EXHIBIT 10.35
LICENSE AGREEMENT
This License Agreement is entered into as of the 25th day of March, 2002, (the
"Effective Date") by VaxGen, Inc., a Delaware corporation ("VaxGen"), and
Celltrion, Inc., a Korean corporation ("Celltrion") (each also singularly a
"Party" and collectively the "Parties") as follows:
WITNESSETH:
WHEREAS, VaxGen is the owner of certain patent rights and knowhow relating to
the fermentation, purification and manufacture of recombinant proteins, as well
as the owner of certain related biological materials, protocols and other
knowhow;
WHEREAS, Celltrion wishes to obtain a license under such intellectual property;
and
WHEREAS, VaxGen is willing to grant such a license to Celltrion on the terms set
forth herein.
NOW, THEREFORE, in consideration of the mutual promises contained herein, the
Parties agree as follows:
Article 1.0 Certain Definitions
The terms defined elsewhere in this Agreement shall have the meanings specified
herein. The following terms shall have the following meanings for purposes of
this Agreement:
1.1 "Facility" shall mean a certain pharmaceutical manufacturing facility to be
constructed by Celltrion in Incheon, Korea, pursuant to other agreements to
which Celltrion and VaxGen (and others) are party.
1.2 "Licensed Knowhow" shall mean any and all proprietary information, methods,
processes, techniques, data and biologic materials which are in the
possession of or controlled by VaxGen presently or hereafter during the
term of this Agreement, which VaxGen is free to license or sublicense, and
which are necessary or useful for the manufacture of any Licensed Product;
provided however, that "Licensed Knowhow" shall not include any rights
licensed to VaxGen pursuant to that certain License and Supply Agreement
between VaxGen and Genentech, Inc. dated as of May 1, 1996 (the "Genentech
Agreement"). "Licensed Knowhow" shall include, without limitation, those
items listed or described on Exhibit "A" attached hereto.
1.3 "Licensed Patent Rights" shall mean all patents and patent applications,
and all patents issuing therefrom, together with all extensions, reissues,
reexaminations, substitutions, renewals, divisions, continuations,
continuations-in-part and foreign counterparts thereof or therefor, that
are in the possession of or controlled by VaxGen presently or hereafter
during the term of this Agreement, and which VaxGen is free to license or
sublicense, to the extent that any of the foregoing relates to or claims
the manufacture of any Licensed Product; provided however, that "Licensed
Patent Rights" shall not include any rights licensed to VaxGen pursuant to
the Genentech Agreement. "Licensed Patent Rights" shall include, without
limitation, those patent applications and patents listed on Exhibit "B"
attached hereto.
1.4 "Licensed Product" shall mean any pharmaceutical formulation that: (i)
could not be manufactured without infringing one or more claims of the
Licensed Patent Rights, or (ii) is manufactured, in whole or part, through
the use of Licensed Knowhow.
Article 2.0 License Grant
2.1 License Grant. Subject to the other terms and conditions of this Agreement,
VaxGen hereby grants to Celltrion an exclusive license under the Licensed
Patent Rights and Licensed Knowhow to make Licensed Products in the
Republic of Korea for sale any where in the world, except for AIDSVAX which
is subject to a separate Sub-License Agreement. With respect to the
Licensed Patent Rights or Licensed Knowhow, Celltrion shall have no rights
other than the rights as granted under this Agreement
2.2 Sub-licenses. Celltrion shall have no right to sublicense its rights
hereunder without the prior written consent of
VaxGen, which consent may be withheld by VaxGen in its sole discretion.
Article 3.0 Technology Transfer
3.1 Celltrion shall have the right to require VaxGen, at Celltrion's expense,
to transfer the Licensed Patent Rights and the Licensed Knowhow to
Celltrion. The Parties shall in good faith determine the most
cost-effective and timely means of effecting such transfer, consistent with
Exhibit "C" attached hereto.
