EXCLUSIVE LICENSE AGREEMENT
(UMass IP)
This Exclusive License Agreement
(“Agreement”) is made and entered into this 14
th day of May, 2004 (the “Effective
Date”), by and between Advanced Cell Technology, Inc., a
Delaware corporation with offices located at One Innovation Drive,
Worcester, Massachusetts 01605 (“LICENSOR”), and PacGen
Cellco, LLC, a California limited liability company with offices
located at 157 Surfview Drive, Pacific Palisades, CA 90272
(“LICENSEE”) (LICENSOR and LICENSEE sometimes
hereinafter referred to individually as a “Party” and
collectively as the “Parties”).
WHEREAS, LICENSOR owns or has licensed with
sublicenseable interest the PATENT RIGHTS (as defined below) and
KNOW-HOW (as defined below); and
WHEREAS, LICENSEE desires to obtain an exclusive
worldwide license under LICENSOR’s rights in such technology
in the FIELD; and
WHEREAS, LICENSOR is willing to grant such a
license to LICENSEE upon the terms and conditions set forth below;
and
NOW, THEREFORE, in consideration of the premises
and the mutual covenants contained herein, the Parties hereto agree
as follows:
For the purposes of this Agreement, the
following words and phrases shall have the following
meanings:
1.1 “ACT ANIMAL CELL LINES” shall
mean cell lines of non-human animal origin developed by ACT. These
cell lines shall include but not be limited to murine and primate
embryonic stem cells derived through parthenogenesis, nuclear
transfer or otherwise isolated from fertilized blastocysts
including the relevant information LICENSOR possesses associated
with these cells, including but not limited to information on the
cell’s karyotype, gene expression and growth
characteristics.
1.2 “AFFILIATE” shall mean, with
respect to any PERSON, any other PERSON which directly or
indirectly controls, is controlled by, or is under common control
with, such PERSON. A PERSON shall be regarded as in control of
another PERSON if it owns, or directly or indirectly controls, at
least fifty percent (50%) of the voting stock or other ownership
interest of the other PERSON, or if it directly or indirectly
possesses the power to direct or cause the direction of the
management and policies of the other PERSON by any means
whatsoever.
1.3 “FIELD” shall mean (1) the
research, development, manufacture and selling of human and
non-human animal cells and ACT ANIMAL CELL LINES for commercial
research use, including small molecule and other drug testing and
basic research, (2) the manufacture and selling of human cells
for therapeutic and diagnostic use in the treatment of human
(a) diabetes and (b) liver diseases, and (3) the use of
ACT ANIMAL CELL LINES in the process of manufacturing and selling
human cells for therapeutic and diagnostic use in the treatment of
human (a) diabetes and (b) liver diseases but where the
final marketed product does not include ACT ANIMAL CELL LINES (i.e.
does not include the field of xenotransplantation); but FIELD shall
exclude applications involving the use of cells in the treatment of
tumors where the primary use of the cells is the destruction or
reduction of tumors and does not involve regeneration of tissue or
organ function.
1.4 “KNOW-HOW” means all
compositions of matter, techniques and data and other know-how and
technical information including inventions (whether or not
patentable), improvements and developments, practices, methods,
concepts, trade secrets, documents, computer data, computer code,
apparatus, clinical and regulatory strategies, test data,
analytical and quality control data, formulation, manufacturing,
patent data or descriptions, development information, drawings,
specifications, designs, plans, proposals and technical data and
manuals and all other proprietary information that is owned or
controlled by LICENSOR as of the Effective Date that relates to
cloning technology or to any of the subject matter described in or
claimed by the PATENT RIGHTS and is relevant to the FIELD. By way
of illustration, but not in limitation, KNOW-HOW shall include
commercial rights to any existing potential research products,
including reagents, developed by LICENSOR in the course of its
in-house research. An example of this is the proprietary culture
medium developed by LICENSOR in the course of the development of
LICENSOR’s proprietary ooplasmic transfer
technology.
1.5 “LICENSED PROCESS” means any
process or method, the research, development, use, practice, sale,
offer for sale, import or export of which cannot be performed
without (i) infringing, in whole or in part, one or more VALID
CLAIMS of the PATENT RIGHTS, or (ii) using or incorporating
some portion of the LICENSED TECHNOLOGY.
1.6 “LICENSED PRODUCT” means any
product that cannot be developed, manufactured, used, imported,
exported, or sold without (i) infringing, in whole or in part,
one or more VALID CLAIMS of the PATENT RIGHTS, or (ii) using
or incorporating some portion of the LICENSED
TECHNOLOGY.
