Exhibit 10.20
EXCLUSIVE LICENSE AGREEMENT
Between BioTime, Inc. and CJ Corp.
TABLE OF CONTENTS
1 Definitions.............................................. 1
2 License Grant............................................ 3
3 License Fees............................................. 4
4 Royalties................................................ 4
5 Royalty and License Payments............................. 4
6 Regulatory Approvals..................................... 6
7 Hydroxyethyl Starch Supply............................... 7
8 Minimum Product Sales.................................... 7
9 Patent and Trademark Marking............................. 8
10 Right of First Refusal - New Products.................... 8
11 Infringement and Indemnification......................... 9
12 Confidentiality.......................................... 12
13 Term and Termination..................................... 12
14 Representations and Warranties of Licensor............... 14
15 Representations and Warranties of CJ..................... 14
16 Notices.................................................. 15
17 Alternate Dispute Resolution............................. 16
18 Applicable Law........................................... 16
19 Assignment............................................... 16
20 Entire Agreement......................................... 16
21 Severability............................................. 16
22 Waiver - Modification of Agreement....................... 17
i
Schedule I..................................................... 19
Schedule II.................................................... 20
Schedule III................................................... 21
Schedule IV.................................................... 22
ii
EXCLUSIVE LICENSE AGREEMENT
This Agreement is made as of March 27, 2003 by and between BioTime, Inc.
("Licensor") and CJ Corp.("CJ").
Premises
This Agreement defines the terms to which CJ and Licensor agree that CJ
will manufacture, market, and sell certain intravenous solutions in the Republic
of Korea (the "Territory").
1. Definitions
Where used in this Agreement the following terms shall have the meanings
ascribed below:
(a) "Affiliate" means any entity controlled by, in control of, under
common control with CJ or Licensor.
(b) "Confidential Information" means any information including, but not
limited to, ideas, proposals, plans, Know-How, reports, drawings, designs, data,
discoveries, inventions, improvements, suggestions, specifications, products,
samples, components and materials relating to a Product or New Product, and all
information relating to the manufacture, formulation, analysis, stability,
pharmacology, toxicology, pathology, clinical data, results of clinical efficacy
studies, clinical effects and indications for use of a Product or New Product
which a party discloses to the other party, except any portion thereof which:
(i) is known to the receiving party at the time of disclosure and
documented by written records made prior to the date of this
Agreement;
(ii) is disclosed to the receiving party by a Third Person who has a
right to make such disclosure;
(iii) becomes patented, published or otherwise part of the public domain
as a result of acts by a Third Person through no fault of the
receiving party or its Subsidiary or other Affiliate of the
receiving party; or
(iv) is independently developed by the receiving party without the use of
Confidential Information, as evidenced by its written records.
(c) "Exclusive License" means a license whereby CJ's rights shall be sole
and exclusive and shall operate to exclude all others, including Licensor.
(d) "Know-How" means that proprietary technology developed by Licensor for
manufacturing or formulating a Product or New Product, including, but not
limited to: manufacturing data; formulation or production technology; methods of
synthesis, isolation and purification methods and other manufacturing
information required to manufacture a Product or New Product; and that
proprietary data developed by Licensor related to pharmacology, toxicology,
pathology, clinical data, results of clinical efficacy studies, clinical effects
and indications for use of a Product or New Product.
(e) "Licensed Patents" means: (i) the patents and patent applications
listed in Schedule III hereto; (ii) all patents arising from applications
identified in (i) and any divisions, continuations and continuations-in-part
defined in (i); (iii) any extension, renewal or reissue of a patent identified
in (i) or (ii); and (iv) any continuation or divisional of any licensed patent
application and any reissue or reexamination of any patent identified in (i)
through (iii).
(f) "Licensed Trademark" means Hextend(R) and PentaLyte(R), and any
other trademark developed, acquired or licensed by Licensor for use in
connection with the sale of the Products in the Territory
.(g) "New Products" means the pharmaceutical product for human use
generally described in Schedule II and identified by Licensor as HetaCool and
HetaFreeze. "New Product" also includes any and all improved versions or
formulations of a New Product made by Licensor which (i) comprise a single
oncotic agent selected from High or Medium Molecular Weight hydroxyethyl starch
(ii) have pharmacologic profiles and therapeutic indications normally considered
medically equivalent to the New Product by specialists in the indications
allowed, (iii) are designed for use below 12E Centigrade, and (iv) are covered
by a Licensed Patent, by a Licensed Trademark, or by Licensed Proprietary
Technology.
(h) "Products" means the pharmaceutical product for human use generally
described in Schedule I and identified by Licensor as Hextend and PentaLyte.
"Product" also includes any and all improved versions or formulations of a
Product made by Licensor which (i) comprise a single oncotic agent selected from
High or Medium Molecular Weight hydroxyethyl starch, (ii) have pharmacologic
profiles and therapeutic indications normally considered medically equivalent to
the Product by specialists in the indications allowed, (iii) are designed for
use above 12ECentigrade, and (iv) are covered by a Licensed Patent, by a
Licensed Trademark, or by Licensed Proprietary Technology.
(i) "Proprietary Rights" means all of Licensor's property rights (except
Licensed Patents and Licensed Trademarks) and interests in, to, or covering a
Product, or the manufacture or use of a Product, to the extent that such
property rights and interests are of such legal status and nature as to permit
the same to be lawfully licensed and, without limiting the generality thereof,
specifically include unpatented inventions, ideas, data, Know-How, technology,
trade secrets and Confidential Information.
