Exhibit 10.19
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED ON PAGES 5, 6, 7, 9, 10, X-0, X-0,
X-0, X-0, X-0, X-0, X-0, X-0, B-10, B-11, C-7, X-00, X-00, X-00 XXX X-00 XXX
XXX BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
LICENSE AND OPTION AGREEMENT
This LICENSE AND OPTION AGREEMENT (the "Agreement") is made and entered
into this 17th day of November 1997 (the "Effective Date"), by and between
Biogen, Inc. ("Biogen"), a Massachusetts corporation, with principal offices
located at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, and Apollon,
Inc. ("Apollon"), a Pennsylvania corporation, with principal offices located at
Xxx Xxxxx Xxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxx 00000-0000. Each of Biogen and
Apollon are a "Party" to this Agreement and collectively they are the "Parties"
to the Agreement.
INTRODUCTION
1. Biogen is the owner of certain technology, patents and other
proprietary rights related to Hepatitis B virus;
2. Apollon desires a license from Biogen under the aforesaid technology,
patents and proprietary rights, and Biogen is willing to grant to Apollon such a
license on the terms and conditions set forth in this Agreement;
3. Apollon is the owner of certain technology, patents and other
proprietary rights related to DNA-based vaccines; and
4. Biogen desires an option from Apollon to obtain the rights to market
and sell products developed by Apollon under the aforesaid technology, patents
and proprietary rights, and Apollon is willing to grant to Biogen such an option
on the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual promises and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties, intending to be legally bound, agree as follows:
SECTION 1 DEFINITIONS
As used in this Agreement, the following terms, whether used in the
singular or plural, shall have the following meanings:
1.1 "Affiliate" shall mean, as applied to either Party, any corporation,
partnership, joint venture or other legal entity which Controls, is Controlled
by, or is under common Control with, such Party. The definition of "Control" is
set forth in Section 4.2 of this Agreement.
1.2 "Apollon Patent Rights" shall mean all Patents throughout the
Territory covering or related to Apollon Technology which Apollon owns on the
Effective Date or as to which Apollon acquires ownership at any time during the
term of this Agreement. Apollon Patent Rights existing as of the Effective Date
are set forth in Appendix A to this Agreement.
1.3 "Apollon Technology" shall mean all Intellectual Property, whether
patentable or not (i) which Apollon owns as of the Effective Date or as to which
Apollon acquires ownership at any time during the term of this Agreement,
related to DNA-based Vaccine Products, and (ii) which is necessary or useful in
order to offer for sale, import, sell or seek approval to market Licensed
Products. For purposes of this Agreement, Apollon Technology specifically
excludes any Intellectual Property, Patent Rights or other rights Apollon
controls or derives under the University Licenses.
1.4 "Biogen Patent Rights" shall mean all Patents throughout the Territory
covering or related to Biogen Technology which Biogen owns or controls on the
Effective Date or as to which Biogen acquires ownership or control at any time
during the term of this Agreement. Biogen Patent Rights existing as of the
Effective Date are set forth in Appendix B to this Agreement.
1.5 "Biogen Technology" shall mean all Intellectual Property, whether
patentable or not (i) which Biogen owns or controls as of the Effective Date or
as to which Biogen acquires ownership or control at any time during the term of
this Agreement, related to DNA sequences encoding Hepatitis B viral antigens,
and (ii) which is necessary or useful in order to discover, research, develop,
make, use, offer for sale, import, sell or seek approval to market Licensed
Products.
1.6 "Clinical Trial Information" shall mean all data and information of
whatever nature specifically developed in connection with the Licensed Products
by either Party under this Agreement and the Supply and License Agreement,
including preclinical and clinical trial protocols, reports and results
(including pharmacological, toxicological, pharmaceutical and other relevant
data) for the Licensed Products, applications for regulatory approval of the
testing, use or sale of Licensed Products, regulatory files and filings
(including master files, INDs, NDAs, BLAs, PLAs, PMAs and the like) made in
connection with the Licensed Products and all licenses from, correspondence
with, or approvals by regulatory authorities for the testing, use or sale of
Licensed Products.
1.7. "DNA-based Vaccine Product" shall mean a vaccine product containing a
DNA sequence encoding an antigen.
-2-
1.8 "Intellectual Property" shall mean information (general and specific),
developments, discoveries, inventions, patents, patent applications, know-how,
trade secrets, whether or not patented or patentable.
1.9 "License and Supply Agreement" shall mean the License and Supply
Agreement substantially in the form of Appendix C attached to this Agreement and
made a part hereof to be entered into between the Parties in the event Biogen
exercises the Option granted pursuant to Section 3.1 hereof.
1.10 "Licensed Products" shall mean any DNA-based Vaccine Product that (a)
comprises DNA encoding a polypeptide displaying Hepatitis B core, Hepatitis B
surface, and/or Hepatitis B e antigen specificity or antigenicity, and (b) the
manufacture, use, sale, offer for sale, or import of which (i) is covered by a
Valid Claim of any Biogen Patent Rights or Apollon Patent Right in the country
where such Licensed Product is manufactured, used, imported, offered for sale or
sold, and/or (ii) embodies or is developed using any of the Biogen Technology or
Apollon Technology. "Licensed Products" shall not include any Hepatitis B virus
vaccine for human use which contains recombinant Hepatitis B virus antigen, any
Prophylactic Vaccine Product or diagnostic products containing a Hepatitis B
virus antigen, or any DNA-based Vaccine Product, which, when injected into a
recipient, is incorporated into the genome of the recipient. For purposes of
this Agreement, "Prophylactic Vaccine Product" shall mean a DNA-based Vaccine
Product which is introduced to a patient prior to infection by the Hepatitis B
virus.
1.11 "Net Sales" shall mean the gross invoiced amount (not less than cost
and not dependent on whether such invoices have been actually paid) on sales of
Licensed Products sold by a Party and its Affiliates and sublicensees, in bona
fide arms' length transactions less the following items, as determined from the
books and records of the Party making such sale, its Affiliates and
sublicensees, provided that such items do not exceed reasonable and customary
amounts in the country in which such Sale occurred: (i) freight and insurance if
billed separately; (ii) amounts repaid or credited by reason of returns or
rejections; (iii) sales taxes, excise taxes and other taxes (other than income
taxes) levied on the invoiced amount; (iv) cash, trade and quantity discounts
actually given or made; (v) rebates paid pursuant to government regulations; and
(vi) commissions paid to distributors or other sales agencies that are included
in the gross sales price, if supported by receipts provided to Biogen. A sale
of Licensed Products to an Affiliate for re-sale of Licensed Products by such
Affiliate shall not be considered a Sale for the purposes of this provision, but
the re-sale of such Licensed Products by the Affiliate shall be a Sale for
purposes of this Agreement. Any use of Licensed Products by a Party or any of
its Affiliates or sublicensees, other than for quality assurance, quality
control or research purposes, shall be considered a Sale for accounting and
royalty purposes and Net Sales for such use or for Sale by gift shall be the
average sales price of Licensed Products Sold in an arms' length transaction by
such Party and its Affiliates and sublicensees during the applicable royalty
reporting period or, if no such arms' length transaction occurred in such
period, during the last royalty reporting period in which such arms' length
transaction occurred.
-3-
In the event that consideration in addition to or in lieu of money is
received for the Sale of Licensed Products in an arms' length transaction, the
fair market value of such consideration shall be included in the determination
of Net Sales for such Sale. To the extent that Licensed Products are Sold in
other than an arms' length transaction, Net Sales for such Sale shall be the
average Sale price of Licensed Products if Sold in an arms' length transaction
during the applicable royalty reporting period in the country in which the
non-arms' length transaction occurred.
In the event that Licensed Products are Sold by a Party or any of its
Affiliates or sublicensees in the form of a combination Licensed Product
containing one or more active ingredients in addition to the Licensed Product,
Net Sales for the combination Licensed Product shall be determined by
multiplying actual Net Sales of the combination Licensed Product (determined by
reference to the standard Net Sales definition) during the royalty payment
period by the fraction A/A+B where A is the average Sale price of the Licensed
Product when Sold by the Party and its Affiliates and sublicensees separately in
finished form and B is the average Sale price of the other active ingredients
when Sold separately in finished form in each case during the applicable royalty
reporting period in the country in which the Sale of the combination Licensed
Product was made, or if Sales of both the Licensed Product and the other active
ingredients did not occur in such period, then in the most recent royalty
reporting period in which Sales of both occurred. In the event that such
average Sale price cannot be determined for both the Licensed Product and all
other active ingredients included in the combination Licensed Product, Net Sales
for purposes of determining payments under this Agreement shall be calculated by
multiplying the Sales with respect to the combination Licensed Product by the
fraction C/C+D where C is the standard fully-absorbed cost of the Licensed
Product portion of the combination and D is the sum of the standard
fully-absorbed costs of all other active ingredients included in the combination
Licensed Product, in each case, as determined by using the standard accounting
procedures used by the Party making the Sale, consistently applied. In no event
shall Net Sales with respect to a combination Licensed Product be reduced to
less than fifty percent (50%) of actual Net Sales with respect to such
combination Licensed Product (determined by reference to the standard Net Sales
definition) by reason of any adjustment provision set forth in this paragraph.
1.12 "Patent" shall mean all letters patents and pending patent
applications for patents of the United States and all countries foreign thereto,
including any provisional applications, priority applications, extensions,
reissues, reexaminations, renewals, continuations, continuations-in-part,
divisionals, certificates of invention and supplemental protection certificates.
1.13 "Person" shall mean an individual, a partnership, a joint venture, a
corporation, a trust, a business trust, a limited liability company or limited
liability partnership, an estate, an unincorporated organization, a government
or any department or agency thereof, or any other entity.
-4-
1.14 "Product Development Program" shall mean the development effort
conducted by Apollon, either alone or in partnership with others, to develop
Licensed Products, as such program is described in Section 5 hereof.
1.15 "Sale(s)" or "Sold" shall mean any gift, grant, sale, assignment,
transfer, conveyance or other disposition of a Licensed Product by a Party to
this Agreement or any of its Affiliates or sublicensees to another Person,
except distribution of samples provided at no charge to physicians, hospitals,
or clinics for promotional purposes or for purposes of the Product Development
Program, provided such distribution is not made in exchange for lower prices on
other products sold by such Party or other noncash consideration.
1.16 "Territory" shall mean worldwide.
1.17 "University License" shall mean any license or rights granted to
Apollon, at any time, under any Patent or Intellectual Property by (i) the
Trustees of the University of Pennsylvania; (ii) the Wistar Institute of Anatomy
and Biology; (iii) the Institute of Biotechnology and Advanced Molecular
Medicine; (iv) The General Hospital Corporation; or (v) any other third party
licensor, which are necessary or useful for the development, manufacture, use,
marketing or sale of Licensed Products.
1.18 "Valid Claim" shall mean (i) a claim of a pending patent
application which claim shall not have been canceled, withdrawn, abandoned or
rejected by an administrative agency from which no appeal can be taken; or (ii)
a claim of an issued and unexpired patent which has not lapsed or become
abandoned or declared invalid or unenforceable by a court of competent
jurisdiction or an administrative agency from which no appeal can be or is
taken.
SECTION 2 LICENSE GRANT TO APOLLON
2.1 License Grant to Apollon.
(a) Biogen hereby grants to Apollon, and Apollon hereby accepts from
Biogen, a semi-exclusive, royalty-bearing license, including the right to grant
certain sublicenses as set forth herein, to the Biogen Patent Rights and Biogen
Technology to research and develop, manufacture, have manufactured, use, sell,
have sold, offer for sale and import Licensed Products in the Territory. This
license shall remain in effect unless or until this Agreement is terminated
pursuant to Section 8 hereof.
