Sub-License Agreement - VaxGen Inc. and Celltrion Inc.
SUB-LICENSE AGREEMENT
This Sub-License Agreement (the "Agreement") is entered into as of 25th 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 licensee of certain patent rights and knowhow owned or
controlled by Genentech, Inc. ("Genentech") relating to the manufacture of
Licensed Products (as defined hereinbelow), as well as the licensee of certain
biologic materials, pre-clinical data, clinical data, protocols and other
knowhow owned or controlled by Genentech relating to the therapeutic and/or
prophylactic uses of a Vaccine (as defined hereinbelow) in humans;
WHEREAS, VaxGen wishes to sub-license to Celltrion the right to manufacture
Licensed Products and Celltrion wishes to accept such sub-license, on the terms
and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual promises contained herein, the
Parties agree as follows:
Article 1. 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 "Adjuvant" and "Adjuvants" shall mean any material that enhances or
modifies the action of the Vaccine.
1.2 "FDA" shall mean the United States Food and Drug Administration.
1.3 "Licensed Knowhow" shall mean all proprietary information, methods,
processes, techniques, data and biologic materials (including, without
limitation, the Vaccine) which are in the possession of or controlled by
VaxGen presently or hereafter during the term of this Agreement, which
VaxGen is free to sublicense, and which are necessary or useful for the
manufacture of any Licensed Product. "Licensed Knowhow" shall include,
without limitation, those items listed or described in Exhibit "A" attached
hereto.
1.4 "Licensed Patent Rights" shall mean all patents and patent applications,
and all patents issuing therefrom, together with all extensions, reissues,
reexaminations, substitutions,
<PAGE>
renewals, divisions, continuations, continuations-in-part and foreign
counterparts thereof or therefor, that are licensed to VaxGen by Genentech
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. "Licensed
Patent Rights" includes, without limitation, the patents and patent
applications specified in Exhibit "B" attached hereto.
1.5 "Licensed Product" shall mean any pharmaceutical formulation that is based
upon, contains, incorporates or uses the Vaccine (or any homolog, analog,
fragment, derivative or variant of the Vaccine), whether alone or
containing, incorporating or using any other substance, product, material
or device (active or not), including, without limitation, one or more
Adjuvants.
1.6 "Vaccine" shall mean "AIDSVAX", i.e., the recombinant HIV surface
glycoprotein gp120 developed by VaxGen as more particularly described in
Exhibit "C" attached hereto.
Article 2. Grant of Rights
2.1 License Grant. Subject to the other terms and conditions of this Agreement,
VaxGen hereby grants to Celltrion a non-exclusive sub-license under the
Licensed Patent Rights and Licensed Knowhow to make Licensed Products in
the Republic of Korea. 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 Sublicenses. Celltrion shall have no right to grant further sub-licenses of
its rights hereunder without the prior written consent of VaxGen, which
consent may be withheld by VaxGen in its sole discretion.
Article 3. Technology Transfer
3.1 Celltrion shall have the right to require VaxGen, at Celltrion's expense,
to transfer to Celltrion the Licensed Patent Rights and Licensed Knowhow,
consistent with Exhibit "D" 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 Knowhow and for the manufacture of the
VACCINE 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
<PAGE>
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. Payments and Record-Keeping
4.1 Stock. In partial consideration for the sub-license granted to Celltrion
hereunder by VaxGen, and in partial consideration of the rights granted to
Celltrion under a certain License Agreement of even date herewith,
Celltrion shall transfer to VaxGen 7,800,000 shares of full-paid and
non-assessable common shares of Celltrion, as more particularly described
in the Joint Venture Agreement dated February 25, 2002, by and among VaxGen
and certain investors in Celltrion.