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(j) "Subsidiary" means a corporation, a limited liability company, or any
other entity that is wholly owned by CJ or Licensor, either directly or through
one or more other such entities that are wholly owned by CJ or Licensor.
(k) "Territory" means the Republic of Korea.
(l) "Third Person" means any natural person, corporation, partnership,
limited partnership, limited liability company, trust, association or other
entity other than CJ, a Subsidiary, an Affiliate, or Licensor.
(m) "Unit" means 500 milliliters of a Product.
2. License Grant
(a) Licensor hereby grants to CJ an Exclusive License to use Licensed
Patents, Licensed Trademarks, and Proprietary Rights to manufacture and sell the
Products in the Territory only for human therapeutic use at temperatures above
12E Centigrade. Such license shall be irrevocable, except as hereinafter
expressly provided.
(b) CJ shall not sublicense or assign to any Third Person any Licensed
Patents, Licensed Trademarks, and Proprietary Rights, or any other rights
granted by Licensor under this Agreement.
(c) CJ agrees not to use or permit any Subsidiary to use any Licensed
Patents, Licensed Trademarks, and Proprietary Rights for any use other than the
manufacture and sale of the Products in the Territory. CJ will not sell and will
not permit any Subsidiary or Affiliate to sell the Products outside the
Territory. If any Product is sold (by CJ or any of its Subsidiaries) to a Third
Person that intends to resell the Products, CJ will require such Third Person to
agree not to resell the Products outside the Territory. If CJ or any of its
Subsidiaries or other Affiliates becomes informed of a violation of that
agreement by the Third Person, CJ will notify Licensor of such violation, and CJ
will take reasonable means to enforce the Third Person's agreement, including by
discontinuing sales to such Third Person if the sales outside the Territory
compete with sales made by Licensor or any of Licensor's licensees.
(d) CJ agrees that it, its Subsidiaries, and other Affiliates will not
challenge or contest the validity of any Licensed Patent or any claim under any
Licensed Patent, or Licensor's ownership of Proprietary Rights, or Licensor's
ownership or registration of any Licensed Trademark.
(e) Licensor retains (i) the rights under Licensed Patents, Proprietary
Rights, and Licensed Trademarks for research, development and clinical testing
of new and improved products, technology, and additional therapeutic indications
of the Products inside and outside the Territory; (ii) all rights to Licensed
Patents, Proprietary Rights, Licensed Trademarks, and the Products for any
purpose outside the Territory, including but not limited to the right to sell,
assign, transfer and license to Third Parties, and the right to make, have made,
use, and sell the Products outside the Territory; and (iii) all rights to
Licensed Patents, Proprietary Rights, and Licensed Trademarks, for
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the purpose of manufacturing, using, and selling new products inside the
Territory, and the right to sell, assign, transfer and license such rights to
Third Parties, with respect to any new products which are not subject to the
Exclusive License under this Agreement.
3. License Fees
In partial consideration for Exclusive License granted to CJ hereunder, CJ
agrees to pay Licensor the License Fees as follows: (a) Five Hundred Thousand
Dollars ($500,000) within thirty (30) days after the signing of this Agreement,
and (b) Three Hundred Thousand Dollars ($300,000) within thirty (30) days after
application for regulatory approval required to manufacture and market for
Hextend(R) in the Territory; provided however, that if Licensor discontinues the
development of PentaLyte(R), then Licensor shall grant to CJ a license fee-free
Exclusive License to use Licensed Patents, Licensed Trademarks, and Proprietary
Rights to manufacture and sell the one of New Products which can be marketed
instead of PentaLyte(R) in the Territory, subject to the payment of royalties
under Section 4.
4. Royalties
(a) CJ agrees to pay to Licensor royalties in the amount of Two Dollars
($2.00) per Unit of Products sold in the Territory ; provided, however, that the
Products sold in the Territory shall exclude any returned Products. The
foregoing amount of royalties shall be adjusted to an amount of (a) One Dollar
and thirty Cents ($1.30) per Unit if the price of the National Health Insurance
("NHI") for the Products in the Territory is less than forty five thousand
Korean Won (KRW 45,000) and (b) Two Dollars and sixty Cents ($2.60) per Unit, if
the price of the NHI for the Products in the Territory is more than ninety
thousand Korean Won (KRW 90,000).
(b) CJ agrees to use its best efforts, including its extensive sales,
marketing and distribution programs and facilities to promote, market,
distribute and sell the Products in the Territory in a manner consistent with
the manner and standards used by leading companies in the industry in the
Territory to promote, market, distribute and sell leading products, and at
prices and on other terms of sale reasonably expected to maximize sales of the
Products. If CJ assigns or sublicenses any of its rights under this Agreement to
a Subsidiary or an Affiliate , CJ shall require such Subsidiary or an Affiliate
to promote, market, distribute and sell the Products as provided in the
immediately preceding sentence. Without limiting the generality of the first
sentence of this paragraph, CJ agrees to: (i) conduct marketing studies and to
consult with Licensor in connection with the design, scope and method of
conducting such studies; and (ii) provide all technical and medical product
support necessary to commence and maintain sales and marketing of the Products.
(c) All sales of the Products by CJ or any Subsidiary or Affiliate shall
be documented by invoices showing the quantity sold in Units.
5. Royalty and License Payments
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(a) Royalty Payment Report. Each royalty payment shall be accompanied by a
statement which sets forth the quantity of Product in Units.
(b) Royalty Payments.
Royalty payments shall be made within thirty (30) days after the last day
of each quarter period ending on March 31, June 30, September 30 and December
31, respectively.
