Exhibit 10.1
PEVION BIOTECH
ACQUISITION & LICENSE AGREEMENT
This ACQUISITION AGREEMENT ("Agreement"), made and entered into as of March
[...], 2008 (the "Execution Date"), is an amended version which replaces the
agreement 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 ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇
▇▇▇▇▇, and a European place of business located at ▇▇, ▇▇▇ ▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ and
PEVION Biotech Ltd., a company organized under the laws of Switzerland with its
principal place of business at ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇-▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇,
("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 desires to acquire from PEVION the rights on PEVION's virosome
formulated malaria Peptide antigens vaccines (the "Product", as further defined
under Section 1.13), 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 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 "Licensed Product" means a product manufactured under the license granted
hereunder by PEVION to MYMETICS as provided for under Section 2.2.
1.5 "MYMETICS Materials" means all materials developed by MYMETICS in relation
with the Product as well as any further improvement thereof.
1.6 "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
1.7 "Non-Profit Markets" means the markets on which the vaccines will be
distributed for free or at a Reduced Price through local charitable
organizations.
1.8 "Peptides" means short chains of amino acids linked together, in principle
containing no more than [***] amino acids; for the purpose of this Agreement,
the use of "Peptide", as far as vaccines are involved, shall mean Peptide or
Protein.
1.9 "PEVION Confidential Information" includes, but is not limited to, PEVION's
virosome technology related to the Product.
1.10 "PEVION Materials" means virosomes as well as any further improvement
thereof, developed or manufactured by PEVION or on which PEVIONS has rights.
1.11 "PEVION Technology" means the virosome technology in all aspects including
any further improvement thereof, and their manufacturing.
1.12 "Product" means PEVION's virosome formulated malaria Peptide antigens
vaccines as described in Exhibit A.
1.13 "Product Information" means all information, available on the Execution
Date or at any later time for the duration of this Agreement, related to the
Product namely 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, as well as the reasonably required know-how
related thereto. However, it is specifically noted that Product Information does
not include information about the PEVION Technology including without
limitation, a formula, pattern, compilation, program, analytical methods, BMF
files, technique, process, biological material, data test, model, result or
analysis related to the Technology
1.14 "Product Patent Rights" means rights relating to 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, as well as patents, patent applications, future
patents and license rights of Pevion not listed on Exhibit B but covering
inventions which have to be reproduced for the manufacture or use of the
Product.
1.15 "Profit Markets" means all markets other than Non-Profit Markets.
1.16 "Proteins" means larger molecules composed of one or more chains of amino
acids, in principle containing more than [***] amino acids; for the purpose of
this Agreement, the use of "Peptide", as far as vaccines are involved, shall
mean Peptide or Protein.
1.17 "Recipient" means the Party who receives Confidential Information from the
other Party.
1.18 "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 [***]%.
1.19 "Sublicensee" means a third party to whom MYMETICS grants a sublicense on
certain rights granted to MYMETICS under this Agreement.
1.20 "Technology Patent Rights" means all patent rights on the virosome
technology needed for the development, use, sale, offer for sale, or
importation/exportation of virosome formulated malaria Peptide antigens vaccines
and namely 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 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, as well as rights relating to patents, patent
applications, future patents and license rights of Pevion and not listed on
Exhibit C but covering inventions which have to be reproduced for the
manufacture or use of the Product.
1.21 "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.
1.22 "Territory" means world-wide.
2 ACQUISITION AND LICENSE
2.1 Subject to the provisions of this Agreement, MYMETICS acquires from PEVION,
which assigns to MYMETICS, the Product, the Product Patent Rights, the Product
Information and all rights thereon, within the Territory and PEVION commits to
execute all necessary documents and to take all necessary actions in order to
complete these assignments.