1.7 “LICENSED SERVICES” means any
service, the developing, using, performing, selling, offering for
sale, importing or exporting of which by LICENSEE would, but for
the licenses granted to LICENSEE in Article 2 of this
Agreement, infringe a VALID CLAIM of the PATENT RIGHTS in the
country in which any such service is so developed, used, performed,
sold, offered for sale, imported or exported by
LICENSEE.
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1.8 “LICENSED TECHNOLOGY” shall
mean, collectively, the licensed PATENT RIGHTS and licensed
KNOW-HOW.
1.9 “NET SALES” shall mean the
amount billed or invoiced by LICENSEE for the sale or provision of
LICENSED PRODUCTS or LICENSED PROCESSES or LICENSED SERVICES
less:
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a)
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discounts, credits, allowances and
rebates allowed;
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b)
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sales, tariff duties, use and other
taxes or governmental charges directly imposed with reference to
particular sales;
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c)
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special packaging, transportation
and insurance costs incurred and directly related to the sale of
LICENSED PRODUCTS;
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d)
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amounts allowed or credited on
returns; and
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e)
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uncollected accounts.
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1.10 “NEURONAL & HEART FIELD
OPTION” means an option described in
Section 15.18 hereof for LICENSEE to negotiate terms
for license to the LICENSED TECHNOLOGY for the field of diseases
related to heart or neurodegenerative diseases
1.11 “PATENT RIGHTS” means
(a) the patent applications and patents identified on
Exhibit A attached hereto and any patents that issue on said
applications and (b) any divisions, continuations, extensions,
reissues or reexaminations of any of the patents identified in the
foregoing clause (a). The Parties agree that Exhibit A
may be revised from time to time after the Effective Date to
reflect changes thereto that result from the course of patent
prosecution.
1.12 “PERSON” shall mean an
individual, corporation, partnership, limited liability company,
trust, business trust, association, joint stock company, joint
venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity
not specifically listed herein.
1.13
“TERM” has the meaning set forth in
Section 9.1 .
1.14
“TERRITORY” means the entire world.
1.15 “1996 UMASS LICENSE” means the
Exclusive License Agreement between LICENSOR and the University of
Massachusetts (the “University”), dated April 16,
1996, as amended by the Amendment to Exclusive License Agreement
dated September 1, 1999, the Second Amendment to Exclusive
License Agreement dated May 31, 2000, and the Third Amendment
to Exclusive License Agreement dated September 19,
2002.
1.16 “2003 UMASS LICENSE” means the
Exclusive License Agreement between LICENSOR and the University
dated April 1, 2003.
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1.17
“UMASS LICENSES” means the 1996 UMASS LICENSE and the
2003 UMASS LICENSE.
1.18 “VALID CLAIM” means a claim of
any issued and unexpired patent within the PATENT RIGHTS which has
not lapsed, become abandoned or been held permanently revoked,
invalid, or unenforceable by a decision of a court or
administrative or government authority or agency of competent
jurisdiction from which no appeal can be or has been taken within
the time allowed for such appeal, or a claim of a pending patent
application included within the Licensed PATENT RIGHTS, which claim
was filed in good faith and has not been abandoned or finally
disallowed without the possibility of appeal or refiling of such
application.
Additional
terms may be defined throughout this Agreement.
2.1 LICENSOR hereby grants to LICENSEE, and
LICENSEE hereby accepts, subject to the terms and conditions
hereof:
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a)
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A
royalty bearing, exclusive license in the TERRITORY in the FIELD
and under the LICENSED TECHNOLOGY to (a) research, develop,
make, have made, use, sell, offer for sale, import and export
LICENSED PRODUCTS, (b) research, develop, use, practice, sell,
offer for sale, import and export LICENSED PROCESSES and
(c) develop, use, perform, sell, offer for sale, import and
export LICENSED SERVICES. By way of example, but not in limitation,
LICENSEE shall have the right to use LICENSED TECHNOLOGY within the
FIELD for the following purposes: to produce mammalian embryonic
stem (ES) cells and to produce from those mammalian embryonic
cells, differentiated cells for human therapeutic purposes or for
commercial research purposes, including drug screening assays, and
to produce pluripotent cells including ES cells, differentiated
human cells for human diagnostic and therapeutic purposes and/or
for commercial research purposes, including drug screening
assays.
