License Agreement - VaxGen Inc. and VaxGen-Celltrion Inc.
LICENSE AGREEMENT
This License Agreement is entered into as of the 7th day of June, 2002, (the
"Effective Date") by VaxGen, Inc., a Delaware corporation ("VaxGen"), and
VaxGen-Celltrion, Inc., a California corporation ("VCI") (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, VCI wishes to obtain a license under such intellectual property; and
WHEREAS, VaxGen is willing to grant such a license to VCI 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 VCI in South San Francisco, California, pursuant to
other agreements to which VCI and VaxGen 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.
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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 VCI a non-exclusive license under the
Licensed Patent Rights and Licensed Knowhow to make Licensed Products in
the United States 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, VCI shall have no rights other
than the rights as granted under this Agreement
2.2 Sub-licenses. VCI 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 VCI shall have the right to require VaxGen, at VCI's expense, to transfer
the Licensed Patent Rights and the Licensed Knowhow to VCI. The Parties
shall in good faith determine the most cost-effective and timely means of
effecting such transfer.
3.2 VaxGen shall provide to VCI 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 VCI and for manufacturing the
Licensed Product by VCI.
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The timing and method of delivery of those documents shall be determined
later based on mutual agreement by the Parties.
3.3 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, VCI
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 VCI Accounting Records. VCI 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.
VCI'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. VCI
shall retain title to any improvements to the Licensed Knowhow or Licensed
Patent Rights developed or invented solely by VCI; 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 VCI 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.
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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
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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 reasonably
object in writing to such proposed disclosure. In the event of an
objection the Parties shall consult with each other in good faith and in a
timely manner to resolve the matter in a manner beneficial to both
Parties.
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 VCI that (i) it has the right to grant the license set forth
hereinabove, free from any inconsistent claims or restrictions in favor of
any third party, and (ii) the Licensed Patent Rights and Licensed Knowhow,
taken together with the intellectual property rights to be licensed and
transferred to VCI 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.
Article 8.0 Liability
8.1 Limitation of Liability. Neither Party shall be liable to the other for
indirect,
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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 VCI. VCI 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 VCI 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. VCI's indemnification
obligations hereunder shall be conditioned upon VaxGen (i) giving
reasonable notice to VCI of any such claim or action, (ii) tendering the
defense of such claim or action to VCI, (iii) reasonably assisting VCI (at
VCI's expense) in investigating and defending such claim or action, and
(iv) not compromising or settling such claim or action without VCI's prior
consent.
8.3 Indemnification by VaxGen. VaxGen shall indemnify, defend and hold
harmless VCI 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 VCI. VaxGen's
indemnification obligations hereunder shall be conditioned upon VCI: (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, VCI 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 VCI'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. VCI 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
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insured, shall state that it is primary to any valid and collectible
insurance available to VaxGen which also covers the same loss for which
VCI 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.
VCI 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. VCI 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, VCI 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
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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. VCI 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) VCI promptly shall return to VaxGen all
tangible Licensed Patent Rights, Licensed Knowhow, Confidential
Information and other property owned by VaxGen (whether solely or
jointly with VCI) that are in VCI'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:
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If to VaxGen, addressed to: VaxGen, Inc.
1000 Marina Boulevard
Brisbane, CA 94005-1841
Attn: Dr. Lance K. Gordon, CEO
If to VCI, addressed to: VaxGen-Celltrion, Inc.
c/o VaxGen, Inc.
1000 Marina Boulevard
Brisbane, CA 94005-1841
Attn: Mr. James P. Panek
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.
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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. 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. VCI 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).
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10.9 Counterparts. This Agreement may be executed in two counterparts, each of
which shall be deemed an original for all purposes, but both 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
VCI 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. VAXGEN-CELLTRION, INC.
By: ______________________ By: ______________________
Name: Dr. Lance K. Gordon Name: Mr. James P. Panek
Title: Chief Executive Officer Title: President
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Exhibit A
Licensed Knowhow
Platform Technology
VaxGen will provide to VCI 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
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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
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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.
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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
o AIDSVAX Process Description
o AIDSVAX Validation Requirements and Master Plan
Launch Facility Start-up, Validation and Operation 1Q03 - 3Q04
overlapping with Incheon Facility Construction
o Platform Technology Startup and Validation
o Platform Technology Operations
o AIDSVAX Validation Requirements and Master Plan (Incheon Facility)
o AIDSVAX Drug Substance Storage and Shipping Requirements
o AIDSVAX Process validation procedures and data
o Copies of completed batch history records for actual AIDSVAX launch
facility qualification production lots (completed Manufacturing and
Analytical Testing "tickets")
o AIDSVAX Regulatory Documents (and subsequent updates)
o Associated Training of VCI Staff
Incheon Facility Start-up and Validation 3Q04 - 4Q05
o AIDSVAX Materials
o AIDSVAX Description and Characterization
o AIDSVAX Process Controls
o AIDSVAX Drug Substance Specifications and Analytical Methods
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o AIDSVAX Manufacturing Documents
o AIDSVAX Analytical Documents
o Other AIDSVAX Quality Documents and Support
o Associated Training of VCI Staff
Incheon Facility Licensure, Technology 4Q05 - Expiration of Supply Agreement
and Quality Support
o Platform Technology and AIDSVAX Specific Licensure Support
o Associated Training of VCI Staff
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