Sub-License Agreement - VaxGen Inc. and VaxGen-Celltrion Inc.
SUB-LICENSE AGREEMENT
This Sub-License Agreement (the "Agreement") is entered into as of 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 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 VCI the right to manufacture Licensed
Products and VCI 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, 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
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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 VCI a non-exclusive sub-license under
the Licensed Patent Rights and Licensed Knowhow to make Licensed Products
in the United States. 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 Sublicenses. VCI 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 VCI shall have the right to require VaxGen, at VCI's expense, to transfer
to VCI the Licensed Patent Rights and Licensed Knowhow. 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 Knowhow and for the manufacture of the
VACCINE by VCI. 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.
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Article 4. Payments and Record-Keeping
4.1 VCI Records. VCI 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 VCI (including, without
limitation, establishing 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 VCI's counsel). 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 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 VCI. VCI shall retain title to its interest in any improvements
to the Licensed Knowhow or Licensed Patent Rights developed or invented
solely by VCI or jointly by VCI 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 VCI
to determine in accordance with the applicable laws of inventorship and
competent written evidence.
5.2 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.
5.3 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.
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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 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.
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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 VCI that 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 License Agreement between the
Parties of even date herewith, are suitable and adequate to manufacture
the Vaccine at the scale currently produced by Genentech;
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 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 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 VCI or its sub-licensees. 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 hereinbelow 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 $25,000,000 per occurrence and annual aggregate combined single
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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. VCI 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
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. 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 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
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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. VCI 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 4.1, 5.2, 5.3, 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) VCI promptly shall return
to VaxGen all tangible Licensed Knowhow 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, pre-clinical and clinical data, and applicable
improvements to Licensed Patent Rights or Licensed Knowhow; and (ii)
VCI 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 VCI) 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 VCI's expense.
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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 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. 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 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
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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. 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. 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.
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.
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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.
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
AIDSVAX Technology
VaxGen will transfer all of the following AIDSVAX specific technology, materials
and knowhow, which together with the Platform Technology licensed to VCI under
that certain License Agreement will enable VCI 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
Description and Characterization
o Product description
o Physiochemical characterization
o Biological characterization
o Demonstration of the comparability of the product
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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
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
o Ongoing Quality Support
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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:
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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
Issue Date: July 18, 2000
Expiration Date: July 8, 2017
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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
Status: Published
Patent No.:
Claims (if Granted):
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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):
Country: OAPI
Application No.: 9900004
Status: Granted
Patent No.: 10954
Claims (if Granted):
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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
Title: METHODS AND COMPOSITIONS FOR
MICROENCAPSULATION OF ANTIGENS FOR USE AS
VACCINES
Application No.: 08/846,933
Filing Date: Dec. 22, 1998
Related Applications:
Status: Pending
Patent No.:
Issue Date:
Foreign Cases:
Country: Canada
Application No.: 2172509
Status: Published
Patent No.:
Claims (if Granted):
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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
Foreign Cases:
Country: Canada
Application No.: 2172507
Status: Published
Patent No.:
Claims (if Granted):
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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
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):
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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
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
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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
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):
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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
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
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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):
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):
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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
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
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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):
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
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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
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):
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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
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):
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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
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):
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Country: United Kingdom
Application No.: 919070771
Status: Granted
Patent No.: 0527760B1
Claims (if Granted):
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Exhibit C
Description of Vaccine
AIDSVAX(R) 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(R) B/B and AIDSVAX(R) B/E, are in currently in active clinical
development for the prevention of HIV-1 infection.
AIDSVAX(R) 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(R) 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.
-1-