(c) Currency; Exchange Rates. All royalties and license fees shall be paid
in United States dollars. For the purpose of determining royalties, Korean won
shall be converted to United States dollars at the exchange rate prevailing at
the close of the last business day of the week immediately preceding the date on
which royalties or license fees are paid. The exchange rates used for such
conversion shall be those set forth by The Bank of Korea.
(d) Royalty and License Fee Payments - - Place and Tax. Payments due under
this Agreement shall be made by wire transfer to an account of Licensor at a
bank designated by Licensor. CJ, its Subsidiaries, or other Affiliate shall use
their best efforts to convert the royalties payable on sales to United States
dollars; provided, however, that if conversion to and transfer of United States
dollars cannot be made in the Territory for any reason, payment of royalties may
be made in the currency of the Territory, and deposited in an account in
Licensor's name in a bank designated by Licensor in the Territory. Any tax which
CJ is required to pay or withhold with respect to money payable to Licensor
hereunder shall be deducted from the amount of such money otherwise due,
provided, however, that in regard to any such deduction CJ shall give Licensor
such assistance as may reasonable be necessary to enable or assist Licensor to
claim exemption therefrom and shall give Licensor proper evidence from time to
time as to the payment of the tax.
(e) No Royalties Payable Between Affiliates. No royalties shall be payable
on sales among CJ and its Subsidiaries, or Affiliates, or between Subsidiaries
and Affiliates, provided that CJ and its Subsidiaries and Affiliates resell to
Third Persons the quantities of the Products in question.
(f) Records and Audit. CJ, its Affiliates and Subsidiaries shall keep and
maintain records of Product sales, hydroxyethyl starch purchases, Product
production, and Product inventory, with respect to each and every Product,
during the term of this Agreement. CJ shall also require each supplier of
hydroxyethyl starch used by CJ in the manufacture of the Products to make
available to Licensor on request all records of sales of hydroxyethyl starch to
CJ and CJ's Subsidiaries and other Affiliates or any Third Person that
manufactures any Product for CJ. Such records shall be open to inspection at any
reasonable time within four (4) years after the royalty period to which such
records relate by an independent certified public accountant selected by
Licensor and retained at Licensor's expense; provided, however, that CJ shall
bear the expense of an audit if the audit discloses that CJ has underpaid any
royalty by an amount of 1% or more during any three month period. Said
accountant shall sign a confidentiality agreement (which shall not prohibit
disclosure of information in any lawsuit, arbitration or other proceeding) and
shall then have the right to examine the records kept pursuant to this Agreement
and report the findings of said examination of records to Licensor as is
necessary to (i) evidence that records were or were not maintained and used in
accordance with this Agreement, and (ii) report any impropriety or inaccuracy in
the
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determination or payment of any amount due to be paid under this Agreement. A
copy of any report provided to Licensor by the independent certified public
accountant shall be given concurrently to CJ.
(g) Payment by Affiliate. Licensor agrees that if any Subsidiary or other
Affiliate of CJ pays, on behalf of CJ, any obligation of CJ under this
Agreement, such payment shall be received in lieu of payment by CJ in
satisfaction of such obligation under this Agreement. The Subsidiary or other
Affiliate shall make payment to Licensor in United States dollars at a bank
account designated by Licensor. The royalty payment shall be converted from
foreign currency to United States dollars using exchange rates and conversion
dates stated in Section 5(c) above.
(h) Royalty License Restrictions and Maximum Payments. If Korea restricts
the royalty rate or amount payable on account of sales of Product in Korea, the
amount payable hereunder shall not exceed the maximum amount payable under
applicable laws, regulations or administrative rulings of Korea. If any royalty
otherwise payable cannot be paid due to such restrictions, CJ shall pay an
additional license fee in the amount of royalties that cannot be paid, if the
payment of such additional license fee would not violate such law, regulation or
administrative ruling.
6. Regulatory Approvals
(a) CJ shall, at its sole cost and expense, use its best efforts to obtain
as promptly as practicable all government regulatory approvals required to
manufacture, market, and use the Products in the Territory for human therapeutic
purposes. CJ shall, at its sole cost and expense, (i) conduct all laboratory
studies and tests, (ii) conduct all clinical studies and tests, (ii) prepare and
file all applications, reports, and documents, (iii) take such other actions,
and (iv) pay all fees, taxes, and assessments necessary to obtain and maintain
in effect all regulatory approvals required to manufacture, market, and use the
Products in the Territory for human therapeutic purposes, and to otherwise
comply with all applicable laws in the Territory pertaining to the manufacture,
use, sale, and marketing of the Products.
(b) CJ shall consult and cooperate with Licensor to obtain all
governmental regulatory approval in the Territory. CJ shall own all data and
other information gathered in clinical studies and testing conducted by CJ at
its own cost and agrees to provide to Licensor to use such data and other
information outside the Territory, which shall be deemed CJ's Confidential
Information.
(c) CJ agrees that all applications for regulatory approval and all
reports and other documents prepared and filed by CJ and its Subsidiaries or
Affiliates with respect to each Product, and all actions taken by CJ and its
Subsidiaries or Affiliates in connection with obtaining regulatory approval,
shall conform in all respects with applicable laws, statutes, rules and
regulations. CJ and its Affiliates will keep Licensor reasonably informed on the
status of the submitted regulatory applications and regulatory approvals. CJ and
its Affiliates shall maintain complete copies of all records, data and reports
pertaining to each study for such period of time as may be required by the laws
of the Territory.
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(d) Licensor agrees to provide to CJ data from all completed clinical
studies of the Products conducted by Licensor in countries outside the
Territory, which data shall be deemed Licensor's Confidential Information.
