Portions herein identified by [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. EXCLUSIVE LICENSE AGREEMENT...
Exhibit
10.8
Portions
herein identified by [***] have been omitted
pursuant to a request for confidential treatment and have been filed separately
with the
Commission
pursuant to Rule 406 of the Securities Act
of 1933, as amended.
between
EMORY
UNIVERSITY
and
TABLE
OF
CONTENTS
DEFINITIONS
|
1
|
|
ARTICLE
2.
|
GRANT
OF LICENSE
|
5
|
ARTICLE
3.
|
ROYALTIES
AND OTHER PAYMENTS
|
6
|
ARTICLE
4.
|
REPORTS
AND ACCOUNTING
|
11
|
ARTICLE
5.
|
PAYMENTS
|
12
|
ARTICLE
6.
|
DEVELOPMENT
AND MARKETING PROGRAM
|
12
|
ARTICLE
7.
|
PATENT
PROSECUTION
|
14
|
ARTICLE
8.
|
INFRINGEMENT
|
15
|
ARTICLE
9.
|
EXCLUSION
OF WARRANTIES
|
16
|
ARTICLE
10.
|
INDEMNIFICATION
AND RELEASE FROM LIABILITY
|
16
|
ARTICLE
11.
|
CONFIDENTIALITY
|
17
|
ARTICLE
12.
|
TERM
AND TERMINATION
|
19
|
ARTICLE
13.
|
ASSIGNMENT
|
21
|
ARTICLE
14.
|
MISCELLANEOUS
|
21
|
ARTICLE
15.
|
NOTICES
|
23
|
APPENDIX
A
APPENDIX
B
APPENDIX
C
THIS
LICENSE AGREEMENT
is made
and entered into as of this 23rd
day of
February, 2004 (hereinafter referred to as “Effective Date”), by and between
EMORY UNIVERSITY, a non-profit Georgia corporation with offices located at
Office of Technology Transfer, Xxxxx Xxxxxxx Xxxx., Xxxxx 000, 0000 X. Xxxxxxx
Xxxx, Xxxxxxx, Xxxxxxx 00000 XXX (hereinafter referred to as “EMORY”), and
COUGAR
BIOTECHNOLOGY, INC.
a
for-profit California corporation with offices at 00000 Xxxxxxxx Xxxx., Xxxxx
000, Xxx Xxxxxxx, Xxxxxxxxxx 00000 XXX (hereinafter referred to as “CBT”).
WITNESSETH
WHEREAS,
EMORY
is the assignee of all right, title, and interest in inventions developed by
employees of EMORY and is responsible for the protection and commercial
development of such inventions;
WHEREAS,
Drs.
Xxxxxx Xxxxx, Xxxxxx Xxxx, Xxxx Ke, Xxxxxxx Xxx, Xxxxx Xxxxxx, Xxxxxx Xxxxxxxxx,
Xxxxx Xxxxxx and Keqiang Ye are employees of EMORY and are named as inventors
on
Emory invention disclosures: (i) no. 97012, titled: “The Antitissue Drug
Noscapine is a Tubulin Binding Anti-Tumor Drug”, (ii) no. 98056, titled: “Use of
the Anti-Cancer Agent, Noscapine, as an Immunological Adjuvant for Tumor
Therapy”, (iii) no. 01028, titled: “Noscapine and Noscapine Derivatives, Useful
as Anticancer Agents”, and (iv) no. 02040, titled: “Delivery Systems and Methods
for Nocapine and Noscapine Derivatives, Useful as Anticancer Agents”, which are
the subject of those issued patents and pending patent applications listed
in
Appendix “A” herein (hereinafter “Inventions”;
WHEREAS,
CBT
represents that it has the necessary expertise and will, as appropriate, acquire
the necessary resources to fully develop, seek approval for, and market
therapeutic products based upon the Inventions claimed in the above referenced
issued patents and pending patent applications; and
WHEREAS,
EMORY
desires to have such Inventions developed, commercialized, and made available
for use by the public.
NOW,
THEREFORE,
for and
in consideration of the mutual covenants and the premises herein contained,
the
parties, intending to be legally bound, hereby agree as follows.
ARTICLE
1. DEFINITIONS
The
following terms as used herein shall have the following meanings:
1.1 “Affiliate”
shall mean any corporation or non-corporate business entity which controls,
is
controlled by, or is under common control with a Party to this Agreement. A
corporation or non-corporate business entity shall be regarded as in control
of
another corporation if it owns, or directly or indirectly controls, at least
fifty percent (50%) of the voting stock of the other corporation, or (i) in
the
absence of the ownership of at least fifty percent (50%) of the voting stock
of
a corporation or (ii) in the case of a non-corporate business entity, or
non-profit corporation, if it possesses the power to direct or cause the
direction of the management and policies of such corporation or non-corporate
business entity, as applicable.
1
1.2 “Agreement”
or "License Agreement" shall mean this Agreement, including all APPENDICES
attached to this Agreement.
1.3 “Authorization”
shall mean all approvals, licenses, registrations or authorizations of any
national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other government entity, necessary
for the manufacture, distribution, use or sale of a pharmaceutical or diagnostic
product in a given regulatory jurisdiction outside of the United
States.
1.4 “Authorized
Third Party” shall mean a Third Party to which CBT grants rights to make, have
made, use, sell or offer for sale Licensed Products and/or a Third Party
designated by CBT to market or co-market Licensed Products and shall not include
distributors, wholesalers, pharmacies or pharmacy chains, managed care
organizations, group purchasers or others to whom CBT or such marketer or
co-marketer sell Licensed Products as a result of arms-length transactions.
1.5 “Consecutive
Licensed Product” shall mean a Licensed Product that has as its active
pharmaceutical ingredient (“API”) a different API than the First Licensed
Product or any other pre-existing Licensed Product. For avoidance of doubt,
a
derivative of noscapine shall be a different API than noscapine or other
derivative of noscapine.
1.6 “Dollars”
shall mean United States dollars.
1.7 “Earned
Royalties” shall mean royalties payable to EMORY by CBT for the Sale of a
Licensed Product.
1.8 “EMORY”
shall mean Emory University.
1.9 “FDA”
shall mean the United States Food and Drug Administration or successor
entity.
1.10 “Field
of
Use” shall mean any therapeutic use that is intended to prevent, treat,
ameliorate or cure a human disease, pathology or condition.
1.11 First
Commercial Sale” shall mean the first Sale of a Licensed Product to a Third
Party after Regulatory Approval or Authorization has been obtained for such
Licensed Product.
1.12 “First
Licensed Product” shall mean the first Licensed Product for which an IND or its
equivalent in a Major Market becomes effective, or any Licensed Product that
replaces such product pursuant to Section 3.3.1.
1.13 “IND”
shall mean an Investigational New Drug application in the United
States.
1.14 “Indemnitees”
shall mean the Inventors, EMORY, its directors, employees and students, and
their heirs, executors, administrators, successors and legal
representatives.
2
1.15 “Inventors”
shall mean Xxxxxx Xxxxx, Xxxxxx Xxxx, Xxxx Ke, Xxxxxxx Xxx, Xxxxx Xxxxxx, Xxxxxx
Xxxxxxxxx , Xxxxx Xxxxxx and Keqiang Ye.
1.16 “Licensed
Patents” shall mean those issued patents and patent applications identified in
Appendix “A”, together with any and all substitutions, extensions, divisionals,
continuations, continuations-in-part (to the extent that the subject matter
is
disclosed and enabled in the parents), or foreign counterparts of such patent
applications and patents which issue thereon any where in the world, including
reexamined and reissued patents.
1.17 “Licensed
Product” shall mean any method, service or product within the Field of Use, the
manufacture, use, offer for sale or sale of which is made or performed from
or
using Licensed Patents or Licensed Technology.