3.2 VaxGen shall provide to Celltrion all the relevant documents, materials,
designs, data and other information necessary for the use of the Licensed
Patents Rights and the Licensed Know-how by Celltrion and for manufacturing
the Licensed Product by Celltrion. The timing and method of delivery of
those documents shall be determined later based on mutual agreement by the
Parties.
3.3 VaxGen shall arrange, to the extent necessary for the construction and
operation of the Facility and manufacture of AIDSVAX as contemplated by the
Parties, for the employees of Celltrion to receive continuing and ongoing
professional training and education at the pilot plant operated by VaxGen,
and/or at the 12 KL facility of VaxGen or elsewhere as requested by
Celltrion. Celltrion shall bear all out-of-pocket expenses for such
training, including airfare and accommodations for the Celltrion employees
and, to the extent such training occurs in Incheon City, for VaxGen
personnel, provided, however, that the salaries of VaxGen personnel
providing such professional training and education shall be borne by
VaxGen. All costs of providing technical assistance relating to the design,
engineering, and construction of the Facility, including out-of-pocket
expenses and salaries of VaxGen personnel, shall be borne by Celltrion.
3.4 Upon the reasonable request by Celltrion, VaxGen shall dispatch its own
technicians and specialists with appropriate experience and qualifications
to Celltrion to assist in the transfer and use of the Licensed Patent
Rights and the Licensed Knowhow by Celltrion for the manufacture of
AIDSVAX. In this case, all out-of-pocket expenses for such visits by VaxGen
personnel, including but not limited to airfare, accommodations, board and
local transportation, shall be borne by Celltrion, and the salary for
VaxGen personnel so dispatched to Celltrion shall be borne by VaxGen.
VaxGen shall provide free of charge all technical assistance as reasonably
necessary, including but not limited to troubleshooting problems, up to the
date of validation of the Facility by the relevant regulatory authorities.
Any and all expenses relating to any technical assistance provided by
VaxGen personnel, including out-of-pocket expenses and their salary, that
is provided to Celltrion after the date of validation shall be borne by
Celltrion.
3.5 In the event that any technical assistance reasonably required by Celltrion
cannot be provided by VaxGen, VaxGen and Celltrion shall meet and discuss
possible approaches to obtaining such assistance, and VaxGen shall make its
best efforts to procure such assistance on favorable terms to Celltrion.
3.6 All other matters relating to the transfer of technology not expressly
provided herein shall be agreed upon by the Parties. The Parties shall meet
and discuss the detailed program for the transfer of technology as soon as
practically possible.
Article 4.0 Accounting Records
4.1 Reports. Within 90 days after the last day of each calendar quarter,
Celltrion shall render to VaxGen an accounting for such calendar quarter
showing, on a Licensed Product-by-Licensed Product and country-by-country
basis, all sales of Licensed Products during such quarter.
4.2 Celltrion Accounting Records. Celltrion shall keep full, true and accurate
books of account containing all particulars which may be necessary for the
purpose of showing sales of all Licensed Products on a country-by-country
basis. Celltrion's complete books of account and supporting data therefor
shall be kept at its principal place of business for at least five years
following the end of the calendar year to which they pertain (and access
shall not be denied thereafter, if reasonably available), and shall be made
available for inspection and copying during regular business hours by an
independent accountant retained by VaxGen at VaxGen's sole expense.
Article 5.0 Intellectual Property Rights
5.1 Ownership. VaxGen shall retain title to the Licensed Knowhow and Licensed
Patent Rights, including, without limitation, any Licensed Knowhow and
Licensed Patent Rights developed or invented by VaxGen in the future.
Celltrion shall retain title to any improvements to the Licensed Knowhow or
Licensed Patent Rights developed or invented solely by Celltrion; provided,
however, that VaxGen shall have a royalty-free non-exclusive right to
practice any such improvements as it sees fit. The Parties shall own
jointly any improvements to any Licensed Knowhow or Licensed Patent Rights
which are developed or invented by both Parties. Designation of inventor(s)
on any patent application is a matter of law, and shall be solely within
the discretion of qualified patent counsel of VaxGen and Celltrion to
determine in accordance with United States laws of inventorship and
competent written evidence of the Parties.