(b) Each of Biogen and Apollon hereby acknowledge that Biogen has
previously granted a non-exclusive license to Viagene with respect to Hepatitis
B core antigen and Hepatitis B e antigen technology. Biogen hereby agrees that
during the term of this Agreement it will not grant further licenses to the
Biogen Patent Rights and Biogen Technology to any non-Affiliate of Biogen for
the development of a DNA-based Vaccine Product comprised of DNA sequences which
encode Hepatitis B viral-derived antigens without the prior written consent of
Apollon, which consent may be unreasonably withheld. [
-5-
]
2.2 Right to Sublicense. Apollon shall have the right to extend to its
Affiliates the rights and licenses granted to Apollon under this Section 2,
and for purposes hereof, such extension shall not be considered the grant of
a sublicense. Apollon shall have the right to grant, under the license
granted under this Section 2, multiple sublicenses to manufacture Licensed
Products and, in each country in the Territory, one sublicense to sell
Licensed Products. Each of Apollon and its sublicensee shall be entitled to
sell Licensed Products in such country in the Territory. For purposes of
this Agreement, distributors and distribution arrangements shall not be
considered sublicensees of Apollon. Apollon agrees that any sublicenses
granted by it shall prohibit further sublicenses by the sublicensee and shall
provide that the obligations of Apollon to Biogen hereunder, except the
Product Development Program obligations set forth in Section 4 hereof and the
supply obligations described in Section 6 hereof, shall be binding upon the
sublicensee as if it were a party to this Agreement. Apollon agrees to
forward to Biogen a copy of any and all sublicense agreements within thirty
(30) days of the execution of such sublicense agreements. Apollon shall have
the right to grant sublicenses to SmithKline Xxxxxxx Corporation or any of
its Affiliates ("SmithKline"), provided, however, that any such sublicense
agreement must include a clause that requires SmithKline to pay to Biogen an
amount equal to [ ] of Biogen's attorneys fees
in the event that Biogen obtains a final non-appealable judgment against
SmithKline in any legal action or arbitration arising in connection with a
dispute under the sublicense agreement.
2.3 Limitations of License Grant. Except as expressly provided in this
Section 2, nothing in this Agreement shall be deemed to xxxxx Xxxxxxx any rights
in, or license to, any product, Patent or Intellectual Property of Biogen.
Without limiting the generality of the foregoing, Apollon shall not be granted
any right hereunder to make, have made, use, offer for sale, sell or import any
products which are not Licensed Products.
2.4 License Fee. In consideration of the license granted by Biogen,
Apollon shall pay Biogen a non-creditable, non-refundable, license fee of
$[ ] (the "License Fee") on the Effective Date.
SECTION 3 OPTION GRANT TO BIOGEN
3.1 Option Grant to Biogen. Apollon hereby grants to Biogen an exclusive
option to obtain (i) an exclusive license under the Apollon Technology, with the
right to grant certain sublicenses, to sell, offer for sale and import Licensed
Products manufactured by or for Apollon for sale by Biogen in Japan and (ii)
associated contingent manufacturing rights in the event Apollon is unable or
unwilling to supply such Licensed Products (the "Option"). The Option is
exercisable by Biogen at any time during an initial period (the "Initial
Period") of two (2) years from the Effective Date of this Agreement. Prior to
expiration of such Initial Period, Biogen shall have the opportunity to renew
the Option in six month increments (the "Additional
-6-
Periods"), for a total Additional Period of up to two (2) additional years.
Notice of Biogen's intent to renew the Option must be received by Apollon at
least ninety (90) days prior to the expiration of the then current Initial
Period or Additional Period, as the case may be. The Initial Period and any
Additional Periods are hereinafter collectively referred to as the Option
Period. Biogen shall exercise the Option by providing Apollon with written
notice of its exercise of the Option during the Option Period. Upon exercise of
the Option, a license shall be granted automatically to Biogen through the
execution by the Parties of the License and Supply Agreement. Biogen may
terminate the Option Period at any time upon written notice to Apollon.
3.2 Option Fee. In consideration of the Option granted by Apollon
hereunder, Biogen shall pay Apollon a non-creditable, non-refundable fee of
$[ ] on the Effective Date. In the event that Biogen elects to extend
the Option beyond the Initial Period, Biogen shall pay Apollon an additional
$[ ] fee for each six-month Additional Period beyond the Initial Period.
Such extension fee shall be paid to Apollon at the time notice of Biogen's
intent to renew the Option is sent to Apollon.
3.3 Limitations of Option Grant. Except as expressly provided in this
Section 3, nothing in this Agreement shall be deemed to grant Biogen any rights
in, or license to, any product, Patent or Intellectual Property of Apollon.
Without limiting the generality of the foregoing, Biogen shall not be granted
any right hereunder to make or have made, or to use, sell, have sold, offer for
sale or import Licensed Products anywhere in the Territory other than in Japan.
In addition, nothing in this Agreement shall be deemed to grant Biogen any
rights in, or sublicense to, any product, Patent or Intellectual Property under
the University Licenses.
SECTION 4 ROYALTIES, OTHER PAYMENTS AND FINANCIAL REPORTS
4.1 Royalties to Biogen. Apollon shall pay to Biogen a royalty equal to
[ ] of the Net Sales of Licensed Products made by
Apollon and its Affiliates and sublicensees in all countries in the Territory
except Japan. If Biogen does exercise the Option granted pursuant to Section
3.1 hereof, the provisions of the License and Supply Agreement shall be
applicable to all Sales of Licensed Products in Japan. If Biogen does not
exercise the Option, following the expiration of the Option Period, Apollon
thereafter shall pay to Biogen a royalty equal to [ ]
of the Net Sales of Licensed Products made by Apollon and its Affiliates and
sublicensees in Japan. In no event shall any Net Sales of Licensed Products
be subject to assessment of more than one scheduled royalty, provided that
the highest applicable royalty shall be assessed on any Net Sales. The
obligation to pay royalties hereunder shall continue separately on a
country-by-country basis within the Territory with respect to each Licensed
Product Sold by Apollon, its Affiliates or sublicensees until the date on
which such Licensed Product or the manufacture, use, offer for sale, import
or sale of such Licensed Product is no longer covered by a Valid Claim of
Biogen Patent Rights in such country.
4.2 Change in Control Payments. In the event a change in Control of
Apollon occurs during the term of this Agreement relative to the Control in
existence on the Effective Date,
-0-
Xxxxxxx shall make each of the following non-refundable, non-creditable payments
to Biogen upon achievement of each of the following milestones:
Event Payment
----- -------
FDA approval of the first Licensed Product $2,700,000
EMEA approval of the first Licensed Product $2,700,000
"Control" shall mean, including, with correlative meaning, the terms "Controlled
by"and "under common Control with", as used with respect to any Person, the
possession, directly or indirectly, of the power to vote fifty percent (50%) or
more of the outstanding voting securities of such Person, or to direct or cause
the direction of the management or policies of such Person, whether through the
ownership of voting securities, by contract or otherwise. Notwithstanding the
foregoing, in the event Control of Apollon is acquired by any entity other than
an entity qualified as a "Fortune 500 company", a majority-owned subsidiary of a
Fortune 500 company or an entity which is the equivalent thereof, such
acquisition shall not be deemed a change in Control of Apollon for purposes of
this Section 4.2. In the event a change in Control of Apollon occurs, each
payment shall become due and payable in full to Biogen within 30 days of a
change in Control of Apollon if the milestone event was achieved prior to, or
concurrently with, such change in Control. If either milestone event is
achieved subsequent to a change in Control of Apollon, the payment obligation
shall vest on the date such milestone event is achieved and shall be paid in
full to Biogen within 30 days of the date such milestone event is achieved.
4.3 Payment Schedule and Reports. On or before forty-five (45) days
following the end of each calendar quarter occurring after the first commercial
Sale of a Licensed Product, Apollon shall pay to Biogen the royalty payments
owed by it with respect to Net Sales of Licensed Products during such calendar
quarter. Such payment shall be accompanied by a report on a country-by-country
basis showing (i) the aggregate actual Sales volume of Licensed Products by
Apollon and its Affiliates and sublicensees, (ii) aggregate Net Sales,
(iii) gross invoice price(s) of Licensed Product(s) Sold, (iv) deductions from
gross invoice price permitted hereunder and (v) the royalty payable hereunder.
Such payment shall also be accompanied by a copy of any reports received by
Apollon from its Affiliates or sublicensees during the preceding calendar
quarter as shall be pertinent to a royalty accounting hereunder. All reports
shall show all amounts reported in the currency in which Sales were made, and in
United States dollars at the conversion rate described in Section 4.7.
4.4 Books and Records. Apollon and each of its Affiliates and
sublicensees shall maintain such books and records as are necessary to establish
the accuracy of the reports submitted under Section 4.3 for a period of five (5)
years from the date of submission of such reports. Such books and records shall
be maintained on the accrual basis of accounting in accordance with generally
accepted accounting principles.
4.5 Audits. Upon the written request of Biogen, and not more than once in
each calendar year, Apollon shall permit Biogen, at Biogen's expense, to have
access during normal
-8-
business hours to such of the records of Apollon as may be reasonably necessary
to verify the accuracy of the royalty reports provided under this Section 4.
Any audit so requested shall be performed on Biogen's behalf by an independent
accounting firm of nationally recognized standing reasonably satisfactory to
both Parties. If Biogen concludes, based on the audit results, that additional
royalties were owed during the financial periods audited, Apollon shall pay the
additional royalties within fifteen (15) days of the date Biogen delivers to
Apollon a written report so concluding. The costs associated with any audit
conducted under this Section 4.5 shall be paid by Biogen; provided, however, if
the audit correctly discloses that the royalties payable by Apollon for the
audited period are more than one hundred ten percent (110%) of the royalties
actually paid for such period, then Apollon shall pay the reasonable fees and
expenses charged by the accounting firm conducting the audit, and provided,
further, that if Apollon grants a sublicense to SmithKline, then Apollon shall
pay [ ] of such reasonable fees and expenses.
4.6 Confidentiality of Financial Information. Both Parties shall treat
all financial information subject to review under this Section 4, and all
reports generated hereunder, as confidential and shall use such reports and
financial information only for the purposes contemplated by this Section 4.
4.7 Currency. All payments required to be made under this Agreement shall
be made in U.S. dollars. Monetary conversions from the currency of a foreign
country into U.S. dollars shall be made at the exchange rate for buying U.S.
dollars in force on the last business day of the period for which the Net Sales
are reported in accordance with Section 4.3 as reported by The Wall Street
Journal, or on another basis mutually agreed upon by the Parties in writing.
4.8 No Deductions. The royalty payments computed or specified under this
Section 4 are the actual amounts to be paid to Biogen and shall not be reduced
in any way including, but not limited to, by any payment obligations owed to
Apollon or its Affiliates and sublicensees by Biogen under this Agreement. In
the event a Party or its Affiliates or sublicensees are required to make a
deduction or withholding of tax, then the amount payable to the other Party
shall be increased to the extent necessary to ensure that after the making of
such deduction or withholding, the other Party receives and retains an amount
equal to what it would have received and retained had no such deduction or
withholding been made by the paying Party or its Affiliates or sublicensees.
Each Party agrees to assist the other by submitting declarations to the relevant
authorities as may be required with regard to each Party's status in relation to
a deduction or withholding of taxes.
SECTION 5 PRODUCT DEVELOPMENT PROGRAM
5.1 Conduct of Program. Apollon will devote sufficient resources and
commercially reasonable efforts to the diligent conduct of a Product Development
Program, the objects of which are: (i) to develop one or more Licensed
Products; (ii) to conduct preclinical and clinical trials of such Licensed
Products; (iii) to obtain regulatory approvals for the sale of such Licensed
Products in all countries throughout the Territory where Apollon reasonably
believes it is
-9-
commercially prudent to offer Licensed Products for Sale; (iv) to develop
markets for such Licensed Products in such countries; and (v) to sell Licensed
Products in such countries. Without limiting the generality of the foregoing,
Apollon shall:
[
]
In the event Apollon does not achieve one of the foregoing milestone events
within the established time period, Apollon shall extend the Option Period set
forth in Section 3.1 hereof, without charge to Biogen, in an amount of time
equal to the delay between the end of such established time period and actual
achievement of the milestone event. Thereafter, the extension of the Option
Period, and the related extension payments set forth in Section 3.2 hereof,
shall continue. In the event Apollon misses one of the foregoing milestone
events by more than one (1) year, Biogen shall thereafter have the right to
terminate this Agreement or the license granted under Section 2 hereof.
5.2 Reporting. Apollon will report regularly (at least every twelve (12)
months) commencing one year from the Effective Date in writing to Biogen on the
progress of the Product Development Program. Failure to report within sixty
(60) days of the required date will result in an increase in the royalties paid
by Apollon to Biogen under Section 4 hereof in the amount of 0.1% for each such
late report, provided that Apollon shall have thirty (30) days from receipt of
notice from Biogen to cure any such failure to report prior to such increase in
the royalty payments. Biogen may, in its discretion, waive its rights under
this Section 5.2 if the ongoing scientific exchange between the Parties is
sufficiently extensive during any calendar year such that a written report is
unnecessary. Without limiting the generality of the foregoing, Apollon will
furnish Biogen with copies of protocols for completed clinical trials for
Licensed Products and reports on progress and summaries of results of
pre-clinical tests and clinical trials for Licensed Products carried out
pursuant to the Product Development Program (including but not limited to
pharmacological, toxicological, clinical, pharmaceutical and other relevant
data), specifications for Licensed Products, reports on progress in obtaining
relevant government approvals with respect to Licensed Products in the
Territory, and steps taken towards marketing Licensed Products in the Territory.
