[***]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
EXHIBIT 10.8
LICENSE AND SUPPLY AGREEMENT
This License and Supply Agreement (this "Agreement") is entered into as
of the last signature hereunder (the "Effective Date") by and between Xxxxx
Biotech AG, a Swiss corporation having its principal place of business at
Xxxxxxxxxxxxx 00, XX-0000 Xxxxx, Xxxxxxxxxxx ("Xxxxx"), and Dynavax Technologies
Corporation, a USA corporation having its offices at 000 Xxxxxx Xxxxxx,
Xxxxxxxx, Xxxxxxxxxx 00000, XXX ("Dynavax"). Xxxxx and Dynavax may be referred
to in the Agreement individually as a "Party", and collectively as the
"Parties".
RECITALS
X. Xxxxx is the inventor of, and possesses certain information,
technology, patents and other intellectual property rights regarding its
proprietary yeast expression system based on the methyltrophic yeast Hansenula
polymorpha (Hansenula Expression System) which are protected as intellectual
property rights owned by Berna's affiliate Xxxxx Xxxxxxx X.X., Xxxxxxxxxx, Xxx
Xxxxxxxxxxx. Based on its proprietary Hansenula Expression System, Berna's
affiliates Rhein Biotech GmbH, Dusseldorf, Germany and Green Cross Vaccine
Corporation, Yongin City, Korea ("GCVC") have developed processes for the
production of adr-HBsAg, a component of vaccines for hepatitis B.
B. Dynavax is developing a prophylactic hepatitis B vaccine
comprising an ISS-1018 oligonucleotide and HBsAg. Dynavax desires to license
from Xxxxx adr-HBsAg for use in such vaccine.
C. Dynavax is also developing a therapeutic hepatitis B vaccine
comprising an ISS oligonucleotide and HBsAg. Dynavax desires to license from
Xxxxx adr-HBsAg for use in such vaccine.
X. Xxxxx is willing to provide Dynavax access to adr-HBsAg,
including the supply thereof by GCVC, and to grant Dynavax a license under such
intellectual property rights of Rhein Biotech N.V., in accordance with the terms
and conditions set forth in this Agreement.
AGREEMENT
For good and valuable consideration, including the covenants and obligations
expressed herein, receipt of which is hereby acknowledged, intending to be
legally bound, the parties hereto agree as follows:
1. DEFINITIONS.
1.1 "adr-HBsAg" shall mean the hepatitis B surface antigen of the
subtype adr produced with the Hansenula polymorpha Expression System.
1.2 "adr-HBsAg Technology" shall mean (a) the technology with
which adr-HBsAg in bulk can be produced and with which quality analysis is being
performed, and (b) all patents, know-how and other intellectual property owned
or controlled by Xxxxx that claims or covers adr-HBsAg or its manufacture or
use, including but not limited to the patents listed in Appendix C.
1.3 "Affiliate" shall mean any business entity that controls, is
controlled by, or is under common control with another corporation or business
entity. As used in this definition, the direct or indirect ownership of at least
fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of
the voting securities or an interest in the assets, profits or earnings of a
business entity shall be deemed to constitute "control" of the business entity.
Rhein Biotech N.V., Rhein Biotech GmbH and GCVC are Affiliates of Xxxxx in the
sense of this definition.
1.4 "Berna" shall mean Berna and/or its affiliates mentioned
above, as is appropriate in view of the rights and obligations under this
Agreement.
1.5 "cGMP" shall mean current good manufacturing practices as
defined by relevant Pharmaceutical Law and Pharmaceutical, Control Authority and
Regulatory guidance in the country of Manufacturing.
1.6 "Confidential Information" shall have the meaning assigned
thereto in Section 14.1.
1.7 "Disease Field" shall mean the field of inducing an active,
long term prophylactic response or therapeutic immune response against Hepatitis
B (including chronic status) in humans.
1.8 "Dynavax" shall mean Dynavax as defined above as well as its
affiliates, as is appropriate in view of the rights and obligations under this
Agreement.
1.9 "Fill and Finish Manufacturer" shall have the meaning assigned
thereto in Section 2.3(c).
1.10 "Government Approval" shall mean any approvals, licenses,
registrations or authorisations of any Regulatory Authorities, necessary for the
use, development, testing, production, marketing, sale or distribution of the
Vaccines in a regulatory jurisdiction.
1.11 "ISS" shall mean ISS 1018 (5'-TGACT GTGAA CGTTC GAGAT GA-3')
or ISS 295 (5'-TCGTCGA-HEG-ACGTTCG-HEG-AGATGAT-3').
1.12 "Manufacturing and Supply" shall mean the commercial
manufacture, processing, packing, holding, all required labelling, testing,
storage, release and supply to Dynavax or its designee of adr-HBsAg in
accordance with the terms and conditions set forth in this Agreement.
1.13 "Net Sales" shall mean the gross amount invoiced by Dynavax or
Sublicensee (if applicable) for the sale or other disposition to an unaffiliated
third party of Vaccines, less the following deductions for amounts actually
incurred or allowed related to the sale or other disposition:
(a) trade, cash and quantity discounts (including
volume discounts), credits and rebates, and credits, rebates
and allowances and adjustments for rejections, recalls or
returns (not in excess of the selling price of the Vaccine);
and
(b) freight, insurance, sales, use, excise,
value-added and similar taxes or duties imposed on the sale
and included in the gross amount invoiced; and
2
(c) reasonable and customary rebates actually granted
to managed health care organizations, federal, state, or local
governments (or their agencies), and managed health
organizations (including Medicaid rebates); and
(d) amounts debited on account of specific bad debts
with respect to Net Sales previously invoiced, determined in
accordance with the selling Party's normal accounting
procedures consistently applied within and across its
pharmaceutical or biopharmaceutical operating unit.
1.14 "Prophylactic Vaccine" shall mean a prophylactic Hepatitis B
vaccine developed by Dynavax or its sublicensee and comprised of an ISS and
adr-HBsAg, and that potentially utilises additional delivery or adjuvant
technology, in pharmaceutical dosage forms suitable for human use.
1.15 "Proposed Publication" shall have the meaning assigned thereto
in Section 8.1.
1.16 "Regulatory Authorities" shall mean those government agencies
or authorities responsible for the regulation of Vaccines and/or adr-HBsAg
(including without limitation the manufacture, supply and sale thereof) in the
Territories.
1.17 "Specifications" shall mean those specifications set forth in
Appendix A
1.18 "Sublicensee" shall mean any permitted sublicensee of the
license granted to Dynavax under this Agreement as further described in Section
2.3.
1.19 "Territory A" shall mean Europe and North America.
1.20 "Territory B" shall mean all countries of the world except
Japan and those named in the definition of Territory A.
1.21 "Territories" shall mean Territory A and Territory B.