4.2 Celltrion Records. Celltrion shall keep full, true and accurate books of
account containing all particulars which may be necessary for the purpose
of documenting all production of Licensed Products by Celltrion (including,
without limitation, establishing
<PAGE>
the fully burdened manufacturing cost of all such Licensed Product and such
other information as may be required of VaxGen to comply with its
obligations to Genentech pursuant to VaxGen's license from Genentech to the
Licensed Patent Rights and Licensed Knowhow, a redacted copy of which has
been provided to Celltrion's counsel). 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 shall be made available for inspection and
copying during regular business hours by an independent accountant retained
by VaxGen or Genentech at VaxGen's (or Genentech's) sole expense; provided,
however, that such inspection shall not take place more often than once per
year during the term of this Agreement. Results of any inspection hereunder
shall be made available promptly to both Parties in writing.
Article 5. Intellectual Property Rights
5.1 Ownership. Nothing in this Agreement shall be deemed to constitute any
assignment of title in or to the Licensed Knowhow and Licensed Patent
Rights to Celltrion. Celltrion shall retain title to its interest in any
improvements to the Licensed Knowhow or Licensed Patent Rights developed or
invented solely by Celltrion or jointly by Celltrion and any third party;
provided, however, that VaxGen and Genentech shall each have a worldwide,
non-exclusive royalty free license to use any such improvements as it sees
fit. The Parties shall own jointly any improvements to any Licensed Knowhow
or Licensed Patent Rights 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 the applicable laws of
inventorship and competent written evidence.
5.2 Patent Filing, Prosecution and Maintenance. Subject to the other terms and
conditions of this Agreement (including the remainder of this Section 5.2),
during the term of this Agreement, VaxGen shall be responsible for the
filing, prosecution and maintenance of all Licensed Patent Rights, and
Celltrion shall reimburse all reasonable costs and expenses incurred by
VaxGen in relation to the filing, prosecution and maintenance of the
Licensed Patent Rights.
VaxGen shall keep Celltrion informed of the status of filing, prosecution
and maintenance of Licensed Patent Rights by: (i) for each patent
application and patent hereunder that contains Broad Claims, providing
Celltrion with VaxGen's reasonable apportionment of out-of-pocket costs and
expenses to date and on a going-forward basis therefor, which Celltrion may
review with VaxGen as reasonably requested; (ii) 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 (iii) notifying Celltrion of any interference,
opposition, re-examination request, nullity proceeding, appeal or other
inter-party action or reissuance proceeding involving the Licensed Patent
Rights. VaxGen shall
<PAGE>
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
(including, without limitation, any interference, opposition,
re-examination request, nullity proceeding, appeal or other inter-party
action or reissuance proceeding involving the Licensed Patent Rights).
However, if VaxGen desires to take (or not take) any such action 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. 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
<PAGE>
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.
6.2 Disclosures. Notwithstanding Section 6.1, each Party may disclose
Confidential Information of the other Party during any official proceeding
before a court or governmental agency, as a part of a patent application
filed on inventions made under this Agreement, or as necessary in order
lawfully 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.
Article 7. 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, to its best knowledge, it is free to enter this
Agreement, in so doing it will not violate any other agreement to which it
is party or subject, and currently has the right to grant the licenses
granted as set forth in this Agreement.
7.3 Representations and Warranties by VaxGen. VaxGen represents and warrants to
Celltrion that:
(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 License Agreement between the Parties
of even date herewith, are suitable and adequate to manufacture the
Vaccine at the scale currently produced by Genentech;
(b) no license of additional intellectual property from any third party is
necessary in
<PAGE>
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. 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 attorney's fees) and damages arising out of or resulting from
the promotion, use or sale by VaxGen or its sub-licensee(s) 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 or its sub-licensees. 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 hereinbelow 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 $25,000,000 per occurrence and annual aggregate
<PAGE>
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 $50,000 per occurrence and annual
aggregate. This insurance shall not contain any exclusions or limitations
in regard to liability relating to AIDS/HIV. Celltrion 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. Term and Termination
9.1 Term. This Agreement shall commence on the Effective Date and, unless
earlier terminated in accordance herewith, shall expire 15 years from the
date of first commercial sale of a Licensed Product manufactured hereunder.