5.3 Access to Clinical Trial Information. Except as hereafter set forth,
Apollon shall not be obligated to provide any Clinical Trial Information to
Biogen until such time as Biogen has exercised the Option granted hereunder.
Apollon shall provide to Biogen all Clinical Trial Information which is
necessary or useful to Biogen for its evaluation of whether to exercise the
-10-
Option granted pursuant to Section 3.1 hereof. In the event Biogen exercises
the Option, Apollon shall provide Biogen further access to Clinical Trial
Information in accordance with the terms of the License and Supply Agreement.
Biogen and its Affiliates shall provide Apollon and its Affiliates with access
to all Clinical Trial Information developed by Biogen and its Affiliates related
to Licensed Products, including all regulatory filings made by Biogen and its
Affiliates in Japan, and all governmental responses thereto. Notwithstanding
the foregoing, Biogen shall own all of its Clinical Trial Information and
regulatory filings in Japan related to Licensed Products and Apollon shall own
all its Clinical Trial Information and all related reports provided pursuant to
Section 5.2, as well as all regulatory filings made throughout the Territory
except in Japan related to Licensed Products.
5.4 Final Product Specifications. Upon the first submission by Apollon,
its Affiliate or a sublicensee of a BLA(PLA) to the United States Food and Drug
Administration (USFDA) or equivalent agency in any country in the Territory for
approval of the marketing of any Licensed Product, Apollon will furnish Biogen
with a detailed specification for such Licensed Product, and thereafter Apollon
will promptly furnish Biogen with any modifications or updates of such
specification (as so modified or updated, the "Specification").
SECTION 6 SUPPLY AGREEMENT
6.1 Agreement to Supply. Upon the exercise of the Option granted under
Section 3.1 hereof, Apollon shall manufacture, or have manufactured on its
behalf, and sell to Biogen sufficient quantities of Licensed Products to meet
the requirements of Biogen, its Affiliates and sublicensees for use by Biogen,
its Affiliates and sublicensees in the conduct of preclinical and clinical
trials in Japan and for the sale of Licensed Products in Japan. The specific
terms of the agreement to supply, and the related contingent manufacturing
rights, are set forth in Section 5 of the License and Supply Agreement, which
License and Supply Agreement shall be executed by the Parties upon exercise of
the Option granted under Section 3.1 hereof.
6.2 Event of Bankruptcy. For the purposes of this Agreement, the Parties
agree and acknowledge that (i) the grant of rights to Biogen upon the exercise
of the Option is a grant of "Intellectual Property" rights to market and sell,
offer for sale and import, and (ii) in interpreting this Agreement, the
provisions of the Agreement granting such rights are to be governed by, and
Biogen is to have the benefit of a licensee under, Section 365(n) of the United
States Bankruptcy Code, as amended.
SECTION 7 WARRANTIES, LIABILITY AND DISCLAIMERS OF WARRANTY
7.1 Warranty of Title. Biogen warrants and represents that it owns all of
the right, title and interest in and to the Biogen Patent Rights.
7.2 Warranty of Authority. Each of the Parties hereto warrants and
represents to the other Party that, as of the Effective Date (i) it has the
full, right power and authority to enter into this Agreement and to carry out
its obligations hereunder, (ii) this Agreement constitutes the valid
-11-
obligation of such Party, enforceable against it in accordance with its terms,
and (iii) the execution and delivery of this Agreement and the performance of
such Party's obligations hereunder (a) does not conflict with or violate any
requirement of applicable laws or regulations, and (b) does not conflict with,
or constitute a default under, any contractual obligation of such Party.
7.3 DISCLAIMER OF WARRANTY. EXCEPT AS PROVIDED IN SECTION 7.1 ABOVE AND
IN THIS SECTION 7.3, BIOGEN AND APOLLON MAKE NO WARRANTIES OR REPRESENTATIONS
WHATSOEVER, WHETHER EXPRESS OR IMPLIED, HEREUNDER; IN PARTICULAR NEITHER PARTY
MAKES A WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY OF ANY
PRODUCT PRODUCED UNDER THE LICENSE OR OPTION GRANTED HEREBY. MOREOVER, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY THAT THE MANUFACTURE OR SALE OF
LICENSED PRODUCTS OR THE USE OF LICENSED PRODUCTS BY ANY PERSON OR ENTITY WILL
NOT CONSTITUTE AN INFRINGEMENT OF THE PATENT OR OTHER INTELLECTUAL PROPERTY
RIGHTS OF OTHERS. NOTWITHSTANDING THE FOREGOING, EACH PARTY HEREBY REPRESENTS
AND WARRANTS THAT AS OF THE DATE HEREOF IT HAS NOT RECEIVED WRITTEN NOTICE FROM
ANY THIRD PARTY OF ANY SUCH INFRINGEMENT. IN NO EVENT SHALL EITHER PARTY BE
LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST REVENUES OR
PROFITS.
7.4 Indemnification and Insurance. (a) Apollon shall indemnify and hold
Biogen and its Affiliates and their respective officers and employees harmless
from and against any losses, liabilities, costs and expenses (including court
costs and attorney's fees) arising out of or relating to any suits or
liabilities whatsoever (including claims for product liability) to the extent
arising out of the design, manufacture, use, sale or promotion of Licensed
Products except, in all instances, (i) to the extent caused by Biogen's
promotional or sales practices in connection with the use or Sales of Licensed
Products by Biogen and/or the manufacture of Licensed Products by Biogen under
the License and Supply Agreement, (ii) negligence or intentional misconduct by
Biogen or its Affiliates and their respective officers and employees or (iii)
breach of any term of this Agreement by Biogen or its Affiliates and their
respective officers and employees.
(b) Biogen shall indemnify and hold Apollon and its Affiliates and
their respective officers and employees harmless from and against any losses,
liabilities, costs and expenses (including costs and attorney's fees) to the
extent arising out of, or relating to any suits or liabilities whatsoever
(including claims for product liability) related to, (i) Biogen's promotional
and sales practices in connection with the use or Sales of Licensed Products by
Biogen and/or the manufacture of Licensed Products by Biogen under the License
and Supply Agreement, (ii) negligence or intentional misconduct by Biogen or its
Affiliates and their respective officers and employees or (iii) breach of any
term of this Agreement by Biogen or its Affiliates and their respective officers
and employees.
-12-
(c) A party (the "Indemnitee") that intends to claim indemnification
under this Section 7.4 shall promptly notify the other party (the "Indemnitor")
of any liability or action in respect of which the Indemnitee intends to claim
such indemnification, and the Indemnitor shall have the right to participate in,
and, to the extent the Indemnitor so desires, jointly with any other Indemnitor
similarly noticed, to assume the defense thereof with counsel selected by the
Indemnitor; provided, however, that an Indemnitee shall have the right to retain
its own counsel, with the fees and expenses to be paid by the Indemnitor, if
representation of such Indemnitee by the counsel retained by the Indemnitor
would be inappropriate due to actual or potential differing interests between
such Indemnitee and any other party represented by such counsel in such
proceedings. The indemnity obligations under this Section 7.4 shall not apply
to amounts paid in settlement of any loss, claim, damage, liability or action if
such settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld unreasonably. The Indemnitor may not settle the action or
otherwise consent to an adverse judgment in such action that diminishes the
rights or interests of the Indemnitee without the express written consent of the
Indemnitee. The Indemnitee, its employees and agents, shall cooperate fully
with the Indemnitor and its legal representatives as requested by the Indemnitor
and at the Indemnitor's expense in the investigation of any action, claim or
liability covered by this indemnification.
(d) Biogen and Apollon each shall maintain product liability
insurance with respect to development, manufacture and sales of Licensed
Products by Biogen or Apollon, as the case may be, in such amount as is
customary in the industry. Each party shall be named as an additional insured
insofar as its rights of indemnification hereunder are concerned on any such
policies of the other party. Biogen and Apollon, as applicable, shall each
maintain such insurance for so long as it continues to manufacture or sell any
Licensed Products.
SECTION 8 TERMINATION
8.1 Breach by Apollon. Biogen may terminate this Agreement or the license
granted to Apollon hereunder upon breach by Apollon of the obligation to pay any
amount due hereunder or of any other obligation or condition, effective thirty
(30) days after giving written notice to Apollon of such termination in the case
of a payment breach and ninety (90) days after giving written notice to Apollon
of such termination in the case of a non-payment breach, which notice shall
describe such breach. The foregoing notwithstanding, if the default or breach
is cured or shown to be non-existent or not material within the thirty (30) or
ninety (90) day period, as the case may be, the notice shall be deemed
automatically withdrawn and of no effect.
8.2 Event of Bankruptcy. Upon the occurrence of an event of bankruptcy
with respect to either Party, the other Party may terminate this Agreement or
the licenses, rights or options granted to the bankrupt Party hereunder with
immediate effect by delivering written notice of said termination to the
bankrupt Party.
8.3 Challenge of Patents. Except in jurisdictions in which it would be
illegal to do so, Biogen may immediately terminate this Agreement or the
licenses granted to Apollon hereunder in the event Apollon or any of its
Affiliates files a revocation or nullity proceeding
-13-
with respect to any of the Biogen Patent Rights or challenges the validity of
any of the Biogen Patent Rights. Except in jurisdictions in which it would be
illegal to do so, Apollon may immediately terminate this Agreement or the Option
granted to Biogen hereunder in the event Biogen or any of its Affiliates files a
revocation or nullity proceeding with respect to any of the Apollon Patent
Rights or challenges the validity of any of the Apollon Patent Rights.
The provisions of this Section 8.3 shall be deemed deleted from this
Agreement in any jurisdiction in which the inclusion of such provisions would be
illegal or would make this Agreement or any part hereof unenforceable.
8.4 Breach by Biogen. Apollon may terminate this Agreement and/or the
Option granted to Biogen hereunder in the event Biogen breaches its obligation
to pay any amount due hereunder to Apollon or breaches any other obligation or
condition hereunder, effective thirty (30) days after giving payment breach and
ninety (90) days after giving written notice to Biogen of such termination in
the case of a non-payment breach, which notice shall describe such breach. The
foregoing notwithstanding, if the default or breach is cured or shown to be
non-existent or not material within the thirty (30) or ninety (90) day period,
as the case may be, the notice shall be automatically withdrawn and of no
effect.
8.5 Effect of Termination of Licenses.
(a) In the event Biogen terminates the licenses granted to Apollon
hereunder, in accordance with the other provisions of this Section 8, but does
not terminate this Agreement, then Section 6 related to the agreement to supply
Licensed Products shall continue in effect and Apollon shall be deemed to have
such licenses from Biogen as may be necessary to fulfill its obligations
thereunder.
(b) Apollon may voluntarily terminate the licenses granted to it
under this Agreement at any time on ninety (90) days prior written notice to
Biogen, provided that if Apollon terminates the licenses granted to it hereunder
but does not terminate this Agreement, then, at Biogen's option, Section 6
related to the agreement to supply Licensed Products shall continue in effect
and Apollon shall be deemed to have such licenses from Biogen as may be
necessary to fulfill its obligations thereunder.
8.6 Survival. All provisions of Section 4.6 and Section 10 shall survive
termination of this Agreement.
8.7 No Prejudice. Any termination under this Section 8 shall be without
prejudice to the rights of either Party against the other then accruing or
otherwise accrued under this Agreement.
-14-
SECTION 9 NOTICES
Any notice required or permitted to be given hereunder shall be sent in
writing by registered or certified mail, postage prepaid, return receipt
requested, by telefax, confirmation received, by overnight delivery using a
nationally recognized overnight courier or by hand delivery, addressed to the
Party to whom it is to be given as follows:
If to Biogen: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telefax: (000) 000-0000
Attention: Vice President - Marketing and Sales
With a copy to: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telefax: (000) 000-0000
Attention: Vice President - General Counsel
If to Apollon: Apollon, Inc.
Xxx Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, Xxxxxxxxxxxx 00000-0000
Telefax: (000) 000-0000
Attention: President and CEO
With a copy to: Xxxxxxx Xxxxx Xxxxxxx & Xxxxxxxxx
0000 Xxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxxxxxxxx, XX 00000
Telefax: (000) 000-0000
Attention: Xxxxxx Xxxxxxx, Xx.
or to such other address or addresses as may from time to time be given in
writing by either Party to the other as aforesaid. Any notice sent pursuant to
this Section shall be deemed delivered within three (3) days if sent by mail and
within twenty-four (24) hours if sent by telefax, overnight courier or hand
delivery.