Licensor shall furnish to CJ and its Subsidiaries or Affiliates all information
that is necessary for CJ and its Subsidiaries or Affiliates to apply for
registration of the Product in the Territory and that is in Licensor's
possession and which Licensor has the right to furnish to CJ and its
Subsidiaries or Affiliates.
(e) Licensor shall have the right to use, outside the Territory, all CJ
data and information, and all rights to use and cross-reference CJ data,
documentation and information referred to above in this Section 6 with respect
to the Products for purposes related to Licensor's product development and
marketing activities, including, obtaining regulatory approvals of Products, and
promoting, marketing and selling Products outside the Territory; and CJ shall
provide Licensor promptly in writing all adverse events and safety data which CJ
or its Subsidiaries and other Affiliates obtain concerning the Products.
(f) CJ shall have the right to use, in the Territory, all Licensor data
and information, and all rights to use and cross-reference Licensor data,
documentation and information referred to above in this Section 6 with respect
to the Products for purposes related to CJ's product development and marketing
activities, including, obtaining regulatory approvals of Products, and
promoting, marketing and selling Products in the Territory, and Licensor shall
provide CJ promptly in writing all adverse events and safety data which Licensor
or its Subsidiaries and other Affiliates obtain concerning the Products.
7. Hydroxyethyl Starch Supply
During the term of this Agreement, CJ will be responsible for obtaining a
supply of hydroxyethyl starch used in the Products sufficient to support market
demand of the Products in the Territory.
8. Minimum Product Sales
(a) Minimum Amounts. CJ agrees to the establishment of the minimum annual
Product sales targets for all Products in the aggregate:
First Year of sales - 8,000 Units
Second Year of sales - 15,000 Units
Third Year of sales - 25,000 Units
Fourth Year - 30,000 Units
Fifth Year - 40,000 Units
If actual sales for any year are less than the minimums shown above, CJ may, at
its option, make supplement payments to Licensor to make up for any shortfall
between royalty payments due on actual sales and royalty payments that would be
due if the target minimum sales were achieved. In
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the event that CJ does not achieve target minimum sales in the Territory or make
up royalty shortfalls, Licensor has the right to convert the Exclusive License
to a non-exclusive license and thereby grant Third Persons license to
manufacture and market Products in the Territory. In the event that CJ's
Exclusive License is converted to an non-exclusive license, Licensor shall not
be obligated to return or refund any License Fee or other payment made by CJ
under this Agreement.
(b) CJ shall deliver to Licensor a report of total annual Product sales
within (60) days after the end of each 12 month period following the
commencement of Product sales.
(c) The first year of sales shall begin after six months from the date of
price registration of the Products at NHI.
9. Patent and Trademark Marking
(a) CJ shall label or ▇▇▇▇ each Product or the Product container or
package made by or on behalf of CJ with the patent number or numbers of any
issued or pending Licensed Patents. The content, form, location and language
used for such marking shall be in accordance with the laws and practices of the
Territory and in accordance with CJ's marketing preferences.
(b) CJ shall label or ▇▇▇▇ each Product container, package, and label with
the Licensed Trademark and Licensor's name and address. All uses of a Licensed
Trademark shall include (i) the symbol (R) if the Licensed Trademark is
registered with the United States Patent and Trademark Office, (ii) the symbol
(TM) if the Licensed Trademark is not registered with United States Patent and
Trademark Office, (iii) such symbols or indications of trademark registration or
non-registration as may be comparable under Korean law to the symbols (R) and
(TM), and (iv) a statement that the Licensed Trademark is licensed from
Licensor.
(c) Licensor will make such filings and take such other actions as
Licensor deems necessary to: (i) apply for and obtain, if feasible, new or
additional patents pertaining to Products that may become Licensed Patents under
this Agreement, (ii) maintain Licensed Patents in effect in the Territory; and
(iii) obtain extensions of Licensed Patents to the extent such extensions are
available. Such actions shall include contesting oppositions to the issuance of
a patent filed in the Territory.
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10. Right of First Refusal - New Products
(a) Licensor grants CJ a right of first refusal to obtain an Exclusive
License in the Territory to manufacture, market, and sell New Products. Within
thirty (30) days after written notice from Licensor offering to license a New
Product under this Agreement and stating (i) the license fee payable for the New
Product, (ii) the minimum annual sales, (iii) the expiration date of the
license, and (iv) any other terms that vary from the terms of this Agreement
with respect to other Products, CJ may exercise its right of first refusal with
respect to that New Product by giving Licensor written notice of acceptance of
the terms stated in Licensor's notice. Licensor and CJ will then proceed to
execute an amendment or supplement to this Agreement that will provide CJ with
an Exclusive License to the New Product on substantially the same terms and
conditions as this Agreement with respect to the other Products, except that the
amendment or supplement will provide for the new license fees, minimum sales,
expiration dates, and any other terms stated in Licensor's notice or otherwise
agreed upon by Licensor and CJ for the Exclusive License of the New Product.
