Document/Exhibit Description Pages Size
1: 8-K Current Report 4 12K
2: EX-99.1 Press Release Issued July 2, 2002 2 10K
3: EX-99.2 Amended and Restated License and Supply Agreement 31 120K
4: EX-99.3 Press Release Issued July 8, 2002 2 11K
EX-99.2 — Amended and Restated License and Supply Agreement
Exhibit Table of Contents
Exhibit 99.2
AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT
This Amended and Restated License and Supply Agreement (the "Amended
Agreement") is entered into as of May 1, 2002 (the "Effective Date") by VaxGen,
Inc., a Delaware corporation ("VaxGen"), and Genentech, Inc., a Delaware
corporation ("Genentech") (each also singularly a "Party" and collectively the
"Parties") as follows:
WHEREAS, Genentech is the owner or licensee of certain patent rights and
knowhow relating to a vaccine (including use with adjuvants) against Human
Immunodeficiency Virus ("HIV") infection and/or Acquired Immune Deficiency
Syndrome ("AIDS"), as well as the owner of certain biologic materials,
pre-clinical data, clinical data, protocols and other knowhow relating to the
therapeutic and/or prophylactic uses of such vaccine (including used with
adjuvants) in humans;
WHEREAS, Genentech and VaxGen are parties to a certain License and Supply
Agreement dated as of May 1, 1996 (the "Original Agreement"), wherein Genentech
granted to VaxGen an exclusive license to such intellectual property so that
VaxGen may develop and commercialize vaccine(s) against HIV; and
WHEREAS, the Parties wish to amend and restate the Original Agreement on
the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual promises contained herein,
the Parties agree as follows:
Article 1.0 Certain Definitions.
The terms defined elsewhere in this Amended Agreement shall have the
meanings specified herein. The following terms shall have the following meanings
for purposes of this Amended Agreement:
1.1 "Adjuvant" and "Adjuvants" shall mean:
(a) the adjuvant comprised of alum (aluminum hydroxide);
(b) the adjuvant comprised of QS-21 saponin extract, which was
licensed to Genentech by Cambridge Biotech Corporation, a
Delaware corporation ("CBC") pursuant to that certain License
and Supply Agreement between Genentech and CBC dated as of
June 28, 1992 (the "QS-21 License");
(c) the adjuvant comprised of biodegradable polylactide
(lactide-co-glycolide) copolymer microspheres encapsulating
the Vaccine; and/or
(d) any other material that enhances or modifies the action of the
Vaccine.
1.2 "Administrative Costs" shall mean, as to each calendar quarter,
10 percent of the sum of a Party's own Marketing Costs and Sales Costs.
1.3 "Allocable Overhead" shall mean costs incurred by a Party or for
its account (and not reimbursed by a third party) which are attributable to its
supervisory, services, occupancy costs, corporate bonus (to the extent not
charged directly to a department), payroll, information systems, human relations
or purchasing functions and which are allocated to company departments based on
space occupied, headcount, full-time equivalents or another activity-based
method. "Allocable Overhead" shall not include any costs attributable to general
corporate activities including, by way of example only, executive management,
investor relations, business development, legal and government affairs, and
shall not include any costs or expenses which are reimbursed by the other Party
or any third party.
1.4 "BLA-Enabling Clinical Trial" shall mean a study in humans of
the efficacy and safety of a Licensed Product which is prospectively designed to
demonstrate statistically whether the Licensed Product is effective for use in a
particular indication in a manner sufficient to obtain regulatory approval to
market that Licensed Product.
1.5 "Clinical Vaccine(s)" shall mean: (a) the MN isolate of the
Vaccine manufactured and supplied by Genentech for use by VaxGen or its
sub-licensees in a BLA-Enabling Clinical Trial or other clinical trial in humans
in compliance with Good Manufacturing Practices at the protein concentration,
formulation and fill volume produced by Genentech as part of its normal
manufacturing and fill process for the Vaccine (the "First Generation Clinical
Vaccine"); and (b) each and every other clinical isolate, strain or other
variant of the Vaccine, if any (a "Vaccine Variant" or "Vaccine Variants"). The
First Generation Clinical Vaccine and each such Vaccine Variant (if any) are
each also referred to hereinbelow singularly as a "type" of Clinical Vaccine,
and collectively as the "Clinical Vaccine(s)".
1.6 "Combination Product Adjustment" shall mean, in the event a
Licensed Product is sold in the form of a combination product containing one or
more active ingredients in addition to a Licensed Product, Net Sales for such
combination product will be adjusted by multiplying actual Net Sales of such
combination product by the fraction A/A+B, where A is the invoice price of the
Licensed Product, if sold separately, and B is the invoice price of any other
active component or components in the combination, if sold separately. If, on a
country-by country basis, the other active component or components in the
combination are not sold separately, in such country,
Net Sales shall be calculated by multiplying the actual Net Sales of such
combination product by the fraction A/C, where A is the invoice price of the
Licensed Product if sold separately, and C is the invoice price of the
combination product. If, on a country-by-country basis, neither the Licensed
Product not the other active component or components of the combination product
is sold separately in such country, Net Sales shall be determined by the Parties
in good faith.
1.7 "Commercial Introduction" shall mean, on a country-by-country
and Licensed Product-by-Licensed Product basis, the date of first commercial
sale (other than for purposes of obtaining market approval) of a Licensed
Product by a Party or its sub-licensees in such country.
1.8 "Commercial Vaccine" or "Commercial Vaccines" shall mean: (a)
the MN isolate of the Vaccine manufactured and supplied by Genentech in
compliance with Good Manufacturing Practices at the protein concentration,
formulation and fill volume produced by Genentech as part of its normal
manufacturing and fill process for the Vaccine, as may be modified under such
regulatory approvals as are applicable and necessary for the sale of a Licensed
Product by VaxGen during the term of this Amended Agreement (the "First
Generation Commercial Vaccine"); and (b) each and every other Vaccine Variant
(as defined in Section 1.4 above). The First Generation Commercial Vaccine and
each such Vaccine Variant (if any) are each also referred to hereinbelow
singularly as a "type" of Commercial Vaccine and collectively as the "Commercial
Vaccine(s)".
1.9 "Cost of Sales" shall mean: (a) the cost of goods sold, defined
as the Fully Burdened Manufacturing Cost of Licensed Product sold, (b) royalties
owed by a Party to third parties as a result of manufacturing, use or sale of
Licensed Product (except for royalties included in Fully Burdened Manufacturing
Cost or reimbursed by a third party), and (c) outbound freight, customs and
duties includible in this category of costs in accordance with United States
generally accepted accounting principles and not reimbursed by the other Party
or any third party.
1.10 "Credit Agreement" shall mean that certain Credit Agreement,
dated as of December 19, 1995, between the Parties and related Promissory Note
dated December 19, 1995.
1.11 "Development Costs" shall mean, in every case, costs (including
Allocable Overhead) incurred by a Party, and not reimbursed, as required to
develop and/or obtain the authorization and/or ability to manufacture,
formulate, fill, ship and/or sell a Licensed Product in commercial quantities in
the Territory. "Development Costs" shall include, without limitation, the cost
of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects
of a Licensed Product conducted internally or by individual investigators,
contract research organizations or consultants necessary for the purpose of
obtaining and/or maintaining approval of a Licensed Product by a government
authority in a country in the Territory, and costs for preparing, submitting,
reviewing or developing data or information for the purpose of submission to a
governmental authority to obtain and/or maintain approval of a Licensed Product
in a country in the Territory, as well as the costs of process development
scale-up and recovery (including plant costs). "Development Costs" shall also
include, without limitation, the cost of research and development of Vaccine
Variants (as defined in Section 1.4 above) as potential Licensed Products,
including, without limitation, research relating to the immunologic and
serologic properties of Vaccine Variants, cloning and expression, and research
and development of processes for expression and manufacture of Clinical
Vaccine(s) and/or Commercial Vaccine(s) including or consisting of Vaccine
Variants. "Development Costs" shall also include, without limitation, the cost
of post-approval studies in support of a Licensed Product in the Field in the
Territory, and the expenses for compensation, benefits and travel and other
employee- related expenses, data management, statistical designs and studies,
document preparation, and other expenses associated with the clinical testing of
a Licensed Product. "Development Costs" in any case shall not include any costs
or expenses which are reimbursed by the other Party or any third party.
1.12 "Distribution Costs" shall mean a percentage of Net Sales
calculated as provided in Section 3.4(h), below.
1.13 "FDA" shall mean the United States Food and Drug
Administration.
1.14 "Field of Use" shall mean any human use of a Licensed Product
for the prevention, but not the treatment, of HIV infection and/or AIDS.
1.15 "Fully Burdened Manufacturing Cost" shall mean the cost of
production of Clinical Vaccine or Commercial Vaccine or, where applicable, of a
Licensed Product, which in any case shall be comprised of the sum of: (a) the
manufacturing cost of goods produced as determined in accordance with United
States generally accepted accounting principles as consistently applied by the
manufacturer of such product including, without limitation, direct labor,
material and product testing costs incurred in connection with the manufacture
or quality control testing of such product, as well as Allocable Overhead and
shipping containers, (b) the manufacturer's allocable intellectual property
licensing and acquisition costs paid to third parties which are necessary for
the manufacture of such product, and (c) any other costs borne by the
manufacturer for the transport, customs clearance and storage of such product
(if necessary) at the request of VaxGen or its sub-licensees (i.e. freight,
duty, insurance, and warehousing).