1.22 "Therapeutic Vaccine" shall mean a therapeutic hepatitis B
vaccine developed by Dynavax or its sublicensee and comprised of an ISS and
adr-HBsAg, and that potentially utilises additional delivery or adjuvant
technology, in pharmaceutical dosage forms suitable for human use.
1.23 "Vaccines" shall mean Prophylactic Vaccine and Therapeutic
Vaccine.
2. LICENSE GRANT.
2.1 Subject to the terms and conditions of this Agreement, Xxxxx
hereby grants to Dynavax for the term of this Agreement, unless earlier
terminated in accordance with Section 15, a non-exclusive license under the
adr-HBsAg Technology, with the right to sublicense solely in accordance with
Sections 2.3, to research, develop, manufacture, have manufactured, market,
distribute, import, use, offer for sale and sell Vaccines in the Territories for
use solely in the Disease Field. Such license grant does not permit the transfer
by Dynavax to any third party of adr-HBsAg other than as part of assembled
Vaccines (including, without limitation, transfer of Vaccines to third parties
for preclinical testing, toxicology, or clinical trials) or in accordance with
Section 2.3, without the prior written approval of Xxxxx, such approval not to
be unreasonably withheld.
2.2 The license granted in Section 2.1 is specific to the Disease
Field. For the purpose of clarification, Dynavax shall have no right to include
the adr-HBsAg in any other
3
product intended for therapeutic or prophylactic use in any field outside of the
Disease Field, whether such other product is formulated as part of the Vaccines
or sold in bundled package together with the Vaccines, unless a separate license
for such other product and other disease field is expressly granted in writing
by Xxxxx to Dynavax.
2.3 Xxxxx hereby grants to Dynavax for the term of this Agreement,
unless earlier terminated in accordance with Section 15, the right to sublicense
the right to research, develop, manufacture, have manufactured, market,
distribute, import, use, offer for sale and sell Vaccines in the Territories
under the adr-HBsAg Technology in the Disease Field as follows:
(a) Prior to the grant of a sublicense, Dynavax shall
notify Xxxxx in writing of the identity of the intended
Sublicensee, and Xxxxx shall have thirty (30) days to consent
to the Sublicensee, such consent not to be unreasonably
withheld. If Xxxxx does not notify Dynavax in writing within
such thirty (30) day period that Xxxxx does not consent to
such Sublicensee, Xxxxx shall be deemed to have consented. All
sublicense agreements shall be consistent with the terms of
this Agreement and shall expressly bind the Sublicensee to the
applicable terms of this Agreement and shall provide for the
automatic assignment of the sublicense agreement to Xxxxx if
this Agreement is terminated by Berna. Dynavax shall promptly
xxxxxxx Xxxxx with a fully executed copy of any sublicense
agreement.
(b) For the avoidance of doubt, either Dynavax or its
Sublicensee may develop, manufacture, have manufactured, use,
market, distribute, import, use, offer for sale and sell
Vaccines in any part of the Territories.
(c) For purposes of clarity, `manufacture' and `have
manufactured' includes the combining of the adr-HBsAg and the
ISS to create the Vaccines, but does not include the
manufacture of adr-HBsAg itself. For further clarity, the use
of a third party (the "Fill and Finish Manufacturer") for the
combining of the adr-HBsAg and the ISS and related formulation
work to create the Vaccines, and related fill and finish work
(including labelling and packaging), which will then be given
to Dynavax or its Sublicensee for sale or other distribution,
shall not be considered a sublicensing per se.
3. SUPPLY OF ADR-HBsAg.
3.1 SUPPLY COMMITMENT. Xxxxx agrees to provide Dynavax on a
non-exclusive basis, under the terms and condictions of this Article 3
(including supply prices) with the quantities of adr-HBsAg meeting the
Specifications as required by Dynavax for use in making Vaccines for sale by
Dynavax and/or its Sublicensees, whether as Prophylactic Vaccine and/or
Therapeutic Vaccine.
3.2 SUPPLY PRICE
3.2.1 PROPHYLACTIC VACCINE. Xxxxx will provide to Dynavax
adr-HBsAg meeting Specifications on a bulk basis for incorporation into
Prophylactic Vaccine, at the following prices:
(a) For pre-clinical and clinical development, [***].
For all subsequent orders for pre-clinical
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
4
and clinical development purposes the price will be [***].
(b) For commercialisation in Territory A, [***].
(c) For commercialisation in Territory B, [***].
3.2.2 THERAPEUTIC VACCINE. Xxxxx will provide to Dynavax
adr-HBsAg meeting Specifications on a bulk basis for incorporation into
Therapeutic Vaccine, at the following prices:
(a) For pre-clinical and clinical development, [***].
(b) For commercialisation in all Territories, [***].
3.2.3 If Berna's manufacturing costs increase due to
Dynavax's requirements for new or modified Specifications or formulations of
adr-HBsAg, the Parties shall negotiate in good faith a new pricing system. Xxxxx
shall not be obligated to manufacture in accordance with any such new or
modified Specifications or formulations until the Parties have agreed to a
price.
3.3 In all cases, sales to Dynavax will be EXW (ex works;Incoterms
2000). To control the shipment conditions, Xxxxx will pack the quantities of
adr-HBsAg suitable for delivery to the destination selected by Dynavax.
Notwithstanding above mentioned EXW, Xxxxx will arrange the shipping. All costs
for freight and insurance will be charged to Dynavax separately with the invoice
for each delivery. Thus the shipping terms on the invoice will show CIP `airport
of destination'.
3.4 TITLE TO ADR-HBsAg. Xxxxx shall retain all title and interest
in and to any and all adr-HBsAg manufactured by Xxxxx hereunder until such
adr-HBsAg is supplied by Xxxxx to Dynavax and paid for by Dynavax as provided in
Section 3.2. Transfer of ownership shall not in any way relieve Dynavax of the
covenants under Section 2.2, which shall continue to apply to all adr-HBsAg
purchased by Dynavax from Xxxxx.
3.5 FORECASTS. Within [***] after the Effective Date and [***],
Dynavax shall provide Xxxxx with a rolling forecast for the amount of adr-HBsAg
required for the [***] period that commences [***] following the date of the
forecast. The amounts for the [***] shall be by [***]. The amounts for the
following [***] months shall be by [***]. The amounts forecasted for the [***]
of the forecast (the "Ordered Amount") shall be automatically [***] firm and
binding; [***] of the amounts forecasted for the following [***] of the forecast
shall be automatically firm and binding; and the amounts forecasted for the
[***] shall be non-binding.
