EXHIBIT 10.58
ASSIGNMENT
AGREEMENT
This ASSIGNMENT AGREEMENT is
made and entered into on December 19, 2005 (the “Effective
Date”) by and between Avigen, Inc., a Delaware corporation
having its principal place of business at 1301 Harbor Bay
Parkway, Alameda, California 94502 (“Avigen”), and
Genzyme Corporation, a Massachusetts corporation having its
principal place of business at 500 Kendall Street, Cambridge,
Massachusetts 02142 (“Genzyme”) (hereinafter, each of
Avigen and Genzyme a “Party” and, collectively, the
“Parties”).
W I T N E S S E T
H:
WHEREAS , Avigen has developed, licensed and/or controls
certain intellectual property relating to gene therapy, including
without limitation products based on adeno-associated virus vector
(“AAV”, as more particularly defined below) that may be
used for the treatment of inherited diseases, and methods of making
and using such products;
WHEREAS , Avigen has in the past conducted or has
ongoing several research and development programs regarding certain
such products (including one for Parkinson’s disease that is
currently the subject of an ongoing phase I/II clinical trial,
one for a Factor IX product to treat hemophilia B that has
previously been in two phase I/II clinical trials, one for a
Factor VIII product to treat hemophilia A that has been studied
preclinically, and other earlier-stage research programs), and has
developed or obtained certain clinical data, know-how and
regulatory filings regarding such products;
WHEREAS , Genzyme is a leading biotechnology company
with expertise in developing and commercializing biopharmaceutical
products; and
WHEREAS , Genzyme wishes to acquire Avigen’s gene
therapy intellectual property and current gene therapy research and
development programs (other than its IL-10 Patent Rights and IL-10
Product, each as defined herein), all for the purpose of pursuing
the further pre-clinical and clinical development and
commercialization of these and other potential therapeutic gene
therapy products;
NOW THEREFORE
, in consideration of the above
stated premises and of the mutual covenants and agreements set
forth below, and intending to be legally bound by the provisions of
this Agreement, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the
following initially capitalized terms shall have the meanings
indicated (with derivative forms being interpreted
accordingly):
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.1 “AAV”
shall mean any adeno-associated virus vector, including without
limitation all [*] .
1.2 “
Affiliate ” shall mean any business entity which
directly or indirectly controls, is controlled by, or is under
common control with either Party to this Agreement. A business
entity shall be deemed to “control” another business
entity if (i) it owns, directly or indirectly, at least fifty
percent (50%) of the issued and outstanding voting securities,
capital stock, or other comparable equity or ownership interest of
such business entity, or (ii) it otherwise has the right or
de facto ability to control or direct the management of such
business entity (through voting agreement or otherwise). If the
laws of the jurisdiction in which such entity operates prohibit
ownership by a Party of fifty percent (50%) or more,
“control” shall be deemed to exist at the maximum level
of ownership allowed by such jurisdiction.
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1.3
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“ Agreement ” shall mean this
Assignment Agreement.
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1.4 “
Ancillary Agreements ” shall mean those agreements and
instruments the Parties are required to execute pursuant to
Section 2.4.
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1.5
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“ Assumed Liabilities ” shall
have the meaning set forth in Section 2.2.
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1.6 “
Avigen Indemnitee ” shall mean Avigen, its Affiliates,
successors and assigns, and each of their respective directors,
officers, employees, and agents.
1.7 “
Avigen Related Know-How ” shall mean all Know-How that
is as of the Effective Date owned or controlled by or licensed to
(with the right to grant sublicenses of the scope and content set
forth herein) Avigen that is not Gene Therapy Listed Know-How but
[*] including without limitation data relating to
[*].
1.8 “
Avigen Trademark ” shall mean all trademarks owned or
controlled by Avigen related to the Products as of the Effective
Date, including without limitation the trademark
“COAGULIN-B” for the use of which in connection with
the Product Avigen has filed and owns an intent to use application.
The Avigen Trademark excludes all Avigen housemarks (i.e., the name
“Avigen” and other names and marks associated with
Avigen as a company).
1.9 “
BLA ” means a Biologics License Application to be
filed with the FDA (or any successor or other filing with the FDA
or such successor serving an equivalent purpose) and/or any other
application required to be filed with an appropriate Regulatory
Agency in a country or group of countries other than the United
States (including, without limitation, a Product License
Application or Marketing Authorization in the European Union) in
order to manufacture, market, sell or use the Product in such
country or group of countries.
1.10 “
Business Day ” means Monday, Tuesday, Wednesday,
Thursday or Friday of any week, other than such a day on which a
United States federal government holiday falls or on which banks in
either California or Massachusetts are closed.
1.11 “
Claim ” shall mean a claim of [*] which has not
been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of
competent
2.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise.
1.12 “
Commercial Launch ” shall mean, with respect to a
country where Regulatory Approval has been obtained and, if
applicable, Pricing Approval has been obtained, for a Product, the
first sale of such Product in such country for consideration from a
Third Party that occurs after such Regulatory Approval has been
obtained and, if applicable, Pricing Approval has been obtained,
for such Product in such country. To avoid any doubt, Pricing
Approval is not applicable with respect to the United States as of
the Effective Date.
1.13 “
Commercially Reasonable and Diligent Efforts ” shall
mean the level of effort which, consistent with [*] would be
applied by a company in the biotechnology industry for a product
owned by it or to which it has rights which [*] taking into
account issues of safety and efficacy, product profile, the
competitiveness of the marketplace, the proprietary position of the
product, the regulatory structure involved, the cost of scaling up
a manufacturing process (including facility costs), the
profitability of the applicable products, and other relevant
factors.
1.14 “
Confidential Information ” shall mean, with respect to
a Party, all confidential and all proprietary information and
Know-How it discloses to the other Party in connection with this
Agreement, including but not limited to, the terms of this
Agreement. All proprietary information and Know-How that is
included in the Gene Therapy Assets assigned from Avigen to Genzyme
hereunder shall be deemed Genzyme’s Confidential Information,
in accordance with Section 7.1 hereof.
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1.15
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“ Consent ” shall have the
meaning given in Section 2.7.
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1.16 “
Cover ” shall mean, with respect to a particular
product and a particular patent, that such patent claims or covers,
[*] or any of [*] or an [*] in the [*]
of [*] (for example (but without limitation) with respect to
[*] ; and as another example (without limitation) with
respect to [*] ).
1.17 “
Current Factor IX Product ” shall mean that certain
Factor IX Product delivered by Gene Therapy that was the subject of
clinical trials under and is described in IND # 9398 and IND #
8033.
1.18 “
Current Parkinson’s Product ” shall mean that
certain Product that contains the AADC gene and that is the subject
of the Ongoing Parkinson’s Trial as of the Effective Date and
is described in IND # 11366.
1.19 “
Current Regulatory Filings ” shall mean the INDs and
other Regulatory Filings set forth in Schedule 1.19
hereto.
1.20 “
Damages ” shall mean damages, losses, liabilities,
costs and expenses, including (without limitation) reasonable
attorneys’ fees and expenses.
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1.21
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“ Dollar ” shall mean the
United States dollar.
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3.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.22 “
Effective Date ” shall have the meaning set forth in
the first paragraph of this Agreement.
1.23 “
EMEA ” shall mean the European Medicines Agency or any
successor agency thereto with responsibilities similar to those of
the European Medicines Agency.
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1.24
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“ Excluded Assets ” shall
have the meaning given in Section 2.3.
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1.25
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“ Excluded Liabilities ”
shall have the meaning given in Section 2.3.
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1.26 “
Facility ” shall mean Avigen’s facility located
at 1201 Harbor Bay Parkway in Alameda, California.
1.27 “
Factor IX Product ” shall mean a Product that is (a)
the Current Factor IX Product or (b) any Product containing a
Factor IX gene or a derivative of such a gene and which is
delivered by Gene Therapy.
1.28 “
Factor VIII Product ” shall mean any Product
containing a Factor VIII gene or a derivative of such a gene and
which is delivered by Gene Therapy.
1.29 “
FDA ” shall mean the United States Food and Drug
Administration or any successor agency thereto with
responsibilities similar to those of the United States Food and
Drug Administration.
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1.30
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“ FDA Decision ” shall have
the meaning given in Section 4.4(b)(ii).
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1.31
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“ Force Majeure ” shall have
the meaning set forth in Section 11.11.
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1.32
“GAAP” shall mean the then-current United States
generally accepted accounting principles, consistently
applied.
1.33
“Gene Therapy” shall mean the treatment or
prevention of a disease, or remedying of a gene deficiency, of
humans or animals, by genetic modification of
[*].
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1.34
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“ Gene Therapy Assets ” shall
have the meaning given in Section 2.1.