(b) If CJ does not exercise its right of first refusal in writing within
the thirty (30) day period provided in paragraph (a) of this Section, or if an
amendment or supplement to this Agreement granting CJ an Exclusive License for
the New Product is not executed within ninety (90) days after CJ's exercise of
its right of first refusal, CJ's right to obtain such Exclusive License shall
expire, CJ shall have no further rights with respect to such New Product, and
Licensor shall be free to manufacture, import, offer for sale, and sell the New
Product, or license the New Product to Third Persons, or to take any and all
other actions with respect to the New Product, in the Territory. Licensor will
not grant a Third Person a license to make, sell, offer to sell, and import the
New Product in the Territory on terms that provide license fee, royalty payment,
or other material financial terms that are more favorable to such Third Person
than the license fee, royalty payment, or other material financial terms offered
to CJ without first offering CJ the opportunity, for a period of thirty (30)
days, to execute a license agreement on such more favorable terms. If CJ fails
to execute the license agreement within a ninety (90) day period after CJ's
positive notice to obtain a license the New Products, Licensor may proceed to
enter into a license agreement on such terms with a Third Person and CJ will
have no further rights to obtain a license to manufacture, import, offer for
sale, or sell the New Product.
(c) CJ shall exercise its rights under this Article 10 at such time so
long as CJ still has license rights covering at least one original Product or
one other New Product.
11. Infringement and Indemnification
(a) Infringement by Third Person. In the event Licensor or CJ have reason
to believe that a Third Person may be infringing any of the Licensed Patents or
infringing or diluting any Licensed Trademark, such party shall promptly notify
the other party. CJ shall take prompt legal action to enforce the Licensed
Patents or Licensed Trademarks, unless Licensor determines that Licensor will
enforce the Licensed Patents or Licensed Trademarks itself. CJ shall pay all of
its costs of such enforcement action (including, without limitation, all of its
attorney's fees, litigation costs
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and costs of investigation). If Licensor elects to institute enforcement action
itself, CJ shall cooperate with Licensor in the enforcement action, and upon
Licensor's request, CJ shall join in any such enforcement action. Licensor shall
be entitled to retain any recovery which may be obtained in any lawsuit brought
by Licensor; provided, however, that at CJ's option, Licensor's right to retain
any such recovery shall either be subject first to CJ's recovery of its costs
incurred in such lawsuit, or CJ may deem such costs to be a non-interest bearing
credit against future royalties due to be paid to Licensor. To the extent that
any award of damages or other compensation obtained by CJ in any lawsuit brought
by CJ exceeds CJ's direct costs of litigation, such excess shall be treated as
sales upon which a royalty shall be paid to Licensor; provided, that the royalty
so payable shall be determined by dividing such amount by the average price per
Unit at which the applicable Products were sold by CJ during the 12 months
preceding the date of the award, and multiplying the result by the royalty per
Unit then in effect under Section 4. Licensor will provide reasonable
cooperation with respect to any lawsuit which CJ may bring pursuant to this
Section 11. CJ shall not settle any lawsuit or other enforcement action without
the prior written consent of Licensor.
(b) Alleged Infringement of Third Person Patents.
(i) If a claim or lawsuit is brought against CJ alleging
infringement of any patent or infringement or dilution of any trademark
owned by a Third Person arising from CJ's use of Licensed Patents,
Licensed Trademarks, or licensed Proprietary Rights in the manufacture,
marketing, or sale of a Product in the Territory, CJ shall promptly give
written notice to Licensor of such claim or lawsuit and provide to
Licensor all information in CJ's possession regarding such claim or
lawsuit. Within a reasonable time after receiving notice of such claim or
lawsuit, but in any event ninety (90) days after receiving such notice,
Licensor shall advise CJ of Licensor's decision as to what action it plans
to take to dispose of such claim or defend such lawsuit.
(ii) Licensor shall defend, indemnify and hold CJ harmless against
any judgment, damage, liability, loss, cost or other expense (including
legal fees) resulting from any claim or lawsuit which relates to or arises
out of the alleged infringement by CJ of any patent owned by a Third
Person to the extent that the alleged infringement relates to CJ's use of
Licensed Patents, Licensed Trademarks, or licensed Proprietary Rights in
the manufacture, marketing, or sale of a Product in the Territory;
provided that, CJ shall promptly give notice to Licensor of any such claim
or lawsuit, shall provide to Licensor all information in CJ's possession
regarding such claim or lawsuit, and shall provide Licensor such
reasonable assistance as Licensor may, from time to time, reasonably
request. Licensor shall have no obligation to indemnify or defend CJ
against any claim or lawsuit pertaining to CJ's use of any technology,
method, process, devise, or equipment in connection with manufacturing or
packaging that was developed by CJ or obtained by CJ from a Third Person.
If Licensor notifies CJ to discontinue manufacturing and selling any
Product because of a potential infringement, then any liability for such
infringement following such notice shall be solely for CJ's account and
shall not be indemnified by Licensor; provided however, that if such
notice is given by Licensor to CJ to discontinue the manufacture and sale
of any Product within one year after the commencement of sale of such
Product in the Territory, then
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Licensor shall refund to CJ the full amount of the License Fees paid by CJ
to Licensor as described in Section 3 above and if such notice is given
within 2 years after the commencement of sale of such Product in the
Territory, then Licensor shall refund to 50% of the License Fees paid by
CJ to Licensor. Licensor, at its option and expense, may dispose of such
claim or may conduct the defense of such lawsuit
(iii) If Licensor disposes of a claim or conducts the defense of a
lawsuit for which it is obligated to indemnify CJ pursuant to Section
11(b)(ii), there shall be no abatement of the applicable royalties payable
for sales of any Product during the pendency of such disposition or
lawsuit or any appeal taken from it. If Licensor elects not to dispose of
such claim or defend such lawsuit, CJ may defend the claim or lawsuit. CJ
shall not be authorized to settle such lawsuit without Licensor's prior
written consent, unless such settlement imposes on Licensor no direct or
indirect liability for the payment of damages or other obligations and CJ
agrees in writing to waive any claims or rights against Licensor for
indemnification under this Agreement or otherwise arising from or in
connection with such lawsuit and settlement. For purposes of CJ's conduct
of the disposition or defense, Licensor shall furnish to CJ such
reasonable assistance as CJ may need and from time to time reasonably
request. If CJ takes on the disposition of a claim or defense of a lawsuit
for which Licensor is obligated to indemnify CJ pursuant to Section
11(b)(ii), then the payments of royalties on sales of such Product, which
would otherwise be payable to Licensor under this Agreement, shall be
reduced during the pendency of such lawsuit or any appeal taken from it by
the actual out of pocket expenses incurred by CJ in disposing of such
claim or defending such lawsuit, or participating in any such appeal;
provided, that CJ provides Licensor with full and accurate documentation
of the expenses so deducted. Upon final resolution of the above described
claim, lawsuit and/or appeal, CJ shall resume paying Licensor full
royalties on sales of the Product or Products in question.