SECTION 10 CONFIDENTIALITY
10.1 Obligations. Except for the proper exercise of its rights under this
Agreement, each of the Parties agrees that it and its Affiliates will not
publish or otherwise divulge or deliver to another Person, except their
sublicensees hereunder, or use for its or their own benefit Technology, Patent
Rights, Clinical Trial Information, reports, records, manuals, regulatory
filings or other confidential information disclosed pursuant to this Agreement
(collectively, the "Confidential Information") provided to it by the other Party
without the prior written approval
-15-
of the Party disclosing such information (the "Disclosing Party") in each
instance. The foregoing obligation shall not be imposed on either Party with
respect to any Confidential Information which it can demonstrate (i) was at the
time of disclosure to it (or thereafter, but prior to its publication,
divulgence or use for the benefit of the Receiving Party or any of its
Affiliates, become through no fault of the Receiving Party or its Affiliates) a
part of the public domain by publication or otherwise; or (ii) was already
properly and lawfully in its possession at the time it was received from the
Disclosing Party; or (iii) was lawfully received from a third party who was
under no obligation of confidentiality to the Disclosing Party with respect
thereto; or (iv) is required by law to be disclosed (but only to the extent of
such required disclosure).
10.2 Confidentiality Agreements. Each Party represents that it has
employment agreements with its and its Affiliate's key employees having
confidentiality commitments consistent with its obligations hereunder and will
require all of its consultants, agents, sublicensees, or others who have access
to any of such Confidential Information of the other Party to execute
confidentiality agreements covering all Confidential Information of the other
Party, and will exercise its best efforts to obtain compliance therewith.
10.3 Remedies. In the event of a breach or a threatened breach of the
terms of this Section 10, the Disclosing Party shall be entitled to an
injunction restraining the Receiving Party and its Affiliates and sublicensees
and their officers, employees, agents and consultants from continuing or
committing such breach, without showing or proving any actual damage. In the
event of such breach, the Disclosing Party shall, in addition to injunctive
relief, be entitled to all other remedies provided by law, including an award of
damages.
SECTION 11 PUBLICITY
If the Parties agree to publicize this Agreement, Biogen and Apollon will
coordinate to issue a joint press release in mutually agreed form concerning the
execution of this Agreement. Such announcement shall be made at such time as
agreed by Biogen and Apollon. Except for such joint release, unless required to
do so by law or by the rules of any exchange or over-the-counter market upon
which any of Biogen's or Apollon's securities are traded or unless such
information has been previously disclosed, neither Party will issue any press
release or make any public disclosure or announcement concerning the terms of
this Agreement or the transactions contemplated hereby without the prior
approval of the other Party hereto. Prior to making any such press release or
public announcement, the Party making such release or public announcement shall
consult with the other Party hereto with respect to the timing and content of
such press release or public announcement at least five (5) business days prior
to the proposed release or announcement. Without limiting the generality of the
foregoing, neither Party shall use the name of the other in connection with the
marketing or sale of Licensed Products without the prior written consent of such
Party.
-16-
SECTION 12 DISPUTES
Any dispute, claim, or difference arising in connection with this Agreement
or as to the rights or liabilities of the Parties hereunder (each such event
being hereinafter called a "dispute"), shall be referred to arbitration, in
accordance with the Commercial Arbitration Rules (the "Rules") of the American
Arbitration Association (hereinafter referred to as the "Association"), as
supplemented hereby. All arbitration proceedings shall occur in Boston,
Massachusetts. The arbitration panel shall consist of three arbitrators. The
Party initiating arbitration shall nominate one arbitrator (who shall not be
affiliated with such Party) in the request for arbitration and the other Party
shall nominate a second arbitrator (who shall not be affiliated with such Party)
in the answer thereto. The two arbitrators so named will then jointly appoint
the third arbitrator as chairman of the arbitration panel. If either Party
fails to nominate its arbitrator, or if the arbitrators named by the Parties
fail to agree on the person to be named as chairman within sixty (60) days, the
President of the Association shall make the necessary appointments of an
arbitrator or the chairman of the arbitration panel.
The arbitration panel as designated above shall proceed to arbitrate the
dispute by giving notice to all parties of its proceedings and hearings in
accordance with the Association's applicable procedures. Within fifteen (15)
days after all three arbitrators have been appointed, an initial meeting among
the arbitrators and counsel for the Parties shall be held for the purpose of
establishing a plan for administration of the arbitration, including: (i)
definition of issues; (ii) scope, timing and type of discovery, which may at the
discretion of the arbitrators include production of documents in the possession
of the Parties, but may not, without the consent of the Parties, include
depositions; (iii) exchange of documents and filing of detailed statements of
claims and prehearing memoranda; (iv) schedule and place of hearings; and (v)
any other matters that may promote the efficient, expeditious and cost-effective
conduct of the proceeding. The substantive law of the Commonwealth of
Massachusetts shall be applied by the arbitrators to the resolution of the
dispute, provided that the arbitrators shall base their decision on the express
terms, covenants and conditions of this Agreement. The arbitrators shall be
bound to make specific findings of fact and reach conclusions of law, based upon
the submissions and evidence of the Parties, and shall issue a written decision
explaining the basis for the decision and award. The Parties agree that the
arbitrators shall have no power to alter or modify any express provision of this
Agreement or to render any award which, by its terms, effects any such
alteration or modification.
The award of the arbitration panel shall be final and judgment upon such an
award may be entered in any competent court or application may be made to any
competent court for judicial acceptance of such an award and an order of
enforcement. In the event of any procedural matter not covered by the aforesaid
Rules, the procedural law of the Commonwealth of Massachusetts shall govern.
-17-
SECTION 13 MISCELLANEOUS
13.1 Amendments, Waivers. This Agreement may be amended and any of its
terms or conditions may be waived only by a written instrument executed by both
Parties, or, in the case of a waiver, by the Party waiving compliance. The
failure of any Party at any time to require performance of any provision hereof
shall in no manner affect its rights at a later time to enforce the same. No
waiver by any Party of any condition or term in any instance shall be construed
as a further or continuing waiver of such condition or term or of another
condition or term.
13.2 Force Majeure. Any delays in or failures of performance by any Party
under this Agreement shall not be considered a breach of this Agreement if and
to the extent caused by occurrences beyond the reasonable control of the Party
affected, including, but not limited to: acts of God; acts, regulations or laws
of any government (including, without limitation, import and export
regulations); peril of the sea; strikes or other concerted acts of workers;
fires; floods; explosions; riots; wars; rebellion and sabotage; and any time for
performance hereunder shall be extended by the actual time of delay caused by
such occurrence. Each Party shall promptly give notice to the other of the
start and stop should it be so affected by any of the above-mentioned
occurrences.
13.3 Interest On Late Payments. Each Party shall have the right to charge
the other interest on a per diem basis on all payments which are past due at an
annual rate of two percent (2.0%) over the prime rate then in effect at the
BankBoston or its successors.
13.4 Cooperation. Each Party agrees to cooperate with the other Party in
any and all efforts by such other party to obtain patent term extensions or
other extensions as provided by law in territories where Valid Claims under such
other Party's patents applicable to Licensed Products now or hereafter exist.
13.5 Binding Nature. This Agreement shall be binding upon and inure to the
benefit of and be enforceable by the Parties hereto and their respective
successors and permitted assigns.
13.6 Assignment. Neither this Agreement nor any of the rights, interests,
or obligations hereunder shall be assignable by either of the Parties hereto or
by operation of law without the prior written consent of the other Party hereto;
provided, however, that any Party may assign its rights, interests and
obligations hereunder to any entity with which such party may merge or
consolidate or to which such Party may transfer substantially all of its assets,
without obtaining the consent of the other Party. Notwithstanding the
foregoing, either Party may assign its right to receive payments hereunder, and
either Party and its sublicensees will execute any documents or instruments
reasonably required by the other Party in connection with any such assignment.
Any purported assignment in violation of the provisions of this Section shall be
void, and all rights, interests or obligations so assigned thereby shall return
to the assigning Party or its successors.
-18-
13.7 Severability. The Parties intend this Agreement to be enforced as
written. However, if any provision of this Agreement should be or become
fully or partly invalid or unenforceable for any reason or violate any
applicable law, this Agreement is to be considered divisible as to such
provision and such provision is to be deleted from this Agreement, and the
remainder of this Agreement shall be deemed valid and binding as if such
provision were not included herein. There shall be substituted for any such
provision deemed to be deleted a suitable provision which, as far as is
legally possible, comes nearest to the Parties' original intent.
13.8 Entire Agreement. This Agreement contains the entire agreement
between the Parties hereto with respect to the subject matter set forth
herein and supersedes any and all other agreements, oral or written, in
respect of the subject matter of this Agreement.
13.9 Captions. The captions to the Sections of this Agreement are for
convenience only and shall not be considered in interpreting this Agreement.
13.10 Governing Law. This Agreement shall be governed by and
construed in accordance with the law of the Commonwealth of Massachusetts
without regard to conflict of law provisions.
13.11 Counterparts. This Agreement may be executed in counterparts,
each of which shall be deemed an original and all of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto have duly caused this Agreement to
be executed in duplicate by their duly authorized representatives as of the
day and year first above written.
BIOGEN, INC. APOLLON, INC.
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxxx X. Xxxxxxxx
------------------------- -------------------------
Name: Xxxxx X. Xxxxx Name: Xxxxxxx X. Xxxxxxxx
Title: President and CEO Title: President and CEO
-19-
APPENDIX A
APOLLON PATENT RIGHTS
APPENDIX A
Apollon Patent Rights
1. [ ]
2. [ ], USSN 08/314,060, "Multifunctional Molecular Complexes for Gene
Transfer to Cells", Xxxxxx, [ ]
3. [ ], USSN 08/809,397, "Multifunctional Molecular Complexes for Gene
Transfer to Cells", Xxxxxx, [ ]
4. [ ]
5. [ ]
6. [ ], USSN 08/642,045, "Chimeric Kanamycin Resistance Gene",
Satishchandran, Snyder, [ ]
7. [ ]
8. [ ]
9. [ ]
A-1
APPENDIX B
BIOGEN PATENT RIGHTS
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (Xxxxxx) (Xxxxx)
------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
Argentina 279,403 12/20/79 Patent 237,579
Australia 54170/79 12/24/79 Patent 539,535
[ ]
[ ]
Brunei 37/95 9/95 Patent
B-1
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
[ ]
Chile 855/79 12/20/79 Patent 32,398
Expired
[ ]
Croatia 381-03/94- 9/22/92 Patent
01/0306 P.940049N
[ ]
Denmark 5480/79 12/20/79 Patent 171,727
B-2
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
[ ]
European 79303017.2 12/21/79 Patent 13 828
Patent Office (EP 13 828)
Austria
Belgium
France
Italy
Luxembourg
Netherlands
Sweden
Switzerland
West Germany
Great Britain
B-3
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
European 185201908.2 11/19/85 Patent 182 442
Patent Office (EP 182 442)
(DIV 1)
Austria
Belgium
France
Italy
Luxembourg
Netherlands
Sweden
Switzerland
West Germany
Great Britain
B-4
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
-----------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
Finland 794001 12/20/79 Patent 00000
Xxxxxx 60822 12/20/79 Patent 73,675
Expired
Hungary BI-601 12/20/79 Patent 000-000
Xxxxxxx 2494/79 12/20/79 Patent 53,176
Israel 59007 12/20/79 Patent 59,007
Japan 164945/79 12/20/79 Patent 2530801
B-5
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
Japan 62-112627 5/11/87 Patent 0000000
(DIV 1)
Japan 62-112628 5/11/87 Patent 0000000
(DIV 2)
Japan 62-112629 5/11/87 Patent 0000000
(DIV 3)
Japan 62-112630 5/11/87 Patent 2511962
(DIV 4)
Macedonia PP-088/94 5/19/94 Patent PP-088/94
[ ]
B-6
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
Malaysia PI-8701323 8/13/87 Patent
MY-102,686-A
Mexico 92-2875 6/15/92 Patent 184,206
New Zealand 192465 12/20/79 Patent 192,465
[ ]
[ ]
B-7
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
Portugal 70626 12/21/79 Patent 70,626
Slovenia P79 1 3127 11/17/92 Patent
79 1 3127
[ ]
South Africa 79/6921 12/20/79 Patent 79/6921
Spain 487,106 12/20/79 Patent 487,106
[ ]
B-8
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
United States 363,763 3/31/82 Patent
(B4A CON) (Xxxxxx) 4,710,463
[ ]
[ ]
[ ]
[ ]
B-9
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
[ ]
[ ]
[ ]
[ ]
[ ]
[ ]
[ ]
[ ]
B-10
B4 - Hepatitis - Xxxxxx and Xxxxxxxx (continued) (Xxxxxx) (Xxxxx)
------------------------------------------------
Filing
Country Serial No. Date Status
------- ---------- ------ ------
[ ]
[ ]
Uruguay 21,021 12/21/79 Patent 11,958
Xxxxxxxxx 0000/00 12/19/79 Patent 43,357
Yugoslavia P-3127/79 12/20/79 Patent 44.186
[ ]
B-11
APPENDIX C
FORM OF SUPPLY AND LICENSE AGREEMENT
SUPPLY AND LICENSE AGREEMENT
This SUPPLY AND LICENSE AGREEMENT (the "Agreement") is made and entered
into this ___ day of ________ ____ (the "Effective Date"), by and between
Biogen, Inc. ("Biogen"), a Massachusetts corporation, with principal offices
located at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, and Apollon,
Inc. ("Apollon"), a Pennsylvania corporation, with principal offices located
at Xxx Xxxxx Xxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxx 00000-0000. Each of
Biogen and Apollon are a "Party" to this Agreement and collectively they are
the "Parties" to the Agreement.