1.16 "Genentech Regulatory Filings" shall mean, collectively,
Investigational New Drug Application No. 3613 covering the IIIB isolate of the
Vaccine with the Adjuvant alum, Investigational New Drug Application No. 4299
covering the MN isolate of the Vaccine with the Adjuvant alum, Master File No.
5024 covering the MN isolate of the Vaccine with the Adjuvant QS21 and without
the Adjuvant alum, and
Investigational New Drug Application No. 5182 covering a skin test using the MN
isolate of the Vaccine without the Adjuvant alum.
1.17 "Good Manufacturing Practices" shall mean the current Good
Manufacturing Practices for Finished Pharmaceuticals pursuant to 21 C.F.R. 210
et seq., as amended from time to time.
1.18 "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
Genentech presently or hereafter during the term of this Amended Agreement,
which Genentech is free to license or sublicense, and which are specific and
necessary for any Licensed Product in the Field of Use or the manufacture, use
or sale of any Licensed Product in the Field of Use, including, without
limitation the rights licensed to Genentech under the third-party license
agreements specified in Exhibit A attached hereto and incorporated herein, to
the extent such rights are necessary for any Licensed Product in the Field of
Use or the manufacture, use or sale of any Licensed Product in the Field of Use;
provided, however, that "Licensed Knowhow" shall not include any rights
Genentech acquires after the effective date of the Original Agreement under any
third-party license agreement unless and until the Parties agree in writing on
binding terms and conditions for the sublicense of such rights from Genentech to
VaxGen.
1.19 "Licensed Patent Rights" shall mean all patents and patent
applications, and all patents issuing therefrom, together with all extensions,
reissues, reexaminations, substitutions, renewals, divisions, continuations,
continuations-in-part and foreign counterparts thereof or therefor, that are in
the possession of or controlled by Genentech presently or hereafter during the
term of this Amended Agreement, and which Genentech is free to license or
sublicense, to the extent that any of the foregoing specifically and directly
relates to or claims any Licensed Product in the Field of Use or the
manufacture, use or sale of any Licensed Product in the Field of Use, including,
without limitation: (a) any Licensed Product that contains, incorporates or uses
one or more Adjuvants, (b) the patents and patent applications listed in Exhibit
A. and (c) the rights licensed to Genentech under the third-party license
agreements specified in Exhibit A, to the extent that such rights are necessary
for any Licensed Product in the Field of Use or the manufacture, use or sale of
any licensed Product in the Field of Use; provided however, that "Licensed
Patent Rights" shall not include any rights Genentech acquires after the
Effective Date under any third-party license agreement unless and until the
Parties agree in writing on binding terms and conditions for the sublicense of
such rights from Genentech to VaxGen.
1.20 "Licensed Product" shall mean any pharmaceutical formulation
within the Field of Use 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.
1.21 "Marketing Costs" shall mean, in every case, the costs
(including Allocable Overhead) incurred by a Party, and not reimbursed, of
marketing, promotion, advertising, professional education, product-related
public relations, relationships with opinion leaders and professional societies,
market research, health care economic studies and other similar activities
directly relating to a Licensed Product. "Marketing Costs" shall include
internal costs (e.g., salaries, benefits, supplies, materials, etc.) as well as
outside services and expenses (e.g., consultants, agency fees, meeting costs,
etc.), in any case specifically identifiable to a Licensed Product, and costs
relating to obtaining reimbursement from payers and sales and marketing data.
"Marketing Costs" shall not include the costs of activities which promote a
Party's business as a whole or that are not product-specific (e.g., corporate
image advertising, etc.), or any costs or expenses which are reimbursed by the
other Party or any third party.
1.22 "Net Profits" shall mean, as to each calendar quarter, the
total aggregate Net Sales in that calendar quarter less the following items for
such quarter: Cost of Sales, Marketing Costs, Sales Costs, Distribution Costs,
and Development Costs incurred after the first marketing approval of a Licensed
Product.
1.23 "Net Sales" shall mean, as to each calendar quarter, the
aggregate gross invoiced sales prices charged for all Licensed Products sold by
a Party and its sublicensees hereunder, after deduction of the following items
paid by a Party or its sub-licensees during such calendar quarter with respect
to such sales of Licensed Products (regardless of the calendar quarter in which
such sales were made), provided and to the extent that such items are incurred,
were included in the price charged, and do not exceed reasonable and customary
amounts in the market in which such sales occurred: (a) trade and quantity
discounts or rebates actually taken and allowed; (b) credits or allowance given
or made for rejection or return of, and for uncollectible amounts on, previously
sold Licensed Products or for retroactive price reductions; (c) any tax, duty or
government charge (including any tax such as a value added or similar tax or
government charge, but not including any income tax) levied on the sale,
transportation or delivery of a Licensed Product and borne by the seller thereof
without reimbursement from any third party; and (d) any charges for freight or
insurance directly related to distribution of a Licensed Product. The sale of a
Licensed Product shall be deemed to occur on the earlier of (i) the date the
product is shipped or (ii) the date of the invoice to the purchaser of the
product. Such amount shall then be adjusted by the Combination Product
Adjustment, if applicable.
1.24 "Sales Costs" shall mean, in every case, the costs (including
Allocable Overhead) of a Party specifically identifiable to the sales of a
Licensed Product in the Territory, including, without limitation, costs
associated with sales representatives, including training, compensation,
benefits and travel, supervision, sales meetings and other sales expenses.
"Sales Costs" shall not include the startup costs associated with a Party's
sales force, including recruiting, relocation and other similar costs, or any
costs or expenses which are reimbursed by the other Party or any third party.
1.25 "Stock Agreements" mean, collectively, (a) that certain Stock
Subscription Agreement, dated as of March 15, , 1996, between the Parties, (b)
that certain Warrant Agreement, dated as of March 15, 1996, between the Parties,
and (c) any and all future agreements entered into between the Parties with
respect to the acquisition by Genentech of additional shares of stock or
securities of VaxGen (including, without limitation, in the Private Placement).
1.26 "Territory" shall mean the world.
1.27 "Vaccine" shall mean the recombinant HIV surface glycoprotein
gp120 developed by Genentech.
Article 2.0 License Grant.
2.1 License Grant. Subject to the other terms and conditions of this
Amended Agreement (including, without limitation, Section 3.4 and Article 10
below), Genentech hereby grants to VaxGen an exclusive license, even as to
Genentech, under the Licensed Patent Rights and Licensed Knowhow to develop,
make, have made, use, offer for sale and sell Licensed Products in the Field of
Use in the Territory; provided however, that Genentech retains the right under
the Licensed Patent Rights and Licensed Knowhow, and to all improvements to the
Licensed Patent Rights or Licensed Knowhow that are solely or jointly owned by
VaxGen (under Section 6.1 below), to perform research, including but not limited
to research and development of Clinical Vaccines for VaxGen, and to use Licensed
Products for such research purposes, and Genentech also retains certain
marketing rights to the extent set forth in Section 3.4 below.
2.2 Sublicenses. Subject to Genentech's marketing option in Section
3.4 below, VaxGen may grant sublicenses of its rights hereunder on 30 days'
prior notice to Genentech, subject in any case to Genentech' s prior approval
(which shall not be unreasonably withheld). Any sublicensee hereunder shall be
subject to all obligations of VaxGen hereunder, and VaxGen hereby guarantees to
Genentech the performance by any and all of its sublicensees of the obligations
of VaxGen hereunder.
Article 3.0 Product Development and Commercialization.
3.1 Technology Transfer and Services to VaxGen.
(a) Subject to the other terms and conditions of this Amended Agreement
(including, without limitation, Article 10), VaxGen shall have the right to
require Genentech to transfer the Licensed Knowhow and Genentech Regulatory
Filings to VaxGen or its designated sublicensee as provided in this Section
3.1(a). VaxGen may reasonably request a transfer by Genentech at any time during
the Term of this Amended Agreement, provided, however, that Genentech shall only
be required to transfer manufacturing processes once, and to the extent that
VaxGen requests that Genentech transfer such process to a sublicensee, such
sublicensee must have facilities and experience with manufacture of biologics
with Chinese hamster ovary cell lines (a
"Qualified Transferee"). For purposes of this Section 3.1(a) the "pilot
facility" publicly announced as of the Effective Date to be operated by VaxGen
in or around South San Francisco, California shall be deemed a Qualified
Transferee.
(i) At VaxGen's expense, Genentech shall provide VaxGen or its
designated sublicensee with the proprietary information, data and biologic
materials listed in Exhibit B attached hereto and incorporated herein.
(ii) At VaxGen's expense, Genentech shall provide VaxGen with a
complete copy of each of the Genentech Regulatory Filings, and shall take
such other steps as may be required on the part of Genentech under such
applicable laws and regulations to assign such Genentech Regulatory
Filings to VaxGen or consent to VaxGen's reference thereto, at Genentech's
option. At its own expense, VaxGen promptly shall submit to the FDA all
such forms, assurances, information and other documentation required on
the part of VaxGen under such applicable laws and regulations to
effectuate such assignment to or reference by VaxGen, including, without
limitation, amendment of the Genentech Regulatory Filings to reflect new
ownership and submission of Forms FDA 1571 on the new medical monitor for
such Genentech Regulatory Filings.