1.18 “Licensed
Technology” shall mean: (a) all technical information and data, whether or not
patented, presently known or learned, invented, or developed by the Inventors
or
any employees of EMORY working under the Inventor’s direct supervision and while
they are under a duty to assign intellectual property rights to Emory, to the
extent that (i) such technical information and data are required for the use
or
practice of the Licensed Patents or Licensed Technology as permitted herein;
and
(ii) Emory possesses the right to license the use of such information to
Licensee for commercial purposes without incurring financial or other
non-contingent, material obligations to any Third Parties and without breaching
any obligations of confidentiality with such Third Parties.
1.19 “Licensed
Territory” shall mean the world.
1.20 “Major
Market” shall mean the European Union, Canada, Japan.
1.21 “Material
Transfer Agreement” shall mean a legal agreement governing the transfer of
material pertaining to the Licensed Technology to a non-profit Third Party
(“Recipient”), the purpose of which is to govern such issues as: (i) ownership
of the transferred material and any of the modifications and derivatives made
by
the Recipient; (ii) limits on the use of the material by the Recipient, and
to
recover, where necessary, any costs in providing the material; (iii)
confidentiality of information relating to the material, and publication
restrictions; (iv) rights to inventions and use of research results; (v) protect
intellectual property or valuable know-how; and (vi) protect EMORY from legal
liability as a result of the use of the material or any results
obtained.
1.22 “NDA”
shall mean a New Drug Application.
1.23 “Net
Sales” shall mean the amounts received by CBT or an Affiliate or sublicensee of
CBT for the Sale of Licensed Products to a Third Party purchaser, less the
following deductions, to the extent that such amounts are included in the gross
amounts received: (a) freight, packaging and insurance costs incurred in
transporting the Licensed Product to customers; (b) quantity, cash and other
trade discounts actually allowed and taken (other than advertising allowances;
and fees or commissions to CBT’ employees); (c) customs duties, surcharges,
sales and other taxes (but excluding income taxes) and other governmental
charges incurred in connection with the sale, transfer, use, exportation or
importation of Licensed Products; and (d) amounts repaid or credited by reason
of returns, recalls, rejections or retroactive price reductions. Where a sale
is
deemed consummated by a receipt of non-cash consideration for Licensed Products,
“Net Sales” shall be calculated based on the average Net Sales of Licensed
Products during the three (3) month period immediately preceding such
sale.
3
1.24 “Parties”
shall mean CBT and EMORY and “Party” shall mean either one.
1.25 “Phase
I”
shall mean a human clinical trial, the principal purpose of which is to
determine toxicity, absorption, metabolism and/or safe dosage range in patients
with the disease target being studied as required in 21 C.F.R. §312 or its
equivalent in a Major Market. A Phase I study shall be deemed to have commenced
when the first patient has been dosed with the drug substance.
1.26 “Phase
III” shall mean a human clinical trial, the principal purpose of which is to
establish safety and efficacy in patients with the disease target being studied
as required in 21 C.F.R. §312 or its equivalent in a Major Market. A Phase III
study shall also include any other human clinical trial intended to provide
the
substantial evidence of efficacy necessary to support the filing of an
approvable NDA (such as a combined Phase II/Phase III study, or any Phase III
study in lieu of a Phase II study) (a “Pivotal Study”), whether or not such
study is a traditional
Phase III study. A
Phase
III study shall be deemed to have commenced when the first patient has been
dosed with the drug substance.
1.27 “Regulatory
Approval” shall mean the approvals, registrations or authorizations of the FDA
or other applicable regulatory agency necessary for the manufacture,
distribution, use or sale of a pharmaceutical or diagnostic product in the
United States.
1.28 “Sale”
or
“Sold” shall mean the sale, transfer, exchange, or other commercial disposition
of Licensed Products whether by gift or otherwise by CBT, its Affiliates or
sublicensees or any Authorized Third Party authorized by CBT to make such sale,
transfer, exchange or disposition including, but not limited to, the commercial
use of Licensed Products by CBT or any other person or entity authorized (other
than concomitant with commercial sale of such product in a royalty-bearing
transaction) to use Licensed Products by CBT. Sales of Licensed Products shall
be deemed consummated upon the first to occur of: (a) receipt of payment from
the purchaser; (b) delivery of Licensed Products to the purchaser or a common
carrier; (c) release of Licensed Products from consignment; (d) if deemed Sold
by use, when first put to such use; or (e) if otherwise transferred, exchanged,
or disposed of, whether by gift or otherwise, when such transfer, exchange,
gift, or other disposition occurs.
1.29 “Third
Party” shall mean any entity or individual other than EMORY, CBT or an Affiliate
of either of them.
1.30 “U.S.
Government License” shall mean the non-exclusive licenses to the U.S. Government
or agencies thereof pursuant to NIH grant No.’s GM51389, CA70372, copies of
which are attached hereto as Appendix “B”.
1.31 “Valid
Claim” shall mean, an issued claim of any unexpired patent or claim of any
pending patent application included among the Licensed Patents, which patent
has
not been held unenforceable, unpatentable or invalid by a decision of a court
or
governmental body of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, which has not been rendered unenforceable through
disclaimer or otherwise, and which has not been lost through an interference
proceeding or abandoned.
4
ARTICLE
2. GRANT
OF LICENSE
2.1 License.
Subject
to the terms and conditions of the License Agreement, Emory hereby grants to
Licensee and its Affiliates the worldwide, exclusive right and license to
practice the Licensed Patents and use the Licensed Technology in the Field
of
Use and to discover, develop, have made, use, sell, have sold, offer for sale
and import Licensed Products in the Licensed Territory in the Field of Use
during the term of this Agreement.
2.2 Government
Rights.
The
license granted in Section 2.1 above is subject to the U.S. Government Licenses
and other rights retained by the United States in inventions developed by
nonprofit institutions with the support of federal funds that are set forth
in
35 XXXX §000 et seq. and 37 CFR 401 et seq. (as they may be amended from time to
time by the Congress of the United States or through administrative procedures)
to the extent such U.S. government Licenses and such rights apply to the
Licensed Patents and Licensed Technology.
2.3 Retained
License.
The
license granted in Section 2.1 above is further subject to a right and license
retained by EMORY on behalf of itself and its research collaborators to use
Licensed Products and practice Licensed Patents and Licensed Technology solely
for non-profit research and education purposes only. EMORY shall require its
research collaborators, employed by other institutions or organizations and
not
by EMORY, to enter into a Material Transfer Agreement, through which EMORY
may
grant the right to use Licensed Products and to practice Licensed Patents and
Licensed Technology solely for non-profit research purposes only to such
research collaborators. A copy of each such executed Material Transfer Agreement
shall be provided to Licensee within sixty (60) days of the date of the last
to
sign.
2.4 Sublicenses.
CBT may
grant sublicenses to practice Licensed Patents and Licensed Technology to
discover, develop, make, have made, use, sell, offer for sale or import Licensed
Products in the Licensed Territory in the Field of Use, provided that: (a)
for
any such Third Party sublicensees that are publicly traded companies and have
a
fully-diluted market capitalization of greater than [***], CBT shall give prompt
written notice to EMORY, and (b) for any such Third Party sublicensees that
are
publicly traded companies and have a fully-diluted market capitalization of
less
than [***], CBT shall first obtain EMORY's prior written approval, which
approval shall not be unreasonably withheld or delayed. CBT shall provide EMORY
with copies of all such sublicense agreements within thirty (30) days of their
execution date, provided, however, that CBT shall have the right to redact
any
confidential information in such copies of sublicense agreements that does
not
relate in any way to either the technology licensed hereunder or the economic
terms therein (such as any technical information relating to other technologies
of CBT or of its sublicensees). CBT shall remain responsible to EMORY for the
payment of all fees and Earned Royalties due under this Agreement, whether
or
not such payments are made to CBT by its sublicensees. CBT shall include in
any
sublicense granted pursuant to this Agreement, a provision requiring the
sublicensee to indemnify EMORY and maintain liability coverage to the same
extent that CBT is so required pursuant to Sections 10.2, 10.3 and 10.4 of
this
Agreement.
5
2.5 No
Implied License.