INTRODUCTION
1. Apollon is the owner or exclusive licensee under certain licenses of
certain technology, patents and other proprietary rights related to DNA-based
vaccines; and
2. Biogen desires a license from Apollon to market and sell products
developed by Apollon under the aforesaid technology, patents and proprietary
rights, and Apollon is willing to grant to Biogen such license on the terms
and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual promises and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties, intending to be legally bound, agree as follows:
SECTION 1 DEFINITIONS
As used in this Agreement, the following terms, whether used in the
singular or plural, shall have the following meanings:
1.1 "Affiliate" shall mean, as applied to either Party, any corporation,
partnership, joint venture or other legal entity which controls, is
controlled by, or is under common control with, such Party. "Control" shall
mean, including, with correlative meaning, the terms "controlled by"and
"under common control with", as used with respect to any Person, the
possession, directly or indirectly, of the power to vote fifty percent (50%)
or more of the outstanding voting securities of such Person, or to direct or
cause the direction of the management or policies of such Person, whether
through the ownership of voting securities, by contract or otherwise.
1.2 "Apollon Patent Rights" shall mean all Patents in the United States
or countries foreign thereto covering or related to Apollon Technology which
Apollon owns or controls on the Effective Date or as to which Apollon
acquires ownership or control at any time during the term of this Agreement.
Apollon Patent Rights existing as of the Effective Date are set forth in
Appendix A to this Agreement.
C-1
1.3 "Apollon Technology" shall mean all Intellectual Property, whether
patentable or not (i) which Apollon owns as of the Effective Date or as to
which Apollon acquires ownership at any time during the term of this
Agreement, related to DNA-based Vaccine Products, and (ii) which is necessary
or useful in order to offer for sale, import, sell or seek approval to market
Licensed Products. For purposes of this Agreement, Apollon Technology
specifically excludes any Intellectual Property, Patent Rights or other
rights Apollon controls or derives under the University Licenses.
1.4 "Apollon and University Technology" shall mean all Intellectual
Property, whether patentable or not (i) which Apollon owns, controls or has
other rights to under University Licenses or otherwise as of the Effective
Date or as to which Apollon acquires ownership or control at any time during
the term of this Agreement, related to DNA-based Vaccine Products, and (ii)
which is necessary or useful in order to discover, research, develop, make,
use, offer for sale, import, sell or seek approval to market Licensed
Products.
1.5 "Biogen Patent Rights" shall mean all Patents in the U.S. or
countries foreign thereto covering or related to Biogen Technology which
Biogen owns or controls on the Effective Date or as to which Biogen acquires
ownership or control at any time during the term of this Agreement. Biogen
Patent Rights existing as of the Effective Date are set forth in Appendix B
to this Agreement.
1.6 "Biogen Technology" shall mean all Intellectual Property, whether
patentable or not (i) which Biogen owns or controls as of the Effective Date
or as to which Biogen acquires ownership or control at any time during the
term of this Agreement, related to DNA sequences encoding Hepatitis B viral
antigens, and (ii) which is necessary or useful in order to discover,
research, develop, make, use, offer for sale, import, sell or seek approval
to market Licensed Products.
1.7 "Clinical Trial Information" shall mean all data and information of
whatever nature specifically developed in connection with the Licensed
Products by either Party under this Agreement and the License and Option
Agreement, including preclinical and clinical trial protocols, reports and
results (including pharmacological, toxicological, pharmaceutical and other
relevant data) for the Licensed Products, applications for regulatory
approval of the testing, use or sale of Licensed Products, regulatory files
and filings (including master files, INDs, NDAs, BLAs, PLAs, PMAs and the
like) made in connection with the Licensed Products and all licenses from,
correspondence with, or approvals by regulatory authorities for the testing,
use or sale of Licensed Products.
1.8 "DNA-based Vaccine Product" shall mean a vaccine product containing
a DNA sequence encoding an antigen.
C-2
1.9 "Intellectual Property" shall mean information (general and
specific), developments, discoveries, inventions, patents, patent
applications, know-how, trade secrets, whether or not patented or patentable.
1.10 "License and Option Agreement" shall mean the License and Option
Agreement dated as of November 17, 1997 between Apollon and Biogen.
1.11 "Licensed Products" shall mean any DNA-based Vaccine Product that
(a) comprises DNA encoding a polypeptide displaying Hepatitis B core,
Hepatitis B surface, and/or Hepatitis B e antigen specificity or
antigenicity, and (b) the manufacture, use, sale, offer for sale, or import
of which (i) is covered by a Valid Claim of any Biogen Patent Rights or
Apollon Patent Right in the country where such Licensed Product is
manufactured, used, imported, offered for sale or sold, and/or (ii) embodies
or is developed using any of the Biogen Technology or Apollon Technology.
"Licensed Products" shall not include any Hepatitis B virus vaccine for human
use which contains recombinant Hepatitis B virus antigen, any Prophylactic
Vaccine Product or diagnostic products containing a Hepatitis B virus
antigen, or any DNA-based Vaccine Product, which, when injected into a
recipient, is incorporated into the genome of the recipient. For purposes of
this Agreement, "Prophylactic Vaccine Product" shall mean a DNA-based Vaccine
Product which is introduced to a patient prior to infection by the Hepatitis
B virus.
1.12 "Net Sales" shall mean the gross invoiced amount (not less than cost
and not dependent on whether such invoices have been actually paid) on sales
of Licensed Products sold by a Party and its Affiliates and sublicensees, in
bona fide arms' length transactions less the following items, as determined
from the books and records of the Party making such sale, its Affiliates and
sublicensees, provided that such items do not exceed reasonable and customary
amounts in the country in which such Sale occurred: (i) freight and insurance
if billed separately; (ii) amounts repaid or credited by reason of returns or
rejections; (iii) sales taxes, excise taxes and other taxes (other than
income taxes) levied on the invoiced amount; (iv) cash, trade and quantity
discounts actually given or made; (v) rebates paid pursuant to government
regulations; and (vi) commissions paid to distributors or other sales
agencies that are included in the gross sales price, if supported by receipts
provided to Apollon. A sale of Licensed Products to an Affiliate for re-sale
of Licensed Products by such Affiliate shall not be considered a Sale for the
purposes of this provision, but the re-sale of such Licensed Products by the
Affiliate to a third party shall be a Sale for purposes of this Agreement.
Any use of Licensed Products by a Party or any of its Affiliates or
sublicensees, other than for quality assurance, quality control or research
purposes, shall be considered a Sale for accounting purposes and Net Sales
for such use or for Sale by gift shall be the average sales price of Licensed
Products Sold in an arms' length transaction by such Party and its Affiliates
and sublicensees during the applicable payment reporting period or, if no
such arms' length transaction occurred in such period, during the last
payment reporting period in which such arms' length transaction occurred.
C-3
In the event that consideration in addition to or in lieu of money is
received for the Sale of Licensed Products in an arms' length transaction,
the fair market value of such consideration shall be included in the
determination of Net Sales for such Sale. To the extent that Licensed
Products are Sold in other than an arms' length transaction, Net Sales for
such Sale shall be the average Sale price of Licensed Products if Sold in an
arms' length transaction during the applicable payment reporting period in
the country in which the non-arms' length transaction occurred.
In the event that Licensed Products are Sold by a Party or any of its
Affiliates or sublicensees in the form of a combination Licensed Product
containing one or more active ingredients in addition to the Licensed
Product, Net Sales for the combination Licensed Product shall be determined
by multiplying actual Net Sales of the combination Licensed Product
(determined by reference to the standard Net Sales definition) during the
payment period by the fraction A/A+B where A is the average Sale price of the
Licensed Product when Sold by the Party and its Affiliates and sublicensees
separately in finished form and B is the average Sale price of the other
active ingredients when Sold separately in finished form in each case during
the applicable payment reporting period in the country in which the Sale of
the combination Licensed Product was made, or if Sales of both the Licensed
Product and the other active ingredients did not occur in such period, then
in the most recent payment reporting period in which Sales of both occurred.
In the event that such average Sale price cannot be determined for both the
Licensed Product and all other active ingredients included in the combination
Licensed Product, Net Sales for purposes of determining payments under this
Agreement shall be calculated by multiplying the Sales with respect to the
combination Licensed Product by the fraction C/C+D where C is the standard
fully-absorbed cost of the Licensed Product portion of the combination and D
is the sum of the standard fully-absorbed costs of all other active
ingredients included in the combination Licensed Product, in each case, as
determined by using the standard accounting procedures used by the Party
making the Sale, consistently applied. In no event shall Net Sales with
respect to a combination Licensed Product be reduced to less than fifty
percent (50%) of actual Net Sales with respect to such combination Licensed
Product (determined by reference to the standard Net Sales definition) by
reason of any adjustment provision set forth in this paragraph.
1.13 "Patent" shall mean all letters patents and pending patent
applications for patents of the United States and all countries foreign
thereto, including any provisional applications, priority applications,
extensions, reissues, reexaminations, renewals, continuations,
continuations-in-part, divisionals, certificates of invention and
supplemental protection certificates.
1.14 "Person" shall mean an individual, a partnership, a joint venture, a
corporation, a trust, a business trust, a limited liability company or
limited liability partnership, an estate, an unincorporated organization, a
government or any department or agency thereof, or any other entity.
C-4
1.15 "Sale(s)" or "Sold" shall mean any gift, grant, sale, assignment,
transfer, conveyance or other disposition of a Licensed Product by a Party to
this Agreement or any of its Affiliates or sublicensees to another Person,
except distribution of samples provided at no charge to physicians,
hospitals, or clinics for promotional purposes or for purposes of the Product
Development Program, provided such distribution is not made in exchange for
lower prices on other products sold by such Party or other noncash
consideration.
1.16 "Territory" shall mean Japan.
1.17 "University License" shall mean any license or rights granted to
Apollon, at any time, under any Patent or Intellectual Property by (i) the
Trustees of the University of Pennsylvania; (ii) the Wistar Institute of
Anatomy and Biology; (iii) the Institute of Biotechnology and Advanced
Molecular Medicine; (iv) The General Hospital Corporation; or (v) any other
third party licensor, which are necessary or useful for the development,
manufacture, use, marketing or sale of Licensed Products.
1.18 "Valid Claim" shall mean (i) a claim of a pending patent
application which claim shall not have been canceled, withdrawn, abandoned or
rejected by an administrative agency from which no appeal can be taken; or
(ii) a claim of an issued and unexpired patent which has not lapsed or become
abandoned or declared invalid or unenforceable by a court of competent
jurisdiction or an administrative agency from which no appeal can be or is
taken.
SECTION 2 LICENSE GRANT TO BIOGEN
2.1 License Grant to Biogen.
(a) Apollon hereby grants to Biogen (i) an exclusive license under
the Apollon Technology, including the right to grant sublicenses as set forth
herein, to use, sell, have sold, offer for sale and import Licensed Products
manufactured by or for Apollon pursuant to the supply arrangements set forth
in Section 5 hereof for sale by Biogen in the Territory, and (ii) in the
event Apollon can no longer supply Licensed Products under the terms of this
Agreement, contingent manufacturing rights under the Apollon and University
Technology to make, have made, use, sell, have sold, offer for sale and
import Licensed Products in the Territory. The license and contingent
manufacturing rights granted hereunder shall remain in effect unless or until
this Agreement is terminated pursuant to Section 7 hereof.
