[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH AS BEEN OMITTED HEREIN AND REPLACE WITH A
SERIES OF THREE ASTERISKS IN BRACKETS [***], HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.]
Exhibit 10.1
MYMETICS/PEVION P E V I O N
Acquisition & License Agreement BIOTECH
PEVION BIOTECH
AQUISITION & LICENSE AGREEMENT
This Aquisition AGREEMENT ("Agreement"), is made and entered into as of October
6, 2007 (the "Effective Date") by and between
MYMETICS Corporation ("MYMETICS"), a company organized under the laws of the
State of Delaware with a registered address at 000 Xxxx Xxxxxx, Xxx Xxxx, XX
00000, and a principal place of business located at 00, xxx xx xx Xxxxxxxxxx, XX
0000 Xxxx, Xxxxxxxxxxx and
PEVION BIOTECH LTD., a company organized under the laws of Switzerland with a
principle place of business at Xxxxxxxxxxxxx 00, XX-0000 Xxxxx Xxxxxxxxxxx,
("PEVION").
MYMETICS and PEVION may be referred to hereinafter as "Party" or "Parties" as
appropriate.
PREAMBLE
WHEREAS, PEVION is a company active in the development, manufacturing and
commercialization of specifically virosome based malaria vaccines;
WHEREAS, MYMETICS is a company active mainly in the development of vaccines for
HIV and other diseases;
WHEREAS MYMETICS is desirous of acquiring from PEVION the rights on PEVION's
virosome formulated malaria peptide antigens vaccines (the "Product", as further
defined under Section 1.12), and PEVION is willing to grant such rights; and
NOW, THEREFORE, the Parties hereto, intending to be legally bound, hereby agree
as follows:
1 DEFINITIONS
The terms, as defined herein, shall have the same meanings in both their
singular and plural forms.
1.1 "Affiliate" means, with respect to either Party, any entity controlling,
controlled by or under common control with, such Party. For purposes of
this definition, "control" of another corporation or entity shall mean
when a person or entity (i) owns or directly controls fifty percent (50%)
or more of the outstanding voting stock or other ownership interest of
the other corporation or entity, (ii) possesses, directly or indirectly
the power to manage, direct or cause the direction of the management and
policies of the
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corporation or other entity or the power to elect or appoint fifty
percent (50%) or more of the members of the governing body of the
corporation or other entity, or (iii) has actual control over the
management, business and affairs of the corporation or other entity.
1.2 "Confidential Information" means information or material related to the
Product including information about the technology or business and
without limitation, a formula, pattern, compilation, program, method,
technique, process, biological material, gene sequence, data test, model,
result or analysis which is disclosed to a party in connection with this
Agreement. Notwithstanding the foregoing, Confidential Information does
not include information that: (1) is now or subsequently becomes
generally available to the public through no wrongful act or omission of
the Recipient; (2) the Recipient can demonstrate to have been rightfully
in its possession prior to disclosure to the Recipient by the Discloser;
(3) is independently developed by the Recipient without use, directly or
indirectly, of any Confidential Information of the Discloser, as
evidenced by written records; or (4) the Recipient rightfully obtains
from a third party who has the right to transfer or disclose it.
1.3 "Discloser" means the Party who possesses Confidential Information and
discloses such information to the other Party.
1.4 "Grant" means all forms of financial supports received or to be received
from third parties in relation with the development of the Product.
1.5 "Licensed Product" means a product manufactured under the license granted
hereunder by PEVION to MYMETICS.
1.6 "MYMETICS Materials" means all materials developed by MYMETICS in
relation with the Product as well as any further improvement thereof.
1.7 "Net Sales" means the total of the gross invoice prices of Licensed
Products sold by MYMETICS, its Sublicensee, an Affiliate, or any
combination thereof, less the sum of the following actual and customary
deductions where applicable and separately listed: cash, trade, or
quantity discounts; sales, use, tariff, import/export duties or other
excise taxes imposed on particular sales (except for value-added and
income taxes imposed on the sales of Product in foreign countries);
transportation charges; or credits to customers because of rejections or
returns. For purposes of calculating Net Sales, transfers to a
Sublicensee or an Affiliate of Licensed Product under this Agreement for
(i) end use (but not resale) by the Sublicensee or Affiliate shall be
treated as sales by MYMETICS at list price of MYMETICS, or (ii) resale by
a Sublicensee or an Affiliate shall be treated as sales at the list price
of the Sublicensee or Affiliate
1.8 "Non-Profit Markets" means the markets on which the vaccines will be
distributed for free or at a Reduced Price through local charitable
organizations.
1.9 "Peptide" means short chains of amino acids linked together. In the
context of this agreement a Peptide does not contain more than 60 amino
acids
Page 2 of 23
1.10 "PEVION Confidential Information" includes, but is not limited to,
PEVION's virosome technology related to the Product.
1.11 "PEVION Materials" means virosomes as well as any further improvement
thereof, developed or manufactured by PEVION or on which PEVIONS has
rights.
1.12 "PEVION Technology" means the virosome technology in all aspects
including any further improvement thereof, and their manufacturing.
1.13 "Product" means PEVION's virosome formulated malaria peptide antigens
vaccines as described in Exhibit A; for the purpose of this Agreement,
the use of "peptide", as far as vaccines are involved, shall mean
"Peptide" or "Protein".
1.14 "Product Information" means all information related to the Product as
listed in Exhibit D, including without limitation, a formula, pattern,
compilation, program, analytical methods, IMPD files, technique, process,
biological material, gene sequence, data test, model, result or analysis
related to the Product.
1.15 "Product Patent Rights" means the patents and patent applications with
respect to PEVION malaria vaccine listed on Exhibit B and any divisional
patent, continuation, or continuation-in-part of such patent applications
to the extent the claims are directed to subject matter specifically
described therein, as well as any patent issued thereon and any reissue
or reexamination of such patent, and any foreign counterparts to such
patents and patent applications.
1.16 "Profit Markets" means all markets other than Non-Profit Markets.