5.2 Patent Filing, Prosecution and Maintenance. During the term of this
Agreement,. VaxGen shall be responsible for the filing, prosecution and
maintenance of all Licensed Patent Rights at its sole cost and expense;
provided, however, that Celltrion shall reimburse all reasonable costs and
expenses incurred by VaxGen in relation to the filing, prosecution and
maintenance in Korea made for the benefit of Celltrion hereunder within 30
days of receipt of an invoice from VaxGen setting forth such costs and
expenses. VaxGen shall keep Celltrion informed of the status of filing,
prosecution and maintenance of Licensed Patent Rights in Korea, by: (i)
updating Celltrion on a regular basis (and in any event not less frequently
than annually) regarding the status of the patent applications and patents
within the Licensed Patent Rights by providing Celltrion with a
then-current version of Exhibit A to this Agreement and reviewing it with
Celltrion as reasonably requested; and (ii) notifying Celltrion of any
interference, opposition, re-examination request, nullity proceeding,
appeal or other interparty action or reissuance proceeding involving the
Licensed Patent Rights in Korea.. VaxGen shall determine in its sole
discretion whether or not to file, perfect, prosecute, maintain or take or
not take any other action with respect to any patent application or patent
within the Licensed Patent Rights generally or in Korea (including, without
limitation, any interference, opposition, re-examination request, nullity
proceeding, appeal or other interparty action or reissuance proceeding
involving the Licensed Patent Rights). However, if VaxGen desires to take
(or not take) any such action in or for the benefit of Korea but Celltrion
is not prepared to reimburse VaxGen therefor as required hereunder, in such
case VaxGen shall be free to take (or not take) such action at its sole
cost and expense and, on notice from VaxGen to Celltrion, the rights
licensed to Celltrion under this Agreement with respect to such patent
application or patent shall return to VaxGen and thereafter be excluded
from the Licensed Patent Rights.
5.3 Patent Infringement
(a) If either Party learns that a third party is infringing or allegedly
infringing any Licensed Patent Rights, it shall promptly notify the
other Party thereof. The Parties shall cooperate and use reasonable
efforts to stop such alleged infringement without litigation.
(b) VaxGen shall have the sole right (but not the obligation) to take the
appropriate steps to remove the infringement or alleged of Licensed
Patent Rights, including, without limitation, initiating a suit,
proceeding or other legal action.
5.4 Third Party Patent Rights. If a notice of infringement is received by, or a
suit is initiated against, either Party with respect to any Licensed
Product, the Parties shall consult in good faith regarding the best
response.
Article 6.0 Confidentiality
6.1 Confidentiality. In the course of performance of this Agreement, one Party
may disclose to the other Party or receive from the other Party information
which is confidential information of the disclosing Party. In order to be
considered confidential information of the disclosing Party, such
information must be in writing and designated as confidential, or if
disclosed orally must be confirmed in writing to the other Party as
confidential within 30 days after such oral disclosure ("Confidential
Information"). In addition, for the purposes of this Agreement,
Confidential Information shall not include information that (in each case
as evidenced by written records or other competent evidence):
(a) was known to the receiving Party at the time of disclosure hereunder
by the disclosing Party;
(b) was generally available to the public or was otherwise part of the
public domain at the time of disclosure hereunder, or became generally
available to the public or otherwise part of the public domain after
disclosure hereunder other than through any act or omission of the
receiving Party in breach of this Agreement;
(c) became known to the receiving Party after disclosure from a source
that had a lawful right to disclose such information to others; or
(d) was independently developed by the receiving Party without the use of
any Confidential Information of the disclosing Party.