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b)
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A
royalty bearing, twelve (12) month exclusive license in the
TERRITORY in the FIELD to expand in culture, prepare for sale,
sell, offer for sale, import and export ACT ANIMAL CELL LINES. The
twelve-month term of exclusivity granted to LICENSEE shall begin
upon the date of the first sale of the ACT ANIMAL CELL LINES.
LICENSOR and LICENSEE agree that after the twelve-month period of
exclusivity has passed, LICENSOR AND LICENSEE shall negotiate in
good faith to establish reasonable minimum sales goals over
reasonable evaluation periods in order to maintain LICENSEE’S
exclusive rights hereunder. If LICENSOR fails to meet the minimum
sales goals then LICENSEE’s exclusive rights shall revert to
nonexclusive rights.
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2.2 LICENSEE shall have the right to sublicense
the rights granted in Section 2.1 to third parties in
connection with contracting with such third parties to
(a) provide LICENSED PRODUCT marketing and distribution
services to LICENSEE on behalf of LICENSEE, (b) provide
LICENSED SERVICES marketing services to LICENSEE on behalf of
LICENSEE or (c) manufacture for LICENSEE LICENSED PRODUCTS for
sale by LICENSEE or a third party pursuant to the foregoing clause
(a).
2.3 LICENSEE shall have the right to grant
sublicenses beyond the scope of those described in
Section 2.2 (a), (b), and (c) without the express prior
written approval of LICENSOR, however, LICENSOR shall be given at
least 30 days prior written notice of an intent to sublicense
and at least 30 days to comment on the text of the proposed
sublicense agreement. In any case, such sublicenses shall meet the
following conditions:
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a)
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the
sublicensee shall not have the right to grant further
sublicenses;
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b)
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the
sublicense shall not be assignable without prior written approval
by LICENSEE and LICENSOR; and
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c)
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the
sublicense shall include fair consideration consistent with
industry norms for upfront fees and royalties.
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2.4 Within thirty (30) business days of the
Effective Date, LICENSOR shall provide and transfer to LICENSEE, in
writing where practicable, all information and data relating to the
LICENSED TECHNOLOGY and the ACT ANIMAL CELL LINES as may be
reasonably necessary and requested to allow LICENSEE to exploit the
licenses granted hereunder. LICENSOR shall work with LICENSEE in
good faith to provide the necessary training for up to a total of
60 days, at LICENSOR’s facilities, necessary to allow
LICENSEE to utilize the LICENSED TECHNOLOGY and expand the ACT
ANIMAL CELL LINES. LICENSEE shall pay to LICENSOR all reasonable
and customary expenses other than normal operating expenses
incurred by LICENSOR in providing such training and technology
transfer, including but not limited to fees incurred to request
documents from patent counsel or the United States Patent and
Trademark Office.
2.5 LICENSEE acknowledges that a portion of the
PATENT RIGHTS licensed to LICENSEE hereunder is owned by the
University and is licensed to LICENSOR under the UMASS LICENSES. In
the event the UMASS LICENSES expire or are terminated for any
reason pursuant to the provisions of the UMASS LICENSES or
otherwise, the terms of the letter agreement attached hereto as
Exhibit B between LICENSOR, LICENSEE and the University
shall apply to this Agreement.
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2.6 Notwithstanding anything stated herein,
nothing in this Agreement shall be construed as preventing LICENSOR
from practicing the LICENSED TECHNOLOGY within the FIELD for
non-commercial in-house research purposes. In the event that
LICENSOR requests that LICENSEE deliver to LICENSOR the LICENSED
TECHNOLOGY or LICENSED PRODUCTS in the FIELD for research purposes,
LICENSEE shall make the LICENSED TECHNOLOGY or LICENSED PRODUCTS
available to LICENSOR on commercially reasonable terms. In the
event LICENSOR requires the use of collaborators in its research,
LICENSEE shall also make such LICENSED TECHNOLOGY OR LICENSED
PRODUCTS available to such collaborator if LICENSEE, in its sole
but reasonable discretion is satisfied that providing such items to
a collaborator will not endanger its exclusive commercial control
of such items or result in their use by a competitor.
ARTICLE 3 — LICENSEE
OBLIGATIONS
RELATING TO COMMERCIALIZATION
3.1 LICENSEE shall use its commercially
reasonable and diligent efforts to bring one or more LICENSED
PRODUCTS, LICENSED PROCESSES or LICENSED SERVICES to market through
an active and diligent program for exploitation of the PATENT
RIGHTS and to continue active, diligent marketing efforts for one
or more LICENSED PRODUCTS, LICENSED PROCESSES or LICENSED SERVICES
throughout the TERM of this Agreement.