1.17 "Protein" means a larger molecule composed of one or more chains of amino
acids. In the context of this agreement a Protein contains more than 60
amino acids
1.18 "Recipient" means the Party who receives Confidential Information from
the other Party.
1.19 "Reduced Price" means a price comprised in the range of (i) at the lowest
the direct production costs (i.e. manufacturing costs excluding costs of
research and development and excluding costs of intellectual property
protection or royalties costs) and (ii) at the highest the direct
production costs, plus a reasonable participation to research and
development, not exceeding COGS + [***]%.
1.20 "Sublicensee" means a third party to whom MYMETICS grants a sublicense on
certain rights granted to MYMETICS under this Agreement.
1.21 "Technology Patent Rights " means all patent rights on the virosome
technology needed for the development, use, sale, offer for sale, or
importation/exportation of the Product, specifically the PEVION's patent
rights listed in Exhibit C and any divisional patent, continuation, or
continuation-in-part of such patent applications to the extent the claims
Page 3 of 23
are directed to subject matter specifically described therein, as well as
any patent issued thereon and any reissue or reexamination of such
patent, and any foreign counterparts to such patents and patent
applications.
1.22 "Term" means the period of time beginning on the Effective Date and
ending with the longest lived patent which is, under this Agreement,
assigned or licensed.
1.23 "Territory" means world-wide.
2 ACQUISITION AND LICENSE
2.1 Subject to the provisions of this Agreement, MYMETICS acquires from
PEVION the Product, the Product Patent Rights, the Product Information
and all rights thereon, within the Territory.
2.2 PEVION grants MYMETICS licenses on the Technology Patent Rights needed
for the development, use, sale, offer for sale, or
importation/exportation of the Product within the Territory and during
the Term however restricted to the field of Malaria vaccines. These
licenses do not include the right to manufacture the Product.
Specifically PEVION grants MYMETICS a non-exclusive license on the
Technology Patent Rights on which PEVION itself does not have exclusive
rights (i.e. EP538437) and commits not to give any license on these
rights to any third party. PEVION grants MYMETICS an exclusive license on
the Technology Patent Rights on which PEVION has exclusive rights (e.g.
WO06/069718)
2.3 PEVION is responsible for maintaining in a reasonable manner the
protection for its intellectual property involved in this Agreement. If
PEVION fails to maintain the protection for its intellectual property,
namely by failing to pay the corresponding maintenance fees, MYMETICS is
entitled to take any reasonable action to maintain this protection,
namely by paying the corresponding maintenance fees, and the reasonable
costs incurred by this intervention shall be borne by PEVION. The amounts
due in this regard by PEVION to MYMETICS may be set off against any
amount due by MYMETICS to PEVION, namely under Section 4 of this
Agreement (Considerations). PEVION shall inform MYMETICS as soon as such
failure to maintain the protection of the intellectual property mentioned
in this Section can reasonably be anticipated and, if possible, three
months before the lapse of such protection following this failure.
2.4 MYMETICS will mandate PEVION to perform the future pre-clinical and
clinical development of the Product (the "Sponsored Development").
Specifically MYMETICS requires for the Sponsored Development the support
of PEVION's CSO (approximately 10% of his time) and an equivalent of a
maximum of 3 (three) full time technicians and PEVION commits to allocate
these resources to such Sponsored Development. PEVION acknowledges that
the Swiss Tropical Institute is its preferred clinical trial site partner
for the clinical development of the Product. The Parties shall
renegotiate in good faith should these resources reveal insufficient or
excessive and they shall in any case enter within 9 months into an
agreement to further define the terms and conditions of this cooperation.
Page 4 of 23
2.5 Insofar as required for the use of the license as provided for under
section 2.2, PEVION will, against adequate remuneration, provide MYMETICS
or third parties with all the required information and documents (namely
all the technical data required to obtain approvals from governmental
bodies such as the US Food and Drug Administration). PEVION reserves the
right to send these information and documents directly to third parties
when it is not necessary for MYMETICS to have knowledge thereof, so as to
preserve its trade secrets.
2.6 PEVION will assign, respectively re-assign all Product Patent Rights to
MYMETICS within 4 months from the Effective Date. Starting from the
effective date, MYMETICS has the right to decide on all prosecution
issues of the Product Patent Rights.
3 GRANTS OF SUPPLY
3.1 The license rights granted under Section 2 do not include the right to
manufacture the Product using the Technology Patent Rights and PEVION
commits to manufacture the Product on behalf of MYMETICS.
3.2 PEVION grants MYMETICS the exclusive supply rights on the Product for
clinical batches. The clinical batches of the Product shall be delivered
by Pevion to Mymetics in the containers chosen by Mymetics (e.g. vials or
pre-filled syringes). The remuneration of the clinical batches will be
COGS and a margin of [***]%. The delivery costs will be charged
separately.
3.3 PEVION grants MYMETICS the exclusive supply rights on the Product for
market batches. The Licensed Product shall be delivered by Pevion to
Mymetics in the containers chosen by Mymetics (e.g. vials or pre-filled
syringes). The remuneration of the market batches will be COGS and a
margin of [***]% for Non-Profit Markets and [***]% for all other markets.
The delivery costs will be charged separately.
3.4 Further terms and conditions of the manufacture and supply of the Product
will be set forth in a Supply Agreement, to be negotiated in good faith
by MYMETICS and PEVION during a period of nine (9) months following the
Effective Date.
3.5 In case PEVION can not guarantee the further supply of the Product, based
on the Supply Agreement, PEVION will grant MYMETICS an exclusive license
with the right to sublicense to make Licensed Product the terms of which
manufacture agreement shall be negotiated in good faith. In such a
situation, PEVION will provide MYMETICS with the technical assistance
required to set up this alternate production source, the remuneration of
the assistance shall be negotiated between PEVION and MYMETICS in good
faith and according fair market prices.