Each Party shall protect and keep confidential and shall not use, publish
or otherwise disclose to any third party the other Party's Confidential
Information for a period of five years from the date of disclosure
hereunder, except as otherwise permitted by this Agreement or with the
other Party's prior consent. The foregoing notwithstanding, each Party may
disclose Confidential Information of the other Party during any official
proceeding before a court or governmental agency, or as a part of a patent
application filed on inventions made under this Agreement, or as necessary
in order to manufacture Licensed Products as contemplated herein; provided
that the Party whose Confidential Information is included in such
application shall have the opportunity to review such proposed disclosure
at least 30 days prior to the date of such filing and does not object in
writing to such proposed disclosure. In the event of an objection the
consultation provisions of Section 7.2 below shall apply.
Article 7.0 Representations and Warranties
7.1 Disclaimer. Except as expressly provided in this Agreement, the Parties
disclaim all other representations and warranties, express or implied,
including, without limitation, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, or NON-INFRINGEMENT.
7.2 Mutual Representations and Warranties. Each party represents and warrants
to the other Party that the representing and warranting Party, to its best
knowledge: is free to enter this Agreement and in so doing it will not
violate any other agreement to which it is party or subject.
7.3 Representations and Warranties by VaxGen. VaxGen represents and warrants to
Celltrion that it has the right to grant the license set forth hereinabove,
free from any inconsistent claims or restrictions in favor of any third
party.
(a) the Licensed Patent Rights and Licensed Knowhow, taken together with
the intellectual property rights to be licensed and transferred to
Celltrion pursuant to a certain sublicense agreement between the
Parties of even date herewith (the "Sublicense Agreement") , are
suitable and adequate to manufacture the Vaccine (as defined in the
Sublicense Agreement) at the scale currently produced by Genentech;
(b) no license of additional intellectual property from any third party is
necessary in order to manufacture the Vaccine as contemplated in that
certain Supply Agreement (the "Supply Agreement") between the Parties
of even date herewith; and
(c) to the best of VaxGen's knowledge, manufacture of the Vaccine as
contemplated in the Supply Agreement will not infringe upon the
intellectual property rights of any third party.
Article 8.0 Liability
8.1 Limitation of Liability. Neither Party shall be liable to the other for
indirect, incidental, special or consequential damages arising out of or
resulting from any term or condition of this Agreement or with respect to
their performance or lack thereof.
8.2 Indemnification by Celltrion. Celltrion shall indemnify, defend and hold
harmless VaxGen and its directors, officers, employees, agents and
affiliates from and against all costs, claims, suits, liabilities, expenses
(including reasonable attorneys' fees) and damages arising out of or
resulting from the manufacture by Celltrion of any Licensed Product, except
to the extent that such cost, claim, suit, expense or damage arose or
resulted from any willful or negligent act or omission by VaxGen.
Celltrion's indemnification obligations hereunder shall be conditioned upon
VaxGen (i) giving reasonable notice to Celltrion of any such claim or
action, (ii) tendering the defense of such claim or action to Celltrion,
(iii) reasonably assisting Celltrion (at Celltrion's expense) in
investigating and defending such claim or action, and (iv) not compromising
or settling such claim or action without Celltrion's prior consent.
8.3 Indemnification by VaxGen. VaxGen shall indemnify, defend and hold harmless
Celltrion and its directors, officers, employees, agents and affiliates
from and against all costs, claims, suits, liabilities, expenses (including
reasonable
attorneys' fees) and damages arising out of or resulting from the use or
sale by VaxGen of any Licensed Product, except to the extent that such
cost, claim, suit, expense or damage arose or resulted from any willful or
negligent act or omission by Celltrion. VaxGen's indemnification
obligations hereunder shall be conditioned upon Celltrion: (i) giving
reasonable notice to VaxGen of any such claim or action, (ii) tendering the
defense of such claim or action to VaxGen, (iii) reasonably assisting
VaxGen (at VaxGen's expense) in investigating and defending such claim or
action, and (iv) not compromising or settling such claim or action without
VaxGen's prior consent.