The
license and rights granted in this Agreement shall not be construed to confer
any rights upon CBT by implication, estoppel, or otherwise as to any technology
not specifically identified in this Agreement as Licensed Patents or Licensed
Technology.
2.6
To
EMORY’s’ knowledge and belief, subject to any rights of the United States
government, EMORY has all right, title, and interest in and to the Licensed
Patents, including exclusive, absolute, irrevocable right, title and interest
thereto, free and clear of all liens, charges, encumbrances or other
restrictions or limitations of any kind whatsoever and to EMORY’s knowledge and
belief there are no licenses, options, restrictions, liens, rights of third
parties, disputes, royalty obligations, proceedings or claims relating to,
affecting, or limiting its rights or the rights of CBT under this Agreement
with
respect to, or which may lead to a claim of infringement or invalidity
regarding, any part or all of the Licensed Patents and their use as contemplated
in the underlying patent applications as presently drafted.
2.7 To
EMORY’s knowledge and belief there is no claim, pending or threatened, of
infringement, interference or invalidity regarding, any part or all of the
Licensed Patents and their use as contemplated in the underlying patent
applications as presently drafted.
2.8 To
EMORY’s knowledge and belief the Inventors of Section 1.15 are the only
inventors of the Licensed Patents and Licensed Technology.
ARTICLE
3. ROYALTIES
AND OTHER PAYMENTS
3.1 Earned
Royalties on Sales of Licensed Products.
3.1.1 On
Sales of Licensed Product by CBT and Affiliates with Valid Claim.
Subject
to Section 3.1.4, for each Licensed Product sold in a country in the Licensed
Territory in which there is, at the time of such sale, at least one Valid Claim
in an issued Licensed Patent in such country that claims (i) such Licensed
Product, (ii) the manufacture of such Licensed Product, or (iii) the use of
such
Licensed Product in the Field of Use, CBT shall pay EMORY Earned Royalties
equal
to the following percentages of the aggregate annual Net Sales of such Licensed
Products sold in such countries in the Licensed Territory in the Field of Use
by
CBT and its Affiliates:
(a) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use less than [***] in any calendar
year, [***] percent [***] of such Net Sales;
(b) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use between [***] and [***] in any calendar year,
[***] percent [***] of such Net Sales; and
6
(c) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use greater than [***] in any calendar
year, [***] percent [***] of such Net Sales.
3.1.2 On
Sales of Licensed Product by CBT and Affiliates with no Valid
Claim.
Subject
to Section 3.1.4, for each Licensed Product sold in a country in the Licensed
Territory in which there is not,
at the
time of such sale, at least one Valid Claim in an issued Licensed Patent in
such
country that claims (i) such Licensed Product, (ii) the manufacture of such
Licensed Product, or (iii) the use of such Licensed Product in the Field of
Use,
CBT shall pay EMORY Earned Royalties equal to the following percentages of
the
aggregate annual Net Sales of such Licensed Products sold in such countries
in
the Licensed Territory in the Field of Use by CBT and its Affiliates:
(a) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use less than [***] in any calendar
year, [***] percent [***] of such Net Sales;
(b) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use between [***] and [***] in any calendar year,
[***] percent [***] of such Net Sales; and
(c) For
the
portion of such aggregate annual Net Sales of such Licensed Products in such
countries in the Field of Use greater than [***] in any calendar
year, [***] percent [***] of such Net Sales.
3.1.3 On
Sales of Licensed Product by CBT’s Sublicensees.
CBT
shall pay EMORY that portion of sublicense fees (excluding Initial Sublicense
Fees) received by CBT on Sales of Licensed Products by its sublicensees as
Earned Royalties in the percentage amount specified below opposite the
occurrence of the corresponding designated event:
Event
|
Earned
Royalties
|
|||
(Sublicense
date of execution)
|
(%
of sublicense fees)
|
|||
(i)
If
a sublicense or other Third Party agreement is executed with CBT
prior to
the commencement of a Phase I trial by CBT for the First Licensed
Product
|
[***]%
|
|
||
(ii)
If
a sublicense or other Third Party agreement is executed with CBT
after the
effective date of the commencement of a Phase I trial by CBT for
the First
Licensed Product but prior to the date of commencement of the first
Phase
III Clinical Trial for the First Licensed Product
|
[***]%
|
|
||
(iii)
If
a sublicense or other Third Party agreement is executed with CBT
after the
date of commencement of the first Phase III Clinical Trial for the
First
Licensed Product
|
[***]%
|
|
7
3.1.4 In
the
event that CBT’s outside patent counsel together with EMORY’s outside patent
counsel agree (which discussion and agreement shall be in good faith) that
patent licenses from Third Parties are reasonably required by CBT, its
Affiliates or its sublicensees to make, use, offer for sale, sell or import
any
Licensed Product in any given country, EMORY and CBT shall negotiate in good
faith with the intention of reaching a fair and equitable formula on how any
amount paid by CBT to such Third Parties shall be shared by CBT and EMORY,
EXCEPT THAT Earned Royalties payable to EMORY on Net Sales of such Licensed
Products shall not be less than [***] percent [***].
3.2 Upfront
Sublicense Fees.
3.2.1 CBT
shall
pay EMORY that portion of any license fee or upfront fee (other than purchases
of debt or equity securities of CBT, payments for research and development
of
the Licensed Technology or the creation of a sales and marketing force) (the
“Initial Sublicense Fee”) received by CBT as consideration paid for access and
rights to the Licensed Patents and/or Licensed Technology by its sublicensees
in
the percentage amount specified below opposite the occurrence of the
corresponding designated event:
Event
|
Upfront
Sublicense Fee
|
|||
(Sublicense
date of execution)
|
(%
of Initial
Sublicense
Fee)
|
|||
(i)
If
a sublicense or other Third Party agreement is executed with CBT
prior to
the commencement of a Phase I trial by CBT for the First Licensed
Product
|
[***]%
|
|
||
(ii)
If
a sublicense or other Third Party agreement is executed with CBT
after the
commencement of a Phase I trial by CBT for the First Licensed Product
but
prior to the date of commencement of the first Phase III Clinical
Trial
for the First Licensed Product
|
[***]%
|
|
||
(iii)
If
a sublicense or other Third Party agreement is executed with CBT
after the
date of commencement of the first Phase III Clinical Trial for the
First
Licensed Product
|
[***]%
|
|
In
the
event that CBT receives equity or other non-cash consideration (collectively,
“Non-liquid Assets”), as payment for the Initial Sublicense Fee, EMORY shall
receive its designated portion of any such Non-liquid Asset as received by
CBT
to the extent transferable by CBT, or in the alternative CBT may, at its
election, pay to XXXXX x xxxx payment equal to EMORY’s designated portion of the
fair value of any such Non-Liquid Asset. The payment to EMORY shall be EMORY’s
designated portion of the then current fair market value of such asset. For
purposes of clarity, if a sublicensee purchases shares of CBT’s stock from CBT
in conjunction with a sublicense hereunder, CBT shall pay to XXXXX x xxxx
payment equal to EMORY’s designated portion of the premium (that is, excess over
fair market value), if any, paid by such sublicensee for such CBT
shares.
8
3.3 Milestone
Payments.
3.3.1 CBT,
its
Affiliates or its sublicensee shall pay EMORY a milestone payment (the
"Milestone Payment") in the amount specified below no later than thirty (30)
days after the occurrence of the corresponding event designated below for the
First Licensed Product:
Event
|
Milestone
Payment
|
|||
(i)
The
date of commencement of the first Phase I trial by CBT, its Affiliates,
or
sublicensees for the First Licensed Product
|
$
|
[***]
|
||
(ii)
The
date of commencement of the first Phase III Clinical Trial for the
First
Licensed Product
|
$
|
[***]
|
||
(iii)
The
date of Regulatory Approval or Authorization of the First Licensed
Product.
|
$ |
[***]
|
||
(iv)
The
date of Regulatory Approval or Authorization of the First Licensed
Product
or Consecutive Licensed Product in an additional new indication (limit
3)
|
$
|
[***] for
each new approval (limit 3)
|
|
Should
the First Licensed Product be abandoned by CBT, its Affiliate or sublicensee
for
any reason following the filing of an IND or its equivalent in a Major Market
and prior to the First Commercial Sale and should another Licensed Product
commence Phase III Clinical Trials, then such Licensed Product shall become
the
replacement First Licensed Product and CBT, its Affiliate or sublicensee shall
resume the Milestone Payments, starting at the event subsequent to the event
for
which a Milestone Payment had already been paid. No Milestone Payment shall
be
paid more than once for the First Licensed Product.