4 CONSIDERATIONS
4.1 Up-front payments; In return for the rights granted hereunder, MYMETICS
will pay to PEVION an up-front payment of a total of EURO [***] ([***]
EURO) in cash; a EURO [***] ([***] EURO) payment shall be due upon
signing the Agreement. A second installment of EURO [***] ([***] EURO)
shall be due on
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December 15, 2007 and a third installment of EURO [***] ([***]
EURO) shall be due on February 6, 2008.
4.2 Milestone Payments; In return for the rights granted hereunder, MYMETICS
will pay to PEVION milestone payments of a total of EURO [***] ([***]
EURO) in cash; a EURO [***] ([***] EURO) payment shall be due upon
delivery of the interim report of the clinical Phase Ib study in Tanzania
and a second milestone payment of EURO [***] ([***] EURO) shall be due at
the end of the first clinical Phase II study in Africa.
4.3 Royalties; In return for the rights granted hereunder, MYMETICS will pay
to PEVION either (a) [***]% on all income generated from royalties, lump
sum payments and any other monetary considerations coming from Profit
Markets if the product was developed using Proteins and/or Peptides or
(b) [***]% on all income generated from royalties, lump sum payments and
any other monetary considerations coming from Profit Markets if the
product was developed using proteins only (not peptides) and [***]% on
all income from Non-Profit Markets received by MYMETICS or an Affiliate
from a third party, provided that such monetary consideration is
attributed to the Product.
4.4 Product Patent Rights; MYMETICS will cover all expenses for the
re-assignment of the Product Patent Rights. If MYMETICS fails to maintain
the protection of the Product Patent Rights, namely by failing to pay the
corresponding maintenance fees, PEVION is entitled to take any reasonable
action to maintain this protection, namely by paying the corresponding
maintenance fees, and the reasonable costs incurred by this intervention
shall be borne by MYMETICS. The amounts due in this regard by MYMETICS to
PEVION may added to the up-front/milestone payments under Section 4 of
this Agreement (Considerations). MYMETICS shall inform PEVION as soon as
such failure to maintain the protection of the Product Patent Rights can
reasonably be anticipated and, if possible, three months before the lapse
of such protection following this failure. Starting from the effective
date, MYMETICS will cover all costs for the prosecution of the Product
Patent Rights. PEVION will charge MYMETICS after the re-assignment of the
Product Patent Rights for the prosecution and re-assignment costs.
4.5 Sponsored Development; PEVION will further develop the Product for
MYMETICS on a fee for service basis. MYMETICS will compensate PEVION for
all expenses including human resources and all chemicals and reagents.
PEVION charges MYMETICS with [***]% on human resources expenses (except
CSO expenses under 4.7) for its overhead and other administrative
expenses. PEVION will define together with MYMETICS 6 (six) months in
advance the development work and resources needed (together as Workplan)
for the following 6 (six) month period. MYMETICS shall confirm to PEVION
four (4) months in advance in writing that it accepts this workplan.
4.6 MYMETICS will pay PEVION [***]% of the salary (including benefits) of
PEVION's CSO ( "CSO") for its work and support in the development of the
Product. MYMETICS will also cover all CSO's expenses (including travel
expenses) incurred during its work for the Product. If the Parties
realize that CSO's contribution needed for the development of the Product
exceeds or is below [***]% of his annual working hours, the Parties will
renegotiate CSO's contribution to the development of the Product and
adjust the part of CSO's salary to be borne by MYMETICS accordingly.
Page 6 of 23
4.7 All milestone payments and royalty payments specified in Sections 4.1
through 4.3 above shall be paid by MYMETICS pursuant to Section 5 and
shall be delivered by MYMETICS to PEVION as noted in Section 5.
4.8 If MYMETICS fails to perform any of its obligations specified in Section
4.1 to 4.5, then PEVION shall have the right to terminate this Agreement
according section 9.2 of this agreement.
5 REPORTS, RECORDS AND PAYMENTS
5.1 Beginning on January 1, 2008 and ending on the date of first commercial
sale of the Product, MYMETICS shall submit to PEVION annual progress
reports covering MYMETICS' (and Affiliate's and sublicensee's) activities
to develop and test the Products and obtain governmental approvals
necessary for marketing the same. Such reports shall include an overview
of work completed; overview of work in progress; current schedule of
anticipated events or milestones; market plans for introduction of
Licensed Products in the reporting period. MYMETICS shall also report to
PEVION, in its immediately subsequent progress report, the date of first
commercial sale of the Product in each country of the Territory.
5.2 MYMETICS shall inform PEVION in writing no later than thirty (30) days
after signing any collaboration-, partnering- or sublicensing agreement
comprising the Product.
5.3 MYMETICS shall inform PEVION in writing no later than thirty (30) days
after receiving any up-front payments, milestone payments and/or other
monetary considerations provided that such monetary consideration is
attributed to the Products. MYMETICS shall pay PEVION the fees according
Section 4.3 no later than sixty (60) days after receiving the up-front
payments, milestone payments and/or other monetary considerations.
5.4 After the first commercial sale of the Product anywhere in the world,
MYMETICS shall submit to PEVION quarterly royalty reports on or before
each February 28, May 31, August 31 and November 30 of each year. Each
royalty report shall cover MYMETICS' (and each Affiliate's and
Sublicensee's) most recently completed calendar quarter and shall show:
- The number of each type of Licensed Product sold and the Net Sales
during the most recently completed calendar quarter;
- The sublicense fees and royalties received during the most recently
completed calendar quarter in Swiss Francs pursuant to Subsection
5.6 of this Agreement;
- The royalties and sublicense fees payable in Swiss Francs,
including the method used to calculate the royalties and the
exchange rates used pursuant to Subsection 5.6 of this Agreement.
If no sale of Licensed Products has been made and no sublicense revenues
have been received by MYMETICS during any reporting period, MYMETICS
shall so report.
Page 7 of 23
5.5 MYMETICS shall keep and shall require its Affiliates and Sublicensees to
keep, accurate and correct records of the Products used, and sold, and
sublicense fees received under this Agreement. Such records shall be
retained by MYMETICS for at least ten (10) years following a given
reporting period.