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
<PAGE>
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 91(56) of the United States Bankruptcy
Code. The Parties agree that in the event of the commencement of a
bankruptcy proceeding by or against one Party under the United States
Bankruptcy Code, the other Party shall be entitled to complete access to
any such intellectual property, and all embodiments of such intellectual
property, pertaining to the rights granted in the licenses hereunder of the
Party by or against whom a bankruptcy proceeding has been commenced.
9.4 Unilateral Termination. Celltrion shall have the right to terminate this
Agreement, in its sole discretion, on no less than three 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, 6.2, 8.1, 8.2, 8.3, 8.4, 9.5,
10.1, 10.2, 10.5 and 10.8 of this Agreement.
(b) On any termination of this Agreement: (i) Celltrion promptly shall
return to VaxGen all tangible 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, pre-clinical and clinical data, and applicable
improvements to Licensed Patent Rights or Licensed Knowhow; and (ii)
Celltrion promptly shall take all appropriate and necessary actions,
including with the FDA and other involved regulatory agencies, to
effect the assignment or transfer to VaxGen (or to no longer permit
further reference to by Celltrion) of all VaxGen Regulatory filings,
as directed by VaxGen. All such activities shall be conducted in a
prompt and orderly fashion such that the value of what is being
transferred is preserved, at Celltrion's expense.
<PAGE>
Article 10. 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 10.1:
If to VaxGen, addressed to: VaxGen, Inc.
1000 Marina Boulevard
Brisbane, CA 94005-1841
Attn: Dr. Lance K. Gordon, CEO
If to Celltrion, addressed to: Celltrion, Inc.
Hanmi Bank Building, 13th Floor
1127, Guwol-Dong, Namdong-Gu
Incheon City, 405-220, Korea
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. This Agreement is the entire agreement and understanding
between the Parties with respect to the Licensed Patent Rights and Licensed
Knowhow, and supersedes and cancels any and all prior negotiations,
correspondence, understandings and agreements, whether written or oral,
between the Parties respecting the Licensed Patent Rights and Licensed
Knowhow. No amendment or other modification of this Agreement shall be
binding on either Party unless reduced to writing and signed by an
authorized officer of each Party.
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 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.
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
<PAGE>
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 under the procedural rules
of the American Arbitration Association, in English. Proceedings shall be
in San Francisco, California if brought by Celltrion and in Seoul, Korea if
brought 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 30 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.
<PAGE>
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.
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: Dr. Lance K. Gordon Name: Mr. Jung-Jin Seo
Title: Chief Executive Officer Title: Co-Representative Director
CELLTRION, INC.
By:_________________________________
Name: Mr. James P. Panek
Title: Co-Representative Director
<PAGE>
Exhibit A
Licensed Knowhow
AIDSVAX Technology
VaxGen will transfer all of the following AIDSVAX specific technology, materials
and knowhow, which together with the Platform Technology licensed to Celltrion
under that certain License Agreement will enable Celltrion to manufacture
AIDSVAX Product:
Materials
o Cell Banks (MCB and WCB)
o Source Cell Lines
o Plasmids, Primers, and/or other Molecular Biology Constructs
o Samples of Bulk Substance
o Inventory of Key Intermediates or Process Aids
o Proprietary affinity resins
o Proprietary Reference and Working Standards
Method of Manufacture:
o Lists of raw material
o Process flow chart
o Cell substrate/host cell descriptions
o Expression vector descriptions
o Cell seed culture procedures
o Cell growth and harvesting procedures
o Purification and downstream processing procedures
o Process validation procedures and data
o Copies of completed batch history records for actual facility
qualification production lots (completed Manufacturing and Analytical
Testing "tickets").
Process Description (Step-by-step description of the entire production process)
o Purpose of each step
o Process conditions and excursion limits (pH, temperature, osmolality,
etc.)
o Operating volumes
o Yields and concentrations
o Raw materials
o Packaging materials
o Process hold and storage points
o Analytical sample points.
<PAGE>
Description and Characterization
o Product description
o Physiochemical characterization
o Biological characterization
o Demonstration of the comparability of the product
Process Controls
o Qualification of in-process controls for all manufacturing operations.