8.4 Insurance. Without limiting any indemnification obligations under this
Agreement, Celltrion shall obtain and maintain on an on-going basis for the
time period specified herein below comprehensive general liability and
products liability insurance (including contractual liability coverage of
Celltrion's indemnification obligations under this Agreement) in the amount
of at least $5 million per occurrence and annual aggregate combined single
limit for bodily injury and property damage liability, with such insurance
coverage to be maintained with an insurance company or companies reasonably
acceptable to VaxGen and with a deductible or maximum self-insured
retention not to exceed $500,000 per occurrence and annual aggregate.
Celltrion shall obtain such insurance coverage no later than 90 days prior
to the commencement of the first human clinical trial testing of any
Licensed Product (other than AIDSVAX, as addressed by separate agreement of
the Parties) and thereafter shall maintain such insurance coverage without
interruption during the term of this Agreement and for a period of at least
10 years after the expiration or termination of this Agreement. Such
insurance shall name VaxGen as an additional insured, shall state that it
is primary to any valid and collectible insurance available to VaxGen which
also covers the same loss for which Celltrion has liability pursuant to the
Agreement shall contain a cross-liability or severability of interest
clause, and shall state that VaxGen will be provided with at least 30 days'
advance written notice of any termination, cancellation or material change
in the insurance policy. Celltrion shall provide VaxGen with evidence of
such insurance coverage as required under this Agreement by no later than
the deadline specified above for obtaining such insurance coverage, and
thereafter shall continue to provide VaxGen with evidence of such required
insurance coverage on an annual basis (by not later than each annual
renewal date of such coverage) during the term of this Agreement and for a
period of at least 10 years after the expiration or termination of this
Agreement. Celltrion may satisfy its obligation to provide evidence of such
required insurance coverage by providing VaxGen with complete copies of the
insurance policies themselves or certificates from its insurance company or
companies evidencing the coverage required hereunder.
Article 9.0 Term and Termination
9.1 Term. This Agreement shall commence on the Effective Date and, unless
earlier terminated in accordance herewith, shall expire on the 15th
anniversary of the Effective Date. Following expiration, Celltrion shall
retain a perpetual, royalty-free right to continue to use the Licensed
Knowhow and Licensed Patents existing as of the date of expiration in the
manner provided in Section 2.1, above.
9.2 Termination for Default. Failure by either Party to comply with any of its
material obligations set forth in this Agreement shall entitle the
non-defaulting Party to give the defaulting Party a notice specifying the
nature of the default and requiring the defaulting Party to make good its
default. If such default is not cured within 30 days after such notice, the
non-defaulting Party shall be entitled, without prejudice to any of its
other rights under this Agreement or available to it at law or in equity,
to terminate this Agreement effective upon a notice of termination to the
defaulting Party.
9.3 Termination for Insolvency or Bankruptcy. Either Party may, in addition to
any other remedies available to it by law or in equity, terminate this
Agreement, in whole or in part as the terminating Party may determine, by
notice to the other Party in the event the other Party shall have become
insolvent or bankrupt, or shall have made an assignment for the benefit of
its creditors, or there shall have been appointed a trustee or receiver of
the other Party or for all or a substantial part of its property, or there
shall have been issued a warrant of attachment, execution, distraint or
similar process against any substantial part of the property of the other
Party, or any case or proceeding shall have been commenced or other action
taken by or against the other Party in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up, arrangement,
composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, provided that in any such case
such event shall have continued for 60 days undismissed, unbonded and
undischarged. Furthermore, all rights and licenses granted under to this
Agreement are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(56) of the United States Bankruptcy
Code.
9.4 Unilateral Termination. Celltrion shall have the right to terminate this
Agreement, in its sole discretion, on six months' prior notice to VaxGen.