All records shall be available during normal business hours for
inspection at the expense of PEVION by a public accountant selected by
PEVION and reasonably acceptable to MYMETICS for the sole purpose of
verifying reports and payments and in compliance with the other terms of
this Agreement. Such accountant shall not disclose to PEVION any
information other than information relating to the accuracy of reports
and payments made under this Agreement or other compliance issues. In the
event that any such inspection shows an underreporting and underpayment
in excess of five percent (5%) for any twelve (12) month period, then
MYMETICS shall pay the cost of the audit as well as any additional sum
that would have been payable to PEVION had the MYMETICS reported
correctly, plus an interest charge at a rate of ten percent (10%) per
year. Such interest shall be calculated from the date the correct payment
was due to PEVION up to the date when such payment is actually made by
MYMETICS. For underpayment not in excess of five percent (5%) for any
twelve (12) month period, MYMETICS shall pay the difference within thirty
(30) days without interest charge or inspection cost.
5.6 PEVION will invoice MYMETICS, based on a detailed statement, every 3
(three) months for its expenses, including PEVION CSO's expenses.
5.7 All fees and royalties due to PEVION shall be paid in Swiss Francs, plus
Swiss VAT when applicable. When Licensed Products are sold in currencies
other than Swiss Francs, MYMETICS shall first determine the earned
royalty in the currency of the country in which Licensed Products were
sold and then convert the amount into equivalent Swiss funds, using the
exchange rate quoted in the Neue Xxxxxxx Zeitung on the last business day
of the applicable reporting period.
5.8 Royalties shall accrue when Licensed Products are paid by a third party
or Affiliate. MYMETICS shall make all reasonable efforts to secure prompt
payments from said third parties and Affiliates. MYMETICS shall pay
earned royalties quarterly on or before February 28, May 31, August 31
and November 30 of each calendar year. Each such payment shall be for
earned royalties accrued within MYMETICS' most recently completed
calendar quarter.
5.9 Royalties earned on sales occurring under sublicense granted pursuant to
this Agreement shall not be reduced by MYMETICS for any taxes, fees, or
other charges imposed by the government of such country on the payment of
royalty income, except that all payments made by MYMETICS in fulfilment
of PEVION's tax liability in any particular country may be credited
against earned royalties or fees due to PEVION for that country. MYMETICS
shall pay all bank charges resulting from the transfer of such royalty
payments.
5.10 In the event that any patent or patent claim related to the intellectual
property transferred or licensed hereunder is held invalid in a final
decision by a patent office from which no appeal or additional patent
prosecution has been or can be taken, or by a
Page 8 of 23
court of competent jurisdiction and last resort and from which no appeal
has or can be taken, all obligations to pay royalties based solely on
that patent or claim or any claim patentably indistinct therefrom shall
cease as of the date of such final decision. MYMETICS shall not, however,
be relieved from paying any royalties that accrued before the date of
such final decision.
6 CONFIDENTIALITY
6.1 Nondisclosure; Except as specifically authorized in this Agreement or as
has been specifically authorized by Discloser in writing, Recipient shall
not reproduce, exploit, use, distribute, disclose or otherwise
disseminate the disclosed proprietary information of the other Party
("Confidential Information") and shall not take any action causing, or
fail to take any reasonable action necessary to prevent any, Confidential
Information disclosed to Recipient to lose its character of Confidential
Information. Upon expiration or termination of this Agreement, or upon
request by Discloser, Recipient shall promptly deliver to Discloser all
Confidential Information of Discloser and all embodiments and/or copies
thereof then in its custody, control or possession and shall deliver
within four weeks after such expiration or termination or destroy such
Discloser's Confidential Information, and deliver to Discloser within six
weeks of such notice a written statement signed by an officer of
Recipient certifying that all unused or remaining Discloser's
Confidential Information have been returned or destroyed with the
exception of one copy kept in its legal file for reference purposes.
6.2 Ownership; All Confidential Information disclosed by Discloser shall
remain the property of Discloser and no license or other right to such
information is granted or implied hereby, other than such rights as are
expressly set out in this Agreement.
6.3 Term; Recipient's duty to protect Discloser's Confidential Information
pursuant to this Agreement expires ten (10) years from the date of
disclosure of the Confidential Information.
Page 9 of 23
7 CONTROL OF MATERIALS
7.1 Control of PEVION Materials. MYMETICS shall not transfer the PEVION
Materials to, or permit access to the PEVION Materials to, any third
party without prior written approval of PEVION, except for purposes
contemplated in this Agreement (commercial development, use, and sale of
the Product). MYMETICS shall not use and/or exploit the PEVION Materials
for any purpose other than as set forth in this Agreement. For the
purposes hereof, "third parties" shall not include those Affiliates,
corporate partners, employees and consultants of MYMETICS who will be
involved in the handling, testing and/or evaluation of PEVION Materials
under this Agreement. The PEVION Materials shall remain the property of
PEVION. Upon termination of this Agreement, MYMETICS shall discontinue
its use of all PEVION Materials, and shall, upon the written request of
PEVION, either return any such unused or remaining PEVION Materials to
PEVION or destroy such PEVION Materials, and deliver to PEVION within 14
days of such notice a written statement signed by an officer of MYMETICS
certifying that all unused or remaining PEVION Materials have been
returned to PEVION or destroyed.
7.2 Control of MYMETICS Materials. PEVION shall not transfer the MYMETICS
Materials to, or permit access to the MYMETICS Materials by, any third
party without prior written approval of MYMETICS. PEVION shall not use
and/or exploit the MYMETICS Materials for any purpose other than as set
forth in this Agreement. For the purposes hereof, "third parties" shall
not include those Affiliates, corporate partners, employees and
consultants of PEVION who will be involved in the handling, testing
and/or evaluation of Products under this Agreement. The MYMETICS
Materials shall remain the property of MYMETICS. Upon termination of this
Agreement, PEVION shall discontinue its use of all MYMETICS Materials,
and shall, upon the written request of MYMETICS, either return any such
unused or remaining MYMETICS Materials to MYMETICS or destroy such
MYMETICS Materials, and deliver to MYMETICS within 14 days of such notice
a written statement signed by an officer of PEVION certifying that all
unused or remaining MYMETICS Materials have been returned to MYMETICS or
destroyed.