Drug Substance Specifications and Analytical Methods
o All product specifications and associated analytical methods
o Certificates of Analysis (C of A's) for the qualification lots
Validation Requirements and Master Plan
o Requirements for the validation of all process equipment, critical
utility systems and automation systems (hardware and software).
o Cleaning and sterilization procedures
o Process and analytical methods validation.
Drug Substance Storage and Shipping Procedures
o Stability Testing Methods
Regulatory Documents
o IND/NDA/BLA/ELA filings including updates, amendments, and supplements
o Minutes of Health Authority Meetings
o Relevant correspondence, including telephone contact reports
o Annual Reports
o Inspection Reports and Observations, Warning Letters, and Responses
Manufacturing Documents
o Bulk Substance Manufacturing Batch Records, including any critical
process aids or components including media and/or resins
o Raw Material Specifications (including approved suppliers, BSE/TSE
certifications)
o In-Process Specifications and Analytical Methods
o Manufacturing Process Development Report (to include process history,
stability of key intermediates or process hold steps)
o Process Validation Protocols and Reports
o Cell Bank (MCB and WCB) Production, Characterization, and Stability
Records
o Cell Line Certifications or Source Documentation as Appropriate
Analytical Documents
o Analytical Methods (SOPs) for Release and/or Stability
o Methods used in all relevant characterization of Bulk Substance or
Final Product Vials
o Method Development/Qualification Reports
<PAGE>
o Methods Validation Protocols and Reports
o OOS Investigation reports for Confirmed OOS events at release or on
stability
o Qualification Reports for Reference Standards Unique to the product
Other Quality Documents and Support
o Release and Shelf Life Specifications for Bulk Substance
o Specification Development Report
o Results of Characterization
o Stability Protocols, Stability Data, and Analysis for Bulk Substance
o Auditing of Documents, Facilities and Compliance
Ongoing Quality Support
<PAGE>
Exhibit B
List of Patents and Patent Applications
Genentech Series Ref.: P0837
Skjerven Series Ref.: M-2820
US Case(s):
Genentech Ref.: P0837P1
Skjerven Ref.: M-2820-1P US
Title: HIV ENVELOPE POLYPEPTIDES
Application No.: 08/448,603
Filing Date: Oct. 10, 1995
Related Applications:
Status: Granted
Patent No.: 5,864,027
Issue Date: Jan. 26, 1999
Expiration Date: Jan. 26, 2016
Genentech Ref.: P0837P1D1
Skjerven Ref.: M-2820-2D US
Title: HIV ENVELOPE POLYPEPTIDES
Application No.: 09/134,075
Filing Date: Aug. 13, 1998
Related Applications: Div. of M-2820-1P US
Status: Granted
Patent No.: 6,042,836
Issue Date: March 28, 2000
Expiration Date: June 7, 2013
Genentech Ref.: P0837P1D2
Skjerven Ref.: M-2820-3D US
Title: HIV ENVELOPE POLYPEPTIDES
Application No.: 09/492,739
Filing Date: January 27, 2000
Related Applications: Div. of M-2820-2D US
Status: Pending
Patent No.:
Issue Date:
<PAGE>
Foreign Cases:
Country: Australia
Application No.: 7047894
Status: Granted
Patent No.: 700371
Claims (if Granted):
Country: Canada
Application No.: 2164505
Status: Pending
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 949192819
Status: Published;
Patent No.:
Claims (if Granted):
Country: New Zealand
Application No.: 267838
Status: Granted
Patent No.: 267838
Claims (if Granted):
Country: PCT
Application No.: US9406036
Status: Completed
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P1008R1
Skjerven Series Ref.: M-3897
US Case(s):
Genentech Ref.: P1008R1
Skjerven Ref.: M-3897-1P US
Title: HIV ENVELOPE POLYPEPTIDES AND VACCINE
Application No.: 08/889,841
Filing Date: July 8, 1997
Related Applications:
Status: Granted
Patent No.: 6,090,392
<PAGE>
Issue Date: July 18, 2000
Expiration Date: July 8, 2017
Genentech Ref.: P1008R1D1