9.5 Effect of Termination
(a) Expiration or termination of this Agreement for any reason shall be
without prejudice to any rights which shall have accrued to the
benefit of either Party prior to such expiration or termination, and
shall not relieve either Party from its obligations which are
expressly indicated to survive expiration or termination of this
Agreement; such rights and obligations include, without limitation,
those under Sections 4.2, 5.3, 5.4, 6.1, 8.1, 8.2, 8.3, 9.5, 10.1,
10.2, and 10.5 of this Agreement.
(b) On any termination of this Agreement (other than by virtue of
expiration of its term) Celltrion promptly shall return to VaxGen all
tangible Licensed Patent Rights, Licensed Knowhow and other property
owned by VaxGen (whether solely or jointly with Celltrion) that are in
Celltrion's possession or control, including, without limitation, all
biological materials and improvements to Licensed Patent Rights or
Licensed Knowhow.
Article 10.0 General Provisions
10.1 Notices. Any notice, request, delivery, demand, report, accounting,
approval or consent required or permitted to be given under this Agreement
shall be in writing and shall be deemed sufficiently given on the same day
as delivery if delivered in person or transmitted by telecopier (with
confirmed answer-back) in any case by 5:00 p.m. local time, on the next
business day if sent by overnight courier service, and in three business
days if sent by registered or certified mail, in any case addressed to the
Party to whom it is directed at its address shown below or such other
address as such Party shall have last given by notice to the other Party in
accordance with this Section:
If to VaxGen, addressed to: VaxGen, Inc.
0000 Xxxxxx Xxxxxxxxx
Xxxxxxxx, XX 00000-0000
Attn: Xx. Xxxxx X. Xxxxxx, CEO
If to Celltrion, addressed to: Celltrion, Inc.
Xxxxx Xxxx Xxxxxxxx, 00xx Xxxxx
0000, Xxxxx-Xxxx, Namdong-Gu
Incheon City, 405-220, Korea
Attn: Xx. Xxxxx X. Xxxxx
10.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California (other than its choice
of law principles).
10.3 Entire Agreement. Except for a certain Sublicense Agreement between the
Parties of even date herewith, this Agreement is the entire agreement and
understanding between the Parties with respect to the subject matter
hereof, and supersedes and cancels any and all prior negotiations,
correspondence, understandings and agreements, whether written or oral,
between the Parties respecting the subject matter hereof.
10.4 Binding Effect and Assignment. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective permitted
successors and assigns, subject to the remainder of this Section 10.4. This
Agreement shall not be assignable by either Party in whole or in part
without the other Party's prior consent in its sole discretion, except that
either Party may assign this Agreement in whole or in part without the
other Party's consent in connection with any consolidation, merger,
redemption, put or sale of stock, conveyance of substantially all of the
assigning Party's assets, or change-of-control transaction that involves
the assigning Party.
10.5 Dispute Resolution. In the event of any dispute, controversy or claim
arising out of or relating to this Agreement, the Parties shall try to
settle it amicably between themselves including first referring such
dispute, controversy or claim to a member of each Party's Board of
Directors for resolution. If the Parties are unable to so settle such
dispute, controversy or claim within 30 days after such referral, then
either Party may, by notice to the other, have it referred to their
respective chief executive officers for attempted resolution by good faith
negotiations within 30 days after such notice. In the event the chief
executive officers are not able to resolve it, either Party may at any time
after the 30-day period invoke the arbitration provisions of this Section
10.5.
All arbitration proceedings shall be conducted in accordance with the
Rules of Arbitration and Conciliation of the International Chamber of
Commerce, in English. All arbitration proceedings shall be in San
Francisco, California if initiated by Celltrion and in Seoul, Korea, if
initiated by VaxGen. The Party requesting arbitration shall serve upon the
other Party a demand for arbitration stating the substance of the
controversy, dispute or claim, and the contention of the Party requesting
arbitration. Within 60 days after the demand, the Parties shall each
select one arbitrator, which arbitrators shall together select a third
arbitrator. The three arbitrators are to act as neutral arbitrators and
shall have no past, present or anticipated future affiliation with the
Parties which would unduly influence the independence of an arbitrator.