8 WARRANTY, REPRESENTATIONS AND LIABILITY
8.1 No Warranty. BOTH PARTIES ACKNOWLEDGE AND AGREE THAT THE PEVION MATERIALS
ARE BEING SUPPLIED WITH NO WARRANTIES, EXPRESS OR IMPLIED, AND PEVION
EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON INFRINGEMENT. PEVION MAKES NO REPRESENTATION
THAT THE USE OF THE PEVION MATERIALS WILL NOT INFRINGE ON THE PATENT OR
PROPRIETARY RIGHTS OF ANY THIRD PARTY. However to PEVION's knowledge, the
use of the PEVION Technology in connection with the business of MYMETICS
as contemplated herein does not conflict with, misappropriate, or
infringe on the intellectual property rights of any third party.
Any Party which has knowledge of an infringement on the Technology Patent
Rights in the present Agreement shall notify the other Party thereof.
PEVION shall take all the
Page 10 of 23
required legal actions in order to put an end to any infringement on its
intellectual property rights regarding the License Products. The costs of
such legal actions shall be borne by PEVION.
If a third party initiates legal actions against MYMETICS on the basis of
alleged preferential rights regarding the Product, the Product Patent
Rights transferred, or the Technology Patent Rights licensed as per
Sections 2.1 and 2.2, and where the legal actions are on the basis of
Pevion Material, then PEVION shall assist MYMETICS in its legal defense
against such action and reimburse to MYMETICS all the costs related to
this legal defense, to the exclusion of any other compensation. For the
duration of such legal proceedings, MYMETICS may pay all amounts due to
PEVION, in particular all payments due under section 5, to a blocked
account. After the termination of the legal proceedings, the funds on the
blocked account will be transferred to PEVION after deduction of all
costs due to MYMETICS for its legal defense as provided for in this
Section.
8.2 Representations. Each Party hereby represents and warrants to the other
Party as follows:
8.2.1 It is a corporation duly organized and validly existing under the
laws of its state or other jurisdiction of incorporation or
formation;
8.2.2 It has the legal power and authority to execute and deliver this
Agreement, and to perform its obligations hereunder; its
activities under this Agreement are subject to insurance coverage;
8.2.3 No authorization, consent or approval of any governmental
authority or third party is required for the execution, delivery
or performance by it of this Agreement, and the execution,
delivery or performance of this Agreement will not violate any
law, rule or regulation applicable to such Party; and
8.2.4 It shall comply with all applicable local, state, national,
regional and governmental laws and regulations relating to its
activities under this Agreement.
8.3 Care in Use of PEVION Materials. MYMETICS acknowledges that the Product
are experimental in nature and may have unknown characteristics and
therefore agrees to use prudence and reasonable care in the use,
handling, storage, transportation and disposition and containment of such
Product.
8.4 Hold Harmless. In no event shall PEVION be liable for any use by MYMETICS
of the PEVION Materials. MYMETICS shall defend, indemnify and hold PEVION
harmless from and against any third-party claims, demands or actions and
liabilities, cost and expenses arising there from which result from
MYMETICS' use, handling, storage, transportation, disposition and
containment of the Product (a "Claim") except to the extent such Claim
result from the negligence or willful misconduct of PEVION. If PEVION
receives notice of any Claim, PEVION shall, as promptly as is reasonably
possible, give MYMETICS notice of such Claim; provided, however, that
failure to give such notice promptly shall only relieve MYMETICS of any
indemnification obligation it may have hereunder to the extent such
failure diminishes the ability of
Page 11 of 23
MYMETICS to respond to or to defend PEVION against such Claim. PEVION and
MYMETICS shall consult and cooperate with each other regarding the
response to and the defense of any such Claim and MYMETICS shall, upon
its acknowledgment in writing of its obligation to indemnify PEVION, be
entitled to and shall assume the defense or represent the interests of
PEVION in respect of such Claim, that shall include the right to select
and direct legal counsel and other consultants to appear in proceedings
on behalf of PEVION and to propose, accept or reject offers of
settlement, all at its sole cost; provided, however, that no such
settlement shall be made without the written consent of PEVION, such
consent not to be unreasonably withheld. Nothing herein shall prevent
PEVION from retaining its own counsel and participating in its own
defense at its own cost and expense.
8.5 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY
INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR
IN CONNECTION WITH THIS AGREEMENT WHETHER OR NOT THAT PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF OR IS OTHERWISE ON NOTICE OF SUCH
POSSIBILITY UNLESS THE PARTY IN DEFAULT HAS ACTED IN WILLFUL MISCONDUCT
OR GROSS NEGLIGENCE.
9 TERM OF AGREEMENT
9.1 Pursuant to Section 1.22, the Term of the Agreement is the period of time
beginning on the Effective Date and ending on the expiration date of the
longest-lived Patent Rights. MYMETICS shall however have the right at any
time and for any reason to terminate this Agreement upon a ninety (90)
day written notice to PEVION. Said notice shall state MYMETICS' reason
for terminating this Agreement. Any termination under this Section shall
not relieve MYMETICS of any obligation or liability accrued under this
Agreement prior to termination or rescind any payment made to PEVION or
action by MYMETICS prior to the time termination becomes effective.
Termination shall not affect in any manner any rights of PEVION arising
under this Agreement prior to termination.
9.2 If one Party fails to perform or violates any term of this Agreement, the
other Party may give written notice of default ("Notice of Default") to
the Party. If the Party fails to cure the default within sixty (60) days
of the Notice of Default, the other Party may terminate this Agreement by
second written notice ("Notice of Termination"). If a Notice of
Termination is sent to one of the Parties, this Agreement shall
automatically terminate on the effective date of that notice. Termination
shall not relieve either Party of its obligation to pay any fees owed at
the time of termination
9.3 In the event any Party becomes the subject of a voluntary or involuntary
petition in bankruptcy, such Party shall immediately notify the other
Party in writing. If such petition is not dismissed with prejudice within
one hundred twenty (120) days after filing, the other Party shall have
the right to terminate this Agreement by giving the bankrupting Party
written notice. Termination of this Agreement pursuant to this Section 9
shall be effective upon the bankrupting Party's receipt of such written
notice.