(b) To the extent Apollon has the right to grant sublicenses under
any University Licenses, Apollon hereby grants to Biogen an irrevocable
option to obtain from Apollon at the time Biogen exercises its contingent
manufacturing rights one or more sublicenses under any University License
solely for use by Biogen to manufacture the Licensed Products. Biogen shall
exercise this option only at the time it exercises its contingent
manufacturing rights, by providing written notice to Apollon not less than
ten (10) business days prior to the date
C-5
which Biogen proposes as the effective date for the sublicense. The
sublicense shall be for the same term as the applicable University License
and shall provide to Biogen all of the rights of Apollon under the applicable
University License, solely for use in the manufacture of Licensed Products.
Apollon shall not cause or allow, through any action or inaction, any
impairment in Biogen's ability to obtain any sublicense as provided in this
Section 2.1(b), provided, however, that in the event Apollon obtains a
University License which does not permit Apollon to grant a sublicense to
Biogen, and Apollon had used reasonable efforts to obtain the right to grant
such a sublicense, such event shall not constitute a breach by Apollon of
this Section 2.1(b) or of this Agreement.
2.2 Right to Sublicense. Biogen shall have the right to extend to its
Affiliates the rights and licenses granted to Biogen under this Section 2,
and for purposes hereof, such extension shall not be considered the grant of
a sublicense. Biogen shall have the right to grant sublicenses to sell
Licensed Products under the license granted under this Section 2, provided,
however, that Biogen is entitled to grant within the Territory a total of two
(2) sublicenses to sell Licensed Products. In the event that Biogen grants
more than one (1) sublicense to sell Licensed Products in the Territory, then
Biogen shall be prohibited from selling Licensed Products itself in the
Territory. For purposes of this Agreement, distributors and distribution
arrangements shall not be considered sublicensees of Biogen. Biogen agrees
that any sublicenses granted by it shall prohibit further sublicenses by the
sublicensee and shall provide that the obligations of Biogen to Apollon
hereunder shall be binding upon the sublicensee as if it were a party to this
Agreement. Biogen agrees to forward to Apollon a copy of any and all
sublicense agreements within thirty (30) days of the execution of such
sublicense agreements.
2.3 Limitations of License Grant. Except as expressly provided in this
Section 2, nothing in this Agreement shall be deemed to grant Biogen any
rights in, or license to, any product, Patent or Intellectual Property of
Apollon. Without limiting the generality of the foregoing, Biogen shall not
be granted any right hereunder to make, have made, use, offer for sale, sell
or import any products which are not Licensed Products or to offer for sale,
sell or import Licensed Products other than in the Territory. In addition,
nothing in this Agreement shall be deemed to grant Biogen any rights in, or
sublicense to, any product, Patent or Intellectual Property under the
University Licenses, except as shall be provided upon exercise of the
contingent manufacturing rights granted pursuant to Section 2.1(b).
SECTION 3 FINANCIAL REPORTS
3.1 Payment Schedule and Reports. On or before forty-five (45) days
following the end of each calendar quarter occurring after the first
commercial Sale of a Licensed Product in the Territory, Biogen shall pay to
Apollon the payments owed by it with respect to Net Sales of Licensed
Products during such calendar quarter. Such payment shall be accompanied by a
report showing (i) the aggregate actual Sales volume of Licensed Products by
Apollon and its Affiliates
C-6
and sublicensees, (ii) aggregate Net Sales, (iii) gross invoice price(s) of
Licensed Product(s) Sold, (iv) deductions from gross invoice price permitted
hereunder and (v) the payment made hereunder. Such payment shall also be
accompanied by a copy of any reports received by Biogen from its Affiliates
or sublicensees during the preceding calendar quarter as shall be pertinent
to an accounting hereunder. All reports shall show all amounts reported in
the currency in which Sales were made, and in United States dollars at the
conversion rate described in Section 3.5.
3.2 Books and Records. Biogen and each of its Affiliates and
sublicensees shall maintain such books and records as are necessary to
establish the accuracy of the reports submitted under Section 3.1 for a
period of five (5) years from the date of submission of such reports. Such
books and records shall be maintained on the accrual basis of accounting in
accordance with generally accepted accounting principles.
3.3 Audits.
(a) Upon the written request of Apollon, and not more than once in
each calendar year, Biogen shall permit Apollon, at Apollon's expense, to
have access during normal business hours to such of the records of Biogen as
may be reasonably necessary to verify the accuracy of the financial reports
provided under this Section 3. Any audit so requested shall be performed on
Apollon's behalf by an independent accounting firm of nationally recognized
standing reasonably satisfactory to both Parties. If Apollon concludes,
based on the audit results, that additional payments were owed during the
financial periods audited, Biogen shall pay the additional payments within
fifteen (15) days of the date Apollon delivers to Biogen a written report so
concluding. The costs associated with any audit conducted under this Section
3.3(a) shall be paid by Apollon; provided, however, if the audit correctly
discloses that the payments payable by Biogen for the audited period are more
than one hundred ten percent (110%) of the payments actually paid for such
period, then Biogen shall pay the reasonable fees and expenses charged by the
accounting firm conducting the audit.
(b) Upon the written request of Biogen, and not more than once in each
calendar year, Apollon shall permit Biogen, at Biogen's expense, to have
access during normal business hours to such of the records of Apollon as may
be reasonably necessary to verify the accuracy of the certified
[ ] provided under Section 5.6 hereof. Any audit so
requested shall be performed on Biogen's behalf by an independent accounting
firm of nationally recognized standing reasonably satisfactory to both
Parties. If Biogen concludes, based on the audit results, that the payments
made during the audited period exceeded the payments owed hereunder, Apollon
shall refund the excess payments within fifteen (15) days of the date Biogen
delivers to Apollon a written report so concluding. The cost of such audit
shall be borne by Biogen unless it is established by Biogen that as a result
of an error in the calculation of such certified [ ] Biogen has
overpaid Apollon by at least 2.0% in the audited period, in which event the
cost of such audit will be borne by Apollon.
C-7
3.4 Confidentiality of Financial Information. Both Parties shall treat
all financial information subject to review under this Section 3, and all
reports generated hereunder, as confidential and shall use such reports and
financial information only for the purposes contemplated by this Section 3.
3.5 Currency. All payments required to be made under this Agreement
shall be made in U.S. dollars. Monetary conversions from the currency of a
foreign country into U.S. dollars shall be made at the exchange rate for
buying U.S. dollars in force on the last business day of the period for which
the Net Sales are reported in accordance with Section 3.1 as reported by The
Wall Street Journal, or on another basis mutually agreed upon by the Parties
in writing.
3.6 No Deductions. The payments computed or specified under this
Section 3 are the actual amounts to be paid to Apollon and shall not be
reduced in any way including, but not limited to, by any payments obligations
owed to Biogen or its Affiliates and sublicensees by Apollon under this
Agreement. In the event a Party or its Affiliates or sublicensees are
required to make a deduction or withholding of tax, then the amount payable
to the other Party shall be increased to the extent necessary to ensure that
after the making of such deduction or withholding, the other Party receives
and retains an amount equal to what it would have received and retained had
no such deduction or withholding been made by the paying Party or its
Affiliates or sublicensees. Each Party agrees to assist the other by
submitting declarations to the relevant authorities as may be required with
regard to each Party's status in relation to a deduction or withholding of
taxes.
SECTION 4 OBTAINING REGULATORY APPROVAL IN THE TERRITORY
4.1 Access to Clinical Trial Information. Apollon shall cooperate with
Biogen and its Affiliates in completing the procedures necessary for Biogen
to obtain regulatory approval for the sale, by Biogen and its Affiliates, of
Licensed Products in the Territory. Without limiting the generality of the
foregoing, Apollon shall promptly provide to Biogen and its Affiliates, or at
Biogen's request authorize the supervised access of Biogen and its Affiliates
to all Clinical Trial Information developed by Apollon for Licensed Products
which is useful to obtain regulatory approval for Licensed Products in the
Territory, and Biogen and its Affiliates shall use such Clinical Trial
Information solely to obtain such regulatory approval in the Territory.
Biogen and its Affiliates shall provide Apollon and its Affiliates with
access to all Clinical Trial Information developed by Biogen and its
Affiliates related to Licensed Products, including all regulatory filings
made in the Territory and all governmental responses thereto.
Notwithstanding the foregoing, Biogen shall own all of its Clinical Trial
Information and all related reports provided pursuant to Section 3.1, and
regulatory filings made in the Territory related to Licensed Products and
Apollon shall own all its Clinical Trial Information, as well as all
regulatory filings made worldwide except in the Territory related to Licensed
Products.
C-8
4.2 Final Product Specifications. Upon the first submission by Apollon,
its Affiliate or a sublicensee of a BLA(PLA) to the United States Food and
Drug Administration (USFDA) or equivalent agency in any country in the
Territory for approval of the marketing of any Licensed Product, Apollon will
furnish Biogen with a detailed specification for such Licensed Product, and
thereafter Apollon will promptly furnish Biogen with any modifications or
updates of such specification (as so modified or updated, the
"Specification").
SECTION 5 SUPPLY AGREEMENT
5.1 Agreement to Supply. Apollon shall manufacture, or have
manufactured on its behalf, and sell to Biogen sufficient quantities of
Licensed Products to meet the requirements of Biogen, its Affiliates and
sublicensees for use by Biogen, its Affiliates and sublicensees in the
conduct of preclinical and clinical trials in the Territory and for the sale
of Licensed Products in the Territory. Licensed Products shall be supplied
in finished form, with labeling as specified by Biogen, its Affiliates or
sublicensees.
5.2 Forecasts. Commencing not less than one hundred and eighty (180)
days prior to the expected commencement by Biogen in the Territory of the
equivalent of Phase II or Phase II/III human clinical trials for Licensed
Products, and by the first day of each calendar quarter thereafter, Biogen
will deliver to Apollon a twelve-month rolling forecast of Biogen's
requirements for Licensed Products for preclinical or clinical uses or for
sale of Licensed Products in the Territory, specifying quantities and
shipment dates, as well as methods of packaging and shipment, therefor. Such
forecasts shall be good faith estimates, and all actual orders shall be in
the form of a purchase order received by Apollon at least sixty (60) days
before the specified delivery date. After approval by the applicable
regulatory authority of the sale by Biogen, its Affiliates or sublicensees of
a Licensed Product in the Territory (a "Regulatory Approval") has been
granted, the first three (3) months of each twelve-month rolling forecast
provided thereafter shall constitute a binding firm commitment purchase order
for the quantities of Licensed Products specified therein. Biogen may revise
its schedule of delivery dates, and methods of packaging and shipment, from
time to time upon not less than thirty (30) days prior notice thereof to
Apollon. Apollon shall use its best efforts to supply all quantities ordered
by Biogen, but in no case shall Apollon be obligated to supply revised
quantities which exceed the original schedule furnished in the most recent
forecast showing for such quarter by more than 20% in any quarter. In the
event of a shortage in availability of Licensed Products despite Apollon's
best efforts, Apollon shall allocate available Licensed Products in a fair
and equitable manner.
5.3 Manufacturing. Apollon shall maintain sufficient manufacturing
capacity to fill Biogen's requirements for Licensed Products under this
Agreement as provided in Section 5.2 hereof. Within twenty (20) days of
receiving any rolling forecast or notice of increased requirements, Apollon
shall provide Biogen with written confirmation of the quantities and delivery
dates of Licensed Products that it is prepared to supply for the twelve-month
period.
C-9
5.4 Shipping. Apollon will package and ship Licensed Products to Biogen
in accordance with such instructions as to methods of packaging and shipment
as Biogen shall specify in the purchase order to which any such shipment
pertains. The shipment shall be made to such place as is designated by
Biogen. Apollon shall be solely responsible for compliance with all
applicable export laws and regulations and payment of any applicable export
duties or tariffs. Biogen shall be solely responsible for compliance with
all applicable import laws and regulations and payment of any applicable
import duties or tariffs.
5.5 Pricing. Apollon will supply Licensed Products to Biogen for Sale
in the Territory and Biogen shall pay Apollon [ ]
for the Licensed Products supplied. Apollon will supply Licensed Products
to Biogen for use in the conduct of preclinical and clinical trials and
Biogen will pay Apollon [ ] for the
Licensed Products supplied for such purpose.
5.6 Books and Records. Apollon shall maintain such books and records as
are necessary to establish the accuracy of the
[ ] referenced in Section 5.5 for a period
of five (5) years from the date of delivery of Licensed Products to Biogen.