(a) Xxxxx shall fill each Ordered Amount within [***]
from receipt of such order from Dynavax; provided, however, in
the event a given order exceeds the requirements estimated in
Dynavax's latest [***] rolling forecast for the [***] in
question, Xxxxx shall have up to [***] from receipt of such
order to fill such excess requirements.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
5
(b) Notwithstanding any other provision of this
Agreement, unless otherwise agreed to in writing by Xxxxx,
Xxxxx shall not be obligated to supply to Dynavax in a given
[***] more adr-HBsAg than [***] above the amount estimated in
Dynavax's latest [***] rolling forecast for the [***] in
question, even if such quantity falls within production
capacities, but Xxxxx shall use commercially reasonable
efforts to supply any such excess amounts.
3.6 CONFORMANCE TO SPECIFICATIONS. The adr-HBsAg supplied by Xxxxx
or its manufacturing designee hereunder shall conform at the time of delivery to
Dynavax to the applicable Specifications. Dynavax may test any adr-HBsAg
delivered hereunder to determine conformance of such adr-HBsAg with the
applicable Specifications. If Dynavax determines that such adr-HBsAg does not
meet such Specifications, Dynavax, shall within [***] of receipt of the
nonconforming adr-HBsAg, notify Xxxxx in writing of such nonconformance,
including test results supporting Dynavax's determination. Xxxxx shall, at no
charge to Dynavax, replace nonconforming adr-HBsAg with adr-HBsAg that meet such
Specifications. If Xxxxx disagrees with the alleged nonconformity of the
adr-HBsAg with the specifications, an independent laboratory, mutually agreed
upon in writing by the Parties, shall analyse samples of the alleged
nonconforming adr-HBsAg to determine compliance with the Specifications. Dynavax
and Xxxxx shall be bound by the laboratory analysis of such adr-HBsAg. The cost
incurred in connection with retaining the independent laboratory shall be borne
by Dynavax if the adr-HBsAg in question is found to conform to the
Specifications and by Xxxxx if it is found to not conform to the Specifications.
3.7 PERMITTED USES. Dynavax shall use the adr-HBsAg supplied by
Xxxxx hereunder only for purposes of research, development (including
pre-clinical testing and toxicology), manufacturing, marketing, distribution and
sale of Vaccines. Dynavax shall use the adr-HBsAg in compliance with this
Agreement and with all applicable federal, state and local laws and regulations.
Dynavax shall not transfer the adr-HBsAg or any related information to any
person who is not under the immediate and direct supervision of Dynavax, except
as may otherwise expressly be provided in this Agreement.
3.8 ACCESS TO FACILITIES. At Dynavax cost, Xxxxx shall permit
Dynavax and the Regulatory Authorities and their respective agents and
representatives reasonable access to the facilities where the Manufacturing and
Supply is being carried out at times mutually agreed to by Xxxxx and Dynavax.
3.9 SHIPPING. Delivery shall be to Dynavax, C.I.P, named place of
destination (Incoterms 2000), this place being outside the geographical region
of Europe, with costs of insurance and freight invoiced to Dynavax, or its
Sublicensee, as mentioned in Section 3.3. Risk for adr-HBsAg shall pass to
Dynavax after delivery. Title shall pass to Dynavax after full payment of the
invoiced price only.
3.10 MAINTENANCE OF RECORDS. Xxxxx shall keep or cause to be kept
complete, accurate and current records relating to all of its Manufacturing and
Supply activities in accordance with all applicable laws, cGMP and the
requirements of the Regulatory Authorities in the European Union.
3.11 ACCESS TO RECORDS. Xxxxx shall provide Dynavax, at Dynavax's
cost, with copies of all documentation under Berna's control relating to its
Manufacturing and Supply of adr-HBsAg to the extent such documentation is
required by any Regulatory Authority to be included in any Vaccines regulatory
approval submission to such Regulatory Authority and to the extent this is
economically reasonable. Xxxxx hereby grants Dynavax and its Sublicensees
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6
the right to reference Berna's regulatory approvals, if any, for adr-HBsAg and
the drug master file for each adr-HBsAg on file with any regulatory agency. Upon
Dynavax's request, Xxxxx shall execute letters of authorisation evidencing
Dynavax' and its Sublicensees' reference rights as set forth above. While Xxxxx
grants the above rights to the adr-HBsAg Technology and the use of the related
documention, it is Dynavax's and its Sublicensees' obligation to comply with all
relevant laws and regulations in the Territories.
3.12 COMPLIANCE WITH GMP STANDARDS. Xxxxx is producing the
adr-HBsAg under local cGMP requirements and is involved in the process of
increasing the cGMP standards towards the level which will be compliant with
European standards. Xxxxx agrees to use reasonable commercial efforts to provide
adr-HBsAg that complies with European and Canadian standards if so required by
Dynavax.
4. PAYMENTS AND REPORTS
4.1 LICENSE FEE. As partial consideration for the rights and
licenses granted hereunder, Dynavax shall pay Xxxxx a non-refundable,
non-creditable license fee of [***] within ten (10) days of the Effective Date
of this Agreement.
4.2 PROPHYLACTIC VACCINE
4.2.1 MILESTONES. As partial consideration for the rights
and licenses granted hereunder, Dynavax shall pay Xxxxx the following
non-refundable, non-creditable milestone payments:
(a) [***] within thirty (30) days of submission of
the first application for licensure of Prophylactic Vaccine
anywhere in the Territories.
Such payment shall only be due if payment for the
corresponding milestone for the Therapeutic Vaccine has not
been made (Section 4.3.1(a)(i)).
(b) [***] within thirty (30) days following the first
licensure of Prophylactic Vaccine anywhere in the Territories.
Such payment shall only be due if payment for the
corresponding milestone for the Therapeutic Vaccine has not
been made (Section 4.3.1 (a)(ii)).
4.2.2 ROYALTY. As partial consideration for the rights and
licenses granted hereunder, Dynavax shall pay Xxxxx a [***] royalty on annual
Net Sales made by Dynavax or its Sublicensee of Prophylactic Vaccine, commencing
with the first commercial sale of Prophylactic Vaccine by Dynavax or its
Sublicensee anywhere in the Territories.
4.3 THERAPEUTIC VACCINE
4.3.1 IN CASE OF COMPLETION OF DEVELOPMENT AND
COMMERCIALISATION BY DYNAVAX, Dynavax shall pay Xxxxx the following:
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7
(a) MILESTONES. As partial consideration for the
rights and licenses granted hereunder, Dynavax shall pay Xxxxx
the following non-refundable, non-creditable milestone
payments based on achievement of the milestone events by
Dynavax:
(i) [***] within thirty (30) days of
submission of the first application for
licensure of Therapeutic Vaccine anywhere in
the Territories.
Such payment shall only be due if payment
for the corresponding milestone for
Prophylactic Vaccine has not been made
(Section 4.2.1(a)).
(ii) [***] within thirty (30) days
following the first licensure of Therapeutic
Vaccine anywhere in the Territories.