9.4 Effects of Termination. Upon the termination of this Agreement for any
reason whatsoever or the expiration of the term of this Agreement:
Page 12 of 23
- all rights of the Parties hereunder shall cease immediately;
- amounts owed by MYMETICS to PEVION shall immediately become due and
payable;
- MYMETICS or its Sublicensees shall have the right to distribute and
sell its remaining inventory of Licensed Products and raw materials,
in the ordinary course of business and pursuant to instructions
received from PEVION.
9.5 The following Sections and Articles shall survive the termination of this
Agreement: 1, 4, 5, 6 7, 8, 10, 18.
Upon termination of this Agreement, MYMETICS may dispose of all previously made
or partially made Licensed Product within a period of one hundred and twenty
(120) days of the effective date of such termination provided that the sale of
such Licensed Product by MYMETICS, its Sublicensees, or Affiliates shall be
subject to the terms of this Agreement, including but not limited to the
rendering of reports and payment of royalties required under this Agreement.
10 PUBLICITY
Except as may otherwise be required by law or regulation, neither Party shall
make any public announcement, directly or indirectly, concerning the existence
or terms of this Agreement or the subject matter hereof without first submitting
a copy of the proposed announcement to the other Party for review and obtaining
the approval of the other Party. The other Party shall have seven (7) business
days or such other time as mutually agreed upon to consent to the publication of
such announcement, such consent not to be unreasonably withheld. If either Party
is required by law or regulation to make a public announcement concerning the
existence or terms of this Agreement, such Party shall give reasonable prior
advance notice of the proposed text of such announcement to the other Party for
its prior review and comment.
11 ASSIGNMENT
The Parties agree not to assign any of their rights or obligations under this
Agreement to any other third party without first obtaining the written approval
of the other Party. Such approval shall not be unreasonably withheld and Pevion
in particular recognizes Mymetics' right to sell the result of its malaria
vaccine project, including its rights and obligations under this Agreement,
provided such a sale does not have material adverse effects on Pevion. The terms
and conditions of this Agreement shall inure to the benefit of and be binding
upon the respective permitted successors and assigns of the Parties. Nothing in
this Agreement, express or implied, is intended to confer upon any Party other
than the Parties hereto or their respective successors and assigns any rights,
remedies, obligations, or liabilities under or by reason of this Agreement,
except as expressly provided in this Agreement.
12 RE-ASSIGNMENT OF RIGHTS TO PEVION
MYMETICS agrees to re-assign for free to PEVION all the rights including the
Product Patent Rights, obtained from PEVION under this Agreement, if it is
established that MYMETICS has stopped its efforts to develop its malaria vaccine
for a period of two years or
Page 13 of 23
more. Upon request from PEVION, MYMETICS shall demonstrate in good faith which
efforts have been undertaken in the last two years in this regard.
13 SEVERABILITY
If one or more provisions of this Agreement are held to be unenforceable under
applicable law, the Parties agree to renegotiate such provision in good faith,
in order to maintain the economic position enjoyed by each Party as close as
possible to that under the provision rendered unenforceable. In the event that
the Parties cannot reach a mutually agreeable and enforceable replacement for
such provision, then (i) such provision shall be excluded from this Agreement,
(ii) the balance of the Agreement shall be interpreted as if such provision were
so excluded and (iii) the balance of the Agreement shall be enforceable in
accordance with its terms
14 AMENDMENTS AND WAIVERS
Any agreement to change the terms of this Agreement in any way shall be valid
only if the change is made in writing and approved by mutual agreement of
authorized representatives of the Parties hereto. This contract is the entire
agreement between the Parties with respect to the subject matter thereof and
supersedes all prior agreements whether written or oral.
No waiver of any right, power or remedy following a breach of this contract is
valid unless it is made in writing.
15 ENTIRE AGREEMENT
MYMETICS acknowledges having read and executed this Agreement and agreed to be
bound by its terms. This Agreement is the product of both of the Parties hereto,
and constitutes the entire agreement between such Parties pertaining to the
subject matter hereof, and merges all prior negotiations and drafts of the
Parties with regard to the transactions contemplated herein. Any and all other
written or oral agreements existing between the Parties hereto regarding such
transactions are expressly canceled.
The preamble hereof shall form an integral part of this Agreement.
16 DUE DILIGENCE REGARDING THE PRODUCT- AND TECHNOLOGY PATENT RIGHTS
MYMETICS has ordered GERMAIN & MAUREAU, patent trade xxxx and design Attorneys,
to make a due diligence regarding PEVION's intellectual property rights
mentioned in this Agreement. The Parties recognize that the adequate protection
of these intellectual property rights is a condition to the continuing execution
of this Agreement.
If such due diligence, which shall be complete by December 15 2007, reveals
inadequate protection of the intellectual property rights mentioned in this
Agreement, MYMETICS shall not have to make any further payment until PEVION has
fixed these lacks of protection at its own costs.
Page 14 of 23
If these lacks of protection are fixed by PEVION in an objectively satisfactory
way, all the rights and remedies of the Parties under this Agreement shall take
full force and effect and, in particular, MYMETICS will resume the various
payments provided for under this Agreement.
If these lacks of protection are not fixed by PEVION in an objectively
satisfactory way, all rights and remedies of the Parties under this Agreement
shall be terminated and no further payment will be due by Mymetics; the first
instalment of EURO [***] ([***] EURO) paid by MYMETICS at the time of
signature of this Agreement as per Section 4.1 shall however not be reimbursed
by Pevion.