2.2 PEVION grants to 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, with the right to sub-license in the situations
described under Sections 2.6 or 3.5 and 3.6. Unless specifically mentioned in
this Agreement, 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; reasons for the existence of, and precisions on, this
non-exclusive license are described in Exhibit E) 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 In the event of bankruptcy of PEVION or similar procedure, the licenses
provided for under this Section in favor of MYMETICS shall become free and
perpetual and shall include the right to sublicense.
2.4 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, and provided the intellectual property
referred to in this Paragraph refers to granted patents which MYMETICS requires
for distributions in Profits Markets, 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 and PEVION
shall provide MYMETICS with all the information and documents required for the
exercise of its rights under this Subsection 2.4.
2.5 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 make all reasonable efforts to
enter within 9 months into an agreement to further define the terms and
conditions of this cooperation unless the Parties agree in writing on a later
deadline to enter into such an agreement.
2.6 PEVION will perform for MYMETICS the formulation and manufacturing of the
Product for pre-clinical and clinical development as well as for the market.
Notwithstanding anything to the contrary in this Agreement, PEVION grants access
to information, documents and know-how required for the use of the license on
the Technology Patent Rights as provided for under Section 2.2 (the "Required
Access") as follows:
2.6.1 In the absence of an assignment by MYMETICS of its rights and obligations
under this Agreement, the Required Access will be granted by PEVION to MYMETICS
or third parties (e.g Clinical Research Organizations or Clinical Manufacturing
Oranizations) designated by MYMETICS on a need-to-know basis and against
compensation for its actual costs (e.g. costs for the preparation of the copies
of required documentation). PEVION reserves the right to send the required
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 (namely
as regards the technical data required to obtain approvals from governmental
bodies such as the US Food and Drug Administration).
2.6.2 In the event MYMETICS sub-licenses or assigns the Product and the rights
to it to a third party (an "Assignee"), the Assignee will have the same rights
and obligations as MYMETICS has under this Agreement under Section 2.6.1. In
particular, PEVION keeps the right for the formulation and manufacturing of the
Product for pre-clinical and clinical development as well as for the market,
2.6.3 In the event MYMETICS sub-licenses or assigns the Product and the rights
to it to an Assignee, the Assignee will have the same rights and obligations as
MYMETICS has under this Agreement. Should the Assignee elect to manufacture the
Product itself as provided for under Section 3.6 and provided such assignee (1)
has (a) revenues of at least [***] or (b) a market capitalization of at least
[***] and (2) has the capacity to manufacture the Product itself, the Required
Access will be granted by PEVION to the Assignee to a full extent in order to
allow the assignee to manufacture the Product itself, against a unique
remuneration of E[***].-, or more if the effective costs related to this
transfer are demonstrated to be higher (a "Transfer Remuneration"). In case of
multiple assignments, a Transfer Remuneration will be paid for each assignment.
The Required Access granted to an assignee under this Section shall be used
strictly and exclusively for the purpose of this Agreement.
2.6.4 In the event that MYMETICS or a third party acquires the right to
manufacture the Product as provided for under Section 3.5, the Required Access
and compensation shall be that provided for under Section 2.6.3.
2.7 PEVION will assign, respectively re-assign all Product Patent Rights to
MYMETICS as soon as possible with all reasonable efforts and in principle within
4 months from the Execution Date. Starting from the Execution 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, unless otherwise
provided for under Sections 3.5 and 3.6, 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 30%. 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 30% 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 Execution
Date, unless the Parties agree in writing on a later deadline to enter into such
an agreement.
3.5 In case PEVION can not guarantee the further supply of the Product, based on
the Supply Agreement, MYMETICS shall have the right to manufacture the Licensed
Product or to have a third party manufacture the Licensed Product. The
information and know-how transferred as provided for under this Section shall be
used strictly for the purpose of this Agreement.
3.6 In case of assignment by MYMETIC of its rights and obligations under this
Agreement in the context of a sale by MYMETICS of its malaria project as
contemplated under Section 2.6.3, if the assignee elects to manufacture the
Product itself, such assignee shall pay to PEVION an amount compensating PEVION
for its loss of profits derived from the manufacture of the Product (a
"Compensation"), amounting to E[***].- per clinical GMP lot.