Such payment shall only be due if payment
for the corresponding milestone for
Prophylactic Vaccine has not been made
(Section 4.2.1(b)).
(b) ROYALTY. As partial consideration for the rights
and licenses granted hereunder, Dynavax shall pay Xxxxx a
[***] royalty on annual Net Sales made by Dynavax of
Therapeutic Vaccine, commencing with the first commercial sale
of Therapeutic Vaccine by Dynavax anywhere in the Territories.
(c) SALES BONUS PAYMENTS. As partial consideration
for the rights and licenses granted hereunder, Dynavax shall
pay Xxxxx the following one-time milestone payments if the
applicable milestone event is achieved:
(iii) [***] upon achievement of [***] in
cumulative Net Sales of Therapeutic Vaccine
anywhere in the Territories.
(iv) [***] upon achievement of [***] in
cumulative Net Sales of Therapeutic Vaccine
anywhere in the Territories.
4.3.2 IN CASE DYNAVAX ELECTS TO SUBLICENSE DEVELOPMENT AND/
OR COMMERCIAL RIGHTS TO THE THERAPEUTIC VACCINE, Dynavax shall pay Xxxxx the
following in lieu of payment under 4.3.1:
(a) [***] of all revenues, in any form (including,
but not restricted to, upfront, milestones, royalty and sales
bonus payments), it receives in consideration of having
granted such sublicense.
(b) For clarity, the following amounts received by
Dynavax shall not be deemed to be revenues in consideration of
the sublicense: equity investment in Dynavax, loans (if
repaid), and R&D funding.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8
4.4 PAYMENT TERM. Royalties, if due, shall be paid for 15 years
from the first commercial sale of Vaccines in each country.
4.5 PAYMENT SCHEDULE. Royalties shall be calculated on a
semi-annual basis, specifically, the periods January 1 through June 30 and July
1 through December 31, ("Semi-Annual Period") and shall be due and payable
within forty-five (45) days after the end of such Semi-Annual Period, commencing
upon the completion of the first Semi-Annual Period during which the first
commercial sale occurs.
Should Dynavax elect to sublicense development and/ or commercial rights to
Therapeutic Vaccine, payment of Xxxxx share of the proceeds as defined in
Section 4.3.2 shall be due and payable within forty-five (45) days after the end
of the Semi-Annual Period, commencing upon completion of the Semi-Annual Period
during which signature of the sublicensing agreement occurs.
4.6 PAYMENT REPORTS. Forty-five (45) days following the end of
each Semi-Annual Period, Dynavax shall furnish to Xxxxx a written report that
includes (a) the identity of the countries in which sales of Vaccines have been
made and (b) the Net Sales of each Vaccine by Dynavax and the number thereof
sold in each such country. Such reports shall be due together with the royalty
and sales bonus payments under Sections 4.2.2, 4.3.1(b) and 4.3.1(c) subsequent
to launch of the Vaccines. Such reports shall be made whether or not Dynavax has
engaged in any sales of Vaccines during the Semi-Annual Period.
Should Dynavax elect to sublicense development and/ or commercial rights to
Therapeutic Vaccine, forty-five (45) days following the completion of the
Semi-Annual Period during which signature of the sublicensing agreement occurs,
Dynavax shall furnish to Xxxxx a written report that includes details of
proceeds due to Dynavax under that agreement. At the end of each Semi-Annual
Period thereafter, Dynavax shall furnish to Xxxxx a written report that details
any proceeds received by Dynavax from the Sublicensee. Such reports shall be due
together with payments under Section 4.3.2. Such report shall be made whether or
not Dynavax has received any proceeds from the Sublicensee during the
Semi-Annual Period.
All information provided by Dynavax pursuant to this Section 4.6 shall be
Confidential Information and subject to the terms of Section 14 hereto.
4.7 AUDITS. Dynavax shall keep, and shall cause its Sublicensee to
keep, full, complete and accurate records and accounts of Net Sales of each
Vaccine and of other proceeds from Sublicensee in sufficient detail to enable
the royalty, sales bonus and other payments payable to Xxxxx to be determined.
Upon reasonable notice to Dynavax, Xxxxx shall have the right to have an
independent certified public accountant audit Dynavax's records pertaining to
Vaccines during normal business hours to verify the royalty, sales bonus and
other payments payable pursuant to this Agreement; provided, however that (a)
such audit shall not take place more frequently than once a year, and (b) shall
not cover such records for more than the preceding three (3) years. Such audits
shall be at Berna's expense unless such audit determines that Dynavax has paid
Xxxxx less than ninety-five percent (95%) of the amount determined to be due for
a given time period, in which case such audit shall be at Dynavax's expense and
Dynavax shall pay to Xxxxx the reasonable cost of such audit and any shortfall
in payments due to Berna within thirty (30) days following Berna's invoice to
Dynavax therefor. Dynavax shall preserve and maintain all such records and
accounts required for audit for a period of three (3) years after the calendar
year to which such records and accounts apply.
4.8 PAYMENT INSTRUCTIONS. All payments due hereunder shall be made
in Swiss Francs (CHF) by wire transfer of immediately available funds to the
following account:
Account No. [***]
Bank: [***]
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
9
Swift Code: [***]
Clearing No. [***]
or to such other account as Xxxxx may designate from time to time.
4.9 PAST DUE AMOUNTS. Any past due payments under this Agreement
shall accrue interest until paid at [***] per annum, or the maximum rate
permitted by law, whichever is less.
5. DEVELOPMENT AND COMMERCIALISATION
As partial consideration for the rights and licenses granted hereunder, Dynavax
and Xxxxx agree to the following terms for development and commercialisation, as
follows:
5.1 PROPHYLACTIC VACCINE
5.1.1 XXXXX TO COMMERCIALISE. As partial consideration for
the rights and licenses granted hereunder, Dynavax grants Xxxxx the exclusive
right to commercialise Prophylactic Vaccine in the Territories on the following
terms:
(a) Within two (2) months after availability to
Xxxxx, in at least a written overview form, of clinical
results from the first pivotal phase III trial of Prophylactic
Vaccine, Xxxxx will negotiate and enter into a
commercialisation agreement with Dynavax for Prophylactic
Vaccine on commercially-reasonable terms as are negotiated by
the Parties, by providing, on a country-by-country basis, an
acceptable sales and marketing plan.
(b) The commercialisation agreement shall be
structured in the form of a distribution agreement under which
Xxxxx shall have [***].
(c) Based on its review of the phase III trial
results and evaluation of the commercial opportunity, Xxxxx
may exercise an option out of such commercialisation agreement
with Dynavax for Prophylactic Vaccine (if entered into) on a
country-by-country basis at its sole discretion. If so,
Dynavax may choose to commercialise Prophylactic Vaccine
alone, subject to the payment provisions of Section 4.2.
