Grants.
(a) By
Maxim.
(i) Research
License. Subject to the terms and conditions of this
Agreement, Maxim hereby grants to Myriad and its Affiliates, during
the Term, a non-exclusive, worldwide, royalty-free license, without
the right to sublicense, under the Maxim Technology solely to
perform Myriad’s obligations under the Research
Plan.
(ii) Development and
Commercialization License. Subject to the terms and
conditions of this Agreement, Maxim hereby grants to Myriad, during
the Term, an exclusive (even as to Maxim), worldwide,
royalty-bearing license, with the right to sublicense, under the
Maxim Technology and Maxim’s interest in the Joint Patents,
to develop, make, have made, use, sell, distribute for sale, offer
for sale, have sold and import or export Products in the
Field. Myriad will at all times be responsible for the
performance of its Sublicensees and Third Party contractors under
this Agreement.
(b) By
Myriad. Subject to the terms and conditions of this
Agreement, Myriad hereby grants to Maxim and its Affiliates, during
the Research Term, a non-exclusive, worldwide, royalty-free
license, without the right to sublicense, under the Myriad
Technology solely to perform Maxim’s obligations under the
Research Plan.
5.2 Diligence
Obligations. Myriad agrees to use commercially reasonable
efforts to develop and commercialize one or more Products in the
Major Markets.
(a) In the event
that Myriad or a Sublicensee is not conducting development or
commercialization of at least one Product in a particular Major
Market, then Myriad shall provide Maxim with prompt written notice
thereof.
(b) In addition,
if Maxim in good faith believes that Myriad is not using its
commercially reasonable efforts to develop or commercialize at
least one Product in a particular Major Market, Maxim may provide
Myriad with written notice thereof, in which event Myriad will have
60 days from the date of such notice in which to show
commercially reasonable efforts. If the parties can not agree
as to what are commercially reasonable efforts, then such matter
shall be resolved pursuant to the resolution procedures set forth
in Section 11.3. If the arbitrators decide that the
efforts undertaken by Myriad have not been commercially reasonable,
Myriad shall have 60 days to have commenced and thereafter
reasonably proceed forward with the completion of such efforts as
determined by the arbitration panel to be commercially
reasonable. If Myriad fails to implement the commercially
reasonable efforts designated by the arbitration panel, then
Maxim’s claim under this Section 5.2(b) shall be deemed
to have been resolved against Myriad.
5.3 Maxim [***]
Rights. If Myriad provides Maxim with notice under
Section 5.2(a) above, or if Maxim provides Myriad with notice
under Section 5.2(b) above (provided, in the event of a
dispute, that the matter under Section 5.2(b) is ultimately
resolved against Myriad), then:
(a) the license
granted to Myriad under Section 5.1(a)(ii) [***]
;
(b) Myriad shall
[***] ; and
(c) Maxim shall
have [***] . Maxim shall have [***] , to notify
Myriad in writing either that (i) [***] or (ii)
[***] . If Maxim notifies Myriad within [***] ,
the parties shall [***] . If Maxim [***] , then
Myriad shall [***] ; provided, however , that for a
period of [***] . For purposes of clarification,
[***] .
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
8
6. FEES AND
PAYMENTS
6.1 Upfront Fee.
Myriad shall pay to Maxim a non-refundable, non-creditable
upfront fee of [ *** ] within 20 days of the
Effective Date.
6.2 Research
Funding. During the Research Term, Myriad shall make
research funding payments to Maxim for [***] FTEs per year,
quarterly in advance, at the rate of [***] per FTE per
year. The first payment under this Section 6.2 shall be
made within 20 days of the Effective Date and each subsequent
payment shall be made on the first day of each Calendar Quarter
during the Research Term. The first and final quarterly
payments shall be prorated to reflect the number of days in the
calendar quarter that the Research Program is in effect. Any
commitment by Maxim of more than [***] FTEs to the Research
Program during the Research Term, and/or any extension of the
Research Term beyond the second (2 nd ) anniversary of the Effective Date, would be subject to
negotiation by the parties and require the mutual written agreement
of the parties.
6.3 Milestone
Payments. Within 30 days following the first
occurrence of each of the events set forth below with respect to a
Product, Myriad shall pay to Maxim the milestone payment set forth
below (whether such milestone is achieved by Myriad, its Affiliate
or any of their respective Sublicensees):
|
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Milestone
Event
|
|
Milestone
Payment
|
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Dosing of first patient in first Phase
1
Clinical Trial of Product
|
|
$1,000,000
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
Each of the milestone payments described
in this Section 6.3 shall be payable one (1) time for
each Product containing a particular active ingredient, regardless
of the number of indications for which such Product is developed or
commercialized; provided, however, that if (a) a
Product is abandoned during development after one (1) or more
of the milestone payments under this Section 6.3 has been made
(a “Dropped Product” ) and
(b) another Product containing a different active ingredient
is developed for substantially the same indication as a replacement
for such Dropped Product, then only those milestone payments under
this Section 6.3 that were not previously made with respect to
such Dropped Product shall be payable with respect to the
replacement Product. All payments made to Maxim pursuant to
this Section 6.3 are non-refundable and, except as set forth
in the preceding sentence, may not be credited against any other
payments payable by Myriad to Maxim under this
Agreement.
6.4 Royalties. Myriad shall pay to Maxim
royalties on Net Sales of Products by Myriad and its Affiliates
(but not their respective Sublicensees) at the following
rates:
(a) [***] of that
portion of total annual Net Sales of Products that is less than or
equal to [***] ;
(b) [***] of that
portion of total annual Net Sales of Products that is greater than
[***] and less than or equal to [***] ;
(c) [***] of that
portion of total annual Net Sales of Products that is greater than
[***] and less than or equal to [***] ;
and
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
9
(d) [***] of that
portion of total annual Net Sales of Products that is greater than
[***] .
6.5 Sublicensing
Revenues.
(a) [***]
Sublicense. Myriad shall pay to Maxim [***] of all
Sublicensing Revenues received by Myriad or any of its Affiliates
with respect to sublicenses of the right to develop, make, have
made, use, distribute for sale, promote, market, offer for sale,
sell, have sold, import or export Products [***]
.
(b) [***]
Sublicense. If Myriad grants to a Sublicensee the right
to develop, make, have made, use, distribute for sale, promote,
market, offer for sale, sell, have sold, import or export Products
[***] , Myriad shall pay to Maxim milestone payments based
on the achievement of any milestone set forth in Section 6.3
above by any such Sublicensee. Myriad shall also pay to Maxim
royalties on the Net Sales of Products by all such Sublicensees
[***] based on th
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