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1.35 “
Gene Therapy Know-How ” shall mean Gene Therapy Listed
Know-How, the Avigen Related Know-How and all other Know-How to
which Avigen derives rights through any Upstream License and/or
Selected Other Gene Therapy Contract.
1.36 “
Gene Therapy Patents ” shall mean the Gene Therapy
Listed Patents, the Gene Therapy Upstream License Patents, and the
Gene Therapy Other Contract Patents.
1.37 “
Gene Therapy Listed Know-How ” shall mean Know-How
that is listed on Schedule 1.37 and that (i) is owned by
Avigen and (ii) relates to, arises from or is useful for any
Product and/or its manufacture or pharmaceutical utility, including
without limitation data relating to formulation, analytical
methods, pre-clinical and clinical trials, pharmacology,
toxicology, regulatory information, and data relating to the
manufacture and use of such
4.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Products, but excluding any
Know-How that is commonly available from another source (other than
Avigen and its Affiliates) or is necessary for the research,
development, manufacture or sale of IL-10 Products.
1.38 “
Gene Therapy Listed Patents ” shall mean [*]
those patent applications listed on Schedule 1.38; all
divisionals, continuations, continuations-in-part and substitutions
thereof; all patents issuing on any of the foregoing; those patents
listed on Schedule 1.38; all re-examinations, re-issues,
extensions and renewals of any of the foregoing patents; [*]
all counterparts in other countries to any of the foregoing; and
[*].
1.39 “
Gene Therapy Other Contract Patents ” shall mean all
patent applications and patents to which Avigen derives rights
through any Selected Other Gene Therapy Contract (including without
limitation the following types of patent applications and patents,
to the full extent of Avigen’s rights under the Selected
Other Gene Therapy Contracts: all divisionals, continuations,
continuations-in-part and substitutions, re-examinations,
re-issues, extensions and renewals and foreign counterparts
thereof). To avoid any doubt, this includes (without limitation)
patent applications and patents to which Avigen derives rights
through any contract that becomes a Selected Other Gene Therapy
Contract through Section 8.5.
1.40 “Gene
Therapy Upstream License Patents” shall mean all patent
applications and patents to which Avigen derives rights through any
Upstream License (including without limitation the following types
of patent applications and patents, to the full extent of
Avigen’s rights under the Upstream Licenses: all divisionals,
continuations, continuations-in-part and substitutions,
re-examinations, re-issues, extensions and renewals and foreign
counterparts thereof).
1.41 “
Genzyme Indemnitee ” shall mean Genzyme, its
Affiliates, successors, assigns and Licensees, and each of their
respective directors, officers, employees, and agents.
1.42
“Genzyme Retained Product” shall mean any
Product that [*] with respect to a [*] together with
all [*] as that of [*] or a [*] or [*]
with respect to which [*] together with all [*] or a
[*] such gene. For purposes of this Section 1.42,
[*] shall mean [*] to be [*] for such
[*] that [*] the [*] with respect to all
[*] Genzyme. [*] this is the [*] of the
[*] The Parkinson’s Product and the Factor IX Product
shall [*] on the [*] of [*] of [*] as
of the Effective Date ( [*] ). If Genzyme [*] then
the Parkinson’s Product shall not [*]
Product.
1.43 “
HSR Act ” shall mean the Hart-Scott-Rodino Antitrust
Improvements Act of 1976, as amended (15 U.S.C. 18a), and the rules
and regulations promulgated thereunder.
1.44 “
IL-10 ” shall mean interleukin 10 and all other
anti-inflammatory cytokines disclosed in the IL-10 Patent Rights
[*]
1.45 “
IL-10 Patent Rights ” shall mean the patents and
patent applications identified in Schedule 2.3
hereto.
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1.46
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“ IL-10 Product ” shall mean
any product [*] .
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5.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.47 “
IND ” shall mean an investigational new drug
application filed with the FDA and/or any other similar application
filed with an appropriate Regulatory Agency in a country or group
of countries other than the United States.
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1.48
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“ Indemnify ” shall have the
meaning given in Section 6.1.
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1.49
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“ IRB ” shall mean an
Institutional Review Board.
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1.50 “
Know-How ” shall mean all technical information, data
(including, without limitation, regulatory data), patentable and
unpatentable inventions, developments, discoveries, methods and
processes that are, in each case, not disclosed in a published
patent application or patent or otherwise publicly
available.
1.51 “
Legal Requirements ” means any applicable present and
future national, state, local, foreign or similar laws (whether
under statute, rule, regulation or otherwise); applicable
requirements under permits, orders, decrees, judgments or
directives, and requirements of applicable Regulatory Agencies
(including, without limitation, current Good Manufacturing
Practices as specified in 21 CFR Parts 210 and 211, and 21 CFR Part
312); and applicable regulations pertaining to Investigational New
Drug Applications (as amended or revised from time to time). To
avoid any doubt, Legal Requirements do not include contractual
obligations to non-governmental Persons.
1.52 “
Licensee ” shall mean any Third Party to which Genzyme
or its Affiliate grants on or after the Effective Date under any
Gene Therapy Patent or Gene Therapy Know-How a license, sublicense,
option, covenant not to sue, non-suit, assignment (other than an
assignment together with this Agreement as a whole pursuant to
Section 11.13), right to use or reference or other right to
practice free from claims of infringement or misappropriation of
any Gene Therapy Patent or Gene Therapy Know-How (each of the
foregoing, a “License”). [*] To avoid any doubt,
if the rights Genzyme obtains to the Gene Therapy Patents and Gene
Therapy Know-How pursuant to this Agreement [*] that Third
Party shall be deemed to be Licensee; provided, however ,
that [*] Licensee also means any Genzyme Affiliate described
in the last paragraph of Section 3.4. References in this Agreement
to any given Licensee shall be deemed to include such
Person’s affiliates (with such term having a perfectly
analogous meaning with respect to such Person as the definition of
“Affiliate” set forth in this Agreement has with
respect to each Party) if and to the extent such affiliates are
also covered by the license granted by Genzyme or its Affiliate to
such Licensee.
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1.53
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“ Licensing Revenue ” shall
have the meaning given in Section 3.4.
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1.54
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“ Licensing Transaction ”
shall have the meaning given in Section 3.4.
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1.55 “
Lysosomal Storage Disorder Product ” shall mean any
Product that is intended to be developed or is developed to treat
any lysosomal storage disorder to be delivered by Gene
Therapy.
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1.56
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“ Major Market Country ”
shall mean any of the following: [*] and [*]
.
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6.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.57 “
Net Sales ” with respect to any Product shall mean the
invoiced sales prices of all such Product to Third Parties by
Genzyme, its Affiliates or its Licensees, less the following items
[*] customary under industry practices and are actually
allowed and taken in accordance with standard allocation
procedures, allowance methodologies and accounting methods
consistently applied, which methods are in accordance with GAAP:
(a) credits or allowances granted upon returns, rejections or
recalls, retroactive price reductions, billing corrections or
allowances for bad debt; (b) freight, shipping and insurance
costs; (c) quantity and other trade discounts, credits or
allowances; (d) customs duties, taxes and surcharges and other
governmental charges imposed on the production, sale,
transportation, delivery, use, exportation or importation of
Products; (e) government mandated rebates and discounts;
(f) Third Party rebates and charge backs, hospital buying
group/group purchasing organization administration fees or managed
care organization rebates; and (g) distribution fees and sales
commissions paid to Third Parties. The transfer of any Product by
Genzyme or one of its Affiliates or Licensees to another Affiliate
of Genzyme or to Genzyme or a Licensee shall not be considered a
sale; in such cases, Net Sales shall be determined based on the
invoiced sales price by Genzyme, the Affiliate or Licensee, as the
case may be, to its Third Party customer, less the deductions
allowed under this Section. “Net Sales” excludes
transfers of Product for the purposes described in
Section 3.5.
If Genzyme or any of its Affiliates
or Licensees [*] or sells a [*] or [*] for
[*] where [*] and such Product is Commercially
Launched anywhere in the world, then the [*] shall equal
[*] the [*] of the [*] Product sold, as
determined in accordance with Section 3.16. Similarly, if
Genzyme or any of its Affiliates or Licensees chooses to sell any
Product in combination with another product of Genzyme or a Genzyme
Affiliate, [*] (i.e. [*] or [*] in part on the
[*] ), then Net Sales will be based on the [*]
Product as determined in accordance with [*] For the
avoidance of doubt, the Parties acknowledge and agree that
[*] not be [*] or any other [*] under this
Agreement [*] sold in combination with such Product
[*] and the determination in [*] with respect to such
Products is intended to [*] based on the [*] not the
[*] with [*] or not [*].