5.2 THERAPEUTIC VACCINE
5.2.1 OPTION TO COLLABORATE. As partial consideration for
the rights and licenses granted hereunder, Dynavax grants Xxxxx an exclusive
option to negotiate and enter into a joint development agreement for the
Therapeutic Vaccine on commercially reasonable terms as are negotiated by the
Parties, on the following terms:
(a) This option shall be valid from the Effective
Date and shall expire [***] after availability to Xxxxx, in at
least a written overview form, of phase II proof-of-concept
data showing statistically significant impact on markers of
viral replication or histological markers of liver damage.
(b) Should Xxxxx exercise the option and the Parties
enter into a joint development agreement with Dynavax. [***].
This sum shall be
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10
payable in semi-annual instalments of one third. The first
payment shall be made within 30 days of expiry of the option
period, with the remaining payments to be made on the two
subsequent six-month anniversaries of this date.
(c) Should Xxxxx exercise the option to enter into a
joint development agreement with Dynavax, [***].
(d) Should Xxxxx exercise the option to enter into a
joint development agreement with Dynavax, the terms of this
Agreement, as applicable to Therapeutic Vaccine according to
Sections 2, 3.2, 4 and 6, become void from the date of
signature of the joint development agreement. The option to
commercialise (Section 5.2.2) becomes void also.
5.2.2 OPTION TO COMMERCIALISE. If Xxxxx does not exercise
its option under Section 5.2.1, and Dynavax has not sublicensed commercial
rights to the Therapeutic Vaccine as part of a combined development and
commercialisation agreement, then Dynavax grants Xxxxx an exclusive option to
commercialise Therapeutic Vaccine on the following terms:
(a) This option shall be valid from the Effective
Date and shall expire [***] after availability of clinical
results to Xxxxx, in at least a written overview form, from
the first pivotal phase III trial, during which time Xxxxx
will be entitled to negotiate and enter into a
commercialisation agreement with Dynavax for the Therapeutic
Vaccine on commercially-reasonable terms as are negotiated by
the Parties, by providing, on a country-by-country basis, an
acceptable sales and marketing plan.
(b) The commercialisation agreement shall be
structured in the form of a distribution agreement under which
Berna shall have [***].
(c) Should Berna exercise the option and the Parties
enter into a commercialisation agreement with Dynavax for
Therapeutic Vaccine, the terms of this Agreement as applicable
to Therapeutic Vaccine become void from the date of signature
of the commercialisation agreement.
6. PERFORMANCE OBLIGATIONS.
6.1 COMMERCIAL DEVELOPMENT. Dynavax shall use its commercially
reasonable diligent efforts to meet the development schedule attached hereto as
Appendix B. Dynavax shall at all times keep Xxxxx generally informed of
Dynavax's updated development plans, which Dynavax shall provide to Xxxxx in
writing [***], for Vaccines, including Dynavax's planned timing for Vaccines
commercial launch dates on a country-by-country basis. All dates and other
information provided by Dynavax in such plan shall be used for planning purposes
only, and shall be subject to reasonable modification by Dynavax based on its
actual progress in the development process. Xxxxx and Dynavax shall meet
annually regarding Dynavax's efforts under this Agreement. Not more than two
representatives from each Dynavax and Xxxxx shall attend such meeting, which may
take place either in person in a mutually agreed-upon location or via
teleconference. At least thirty (30) days prior to each such meeting, Dynavax
shall submit an annual written report to Xxxxx that summarises Dynavax's efforts
toward development and commercialisation of Vaccines.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
11
6.2 MARKETING DOCUMENTATION. At all times during the term of this
Agreement, Dynavax agrees to furnish reasonably promptly to Xxxxx upon request
all documentation and data that is or may hereafter be in Dynavax's possession
relating to Dynavax's marketing of Vaccines, including, but not limited to,
marketing support data. All such information and data shall be Confidential
Information subject to Section 14 hereof.
7. GOVERNMENTAL APPROVALS.
7.1 A Party shall be responsible at its own expense for obtaining
all Government Approvals for a Vaccine in any country where that Vaccine shall
be sold or otherwise distributed by that Party. Each Party, at its own expense,
agrees to provide the other Party with any assistance reasonably requested by it
in obtaining such Governmental Approvals. While Xxxxx grants the above rights to
the adr-HBsAg Technology and the use of the related documention, it is Dynavax's
and its Sublicensees' obligation to comply with all relevant laws and
regulations in the Territories.
7.2 Within sixty (60) days following receipt by a Party, it shall
promptly provide the other Party with notice of all Government Approvals
received by it regarding Vaccines.
8. PUBLICATIONS.
8.1 IN GENERAL. Dynavax shall not publish or present, orally or in
writing, including without limitation at symposia, national or regional
professional meetings, or to publish in journals or other publications, any
Confidential Information of Xxxxx in any way relating to any aspect of the
adr-HBsAg, whether separately or as part of Vaccines, including, but not limited
to, the development or manufacture of the adr-HBsAg, whether separately or as
part of Vaccines (the "Proposed Publication"), without providing Xxxxx the
opportunity for prior review. The Proposed Publication will be submitted to
Xxxxx at least [***] prior to the date on which it is to be submitted or
disclosed to any person or entity not a party to this Agreement. During the
[***] period, Xxxxx will review the Proposed Publication for accuracy,
disclosure of patentable material or disclosure of its Confidential Information.
If, in Berna's sole opinion, a Proposed Publication contains patentable
material, Xxxxx will so notify Dynavax before the expiration of the [***] review
period. After such notice, Xxxxx may delay publishing for a period of up to
[***], to permit filing of appropriate patent applications. Xxxxx shall have the
right to remove its Confidential Information from any Proposed Publication.
8.2 PUBLIC ANNOUNCEMENTS.
8.2.1 Within 7 days of the execution of this Agreement, the
Parties agree to issue a joint press release on the same date. This press
release must receive the prior written approval of each party prior to issuance,
which approval shall not be unreasonably withheld
8.2.2 During the term of this Agreement, the Parties agree
to consult with each other before issuing any press release or making any public
statement based on new or previously undisclosed information with respect to
this Agreement or any other transaction contemplated herein and, except as may
be required by applicable law or any listing agreement with any national
securities exchange, shall not issue any such press release or make any such
public statement prior to obtaining the written consent of the other Party, such
consent not to be unreasonably withheld.
[***]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
12
9. REPRESENTATIONS AND WARRANTIES.
9.1 NONTRANSFER. Dynavax represents and warrants that it will not
transfer the adr-HBsAg, other than as part of the Vaccines, to any third party
without the prior written consent of Xxxxx, save for Dynavax's transfer of
adr-HBsAg to its Sublicensee or Fill and Finish Manufacturer as stipulated in
Section 2.3, or as a Permitted Use under Section 3.7.