Skjerven Ref.: M-3897-2D US
Title: HIV ENVELOPE POLYPEPTIDES AND VACCINE
Application No.: 09/419,362
Filing Date: Oct. 15, 1999
Related Applications: Div. of M-3897-1P US
Status: Pending
Patent No.:
Issue Date:
Foreign Cases:
Country: ARIPO
Application No.: APP9901432
Status: Pending
Patent No.:
Claims (if Granted):
Country: Argentina
Application No.: P970102984
Status: Pending
Patent No.:
Claims (if Granted):
Country: Australia
Application No.: 3567797
Status: Pending
Patent No.:
Claims (if Granted):
Country: Canada
Application No.: 2259965
Status: Pending
Patent No.:
Claims (if Granted):
Country: China
Application No.: 971962448
<PAGE>
Status: Published
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 979321460
Status: Published
Patent No.:
Claims (if Granted):
Country: Hong Kong
Application No.: 99106208.7
Status: Published
Patent No.:
Claims (if Granted):
Country: Indonesia
Application No.: P972342
Status: Published
Patent No.:
Claims (if Granted):
Country: Israel
Application No.: 127701
Status: Pending
Patent No.:
Claims (if Granted):
Country: India
Application No.: 1266CAL97
Status: Pending
Patent No.:
Claims (if Granted):
Country: Japan
Application No.: 5051901998
Status: Pending
Patent No.:
Claims (if Granted):
Country: New Zealand
Application No.: 333500
Status: Allowed
Patent No.:
Claims (if Granted):
<PAGE>
Country: OAPI
Application No.: 9900004
Status: Granted
Patent No.: 10954
Claims (if Granted):
Country: Thailand
Application No.: 038312
Status: Published
Patent No.:
Claims (if Granted):
Country: Taiwan
Application No.: 86109394
Status: Pending
Patent No.:
Claims (if Granted):
Country: PCT
Application No.: US9709690
Status: Completed
Patent No.:
Claims (if Granted):
Country: South Africa
Application No.: 975889
Status: Granted
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P0825B
Skjerven Series Ref.: M-9169
US Case(s):
Genentech Ref.: P0825BC3
Skjerven Ref.: M-9169-3C US
METHODS AND COMPOSITIONS FOR
MICROENCAPSULATION OF ANTIGENS FOR USE AS
Title: VACCINES
Application No.: 08/846,933
Filing Date: Dec. 22, 1998
Related Applications:
Status: Pending
Patent No.:
Issue Date:
<PAGE>
Foreign Cases:
Country: Canada
Application No.: 2172509
Status: Published
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 949307946
Status: Pending
Patent No.:
Claims (if Granted):
Country: Japan
Application No.: 5121181995
Status: Pending
Patent No.:
Claims (if Granted):
Country: PCT
Application No.: US9411753
Status: Completed
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P0845B
Skjerven Series Ref.: M-9171
US Case(s):
Genentech Ref.: P0845B
Skjerven Ref.: M-9171-1C US
Title: METHODS AND COMPOSITIONS FOR
MICROENCAPSULATION OF ADJUVANTS
Application No.: 08/460,363
Filing Date: June 2, 1995
Related Applications:
Status: Granted
Patent No.: 5,643,605
Issue Date: July 1, 1997
Expiration Date: July 1, 2014
<PAGE>
Foreign Cases:
Country: Canada
Application No.: 2172507
Status: Published
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 949307680
Status: Pending
Patent No.:
Claims (if Granted):
Country: Japan
Application No.: 5120731995
Status: Pending
Patent No.:
Claims (if Granted):
Country: PCT
Application No.: US9411674
Status: Completed
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P0846B
Skjerven Series Ref.: M-9173
US Case(s):
Genentech Ref.: P0846BC2
Skjerven Ref.: M-9173-2C US
Title: METHOD FOR DRYING MICROSPHERES
Application No.: 08/966,850
Filing Date: November 7, 1997
Related Applications:
Status: Granted
Patent No.: 6,080,429
Issue Date: June 27, 2000
Expiration Date: Oct. 25, 2013
<PAGE>
Foreign Cases:
Country: Argentina
Application No.: 329860
Status: Granted
Patent No.: AR254698V1
Claims (if Granted):
Country: Austria
Application No.: 949313696
Status: Granted
Patent No.: E175110
Claims (if Granted):
Country: Belgium
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Canada