The decision of the arbitrators shall be in writing setting forth the
basis therefore.
The arbitrators shall have the authority to award compensatory damages,
interest, tort damages (but not punitive or similar damages) and specific
performance and other equitable relief. The Parties shall abide by the
award rendered in such arbitration proceeding, and such award may be
enforced and executed upon in any court having jurisdiction over the Party
against whom enforcement of such award is sought. During such arbitration
proceedings, each Party shall pay its arbitrators' fees, administration
charges and related expenses of arbitration. The losing Party shall
thereafter reimburse the prevailing Party for all such costs incurred in
connection with such arbitration.
10.6 Waiver. The waiver by either Party of any breach of or default under any
of the provisions of this Agreement or the failure of either Party to
enforce any of the provisions of this Agreement or to exercise any right
thereunder shall not be construed as a waiver of any other breach or
default or a waiver of any such rights or provisions hereunder.
10.7 Severability. If any part of this Agreement shall be held invalid, illegal
or unenforceable by any court of authority having jurisdiction over this
Agreement or either Party, such part shall be ineffective only to the
extent of such invalidity, illegality or unenforceability, and shall be
validly reformed by addition or deletion of wording as appropriate to
avoid such result and as nearly as possible approximate the intent of the
Parties. If unreformable, this Agreement shall be divisible and deleted in
such jurisdiction, but elsewhere shall not be affected.
10.8 Publicity. Celltrion and VaxGen shall consult and obtain mutual consent
before making any public announcement concerning this Agreement, the
subject matter hereof or use of the other Party's name, except for
information that is already in the public domain or where the nature of
such information has been previously approved for disclosure (in which
case this Section 10.8 will no longer apply to that previously approved
information).
10.9 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original for all purposes, but all of
which together shall constitute one and the same instrument.
10.10 No Other Rights. No rights or licenses, express or implied, are granted to
Celltrion by this Agreement to use in any manner any trade name or
trademark of VaxGen, or any other intellectual property not expressly
covered by this Agreement.
10.11 Force Majeure. Neither Party shall be liable to the other for loss or
damages or shall have any right to terminate this Agreement (except as
otherwise provided in this Agreement) for any default or delay of the
other Party in its performance under this Agreement that is attributable
to an act of God, flood, fire, explosion, strike, lockout, labor dispute,
casualty or accident, war, revolution, civil commotion, act of public
enemies, blockage or embargo, injunction, law, order, proclamation,
regulation, ordinance, demand or requirement of any government or
subdivision, authority or representative of any such government, or any
other cause beyond the reasonable control of the affected Party, if the
Party affected shall give prompt notice of any such cause to the other
Party. The Party giving such notice shall thereupon be excused from such
of its obligations hereunder for the period of time that it is so
disabled.
10.12 Headings. Headings are for the convenience of reference only and shall not
control the construction or interpretation of any of the provisions of
this Agreement.
10.13 No Partnership. Nothing in this Agreement is intended or shall be deemed
to constitute a partnership, agency, employer-employee, or joint venture
relationship between the Parties. Neither Party shall incur any debts or
make any commitments for the other Party.
10.14 Modification. Any modification to this Agreement shall be made in writing
duly signed by both Parties.
IN WITNESS WHEREOF, the Parties each have caused this Agreement to be duly
executed by its duly authorized representative as of the date set forth above.
VAXGEN, INC. CELLTRION, INC.
By: ______________________ By: ______________________________
Name: Xx. Xxxxx X. Xxxxxx Name: Xx. Xxxx-Xxx Seo
Title: Chief Executive Officer Title: Co-Representative Director
CELLTRION, INC.
By: ______________________________
Name: Xx. Xxxxx X. Xxxxx
Title: Co-Representative Director
Exhibit A
Licensed Knowhow
Platform Technology
VaxGen will provide to Celltrion all necessary knowhow to establish a platform
technology capability for the design, startup and validation, operation and FDA
licensure of a commercial scale cell culture manufacturing operation suitable
for production of bulk human therapeutic proteins, including AIDSVAX and
monoclonal antibodies.