9.2 COMPLIANCE WITH LAW. Dynavax warrants that Vaccines
manufactured and/or sold or distributed by Dynavax will be manufactured, sold
and distributed in accordance with all applicable laws, rules and regulations of
the country of manufacture, sale or distribution of such Vaccines. Xxxxx
warrants that all adr-HBsAg manufactured and sold to Dynavax will be
manufactured, sold and distributed in accordance with all applicable laws, rules
and regulations of the country of manufacture.
9.3 NO CONFLICT. Each Party hereby represents and warrants that it
is authorised to enter into this Agreement and that this Agreement does not
create a conflict with any other right or obligation provided under any other
agreement or obligation that such Party has with any third party.
10. INDEMNIFICATION.
10.1 Dynavax hereby agrees to indemnify, defend and hold harmless
Xxxxx, its Affiliates and their officers, agents and employees from and against
any and all claims, actions, proceedings, liabilities or losses, including
reasonable legal expenses and costs, including attorney fees (collectively,
"Losses"), that arise from (a) any material breach of this Agreement, including
a breach of any representation, warranty or covenant made by Dynavax hereunder,
by Dynavax, (b) the negligence or wilful misconduct of Dynavax, its Affiliates
or Sublicensee(s) and the employees, agents and contractors thereof, (c) any
manufacturing of Vaccines, (d) the Vaccines infringing upon or violating any
third party's patent or other proprietary rights , or (e) any handling,
possession, use, marketing, distribution or sales of Vaccines by Dynavax or its
Sublicensee(s); provided, however, that Dynavax shall have no obligation to
indemnify Xxxxx to the extent that such losses are the result of Berna's gross
negligence or wilful misconduct or supply of defective adr-HBsAg.
10.2 Xxxxx hereby agrees to indemnify, defend and hold harmless
Dynavax, its Affiliates and their officers, agents and employees from and
against any and all claims, actions, proceedings, liabilities or losses,
including reasonable legal expenses and costs, including attorney fees
(collectively, "Losses"), that arise from (a) any material breach of this
Agreement, including a breach of any representation, warranty or covenant made
by Xxxxx hereunder, by Xxxxx, (b) the negligence or wilful misconduct of Xxxxx,
its Affiliates or Sublicensee(s) and the employees, agents and contractors
thereof, (c) any manufacturing of adr-HBsAg, (d) the adr-HBsAg infringing upon
or violating any third party's patent or other proprietary rights in the country
of manufacturing, or (e) any handling, possession, use, marketing, distribution
or sales of Vaccines by Xxxxx or its sublicensees; provided, however, that Xxxxx
shall have no obligation to indemnify Dynavax to the extent that such Losses are
the result of Dynavax's gross negligence or wilful misconduct.
11. INSURANCE.
11.1 Dynavax shall obtain and maintain in effect during the term of
this Agreement and for five (5) year thereafter, with financially strong
insurance carriers, commercial general liability insurance covering bodily
injury and property damage necessary to meet its liability obligations under
this Agreement or amounts comparable to other companies of the same size
13
and having the same business as Dynavax. Dynavax shall provide a statement to
Xxxxx in which Dynavax identifies its insurer and warrants that its coverage is
sufficient to meet its obligations set forth herein. The insurance limits will
be increased as a function of increasing sales levels. There shall be a thirty
(30) day notice of cancellation with respect to the insurance coverage, and
Xxxxx shall be notified in the event of any material change directly affecting
Xxxxx in the insurance contract or coverages afforded. Dynavax shall be solely
responsible for the payment of any deductible. Xxxxx shall maintain similar
insurance levels as the above.
12. LIMITATION OF LIABILITY
In no event will either Party hereto be liable for any special, incidental,
consequential or indirect damages suffered by the other Party arising in any way
out of this Agreement, however caused and on any theory of liability. This
limitation will apply even if the Party has been advised of the possibility of
such damage.
13. DISCLAIMER OF WARRANTIES.
All adr-HBsAg are licensed and supplied hereunder "as is," and Xxxxx hereby
disclaims any and all representations and warranties with regard to the
adr-HBsAg and Vaccines, express or implied, and specifically disclaims any other
express or implied warranties, including any implied warranties of
merchantability or fitness for a particular purpose or use and any other
statutory warranties or any warranty of patentability or noninfringement.
14. CONFIDENTIALITY.
14.1 CONFIDENTIAL INFORMATION. "Confidential Information" shall
mean any proprietary information of a Party that is specifically designated as
"confidential" and that is disclosed by such Party to the other Party in any
form in connection with this Agreement. For the term of this Agreement and five
(5) years from the date of expiration or termination, each party (a) shall treat
as confidential all Confidential Information provided by the other Party, (b)
shall not use such Confidential Information except as expressly permitted under
the terms of this Agreement or otherwise authorised in writing by the disclosing
party, (c) shall implement reasonable procedures to prohibit the disclosure,
unauthorised duplication, misuse or removal of such Confidential Information,
and (d) shall not disclose such Confidential Information to any third party
except as permitted under the Agreement. Without limiting the foregoing, each of
the Parties shall use at least the same procedures and degree of care to prevent
the disclosure of Confidential Information as it uses to prevent the disclosure
of its own confidential information of like importance, and shall in any event
use no less than reasonable procedures and a reasonable degree of care.
14.2 EXCEPTIONS. Notwithstanding the above, a Party shall have no
obligation under Section 14.1 with regard to any Confidential Information of the
other Party that such Party can demonstrate by competent evidence:
(a) was generally known and available to the public
domain at the time it was disclosed, or becomes generally
known and available to the public domain through no fault of
the receiver;
(b) was known to the receiver at the time of
disclosure as shown by the written records in existence at the
time of disclosure;
(c) is disclosed with the prior written approval of
the disclosing Party;
14
(d) becomes known to the receiving Party from a
source other than the disclosing Party without breach of this
Agreement by the receiving party and in a manner which is
otherwise not in violation of the disclosing party's rights;
or
(e) was independently developed by receiving Party
without any use of Confidential Information of the disclosing
Party.
14.2.2 REQUIRED DISCLOSURE. Notwithstanding the foregoing, a
Party may disclose specific Confidential Information of the other Party solely
to the extent such disclosure is required pursuant to the order or requirement
of a court, administrative agency, or other governmental body; provided, that
the disclosing Party shall provide reasonable advance notice to enable the other
Party to seek a protective order or otherwise prevent such disclosure.
15. TERM AND TERMINATION.
15.1 TERM. The term of this Agreement shall be from the Effective
Date until expiration of Dynavax obligations to pay royalties pursuant to
Section 4.4.
15.2 TERMINATION BY AGREEMENT. This Agreement may be earlier
terminated by either party upon mutual written agreement.