(b) In furtherance of the foregoing, Genentech shall provide VaxGen with
various support services agreed on by the Parties, at VaxGen's expense
including, without limitation, cell banking, analytical testing, regulatory
services, filling, packaging, shipping, inventory storage and management,
maintenance of stability program and process science support. All of such
services shall be transitioned from Genentech to VaxGen according to Attachment
1 hereto, such that by the end of calendar year 2002, Genentech's support shall
consist exclusively of process science support, the extent of such process
science support to be established by the Parties through good faith negotiations
as soon as practicable after the Effective Date. In furtherance of the
foregoing, the Parties acknowledge and agree that the process science support to
be provided by Genentech pursuant to this Section 3.1 shall be greater in the
event that Genentech exercises its commercialization option pursuant to Section
3.4(a). Until such time as Genentech has exercised or declined to exercise such
option or such option has expired, the process science support to be provided by
Genentech will be no less than 0.2 full time equivalents ("FTEs") per year.
3.2 Due Diligence. During the term of this Amended Agreement, VaxGen shall
use due diligence in developing, seeking regulatory approval for, marketing of
and commercializing Licensed Products in the Field of Use in the Territory. As
an objective measure of such due diligence efforts, VaxGen agrees to the binding
development milestone set forth in Section 3.3 below. Except as otherwise
expressly provided in this Amended Agreement, VaxGen shall be responsible for
all aspects and costs of development and commercialization of Licensed Products
under this Amended Agreement, including, without limitation, the conduct of
pre-clinical and clinical trials, regulatory filings, marketing applications and
approvals, and post-approval studies. The Parties shall consult and agree upon:
which Party shall hold any such establishment,
product or other regulatory license(s) and other matters relating to
manufacturing and commercialization arrangements hereunder.
3.3 Development Milestone.
(a) (i) In the event that the BLA-Enabling Clinical Trial underway as of
the Effective Date meets all of its primary endpoints, VaxGen, directly or
through a sublicensee, shall have filed for first market approval of a Licensed
Product in the Field of Use (the "Milestone"), on or before May 1, 2004.
(ii) In the event that the BLA-Enabling Clinical Trial underway as
of the Effective Date does not meet all of its primary endpoints, VaxGen,
directly or through a sub licensee, shall have filed for first market approval
of a Licensed Product in the Field of Use (the "Milestone"), on or before May 1,
2006.
(iii) VaxGen shall promptly notify Genentech when it has achieved
the Milestone.
(b) In connection with VaxGen's development and commercialization of
Licensed Products pursuant to this Amended Agreement, commencing approximately
90 days after the Effective Date, and thereafter semi-annually on or about each
January 1 and July 1 of the term of this Amended Agreement, VaxGen shall supply
Genentech with a brief but complete report on VaxGen's and its sublicensees'
development and commercialization programs for all Licensed Products in the
Field of Use, which shall describe VaxGen's (and its sublicensee's) progress in
such programs in the prior six months and planned programs for the upcoming six
months. Each report shall include, for the 12-month period it covers: (a) a
summary of VaxGen's previous and planned development efforts for each indication
or use, including each clinical trial, regulatory filing, application and
approval with respect to Licensed Products that VaxGen (or its sublicensees)
have performed, sought or obtained or will perform, seek or obtain, and (b) a
summary of VaxGen's previous and planned commercialization efforts for each
indication and use. VaxGen will cooperate as reasonably requested by Genentech
in its review of each report. In connection therewith, Genentech shall have the
right to visit VaxGen's or its sublicensee's facilities, examine their records,
discuss matters with key officers and employees, and comment on such development
plans. At Genentech's request during the term of this Amended Agreement, the
Parties shall meet to discuss such development and commercialization plans;
provided, however, that such meetings shall not occur more frequently than
semi-annually unless VaxGen agrees otherwise.
(c) If VaxGen is unable to meet the Milestone due to: (i) issues raised by
the FDA that are not within VaxGen's control, and could not have been reasonably
anticipated by VaxGen, (ii) the occurrence of a serious and unexpected adverse
experience (as defined in 21 C.F.R. Section 312.32), the principal cause of
which is Clinical Vaccine and/or Commercial Vaccine manufactured and supplied by
Genentech under Article 4, and/or (iii) an event solely within Genentech's
control, including, without limitation, material delay in the performance by
Genentech of any of its material
obligations hereunder (e.g., the transfer of technology, regulatory filings,
data or materials to VaxGen hereunder), then VaxGen may notify Genentech in
writing of such inability and request an extension of time to complete the
Milestone. Provided that VaxGen can demonstrate to Genentech's reasonable
satisfaction that the reason(s) for such inability to meet the Milestone are
solely as set forth in clauses (i), (ii) and/or (iii) above, Genentech and
VaxGen shall agree in good faith on a new Milestone date (subject, however, to
the two (2) year limit under Section 3.3(d) below). Any extension of the
Milestone due to any reason(s) other than those set forth in clauses (i) through
(iii), above, may be granted or denied in Genentech' s sole and absolute
discretion. In connection with any request by VaxGen for an extension hereunder,
if VaxGen and Genentech cannot agree on the reason(s) for such inability to meet
the Milestone, the need for such an extension or the appropriate duration of
such extension, then such matter(s) (and only such matter(s) shall be referred
to a committee of three clinical investigators for resolution. Such committee
shall consist of a clinical investigator selected by each of Genentech and
VaxGen who shall not be an employee of either and who shall have at least five
years' experience in conducting clinical investigations. The two investigators
so selected shall promptly select a third mutually agreeable investigator with
like qualifications. The committee shall render a written opinion to the
Parties, within 30 days after selection of the third investigator, regarding the
matter(s) at issue. Each Party agrees to be bound by such written opinion. Each
Party shall separately indemnify and hold harmless each member of the committee
from any and all claims, actions, liabilities, damages and expenses asserted
against or incurred by him or her as a result of providing his or her services
pursuant to this Section 3.3.
(d) Any disputes between the Parties hereunder that are not matter(s) for
resolution by the committee to be appointed under Section 3.3(c) above shall be
resolved in accordance with Section 11.5 below; provided, however, that VaxGen
shall have the burden of demonstrating its due diligence hereunder. Subject to
the foregoing, VaxGen's failure to exercise due diligence hereunder, including,
without limitation, its failure to meet the Milestone (or the Milestone as
extended in accordance with Section 3.3(c) above), shall be considered a
material default by VaxGen of this Amended Agreement, giving Genentech the
right, in its sole discretion, to elect to convert VaxGen's exclusive license
hereunder to a non-exclusive license to VaxGen or terminate this Amended
Agreement in accordance with Section 10.2, effective 30 days after notice from
Genentech to VaxGen, unless VaxGen shall have cured its default (including,
where VaxGen has failed to meet the Milestone, meeting the Milestone within such
30-day period) Notwithstanding the foregoing or any other term of this Agreement
(and without the need to resort to Section 11.5 below), if Vaxgen has not met a
Milestone (whether or not extended) within two (2) years after the original date
for such Milestone as set forth in Section 3.3(a) above, then Genentech shall
have the right, in its sole discretion, to terminate this Agreement under
Section 10.2 below, effective on thirty days prior written notice from Genentech
to Vaxgen, unless Vaxgen shall have met such Milestone within such thirty day
period. The two (2) year limit set forth herein may be waived only in
Genentech's sole and absolute discretion..
3.4 Sale of Licensed Products by Genentech.
(a) Subject to the other terms and conditions of this Amended Agreement
(including, without limitation, Article 10), VaxGen hereby grants to Genentech
an exclusive option to use, sell, offer for sale and import, on an exclusive
basis, all Licensed Products in the United States of America, Mexico and Canada
("the "Option Territory"). Such option is exercisable, in Genentech's sole
discretion, by written notice to VaxGen at any time prior to 90 days from the
date VaxGen delivers to Genentech (i) the final report of a BLA-Enabling Trial
that has met all of its primary endpoints in a form suitable for filing with the
FDA, and (ii) a detailed calculation of the aggregate total of VaxGen's
Development Costs through the date of such notice. Genentech shall have the
right, at its sole expense, to audit VaxGen's Development Costs in accordance
with Section 5.3 below, and the 90-day period for exercise of Genentech's option
shall be extended by the number of days (up to an additional 60 days) reasonably
required in order for Genentech to complete any such audit of Development Costs.
If Genentech elects to exercise its option hereunder, its notice of exercise to
VaxGen shall be accompanied by payment to VaxGen of an option fee (the "Option
Fee") equal to 33 percent of the aggregate total of VaxGen's Development Costs
for the first Licensed Product intended for commercialization in, and incurred
in, the Option Territory for such Licensed Product through the date VaxGen
delivers the report and detailed calculation as set forth above (subject to
Section 5.3 below). Genentech's license as set forth above shall become and
remain effective automatically upon such notice and payment from Genentech to
VaxGen as provided for herein, subject to the other terms of this Amended
Agreement.