3.2 LICENSEE shall maintain minimum R&D
requirements to maintain exclusivity under this Agreement .
Commencing 30 months following the Effective Date hereof and
until the launch of the first human cell-based therapeutic product,
LICENSEE shall be required to invest a minimum of $400,000 per year
in research and development of the FIELD covered by this Agreement
or other agreements with LICENSOR affecting the FIELD in order to
maintain the exclusive license rights granted hereunder. In the
event LICENSEE fails to perform this minimum expenditure in R&D
in the FIELD during the course of a calendar year during the
above-mentioned period, the license under this Agreement shall
become nonexclusive and such minimum expenditure for research and
development shall be reduced to $200,000 per year.
3.3 LICENSEE shall maintain complete and
accurate records of LICENSED PRODUCTS, LICENSED PROCESSES, LICENSED
SERVICES and ACT ANIMAL CELL LINES that are made, used, sold or
performed by LICENSEE under this Agreement. Not later than April
1 st
of each year following the Effective
Date, LICENSEE shall furnish LICENSOR with a summary report on the
progress of its efforts during the prior year to develop and
commercialize LICENSED PRODUCTS, LICENSED PROCESSES, LICENSED
SERVICES or ACT ANIMAL CELL LINES, including without limitation
research and development efforts, efforts to obtain regulatory
approval, marketing efforts (including LICENSED PRODUCTS, LICENSED
PROCESSES, LICENSED SERVICES and ACT ANIMAL CELL LINES made, used,
sold or performed) and sales figures, provided that such reports
shall be deemed Confidential Information (as defined in
Section 10.1 herein) subject to the provisions of
Article 10 of this Agreement.
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3.4 In the event that LICENSOR determines that
LICENSEE has not fulfilled its obligations under this
Article 3 , LICENSOR shall furnish LICENSEE with
written notice of such determination. Within thirty (30) days
after receipt of such notice, LICENSEE shall (i) fulfill the
relevant obligation, (ii) negotiate with LICENSOR a mutually
acceptable schedule of revised obligations, or (3) if LICENSEE
disputes the alleged failure to fulfill its obligations, it shall
promptly seek appropriate judicial determination of the matter and
diligently pursue such action to a final determination with all
appropriate speed; failing which, LICENSOR shall have the right,
immediately upon written notice to LICENSEE, to terminate this
Agreement as provided in Section 9.2 hereof.
ARTICLE 4 —
CONSIDERATION
4.1 Initial Payment . In partial
consideration of the license granted to LICENSEE from LICENSOR in
Article 2 of this Agreement, LICENSEE agrees to pay as
a “License Fee” to LICENSOR $150,000 in a convertible
promissory note in the form attached hereto as
Exhibit C.
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a)
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In
partial consideration of the license in the FIELD granted by
LICENSOR to LICENSEE in Article 2 of this Agreement,
LICENSEE agrees to pay to LICENSOR an earned royalty equal to the
following percentages of the NET SALES in the FIELD made, used,
sold, imported, exported or performed by LICENSEE in the
TERRITORY.
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(i) 6% on
therapeutics,
(ii) 3% on diagnostics, and
(iii) 10% on commercial research use of LICENSED TECHNOLOGY in
all FIELDS except (iv) below and
(iv) 12% on ACT ANIMAL CELL LINES
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b)
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No
multiple royalties shall be payable because any LICENSED PRODUCT,
LICENSED PROCESS or LICENSED SERVICE in the FIELD, its manufacture,
use, lease, sale or performance are or shall be covered by more
than one patent or patent application within the PATENT
RIGHTS.
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c)
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The
obligation of LICENSEE to pay royalties or Sublicense Income (as
defined in Section 4.5 herein) hereunder shall
terminate for each country in the TERRITORY concurrently with the
expiration or termination of the last applicable VALID CLAIM within
the PATENT RIGHTS in such country in which the LICENSED PRODUCT,
LICENSED PROCESS or LICENSED SERVICE is, (as applicable), used,
practiced, performed, sold, offered for sale, imported, exported or
manufactured.
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4.3 Minimum Royalties . Within 2
business days from the Effective Date hereof, LICENSEE shall pay to
LICENSOR a minimum royalty fee of $100,000 in cash or by wire
transfer. In addition, commencing 12 months following the
Effective Date, LICENSEE shall pay to LICENSOR additional minimum
royalty fees equal to the difference between total Royalties
actually paid in the preceding 12 months and the following
minimum amounts:
(i) At
12 months, $10,000
(ii) At 24 months, $20,000
(iii) At 36 months, $30,000
(iv) Annually thereafter, $40,000.