Any determination of [*]
pursuant to [*] shall apply only to determine Net Sales for
purposes of payments to Avigen hereunder. It shall not be deemed to
give Avigen input or control over the price set by Genzyme, its
Affiliate or Licensee for Products or any other product. Genzyme
shall be bound by such determination of [*] for purposes of
making payments to Avigen hereunder only, and not for purposes of
determining the price at which Products or other products are sold
to customers.
1.58 “
Notice ” shall
have the meaning set forth in Section 11.6 of this
Agreement.
1.59 “
Ongoing Parkinson’s Trial ” shall mean that
certain Phase I/II Trial (IND # 11366) that Avigen is
conducting as of the Effective Date entitled “A Phase 1
Open-label Safety Study of Intrastriatal Infusion of
Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid
Decarboxylase (AAV-hAADC-2) in Subjects with Advanced
Parkinson’s Disease {AAV-hAADC-2-003}” and identified
as AAV-hAADC-2-003.
1.60 “
Other Gene Therapy Contracts ” shall mean the
contracts, purchase orders and other commitments listed on
Schedule 1.60.
7.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.61 “
Parkinson’s Product ” shall mean a Product that
is (a) the Current Parkinson’s Product or (b) any
other Product that contains the same gene to be delivered by Gene
Therapy as that of the Current Parkinson’s Product, or a
derivative of such gene.
1.62
“Patent Rights” shall mean any patents and/or
patent applications including (without limitation) all of the
following types: all divisionals, continuations,
continuations-in-part, substitutions, re-examinations, reissues,
extensions and renewals, and all counterparts in other countries to
any of the foregoing).
1.63 “
Person ” shall mean any individual, partnership,
corporation, limited liability company, unincorporated organization
or association, any trust or any other legal entity.
1.64 “
Phase I Clinical Trial ” shall mean a
clinical trial in humans that is in the portion of a clinical
development program that involves controlled trials of the Product
in a pilot study on a group of patients for the primary purposes of
evaluating safety, dose escalation and pharmacokinetic studies, as
more specifically defined in 21 C.F.R. §312.21(a).
1.65 “
Phase II Clinical Trial ” shall mean a
clinical trial in humans that is designed to establish the safety
and biological activity of the product for its intended use, and to
define the dosage range to be tested in further clinical trials, as
more specifically defined in 21 C.F.R. §312.21(b).
1.66 “
Phase III Clinical Trial ” shall mean a
clinical trial in humans that is designed to serve the same purpose
as a Phase II Clinical Trial, and in addition is designed to
obtain data to support a filing to request Regulatory Approval for
the Product, as more specifically defined in 21 C.F.R.
§312.21(c).
1.67 “
Pivotal Trial ” shall mean any human clinical trial
the results of which are used, or that is designed so that the
results of it may be used, in a filing to request Regulatory
Approval for the product candidate being studied (without the need
for additional later trials in a phase of development prior to
Regulatory Approval of that product candidate to treat that
indication). Pivotal Trials for purposes of the milestones set
forth in Schedule 3.2 includes any trial designed or intended
to serve the foregoing purpose, regardless of whether it is or is
denominated to be a Phase II Clinical Trial, Phase II/III
Clinical Trial or Phase III Clinical Trial, or is otherwise
denominated.
1.68 “
Price Approval ” shall mean, with respect to any
country in which the price at which Genzyme or its Affiliate or
Licensee sells Product must be approved by a governmental or
regulatory authority for reimbursement or payment purposes, the
receipt of approval by the applicable authority with respect to
such price.
1.69 “
Product ” shall mean any product [*] Covered by
at least one (1) Claim of the Gene Therapy Patents [*] All
such pharmaceutical products that are based on or incorporate a
particular gene sequence (or sequences) shall be deemed to be a
single Product. The Products include (without limitation) the
Parkinson’s Product, the Factor IX Product, the Factor VIII
Product and Lysosomal Storage Disorder Products. The Products
specifically exclude all IL-10 Products. To avoid any confusion,
[*] for purposes of this definition [*] is determined
as if [*] in [*] regardless of the
[*]
8.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
1.70 “
RAC ” shall have
the meaning given in Section 4.4(a)(iii).
1.71 “
Regulatory Agency ” means, with respect to the United
States, the FDA, and, in the case of a country other than the
United States, such other appropriate regulatory agency with
similar responsibilities, including, without limitation, the
EMEA.
1.72 “
Regulatory Approval ” shall mean, with respect to a
particular country and Product, the receipt of all regulatory
approvals (including, without limitation, through mutual
recognition of Regulatory Approval by another country), other than
any Price Approval, necessary for sale of the Product in that
country.
1.73 “
Regulatory Filing ” shall mean any filing with any
Regulatory Agency with respect to the manufacture, use in clinical
trials or marketing of a pharmaceutical or biologic product
(including without limitation INDs, BLAs, NDAs, DMFs and CMCs filed
with the FDA).
1.74 “
Royalty Term ” shall mean, with respect to a
particular Product, the period from Commercial Launch of such
Product until [*] the expiration of the last Claim of
a Gene Therapy Patent that Covers such Product [*] or
[*] if the [*] (regardless of whether or not
[*] until the [*] of the [*] of the [*]
of the [*] Royalty Terms shall be determined on a
Product-by-Product basis.
1.75
“Selected Other Gene Therapy Contracts” shall
mean those Other Gene Therapy Contracts that are listed in Schedule
1.75, and all other Other Gene Therapy Contracts that Genzyme by
timely written notice under Section 2.12 elects to include among
the Selected Other Gene Therapy Contracts.
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1.76
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“SOP(s)” shall mean standard operating
procedure(s).
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1.77
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“ Term ” shall have the
meaning given in Section 9.1.
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1.78
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“ Third Party ” shall mean
any Person who is not a Party or a Party’s
Affiliate.
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1.79 “
Upstream Licenses ” shall mean those agreements
that are listed in Schedule 1.79.
ARTICLE 2
ACQUISITION AND ACTIONS TO
TRANSFER
2.1
Assets Acquired . Upon the terms and subject to the terms
and conditions set forth in this Agreement, on the Effective Date,
Avigen shall convey, sell, transfer, and assign to Genzyme and
Genzyme shall purchase from Avigen, free and clear of any
encumbrances, all of the following:
(a) All
of Avigen’s right, title and interest as of the Effective
Date in and to the Gene Therapy Listed Patents, including but not
limited to all rights to obtain patent term
9.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
extensions, renewals, continuations,
divisions or other extensions of legal protections pertaining
thereto;
(b) All
of Avigen’s rights as of the Effective Date in and to claims,
causes of action, actions or suits and all rights to sue at law or
equity for any past or future infringement or other impairment of
any Gene Therapy Patent, including the right to receive all
proceeds and damages therefrom;
(c) All
of Avigen’s right, title and interest as of the Effective
Date in and to the Gene Therapy Listed Know-How;
(d) All
of Avigen’s rights as of the Effective Date under the
Upstream License Agreements, except as provided in
Section 2.7;
(e) All
of Avigen’s rights as of the Effective Date under the
Selected Other Gene Therapy Contracts, except as provided in
Section 2.7;
(f) All
of Avigen’s rights as of the Effective Date in and to
finished product inventories, work-in-process inventories,
product-in-transit inventories and other inventories of the Current
Parkinson’s Product and Current Factor IX Product, and all
AAV or active pharmaceutical ingredient inventories [*]
either such Product that are owned by Avigen, including in any
event those items listed on Schedule 2.1(f), but excluding
[*] and all SOPs, batch records, release data, stability
data and other data related to the production of such
Products;
(g) All
laboratory supplies, cell lines, raw materials, reagents and
related research materials owned by Avigen as of the Effective Date
that [*] Gene Therapy Assets [*] and are listed on
Schedule 2.1(g) hereto (subject only to any applicable
contractual use restrictions and Legal Requirements), including
without limitation all standards, internally produced reagents and
controls for performing the quality control tests on the Products
and all stability samples currently in inventory and all materials
(cell lines, SOPs, media, etc.) for producing any non-commercially
available reagents [*] with the Products and all SOPs
related to performing release and stability assays ( but
excluding items specifically [*] IL-10
Products);
(h) Those
books, documents and records of Avigen (existing and owned by
Avigen as of the Effective Date) that contain preclinical and
clinical data with respect to Product, or that otherwise relate
exclusively to AAV (but not IL-10 Products) and/or Products, except
that Avigen is entitled to provide redacted versions (or copies) of
any such books, documents and records that relate to Products or
AAV as well as to the IL-10 Product or products that are not deemed
Products (which shall be redacted to only the extent necessary to
remove information that specifically relates to the IL-10 Product
or such other non-Products) (collectively, “Transferred
Records”); provided however , that, subject to
Avigen’s obligations of confidentiality and non-use set forth
in ARTICLE 7, Avigen may retain an archival copy of all Transferred
Records in the confidential files of its legal counsel);
(i) All
of Avigen’s rights as of the Effective Date in all licenses,
permits, consents, authorizations and approvals of any federal,
state or local regulatory, administrative or
10.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
other governmental agency or body
relating to Gene Therapy and/or the Products, including without
limitation the Current Regulatory Filings;
(j) All
of Avigen’s right, title and interest as of the Effective
Date in and to the Avigen Trademark;
(k) To
the extent permitted under the applicable agreement, the right to
enforce any agreement that requires the counterparty or
counterparties to maintain the confidentiality of any information
Avigen is required to maintain confidential pursuant to ARTICLE 7,
to the extent required for Genzyme to enjoin, restrain, recover
damages from or obtain specific performance against such
counterparty or counterparties for any breach, suspected breach or
anticipatory breach of such confidentiality requirement (with the
mechanics of cooperation from Avigen to provide copies of the
executed version of any such agreement that has been breached with
respect to such information protected by ARTICLE 7 being as set
forth in Section 7.4);
(l) All
claims of Avigen against Third Parties relating to the Gene Therapy
Assets (as defined below), whether choate or inchoate, known or
unknown, contingent or noncontingent; and
(m) All of
Avigen’s right, title and interest in the assets listed on
Schedule 2.1(m), whether or not such assets are listed in 2.1(a)
through 2.1(l) and notwithstanding anything in Section 2.3 to the
contrary.