(b) If Genentech timely exercises its option hereunder, Genentech shall
have an exclusive License (even as to VaxGen) under the Licensed Patent Rights
and Licensed Knowhow, to all improvements to the Licensed Patent Rights or
Licensed Knowhow that are solely or jointly owned by VaxGen (under Section 6.1
below), and to any other intellectual property or proprietary information owned
or controlled by VaxGen that is within the Field of Use, to use, sell, offer for
sale and import all Licensed Products throughout the Option Territory during the
term of this Amended Agreement, with no further consideration other than the
Option Fee and sharing of Net Profits from sales of such Licensed Products as
provided below in this Section 3.4. Genentech may grant sublicenses to its
rights under this Section 3.4, effective upon written notice to VaxGen.
(c) If Genentech timely exercises its option hereunder, thereafter during
the term of this Amended Agreement commencing if and when the FDA approves the
filing for market approval of the first Licensed Product, Genentech shall use
due diligence in marketing and selling Licensed Products that receive approval
for marketing in the Option Territory. For purposes of this Amended Agreement,
such "due diligence" shall mean the maximum commercial effort consistent with
Genentech's prudent business judgment, and consistent with the market potential
of Licensed Products relative to other products in Genentech's commercial
portfolio. In connection with the foregoing, within 30 days after Genentech's
notice of exercise of its option under Section 3.4(a) above, the Parties will
establish a joint development and commercialization committee (the
"Commercialization Committee"), to be comprised of two representatives appointed
and replaced by each Party. Such representatives will include individuals with
expertise and
responsibilities in the areas of product development and marketing, sales
management or market research. The Commercialization Committee will meet as
requested by either Party by notice to the other Party (but in any event not
more frequently than semiannually), at such times and locations as are
reasonably acceptable to the Parties. The Commercialization Committee shall
monitor and review the development and commercialization of all Licensed
Products and the Development Costs associated therewith. The Commercialization
Committee shall also monitor and review the marketing and sale of Licensed
Products by Genentech (and its sublicensees) under this Section 3.4 (including,
without limitation, annual marketing and sales budgets, annual forecasts of
sales and marketing plan, product positioning and campaign strategies, pricing,
managed care contract strategies and trademarks). In addition, if VaxGen
notifies Genentech that VaxGen believes, in good faith, that Genentech is
failing to exercise due diligence hereunder in a specified portion or portion(s)
of the Option Territory, the Commercialization Committee shall review
Genentech's due diligence hereunder. The Commercialization Committee will
operate by consensus, and if it is unable to resolve a dispute regarding any
issue presented to it, such dispute shall be resolved in accordance with Section
11.5 below; provided, however, that VaxGen shall have the burden of
demonstrating Genentech's lack of due diligence hereunder. Subject to the
foregoing, Genentech's failure to exercise due diligence hereunder shall be
considered a material default by Genentech of this Amended Agreement, giving
VaxGen the right, in its sole discretion, to elect to convert Genentech' s
exclusive license to a non-exclusive license to Genentech, effective 30 days
after notice from VaxGen to Genentech unless Genentech shall have cured its
default within such 30-day period. The Commercialization Committee (if any)
automatically will cease to operate upon the expiration of the term of this
Amended Agreement.
(d) If Genentech timely exercises its option hereunder, Genentech and
VaxGen thereafter shall share in the Net Profits in the Option Territory, 70% to
Genentech and 30% to VaxGen.
(e) In connection with the sharing of Net Profits contemplated under this
Section 3.4, within 30 days after Genentech's notice of exercise of its option
under Section 3.4(a) above, the Parties will establish a joint finance committee
(the "Finance Committee"), to be comprised of two representatives appointed and
replaced by each Party. Such representatives will include individuals with
expertise and responsibilities in the areas of accounting, cost allocation,
budgeting or financial reporting. The Finance Committee will meet quarterly or
as otherwise agreed upon by the Parties, at such times and locations as are
reasonably acceptable to the Parties. The Finance Committee will operate by
consensus, and if it is unable to resolve a dispute regarding any issue
presented to it, such dispute shall be resolved in accordance with Section 11.5
below. The Finance Committee shall address the financial, budgeting and
accounting issues which arise in connection with the sharing of Net Profits
contemplated under Section 3.4(d) above (including, without limitation, the
Parties' respective cost structures and generally acceptable accounting
practices and other practical aspects of implementation of the terms of this
Amended Agreement). The Finance Committee (if any) automatically will cease to
operate upon the expiration of the term of this Amended Agreement.
(f) After the expiration of the term of this Amended Agreement; provided
that Genentech has timely exercised its option under this Section 3.4, Genentech
shall have a perpetual, fully paid-up, non-exclusive license under all
improvements to the Licensed Patent Rights or Licensed Knowhow that are solely
or jointly owned by VaxGen (to the extent that VaxGen has the right to grant
such a license), to make, have made, use, sell offer for sale and import
Licensed Products in the Field in the Option Territory.
(g) If Genentech timely exercises its option hereunder, Genentech shall
not be required to purchase Licensed Product from VaxGen that is produced by
VaxGen's Korean joint venture. In the event that Genentech elects not to
purchase Licensed Product produced by such joint venture, VaxGen shall use
commercially reasonable efforts to supply Licensed Product from a
VaxGen-operated or controlled facility or to seek supply from an alternate
source, in either case on terms and conditions acceptable to Genentech, such
acceptance not to be unreasonably withheld. If VaxGen is unable to secure supply
of acceptable quality, quantity and reliability from an alternate source on
terms and conditions reasonably acceptable to Genentech, Genentech will have the
non-exclusive royalty-free right to manufacture Licensed Product or contract
with a third party to manufacture Licensed Product for sale in the Option
Territory, and VaxGen shall complete a technology transfer as necessary to
effectuate the foregoing, at Genentech's expense, within six months of such
request.
(h) No fewer than six months prior to the date on which Genentech, having
timely exercised its option pursuant to Section 3.4(a), below, anticipates first
lawful commercial sale of a Licensed Product in the Option Territory. Genentech
shall in good faith determine its Distribution Costs (expressed as a percentage
of Net Sales in the Option Territory) specifically identifiable for distribution
of Licensed Product in the Option Territory: (i) in bulk form, and (ii) in final
finished and filled form including, without limitation, Allocable Overhead,
order processing, invoicing and collection, customer services, collection of
data of sales to end users, credit, handling returns and recalls of Licensed
Product, warehousing, distribution and inventory and receivables, but excluding
costs and expenses: (i) reimbursed to Genentech by VaxGen or a third party, or
(ii) otherwise borne by or charged to VaxGen under a different provision of this
Agreement. Genentech shall complete such determinations (the "Initial
Determinations") within 45 days after commencing and thereafter shall promptly
notify VaxGen of the results, providing VaxGen with reasonable written
documentation in support of such determinations.
At any time following the second anniversary of first lawful commercial
sale of a Licensed Product in the United States, either Party shall have the
right to retain an independent accounting firm reasonably acceptable to the
other Party to audit Genentech's actual Distribution Costs as to Licensed
Product sold in bulk form, in final finished and filled form or both, as of the
time of such audit. The costs of such audit shall be borne by the Party
commissioning such audit; provided, however, that if such audit shows that
Genentech's actual Distribution Costs at the time of the audit (the "Second
Determinations") are more than five percent greater than that set in the Initial
Determinations (if Genentech is a Party commissioning such audit) or five
percent lower than that set in the Initial Determinations (if VaxGen is the
Party commissioning such audit), then the costs of the audit shall be borne by
the other Party. The results of such audit shall be shared by the Parties and to
the extent that the Second Determinations differ from the Initial
Determinations, the Distribution Costs established in the Second Determinations
(expressed as a percentage of Net Sales) shall govern prospectively, effective
as of the date of completion of the audit.
At any time following the first anniversary of the Second Determinations,
either Party shall have the right to commission one further audit of Genentech's
actual Distribution Costs (the "Final Determinations") on the terms and
conditions set forth hereinabove with respect to the Second Determinations. To
the extent that the Final Determinations differ from the Second Determinations,
the Distribution Costs established in the Final Determinations (expressed as a
percentage of Net Sales) shall govern prospectively, effective as of the date of
completion of the audit.
Notwithstanding the possibility of more than one audit under this Section
3.4(h), only one audit will be performed with respect to any given calendar
period or set of financial transactions.
Article 4.0 Manufacture and Supply.
4.1 (a) First Generation Clinical Vaccine. In developing and
commercializing Licensed Products hereunder, VaxGen has conducted, and
contemplates hereafter conducting, certain BLA-Enabling Clinical Trials
including the First Generation Clinical Vaccine. Subject to the other terms and
conditions of this Amended Agreement, Genentech shall supply VaxGen with First
Generation Clinical Vaccine from inventory being maintained for VaxGen as of the
Effective Date, as well as placebo, for such BLA-Enabling Clinical Trials.
(b) Vaccine Variants. In addition to the First Generation Clinical
Vaccine described above, Genentech shall supply VaxGen with two Vaccine Variants
as Clinical Vaccine or for BLA-Enabling Trials as well as placebo, at such times
and in such amounts as are contained in Attachment 1 to this Agreement. The cost
to VaxGen for such Vaccine Variants shall be Genentech's Fully Burdened
Manufacturing Cost.
(c) Bridge Services. With regard to First Generation Clinical
Vaccine and the two Vaccine Variants described above, Genentech shall provide
temporary bridge services to VaxGen as agreed to by the parties, such services
to include maintenance of stability program, inventory storage and management,
packaging, shipping, and regulatory support. The cost to VaxGen for such
services shall be Genentech's fully burdened cost, including Allocable Overhead.