3.4 License
Maintenance and Performance Fees on Licensed Products:
In the
event no Milestone Payment has been paid pursuant to Section 3.3.1 on the
applicable anniversary of the Effective Date of the License Agreement set forth
below, CBT shall pay to EMORY the license maintenance fee (the “License
Maintenance Fee”) amount set forth below opposite such anniversary date unless
CBT has given notice of termination of the Agreement prior to such due date.
Such License Maintenance Fees shall no longer apply, and this Section shall
terminate, once a Milestone Payment pursuant to Section 3.3.1 has been
made.
Anniversary
|
License
Maintenance Fee
|
|||
Fifth
|
$
|
[***]
|
||
Sixth
|
$
|
[***]
|
||
Seventh
and Each Year After
|
$
|
[***]
|
3.5 Annual
Minimum Royalties on Licensed Products:
3.5.1 In
the
event that the annual Earned Royalties payment for Licensed Products to EMORY
pursuant to Section 3.1 (excluding Upfront Sublicense Fees) during the second
calendar year following the date of Regulatory Approval or Authorization for
a
Licensed Product, or in any calendar year thereafter, is less than the annual
minimum royalties set forth opposite such year below (the “Minimum Earned
Royalties”), CBT shall make a payment to EMORY at the end of such applicable
calendar year equal to the difference between such Minimum Earned Royalties
and
the total Earned Royalties payment to EMORY for all Licensed Products for that
calendar year, together with the report for the fourth quarter of such calendar
year:
9
Calendar
Year After Regulatory Approval or Authorization
|
Minimum
Earned Royalties
|
|||
Second
|
$
|
[***]
|
||
Third
|
$
|
[***]
|
||
Fourth
and Each Year After
|
$
|
[***]
|
3.5.2 If
during
a given calendar year, the Earned Royalties payment to EMORY pursuant to Section
3.1 (excluding Initial Sublicense Fees) for all Licensed Products exceeds the
sum of the applicable Minimum Earned Royalties which are required to be paid
for
such year pursuant to Section 3.5.1, CBT shall be deemed to have satisfied
the
requirements of Section 3.5.1 for such year.
3.6 Research
Agreement.
CBT and
EMORY agree to enter into and execute a Research Agreement with a term of 2
year(s), within ninety (90) days of the last date of signing below, regarding
work by the Inventors, led by Xx. Xxxxxx Xxxx, in accordance with a mutually
agreed upon project plan. Such Research Agreement shall be consistent with
the
terms of this Agreement, including but not limited to, terms of this Section
3.6
and shall be in the form attached to this License Agreement as Appendix “C”.
Such Research Agreement shall require CBT to commit [***] of direct
research funds plus [***] percent [***] for EMORY’s benefits and
overhead in the amount [***] in unrestricted indirect funding to
EMORY.
The
Inventors shall provide to CBT written progress reports of all work performed
pursuant to the Research Agreement and shall regularly discuss such work with
CBT. Each Party shall solely own all inventions it makes pursuant to the
Research Agreement and the parties shall jointly own all inventions jointly
made
directly as a result of work under the Research Agreement. Such inventions
of
EMORY employees shall be Licensed Patents or Licensed Technology, as applicable.
Both parties shall have confidentiality obligations under the Research Agreement
that are at least as stringent as those set forth in Article 11 herein. Should
CBT and EMORY not enter into and execute the Research Agreement within ninety
(90) days of the last date of signing below due to CBT’s failure to negotiate in
good faith or enter into a negotiated agreement, the License Agreement shall
be
null and void unless CBT and EMORY mutually agree in writing to extend the
ninety (90) day period.
3.7 Patent
Expenses. CBT shall reimburse and pay EMORY within ten (10) days of the
Effective Date, all actual, out-of-pocket costs, fees and expenses in connection
with the filing, prosecution and maintenance of Licensed Patents incurred by
EMORY prior to the Effective Date of this Agreement (the “Past Patent Costs”).
EMORY warrants that such actual, out-of-pocket costs, fees and expenses are
[***].
10
ARTICLE
4. REPORTS
AND ACCOUNTING
4.1 Earned
Royalties Reports and Records.
During
the term of this Agreement, CBT shall furnish, or cause to be furnished to
EMORY, written reports governing each of CBT, its Affiliates and sublicensees
for each fiscal quarter showing:
(a) the
gross
sales of all Licensed Products Sold by CBT, its Affiliates and sublicensees,
in
each country of the Licensed Territory during the reporting period, together
with the calculations of Net Sales in accordance with Section 1.23;
(b) the
Earned Royalties payable in Dollars, which shall have accrued hereunder in
respect to such Net Sales;
(c) the
exchange rates, if any, in determining the amount of Dollars;
(d) a
summary
of all reports provided to CBT by CBT's sublicensees;
(e) the
amount of any consideration received by CBT from sublicensees and an explanation
of the contractual obligation satisfied by such consideration; and
(f) the
occurrence of any event triggering a Milestone Payment obligation in accordance
with Section 3.3.
Reports
shall be made semiannually until the first Sale of a Licensed Product and
quarterly thereafter. Semiannual reports shall be due within thirty (30) days
of
the close of every second and fourth CBT fiscal quarter. Quarterly reports
shall
be due within thirty (30) days of the close of every CBT fiscal quarter. CBT
shall keep accurate records in sufficient detail to enable Earned Royalties
and
other payments payable hereunder to be determined. CBT shall be responsible
for
all Earned Royalties and late payments that are due to EMORY that have not
been
paid by CBT's Affiliates and sublicensees. CBT's sublicensees shall have, and
shall be notified by CBT that they have, the option of making any Earned
Royalties payment directly to EMORY.
4.2 Right
to Audit.
EMORY
shall have the right, upon prior notice to CBT, not more than once in each
CBT
fiscal year, through an independent public accountant selected by EMORY and
acceptable to CBT, which acceptance shall not be unreasonably refused, to have
access during normal business hours of CBT as may be reasonably necessary to
verify the accuracy of the Earned Royalties reports required to be furnished
by
CBT pursuant to Section 4.1 of the Agreement. CBT shall include in any
sublicenses granted pursuant to this Agreement, a provision requiring the
sublicensee to keep and maintain records of Sales made pursuant to such
sublicense and to grant access to such records by EMORY's independent public
accountant. If such independent public accountant's report shows any
underpayment of Earned Royalties by CBT, its Affiliates or sublicensees, within
thirty (30) days after CBT's receipt of such report, CBT shall remit or shall
cause its sublicensees to remit to EMORY:
11
(a) the
amount of such underpayment; and
(b) if
such
underpayment exceeds [***] percent [***] of the total Earned Royalties
owed for the fiscal year then being reviewed, the reasonably necessary fees
and
expenses of such independent public accountant performing the audit. Otherwise,
EMORY's accountant's fees and expenses shall be borne solely by EMORY. Any
overpayment of Earned Royalties shall be fully creditable against future Earned
Royalties payable in any subsequent royalty period.
4.3 Confidentiality
of Records.
All
information subject to review under this Article 4 shall be confidential. Except
where disclosure is required by law, EMORY and its accountant shall retain
all
such information in confidence.
ARTICLE
5. PAYMENTS
5.1 Payment
Due Dates.