17 NOTICES
Notices, invoices, communications, and payments hereunder shall be deemed made
if given by traceable mail and addressed to the Party to receive such notice,
invoice, or communication at the address given below, or such other address as
may hereafter be designated by notice in writing:
If to MYMETICS: If to PEVION:
MYMETICS Corporation, PEVION Ltd.
00, xxx xx xx Xxxxxxxxxx, Xxxxxxxxxxxxx 79
CH 1260 Xxxx XX 0000 Xxxx
Xxxxxxxxxxx Xxxxxxxxxxx
Att: Xxxxxxxxx Xxxxxx (CEO) Att: Xxxxxx Xxxxxxxx (COO)
18 APPLICABLE LAW AND CONFLICT RESOLUTION.
This Agreement will be governed by the laws of Switzerland without regard to its
conflict of laws rules. All disputes arising out of or in connection with this
Agreement shall finally be resolved by the competent court of Zurich,
Switzerland.
(Remaining of page intentionally left blank)
Page 15 of 23
19 SIGNATURES
IN WITNESS WHEREOF, the proper Parties, duly authorized, have executed this
Agreement in duplicate as of the day and year first written above.
For MYMETICS: For PEVION:
President & CEO: CEO
Place: Place:
----------------------- -----------------------
Date: Date:
----------------------- -----------------------
Name: Xxxxxxxxx Xxxxxx Name: Xxxxx Xxxxx
Signature: /s/Xxxxxxxxx Xxxxxx Signature: /s/ Xxxxx Xxxxx
------------------- -------------------
CFO: COO:
Place: Place:
----------------------- -----------------------
Date: Date:
----------------------- -----------------------
Name: Xxxxx Xxxxx Name: Xxxxxx Xxxxxxxx
Signature: /s/ Xxxxx Xxxxx Signature: /s/ Xxxxxx Xxxxxxxx
----------------- --------------------
Page 16 of 23
EXHIBIT A
CONCEPT
Pevion Biotech uses its well-established virosome technology platform PeviPROTM
for the delivery of the newly developed peptide antigens. The virosomes allow
inducing a strong and reliable immune response even against weak immunogens, as
peptides are. Together with the excellent safety profile known for virosome
vaccines, the in-depth experience of virosome vaccines in children and infants
makes the combination of peptide antigens with PeviPROTM a vaccine candidate
with outstanding chances to actually defeat Malaria. A recent development makes
this combination even more attractive for vaccines in tropical regions. Pevion
Biotech was able for the first time to lyophilize virosome vaccines. This
process allows the storage of the vaccine even at room temperature and solves
common stability issues for a number of vaccines. After reconstitution of the
lyophilized vaccine it is still fully active.
DATA
Peptides from regions of different protein antigens were tested for their
ability to evoke a protective immune response. They were synthesized,
intensively tested and improved over sequential rounds of peptide optimization.
In detail, identified peptides were formulated with virosomes and tested for
their immunogenicity by injecting the virosome/peptide combination in mice. The
quality and quantity of the resulting antibodies was evaluated by western blot
and ELISA analysis. Additionally, their ability to bind native proteins was
shown by immuno fluorescence on parasites. The final test was to evaluate,
whether the antibodies are functional, i.e. inhibit growth of the parasite.
Therefore the antibodies were assessed for their ability to inhibit growth of
living parasite or inhibit their invasion of cells. This represents the
milestone: proof of concept in animals. The company identified four lead
structures originating from protein antigens of different life stages of the
parasite. PEV301 is derived from the apical membrane antigen 1 (AMA-1), an
antigen of the blood stage. PEV302 is originally located within major surface
protein of the pre-erythrocytic stage, representing the incoming parasite,
called circum sporozoite protein (CSP). PEV303 is a major peptide antigen of the
MSP-1 protein (blood stage) and PEV304 originates of the blood stage protein
MSP-3. All molecules successfully finished proof of concept in animals and
entered preclinical development.
Preclinical development was pursued for the two components PEV301 and PEV302. It
included the establishment of the GMP manufacturing of the final vaccine
component, and an in-depth toxicology study. The latter demonstrated that
peptide vaccines were safe and well tolerated in rabbits and rats. Furthermore,
the company set up stability and analytic programs (HPLC, potency tests and
competitive ELISA).
The two components met another milestone by successfully finishing a first
clinical testing. The synthetic peptide vaccine components were evaluated in
healthy volunteers in order to test their tolerability and immunogenicity. After
two vaccinations the clinical data showed that the tested peptide vaccine
components possess a unique safety profile. At the same time they are highly
immunogenic, which was shown by a response rate of 100%. Remarkable is the
longevity of the response: in the groups tested antigen specific antibodies were
detected even one year after the first immunization. The antibodies induced by
the two components are
Page 17 of 23
fully functional, recognize the native proteins (western blot analysis and
immune fluorescence) and were able to inhibit growth of the parasite. These
results were clearly over all expectations. Most importantly, the results
indicate, that already two application may be sufficient in endemic regions.
This would substantially reduce the costs of the vaccine in these regions.
Pevion Biotech developed the vaccine formulations PEV301 and PEV302 to clinical
Phase II which started in Q4 2005.
NEXT STEPS
First results of the clinical IIa study are expected by end 2007. In parallel,
Pevion Biotech will test PEV301 and PEV302 in endemic regions. This allows to
verify the finding, that immune response to these antigens can amplified even by
very low pre-existing immunity. This effect would allow to get easy access to
the a market consisting of military personal and private persons in endemic
regions. The start of this clinical program is planned for Q3/2007. Further
clinical studies depends on the collaboration with a NGO (see below). Pevion
Biotech is already partner in an EU-network for the development of malaria
vaccine.