(d) Additional Supply. From time to time, upon advance written
notice no less than six months in advance of the proposed manufacturing date,
VaxGen may request that Genentech supply Clinical Vaccine and/or services in
addition to what is
described above, which Genentech may accept or refuse in whole or in part in its
sole discretion. In the event that Genentech agrees to provide such Clinical
Vaccine or services, the Cost to VaxGen will be as negotiated by the Parties in
good faith on a case-by-case basis.
4.2 Technology Transfer. VaxGen shall have the right to require Genentech,
at VaxGen's expense, to transfer the Licensed Patent Rights and Licensed Knowhow
necessary for the manufacture and supply of the GNE8 form of Vaccine Variant of
Clinical Vaccine, together with the additional information and Licensed Knowhow
described on Exhibit B attached hereto applicable to other Vaccine Variants, to
VaxGen (or a Qualified Transferree as set forth in Section 3.1(a)), provided
that Genentech shall be required to perform such transfer only once. In
connection with such transfer: (i) VaxGen shall be entitled to arrange for such
manufacture and supply with alternative supplier(s) at VaxGen's expense, and in
connection therewith may sublicense its right and license hereunder to such
alternate supplier(s), subject to Section 2.2 above; and (ii) VaxGen shall not
owe Genentech the Fully Burdened Manufacturing Cost for such alternate
manufacture and supply outside the Option Territory (or worldwide, in the event
Genentech does not opt-in pursuant to Section 3.4(h)), but the other terms of
this Amended Agreement (including the royalty and profit-sharing provisions)
shall continue to apply. Except to the extent otherwise provided in this Section
4.2, Genentech shall have no obligation to transfer any Licensed Patent Rights
Licensed Knowhow or other technology relating to manufacture of Clinical Vaccine
and/or Commercial Vaccine to VaxGen or any of its sublicensees or any other
third party.
4.3. Supply Agreement. In anticipation of Vaxgen's supply under Section
4.1 above, the Parties shall agree upon and enter into a separate supply
agreement ("Supply Agreement") setting forth the Parties' understandings with
respect to forecasting of expected requirements, ordering, scheduling of
manufacturing and delivery, quality control testing, invoicing and payment and
record keeping.
Article 5.0 Payments and Accounting Records.
5.1 Royalties.
(a) In consideration for the license granted to VaxGen hereunder by
Genentech, VaxGen shall pay royalties to Genentech as set forth hereinbelow in
connection with sales of each Licensed Product by VaxGen or its sublicensees,
unless Genentech has elected to exercise its marketing rights in the Option
Territory with respect to Licensed Products under Section 3.4 above (in which
case the Parties will share Net Profits in the Option Territory as specified
therein, and VaxGen shall owe royalties only with respect to Net Sales outside
of the Option Territory). Such royalties shall equal fifteen percent of
aggregate total Net Sales of Licensed Product by VaxGen and its sublicensees on
a country-by-country basis (including the Option Territories if Genentech does
not timely exercise its option to market in the Option Territories).
Notwithstanding the foregoing, to the extent that VaxGen sells Licensed Product
to the World Health Organization or the United Nations for use in a third world
country at a
price lower than the average price charged in private markets in such country,
then the royalty owed to Genentech for such sales shall be reduced by a
proportional amount (on a percentage basis), to a minimum rate of 7.5 percent.
If no private market exists in such a country, then the Parties shall in good
faith agree on an adjustment to the royalty rate payable by VaxGen to Genentech
for sales to the World Health Organization or United Nations (or a similar
non-profit organization agreed to by Genentech); provided, however, that the
applicable royalty rate shall in no event be less than 7.5 percent.
(b) Royalties shall be payable to Genentech for any product that is
a Licensed Product under this Amended Agreement, and the Parties intend and
agree that such royalties will not increase in the event of issuance of a valid
patent included within the Licensed Patent Rights. The intellectual property
licensed to VaxGen pursuant to this Amended Agreement includes substantial
Licensed Knowhow. There can be no assurance that any patent will issue based on
any patent applications within the Licensed Patent Rights.
(c) Throughout the term of this Agreement VaxGen shall be free to
in-license from or otherwise collaborate with any third party which owns or
controls a proprietary Adjuvant. In the event that the Licensed Product as
currently formulated fails to meet its primary end-points or is otherwise
determined to be unlicensable by the FDA or European Agency for the Evaluation
of Medicinal Products ("EMEA"), then VaxGen shall have the right, with the
approval of Genentech (such approval shall not be unreasonably withheld), to
deduct from royalties otherwise payable to Genentech pursuant to this Section
5.1 one-half of all royalties paid to such third party for the right to use or
sell such Adjuvant; provided, however, that the royalty payable to Genentech
shall in no event be less than two-thirds of the amount specified in Section
5.1(a), above.
5.2 Payments and Reports. Royalties owed by VaxGen to Genentech under this
Agreement, or, if applicable, profit-sharing amounts owed by Genentech to VaxGen
under Section 3.4 above, with respect to any Licensed Product shall accrue
during each calendar quarter (or portion thereof) during the term of this
Amended Agreement after the Commercial. Introduction of such Licensed Product,
and shall be due and payable for such calendar quarter within 60 days after the
end of such quarter. VaxGen shall calculate the royalties owed or, if
applicable, Genentech shall calculate the profit-sharing owed, in any case in
accordance with and subject to the terms and conditions of this Amended
Agreement. Each Party shall remit any such payment due to the other Party
hereunder by bank wire transfer in immediately available funds to a bank account
designated by the Party to whom such payment is owed, in any case free and clear
of any taxes, duties, levies, fees or charges thereon (unless legally required
to do so), and the Party remitting such payment shall make any applicable
withholding payments due on behalf of the other Party and provide the other
Party with written documentation of such withholding. For sales of any Licensed
Product that occur in a currency other than United States dollars ("foreign
currency sales"), the quarterly payment shall be calculated as follows:
{A/B}x C = United States dollars royalty or profit-sharing payment on
foreign currency sales, where
A = foreign currency "Net Sales" or "Net Profits" per quarter;
B = foreign exchange conversion rate, expressed in local currency per
United States dollar (using as the applicable foreign exchange
conversion rate the rate published in Reuters, or any other source
mutually agreed upon by the Parties, for the average rate during the
applicable calendar quarter); and
C = the royalty rate or profit-sharing percentage applicable to such
sales under this Amended Agreement.
Together with any royalty payment or profit-sharing payment on sales of Licensed
Products under this Amended Agreement, remitting Party shall render to the other
Party an accounting for such calendar quarter showing (i) total gross sales and
total Net Sales by the remitting Party and its sublicensees in the currency in
which such Net Sales were made and in US dollars, (ii) total gross profits and
Net Profits by the remitting Party and its sublicensees in currency in which
such Net Profits were made and in US dollars, and (iii) a Licensed
Product-by-Licensed Product and country-by-country calculation of the aggregate
total of royalty and/or profit-sharing amounts payable with respect to all such
sales of Licensed Products (including, in the case of foreign currency sales,
the calculations set forth hereinabove).
5.3 VaxGen Accounting Records. VaxGen shall keep full, true and accurate
books of account containing all particulars which may be necessary for the
purpose of showing Net Sales of all Licensed Products by VaxGen and its
sublicensees, and, in case Genentech exercises its option under Section 3.4
above, showing VaxGen's Development Costs for the first Licensed Product.
VaxGen's complete books of account and supporting data therefor shall be kept at
its principal place of business for at least two years following the end of the
calendar year to which they pertain (and access shall not be denied thereafter,
if reasonably available), and shall be made available for inspection and copying
during regular business hours by an independent accountant retained by Genentech
at Genentech's sole expense (except as otherwise provided hereinbelow) and
reasonably acceptable to VaxGen; provided, however, that such inspection shall
not take place more often than once per year during the term of this Amended
Agreement; and provided further, however, that any such independent accountant
shall have previously entered into a confidentiality agreement limiting its
disclosure of such information to authorized representatives of the Parties or
as required under applicable law (with advance notice to the Parties of such
need for disclosure) or arbitration or litigation between the Parties relating
to this Amended Agreement. Any such inspection shall be for the purpose of
verifying Net Sales on sales of Licensed Products by VaxGen and its
sublicensees, or VaxGen's Development Costs under Section 3.4 above, as the case
may be. Results of any inspection hereunder shall be made available promptly to
both Parties in writing. If any inspection reveals a miscalculation of royalty
amounts that results in an underpayment to Genentech, or a miscalculation of
Development Costs that results in an overpayment by Genentech, VaxGen shall
promptly and completely correct any such
miscalculation by payment to Genentech, and if such underpayment or overpayment
is by five percent or more VaxGen shall pay all costs and expenses of such
inspection and shall pay interest in such amount at the prime rate as listed in
the Federal Reserve Bulletin H.15 or a successor bulletin thereto.
1 Notwithstanding the possibility of more than one audit under this
Section 5.3, only one audit shall be performed with respect to any given
calendar period or set of financial transactions.