The assets referred to in (a)
through (m) are, together with the license set forth in the next
paragraph, collectively, the “Gene Therapy Assets.” If
after the Effective Date, Avigen discovers any item of Know-How
that was owned by Avigen as of the Effective Date, and [*]
any Product and/or its manufacture or pharmaceutical utility
(including without limitation any such items of Know-How that are
data relating to formulation, analytical methods, pre-clinical and
clinical trials, pharmacology, toxicology, regulatory information,
and data [*] ; but excluding any Know-How that falls
into any of the following categories: (x) Know-How that is commonly
available from another source (other than Avigen and its
Affiliates), (y) Know-How that is subject to any existing (as of
the Effective Date) written agreement with the University of
Colorado in connection with IL-10 Products or necessary for the
research, development, manufacture or sale of IL-10 Products, and
(z) Know-How that is an Excluded Asset (the Know-How described in
this sentence that does not fall into any of (x), (y) or (z), the
“Later-Identified Know-How”), then Avigen will promptly
provide Notice to Genzyme of such item of Later-Identified Know-How
and such item of Later-Identified Know-How will, effective upon
such notice, automatically be deemed included in the Gene Therapy
Listed Know-How and retroactively assigned to Genzyme in accordance
with the assignment of Gene Therapy Listed Know-How provided for in
this Section 2.1.
Effective as of the Effective Date,
Avigen hereby grants Genzyme an exclusive (even as to Avigen)
license under the Avigen Related Know-How, to make, have made, use,
sell, offer for sale and import Products throughout the world. Such
license shall be fully and freely sublicenseable one (1) or more
times through one (1) or more tiers of sublicensees
without
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Avigen’s consent, provided,
however, that this license and the definition of Avigen Related
Know-How do not obligate Avigen to disclose any Avigen Related
Know-How to Genzyme.
2.2
Liabilities Assumed . Upon the terms and subject to the
conditions set forth in this Agreement, on the Effective Date,
Genzyme shall assume from Avigen and agree to satisfy and/or
perform when due: (a) those liabilities and obligations of
Avigen identified on Schedule 2.2 hereto; (b) all of the
duties, obligations and liabilities of Avigen arising after the
Effective Date under all Upstream Licenses that are assigned to
Genzyme under this Agreement; (c) all of the liabilities of Avigen
[*] ; and (d) all of the duties, obligations and liabilities
of Avigen under all Selected Other Gene Therapy Contracts
[*]. The foregoing obligations described in this
Section 2.2 are hereinafter collectively referred to as the
“Assumed Liabilities.”
2.3
Excluded Assets and Excluded Liabilities . Other than the
assets specifically referred to in Section 2.1 and the
liabilities specifically referred to in Section 2.2, Avigen
shall not be required to transfer to Genzyme, and Genzyme shall not
be required to acquire or assume, any other assets or liabilities
of Avigen or its Affiliates. Without limiting the foregoing
sentence, notwithstanding the provisions of Sections 2.1 and
2.2 -- except as they operate to include those assets listed in
Schedule 2.1(m) among the Gene Therapy Assets or those liabilities
listed in Schedule 2.2 among the Assumed Liabilities -- neither the
Gene Therapy Assets nor the Assumed Liabilities shall include, and
Avigen shall not be required to transfer to Genzyme and Genzyme
shall not be required to acquire or assume:
(i) Any
cash, cash equivalents or accounts receivable;
(ii) The
Facility and any equipment, fixtures, and furniture located
therein;
(iii) In
accordance with Section 2.7, any Selected Other Gene Therapy
Contract for which a Consent (as defined in Section 2.7) is
required to be obtained from any Person in order to permit the
assignment to Genzyme of Avigen’s rights under such Contract
which Consent shall not have been obtained on or prior to the
Effective Date;
(iv) All
materials that Avigen must retain in order to comply with Legal
Requirements (including without limitation samples of plasmids and
cell lines);
(v) The
other assets listed on Schedule 2.3 (Certain Excluded
Assets);
(vi) Avigen’s
equity or debt interests in any subsidiaries or other Affiliates of
Avigen;
(vii) Any
contractual obligations of Avigen to Third Parties other than
pursuant to the Upstream Licenses or Selected Other Gene Therapy
Contracts or as described in Section 2.2 (i.e. as included
among the Assumed Liabilities under Section 2.2 without reference
to this Section 2.3);
(viii) Any debts (in the
form of indebtedness or a loan), [*] or outstanding amounts
(pursuant to a payment obligation) owed by Avigen related to any
Gene Therapy Asset on or prior to the Effective Date and any
payments due by Avigen pursuant to the
12.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Selected Other Gene Therapy
Contracts or the Upstream Licenses on or prior to the Effective
Date;
(ix) Any
liabilities with respect to the Facility or any equipment, fixtures
or furniture located therein;
(x) Any
liability of Avigen incurred in connection with entering into this
Agreement or any Ancillary Agreement, including (but limited to)
brokerage, accounting and counsel fees, transfer and other taxes
and fees due Third Parties with respect to the execution of this
Agreement or any Ancillary Agreement, and expenses of Avigen
arising from performance by Avigen of its obligations hereunder or
thereunder (except to the extent required to be reimbursed by
Genzyme as explicitly provided elsewhere in this
Agreement);
(xi) Any
obligations to Avigen’s current or former employees,
including without limitation, any salaries, wages, bonuses,
benefits, severance payments, or pension, retirement, or
profit-sharing plan or trust payments or benefits;
(xii) Any
litigation, proceeding or claim by any person or entity against
Avigen or other obligation of Avigen related to the business or
operations of Avigen or otherwise relating to the Gene Therapy
Assets prior to the Effective Date, [*] and except to
the extent such litigation, proceeding or claim constitutes an
Assumed Liability (with Assumed Liabilities being determined
without reference to any exclusion provided under this Section 2.3,
and Assumed Liabilities therefore, to avoid any doubt, including
without limitation those liabilities referred to in
Schedule 2.2);
(xiii) Any tax
obligations or benefits of Avigen or its Affiliates, whether
relating to periods before or after the Effective Date;
(xiv) Any obligations or
liabilities (for violations or otherwise) of Avigen under any Legal
Requirements (including without limitation pertaining to antitrust,
civil rights, labor, employment, discrimination and environmental
laws) or arising from or related to the gross negligence or
intentional misconduct of Avigen or its Affiliates or their
respective current or former officers, directors, employees,
consultants or agents (other than any such obligation or liability
that constitutes an Assumed Liability (with Assumed Liabilities, to
avoid any doubt, including without limitation those liabilities
referred to in Schedule 2.2)); or
(xv) Any expenses
or liabilities resulting from the closure of AAV production at the
Facility or any other facilities and/or the termination of any
employees of Avigen;
Subject to the introductory
paragraph to this Section 2.3, the assets referred to in (i)
through (vi) and the tax benefits referred to in (xiii) are,
collectively, but excluding any asset referred to in Schedule
2.1(m), the “Excluded Assets” and the liabilities
referred to in (vii) through (xv) are, collectively, but excluding
any liability referred to in Schedule 2.2, the “Excluded
Liabilities.” To avoid any shadow of a doubt, nothing in this
Section 2.3 is intended to remove those assets referred to in
Schedule 2.1(m) from the Gene Therapy Assets or those liabilities
referred to in Schedule 2.2 from the Assumed
Liabilities.