4.4 Stacking Royalties . With the
exception of minimum royalties due to LICENSOR, if LICENSEE, its
Affiliates or sublicensees are required to pay royalties relating
to any additional intellectual property from LICENSOR in order to
exercise its rights hereunder to make, have made, use or sell any
Product, then LICENSEE shall have the right to credit a pro-rated
portion of such royalty payments against the royalties owing to
LICENSOR under Section 4.2 of this Agreement with
respect to sales of such Product such that in no event shall the
total of royalty payments that are due to LICENSOR in such royalty
period exceed the royalty payments payable under Subsection
4.2(a) above. Prorations shall be made in the same manner as
specified for combination products under Section 4.9
below.
4.5 Sublicense Income . LICENSEE shall
pay to LICENSOR a total of Thirty Three percent (33%) of all
Sublicense Income. “Sublicense Income” means
consideration that LICENSEE receives for the sublicense of rights
that are granted LICENSEE under Article 2 , including
without limitation license fees, milestone payments, equity
payments, up front fees, success fees, and license maintenance
fees.
4.6 Stacking Sublicense Income. The fees
payable on Sublicense Income under Section 4.5 above
shall be in addition to any royalties specified elsewhere in this
Article 4 , but if LICENSEE is obligated to pay or has
paid to LICENSOR similar fees on Sublicense Income under another
license agreement with respect to the FIELD, then LICENSEE shall
have the right to pro-rate such fees against the fees owing to
LICENSOR under this Agreement such that in no event shall the total
of fees due from LICENSEE, as a result of Sublicense Income, to
LICENSOR exceed the payments payable under Section 4.5
. Pro-rating of payments shall be made in the ratio of the minimum
royalties payable under this Agreement to the minimum royalties
payable under any other agreement covered hereby under which fees
on Sublicense Income are owed.
4.7 Milestone Payments. Upon the launch
of a commercial therapeutic product based on the LICENSED
TECHNOLOGY, LICENSEE shall pay additional Milestone Payments
totaling $1,750,000 on the following schedule:
$250,000 within
30 days following the launch of the first commercial
Product;
$500,000 upon reaching $5,000,000 in sales from one or both Product
Fields;
$1,000,000 upon reaching $10,000,000 in sales from one or both
Product Fields.
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4.8 Stacking Milestone Payments. The
milestone payments shall be in addition to any royalties specified
elsewhere in this Article 4 , but shall not apply to
diagnostic, commercial research, or any other non-therapeutic uses.
If LICENSEE is obligated to pay or has paid to LICENSOR similar
Milestone Payments under another license agreement with respect to
the FIELD, then LICENSEE shall have the right to pro-rate such
Milestone Payments against the Milestone Payments owing to LICENSOR
under this Agreement such that in no event shall the total of all
Milestone Payments due from LICENSEE to LICENSOR exceed the amounts
stated in Section 4.7 . Pro-rating of payments shall be
made in the ratio of the minimum royalties payable under this
Agreement to the minimum royalties payable under any other
agreement covered hereby under which Milestone Payments are
owed.
4.9 Combination Product . In the event a
Product is sold in a combination product with other devices or
biologically active components, NET SALES, for purposes of royalty
payments on the combination product, shall be calculated by
multiplying the NET SALES of that combination by the fraction A/B,
where A is the gross selling price of the Product sold separately
and B is the gross selling price of the combination product. In the
event that no such separate sales are made by LICENSEE, its
Affiliates or permitted sublicensees, NET SALES for royalty
determination shall be calculated by multiplying NET SALES of the
combination by the fraction C/(C+D), where C is the fully allocated
cost of the Product and D is the fully allocated cost of such other
biologically active components.
4.10 Payments in U.S. Currency . All
payments due under this Agreement shall be paid in cash to LICENSOR
and all payments shall be made in United States currency.
Conversion of foreign currency to U.S. dollars shall be made at the
conversion rate reported in The Wall Street Journal on the
last working day of the calendar quarter to which the payment
relates.