5.4 Genentech Accounting Records. Genentech shall keep full, true and
accurate books of account containing all particulars which may be necessary for
the purpose of showing its Fully Burdened Manufacturing Cost, and, if Genentech
exercises its option under Section 3.4 above, showing Net Profits of all
Licensed Products by Genentech and its sublicensees. Genentech's complete books
of account and supporting data therefor shall be kept at its principal place of
business for at least two years following the end of the calendar year to which
they pertain, and shall be made available for inspection during regular business
hours by an independent accountant retained by VaxGen at VaxGen's sole expense
(except as otherwise provided hereinbelow) and reasonably acceptable to
Genentech; provided however, that such inspection shall not take place more
often than once per year during the term of this Amended Agreement; and provided
further, however, that any such independent accountant shall have previously
entered into a confidentiality agreement limiting its disclosure of such
information to authorized representatives of the Parties or as required under
applicable law (with advance notice to the Parties of such need for disclosure)
or arbitration or litigation between the Parties relating to this Amended
Agreement. Any such inspection shall be for the purpose of verifying Net Profits
on sales of Licensed Products by Genentech and its sub-licensees under Section
3.4 above, or Genentech's Fully Burdened Manufacturing Cost, as the case may be.
Results of any inspection hereunder shall be made available promptly to both
Parties in writing. If any inspection reveals a miscalculation of profit-sharing
amounts that results in an underpayment to VaxGen, or a miscalculation of Fully
Burdened Manufacturing Cost that results in an overpayment by VaxGen to
Genentech, Genentech shall promptly and completely correct any such
miscalculation by payment to VaxGen, and if such underpayment or overpayment is
by five percent or more Genentech shall pay all costs and expenses of such
inspection and shall pay interest in such amount at the prime rate as listed in
the Federal Reserve Bulletin H.15 or a successor bulletin thereto.
Notwithstanding the possibility of more than one audit under this Section
5.4, only one audit shall be performed with respect to any given calendar period
or set of financial transactions.
Article 6.0 Intellectual Property Rights.
6.1 Ownership. Genentech shall retain title to the Licensed Knowhow and
Licensed Patent Rights, including, without limitation, any Licensed Knowhow and
Licensed Patent Rights developed or invented by Genentech in the future. VaxGen
shall
retain title to any improvements to the Licensed Knowhow or Licensed Patent
Rights developed or invented solely by VaxGen or its sublicensees or jointly by
VaxGen and any third party (but not Genentech). 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 Genentech and VaxGen to determine in accordance with United
States laws of inventorship and competent written evidence of the Parties.
6.2 Patent Filing, Prosecution and Maintenance. Subject to the other terms
and conditions of this Amended Agreement (including the remainder of this
Section 6.2), during the term of this Amended Agreement, Genentech shall be
responsible for the filing, prosecution and maintenance of all Licensed Patent
Rights, in consultation with VaxGen, and VaxGen agrees to reimburse all
reasonable costs and expenses incurred by Genentech for the benefit of VaxGen
hereunder within 30 days of receipt of an invoice from Genentech setting forth
such costs and expenses, including a reasonable apportionment of such costs and
expenses for patent applications and patents within the Licensed Patent Rights
that contain claims outside of or overlapping with the scope of rights licensed
to VaxGen under this Amended Agreement (hereinafter, "Broad Claims"). Genentech
shall keep VaxGen informed of the status of filing, prosecution and maintenance
of Licensed Patent Rights in each country in the Territory, by: (i) providing
VaxGen with a copy of each patent application filed by Genentech hereunder
promptly after filing; (ii) for each patent application and patent hereunder
that contains Broad Claims, providing VaxGen with Genentech's reasonable
apportionment of out-of-pocket costs and expenses to date and on a going-forward
basis therefore, which VaxGen may review with Genentech as reasonably requested;
(iii) updating VaxGen 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 VaxGen with a then-current
version of Exhibit A to this Amended Agreement and reviewing it with VaxGen as
reasonably requested; and (iv) notifying VaxGen of any interference, opposition,
re-examination request, nullity proceeding, appeal or other interparty action or
reissuance proceeding involving the Licensed Patent Rights. Genentech shall
determine in its sole discretion. but with consultation with VaxGen as provided
herein, whether or not to file, perfect, prosecute, maintain or take or not take
any other action with respect to any patent application or patent within the
Licensed Patent Rights generally or in a particular country or territory within
the Territory (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
Genentech desires to take (or not take) any such action but VaxGen is not
prepared to reimburse Genentech therefor as required hereunder, in such case
Genentech shall be free to take (or not take) such action at its sole cost and
expense and, on notice from Genentech to VaxGen, the rights licensed to VaxGen
under this Amended Agreement, with respect to such patent application or patent
shall return to Genentech and thereafter be excluded from the Licensed Patent
Rights; provided, however, that VaxGen shall be entitled to relicense such
rights later on terms to be agreed upon by the Parties. The foregoing shall not
preclude Genentech from licensing such rights to a third
55
party in the interim; provided, however, that Genentech shall notify VaxGen if
Genentech is interested in licensing such rights and VaxGen shall have a right
of first negotiation with respect to such rights for thirty (30) days from such
notice from Genentech. Furthermore, if Genentech in its sole discretion elects
not to file, perfect, prosecute, maintain or take any other action with respect
to any patent application or patent within the Licensed Patent Rights generally
or in a particular country or territory within the Territory (including, without
limitation, any interference, opposition, reexamination request, nullity
proceeding, appeal or other inter-party action or reissuance proceeding
involving the Licensed Patent Rights), VaxGen may elect to take such action at
its own expense. Genentech shall provide reasonable assistance to VaxGen and
execute such necessary documents as VaxGen may request in connection therewith,
at VaxGen's expense.
6.3 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) Genentech shall have the first 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. If Genentech determines in its sole discretion not to take any
steps within 180 days of discovering or being notified of the alleged
infringement, VaxGen shall have the right (but not the obligation) to do so. Any
suit, proceeding or other legal action taken under this Section 6.3 shall be at
the expense of and controlled by the Party bringing or undertaking it, who shall
be entitled to all proceeds of any damages or costs recovered in such suit,
proceeding or other legal action. The other Party may choose to be represented
in any such suit, proceeding or other legal action by counsel of its own choice,
at its own expense. If either Party lacks standing to bring any suit, proceeding
or other legal action hereunder or finds its necessary to join the other Party
in it, the other Party shall execute papers and perform such other actions as
may be reasonably required; provided, however, that neither Party shall be
required to transfer any right, title or interest in or to any property to the
other Party or any other party to confer standing on a Party hereunder. Both
Parties may elect to bring a suit, proceeding or other legal action hereunder,
and if so, before commencement thereof the Parties shall agree on equitable
apportionment of the costs and expenses and the damages to be recovered from it.
6.4 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 7.0 Confidentiality.
7.1 Confidentiality. In the course of performance of this Amended
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 Amended 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 Amended 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 Amended Agreement (including, without limitation,
under Section 7.2 below) or with the other Party's prior consent. The foregoing
notwithstanding, each Party may disclose Confidential Information of the other
Party during any official proceeding before a court or governmental agency, or
as a part of a patent application filed on inventions made under this Amended
Agreement, provided that the Party whose Confidential Information is included in
such application shall have the opportunity to review such proposed disclosure
at least 30 days prior to the date of such filing and does not object in writing
to such proposed disclosure. In the event of an objection the consultation
provisions of Section 7.2 below shall apply.
7.2 Publications. The Parties shall consult prior to the submission of any
manuscript for publication or other disclosure (e.g., abstract, poster,
presentation), to determine if the proposed disclosure contains any Confidential
Information of the other Party. In connection therewith, each Party shall
provide the other Party with a copy of the proposed disclosure at least 30 days
prior to the first disclosure thereof (such as submission of an abstract). In
the course of such consultation, the Party whose Confidential Information is
proposed to be disclosed shall have the right to incorporate appropriate changes
into the proposed disclosure and to delete any of its Confidential Information
which such Party does not agree to the publication or other disclosure thereof.
Article 8.0 Representations and Warranties.
8.1 Disclaimer. Except as expressly provided in this Amended 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.
8.2 Representations and Warranties. Each party represents and warrants to
the other Party that the representing and warranting Party, to its best
knowledge: is free to enter this Amended 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 Amended Agreement.
Article 9.0 Liability.
9.1 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 Amended Agreement or with respect
to their performance or lack thereof.
9.2 Indemnification by VaxGen. VaxGen shall indemnify, defend and hold
harmless Genentech 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
development, manufacture, administration, use or sale by VaxGen and its
sublicensees of any Licensed Product, Clinical Vaccine or Commercial Vaccine,
except to the extent that such cost, claim, suit, expense or damage arose or
resulted solely from: (i) any willful or grossly negligent act or omission by
Genentech or (ii) any defect in the manufacture of any Clinical Vaccine or
Commercial Vaccine by Genentech which was not discovered or reasonably
discoverable by VaxGen or its sublicensees. VaxGen's indemnification obligations
hereunder shall be conditioned upon Genentech: (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.