(iv) If CJ becomes obligated to pay royalties to any Third Person,
in order to use Licensed Patents and Licensed Trademarks to manufacture,
market, or sell a Product in the Territory without infringing upon a
patent or trademark held by that Third Person, the entire amount of the
royalties paid to the Third Person shall be creditable against royalties
otherwise payable to Licensor under this Agreement; provided, that no such
credit shall be allowed with respect to (a) any royalty paid in connection
with a settlement or compromise of a Third Party claim or lawsuit unless
Licensor shall have approved or consented to such settlement or
compromise, and (b) any royalty paid for the use of any technology,
method, process, devise, or equipment in connection with manufacturing,
packaging or any container or delivery system, or the use of any
trademark, that was developed by CJ, any Subsidiary or other Affiliate of
CJ
(c) By Licensor. Licensor shall defend, indemnify and hold CJ harmless
against any liability, damage, loss, cost or expense, including legal
fees, arising out of or resulting from any Third Person claims or lawsuits
made or brought against CJ due to
11
(i) Licensor's breach and failure to cure such breach in accordance with
Section (b)(ii); and
(ii) Licensor's breach of a representation or warranty set forth in
Section 14.
(d) By CJ. CJ shall defend, indemnify and hold Licensor harmless against
any liability, damage, loss, cost or expense, including legal fees, arising out
of or resulting from any Third Person claims or lawsuits made or brought against
Licensor to the extent such damage, loss, cost or expense arises out of or
relates to negligence or willful misconduct of CJ or any Subsidiary or other
Affiliate with regard to the manufacture, use, testing, storage, promotion,
shipment or sale of, or other action or omission with respect to, a Product, or
any container, packaging or delivery system of a Product, or the use of the
Proprietary Rights.
(e) Conditions to Indemnification. The agreement of the parties to
indemnify each other, as provided in this Section 11, is conditioned upon the
indemnified party's obligation to: (i) advise the indemnifying party of any
claim or lawsuit, in writing, within twenty (20) days after the indemnified
party has received notice of said claim or lawsuit, or within such a time frame
as not to materially prejudice the rights of the indemnifying party to defend or
settle such claim or lawsuit, and (ii) assist the indemnifying party and its
representatives in the investigation and defense of any claim and/or lawsuit for
which indemnification is provided. The agreement of the parties to indemnify
each other shall not be valid as to any settlement of a claim or lawsuit or
offer of settlement or compromise without the prior written approval of the
indemnifying party.
(f) Limit on Consequential Damages. Notwithstanding any other provision of
this Agreement, neither party shall be liable to the other for any
consequential, incidental, or special damages whatsoever, unless such damages
are awarded to a Third Person with respect to an infringement against which one
party is to indemnify the other.
12. Confidentiality
(a) Confidentiality. Neither party shall disclose any Confidential
Information received from the other party pursuant this Agreement. This
obligation will continue for a period of ten (10) years after expiration or
prior termination of this Agreement.
(b) Disclosure. Nothing contained in this Section shall be construed to
restrict the parties from disclosing Confidential Information as required:
(i) For regulatory, tax or customs reasons;
(ii) For audit purposes;
(iii) By court order or other government order or request as long as
reasonable efforts have been made to assure its
confidentiality or Licensor is timely notified to make such
efforts; or
12
(iv) For using such Confidential Information as is reasonably
necessary to perform acts permitted by this Agreement.
13. Term and Termination
(a) Term. Unless otherwise terminated as herein provided, this Agreement
shall terminate upon expiration of the last to expire Licensed Patent in the
Territory, or on approval and marketing of a generic equivalent of the most
recently introduced Product (including any improved version or formulation of a
Product) by a Third Person in the Territory, whichever first occurs. CJ agrees
not to market a generic equivalent before termination of this Agreement.
(b) Early Termination. Either party may terminate this Agreement by giving
to the other party sixty (60) days prior written notice as follows:
(i) Upon the bankruptcy or the insolvency of the other party; or
(ii) Upon the breach of any material provision of this Agreement by
the other party if the breach is not cured within sixty (60)
days after written notice thereof to the party in default; or
(iii) At any time after June 30, 2005, if CJ has not obtained all
regulatory approvals required to manufacture and market at
least one Product in the Territory and commenced sales of at
least one Product in the Territory in case that clinical
testing is not required.
(c) Consequences of Termination.
(i) Survival of Liability. Termination, expiration, cancellation
or abandonment of this Agreement through any means and for any
reason shall not relieve the parties of any obligation
accruing prior thereto and shall be without prejudice to the
rights and remedies of either party with respect to any
antecedent breach of any of the provisions of this Agreement.