13.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
In addition, Genzyme hereby grants
Avigen an exclusive (even as to Genzyme) license under the Gene
Therapy Patents and Gene Therapy Listed Know-How, to make, have
made, use, sell, offer for sale and import IL-10 Products
throughout the world, subject to the terms and conditions of the
Upstream Licenses and Selected Other Gene Therapy Contracts
including without limitation any royalty obligations contained
therein. Such license shall be fully and freely sublicenseable one
(1) or more times through one (1) or more tiers of sublicensees
without Genzyme’s consent, subject to the terms and
conditions of the Upstream Licenses and Selected Other Gene Therapy
Contracts. If Genzyme has a prospective sublicensee within the
scope of this license to Avigen for Avigen to consider, and wishes
to discuss the possibility of a sublicense with Avigen, Genzyme
will Notify Avigen. Avigen agrees to discuss and consider in good
faith the possibility of granting such a sublicense on appropriate
terms, but retains discretion over whether or not to grant such
sublicense.
2.4
Ancillary Agreements . On the Effective Date, the Parties
shall enter into the following additional agreements and deliver
the following instruments (collectively, the “Ancillary
Agreements”):
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(a)
|
A bill of sale substantially in the form of
Exhibit A;
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(b)
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An assignment and assumption agreement in the
form of Exhibit B;
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|
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(c)
|
A general technology assignment instrument in
the form of Exhibit C; and
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(d) A
trademark assignment instrument in the form of Exhibit D; provided
that such trademark assignment instrument, though signed, notarized
and effective as of the Effective Date, may be delivered within one
business day thereafter.
2.5
Transition Assistance . For a period of six (6) months after
the Effective Date (or such longer period as may be mutually agreed
upon by the Parties), at Genzyme’s request and upon
reasonable advance notice and at reasonable (in view of the
relevant personnel’s other responsibilities) times, Avigen
shall make the Avigen personnel set forth in Schedule 2.5
hereto available to Genzyme for transition services related to the
Gene Therapy Assets on a consulting basis ( provided that
such personnel continue to be employed by Avigen or an Affiliate of
Avigen and only for so long as such personnel continue to be so
employed). Avigen shall provide (as requested by Genzyme) up to the
applicable number of hours of such transition services per month
set forth in Schedule 2.5 in exchange for Genzyme paying to
Avigen for the time of each person at an hourly rate equal to
[*] as calculated above. Promptly following a request from
Genzyme delivered no earlier than January 3, 2006, Avigen will
provide Genzyme with a true and correct list of the [*].
Avigen shall not be required to provide access to each Avigen
person’s time beyond the maximum number of hours for such
person stated in Schedule 2.5, and Genzyme shall pay Avigen
for the number of hours actually spent providing such services
within forty-five (45) days after receipt of a reasonably detailed
invoice therefor from Avigen.
2.6
Regulatory Filings . Within thirty (30) days after the
Effective Date, Avigen shall deliver to Genzyme executed original
letters and other documentation necessary or desirable to be
delivered to each Regulatory Agency to assign and officially
transfer authority and responsibility for each of the Current
Regulatory Filings to Genzyme. Genzyme and Avigen
14.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
shall mutually agree on the form and
content of each such letter or other documentation, but in any
event Genzyme shall not unreasonably withhold its consent to
letters and other documentation provided by Avigen that are
consistent with this Agreement and legally effective to transfer
such authority and responsibility in accordance with the relevant
Regulatory Agency’s practices. Genzyme shall file such
letters or other documents with the relevant Regulatory Agencies
within three (3) Business Days after provided by Avigen. If Genzyme
does not timely do so, then Avigen shall be entitled to file these
letters on Genzyme’s behalf.
2.7
Non-Assignment of Certain Contracts . Notwithstanding
anything to the contrary in this Agreement, to the extent that the
assignment hereunder of any contracts included in the Gene Therapy
Assets shall require the consent of any Third Party (each, a
“Consent”) that has not been obtained by Avigen on or
prior to the Effective Date, neither this Agreement nor any action
taken pursuant to it shall constitute an assignment or an agreement
to assign if such assignment or attempted assignment would
constitute a breach of the relevant contract and/or result in the
loss or diminution of any Gene Therapy Asset; provided,
however , that in each such case, Avigen shall, [*] use
its reasonable efforts to obtain the Consent of such other party to
an assignment to Genzyme equivalent to that otherwise provided for
herein as soon as practicable after the Effective Date and,
promptly upon such receipt, execute and deliver to Genzyme such
documentation as the Parties mutually agree is reasonably necessary
or appropriate to effect the assignment of such contract (with it
being acknowledged that documentation in the form of Exhibit C
(Form of Assignment and Assumption Agreement) shall suffice);
provided further that Avigen shall not be required to
[*] . Nothing herein shall be deemed a waiver by Genzyme of
its right to receive on a timetable that is consistent with this
Agreement an effective assignment of or sublicense under each
Upstream License that is included in the Gene Therapy
Assets.
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2.8
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Other Closing-Related Deliveries of the
Parties .
|
(a)
Inventory . Avigen shall physically transfer to Genzyme all
materials required to be transferred to Genzyme under Sections
2.1(f)-2.1(g), except that Avigen may retain a sufficient amount of
such materials (other than any such materials described on Schedule
2.1(m)) to the full extent required by Legal Requirements. The
transfer of these materials shall be at [*] expense and
[*] costs incurred in connection with such
transfer.
(b)
Files . Avigen shall deliver to Genzyme, an original (or, if
Avigen is required under Legal Requirements to retain the original,
a copy) of all files possessed and maintained by Avigen related to:
the Upstream License and the, Selected Other Gene Therapy Contracts
(and activities thereunder), Gene Therapy Listed Patents and Gene
Therapy Listed Know-How and the other Gene Therapy Assets (other in
each case than those files that fall within the categories of
Sections 2.1(h) and (i)); those items assigned to Genzyme in
Sections 2.1(h) and (i); and the Current Regulatory Filings,
including without limitation all correspondence and minutes of
meetings and teleconferences with Regulatory Agencies relating
thereto (other in each case than those files that fall within the
categories of Sections 2.1(h) and (i)). Avigen shall be entitled to
retain a copy of each such item for archival purposes in the
confidential files of its legal counsel or, with respect to
regulatory matters, in the confidential files of its regulatory
department.
15.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
(c)
Recordation . Promptly following receipt from Genzyme of a
patent assignment acknowledgement substantially in the form of
Exhibit E with respect to a Gene Therapy Listed Patent on file as
of the Effective Date, Avigen will execute and deliver such patent
assignment acknowledgement to Genzyme in a form suitable for
recordation with the applicable governmental entity. Genzyme shall
properly record at its own expense all Gene
Therapy Listed Patent assignment
acknowledgement documents provided by Avigen pursuant to this
Section 2.8(c) as and when reasonably determined by Genzyme in a
manner consistent with its patent practices, policies and
procedures.
(d)
Opinion of Counsel . Avigen shall provide to Genzyme an
opinion from Avigen’s outside counsel in the form of Exhibit
F, dated the Effective Date.
(e)
Inventor Signatures . Avigen shall (i) seek to contact the
inventors of the patents and/or patent applications listed on
Schedule 8 [*] its [*] to obtain signatures from such
inventors on the applicable patent assignment recordation documents
and [*] information and declarations required to make the
proper filings with the U.S. Patent and Trademark Office to proceed
with respect to the patents and/or patent applications listed on
Schedule 8 [*] including without limitation providing
Genzyme with copies of the employment agreements of such inventors
and documenting Avigen's efforts to contact such inventors if
requested by Genzyme.
The mechanics and timing of the
transfer and deliveries called for in this Section 2.8 shall
be as set forth in Schedule 2.8. In accordance with such
Schedule, certain aspects of this transfer shall be accomplished by
Genzyme’s personnel visiting Avigen’s facility.
Accordingly, Avigen’s responsibility to “physically
transfer” these items to Genzyme is limited to making these
items available to Genzyme at Avigen’s facility as per the
procedures provided in such Schedule. With respect to the clinical
trial material inventories covered by Section 2.8(a), at
Genzyme’s expense, Avigen shall (x) continue to store such
materials in accordance with all of its internal standard operating
procedures and representations made to the FDA in connection with
the production and maintenance of clinical trial material for IND #
11366 (for the Current Parkinson’s Product inventory) and IND
# 9398 or 8033 (for the Current Factor IX Product inventory), (y)
until [*] continue to perform such testing and assays as are
required in such internal standard operating procedures and such
representations made to the FDA, and (z) until the inventories of
the Current Parkinson’s Product have been transferred to
Genzyme, ship quantities of the inventories of the Current
Parkinson’s Product to clinical sites of the Ongoing
Parkinson’s Trial in accordance with Genzyme’s written
requests. As regards (z), Genzyme must provide reasonable notice
prior to any requested shipment.