Earned
Royalties, Upfront Sublicense Fees and Milestone Payments payable to EMORY
as a
result of activities occurring during the period covered by each Earned
Royalties report provided for under Article 4 of this Agreement shall be due
and
payable on the date such royalty report is due. Payments of Earned Royalties,
Upfront Sublicense Fees and Milestone Payments in whole or in part may be made
in advance of such due date. Any payment in excess of [***] shall be made
by wire or transferred to an account of EMORY designated in writing by EMORY
from time to time; provided, however, that in the event that EMORY fails to
designate such account, CBT, its Affiliates or sublicensees may remit payment
to
EMORY to the address applicable for the receipt of notices hereunder; providing,
further, that any notice by EMORY of such account or change in such account,
shall not be effective until fifteen (15) days after receipt thereof by
CBT.
5.2 Currency
Restrictions.
Except
as hereinafter provided in this Section 5.2, all Earned Royalties, Upfront
Sublicense Fees and Milestone Payments shall be paid in Dollars. If, at any
time, legal restrictions prevent the prompt remittance of part of or all Earned
Royalties or Upfront Sublicense Fees with respect to any country in the Licensed
Territory where Licensed Products are Sold, CBT, its Affiliates or sublicensees
shall have the right and option to make such payments by depositing the amount
thereof in local currency to EMORY's account in a bank or depository in such
country.
5.3 Interest.
Earned
Royalties, Upfront Sublicense Fees, Milestone Payments and other payments
required to be paid by CBT pursuant to this Agreement shall, if overdue, bear
interest at the lesser of the maximum applicable legal rate of interest on
overdue commercial accounts or a per annum rate of [***] percent [***]
until paid. The payment of such interest shall not foreclose EMORY from
exercising any other rights it may have because any payment is
overdue.
ARTICLE
6. DEVELOPMENT
AND MARKETING PROGRAM
6.1 Diligence
Obligations for Licensed Products.
CBT
shall directly, or in collaboration with Affiliates and sublicensees, use its
best efforts (as defined below) to:
12
(a) conduct
a
research and development program relating to the use of those Licensed Products
in the Field of Use selected by CBT as it deems appropriate;
(b) expend
reasonable amounts towards the research and development of such Licensed
Products, such amounts to include those described in Section 3.6;
(c) diligently
pursue Regulatory Approval or Authorization of selected Licensed Products;
and
(d) commence
marketing of at least one Licensed Product within six (6) months following
Regulatory Approval or Authorization thereof.
6.2 Best
Efforts.
For
purposes of this Agreement, “best efforts” shall mean that CBT shall use
reasonable efforts consistent with those used by comparable biotechnology
companies in the United States in research and development projects for
diagnostic methods or kits and therapeutic methods or compositions deemed to
have commercial value comparable to the Licensed Products.
6.3 Effect
of Failure.
If CBT
fails to use its best efforts pursuant to Section 6.1, EMORY may, upon at least
sixty (60) days' prior written notice of such failure to CBT, grant Third
Parties identical or lesser rights in the Licensed Patents and Licensed
Technology as granted to CBT hereunder for Licensed Products, unless within
such
sixty (60) day period, CBT cures such failure. Any disputes as to failure by
CBT
to meet its diligence obligations in accordance with this Article 6 shall be
resolved pursuant to Section 14.1.
6.4 Progress
Reports.
CBT
shall, no less frequently than once every twelve (12) months until a Licensed
Product has achieved Regulatory Approval or Authorization, provide EMORY with
a
written report detailing CBT’s, its Affiliates’s or sublicensees’s activities
related to developing Licensed Products and pursuing Regulatory Approval or
Authorization of Licensed Products. Such reports shall also incorporate
sufficient detail regarding the amount and use of research and development
funds
to enable EMORY to verify CBT's compliance with Section 6.1 herein.
6.5 Development
in the United States and Major Markets.
No
later than CBT's filing of an NDA or its equivalent in a Major Market for a
Licensed Product in the United States or a Major Market, CBT shall directly,
or
in collaboration with its Affiliates or sublicensees, use its best
efforts:
(a) to
obtain
Regulatory Approval or Authorization for such Licensed Product in such other
countries of the Licensed Territory as CBT, CBT’s Affiliates or sublicensees
deem appropriate; and
(b) upon
Regulatory Approval or Authorization of such Licensed Product in a particular
country, proceed with due diligence to market such Licensed Product in such
country.
6.6 Development
of Indications.
CBT and
EMORY acknowledge that the compositions and methods claimed in the Licensed
Patents may be useful for a number of indications. CBT shall, in accordance
with
its diligence obligations, attempt to develop the Licensed Patents and Licensed
Technology for such other indications if scientific evidence provided by EMORY,
and accepted as significant evidence in the scientific community, supports
that
the Licensed Patents and Licensed Technology are useful for such other
indications.
13
If
EMORY
reasonably believes that CBT is not using diligence to attempt to develop an
indication for which the diligence obligation has accrued under the above
paragraph, then EMORY may, commencing on the fifth anniversary date of this
Agreement, request in writing that CBT enter into negotiations with prospective
sublicensees which EMORY believes are interested in developing such indication
which CBT, or its Affiliate or sublicensee, is not then developing. Within
thirty (30) days of receipt of such written request, CBT shall either: (i)
commence and diligently pursue good faith negotiations with such prospective
sublicensee, (ii) provide EMORY with a reasonable development plan, including
milestones, for such indication, or (iii) release any rights granted to CBT
by
EMORY under this Agreement as may be required to enable EMORY to license Third
Parties the rights required to develop such indication.
ARTICLE
7. PATENT
PROSECUTION
7.1 Licensed
Patents Assigned to EMORY.
7.1.1 EMORY
shall be primarily responsible for all patent prosecution activities pertaining
to Licensed Patents assigned solely to EMORY. EMORY shall provide CBT with
copies of all filings and correspondence pertaining to such patent prosecution
activities, in a timely manner, so as to give CBT an opportunity to comment
thereon. EMORY shall use good faith efforts to accommodate all such comments
if
timely received. EMORY shall pursue prosecution of such Licensed Patents in
at
least the following countries: United States, EPO countries, Canada, and
Australia.
7.1.2 For
all
out-of-pocket costs after the Effective Date for on-going patent prosecution
activities on Licensed Patents (the “Future Patent Costs”), EMORY shall submit
such costs to CBT for approval prior to expenditure. CBT shall reimburse EMORY,
not later than thirty (30) days after receiving an invoice therefore from EMORY,
all such approved Future Patent Costs. If CBT fails to promptly reimburse EMORY
within sixty (60) days after receipt of invoice from EMORY for approved Future
Patent Costs, EMORY shall provide written notice to CBT of such failure and
if
CBT does not pay the undisputed amount of such invoice within thirty (30) days
after such notice, then the patent application or issued patent associated
with
such Future Patent Costs shall not be considered a Licensed Patent and EMORY
shall be free, at its election, to abandon or maintain the prosecution of such
patent application or issued patent or grant rights to such patent application
or issued patent to Third Parties.
7.2 Licensed
Patents Jointly Assigned to CBT and EMORY.
7.2.1 EMORY
shall be primarily responsible for all patent prosecution activities pertaining
to any Licensed Patents arising out of the Research Agreement pursuant to
Section 3.6 and jointly assigned to EMORY and CBT. EMORY, with the agreement
of
CBT, shall select patent counsel to prosecute all such Licensed Patents and
shall provide CBT with copies of all filings and correspondence pertaining
to
such patent prosecution activities, in a timely manner, so as to give CBT an
opportunity to comment thereon. EMORY shall advise such patent counsel in
writing that for purposes of such patent activities, such counsel represents
both EMORY and CBT. EMORY shall pursue prosecution of such Licensed Patents
in
at least the following countries: [***].
14
7.2.2 For
all
out-of-pocket costs for on-going patent prosecution activities pertaining to
any
Licensed Patents arising out of the Research Agreement pursuant to Section
3.6
and jointly assigned to EMORY and CBT, EMORY shall submit such costs to CBT
for
approval prior to expenditure. CBT shall reimburse EMORY, not later than thirty
(30) days after receiving an invoice therefor from EMORY, all such approved
patent costs. If CBT fails to promptly reimburse EMORY within sixty (60) days
after receipt of invoice from EMORY for approved patent costs, EMORY shall
provide written notice to CBT of such failure and if CBT does not pay the
undisputed amount of such invoice within thirty (30) days after such notice,
then CBT shall, upon EMORY's request, assign its interests in such patent
application or issued patent to EMORY. After such assignment, such patent
application or issued patent shall no longer be considered a Licensed Patent
and
EMORY shall be free, at its election, to abandon or maintain the prosecution
of
such patent application or issued patent or grant rights to such patent
application or issued patent to Third Parties.