(ii) Return of Confidential Information. Upon expiration or
termination of this Agreement, CJ shall promptly return to
Licensor all copies of Licensor's Confidential Information.
(iii) Discontinuation of Use of Licensed Patents, Licensed
Trademarks and Confidential Information. Upon the expiration
or termination of this Agreement, CJ, its Subsidiaries,
Affiliates, and any sublicensees shall immediate cease all use
of Licensed Patents, Licensed Trademarks, Proprietary Rights,
and Confidential Information, and shall discontinue the
manufacture and sale of the Products, except that Licensed
Trademarks may be used for a period of 180 days exclusively
for the
13
purpose of selling inventory of Products on hand on the date
this Agreement terminated.
(d) Option to Extend. Upon the commencement of marketing of a generic
equivalent of the most recently introduced Product (including any improved
version or formulation of a Product) by a Third Person in the Territory after
(i) expiration of the last issued patent contained in Licensed Patents, or (ii)
loss of patent protection under all Licensed Patents, whichever comes first, CJ
shall have the right to continue to manufacture and sell the Products in the
Territory under this Agreement upon notice to Licensor; provided that the
royalties payable with respect to Sales shall be reduced by 50%
14. Representations and Warranties of Licensor
Licensor represents and warrants that:
(a) Licensor has the full right and power to perform the obligations and
grant the Exclusive License set forth in this Agreement, and there are no
outstanding agreements, assignments or encumbrances in existence inconsistent
with the provisions of this Agreement;
(b) The Licensed Patents and/or Proprietary Rights have not knowingly been
obtained through any activity that would limit or destroy the validity of the
Licensed Patents and/or Proprietary Rights, and the Licensor has no knowledge or
information that would materially adversely impact the validity and/or
enforceability of the existing Licensed Patents and/or Proprietary Rights;
(c) To the best of Licensor's knowledge, there are no actions, threatened
or pending, before any court relating to the Licensed Patents and/or Proprietary
Rights;
(d) Licensor has not authorized others to practice the Licensed Patents
and/or Proprietary Rights in the Territory;
(e) Licensor owns and possesses all right, title and interest in and to
the Licensed Patents and/or Proprietary Rights and, to the best of Licensor's
knowledge, no Third Person has acquired, owns or possesses any right, title or
interest in or to the Licensed Patents and/or Proprietary Rights in the
Territory;
(f) Schedule III lists all patents issued and patent applications filed by
Licensor in the Territory on or before the date of this Agreement within the
scope of the Licensed Patents and hence subject to this Agreement.
14
15. Representations and Warranties of CJ
CJ represents and warrants that:
(a) This Agreement has been duly authorized, executed and delivered by CJ
and is the valid and binding agreement of CJ, enforceable in accordance with its
terms.
(b) The execution and delivery of this Agreement does not, and manufacture
and sale of the Products by CJ will not (a) violate the terms of any order, writ
or decree of any court or judicial or regulatory authority or body, or (b)
conflict with or result in a breach of any condition or provision or constitute
a default under or pursuant to the terms of any contract, license, or agreement
to which CJ or any Affiliate is a party, or which is or purports to be binding
upon CJ or any Affiliate, or upon any of the properties or assets of CJ or any
Affiliate.
(c) CJ has no knowledge or information that would lead CJ to believe that
the existing Licensed Patents and/or Proprietary Rights are not valid or
enforceable;
(d) CJ has or will obtain a supply of hydroxyethyl starch sufficient to
meet market demand for the Products.
(e) CJ has or will obtain manufacturing facilities capable of producing a
sufficient quantity of the Products, under good manufacturing practices and the
applicable laws, statutes, rules, and regulations of the Territory, to meet
market demand.
(f) CJ and its Subsidiaries will manufacture the Products under good
manufacturing practices, in compliance with all applicable laws, statutes, rules
and regulations of the Territory.
(g) CJ and its Subsidiaries will distribute, market and sell the Products
in compliance with all applicable laws, statutes, rules and regulations of the
Territory.
16. Notices
All notices given under this Agreement shall be in writing and shall be
delivered personally, by facsimile confirmed by postage prepaid first-class
mail, by over-night or next business day air courier, or by postage prepaid
certified mail to the following addresses of the respective parties:
CJ Corp.
500, 5-Ga, Namdaemun-No
Jung-Gu, ▇▇▇▇▇, ▇▇▇-▇▇▇, ▇▇▇▇▇
FAX: ▇▇-▇-▇▇▇-▇▇▇▇/8389
Attention:
BioTime, Inc.
15
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
FAX: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Chief Executive Officer
With copies to: Chief Financial Officer of the Corporation
Notices shall be effective upon receipt if personally delivered or
delivered by facsimile or air courier, or on the fifth business day following
the date of mailing. A party may change its address listed above by notice to
the other party.
17. Alternate Dispute Resolution
The parties recognize that bona fide disputes may arise which relate to
the parties' rights and obligations under this Agreement. The parties agree that
any such dispute shall be resolved by arbitration in accordance with the
procedures set forth in Schedule IV.
18. Applicable Law
This Agreement shall be governed by and interpreted in accordance with the
laws of the State of California, regardless of the choice of law principles of
California or any other jurisdiction.
19. Assignment
Neither party shall assign this Agreement or any part thereof without the
prior written consent of the other party; provided, however, that without the
consent of the other party (a) CJ may assign this Agreement to a Subsidiary or
an Affiliate, but such assignment shall not relieve CJ of responsibility for the
performance of all of the obligations which CJ assigns, (b) Licensor may assign
this Agreement to a wholly owned subsidiary of Licensor, (c) Licensor may assign
its rights to receive license fees or royalty payments, and (d) Licensor may
assign or sell its rights and obligations under this Agreement in connection
with the transfer or sale of substantially its entire business to which this
Agreement pertains or through a merger or consolidation with another company.