Application No.: 2172508
Status: Published
Patent No.:
Claims (if Granted):
Country: Switzerland
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Chile
Application No.: 154494
Status: Pending
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Germany
Application No.: 949313696
Status: Granted
<PAGE>
Patent No.: 694156841
Claims (if Granted):
Country: Denmark
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: France
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Great Britain
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Ireland
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Japan
Application No.: 5120761995
Status: Pending
Patent No.:
Claims (if Granted):
Country: Luxembourg
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Monaco
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Mexico
Application No.: 948028
<PAGE>
Status: Granted
Patent No.: 1999050
Claims (if Granted):
Country: Netherlands
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Sweden
Application No.: 949313696
Status: Granted
Patent No.: 0724433
Claims (if Granted):
Country: Uruguay
Application No.: 23846
Status: Granted
Patent No.: 13681
Claims (if Granted):
Country: Uruguay
Application No.: 25718
Status: Pending
Patent No.:
Claims (if Granted):
Country: Venezuela
Application No.: 165094
Status: Granted
Patent No.: 165094
Claims (if Granted):
Country: PCT
Application No.: US9411678
Status: Completed
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P0278P2D1
Skjerven Series Ref.: M-9182
US Case(s):
Genentech Ref.: P0278P2D1C3
<PAGE>
Skjerven Ref.: M-9182-5C US
Title: MOLECULARLY CLONED ACQUIRED
IMMUNODEFICIENCY SYNDROME POLYPEPTIDES AND
THEIR METHODS OF USE
Application No.: 08/282,857
Filing Date: July 29, 1994
Related Applications:
Status: Granted
Patent No.: 5,853,978
Issue Date: December 29, 1998
Expiration Date: December 29, 2015
Genentech Ref.: P0278P2D1C5
McCutchen Ref.: M-9182-7C US
Title: MOLECULARLY CLONED ACQUIRED
IMMUNODEFICIENCY SYNDROME POLYPEPTIDES AND
THEIR METHODS OF USE
Application No.: 09/547,692
Filing Date: April 12, 2000
Related Applications: Con of M-9182-6C US
Status: Pending
Patent No.:
Issue Date:
Genentech Series Ref.: P0278P1
Skjerven Series Ref.: M-9182
Foreign Cases:
Country: Austria
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Belgium
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
<PAGE>
Country: Canada
Application No.: 498600
Status: Pending
Patent No.:
Claims (if Granted):
Country: Europe
Application No.: 853094548
Status: Opposition
Patent No.: 187041
Claims (if Granted):
Country: France
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Germany
Application No.: 853094548
Status: Granted
Patent No.: P3588134808
Claims (if Granted):
Country: Italy
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Liechtenstein
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Luxembourg
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Netherlands
Application No.: 853094548
Status: Granted
<PAGE>
Patent No.: 187041
Claims (if Granted):
Country: Sweden
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: Switzerland
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Country: United Kingdom
Application No.: 853094548
Status: Granted
Patent No.: 187041
Claims (if Granted):
Genentech Series Ref.: P0372P2
Skjerven Series Ref.: M-9183
US Case(s):
Genentech Ref.: P0372P2C1D1C4
Skjerven Ref.: Not in docket
Title: METHODS AND COMPOSITIONS FOR THE USE OF
HIV ENV POLYPEPTIDES AND ANTIBODIES
THERETO
Application No.: 08/953,550
Filing Date: October 17, 1997
Related Applications:
Status: Unknown (File history received from
Genentech)
Patent No.:
Issue Date:
Foreign Cases:
Country: Japan
Application No.: 0384591988
Status: Granted
Patent No.: 2813630
Claims (if Granted):
<PAGE>
Country: Japan (DIV 1)
Application No.: 3493561996