Page 18 of 23
EXHIBIT B
Product Patent Rights
US2004/ 0176283: Methods and composition for the design of synthetic vaccines
WO 04/ 078099: Composition and Methods for the generation of protective
immune response against malaria
WO 04/ 106366: Methods for synthesizing conformationally constrained peptides,
peptidomimetics and use of such peptidomimetics as synthetic
vaccines
US2004/ 0176283
-----------------------------------------------------------------------------------------------------------------------
PUBLICATION NO APPLICATION NO PRIORITY FILING
TITLE / INVENTORS /
INTERNAL TITLE, INTERNAL NO Patent Family
-----------------------------------------------------------------------------------------------------------------------
METHODS AND COMPOSITIONS FOR THE
DESIGN OF SYNTHETIC VACCINES
-----------------------------------------------------------------------------------------------------------------------
Representative: Xxxxx Day, USA US2004/ 0176283 US 10/114,918 01.04.2002
--------------- ---------------
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (Swiss Tropical
Inst.)
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxx Xxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxxx Xxxxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxx Xxxxxxxxxx (Pevion
Biotech)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxxx Xxxxxx (Pevion Biotech)
-----------------------------------------------------------------------------------------------------------------------
Applicant:
----------
-----------------------------------------------------------------------------------------------------------------------
Pevion Biotech Ltd.,
-----------------------------------------------------------------------------------------------------------------------
University of Zurich,
-----------------------------------------------------------------------------------------------------------------------
Swiss Tropical Institute
-----------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------
"MALARIA CSP-MIMETIC (PEV302)"
-----------------------------------------------------------------------------------------------------------------------
00002; P
-----------------------------------------------------------------------------------------------------------------------
WO 04/ 078099
Page 19 of 23
-----------------------------------------------------------------------------------------------------------------------
PUBLICATION NO APPLICATION NO PRIORITY FILING
TITLE / INVENTORS /
INTERNAL TITLE, INTERNAL NO Patent Family
-----------------------------------------------------------------------------------------------------------------------
COMPOSITIONS AND US2004/ 0175392 US10/379,417 03.03.2003 03.03.2003
METHODS FOR THE
GENERATION OF
PROTECTIVE
IMMUNE RESPONSES
AGAINST MALARIA
-----------------------------------------------------------------------------------------------------------------------
WO 04/ 078099 PCT/EP04/002126 03.03.2003 03.03.2004
-------------
-----------------------------------------------------------------------------------------------------------------------
AU AU2004216833 03.03.2003 03.03.2004
-----------------------------------------------------------------------------------------------------------------------
Applicants: CA2,545,779 CA 03.03.2003 03.03.2004
----------
-----------------------------------------------------------------------------------------------------------------------
Pevion Biotech LTD.., EP1599225B1 EP04716571.7 03.03.2003 03.03.2004
-----------------------------------------------------------------------------------------------------------------------
University of Zurich;
-----------------------------------------------------------------------------------------------------------------------
Swiss Tropical Institute
-----------------------------------------------------------------------------------------------------------------------
Inventors:
----------
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (Swiss Tropical
Inst.)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxx Xxxxxx (Swiss Tropical
Inst.)
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxxxx Xxxxxx-Xxxxxxx
(University of Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxx Xxxxxxxxxx (Pevion
Biotech)
-----------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------
AMA-49/PEV301
-----------------------------------------------------------------------------------------------------------------------
00004; P
-----------------------------------------------------------------------------------------------------------------------
WO 04/ 106366
-----------------------------------------------------------------------------------------------------------------------
PUBLICATION NO APPLICATION NO PRIORITY FILING
TITLE / INVENTORS /
INTERNAL TITLE, INTERNAL NO Patent Family
-----------------------------------------------------------------------------------------------------------------------
METHODS FOR SYNTHESIZING XX0000000 EP03012520 02.06.2003 02.06.2003
CONFORMATIONALLY CONSTRAINED
PEPTIDES, PEPTIDOMIMETICS AND
USE OF SUCH PEPTIDOMIMETICS AS
SYNTHETIC VACCINES
-----------------------------------------------------------------------------------------------------------------------
WO 04/106366 PCT/EP04/005952 02.06.2003 02.06.2004
------------
-----------------------------------------------------------------------------------------------------------------------
Applicants:
-----------
-----------------------------------------------------------------------------------------------------------------------
Pevion Biotech Ltd.., AU 4242787 AU2004242787 02.06.2003 02.06.2004
-----------------------------------------------------------------------------------------------------------------------
University of Zurich; CA 2,527,795 02.06.2003 02.06.2004
-----------------------------------------------------------------------------------------------------------------------
Page 20 of 23
-----------------------------------------------------------------------------------------------------------------------
PUBLICATION NO APPLICATION NO PRIORITY FILING
TITLE / INVENTORS /
INTERNAL TITLE, INTERNAL NO Patent Family
-----------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------
Swiss Tropical Institute EP 1629002 EP04739532 02.06.2003 02.06.2004
-----------------------------------------------------------------------------------------------------------------------
Inventors: US 2006/0258564 10/559,010 02.06.2003 02.06.2004
----------
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (Swiss Tropical
Inst.)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxx Xxxxxx (Swiss Tropical
Inst.)
-----------------------------------------------------------------------------------------------------------------------
Xxxx Xxxxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxx Xxxxxx (University of
Zurich)
-----------------------------------------------------------------------------------------------------------------------
Xxxxxxx Xxxxxxxxxx (Pevion
Biotech)
-----------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------
UK39 / PEV302
-----------------------------------------------------------------------------------------------------------------------
00005; P
-----------------------------------------------------------------------------------------------------------------------
Page 21 of 23
EXHIBIT C
Technology Patent Rights
EP538 437 B1: Immunostimulating and immunopotentiating reconstituted
influenza virosomes and vaccines containing them
WO06/069718 A1: Lyophilization of virosomes
Page 22 of 23
EXHIBIT D
PRODUCT INFORMATION
Immunological data:
- Pre-clinical data set for PEV301-304
- Clinical Phase I and clinical Phase IIa data set for PEV301/PEV302
Regulatory data:
- Toxicology data set for PEV301/302
- IMPD for PEV301-PEV304 (drug substance part; issues concerning the virosome
technology and the manufacturing will be provided directly to the
corresponding regulatory authorities)
- Safety data set from clinical Phases I and IIa
Manufacturing data:
- Analytical test and methods (GMP)
- SOP for manufacturing
- All QA/QC relevant aspects
Page 23 of 23