4.11 Taxes . Subject to the limits of
Section 1.9 hereof, all payments due hereunder shall be
paid in full without deduction of taxes or other fees which may be
imposed by any government and which shall be paid by LICENSEE;
provided, however, that any withholding tax required to be withheld
by LICENSEE on royalty payments under the laws of any country in
the TERRITORY on behalf of LICENSOR will be timely paid by LICENSEE
to the appropriate governmental authority, and LICENSEE will
furnish LICENSOR with proof of payment of such tax. Any such tax
actually withheld may be deducted from royalty payments due to
LICENSOR under this Agreement. If at any time legal restrictions
prevent the prompt remittance of part or all of any payments owed
by LICENSEE to LICENSOR hereunder with respect to any country in
the TERRITORY, payment shall be made through any lawful means or
methods that may be available, and as LICENSEE shall reasonably
determine is appropriate.
4.12 Overdue Payments . Any payments to
be made by LICENSEE hereunder that are not paid on or before the
date such payments are due under this Agreement shall bear
interest, to the extent permitted by law, at two percentage points
above the Prime Rate of interest as reported in The Wall Street
Journal on the date payment is due, with interest calculated
based on the number of days that payment is delinquent.
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ARTICLE 5 — REPORTS AND
RECORDS
5.1 LICENSEE shall keep full, true and accurate
books of account containing all particulars that may be necessary
for the purpose of showing the amounts payable to LICENSOR
hereunder and to enable the reports provided under
Section 5.2 to be verified. Said books of account shall
be kept at LICENSEE’s principal place of business. Said books
and the supporting data shall be open upon reasonable advance
notice (but not less than five (5) business days notice and no
more frequently than once per calendar year) for three
(3) years following the end of the calendar year to which they
pertain, to the inspection of LICENSOR or its agents for the
purpose of verifying LICENSEE’s royalty and Sublicense Income
statement or compliance in other respects with this Agreement. If
any such audit determines an error in any royalty or Sublicense
Income payment, LICENSEE shall pay to LICENSOR, within thirty
(30) days of the discovery of the error, (a) all
deficiencies in royalty or Sublicense Income payments,
(b) interest on such deficiencies from the date such royalty
or Sublicense Income payment was due until the date paid at the
rate set forth in Section 4.12 above, and (c) if
such error is in excess of five percent (5%) of any royalty or
Sublicense Income payment, the cost of the audit. In all other
cases, the costs of the audit shall be paid for by LICENSOR. All
information disclosed pursuant to an audit shall be treated as
Confidential Information (as defined in Section 10.1
herein) and shall not be disclosed to any third party or used for
any purpose other than to determine the correctness of
LICENSEE’s royalty and Sublicense Income statement or
compliance in other respects with this Agreement.
5.2 After the first commercial sale of a
LICENSED PRODUCT, LICENSED PROCESS, LICENSED SERVICES, or ACT
ANIMAL CELL LINES, LICENSEE, within forty-five (45) days after
March 31, June 30, September 30 and December 31
of each year, shall deliver to LICENSOR a true and accurate report,
giving such particulars of the business conducted by LICENSEE and
its permitted sublicensees during the preceding three-month period
under this Agreement as shall be pertinent to a royalty and
Sublicense Income accounting hereunder. Without limiting the
generality of the foregoing, these reports shall include at least
the following:
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a)
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the
number of LICENSED PRODUCTS and ACT ANIMAL CELL LINES manufactured
and sold by LICENSEE and all sublicensees;
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b)
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total billings and the amounts
actually received for LICENSED PRODUCTS and ACT ANIMAL CELL LINES
sold by LICENSEE and all sublicensees;
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c)
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an
accounting for all LICENSED PROCESSES or LICENSED SERVICES used in
the provision of services to others or sold by LICENSEE;
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d)
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the
deductions applicable as provided in Section 1.9 ;
and
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e)
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the
names and addresses of all parties making LICENSED PRODUCTS on
behalf of LICENSEE.
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The reports shall provide the above-identified
information by product, process, or service type.
5.3 With each such report submitted, LICENSEE
shall pay to LICENSOR the royalties and Sublicense Income due and
payable for such three-month period. If no royalties or Sublicense
Income shall be due, LICENSEE shall so report.
ARTICLE 6 — PATENT
PROSECUTION
6.1 LICENSOR shall be solely responsible for the
continued prosecution of pending patent applications included in
the PATENT RIGHTS and the issuance of such applications after
allowance. The prosecution, filing and maintenance of all patents
and applications shall be the primary responsibility of LICENSOR.
LICENSEE agrees to cooperate fully with LICENSOR, as requested by
LICENSOR and at LICENSOR’s expense, in the preparation,
filing, prosecution, and maintenance of the patent applications and
patents included in the PATENT RIGHTS. With respect to Australia,
Canada, Europe, Mexico, Japan and Israel, LICENSEE shall pay to
LICENSOR on or before the due date one half (1/2) of any future
annuity and maintenance fees with respect to UMA 99-19, provided
LICENSOR notifies LICENSEE of the amount of such payments due at
least 30 days prior to their due date.