15.3 TERMINATION BY DYNAVAX.
15.3.1 TERMINATION. This Agreement may be earlier terminated
by Dynavax upon twelve (12) months written notice to Xxxxx. If Dynavax
terminates under this provision, Xxxxx may continue to manufacture the amounts
of adr-HBsAg that are then considered "firm and binding" pursuant to Section 3.5
above, and, if Xxxxx provides or has provided adr-HBsAg to Dynavax, then Dynavax
shall make all payments later due to Xxxxx pursuant to Sections 3.2 and 4.
15.3.2 PARTIAL TERMINATION. If Xxxxx does not exercise its
option to collaborate under Section 5.2.1 above, then Dynavax may terminate this
Agreement solely as to the Therapeutic Vaccine if, in its sole discretion, it
determines based on technical and commercial considerations that further
development of the Therapeutic Vaccine is not feasible.
15.4 TERMINATION FOR BREACH. Upon any material breach of this
Agreement by a Party, the non-breaching Party may terminate this Agreement upon
sixty (60) days written notice to the breaching party, provided that such notice
shall become effective at the end of the sixty (60) day period only if the
breaching party shall not have cured such breach within such period. For
purposes of this Agreement, breach shall be deemed to "material" if it includes,
but not be limited to, (a) the promotion and sale of Vaccines for use outside of
the Disease Field, (b) distribution of adr-HBsAg other than as allowed under
this Agreement, (c) failure to pay the royalties and other payments due under
Section 4, (d) failure to comply with the publication obligations specifically
related to adr-HBsAg under Section 8.1, and (e) failure to comply with the
insurance requirements under Section 11.
15.5 BANKRUPTCY. Either Party may terminate this Agreement by
giving thirty (30) days written notice to the other Party if such other Party
(a) files a petition of bankruptcy or has any such petition filed against such
other Party; (b) goes into compulsory liquidation; (c) has its business placed
in the possession of a receiver, a government or a government agency; (d) makes
an assignment for the benefit of creditors; or (e) is subject to a dissolution
or winding up.
15
15.6 EFFECTS OF TERMINATION. Neither expiration nor termination
shall relieve either party of its obligations under Sections 4.4 through 4.9, 8,
9 through 14 and 16. Further, Dynavax shall make all reports and payments as are
required for the final quarter. Upon expiration or termination hereof, at
Berna's option, Dynavax shall return or destroy, and certify destruction of, any
adr-HBsAg in Dynavax's possession or control.
16. MARCH-IN RIGHTS
In the event that Xxxxx is unable to manufacture and/or to supply to Dynavax the
forecasted and ordered amount of adr-HBsAg requested by Dynavax (subject to the
exceptions of Section 3.5(a) and 3.5(b) above) for any reason whatsoever
(including, but not limited to, bankruptcy, reorganization or merger), and does
not cure such failure within one hundred and twenty (120) days of written notice
by Dynavax, then Xxxxx grants Dynavax a non-exclusive, non-sublicensable, right
and license under the adr-HBsAg Technology in the Territories to make or have
made by a third party adr-HBsAg for purposes solely of satisfying Dynavax's
requirements for making Vaccines. The choice of such third party will require
the explicit consent of Xxxxx, the declaration of which should not be
unreasonably withheld.
Dynavax shall thereafter be entitled to access to all material and proprietary
rights owned or licensed by Xxxxx necessary to make adr-HBsAg. Such access
includes, but is not limited to:
(a) access to Berna's Manufacturing Working Cell
Bank, and manufacturing process for adr-HbsAg and the relevant
analytical procedures.
(b) reasonable technical assistance by Xxxxx to
enable such manufacturing technology transfer.
All information provided by Xxxxx pursuant to this Section 16 shall be
Confidential Information and subject to the terms of Section 14. Dynavax shall
use its best efforts to enter into any such manufacturing agreement on customary
commercial terms that will allow for termination upon Berna's ability to again
supply adr-HBsAg. If Dynavax does enter into such a manufacturing agreement,
then such right and license shall not be revoked until such time as Xxxxx is
once again in a position to meet its supply obligations under this Agreement, at
which time Dynavax's agreement with any third-party manufacturer will be
terminated in accordance with the terms therein.
To prevent above mentioned inability to manufacture and/or to supply, Xxxxx has
the right to supply to Dynavax, observing reasonable lead times for change,
adr-HbsAg from a different manufacturing site that meets the specifications of
Annex 2 and is accompanied by documentation satisfying Article 3.12 of this
Agreement.
17. GENERAL PROVISIONS.
17.1 INDEPENDENT CONTRACTORS. Xxxxx and Dynavax shall be independent contractors
and shall not be deemed to be partners, joint venturers or each other's agents,
and neither party shall have the right to act on behalf of the other except as
is expressly set forth in this Agreement.
17.2 ENTIRE AGREEMENT; AMENDMENT. This Agreement sets forth the entire agreement
and understanding between the parties and supersedes all previous agreements,
promises, representations, understandings, and negotiations, whether written or
oral between the parties with respect to the subject matter hereof. There shall
be no amendments or modifications to
16
this Agreement, except by a written document signed by both parties.
17.3 ASSIGNMENT. This Agreement shall be binding upon and shall inure to the
benefit of any successor or successors of Xxxxx and Dynavax by reorganisation,
merger, consolidation or otherwise, and any assignee that has acquired all of
substantially all of the business and properties of either. Xxxxx and Dynavax
shall not otherwise assign their rights and obligations hereunder unless having
obtained the prior written consent of the other party hereto, which consent will
not be unreasonably withheld or delayed.
17.4 GOVERNING LAW; INJUNCTIVE RELIEF. This Agreement shall be construed and
enforced in accordance with the laws of Switzerland. It is understood that the
application of the United Nations Convention on Contracts for the International
Sales of Goods (CISG, Vienna 1980) shall be excluded.Xxxxx shall have the right
to such injunctive relief or other legal or equitable relief as is reasonable to
ensure that Dynavax does not transfer the adr-HBsAg to a third party, except as
allowed under this Agreement, without Berna's prior written consent
17.5 DISPUTE RESOLUTION. Any dispute or claim arising out of or in
connection with this Agreement shall be resolved as follows: (a) for a period of
thirty (30) days after a dispute arises the respective chief executive officers
of the parties or their designees shall negotiate in good faith in an effort to
resolve the dispute, and (b) if the dispute has not been resolved at the close
of such thirty (30) day period, the matter will be finally settled by binding
arbitration. The arbitration proceedings shall be governed by the procedural
rules of Chapter 12 of the Swiss Private International Law Act of December18,
1987 (SPIL;SR 291) and by any further rules subsequently agreed upon by the
PARTIES or fixed by the arbitration tribunal.
17.6 SEVERABILITY. If any provision of this Agreement is finally held to be
invalid, illegal or unenforceable by a court of competent jurisdiction, the
validity, legality and enforceability of the remaining provisions shall not be
affected or impaired in any way.