ARTICLE
8. INFRINGEMENT
8.1 Enforcement
by CBT.
If
either CBT or EMORY becomes aware of a product made, used or sold in the
Licensed Territory, which it believes infringes a Valid Claim, the Party
obtaining such knowledge shall promptly advise the other Party of all relevant
facts and circumstances pertaining to the potential infringement. CBT shall
have
the first right to enforce any patent rights against such infringement, at
its
own expense. EMORY shall cooperate with CBT in such effort, at CBT's expense,
including being joined as a Party to such action, if necessary. Any damages
or
costs recovered in connection with any action filed by CBT hereunder which
exceed CBT's out-of-pocket costs and expenses of litigation, shall be deemed
to
be Net Sales from Sales of Licensed Products in the fiscal quarter in which
received by CBT, and Earned Royalties shall be payable by CBT to EMORY thereon
in accordance with the terms of this Agreement.
8.2 Backup
Enforcement Right by EMORY.
If CBT
fails, within one hundred twenty (120) days after receiving notice from EMORY
of
a potential infringement, or providing EMORY with notice of such infringement,
to either (a) terminate such infringement or (b) institute an action to prevent
continuation thereof and, thereafter to prosecute such action diligently, or
if
CBT notifies EMORY that it does not plan to terminate the infringement or
institute such action, then EMORY shall have the right to do so at its own
expense; provided however, that EMORY first consults with CBT and gives due
consideration to CBT’s reasons for not instituting actions to terminate or
otherwise prevent continuation of such infringement. If EMORY decides to pursue
such infringement, CBT shall cooperate with EMORY in such effort including
being
joined as a Party to such action if necessary. EMORY shall be entitled to retain
all damages or costs awarded to EMORY in such action.
15
ARTICLE
9. EXCLUSION
OF WARRANTIES
CBT
possesses the necessary expertise and skill in the technical areas pertaining
to
the Licensed Patents, Licensed Products and Licensed Technology to make, and
has
made, its own evaluation of the capabilities, safety, utility and commercial
application of the Licensed Patents, Licensed Products and Licensed Technology.
ACCORDINGLY, EMORY DOES NOT MAKE ANY REPRESENTATION OR WARRANTY OF ANY KIND
WITH
RESPECT TO THE LICENSED PATENTS, LICENSED TECHNOLOGY OR LICENSED PRODUCTS AND
EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE AND ANY OTHER IMPLIED WARRANTIES WITH RESPECT TO THE
CAPABILITIES, SAFETY, UTILITY, OR COMMERCIAL APPLICATION OF THE LICENSED
PATENTS, LICENSED TECHNOLOGY OR LICENSED PRODUCTS.
ARTICLE
10. INDEMNIFICATION
AND RELEASE FROM LIABILITY
10.1 No
Liability.
Neither
Party shall be liable to the other Party, its Affiliates, customers or
sublicensees for compensatory, special, incidental, indirect, consequential
or
exemplary damages resulting from the manufacture, testing, design, labeling,
use
or sale of Licensed Products.
10.2 Indemnification.
10.2.1 CBT
shall
defend, indemnify, and hold harmless the Indemnitees, from and against any
and
all Third Party claims, demands, losses, liabilities, expenses, or damages
(including investigative costs, court costs and attorneys' fees) (collectively
“Losses”) arising or alleged to arise by reason of, or in connection with, any
and all personal injury (including death) and property damage caused or
contributed to, in whole or in part, by the manufacture, testing, design, use,
Sale, or labeling of any Licensed Products by CBT, its Affiliates, contractors,
agents, or sublicensees, except to the extent of any Losses that arise from
the
negligence or intentional misconduct of Indemnitees. CBT’s obligations under
this Article 10 shall survive the expiration or termination of this Agreement
for any reason.
10.2.2 To
be
eligible to be indemnified hereunder, the Indemnitees shall provide CBT with
prompt notice of the claim giving rise to the indemnification obligation
pursuant to this Article 10 and the exclusive ability to defend (with the
reasonable cooperation of the Indemnitees) or settle any such claim;
provided
however,
that
CBT shall not enter into any settlement for damages other than monetary damages
without the Indemnitees’s written consent, such consent not to be unreasonably
withheld or delayed. The Indemnitees shall have the right to participate, at
their own expense and with counsel of their choice, in the defense of any claim
or suit that has been assumed by CBT.
10.3 Insurance.
Without
limiting CBT's indemnity obligations under the preceding paragraph, CBT shall,
prior to any clinical trial or Sale of any Licensed Product, cause to be in
force, an “occurrence based type” liability insurance policy which:
16
(a) insures
Indemnitees for all claims, damages, and actions mentioned in Section 10.2.1
of
this Agreement;
(b) includes
a contractual endorsement providing coverage for all liability which may be
incurred by Indemnitees in connection with this Agreement for which CBT has
an
indemnification obligation under Section 10.2; and
(c) requires
the insurance carrier to provide EMORY with no less than thirty (30) days'
written notice of any change in the terms or coverage of the policy or its
cancellation; and
(d) provides
Indemnitees product liability coverage in an amount no less than [***] per
occurrence for bodily injury and [***] per occurrence for property damage,
subject to a reasonable aggregate amount.
10.4 Occurrence
Based Coverage Not Available.
If CBT
is unable to obtain “occurrence based type” liability insurance, CBT shall
procure “claims made type” liability coverage to be effective prior to any
clinical trial or Sale of any Licensed Patent, and throughout the term of this
Agreement and “tail coverage”, extending at least ten (10) years after
termination of this Agreement. CBT shall notify EMORY prior to its first
clinical trial or First Commercial Sale of any Licensed Product, of all
insurance coverage available to CBT to meet CBT's obligations under Sections
10.2 and 10.3 of this Agreement and other assets available to CBT which may
be
used by CBT should the insurance coverage available to CBT not be sufficient
to
meet CBT’ obligations under Sections 10.2 and 10.3.
10.5 Notice
of Claims.
CBT
shall promptly notify EMORY of all claims involving the Indemnitees and shall
advise EMORY of the policy amounts that might be needed to defend and pay any
such claims.
ARTICLE
11. CONFIDENTIALITY
11.1 Treatment
of Confidential Information.
Except
as otherwise provided hereunder, during the term of this Agreement and for
a
period of five (5) years thereafter:
(a) CBT,
its
Affiliates and sublicensees shall retain in confidence and use only for purposes
of this Agreement, any written information and data supplied by EMORY to CBT
under this Agreement and marked as proprietary or confidential; and
(b) EMORY
shall retain in confidence and use only for purposes of this Agreement, any
written information and data supplied by CBT or on behalf of CBT to EMORY under
this Agreement and marked as proprietary or confidential.
For
purposes of this Agreement, all such information and data which a Party is
obligated to retain in confidence shall be called "Information."
11.2 Right
to Disclose.
To the
extent that it is reasonably necessary to fulfill its obligations or exercise
its rights under this Agreement, or any rights which survive termination or
expiration hereof, each Party may disclose Information to its Affiliates,
sublicensees, consultants, outside contractors, governmental regulatory
authorities and clinical investigators on condition that such entities or
persons agree:
17
(a) to
keep
the Information confidential for at least the same time periods and to the
same
extent as each Party is required to keep the Information
confidential;
(b) to
use
the Information only for such purposes as such Parties are authorized to use
the
Information.
Each
Party, its Affiliates or sublicensees may disclose Information to the government
or other regulatory authorities to the extent that such disclosure is necessary
for the prosecution and enforcement of patents, authorizations to conduct
clinical trials or commercialization of Licensed Products, provided that such
Party is otherwise entitled to engage in such activities under this
Agreement.