Such books and records shall be maintained on the accrual basis of accounting
in accordance with U.S. generally accepted accounting principles. On or
before thirty (30) days following the end of each calendar quarter occurring
after the first commercial Sale of a Licensed Product in the Territory,
Apollon shall deliver to Biogen a report of the
[ ] applicable to the Licensed Products
supplied in such calendar quarter and a certificate signed by Apollon's chief
financial officer or designee stating that he or she has verified the
accuracy of such report. Within ninety (90) days after the end of each annual
audit period, Apollon's independent certified public accounting firm shall
deliver to Biogen a certificate stating that it has verified the
[ ] delivered to Biogen during the applicable period as correct.
5.7 Quality and Inspection. Apollon hereby warrants that Licensed
Products sold and delivered hereunder (including all processes, procedures,
facilities and equipment for the manufacture thereof) shall conform to the
requirements for such Licensed Products of the USFDA, including current Good
Manufacturing Practices ("cGMP"), and the requirements of equivalent
regulatory authorities in the Territory, shall not be adulterated or
misbranded within the meaning of the Food, Drug & Cosmetic Act as amended
from time to time, and shall conform to the Specifications for such Licensed
Product developed by Apollon. Biogen shall have the right, after reasonable
notice to Apollon, to conduct cGMP compliance inspections and other
inspections and audits and investigations of Apollon's facilities, equipment
and records from time to time. Apollon shall undertake quality control and
inspection procedures as required by the protocols filed and approved by the
appropriate regulatory agency. If, within thirty (30) days after receiving
any shipment of any Licensed Products, Biogen shall, in its reasonable
judgment, determine and notify Apollon that any of such shipment is
non-conforming, Apollon will, at Biogen's option, either: (i) give Biogen
appropriate credit therefor or (ii) within thirty (30) days
C-10
of Biogen's notice, ship new Licensed Products to Biogen in replacement for
the non-conforming Licensed Products. Biogen shall return any non-conforming
Licensed Products to Apollon at Apollon's expense or otherwise hold or
dispose of them at Apollon's expense as Apollon may direct.
5.8 Title and Risk of Loss. Title to Licensed Products delivered
hereunder shall pass to Biogen at such time as Licensed Products are
delivered to and accepted by Biogen or its agents. Risk of loss shall pass
on delivery F.O.B. Malvern, Pennsylvania.
5.9 Grant of Contingent Manufacturing Rights.
(a) Apollon hereby grants to Biogen the right to manufacture any
Licensed Products with respect to which Apollon is unable or unwilling to
satisfy its obligations pursuant to Section 5.1 hereof. At such time as
Biogen shall be entitled to exercise its rights under this Section 5.9,
Apollon will provide to Biogen with the necessary amendment to this Agreement
to reflect the sublicenses described in Section 2.1(b) hereof, such technical
information in the possession of Apollon relating to the manufacture of
Licensed Products that is then necessary and useful in the manufacture of
Licensed Products, and will otherwise provide Biogen with reasonable
assistance to manufacture such Licensed Products according to the best
systems then known to Apollon. All written materials will be supplied in
English. Apollon shall actively support and participate in a meaningful
manner in the procurement by Biogen of all government approvals requisite for
any such right to manufacture, including the granting of assistance in
accordance with the provisions of Paragraph 5.9(c) hereof. Apollon's
inability or unwillingness to satisfy its obligations pursuant to Section 5.1
hereof shall not be deemed a breach of this Agreement.
(b) If Apollon is unable to supply any quantity of a Licensed
Products required to be supplied by Apollon pursuant to Section 5.1 for
forty-five (45) consecutive days, Biogen shall, pursuant to this Section 5.9,
be entitled to make its entire requirements for such Licensed Products until
such time as Apollon has built inventories for such Licensed Products equal
to twice the average monthly quantity of such Licensed Products sold during
the prior twelve-month period; provided that such inventories have been
manufactured on a production schedule reasonably consistent with that
required to regularly meet Biogen's requirements. In the event that Biogen
shall, pursuant to this Section 5.9, elect to manufacture or have
manufactured its requirements for a Licensed Products:
(i) Apollon shall grant to Biogen reasonable access and the
right to use all Licensed Products information and government approvals and
otherwise assist Biogen in all material respects in this alternate
manufacture and supply; and
(ii) For any Licensed Products manufactured by Biogen, Biogen
shall pay Apollon a royalty equal to [
C-11
], which payment obligation shall continue until
the earlier of termination of manufacture of the Licensed Products by Biogen
hereunder or the date on which such Licensed Product or the manufacture, use,
offer for sale, import or sale of such Licensed Products is no longer covered
by a Valid Claim of Biogen Patent Rights in the Territory.
(c) In the event that Biogen shall exercise its contingent
manufacturing rights pursuant to this Section 5.9:
(i) Apollon shall, from time to time, at the request of
Biogen, arrange to have taken into Apollon's manufacturing facilities, or
those of its permitted subcontractors, technical representatives of Biogen,
for the purpose of instruction in all applicable processes of manufacture for
such Licensed Products. Such representatives shall comply with all of the
ordinary regulations of such facility(s) in respect of visitors.
(ii) At Biogen's request, and at times and for durations
convenient to Apollon, Apollon shall furnish the services of Apollon
scientists and technicians, or any technicians involved in the manufacture of
the applicable Licensed Products, in such numbers as shall be mutually
agreeable to the parties, to advise Biogen in connection with the operation
of such manufacturing facility for manufacture hereunder.
(iii) To the extent Apollon has not already done so,
Apollon shall further provide the names of all suppliers of, and a statement
setting forth Apollon's inventory of, the raw materials used in the
manufacture of the applicable Licensed Products. To the extent consistent
with Apollon's prior written contractual obligations with such suppliers, and
at the request of Biogen, Apollon shall transfer to Biogen such proportion of
such inventories, at prices to be agreed upon by the Parties, and if
requested, temporarily assign an applicable proportion of purchase orders or
other agreements with such suppliers, as applicable, to enable Biogen or its
designee to act as an alternate manufacturer for the applicable Licensed
Products hereunder and to manufacture the quantities of Licensed Products
necessary to meet their requirements.
(d) In the event Biogen shall have exercised its right to
manufacture a Licensed Products pursuant to this Section 5.9, Apollon shall
notify Biogen when it is able and willing to resume manufacture and supply of
such Licensed Products in accordance with its obligations hereunder, and the
parties shall negotiate a reasonable timetable for Apollon to resume the
supply of such Licensed Products hereunder, subject to Biogen's then existing
contractual commitments which shall be reasonable in magnitude and duration.
SECTION 6 WARRANTIES, LIABILITY AND DISCLAIMERS OF WARRANTY
6.1 Warranty of Title. Apollon warrants and represents that it owns all
of the right, title and interest in and to the Apollon Patent Rights.
C-12
6.2 Warranty of Authority. Each of the Parties hereto warrants and
represents to the other Party that, as of the Effective Date (i) it has the
full, right power and authority to enter into this Agreement and to carry out
its obligations hereunder, (ii) this Agreement constitutes the valid
obligation of such Party, enforceable against it in accordance with its
terms, and (iii) the execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (a) does not conflict with
or violate any requirement of applicable laws or regulations, and (b) does
not conflict with, or constitute a default under, any contractual obligation
of such Party.
6.3 DISCLAIMER OF WARRANTY. EXCEPT AS PROVIDED IN SECTIONS 5.7 AND 6.1
ABOVE AND IN THIS SECTION 6.3, APOLLON MAKES NO WARRANTIES OR REPRESENTATIONS
WHATSOEVER, WHETHER EXPRESS OR IMPLIED, HEREUNDER; IN PARTICULAR MAKES NO
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY OF ANY
PRODUCT PRODUCED UNDER THE LICENSE GRANTED HEREBY. MOREOVER, APOLLON MAKES
NO REPRESENTATION OR WARRANTY THAT THE MANUFACTURE OR SALE OF LICENSED
PRODUCTS OR THE USE OF LICENSED PRODUCTS BY ANY PERSON OR ENTITY WILL NOT
CONSTITUTE AN INFRINGEMENT OF THE PATENT OR OTHER INTELLECTUAL PROPERTY
RIGHTS OF OTHERS. NOTWITHSTANDING THE FOREGOING, APOLLON HEREBY REPRESENTS
AND WARRANTS THAT AS OF THE DATE HEREOF IT HAS NOT RECEIVED WRITTEN NOTICE
FROM ANY THIRD PARTY OF ANY SUCH INFRINGEMENT. IN NO EVENT SHALL APOLLON BE
LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST REVENUES OR
PROFITS.
6.4 Indemnification and Insurance. (a) Apollon shall indemnify and
hold Biogen and its Affiliates and their respective officers and employees
harmless from and against any losses, liabilities, costs and expenses
(including court costs and attorney's fees) arising out of or relating to any
suits or liabilities whatsoever (including claims for product liability) to
the extent arising out of the design, manufacture, use, sale or promotion of
Licensed Products, except (i) to the extent caused by Biogen's promotional or
sales practices in connection with the use or Sales of Licensed Products by
Biogen hereunder and the manufacture of Licensed Products by Biogen pursuant
to Apollon and University Technology upon the exercise of the contingent
manufacturing rights granted hereunder, (ii) negligence or intentional
misconduct by Biogen or its Affiliates and their respective officers and
employees or (iii) breach of any term of this Agreement by Biogen or its
Affiliates and their respective officers and employees.
(b) Biogen shall indemnify and hold Apollon and its Affiliates and
their respective officers and employees harmless from and against any losses,
liabilities (including claims for product liability), costs and expenses
(including costs and attorney's fees) to the extent arising out of (i)
Biogen's promotional and sales practices in connection with the use or Sales
of Licensed Products by Biogen hereunder and the manufacture of Licensed
Products by Biogen pursuant to the Apollon and University Technology upon the
exercise of the contingent
C-13
manufacturing rights granted hereunder, (ii) negligence or intentional
misconduct by Biogen or its Affiliates and their respective officers and
employees or (iii) breach of any term of this Agreement by Biogen or its
Affiliates and their respective officers and employees.
(c) A party (the "Indemnitee") that intends to claim
indemnification under this Section 6.4 shall promptly notify the other party
(the "Indemnitor") of any liability or action in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall
have the right to participate in, and, to the extent the Indemnitor so
desires, jointly with any other Indemnitor similarly noticed, to assume the
defense thereof with counsel selected by the Indemnitor; provided, however,
that an Indemnitee shall have the right to retain its own counsel, with the
fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate
due to actual or potential differing interests between such Indemnitee and
any other party represented by such counsel in such proceedings. The
indemnity obligations under this Section 6.4 shall not apply to amounts paid
in settlement of any loss, claim, damage, liability or action if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld unreasonably. The Indemnitor may not settle the action
or otherwise consent to an adverse judgment in such action that diminishes
the rights or interests of the Indemnitee without the express written consent
of the Indemnitee. The Indemnitee, its employees and agents, shall cooperate
fully with the Indemnitor and its legal representatives as requested by the
Indemnitor and at the Indemnitor's expense in the investigation of any
action, claim or liability covered by this indemnification.
(d) Biogen and Apollon each shall maintain product liability
insurance with respect to development, manufacture and sales of Licensed
Products by Biogen or Apollon, as the case may be, in such amount as is
customary in the industry. Each party shall be named as an additional
insured insofar as its rights of indemnification hereunder are concerned on
any such policies of the other party. Biogen and Apollon, as applicable,
shall each maintain such insurance for so long as it continues to manufacture
or sell any Licensed Products.
SECTION 7 TERMINATION
7.1 Breach by Biogen. Apollon may terminate this Agreement and the
license granted to Biogen hereunder in the event Biogen breaches its
obligation to pay any amount due hereunder to Apollon or breaches any other
obligation or condition hereunder, effective thirty (30) days after giving
payment breach and ninety (90) days after giving written notice to Biogen of
such termination in the case of a non-payment breach, which notice shall
describe such breach. Following such termination, Apollon shall have all
rights to make, have made, use sell and import Licensed Product in the
Territory and Biogen shall assign to Apollon all regulatory or other
approvals relevant to Licensed Products in the Territory. If this Agreement
is terminated but the License and Option Agreement between the Parties
continues, Apollon shall pay to Biogen a royalty equal to [
] of the Net Sales of Licensed Products made by Apollon in the
Territory, which payment obligation shall continue until the earlier of
C-14
termination of the License and Option Agreement or the date on which such
Licensed Products or the manufacture, use, offer for sale, import or sale of
such Licensed Products is no longer covered by a Valid Claim of Biogen Patent
Rights in the Territory. The foregoing notwithstanding, if the default or
breach is cured or shown to be non-existent or not material within the thirty
(30) or ninety (90) day period, as the case may be, the notice shall be
automatically withdrawn and of no effect.