2.9
Sales and Transfer Taxes . Except as otherwise provided
herein, each Party shall bear and be solely responsible for any
sales taxes, use taxes, transfer taxes, documentary charges,
recording fees, filing fees and similar taxes, charges, fees and
expenses that may become payable by such Party in connection with
the transactions contemplated by this Agreement.
2.10 Clinical
Trial Insurance Coverage . At Genzyme’s request, Avigen
shall (a) purchase an extended reporting period for its insurance
policies with respect to liabilities incurred prior to the
Effective Date that arise out of the clinical trials conducted
pursuant to IND # 9398 and IND # 8033 and (b) cause Genzyme to be
added to such policies as an additional
16.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
named insured. The length of the
extended reporting period and the liability limits of such policies
shall be those requested by Genzyme, and Genzyme shall reimburse
Avigen for the premium payments required to purchase such coverage
and to add Genzyme as an additional insured within 45 days of
receipt of Notice from Avigen that such premium payment has been
made. It is understood and agreed that Avigen is not required to
make any claim under an insurance policy other than those policies
described in this Section 2.10 to discharge, satisfy or mitigate
(in whole or in part) any Assumed Liability.
2.11
Non-Compete . Except as otherwise expressly provided herein,
prior to the expiration of the Royalty Term applicable to each
Product, neither Avigen nor any of its Affiliates shall directly by
the actions of any of them or indirectly by acting with or through
a Third Party (including, without limitation, by granting a Third
Party a license under intellectual property rights), conduct
research or development activities regarding, or engage in the
manufacture, marketing, sale or distribution of Products;
provided, however, that if Genzyme [*] then this
non-compete shall not apply to [*] effective upon receipt by
Avigen of the Notice delivered by Genzyme pursuant to [*] .
In the event that this Agreement is terminated in its entirety
pursuant to Section 9.2, then the non-compete under this
Section 2.11 shall expire effective on the effective date of
such termination.
2.12
Selection of Additional Other Gene Therapy Contracts .
Avigen will, beginning January 5 2006, make available to Genzyme at
Avigen’s facility all Other Gene Therapy Contracts not listed
on Schedule 1.75. On or before February 20, 2006, Genzyme shall
Notify Avigen which of the Other Gene Therapy Contract not listed
on Schedule 1.75 Genzyme wishes to include among the Selected Other
Gene Therapy Contracts, and they shall be so included, provided
that no Other Gene Therapy Contracts that become Selected Other
Gene Therapy Contracts after the Effective Date will be Represented
Contracts for the purpose of Section 8.1(j), and [*]
.
2.13
Maintenance of Essential Materials . Genzyme shall maintain
those quantities of materials included among the Gene Therapy
Assets that are listed in Schedule 2.13, under the storage
conditions set forth in that Schedule. The purpose of this (in
addition to being part of Genzyme risk management and operational
practices with like materials) is [*] . Avigen acknowledges
and agrees that the quantities of such materials set forth in
Schedule 2.13 will be sufficient to serve this purpose, and in no
circumstances shall Genzyme’s obligation to maintain tangible
Gene Therapy Assets be deemed to extend beyond the materials listed
in Schedule 2.13.
2.14 Lists of
In-Licensed and Contracted-For Patents . On the Effective Date,
Avigen shall deliver to Genzyme (a) a list prepared in good faith
by Avigen of those Gene Therapy Upstream License Patents of which
Avigen is aware, and (b) a list prepared in good faith by Avigen of
those Gene Therapy Other Contract Patents of which Avigen is
aware.
ARTICLE 3
FINANCIAL CONSIDERATION; PAYMENT
TERMS
As partial consideration for the
sale of the Gene Therapy Assets, Genzyme shall make the following
payments to Avigen on the following terms and
conditions:
17.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
3.1
Initial Consideration . Genzyme shall pay to Avigen Twelve
million Dollars ($12,000,000) in cash by wire transfer (the
“Upfront Payment”) within two (2) Business Days after
the Effective Date. The Upfront Payment shall be non-refundable,
shall not be creditable against any other amount due hereunder and
shall not be subject to offset or reduction of any kind except, if
applicable, as provided in Section 3.8. Without limiting the
requirements of Section 3.8, Genzyme shall make the Upfront
Payment from a U.S. entity to Avigen (itself a U.S.
entity).
3.2
Milestone Payments . Subject to Section 9.6 (to the
extent it applies) and the additional terms and conditions set
forth in Schedule 3.2, Genzyme shall pay to Avigen each of the
amounts in Dollars set forth in the tables set forth in
Schedule 3.2 within [*] days after the first
achievement of the corresponding milestone event by or on behalf of
Genzyme, its Affiliate or any Licensee with respect to each
Product. Each such amount shall be non-refundable, shall not be
creditable against any other amount due hereunder and shall not be
subject to offset or reduction of any kind, except as explicitly
set forth in the first paragraph after Part F of Schedule 3.2
and except as provided in Section 3.8 (if applicable) and
Section 6.8. The milestones in Part A, Part B and Part C of
Schedule 3.2 shall be [*] . The milestones in Part D,
Part E and Part F of Schedule 3.2 shall be [*]
.
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3.3
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Royalty Payments; One Royalty; Offsets for Third
Party Royalties .
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(a) Genzyme
shall pay to Avigen a royalty on worldwide Net Sales of each
Product during the Royalty Term for such Product as follows based
on cumulative (not annual) Net Sales of such Product worldwide
during said Royalty Term:
(i) For
all Net Sales of such Product up to or equal to [*] ,
[*] percent [*] of such Net Sales;
(ii) For
all Net Sales of such Product above [*] and less than
[*] , [*] percent [*] of such Net Sales;
and
(iii) For
all Net Sales of such Product equal to and above [*] ,
[*] percent [*] of such Net Sales;
provided, however
, that if a royalty is payable with
respect to [*] solely because [*] then the royalties
payable with respect to [*] shall be at [*] Royalties
payable pursuant to this Section 3.3 shall not be subject to
offset, deduction or reduction of any kind except as provided in
Section 3.8 (if applicable) and Section 6.8. Such
royalties shall be payable quarterly within sixty (60) days after
the end of the calendar quarter in which the Net Sales on which the
royalty is due were made.
(b) Only
one earned royalty will accrue and be paid on a given Product
regardless of the number of Claims of Gene Therapy Patent or number
of countries having Claims of Gene Therapy Patent, even if the
manufacture of such Product in one country is Covered by the Claims
of the Gene Therapy Patents and the use, sale or importation in
another country is Covered by the Claims of the Gene Therapy
Patents. This Section 3.3(b) shall not be read to modify the
way “Coverage” is determined for purposes of the
“Product” definition and the “Royalty Term”
definition, rather this Section 3.3(b)) relates to clarifying
that the royalty
18.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
rates of Section 3.3(a) are the
rates that apply, and they are not doubled nor applied multiple
times to the same Net Sales under the circumstances described above
in this Section 3.3(b).
3.4
Licensing Revenues . Genzyme shall pay to Avigen the cash
equivalent of [*] percent [*] of any and all payments
(whether received by Genzyme in cash, equity, loan forgiveness or
other form) that Genzyme or any of its Affiliates receives from any
Licensee through, in connection with or pursuant to any transaction
(or series of transactions) in which the Licensee obtained any
right that qualifies it as a Licensee in accordance with the
definition of such term (“Licensing Transaction”), but
excluding any payment that is calculated as a percentage of net
sales or profits or similar metric (all such payments that Genzyme
is required to pay a share of to Avigen, “Licensing
Revenues”). Licensing Revenues include (without limitation)
Licensing Transaction initial payments, upfront payments, milestone
payments and annual maintenance fees. Licensing Revenues exclude
payments that are in explicit consideration of funding for
research, development, manufacturing, commercialization or other
actual costs, or reimbursement on a pass-through basis of such
actual costs [*] .
If there are multiple connected or
otherwise related transactions any one (1) of which alone would be
a Licensing Transaction (but including at least one (1) other
transaction that would not alone be a Licensing Transaction), then
the value of Licensing Revenues for that overall Licensing
Transaction will be proportionally reduced based on the relative
fair market values of the Gene Therapy Assets included therein, and
of the other consideration provided by Genzyme, as determined in
accordance with Section 3.16.