11.3 Release
from Restrictions.
The
obligation under Section 11.1 not to use or disclose Information shall not
apply
to any part of such Information that:
(a) is
or
becomes patented, published or otherwise part of the public domain, other than
by unauthorized acts of the Party obligated not to disclose such Information;
(for purposes of this Article 11 the “Receiving Party”), its Affiliates or
sublicensees in contravention of this Agreement;
(b) is
disclosed to the Receiving Party, its Affiliates or sublicensees by a Third
Party provided that such Information was not obtained by such Third Party
directly or indirectly from the other Party under this Agreement;
(c) prior
to
disclosure under this Agreement, was already in the possession of the Receiving
Party, its Affiliates or sublicensees, provided that such Information was not
obtained directly or indirectly from the other Party under this Agreement;
(d) results
from the research and development by the Receiving Party, its Affiliates or
sublicensees, independent of disclosures from the other Party of this Agreement,
provided that the persons developing such information have not had exposure
to
the Information received from the disclosing Party;
(e) is
required by law to be disclosed by the Receiving Party, provided that the
Receiving Party uses its best efforts to notify the other Party immediately
upon
learning of such requirement in order to give the other Party reasonable
opportunity to oppose such requirement; or
(f) CBT
and
EMORY agree in writing may be disclosed.
18
ARTICLE
12. TERM
AND TERMINATION
12.1 Term.
Unless
sooner terminated as otherwise provided in this Agreement, the term of this
Agreement shall commence on the Effective Date hereof and shall continue in
full
force and effect until the expiration of the last to expire Valid Claim. If
no
Valid Claim should issue within ten (10) years of the Effective Date of this
Agreement, this Agreement shall terminate on the tenth (10th) anniversary of
the
Effective Date. After termination hereunder, CBT shall retain the non-exclusive,
worldwide, perpetual right and license under the Licensed Technology to make,
have made, use, offer for sale, import and sell Licensed Products, with full
rights to sublicense.
12.2 Termination
by EMORY.
EMORY
shall have the right to terminate this Agreement pursuant to the provisions
below, provided that EMORY has given CBT the notice required in accordance
with
Section 12.3 and CBT has failed to cure the breach described in such notice:
(a) breach
by
CBT of a material term of the Agreement;
(b) the
institution of any proceeding by CBT under any bankruptcy, insolvency, or
moratorium law;
(c) any
assignment by CBT of substantially all of its assets for the benefit of
creditors;
(d) placement
of CBT's assets in the hands of a trustee or a receiver unless the receivership
or trust is dissolved within thirty (30) days thereafter and provided that
in
the case of in involuntary bankruptcy proceeding, which is contested by CBT,
such termination shall not become effective until the bankruptcy court of
jurisdiction has entered an order upholding the petition; or
(e) a
decision by CBT or CBT's licensee or assignee of rights under this Agreement
to
quit the business of developing or selling Licensed Products;
(f) breach
or
default by CBT of any material term of the Research Agreement, provided that
EMORY has given CBT the notice required in accordance with Section 12.2 of
the
Research Agreement and CBT has failed to cure that breach, and as a result,
EMORY terminates the Research Agreement.
12.3 Exercise.
EMORY
may exercise its right of termination pursuant to Section 12.2 by giving CBT
sixty (60) days' prior written notice (the “Written Notice”) of EMORY's election
to terminate. Such notice shall include the basis for such termination. Upon
the
expiration of such period, EMORY shall provide written notice of termination
to
CBT, effective upon receipt, unless CBT has cured the material breach or the
other basis for such proposed termination. Such notice and termination shall
not
prejudice EMORY's right to receive Earned Royalties accrued prior to
termination, or other sums due hereunder and shall not prejudice any cause
of
action or claim of EMORY accrued or to accrue on account of any breach or
default by CBT.
19
12.4 Termination
by CBT.
CBT
shall have the right to terminate this Agreement pursuant to the provisions
below, provided that CBT has given EMORY the notice required in accordance
with
Section 12.5:
(a) CBT
may
terminate this Agreement upon breach by EMORY of a material term of the
Agreement; or
(b) CBT
may
terminate this Agreement upon CBT's convenience and written notice of such
termination given to EMORY at least ninety (90) days prior to the date of such
termination.
12.5 Exercise.
CBT may
exercise its right of termination pursuant to Section 12.4(a), by giving EMORY
sixty (60) days' prior written notice of CBT's election to terminate and by
providing in its termination notice the basis for such termination. Upon the
expiration of the sixty (60) day period, CBT shall provide written notice of
termination to EMORY, effective upon receipt, unless EMORY has cured the breach.
Such notice of termination shall not prejudice any cause of action or claim
of
CBT accrued or to accrue on account of any breach or default by EMORY.
12.6 Effect
for Certain Terminations.
If this
Agreement is terminated as a result of CBT's uncured material breach pursuant
to
Section 12.2(a), or otherwise pursuant to the other provisions of Section 12.2,
then CBT shall return to EMORY, or at EMORY's direction, destroy all data,
writings and other documents and tangible materials supplied to CBT by EMORY.
12.7 Further
Rights to Emory.
If this
Agreement is terminated pursuant to Section 12.2 or 12.4(b), CBT shall further,
upon EMORY's request and with no need for additional consideration, grant to
EMORY an exclusive, worldwide, fully paid, perpetual license, with full rights
to sublicense, under all of CBT's rights in any Licensed Patents to practice
Licensed Patents. Further, at EMORY’s request, CBT agrees to negotiate in good
faith for an agreement, which shall be on commercially reasonable terms, under
which CBT would provide to EMORY and grant the rights to use full and complete
copies of all toxicity, efficacy, and other data generated by CBT or CBT's
Affiliates, (including by contractors or agents on their behalf) in the course
of CBT's efforts to develop Licensed Products or obtain governmental approval
for the Sale of Licensed Products, for use in connection with the development
and commercialization of Licensed Products. Under the terms of such agreement
(if entered into): (i) EMORY would be authorized to provide such data pertaining
to the Licensed Patents and Licensed Technology to any Third Party with a bona
fide interest in licensing such technology, (ii) such data would be provided
on
a confidential basis, provided, however, that if such Third Party concludes
a
license with EMORY, such Third Party would be free to use such data for all
purposes, including to obtain government approvals to sell products.
12.8 Failure
to Enforce.
The
failure of either Party, at any time, or for any period of time, to enforce
any
of the provisions of this Agreement, shall not be construed as a waiver of
such
provisions or as a waiver of the right of either Party’s thereafter to enforce
each and every such provision of this Agreement.
20
ARTICLE
13. ASSIGNMENT
CBT
may
grant, transfer, convey, or otherwise assign any or all of its rights and
obligations under this Agreement in conjunction with a merger, acquisition
or
the transfer of all, or substantially all, of the business interests of CBT
to
which this Agreement relates. EMORY's written consent, which shall not be
unreasonably withheld, shall be required prior to any other assignment of CBT's
rights or obligations under this Agreement.
ARTICLE
14. MISCELLANEOUS
14.1 Dispute
Resolution.
EMORY
and CBT shall initially attempt in good faith to resolve any significant
controversy, claim, or dispute arising out of or relating to this Agreement
or
significant breach thereof (hereinafter referred to as a “Dispute”) through at
least one face-to-face negotiation between senior executives of the rank of
at
least Senior Vice President, or in the case of EMORY and/or CBT, an officer
of
EMORY and/or CBT of equivalent rank and with power to bind each of EMORY and/or
CBT, at the place of business of the Party of whom the meeting is first
requested, or in the case of a meeting requested by EMORY and CBT, at EMORY.
If
the Dispute is not resolved within thirty (30) business days (or such other
period of time mutually agreed upon by the parties) of commencing such
face-to-face negotiations, or if the Party against which a claim has been
asserted refuses to attend such negotiations or does not otherwise participate
in such negotiations within thirty (30) business days (or such other period
of
time mutually agreed upon by the Parties) from the date of notice of a Dispute,
then the Parties agree to submit the Dispute to arbitration conducted under
the
auspices of the American Arbitration Association pursuant to that organization’s
rules for commercial arbitration. Any hearings shall be held in Atlanta,
Georgia.