6.2 Licensors will not allow any patent or
patent application within the PATENT RIGHTS to become expired or
abandoned without giving (a) prior written notice to LICENSOR
of such expiration or abandonment, and (b) LICENSOR the right
to assume responsibility for such patent or patent application
subject to the rights of the University under the UMASS LICENSES
and the rights of pre-existing licensees under their respective
licenses. LICENSOR will then assign such patent or patent
application to LICENSEE and LICENSEE will thereafter assume control
thereof and all expenses related thereto.
ARTICLE 7 — PROSECUTION OF
INFRINGERS
AND DEFENSE OF PATENT RIGHTS
The Parties agree to notify each other in
writing of any actual or threatened infringement by a third party
of the PATENT RIGHTS or of any claim of invalidity,
unenforceability, or non-infringement of the PATENT RIGHTS.
LICENSOR shall have the sole responsibility to prosecute or defend
such claims, as applicable. LICENSEE shall, if requested, provide
reasonable assistance to LICENSOR in connection with the
prosecution or defense of such claims.
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ARTICLE 8 —
INDEMNIFICATION
8.1 Indemnification of the LICENSOR and the
University . LICENSEE shall be responsible for and shall
indemnify, defend, and hold harmless LICENSOR and the University,
and their agents, attorneys, representatives, third party
beneficiaries and their respective heirs, executors, successors and
assigns (collectively, the “LICENSOR Indemnitees”) from
and against all liabilities of any kind whatsoever, including legal
expenses and reasonable attorneys’ fees, incurred or imposed
upon any of the LICENSOR Indemnitees in connection with or as a
consequence of any claims (including third party claims), suits,
actions, demands or judgments arising out of the death of or injury
to any person or persons or out of any damage to property resulting
from the development, production, manufacture, sale, use,
performance, rendering, consumption or advertisement of the
LICENSED PRODUCT(s) and/or LICENSED PROCESS(es), LICENSED
SERVICE(s), and/or ACT ANIMAL CELL LINES or arising from any
obligation, act or omission performed or failed to be performed
hereunder, or from a breach of any representation or warranty of
LICENSEE hereunder unless and to the extent that such liability
arises solely from any action of LICENSOR or any of its Affiliates.
If the exercise of LICENSEE’s rights under this Agreement in
any country in the TERRITORY is the subject of a bona fide claim by
a third party, filed in a court of competent jurisdiction after the
date hereof, that the exercise of such rights infringes or
conflicts with any intellectual property rights of such third party
(a “Third Party Infringement Claim”), then LICENSEE
shall not have any of the rights granted herein in such country and
shall have no obligation to pay LICENSOR any further payments under
Article 4 of this Agreement with respect to any country
of the TERRITORY until such claim is resolved by proper
adjudication or settlement permitting LICENSEE to exercise
LICENSEE’s rights under this Agreement in the applicable
country of the TERRITORY. Notwithstanding anything herein to the
contrary, LICENSOR covenants that it will not (a) assert or
bring any suit, action, claim or other proceeding against LICENSEE
based on, in whole or in part, LICENSEE’s exercise of
LICENSEE’s rights, in accordance with the terms and
conditions of this Agreement, with respect to the LICENSED
TECHNOLOGY and/or (b) join in any third party suit, action,
claim or other proceeding against LICENSEE based on, in whole or in
part, any intellectual property rights (including without
limitation, patent rights and/or know how) owned by the applicable
third party, so long as LICENSEE is not in violation of this
Agreement.
8.2 Indemnification of the LICENSEE .
LICENSOR shall be responsible for and shall indemnify, defend, and
hold harmless LICENSEE and the officers, directors, shareholders,
employees, agents, attorneys, representatives, and Affiliates, and
their respective heirs, executors, successors and assigns. (the
“LICENSEE Indemnitees”) from and against all
liabilities of any kind whatsoever, including legal expenses and
reasonable attorneys’ fees, incurred or imposed upon any of
the LICENSEE Indemnitees in connection with or as a consequence of
any claims (including third party claims), suits, actions, demands
or judgments arising out of, directly or indirectly, or in any way
relating to: (a) any breach by LICENSOR of any representation,
warranty, covenant or obligation set forth in this Agreement; or
(b) arising from LICENSOR’s ownership, management,
control, use or disposition of the LICENSED TECHNOLOGY or ACT
ANIMAL CELL LINES unless and to the extent that such liability
arises solely from any action of LICENSEE or any of its Affiliates
after the Effective Date.