This transfer will include platform technology required for:
o Seed culture preparation and culture expansion
o Commercial scale cell culture
o Cell separation, harvest and cell inactivation
o Commercial scale affinity, ion exchange and size exclusion
chromatography
o Viral inactivation/removal
o Ultrafiltration, diafiltration and tangential flow filtration
o Media and buffer preparation
o All associated analytical methods
VaxGen will establish this platform technology capability by providing knowhow
in the following categories:
Facility Design
Overall plant design and layout concepts
Process flow, material flow and personnel flow requirements
Area classifications and architectural finish requirements
Air flow and pressurization requirements
Utility requirements
Support services and laboratory requirements
Process Design
Process descriptions
Process flow diagrams
Process controls and automation strategy
Equipment lists
Equipment layouts
Process and instrumentation drawings
Startup and Validation
Validation Master Plan
Turn-over Package requirements
Installation, Operation and Performance Qualification (IQ,OQ,PQ) requirements
Controls Qualification
Environmental monitoring (particulate, bioburden)requirements
Equipment cleaning and product change-over requirements
Sterility testing requirements
Documentation system requirements
Calibration and preventative maintenance requirements
Operations
Personnel training requirements and records
Access and gowning procedures
Process and equipment trouble shooting
Trial run and "buffer blank" planning and execution support
Process deviation and Out Of Spec (OOS) investigation requirements and support
Cell Culture contamination prevention plans and investigation support
Quality Systems SOP's
Licensure Support
FDA Facility Plan review preparation and coordination
CMC section requirements to support BLA amendment
FDA inspection preparation and mock audits
FDA inspection participation and coordination
Inspection observations resolution
Exhibit B
Licensed Patent Rights
There are no issued patents or patent applications filed relating to the
Licensed Patent Rights as of the date of execution of the License Agreement.
Exhibit C
Schedule of Technology Transfer
The knowhow described in Exhibit A will be transferred in phases corresponding
to the forecasted schedule for development of the Launch facility and the
Incheon facility. Transfer of knowhow will be initiated in the following phases:
Launch and Incheon Facilities Design 1Q02 - 4Q02
o Platform Technology Facility Design
o Platform Technology Process Design
o AIDSVAX Method of Manufacture
Lists of raw material
Process flow chart
Cell substrate/host cell descriptions
Expression vector descriptions
Cell seed culture procedures
Cell growth and harvesting procedures
Purification and downstream processing procedures
|_| AIDSVAX Process Description
|_| AIDSVAX Validation Requirements and Master Plan
Launch Facility Start-up, Validation and Operation 1Q03 - 3Q04
overlapping with Incheon Facility Construction
|_| Platform Technology Startup and Validation
|_| Platform Technology Operations
|_| AIDSVAX Validation Requirements and Master Plan (Incheon Facility)
|_| AIDSVAX Drug Substance Storage and Shipping Requirements
|_| AIDSVAX Process validation procedures and data
|_| Copies of completed batch history records for actual AIDSVAX launch
facility qualification production lots (completed Manufacturing and
Analytical Testing "tickets").
|_| AIDSVAX Regulatory Documents (and subsequent updates)
|_| Associated Training of Celltrion Staff
Incheon Facility Start-up and Validation 3Q04 - 4Q05
|_| AIDSVAX Materials
|_| AIDSVAX Description and Characterization
|_| AIDSVAX Process Controls
|_| AIDSVAX Drug Substance Specifications and Analytical Methods
|_| AIDSVAX Manufacturing Documents
|_| AIDSVAX Analytical Documents
|_| Other AIDSVAX Quality Documents and Support
|_| Associated Training of Celltrion Staff
Incheon Facility Licensure, Technology 4Q05 - Expiration of Supply
Agreement and Quality Support
|_| Platform Technology and AIDSVAX Specific Licensure Support
|_| Associated Training of Celltrion Staff