14.2 Export
Controls.
CBT
acknowledges that EMORY is subject to United States laws and regulations
controlling the export of technical data, biological materials, chemical
compositions and other commodities and that EMORY's obligations under this
Agreement are contingent upon compliance with applicable United States export
laws and regulations. The transfer of technical data, biological materials,
chemical compositions and commodities may require a license from the cognizant
agency of the United States government or written assurances by CBT that CBT
shall not export data or commodities to certain foreign countries without the
prior approval of certain United States agencies. EMORY neither represents
that
an export license shall not be required nor that, if required, such export
license shall issue.
14.3 Legal
Compliance.
CBT
shall comply with all laws and regulations relating to its manufacture, use,
Sale, labeling or distribution of Licensed Products and shall not take any
action which would cause EMORY or CBT to violate any applicable laws or
regulations.
14.4 Independent
Contractor.
CBT's
relationship to EMORY shall be that of a licensee only. CBT shall not be the
agent of EMORY and shall have no authority to act for, or on behalf of, EMORY
in
any matter. Persons retained by CBT as employees or agents shall not, by reason
thereof, be deemed to be employees or agents of EMORY.
14.5 Patent
Marking.
CBT
shall xxxx Licensed Products Sold in the United States with the relevant United
States patent numbers. Licensed Products manufactured or Sold in other countries
shall be marked in compliance with the intellectual property laws in force
in
such foreign countries.
21
14.6 Use
of
Names.
CBT
shall obtain the prior written approval of EMORY prior to making use of the
name
of any EMORY employee or the name EMORY for any commercial purpose, except as
required to comply with law, regulation or court order.
14.7 Place
of Execution.
This
Agreement and any subsequent modifications or amendments hereto shall be deemed
to have been executed in the State of Georgia, U.S.A. This Agreement shall
not
become effective or binding upon EMORY until signed by its Assistant Vice
President and Director, Office of Technology Transfer in the State of Georgia,
U.S.A.
14.8 Governing
Law.
This
Agreement and all amendments, modifications, alterations, or supplements hereto,
and the rights of the parties hereunder, shall be construed under and governed
by the laws of the State of Georgia and the United States of America.
14.9 Entire
Agreement.
This
Agreement and the Appendices attached hereto and incorporated herein constitutes
the entire agreement between EMORY and CBT with respect to the subject matter
hereof and shall not be modified, amended or terminated, except as herein
provided or except by another agreement in writing executed by the parties
hereto.
14.10 Survival.
Articles 10 and 11 shall survive termination of this Agreement for any reason.
Sections 12.6 and 12.7 shall survive termination pursuant to Section 12.2 or
Section 12.4(b), as applicable.
14.11 Severability.
All
rights and restrictions contained herein may be exercised and shall be
applicable and binding only to the extent that they do not violate any
applicable laws and are intended to be limited to the extent necessary so that
they will not render this Agreement illegal, invalid or unenforceable. If any
provision or portion of any provision of this Agreement, not essential to the
commercial purpose of this Agreement, shall be held to be illegal, invalid
or
unenforceable by a court of competent jurisdiction, it is the intention of
the
parties that the remaining provisions or portions thereof shall constitute
their
agreement with respect to the subject matter hereof, and all such remaining
provisions, or portions thereof, shall remain in full force and effect. To
the
extent legally permissible, any illegal, invalid or unenforceable provision
of
this Agreement shall be replaced by a valid provision which shall implement
the
commercial purpose of the illegal, invalid, or unenforceable provision. In
the
event that any provision essential to the commercial purpose of this Agreement
is held to be illegal, invalid or unenforceable and cannot be replaced by a
valid provision which will implement the commercial purpose of this Agreement,
the Party who is the beneficiary of such illegal, invalid or unenforceable
provision has the right to terminate this Agreement upon written notice,
effective upon receipt, to the other Party.
14.12 Force
Majeure.
Any
delays in, or failure of performance of any Party to this Agreement, shall
not
constitute a default hereunder, or give rise to any claim for damages, if and
to
the extent caused by occurrences beyond the control of the Party affected,
including, but not limited to, acts of God, strikes or other concerted acts
of
workmen, civil disturbances, fires, floods, explosions, riots, war, rebellion,
sabotage, acts of governmental authority or failure of governmental authority
to
issue licenses or approvals which may be required.
22
14.13 Counterparts.
This
Agreement may be executed in one or more counterparts, each of which shall
be
deemed an original, but all of which shall constitute one and the same
instrument.
ARTICLE
15. NOTICES
All
notices, statements, and reports required to be given by one Party to the other
shall be in writing and shall be deemed to have been given upon delivery in
person or upon the expiration of five (5) days after deposit in a lawful mail
depository in the country of residence of the Party giving the notice,
registered or certified postage prepaid, and addressed as follows:
To
EMORY:
Office
of
Technology Transfer
Attn:
Director
Xxxxx
Xxxxxxxxxx
Xxxxx
Xxxxxxx Xxxx., Xxxxx 000
0000
X.
Xxxxxxx Xxxx
Xxxxxxx,
Xxxxxxx 00000
To
CBT:
Attn:
Chief Executive Officer
00000
Xxxxxxxx Xxxx.
Xxxxx
000
Xxx
Xxxxxxx, Xxxxxxxxxx 00000
Either
Party hereto may change the address to which notices to such Party are to be
sent by giving notice to the other Party at the address and in the manner
provided above. Any notice may be given, in addition to the manner set forth
above, by telex, facsimile or cable, provided that the Party giving such notice
obtains acknowledgement by telex, facsimile or cable that such notice has been
received by the Party to be notified. Notice made in this manner shall be deemed
to have been given when such acknowledgement has been transmitted.
[Signature
page follows]
23
IN
WITNESS WHEREOF,
EMORY
and CBT have caused this Agreement to be signed, under seal, by their duly
authorized representatives, as of the day and year indicated below.
EMORY
UNIVERSITY:
|
|||
By:
/s/ Xxxx X. Xxxxxx
|
By:
/s/ Xxxx X. Xxxxxxxx
|
||
Name:
Xxxx X. Xxxxxx, Ph.D.
|
Name:
Xxxx X. Xxxxxxxx
|
||
Title:
Asistant Vice President and Director Office
of Technology Transfer
|
Title:
Chief Executive Officer
|
||
Date:
2-25-2004
|
Date:
3-9-2004
|
24
APPENDIX
“A”
LICENSED
PATENTS
Licensed
Patents shall include, but not be limited to, the following issued patents
and
pending patent applications:
1. |
United
States Patent No.: 6,376,516, titled: “Noscapine Derivatives, Useful as
Anticancer gents”;
|
2.
|
International
Patent Application No.: PCT/US98/14979, titled: “Noscapine Derivatives,
Useful as Anticancer Agents”;
|
3.
|
United
States Patent Application No.: 09/558,042, titled: “Noscapine Derivatives
as Adjuvant Compositions and Methods of Use
Thereof”;
|
4:
|
United
States Patent Application No.: 10/288,442, titled: “Noscapine Derivatives
as Adjuvant Compositions and Methods of Use
Thereof”;
|
5.
|
International
Patent Application No.: PCT/US00/11082, titled: “Noscapine Derivatives as
Adjuvant Compositions and Methods of Use
Thereof”;
|
6.
|
Canadian
Patent Application No.: 2,370,643, titled: “Noscapine Derivatives as
Adjuvant Compositions and Methods of Use
Thereof”;
|
7.
|
European
Patent Application No.: 00928370.6, titled: “Noscapine Derivatives as
Adjuvant Compositions and Methods of Use Thereof”;
and
|
8.
|
United
States Patent No.: 6,673,814, titled: “Delivery Systems and Methods for
Noscopine and Noscapine Derivatives, Useful as Anticancer
Agents”.
|