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8.3 Demands for Third Party Claims . Each
indemnified Party hereunder (an “Indemnified Party”)
agrees that promptly upon its discovery of facts giving rise to a
claim for indemnity under this Agreement, including the receipt of
any demand, assertion, claim, action or proceeding, judicial or
otherwise, by any third party (being referred to herein as a
“Claim”), with respect to any matter as to which it
claims to be entitled to indemnity under the provisions of this
Agreement, it will give prompt notice thereof in writing to the
Indemnifying Party (the “Indemnifying Party”), together
with a statement of such information respecting any of the
foregoing as it shall have. Such notice shall include a formal
demand for indemnification under this Agreement.
8.4 Right to Contest and Defend . The
Indemnifying Party shall contest and defend, at its sole cost and
expense, by all appropriate legal proceedings any Claim with
respect to which it is called upon to indemnify the Indemnified
Party under the provisions of this Agreement; provided, that notice
of the intention to so contest shall be delivered by the
Indemnifying Party to the Indemnified Party as soon as reasonably
possible after (but no later than twenty 20 days from) the
date of receipt by the Indemnifying Party of notice by the
Indemnified Party of the assertion of the Claim. Any such contest
may be conducted in the name and on behalf of the Indemnifying
Party or the Indemnified Party as may be appropriate. Such contest
shall be conducted by reputable counsel employed by the
Indemnifying Party, but the Indemnified Party shall have the right
but not the obligation to participate in such proceedings and to be
represented by counsel of its own choosing at its sole cost and
expense. The Indemnifying Party shall have full authority to
determine all action to be taken with respect thereto; provided,
however, that the Indemnifying Party will not have the authority to
subject the Indemnified Party to any obligation whatsoever (whether
financial or the imposition of equitable or injunctive relief),
other than the performance of purely ministerial tasks or
obligations not involving material expense (for which the
Indemnified Party shall be reimbursed). If the Indemnifying Party
does not elect to contest any such Claim, the Indemnifying Party
shall be bound by the result obtained with respect thereto by the
Indemnified Party.
8.5 Cooperation . If requested by the
Indemnifying Party, the Indemnified Party agrees to cooperate with
the Indemnifying Party and its counsel in contesting any Claim that
the Indemnifying Party elects to contest or, if appropriate, in
making any counterclaim against the PERSON asserting the Claim, or
any cross-complaint against any PERSON, and the Indemnifying Party
will reimburse the Indemnified Party for any expenses incurred by
it in so cooperating.
8.6 Right to Participate . The
Indemnified Party agrees to afford the Indemnifying Party and its
counsel the opportunity to be present at, and to participate in,
conferences with any PERSON, including governmental authorities,
asserting any Claim against the Indemnified Party or conferences
with representatives of or counsel for such PERSON.
8.7 Payment of Damages . The Indemnifying
Party shall pay to the Indemnified Party in immediately available
funds any amounts to which the Indemnified Party may become
entitled by reason of the provisions of this Agreement, such
payment to be made within five (5) days after any such amounts
are finally determined either by mutual agreement of the Parties
hereto or pursuant to the final non-appealable judgment of a court
of competent jurisdiction.
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8.8 Independent Indemnities . The Parties
acknowledge and agree that each of the indemnities under
Sections 8.1 and 8.2 may be relied upon
independently.
8.9 Insurance. LICENSEE and LICENSOR
mutually agree to maintain insurance or self-insurance that is
reasonably adequate to fulfill any potential obligation to the
Indemnified Parties. LICENSEE and LICENSOR shall continue to
maintain such insurance or self-insurance during the term of this
Agreement and after the expiration or termination of this Agreement
for a period of five (5) years. Each Party shall provide to
the other Party, upon request, proof of any such insurance policy
maintained by such Party.
9.1 The term of this Agreement
(“TERM”) shall commence on the Effective Date and
continue until the expiration of the last VALID CLAIM within the
PATENT RIGHTS to expire , unless sooner terminated as provided in
this Article 9 ; provided that LICENSEE’s
obligation to pay royalties or Sublicense Income on NET SALES in
any country will terminate pursuant to Subsection 4.2(c)
(subject to LICENSEE’s obligations under
Section 9.4 herein).
9.2 If either Party commits a material breach of
a material term of this Agreement (including any failure to make
any payment due under this Agreement), the non-breaching Party
shall have the right to terminate thi
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