Any permitted assignee (other than an assignee of a right to receive payments
due Licensor) shall assume all obligations of its assignor under this Agreement.
No assignment shall relieve any party of responsibility for the performance of
any obligation which such party has hereunder.
20. Entire Agreement
This Agreement and the Exhibits and Schedules constitute the entire
agreement between the parties concerning the subject matter hereof and supersede
all written or oral prior agreements or understandings with respect thereto. No
course of dealing or usage of trade shall be used to modify the terms and
conditions hereof.
16
21. Severability
This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable laws, governmental regulations, approvals and
clearances. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalid, illegal or
unenforceable provision shall be modified so as to conform to the applicable
requirements, and this Agreement shall be modified by the parties so as to
accomplish as nearly as possible the original intention of the parties
consistent with applicable laws and regulations.
17
22. Waiver - Modification of Agreement
No waiver or modification of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of the party to
be charged. Failure or delay by either party to enforce any rights under this
Agreement shall not be construed as a waiver of such rights nor shall a waiver
by either party in one or more instances be construed as constituting a
continuing waiver or as a waiver in other instances.
18
The parties intending to be bound by the terms and conditions hereof have
caused this Agreement to be signed by their duly authorized representatives on
the date first above written.
CJ CORP. BIOTIME, INC.
By: /s/ Dong-▇▇ ▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇▇▇
--------------------- ---------------------
Title: President Title: Chairman and Chief Executive Officer
Head of Pharmaceutical Business Unit, BioTime, Inc.
CJ Corp.
19
BIOTIME, INC.
AND
CJ Corp.
Exclusive License Agreement
Schedule I
Product Formulation
Hextend and PentaLyte Formulation
Hydroxyethyl Starch 6%
Sodium Chloride 115 millimoles/liter
Magnesium Chloride Hexahydrate 0.45 millimoles/liter
Calcium Chloride Dihydrate 2.5 millimoles/liter
Potassium Chloride 3 millimoles/liter
Glucose 5 millimoles/liter
Sodium Lactate 28 millimoles/liter
20
BIOTIME, INC.
AND
CJ Corp.
Exclusive License Agreement
Schedule II
New Product Formulation
HetaCool Formulation
Same as Hextend plus bicarbonate.
HetaFreeze Formulation
Same as HetaCool with generally known freeze-protective agents added alone or in
combination for example: glucose, glycerol, DMSO (dimethyl sulfoxide)
21
BIOTIME, INC.
AND
CJ Corp.
Exclusive License Agreement
Schedule III
Patent Rights
Patent Applications:
Korean Patent 95-705531, issued July 6, 2000
22
BIOTIME, INC.
AND
CJ Corp.
Exclusive License Agreement
Schedule IV
Arbitration
In the event that any controversy or claim arises out of or relating to
any provision of this Agreement, the parties shall try to settle their
differences amicably between themselves. Any unresolved disputes arising between
the parties relating to, arising out of or in any way connected with this
Agreement or any term or condition of this Agreement, or the performance of
either party under this Agreement, whether before or after termination of this
Agreement, shall be resolved by the final and binding arbitration.
Whenever a party shall decide to institute arbitration proceedings, it
shall give written notice to that effect to the other party. The party giving
such notice shall refrain from instituting the arbitration proceedings for a
period of sixty (60) days following such notice to allow the parties time to
further attempt to come to an amicable resolution of the dispute.
The arbitration will be conducted by a panel of three (3) arbitrators
appointed in accordance with American Arbitration Association ("AAA") rules;
provided, however, that each party shall within thirty (30) days after the
institution of the arbitration proceedings appoint an arbitrator, and the two
arbitrators so appointed shall select a neutral arbitrator to be the chairman of
the arbitration panel, within thirty (30) days thereafter. If the arbitrators
appointed by the parties are unable to select a neutral arbitrator within such
thirty (30) day period, the neutral arbitrator shall be appointed in accordance
with the AAA rules. All arbitrators eligible to conduct the arbitration must
agree to render their opinion(s), determination(s) and award(s) within thirty
(30) days after the final arbitration hearing.
Arbitration shall be held in San Francisco, California according to the
commercial rules of the AAA; provided, however, that the parties shall be
entitled to take depositions and obtain discovery as provided in California Code
of Civil Procedure Section 1283.05, and the arbitrator or arbitrators shall have
the powers as set forth therein. In addition, the arbitrators shall have the
authority to impose sanctions for the failure of refusal of any party to permit
discovery as provided in California Code or Civil Procedure Section 1283.05 or
to comply with any discovery order or the arbitrators. Such sanctions against a
party may include, without limitation, one or more of the following: (i)
inference that facts alleged by the adverse party are true and correct; (ii) a
prohibition or limitation upon the evidence that may be presented by the party
being sanctioned; (iii) the entry of a default award in against the party being
sanctioned and in favor of the adverse
23
party, and (iv) the imposition or assessment of costs and attorneys' fees
against the party being sanctioned.
Neither any individual arbitrator nor the panel of arbitrators shall have
the power to award punitive damages under this Agreement, and any award of
punitive damages is expressly prohibited.
Decisions of the arbitrators shall be final and binding upon the parties.
Judgment on the arbitration award rendered by the arbitrators may be entered in
a court having jurisdiction. In any arbitration pursuant to this Agreement, the
arbitrators shall apply the substantive laws of the state of California.
24