Status: Pending
Patent No.:
Claims (if Granted):
Country: Japan (DIV 2)
Application No.: 2355251999
Status: Pending
Patent No.:
Claims (if Granted):
Genentech Series Ref.: P0633
Skjerven Series Ref.: M-9184
US Case(s):
Genentech Ref.: P0633D2
Skjerven Ref.: M-9184-2D US
Title: METHOD FOR ISOLATION OF UNCLIPPED HIV
ENVELOPE PROTEIN
Application No.: 08/226,162
Filing Date: April 11, 1994
Related Applications:
Status: Granted
Patent No.: 5,674,984
Issue Date: October 7, 1997
Expiration Date: October 7, 2014
Genentech Ref.: P0633D2C1
Skjerven Ref.: Not transferred to Skjerven
Title: METHOD FOR ISOLATION OF UNCLIPPED HIV
ENVELOPE PROTEIN
Application No.: 08/802,361
Filing Date: February 19, 1997
Related Applications:
Status: Granted
Patent No.: 5,849,533
Issue Date: December 15, 1998
Genentech Ref.: P0633D2C2
<PAGE>
Skjerven Ref.: M-9184-4C US
Title: METHODS AND COMPOSITIONS FOR VACCINATION
AGAINST HIV
Application No.: 09/103,262
Filing Date: June 23, 1998
Related Applications:
Status: Pending
Patent No.:
Issue Date:
Foreign Cases:
Country: Austria
Application No.: 919070771
Status: Granted
Patent No.: E125157
Claims (if Granted):
Country: Belgium
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Canada
Application No.: 2078546
Status: Pending
Patent No.:
Claims (if Granted):
Country: Denmark
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Europe
Application No.: 919070771
Status: Opposition
Patent No.: 0527760B1
Claims (if Granted):
Country: France
<PAGE>
Application No.: Granted
Status: 919070771
Patent No.: 0527760B1
Claims (if Granted):
Country: Germany
Application No.: 919070771
Status: Granted
Patent No.: 69111440408
Claims (if Granted):
Country: Greece
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Italy
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Japan
Application No.: 5066831991
Status: Pending
Patent No.:
Claims (if Granted):
Country: Liechtenstein
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Luxembourg
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
<PAGE>
Claims (if Granted):
Country: Netherlands
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: PCT
Application No.: US9102250
Status: Completed
Patent No.:
Claims (if Granted):
Country: Spain
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Sweden
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: Switzerland
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
Country: United Kingdom
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
<PAGE>
Exhibit C
Description of Vaccine
AIDSVAX(TM) is the tradename for a line of vaccine products based on recombinant
glycoprotein 120 (rgp120/HIV-1) derived from the HIV-1 virus. Two vaccines,
AIDSVAX(TM) B/B and AIDSVAX(TM) B/E, are in currently in active clinical
development for the prevention of HIV-1 infection.
AIDSVAX(TM) B/B is a bivalent recombinant DNA-derived glycoprotein 120
(rgp120/HIV-1) vaccine containing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1.
MN-rgp120/HIV-1 antigen and GNE8 rgp120/HIV-1 antigens are representative of B
subtypes of HIV-1.
AIDSVAX(TM) B/E is a bivalent recombinant DNA-derived glycoprotein 120
(rgp120/HIV-1) vaccine containing MN rgp120/HIV-1 and A244 rgp120/HIV-1.
MN-rgp120/HIV-1 antigen is representative of B subtypes of HIV-1 and A244
rgp120/HIV-1 is representative of the E subtype of HIV-1.
<PAGE>
Exhibit D
Schedule of Technology Transfer
The knowhow described in Exhibit A will be transferred in phases corresponding
to the forecasted schedule for development of fthe 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 Celltrion Staff
<PAGE>
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
o AIDSVAX Manufacturing Documents
o AIDSVAX Analytical Documents
o Other AIDSVAX Quality Documents and Support
o Associated Training of Celltrion 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 Celltrion Staff