9.3 Indemnification by Genentech. Genentech 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 any defect in the manufacture of any Clinical Vaccine or Commercial Vaccine
that was not discovered or reasonably discoverable by VaxGen or its
sub-licensees, except to the extent that such cost, claim, suit, expense or
damage arose or resulted solely from any willful or grossly negligent act or
omission by VaxGen or its sublicensees. Genentech's indemnification obligations
hereunder shall be conditioned upon VaxGen: (i) giving reasonable notice to
Genentech
of any such claim or action; (ii) tendering the defense of such claim or action
to Genentech; (iii) reasonably assisting Genentech (at Genentech's expense) in
investigating, and defending such claim or action, and (iv) not compromising or
settling such claim or action without Genentech' s prior consent.
9.4 Insurance. Without limiting any indemnification obligations under this
Amended Agreement, VaxGen 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 VaxGen's
indemnification obligations under this Amended Agreement) in the amount of at
least $25,000,000 per occurrence and annual aggregate combined single limit for
bodily injury and property damage liability, with such insurance coverage to be
maintained with an insurance company or companies reasonably acceptable to
Genentech and with a deductible or maximum self-insured retention not to exceed
$500,000 per occurrence and annual aggregate. This insurance shall not contain
any exclusions or limitations in regard to liability relating to AIDS/HIV.
VaxGen shall obtain such insurance coverage no later than 90 days prior to the
commencement of the first human clinical trial testing any Clinical Vaccine
(including any First Generation Clinical Vaccine or any Vaccine Variants), and
thereafter shall maintain such insurance coverage without interruption during
the term of this Amended Agreement and for a period of at least 10 years after
the expiration or termination of this Amended Agreement. Such insurance shall
name Genentech as an additional insured, shall state that it is primary to any
valid and collectible insurance available to Genentech which also covers the
same loss for which VaxGen has liability pursuant to the Agreement (including,
without limitation, under Article 9.0 of the Agreement), shall contain a
cross-liability or severability of interest clause, and shall state that
Genentech will be provided with at least 30 days' advance written notice of any
termination; cancellation or material change in the insurance policy. VaxGen
shall provide Genentech with evidence of such insurance coverage as required
under this Amended Agreement by no later than the deadline specified above for
obtaining such insurance coverage, and thereafter shall continue to provide
Genentech 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 Amended Agreement and for a period of at least 10 years after the
expiration or termination of this Amended Agreement. VaxGen may satisfy its
obligation to provide evidence of such required insurance coverage by providing
Genentech with complete copies of the insurance policies themselves or
certificates from its insurance company or companies evidencing the coverage
required hereunder. To assist VaxGen in complying with the provisions of this
Section 9.4, VaxGen may consult as reasonably requested with Genentech's risk
manager and insurance brokers.
Article 10.0 Term and Termination.
10.1 Term. This Amended Agreement shall commence on the Effective Date
and, unless earlier terminated in accordance herewith, shall expire on a
country-by-country and Licensed Product-by-Licensed Product basis 15 years from
the date of Commercial Introduction of such Licensed Product in such country.
Upon the expiration
of the term of this Amended Agreement in a given country VaxGen shall have a
perpetual, fully paid-up, non-exclusive license under the Licensed Patent Rights
and Licensed Knowhow to make, have made, use and sell Licensed Products in the
Field in such country, and if Genentech has timely exercised its option under
Section 3.4 above, Genentech shall have a perpetual, fully paid-up,
non-exclusive license under all improvements to the Licensed Patent Rights or
Licensed Knowhow that are solely or jointly owned by VaxGen (under Section 6.1
above), to make, have made, use and sell Licensed Products in the Option
Territory.
10.2 Termination for Default. Failure by either Party to comply with any
of its material obligations set forth in this Amended 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 Amended Agreement or available to it at law or in equity, to
terminate this Amended Agreement effective upon a notice of termination to the
defaulting Party.
10.3 Termination for Insolvency or Bankruptcy. Either Party may, in
addition to any other remedies available to it by law or in equity, terminate
this Amended Agreement, in whole or in part as the terminating Party may
determine, by notice to the other Party in the event the other Party shall have
become insolvent or bankrupt, or shall have made an assignment for the benefit
of its creditors, or there shall have been appointed a trustee or receiver of
the other Party or for all or a substantial part of its property, or there shall
have been issued a warrant of attachment, execution, distraint or similar
process against any substantial part of the property of the other Party, or any
case or proceeding shall have been commenced or other action taken by or against
the other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any jurisdiction now or hereafter in effect, provided that
in any such case such event shall have continued for 60 days undismissed,
unbonded and undischarged. Furthermore, all rights and licenses granted under to
this Amended Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365 (n) of the Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101 (56) of the United States Bankruptcy
Code. 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.
10.4 Unilateral Termination. VaxGen shall have the right to terminate this
Amended Agreement, in its sole discretion, on six months' prior notice to
Genentech. If VaxGen terminates this Amended Agreement pursuant to this Section
10.4, VaxGen agrees that for the following five (5) years, it will not develop,
manufacture, use, sell or
acquire from any third party (whether by license or otherwise) any Licensed
Product in the Field of Use in the Territory.
10.5 Effect of Termination.
(a) Expiration or termination of this Amended 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 Amended Agreement; such rights and obligations
include, without limitation, those under Sections 5.2, 5.3, 5.4, 10.4, 10.5,
11.1 and 11.5, and under Articles 6, 7, 8 and 9, of this Amended Agreement.
Notwithstanding anything to the contrary, and except as set forth below, upon
termination by either Party under Section 10.2 or 10.4, all licenses granted to
the defaulting Party shall terminate.
(b) No termination of this Amended Agreement , shall be construed as
termination of any sublicenses granted by VaxGen under Section 2.2 above or
sublicensees granted by Genentech under Section 3.4 above, in which case each
such sublicensee shall be thereafter a direct sublicensee of Genentech (or a
direct sublicensee of VaxGen, in the case of Genentech sublicensees), but only
if each such sublicensee is then in full compliance with all terms and
conditions of its sublicense, all payments owed under such sublicense to
Genentech (or VaxGen, in the case of Genentech, sublicensees) have been paid,
and the sublicensee agrees at least 10 days prior to the effective termination
of the main license to assume all obligations of VaxGen (or all obligations of
Genentech, in the case of Genentech sublicensees) under this Amended Agreement.
Termination of this Amended Agreement by Genentech under Section 10.4(a) shall
automatically terminate all sublicenses of VaxGen hereunder.
(c) On any termination of this Amended Agreement: (i) VaxGen promptly
shall return to Genentech all tangible Licensed Patent Rights, Licensed Knowhow
and other property owned by Genentech (whether solely or jointly with VaxGen)
under Section 6.1 above that are in VaxGen'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) VaxGen promptly shall take all appropriate and necessary actions, including
with the FDA and other involved regulatory agencies, to effect the assignment or
transfer to Genentech (or to no longer permit further reference to by VaxGen) of
all Genentech Regulatory filings, as directed by Genentech. All such activities
shall be conducted in a prompt and orderly fashion such that the value of what
is being transferred is preserved, and shall be at VaxGen's expense if this
Amended Agreement is terminated by Genentech or terminated by VaxGen under
Section 10.4, and otherwise at Genentech's expense. In addition, on any
termination of this Amended Agreement by Genentech, or any termination of this
Amended Agreement by VaxGen under Section 10.4 above, Genentech automatically
shall be granted a non-exclusive, royalty-free license in the Territory to all
improvements to Licensed Patent Rights or Licensed Knowhow that are solely or
jointly owned by
VaxGen (under Section 6.1 above), and VaxGen at its own expense promptly shall
transfer to Genentech all such improvements that are in VaxGen's possession or
control.
10.6 Original Agreement. Effective upon the Effective Date this Amended
Agreement shall replace the Original Agreement which shall thereupon be deemed
to have been terminated by mutual agreement of the Parties effective as of the
Effective Date.
Article 11.0 General Provisions.
11.1 Notices. Any notice, request, delivery, demand, report, accounting,
approval or consent required or permitted to be given under this Amended
Agreement shall be in writing and shall be deemed sufficiently given on the same
day as delivery if delivered in person or transmitted by telecopier (with
confirmed answer-back) in any case by 5:00 p.m. local time, on the next business
day if sent by overnight courier service, and in three business days if sent by
registered or certified mail, in any case addressed to the Party to whom it is
directed at its address shown below or such other address as such Party shall
have last given by notice to the other Party in accordance with this Section:
If to VaxGen, addressed to: VaxGen, Inc.
1000 Marina Boulevard
Brisbane, CA 94005-1841
Attn: Chief Executive Officer
Telecopy: (650) 624-1019
If to Genentech, addressed to: Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
Attn: Corporate Secretary
Telecopy: (650) 952-9881
with a copy to:
Vice President of Business Development
Telecopy: (650) 225-3009
11.2 Governing Law. This Amended Agreement shall be governed by and
construed in accordance with the laws of the State of California (other than its
choice of law principles).
11.3 Entire Agreement. Except for the Credit Agreement, the Services
Agreement, the Supply Agreement and the Stock Agreements, this Amended Agreement
is the entire agreement and understanding between the Parties, and supercedes
and cancels any and all prior negotiations, correspondence, understandings and
agreements, whether written or oral, between the Parties respecting the subject
matter hereof, including, without limitation, the Original Agreement and that
certain Letter of Intent between the Parties dated as of November 17, 1995. No
amendment or other modification
of this Amended Agreement shall be binding on either Party unless reduced to
writing and signed by an authorized officer of each Party.