7.2 Event of Bankruptcy. Upon the occurrence of an event of bankruptcy
with respect to either Party, the other Party may terminate this Agreement or
the licenses or rights granted to the bankrupt Party hereunder with immediate
effect by delivering written notice of said termination to the bankrupt Party.
7.3 Challenge of Patents. Except in jurisdictions in which it would be
illegal to do so, Biogen may immediately terminate this Agreement in the
event Apollon or any of its Affiliates files a revocation or nullity
proceeding with respect to any of the Biogen Patent Rights or challenges the
validity of any of the Biogen Patent Rights. Except in jurisdictions in which
it would be illegal to do so, Apollon may immediately terminate this
Agreement or the license granted to Biogen hereunder in the event Biogen or
any of its Affiliates files a revocation or nullity proceeding with respect
to any of the Apollon Patent Rights or challenges the validity of any of the
Apollon Patent Rights.
The provisions of this Section 7.3 shall be deemed deleted from this
Agreement in any jurisdiction in which the inclusion of such provisions would
be illegal or would make this Agreement or any part hereof unenforceable.
7.4 Breach by Apollon. Biogen may terminate this Agreement upon breach
by Apollon of the obligation to pay any amount due hereunder or of any other
obligation or condition, effective thirty (30) days after giving written
notice to Apollon of such termination in the case of a payment breach and
ninety (90) days after giving written notice to Apollon of such termination
in the case of a non-payment breach, which notice shall describe such breach.
The foregoing notwithstanding, if the default or breach is cured or shown to
be non-existent or not material within the thirty (30) or ninety (90) day
period, as the case may be, the notice shall be deemed automatically
withdrawn and of no effect.
7.5 Survival. All provisions of Section 3.6, Section 7.1 and Section 9
shall survive termination of this Agreement.
7.6 No Prejudice. Any termination under this Section 7 shall be without
prejudice to the rights of either Party against the other then accruing or
otherwise accrued under this Agreement.
C-15
SECTION 8 NOTICES
Any notice required or permitted to be given hereunder shall be sent in
writing by registered or certified mail, postage prepaid, return receipt
requested, by telefax, confirmation received, by overnight delivery using a
nationally recognized overnight courier or by hand delivery, addressed to the
Party to whom it is to be given as follows:
If to Biogen: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telefax: (000) 000-0000
Attention: Vice President - Marketing and Sales
With a copy to: Biogen, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telefax: (000) 000-0000
Attention: Vice President - General Counsel
If to Apollon: Apollon, Inc.
Xxx Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, Xxxxxxxxxxxx 00000-0000
Telefax: (000) 000-0000
Attention: President and CEO
With a copy to: Xxxxxxx Xxxxx Xxxxxxx & Xxxxxxxxx
0000 Xxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxxxxxxxx, XX 00000
Telefax: (000) 000-0000
Attention: Xxxxxx Xxxxxxx, Xx.
or to such other address or addresses as may from time to time be given in
writing by either Party to the other as aforesaid. Any notice sent pursuant
to this Section shall be deemed delivered within three (3) days if sent by
mail and within twenty-four (24) hours if sent by telefax, overnight courier
or hand delivery.
SECTION 9 CONFIDENTIALITY
9.1 Obligations. Except for the proper exercise of its rights under
this Agreement, each of the Parties agrees that it and its Affiliates will
not publish or otherwise divulge or deliver to another Person, except their
sublicensees hereunder, or use for its or their own benefit Technology,
Patent Rights, Clinical Trial Information, reports, records, manuals,
regulatory filings
C-16
or other confidential information disclosed pursuant to this Agreement
(collectively, the "Confidential Information") provided to it by the other
Party without the prior written approval of the Party disclosing such
information (the "Disclosing Party") in each instance. The foregoing
obligation shall not be imposed on either Party with respect to any
Confidential Information which it can demonstrate (i) was at the time of
disclosure to it (or thereafter, but prior to its publication, divulgence or
use for the benefit of the Receiving Party or any of its Affiliates, become
through no fault of the Receiving Party or its Affiliates) a part of the
public domain by publication or otherwise; or (ii) was already properly and
lawfully in its possession at the time it was received from the Disclosing
Party; or (iii) was lawfully received from a third party who was under no
obligation of confidentiality to the Disclosing Party with respect thereto;
or (iv) is required by law to be disclosed (but only to the extent of such
required disclosure).
9.2 Confidentiality Agreements. Each Party represents that it has
employment agreements with its and its Affiliate's key employees having
confidentiality commitments consistent with its obligations hereunder and
will require all of its consultants, agents, sublicensees, or others who have
access to any of such Confidential Information of the other Party to execute
confidentiality agreements covering all Confidential Information of the other
Party, and will exercise its best efforts to obtain compliance therewith.
9.3 Remedies. In the event of a breach or a threatened breach of the
terms of this Section 9, the Disclosing Party shall be entitled to an
injunction restraining the Receiving Party and its Affiliates and
sublicensees and their officers, employees, agents and consultants from
continuing or committing such breach, without showing or proving any actual
damage. In the event of such breach, the Disclosing Party shall, in addition
to injunctive relief, be entitled to all other remedies provided by law,
including an award of damages.
SECTION 10 PUBLICITY
If the Parties agree to publicize this Agreement, Biogen and Apollon will
coordinate to issue a joint press release in mutually agreed form concerning
the execution of this Agreement. Such announcement shall be made at such
time as agreed by Biogen and Apollon. Except for such joint release, unless
required to do so by law or by the rules of any exchange or over-the-counter
market upon which any of Biogen's or Apollon's securities are traded or
unless such information has been previously disclosed, neither Party will
issue any press release or make any public disclosure or announcement
concerning the terms of this Agreement or the transactions contemplated
hereby without the prior approval of the other Party hereto. Prior to making
any such press release or public announcement, the Party making such release
or public announcement shall consult with the other Party hereto with respect
to the timing and content of such press release or public announcement at
least five (5) business days prior to the proposed release or announcement.
Without limiting the generality of the foregoing, neither Party shall use the
name of the other in connection with the marketing or sale of Licensed
Products without the prior written consent of such Party.
C-17
SECTION 11 DISPUTES
Any dispute, claim, or difference arising in connection with this
Agreement or as to the rights or liabilities of the Parties hereunder (each
such event being hereinafter called a "dispute"), shall be referred to
arbitration, in accordance with the Commercial Arbitration Rules (the
"Rules") of the American Arbitration Association (hereinafter referred to as
the "Association"), as supplemented hereby. All arbitration proceedings shall
occur in Boston, Massachusetts. The arbitration panel shall consist of three
arbitrators. The Party initiating arbitration shall nominate one arbitrator
(who shall not be affiliated with such Party) in the request for arbitration
and the other Party shall nominate a second arbitrator (who shall not be
affiliated with such Party) in the answer thereto. The two arbitrators so
named will then jointly appoint the third arbitrator as chairman of the
arbitration panel. If either Party fails to nominate its arbitrator, or if
the arbitrators named by the Parties fail to agree on the person to be named
as chairman within sixty (60) days, the President of the Association shall
make the necessary appointments of an arbitrator or the chairman of the
arbitration panel.
The arbitration panel as designated above shall proceed to arbitrate the
dispute by giving notice to all parties of its proceedings and hearings in
accordance with the Association's applicable procedures. Within fifteen (15)
days after all three arbitrators have been appointed, an initial meeting
among the arbitrators and counsel for the Parties shall be held for the
purpose of establishing a plan for administration of the arbitration,
including: (i) definition of issues; (ii) scope, timing and type of
discovery, which may at the discretion of the arbitrators include production
of documents in the possession of the Parties, but may not, without the
consent of the Parties, include depositions; (iii) exchange of documents and
filing of detailed statements of claims and prehearing memoranda; (iv)
schedule and place of hearings; and (v) any other matters that may promote
the efficient, expeditious and cost-effective conduct of the proceeding. The
substantive law of the Commonwealth of Massachusetts shall be applied by the
arbitrators to the resolution of the dispute, provided that the arbitrators
shall base their decision on the express terms, covenants and conditions of
this Agreement. The arbitrators shall be bound to make specific findings of
fact and reach conclusions of law, based upon the submissions and evidence of
the Parties, and shall issue a written decision explaining the basis for the
decision and award. The Parties agree that the arbitrators shall have no
power to alter or modify any express provision of this Agreement or to render
any award which, by its terms, effects any such alteration or modification.
The award of the arbitration panel shall be final and judgment upon such
an award may be entered in any competent court or application may be made to
any competent court for judicial acceptance of such an award and an order of
enforcement. In the event of any procedural matter not covered by the
aforesaid Rules, the procedural law of the Commonwealth of Massachusetts
shall govern.
C-18
SECTION 12 MISCELLANEOUS
12.1 Amendments, Waivers. This Agreement may be amended and any of its
terms or conditions may be waived only by a written instrument executed by
both Parties, or, in the case of a waiver, by the Party waiving compliance.
The failure of any Party at any time to require performance of any provision
hereof shall in no manner affect its rights at a later time to enforce the
same. No waiver by any Party of any condition or term in any instance shall
be construed as a further or continuing waiver of such condition or term or
of another condition or term.
12.2 Force Majeure. Any delays in or failures of performance by any
Party under this Agreement shall not be considered a breach of this Agreement
if and to the extent caused by occurrences beyond the reasonable control of
the Party affected, including, but not limited to: acts of God; acts,
regulations or laws of any government (including, without limitation, import
and export regulations); peril of the sea; strikes or other concerted acts of
workers; fires; floods; explosions; riots; wars; rebellion and sabotage; and
any time for performance hereunder shall be extended by the actual time of
delay caused by such occurrence. Each Party shall promptly give notice to
the other of the start and stop should it be so affected by any of the
above-mentioned occurrences.
12.3 Interest On Late Payments. Each Party shall have the right to
charge the other interest on a per diem basis on all payments which are past
due at an annual rate of two percent (2.0%) over the prime rate then in
effect at the BankBoston or its successors.
12.4 Cooperation. Each Party agrees to cooperate with the other Party in
any and all efforts by such other party to obtain patent term extensions or
other extensions as provided by law in territories where Valid Claims under
such other Party's patents applicable to Licensed Products now or hereafter
exist.
12.5 Binding Nature. This Agreement shall be binding upon and inure to
the benefit of and be enforceable by the Parties hereto and their respective
successors and permitted assigns.
12.6 Assignment. Neither this Agreement nor any of the rights,
interests, or obligations hereunder shall be assignable by either of the
Parties hereto or by operation of law without the prior written consent of
the other Party hereto; provided, however, that any Party may assign its
rights, interests and obligations hereunder to any entity with which such
party may merge or consolidate or to which such Party may transfer
substantially all of its assets, without obtaining the consent of the other
Party. Notwithstanding the foregoing, either Party may assign its right to
receive payments hereunder, and either Party and its sublicensees will
execute any documents or instruments reasonably required by the other Party
in connection with any such assignment. Any purported assignment in
violation of the provisions of this Section shall be void, and all rights,
interests or obligations so assigned thereby shall return to the assigning
Party or its successors.
C-19
12.7 Severability. The Parties intend this Agreement to be enforced as
written. However, if any provision of this Agreement should be or become
fully or partly invalid or unenforceable for any reason or violate any
applicable law, this Agreement is to be considered divisible as to such
provision and such provision is to be deleted from this Agreement, and the
remainder of this Agreement shall be deemed valid and binding as if such
provision were not included herein. There shall be substituted for any such
provision deemed to be deleted a suitable provision which, as far as is
legally possible, comes nearest to the Parties' original intent.
12.8 Entire Agreement. This Agreement contains the entire agreement
between the Parties hereto with respect to the subject matter set forth
herein and supersedes any and all other agreements, oral or written, in
respect of the subject matter of this Agreement.
12.9 Captions. The captions to the Sections of this Agreement are for
convenience only and shall not be considered in interpreting this Agreement.
12.10 Governing Law. This Agreement shall be governed by and
construed in accordance with the law of the Commonwealth of Massachusetts
without regard to conflict of law provisions.
12.11 Counterparts. This Agreement may be executed in counterparts,
each of which shall be deemed an original and all of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto have duly caused this Agreement to
be executed in duplicate by their duly authorized representatives as of the
day and year first above written.
BIOGEN, INC. APOLLON, INC.
By: ________________________ By: ________________________
Name: Name:
Title: Title:
C-20