Licensing Revenues shall be
proportionally reduced if a Licensing Transaction includes a grant
of a license or other right under intellectual property other than
those included within the Gene Therapy Patents and Gene Therapy
Know How transferred hereunder, based on the relative fair market
values of the Gene Therapy Patents and Gene Therapy Know How and
such other intellectual property, as determined in accordance with
Section 3.16.
Genzyme shall pay Avigen its share
of each payment (in whatever form) of Licensing Revenue received by
Genzyme or its Affiliate within sixty (60) days after the later of
(i) Genzyme’s receipt thereof or (ii), if applicable, the
fair market value of the Licensing Revenues is finally determined
pursuant to Section 3.16.
If [*] and [*] shall
be deemed a Licensee for all purposes hereunder, provided ,
however , that [*] Licensing Revenue.
3.5
Samples, Compassionate Use, Expanded Access, Charitable
Donations and Investigator-Sponsored Studies . The Parties
hereby agree that Genzyme may make Product available (i) for
use as samples in the ordinary course of business, (ii) to
patients under expanded access compassionate use programs prior to
receipt of the necessary Regulatory Approvals for market such
Product in the relevant country, (iii) through charitable
donations or (iv) for preclinical studies, clinical trials and
investigator-sponsored studies, in each case (i) through (iv)
without including the value of the Product transferred for such
purposes in Net Sales (and thus without paying any royalty
hereunder on such the quantities of Product). However, if Genzyme
sells a [*] , then the levels of the corresponding Product
disposed of or transferred under Section 3.5(i), (ii) or (iii)
shall be subject to the procedures contained in Section 3.16
including
19.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Industry Expert determination if
applicable, applied to determine the fair market value on which a
royalty shall be paid to Avigen pursuant to Section 3.16, such
fair market value as determined under Section 3.16 to be equal to
the imputed Net Sales value of any Product disposed of under this
Section 3.5 that are in excess of customary levels of
charitable or compassionate use of pharmaceutical products relative
to actual sales of such products (determined on product-by-product
basis).
3.6
Wire Transfer . Genzyme shall make payments by wire transfer
of Dollars to the account specified by Avigen in writing prior to
the Effective Date (as such address may be changed or updated by
Avigen by providing Notice reasonably in advance of any payment
becoming due or payable), or by such other payment method as the
Parties may agree in writing upon from time to time.
3.7
Foreign Currency . Payments made under this Agreement shall
be payable in Dollars. Net Sales calculated under this Agreement
shall be computed for each quarter with foreign Net Sales converted
into Dollars in accordance with GAAP, using the average of the
relevant exchange rates for each month of such quarter (based on
the rates published in The Wall Street Journal, East Coast Edition
for such month).
3.8
Withholding . Any income or other taxes which Genzyme is
required by Legal Requirements to pay or withhold on behalf of
Avigen with respect to monies payable to Avigen under this
Agreement shall be deducted from the amount of such payments and
paid to the relevant competent taxing authority. If Genzyme is
required to make any such withholding, Genzyme shall indicate the
details of the withholding in its report to Avigen accompanying the
payment from which withholding has been made. Upon written request
from Avigen, Genzyme shall promptly provide Avigen with a
certificate or other documentary evidence to enable Avigen to
support a claim for a refund or a foreign tax credit with respect
to any such tax so withheld or deducted by Genzyme. Genzyme and
Avigen will reasonably cooperate in completing and filing documents
required under the provisions of any applicable tax treaty or under
any other applicable law, in order to enable Genzyme to make such
payments to Avigen without any deduction or withholding, if
possible. Genzyme is a U.S. entity and, except as provided in
Section 3.12 below, shall make all [*] required of it
hereunder from a U.S. entity or from a non-U.S. entity in a
circumstance where tax or other withholding of any portion of such
payment is not required, provided, that in a circumstance where
withholding is required: (a) at the reasonable request of Genzyme,
Avigen will execute and deliver such administrative or ministerial
certificates that will enable such a payment to be made without
withholding and in a circumstance where withholding is required and
(b) Genzyme may make the payment from such entity if Genzyme also
makes a gross-up payment to Avigen that makes Avigen whole for the
amount withheld.
3.9
Reports . With each payment that Genzyme is required to make
to Avigen under ARTICLE 3, Genzyme shall provide a written report,
showing the calculation of Net Sales together with the calculation
of the royalty thereon that is required to be paid. The calculation
of Net Sales in the report shall include a statement of gross sales
and in aggregate form within each category the amount of each
deduction provided for in the definition of Net Sales. With each
milestone or Licensing Revenue payment that Genzyme is required to
make to Avigen under ARTICLE 3, Genzyme shall provide a written
report stating the amount and calculation of the
20.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
payment, the milestone or other
event triggering such payment and the Product and/or Licensing
Transaction, as applicable, for which such payment is being
made.
3.10
Records . Genzyme shall, and shall cause its Affiliates and
Licensees to, keep and maintain for [*] after the relevant
calendar quarter complete and accurate books and records in
sufficient detail so that Net Sales and payments made hereunder can
be properly calculated.
3.11 Interest
on Late Payments . Interest shall accrue on late payments by
Genzyme at the rate announced from time to time by Bank of America
in Boston, Massachusetts U.S.A. (or its successors or assigns) as
its prime rate, calculated on the number of days payment is
delinquent, or the maximum amount permitted by law, whichever is
less; provided , that if such payment has been delayed
because it is related to a dispute raised by a Party in good faith
that is undergoing the dispute resolution procedures set forth in
ARTICLE 10 hereof, interest shall be calculated on the number of
days payment is delinquent starting on the day after such dispute
is finally resolved.
3.12 Exchange
Controls . Notwithstanding any other provision of this
Agreement, if at any time legal restrictions prevent the prompt
remittance of part or all of the royalties with respect to Net
Sales in any country, payment shall be made through such lawful
means or methods as Genzyme may determine after reasonable
consultation with Avigen. When in any country the law or
regulations prohibit both the transmittal and deposit of royalties
on sales in such a country, royalty payments may be suspended for
as long as such prohibition is in effect (and such suspended
payments shall not accrue interest), and promptly after such
prohibition ceases to be in effect, all royalties that Genzyme
would have been obligated to transmit or deposit, but for the
prohibition, shall be deposited or transmitted, as the case may be,
to the extent allowable (with any interest earned on such suspended
royalties which were placed in an interest-bearing bank account in
that country, less any transactional costs).
3.13
Audit . No more frequently than once during each calendar
year during the Term and once during the [*] period
thereafter, Genzyme shall permit Avigen’s independent
auditors, to whom Genzyme has no reasonable objection and with
reasonable advance notice at any time during normal business hours,
accompanied at all times, to inspect, audit and copy reasonable
amounts of relevant accounts and records of Genzyme, its Affiliates
and reports submitted to Genzyme and its Affiliates by Licensees,
for the sole purpose of verifying the accuracy of the calculation
of payments to Avigen pursuant to ARTICLE 3 and the reports which
accompanied them. The accounts, records and reports related to any
particular period of time may only be audited one time under this
Section 3.13. Avigen will cause its independent auditors not
to provide Avigen with any copies of such accounts, records or
reports and not to disclose to Avigen any information other than
information relating solely to the accuracy of the accounting and
payments made by Genzyme pursuant to ARTICLE 3. Avigen shall cause
its independent auditors to promptly provide a copy of their report
to Genzyme. If such audit determines that payments are due to
Avigen, Genzyme shall pay to Avigen any such additional amounts
within thirty (30) days after the date on which such
auditor’s written report is delivered to Genzyme and Avigen,
unless such audit report is disputed by Genzyme, in which case the
dispute shall be resolved in accordance with ARTICLE 10. If such
audit determines that Genzyme has overpaid any amounts to Avigen,
Avigen shall refund any such overpaid amounts to Genzyme within
thirty (30) days after the date on which such auditor’s
written report is delivered to Genzyme and
21.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Avigen. Any such inspection of
records shall be at Avigen’s expense unless such audit
discloses a deficiency in the payments made by Genzyme (whether for
itself or on behalf of its Affiliates and Licensees) of more than
[*] of the aggregate amount payable for the relevant period,
in which case Genzyme shall bear the cost of such audit. Each of
the Parties agree that all information subject to review under this
Section 3.13 is Genzyme’s Confidential Information that
is subject to Avigen’s confidentiality and non-use
obligations under ARTICLE 7, and Avigen agrees that it shall cause
its accounting firm to also retain all such information subject to
the confidentiality and non-use restrictions of ARTICLE 7 or
similar (but no less stringent) obligations of confidentiality and
non-use customary in the accounting industry.
3.14 Fair
Market Value of Gene Therapy Assets . The Parties acknowledge
that the purchase price represents the fair market value for the
Gene Therapy Assets and was determined by arm’s length
negotiations. The Parties agree that no consideration is or will be
paid for the value of any referrals to or from either Party to the
other, or their respective Affiliates that violates any Legal
Requirements.