17.7 WAIVER. Any delay or failure in enforcing a party's rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of a party's right to the future enforcement of its rights
under this Agreement.
17.8 NOTICE. Any notice required or permitted by this Agreement to be given to
either party shall be in writing and shall be deemed given when delivered
personally, by confirmed telecopy to a fax number designated in writing by the
party to whom notice is given, or by registered, recorded or certified mail,
return receipt requested, and addressed to the party to whom such notice is
directed, at:
If to Berna: Berna Biotech AG.
Xxxxxxxxxxxxx 00
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: CEO
Fax: x00 00 000 00 00
17
with a copy to: Xxxxx Biotech Ltd.
Xxxxxxxxxxxxx 00
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: VP Legal/Regulatory Affairs
Fax: + 00 00 000 0000
If to Dynavax: Dynavax Technologies Corporation
000 Xxxxxx Xxxxxx, Xxxxx #000
Xxxxxxxx, Xxxxxxxxxx 00000, XXX
Attention: President
Fax: (000) 000-0000
with a copy to: Xxxxxx Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx Xxxxx Xxxx, Esq.
Fax: (000) 000-0000
or at such other address or telecopy number as such party to whom notice is
directed may designate to the other party in writing.
17.9 FORCE MAJEURE. If the performance of this Agreement or any obligations
hereunder is prevented, restricted or interfered with by reason of fire or other
casualty or accident, strikes or labour disputes, war or other violence, any
law, order, proclamation, ordinance, demand or requirement of any government
agency, or any other act or condition beyond the control of the parties hereto,
the party so affected, upon giving prompt notice to the other party shall be
excused from such performance (other than the obligation to pay money) during
such prevention, restriction or interference.
17.10 HEADINGS. The section headings appearing in this Agreement are inserted
only as a matter of convenience and in no way define, limit, construe or
describe the scope or extent of such section or in any way affect such section.
17.11 COUNTERPARTS. This Agreement may be signed in counterparts, each of
which shall be deemed an original and all of which together shall constitute one
instrument.
18. LIST OF APPENDICES
Appendix A: Specification of adr-HBsAg, extra highly concentrated
Appendix B: Commercial Development schedules of Prophylactic Vaccine and of
Therapeutic Vaccine.
Appendix C: Xxxxx Biotech List of relevant Patents
18
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date last written below.
DYNAVAX, 000 Xxxxxx Xxxxxx, Xxxxx #000
Xxxxxxxx, Xxxxxxxxxx 00000 U.S.A.
/s/ Dino Dina October 28, 03
--------------------------- --------------
Xx. Xxxx Xxxx Date:
President and Chief Executive Officer
XXXXX BIOTECH AG, Xxxxxxxxxxxxx 00
XX-0000 Xxxxx, Xxxxxxxxxxx
/s/ Xxxx Xxxxxx
---------------------------
[Name] XXXX XXXXXX Date: 28 October 2003
[Title] CHIEF OPERATION OFFICER
CEO, Rhein Biotech N.V.
/s/ Illegible
---------------------------
[Name] Illegible Date: 28 October 2003
[Title] Director Rhein Biotech NV
/s/ X. x. Xxxxxx - Xxxxxx 28 October 2003
---------------------------
Xxxx xxx Xxxxxx - Xxxxxx
Executive Vice President
Legal/Regulatory Affairs
Intellectual Property Rights
19
APPENDIX A
SPECIFICATION OF adr-HBsAg, EXTRA HIGHLY CONCENTRATED BULK
- Not formaldehyde treated
- No preservative (thimerosal) has been added.
NR. TEST-ITEM METHOD DIMENSIONS SPECIFICATIONS
--------------------------------------------------------------------------------------------------------------------
1. Protein content Xxxxx method (Mu)g/mL 1.8x10(3) < or = X < or = 2.6x10(3)
--------------------------------------------------------------------------------------------------------------------
2. HBsAg protein content ELISA % on protein > or = 95
--------------------------------------------------------------------------------------------------------------------
3. Polysaccharide content Anthrone method (Mu)g/100 (Mu)g protein < or = 10
--------------------------------------------------------------------------------------------------------------------
4. Lipid content Sulfphospho (Mu)g/100 (Mu)g protein < or = 100
vanillin method
--------------------------------------------------------------------------------------------------------------------
5. Agents used for determination by (Mu)g/100 (Mu)g protein < or = 50
purification process: spectrophotometer
Tween 20 content
--------------------------------------------------------------------------------------------------------------------
6. Agents used for detection of (Mu)g/20 (Mu)g protein < or = 5
purification process: residual Cesium by
CsCl content ion chromatography
--------------------------------------------------------------------------------------------------------------------
7. Endotoxin LAL E.U./ 100 (Mu)g < or = 10
protein
--------------------------------------------------------------------------------------------------------------------
8. Sterility Direct method or Sterile
Membrane filter
method
--------------------------------------------------------------------------------------------------------------------
9. Conclusion release Pass
--------------------------------------------------------------------------------------------------------------------
00
XXXXXXXX X
COMMERCIAL DEVELOPMENT SCHEDULES: PROPHYLACTIC VACCINE AND THERAPEUTIC VACCINE
HEPATITIS B PROPHYLACTIC DEVELOPMENT PLAN
[***]
[***]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
00
XXXXXXXX X
COMMERCIAL DEVELOPMENT SCHEDULES: PROPHYLACTIC VACCINE AND THERAPEUTIC VACCINE
HEPATITIS B THERAPEUTIC DEVELOPMENT PLAN
[***]
[***]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
22
APPENDIX C
Licensed Patents
Docket Title Country Serial No/Filing Date Status
Number
Rhein Biotech Process for preparing a EP Filed 25.07.1985 Granted 12.06.1991 as EP
173 378
Polypeptide by culturing a Granted 31.08.1993 as US
transformed US Filed 24.09.1990 5,240,838
Microorganism suitable US Filed 07.06.1995 Granted 21.04.1998 as US
5,741,672
Therefore and DNA sequences
suitable for preparing such JP Granted as JP 2 592 444
microorganism
JP Granted as JP 2 675 202
JP Granted as JP 2 575 284
DK Pending
CA pending
23
Rhein Biotech DNA molecules coding for EP Filed 17.07.1987 Granted 18.05.1994 as
FMDH control regions and EP 299 108 Granted
structured gene for a US Filed 03.03.1992 14.02.1995 as US
protein having FMDH 5,389,525 Granted
activity and their uses CA Filed 28.10.1988 25.03.1997 as CA
1,339,012 Granted
JP Filed 01.11.1988 02.06.2000 as JP 307 299
3 Granted
BR Filed 17.10.1996 01.08.2000 as BR PI
1100065-1
CL Filed 24.09.1996 Pending
DK Filed 26.10.1988 Pending
24