11.4 Binding Effect and Assignment. This Amended 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
Amended Agreement shall not be assignable by VaxGen in whole or in part without
Genentech's prior consent in its sole discretion. This Amended Agreement shall
not be assignable by Genentech in whole or in part without VaxGen's consent in
its sole discretion, except that Genentech may assign this Amended Agreement in
whole or in part without VaxGen's consent in connection with any consolidation,
merger, redemption, put or sale of stock, or conveyance of substantially all of
Genentech's assets, or change-of-control transaction that involves Genentech,
Genentech's parent company F. Hoffmann La-Roche Ltd., a Swiss corporation, or
their affiliates.
11.5 Dispute Resolution. Except as otherwise expressly provided in this
Amended Agreement (including Sections 3.3 or 3.4 above), in the event of any
dispute, controversy or claim arising out of or relating to this Amended
Agreement, the Parties shall try to settle it amicably between themselves
including first referring such dispute, controversy or claim to a member of
Genentech's Executive Committee and VaxGen's Board of Directors for resolution.
If the Parties are unable to so settle such dispute, controversy or claim within
60 days after such referral, then either Party may, by notice to the other, have
it referred to their respective chief executive officers or their designees for
attempted resolution by good faith negotiations within 30 days after such
notice. In the event the chief executive officers or their designees are not
able to resolve it, either Party may at any time after the 30-day period invoke
the arbitration provisions of this Section 11.5.
All arbitration proceedings shall be conducted in San Francisco,
California, under the procedural rules of the American Arbitration Association.
The Party requesting arbitration shall serve upon the other Party a demand for
arbitration stating the substance of the controversy, dispute or claim, and the
contention of the Party requesting arbitration. Within 60 days after the demand,
the Parties shall each select one arbitrator, which arbitrators shall together
select a third arbitrator. The three arbitrators are to act as neutral
arbitrators and shall have no past, present or anticipated future affiliation
with the Parties which would unduly influence the independence of an arbitrator.
The decision of the arbitrators shall be in writing setting forth the basis
therefor.
Prior to the commencement of the arbitration proceeding, each Party
shall submit to the arbitrators its "best offer" to resolve the dispute,
controversy, or claim. The arbitrators shall consider the "best offer" of each
Party, communicate to the Parties their respective "best offers" and after the
arbitration proceeding select the "best offer" of the Party which prevailed over
the other Party based on the arbitration proceeding. 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.
11.6 Waiver. The waiver by either Party of any breach of or default under
any of the provisions of this Amended Agreement or the failure of either Party
to enforce any of the provisions of this Amended 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.
11.7 Severability. If any part of this Amended Agreement shall be held
invalid, illegal or unenforceable by any court of authority having jurisdiction
over this Amended 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 Amended Agreement shall be divisible and deleted in such
jurisdiction, but elsewhere shall not be affected.
11.8 Publicity. VaxGen and Genentech shall consult and obtain mutual
consent before making any public announcement concerning this Amended Agreement,
the subject matter hereof or use of the other Party's name, except for
information that is already in the public domain or where the nature of such
information has been previously approved for disclosure (in which case this
Section 11 .8 will no longer apply to that previously approved information).
11.9 Counterparts. This Amended 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.
11.10 No Other Rights. No rights or licenses, express or implied, are
granted to VaxGen by this Amended Agreement to use in any manner any trade name
or trademark of Genentech, or any other intellectual property not expressly
covered by this Amended Agreement.
11.11 Force Majeure. Neither Party shall be liable to the other for loss
or damages or shall have any right to terminate this Amended Agreement (except
as otherwise provided in this Amended Agreement) for any default or delay of the
other Party in its performance under this Amended 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 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.
11.12 Headings. Headings are for the convenience of reference only and
shall not control the construction or interpretation of any of the provisions of
this Amended Agreement.
11.13 No Partnership. Nothing in this Amended 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 Amended Agreement to be
duly executed by its duly authorized representative as of the date set forth
above.
GENENTECH, INC. VAXGEN, INC.
By: By:
------------------------------ -----------------------------
Name: Name:
------------------------------ -----------------------------
Title: Title:
------------------------------ -----------------------------
Exhibit A
Licensed Patent Rights
[Enlarge/Download Table]
===================================================================================================
Subject Country Status Appln. No. Appln. Dt. Pat. No. Date Granted
===================================================================================================
Vaccine Australia Granted 51705/85 DEC 23 1985 600658 DEC 11 1990
---------------------------------------------------------------------------------------------------
Vaccine Canada Pending 498600 DEC 24 1985
---------------------------------------------------------------------------------------------------
Vaccine European Pending 85309454.8 DEC 23 1985
---------------------------------------------------------------------------------------------------
Vaccine Malaysia Granted PI8701924 SEP 24 1987 MY102030A FEB 29 1992
---------------------------------------------------------------------------------------------------
Vaccine Canada Granted 559508 FEB 22 1988 1330038 JUN 07 1994
---------------------------------------------------------------------------------------------------
Vaccine European Pending 88301425 FEB 19 1988
---------------------------------------------------------------------------------------------------
Vaccine Japan Pending 38459/88 FEB 20 1988
---------------------------------------------------------------------------------------------------
United
Vaccine States Pending 08/405616 MAR 15 1995
---------------------------------------------------------------------------------------------------
Vaccine Australia Granted 75847/91 APR 01 1991 647108 JUN 30 1994
---------------------------------------------------------------------------------------------------
Vaccine Austria Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Belgium Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Canada Pending 2078546-2 APR 01 1991
---------------------------------------------------------------------------------------------------
Vaccine Denmark Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine European Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine France Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Germany Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Great
Vaccine Britain Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Greece Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Italy Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Japan Pending 506683/91 APR 01 1991
---------------------------------------------------------------------------------------------------
Vaccine Luxembourg Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Netherlands Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine New Zealand Pending 237666 APR 03 1991
---------------------------------------------------------------------------------------------------
Vaccine Spain Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Vaccine Sweden Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
Switzerland
Vaccine (& LI) Granted 91907077.1 APR 01 1991 527760 JUL 19 1995
---------------------------------------------------------------------------------------------------
United
Vaccine States Pending 08/226162 APR 11 1994
---------------------------------------------------------------------------------------------------
PCT/US94/
Adjuvant PCT Pending 11753 OCT 13 1994
---------------------------------------------------------------------------------------------------
[Enlarge/Download Table]
===================================================================================================
Subject Country Status Appln. No. Appln. Dt. Pat. No. Date Granted
===================================================================================================
United
Adjuvant States Pending 08/365986 DEC 28 1994
---------------------------------------------------------------------------------------------------
United
Adjuvant States Pending 08/447291 MAY 22 1995
---------------------------------------------------------------------------------------------------
Vaccine Australia Pending 7047894 JUN 07 1994
---------------------------------------------------------------------------------------------------
Vaccine European Pending 94919281.9 JUN 07 1994
---------------------------------------------------------------------------------------------------
Vaccine New Zealand Pending 267838 JUN 07 1994
---------------------------------------------------------------------------------------------------
United
Vaccine States Pending 08/448603 JUN 07 1995
---------------------------------------------------------------------------------------------------
Adjuvant PCT Pending PCT/US94/11674 OCT 13 1994
---------------------------------------------------------------------------------------------------
United
Adjuvant States Pending 08/460363 JUN 01 1995
---------------------------------------------------------------------------------------------------
Adjuvant Argentina Pending 329860 OCT 21 1994
---------------------------------------------------------------------------------------------------
Adjuvant Chile Pending 1544-94 OCT 21 1994
---------------------------------------------------------------------------------------------------
Adjuvant Mexico Pending 948028 OCT 17 1994
---------------------------------------------------------------------------------------------------
Adjuvant PCT Pending PCT/US94/11678 OCT 13 1994
---------------------------------------------------------------------------------------------------
United
Adjuvant States Pending 08/143313 OCT 25 1993
---------------------------------------------------------------------------------------------------
Adjuvant Uruguay Pending 23846 OCT 21 1994
---------------------------------------------------------------------------------------------------
Adjuvant Venezuela Pending 1650-94 OCT 27 1994
---------------------------------------------------------------------------------------------------
United
Process States Pending 08/650364 MAY 20 1996
---------------------------------------------------------------------------------------------------
United GNE Docket
Vaccine States Pending P1008 JUL 8 1996
---------------------------------------------------------------------------------------------------
*Pending in 17 European countries.
Third Party Agreements
License and Supply Agreement, dated as of June 28, 1992, between Genentech
and Cambridge Biotech Corporation.
Sublicense Agreement, dated as of September 30, 1991, between Genentech
and Cambridge Biotech Corporation.
Letter agreement, dated November 28, 1995, between Genentech and Univax
Biologics.
Dates Referenced Herein
| Referenced-On Page |
|---|
| This ‘8-K’ Filing | | Date | | First | | Last | | | Other Filings |
|---|
| |  |
| | 5/1/06 | | 9 | | | | | None on these Dates |
| | 5/1/04 | | 9 |
| Filed on: | | 7/15/02 |
| For Period End: | | 7/2/02 |
| | 5/1/02 | | 1 |
| | 5/1/96 | | 1 |
| | 3/15/96 | | 7 |
| | 12/19/95 | | 3 |
| | 11/28/95 | | 31 |
| | 11/17/95 | | 26 |
| | 6/28/92 | | 1 | | 31 |
| List all Filings |
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