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 E[***] EURO) in cash, out of
which a E[***]EURO) payment was paid in October 2007, a second installment of
E[***] EURO) was paid by December 15, 2007 and a third installment of E[***]
EURO) shall be paid within five (5) days from the signatures of both this
Agreement and the assignment of rights agreement mentioned under Section 2.7 by
STI and University of Zurich .
4.2 Milestone Payments; In return for the rights granted hereunder, MYMETICS
will pay to PEVION milestone payments of a total of E[***] EURO) in cash; a
E[***]EURO) payment shall be due upon delivery of the interim report of the
clinical Phase Ib study in Tanzania (A phase Ib double-blind randomized
controlled age-deescalating trial of two virosome formulated anti-malaria
vaccine components (PEV301T and PEV302T) administered in combination (PEV3B) to
healthy semi-immune Tanzanian volunteers) and a second milestone payment of
E[***]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
(including all monetary considerations received from sub-licenses), if the
product includes at least one of the Proteins and/or Peptides sold under this
Agreement or (b) [***] % on all income generated from royalties, lump sum
payments and any other monetary considerations coming from Profit Markets
(including all monetary considerations received from sub-licenses) if the
product does not include at least one of the Proteins and Peptides sold under
this Agreement 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 10% on human resources expenses (except CSO expenses as provided
for under Section 4.6) 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 10% 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.
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 PEVION commits to keep MYMETICS management informed of the significant
evolutions of its virosome technology on a regular basis, but at least annually,
with more in depths information being available to MYMETICS' CSO through
PEVION's CSO, on a need-to-know basis.
5.2 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.
5.3 MYMETICS shall inform PEVION in writing no later than thirty (30) days after
signing any collaboration-, partnering- or sublicensing agreement comprising the
Product.
5.4 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.
5.5 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.
5.6 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.
5.7 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.
5.8 PEVION will invoice MYMETICS, based on a detailed statement, every 3 (three)
months for its expenses, including PEVION CSO's expenses.
5.9 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 ▇▇▇▇▇▇▇ Zeitung on the last business day of the applicable reporting
period.
5.10 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 [***] of each calendar year. Each such payment shall be
for earned royalties accrued within MYMETICS' most recently completed calendar
quarter.
5.11 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.
5.12 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 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
Confidential Information disclosed by the other Party 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; unless otherwise provided for under this Agreement, 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.
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 of this paragraph, "Third Party"
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 property of the Product
passes to MYMETICS as provided for under this Agreement but 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 purpose of this paragraph, "Third Party" 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.
8.2 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 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.
8.3 If a third party initiates legal actions against MYMETICS on the basis of
alleged preferential rights regarding the Product or the Product Patent Rights
transferred, , 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.
8.4 Representations. Each Party hereby represents and warrants to the other
Party as follows:
8.4.1 It is a corporation duly organized and validly existing under the laws of
its state or other jurisdiction of incorporation or formation;
8.4.2 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;
8.4.3 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
8.4.4 It shall comply with all applicable local, state, national, regional and
governmental laws and regulations relating to its activities under this
Agreement.
8.5 PEVION has not assigned, or committed to assign, to any third party any of
the Technology Patent Rights on which a license is granted to MYMETICS under
this Agreement.
8.6 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.
8.7 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 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. If a third party initiates legal actions
against MYMETICS on the basis of alleged preferential rights regarding the
Technology Patent Rights licensed as per Section 2, then PEVION shall defend,
indemnify and hold harmless MYMETICS, its Affiliates and their respected
directors, officers and employees, from and against any and all liabilities,
damages, losses, penalties, fines, costs, interests, and expenses, arising from
or occurring as a result of a third party's claim, action, suit, judgment or
settlement, except to the extent that such third party legal action result from
the negligence or wilful misconduct of MYMETICS. If MYMETICS receives notice of
any third party legal action, MYMETICS shall, as promptly as is reasonably
possible, give PEVION notice of such third party legal action; provided,
however, that failure to give such notice promptly shall only relieve PEVION of
any indemnification obligation it may have hereunder to the extent such failure
diminishes the ability of PEVION to respond to or to defend MYMETICS against
such third party legal action. MYMETICS and PEVION shall consult and cooperate
with each other regarding the response to and the defense of any such third
party legal action and PEVION shall, upon its acknowledgment in writing of its
obligation to indemnify MYMETICS, be entitled to and shall assume the defense or
represent the interests of MYMETICS in respect of such third party legal action,
that shall include the right to select and direct legal counsel and other
consultants to appear in proceedings on behalf of MYMETICS 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 MYMETICS,
such consent not to be unreasonably withheld. Nothing herein shall prevent
MYMETICS from retaining its own counsel and participating in its own defense at
its own cost and expense.
8.8 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 of the Product Patent Rights or Technology Patent Rights on a
country-by-country basis. 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 or similar procedure, 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 a written
notice. Termination of this Agreement pursuant to this Section 9.3 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:
* 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 Unless otherwise provided for, all rights and obligations under this
Agreement shall survive the termination thereof.
9.6 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 object to the publication of
such announcement, such objection not to be unreasonably made. 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, as
defined under Section 2.6. 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.
PEVION will not assign, or commit to assign, to any third party any of the
Technology Patent Rights on which a license is granted to MYMETICS under 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 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 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:
MYMETICS Corporation,
▇▇, ▇▇▇ ▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇ ▇▇▇▇
Switzerland
Att: ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (CEO)
If to PEVION:
PEVION Ltd.
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇
Att: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (COO)
17 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)
18 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: ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇
Signature: Signature:
--------------------------- ------------------------------
CFO: COO:
Place: Place:
------------------------------- ----------------------------------
Date: Date:
-------------------------------- -----------------------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Signature: Signature:
--------------------------- ------------------------------
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 outstandingvery good 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.
[***]
Exhibit B
Product Patent Rights
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
WO 04/ 078099
Title / Inventors /
Internal Title, Publication No
Internal No Patent Family Application No Priority Filing
---------------------- --------------- --------------- ---------- ----------
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:
▇▇▇▇ ▇▇▇▇▇▇▇▇ (Swiss
Tropical Inst.)
▇▇▇▇▇▇ ▇▇▇▇▇▇ (Swiss
Tropical Inst.)
▇▇▇▇ ▇▇▇▇▇▇▇▇
(University of Zurich)
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇-
▇▇▇▇▇▇▇ (University of
Zurich)
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
(Pevion Biotech)
AMA-49/PEV301
00004; P
Title / Inventors /
Internal Title, Publication No
Internal No Patent Family Application No Priority Filing
---------------------- --------------- --------------- ---------- ----------
Methods for ▇▇▇▇▇▇▇▇▇ EP03012520 02.06.2003 02.06.2003
synthesizing
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
Swiss Tropical EP 1629002 EP04739532 02.06.2003 02.06.2004
Institute
Inventors: US 2006/0258564 10/559,010 02.06.2003 02.06.2004
▇▇▇▇ ▇▇▇▇▇▇▇▇ (Swiss
Tropical Inst.)
▇▇▇▇▇▇ ▇▇▇▇▇▇ (Swiss
Tropical Inst.)
▇▇▇▇ ▇▇▇▇▇▇▇▇
(University of Zurich)
▇▇▇▇▇▇ ▇▇▇▇▇▇
(University of Zurich)
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
(Pevion Biotech)
UK39 / PEV302
00005; P
WO 04/ 106366
Exhibit C
Technology Patent Rights
EP538 437 B1: Immunostimulating and immunopotentiating reconstituted influenza
virosomes and vaccines containing them
WO06/069718 A1: Lyophilization of virosomes
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
Exhibit E
Precisions on the non-exclusive rights regarding EP538437