3.15
Allocation of Consideration . Within sixty (60) days after
the Effective Date, Genzyme shall allocate the consideration among
the Gene Therapy Assets. Such allocation shall be made in
accordance with the provisions of Section 1060 of the Internal
Revenue Code of 1986, as amended (the “Code”), and
shall be binding upon both Parties for tax purposes. The Parties
also each agree to file tax returns consistently with the foregoing
and in accordance with Section 1060 of the Code.
3.16 Fair
Market Value Determination for Products or Licensing
Transactions
(a) If
Genzyme or an Affiliate or Licensee [*] as described in the
second sentence of Section 3.5, Genzyme will notify Avigen of the
per-unit Net Sales value Genzyme proposes with respect to the
relevant Product, reflecting the fair market value of the Product.
[*] in excess of the limitations contained in Section 3.5,
as described in the last sentence of Section 3.5.)
(b) If
there are multiple connected or otherwise related transactions any
one (1) of which alone would be a Licensing Transaction (but at
least one (1) of which would not alone be a Licensing Transaction),
as soon as practicable after Genzyme consummates such transaction,
Genzyme will notify Avigen of the value Genzyme proposes to
allocate to Licensing Revenue for the overall Licensing
Transaction, based on the fair market value of the rights to Gene
Therapy Assets that are granted as part of the Licensing
Transaction relative to the fair market value of the other
consideration provided by Genzyme under the Licensing Transaction
(excluding consideration provided to Genzyme which is already
excluded from Licensing Revenue based on the definition of such
term set forth in Section 3.4).
(c) If
there is a Licensing Transaction that involves the grant of a right
under Gene Therapy Patents and Gene Therapy Know-How as well as the
grant of the right under other intellectual property, as soon as
practicable after Genzyme consummates such transaction, Genzyme
will notify Avigen of the value Genzyme proposes to allocate to
Licensing Revenue based on such Licensing Transaction, based on the
fair market value of the rights to Gene Therapy Patents and Gene
Therapy Know-How that are granted as part of the
Licensing
22.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Transaction relative to the fair
market value of the rights to the other intellectual property
provided by Genzyme under the Licensing Transaction (excluding
consideration provided to Genzyme which is already excluded from
Licensing Revenue based on the definition of such term set forth in
Section 3.4).
(d) If
Avigen and Genzyme fail to agree on the relevant fair market
value(s) within [*] days after Avigen receives
Genzyme’s proposal, the Parties shall attempt to resolve the
dispute amicably and promptly by negotiations between senior
executives (at the level of Vice President or above) who have
authority to settle the dispute. Within [*] Business Days
after the dispute is submitted to such senior executives, they
shall meet at a mutually acceptable time and place, or by means of
telephone or video conference, and thereafter as often as they
reasonably deem necessary, to attempt to resolve the dispute. Each
Party’s such senior executives shall be reasonably available
during a [*] day period for such discussions. If the matter
is not resolved within such [*] days, either Party may
proceed under clause (e) below.
(e) If
the Parties fail to resolve the dispute on the relevant fair market
value(s) pursuant to clause (d) above, then the Parties shall refer
the determination of fair market value(s) to an industry expert
with no less than [*] of experience valuing
biopharmaceutical assets (such as [*] ) who has not been
affiliated with either of the Parties or their Affiliates (an
“Industry Expert”) to determine the fair market
value(s). If the Parties cannot agree on a single Industry Expert
within such [*] days, each shall choose one (1) Industry
Expert by the end of the [*] days and such two (2) experts
shall choose a third Industry Expert within an additional
[*] . In this case, the Parties would engage the third
Industry Expert to resolve the dispute, and the third Industry
Expert is the person who shall make the determination as to fair
market value. Within thirty (30) days after engaging the expert,
each Party shall submit no more than ten (10) pages of analysis
demonstrating its view of the fair market value of the relevant
Product (the ten-page limit is on a per-country basis in cases
where per-unit Product fair market values for sales in different
countries are being determined). Within [*] days after these
written analyses are due, the Industry Expert shall hold a
proceeding in which each Party is entitled to make a presentation
of no more than [*] . Neither Party shall engage in any
ex parte communications with the Industry Expert. Within
[*] days after the in-person proceeding, the Industry Expert
shall deliver in writing his or her decision as to all fair market
values referred for determination simultaneously to both Parties.
This decision must be for a value that is [*] , as to each
fair market value. The Industry Expert is instructed (i) to make
this determination based on valuation techniques that are customary
and usual in the biopharmaceutical industry, including without
limitation for [*] and all other relevant factors typically
taken into account, including without limitation issues of safety
and efficacy, product profile, the competitiveness of the
marketplace, the proprietary position of the product, the
regulatory structure involved, the cost of scaling up a
manufacturing process (including facility costs), and the
profitability of the applicable products; and (ii) that the purpose
of the procedures under this Section 3.16 is to ensure that
[*] in accordance with the terms and conditions of this
Agreement based on Net Sales and Licensing Revenue values that
fairly reflect the fair market values of Products, Gene Therapy
Patents and Gene Therapy Know How or Gene Therapy Assets, as
applicable. The Industry Expert’s decision shall not result
in any payments being made to Avigen based on [*] rather
Avigen must be compensated in accordance with the terms and
conditions of this Agreement based on the fair market value of
Products, Gene Therapy Patents and Gene Therapy Know How or Gene
Therapy
23.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Assets, as applicable. The Industry
Expert’s decisions shall be final and binding on the Parties
absent fraud.
(f)
[*] to an [*] under subsection (b) one time
only, provided that [*] shall [*] based on
[*] in the [*] for Finished Goods published by the
[*] the [*] and [*] of the [*] as the
[*] for [*] .
(g) The
Parties shall bear equally the costs of engaging the Industry
Expert under this Section 3.16, including without limitation
the Industry Expert’s fees and expenses and any other costs
incurred to conduct the proceedings contemplated
hereunder.
3.17
Recognition of Potential Reversion in Licensing Transactions
. If, after the Effective Date, Genzyme licenses Gene Therapy
Assets to a Third Party for the research and development of the
Parkinson’s Product, Genzyme will cause the terms and
conditions of such license to recognize and permit the potential
reversion of Gene Therapy Assets and grant of other rights with
respect to the Parkinson’s Product set forth in Section
ARTICLE 9, for no consideration to Genzyme’s counterparty to
the applicable transaction. This Section is not intended to limit
Avigen’s rights under ARTICLE 9.
ARTICLE 4
DEVELOPMENT;
COMMERCIALIZATION
4.1
General Diligence Obligation . Genzyme (either itself or
through its Affiliates, Licensees or any Third Party selected by
Genzyme) shall be responsible [*] for: (i) the
research, development, manufacturing, commercialization and
distribution of Products selected by Genzyme and the related
regulatory, reimbursement and marketing activities; (ii) the
identification and selection of any Third Party to be utilized in
connection with any clinical trials or research project related to,
or the manufacture, distribution or marketing of, the Products and
the negotiation of the arrangements with such Third Party and
(iii) preparing, submitting and obtaining (in the name of
Genzyme or its Affiliates or Licensees) all Regulatory Approvals
and orphan drug designations (and similar designations outside of
the United States) for Products. In addition to complying with the
more specific diligence obligations set forth in Section 4.4
below, Genzyme shall use its Commercially Reasonable and Diligent
Efforts to research, develop (including without limitation
preclinically, clinically and with respect to manufacturing
processes), manufacture and seek Regulatory Approval [*] .
This [*] but if [*] to [*] the [*] to
the [*] then this shall be [*] . Genzyme may satisfy
its diligence obligations under Sections 4.1 and 4.4 through its
own efforts, and through those of its Affiliates, Licensees and
subcontractors.
4.2
Development Reports . By January 31st and July 31st of each
year until the Commercial Launch of the first Product, Genzyme
shall submit a written report setting forth in reasonable detail:
(a) Genzyme’s (and its Affiliates’ and
Licensees’) efforts to research and develop Products since
the date of the last report delivered to Avigen under this Section
and (b) Genzyme’s plan for such activities in the next
year (including without limitation any milestone events described
in Schedule 3.2 that are anticipated to occur during the
covered year. The first such report shall be due on March 31, 2006
and shall be in lieu of the report that would otherwise be required
on January 31, 2006. Genzyme’s obligations under this
Section 4.2 shall
24.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
be subject to
(i) Genzyme’s confidentiality obligations to Third
Parties, (ii) any restrictions under Legal Requirements and
(iii) [*] All reports delivered by Genzyme pursuant to this
Section 4.2 shall be deemed Genzyme’s Confidential
Information and shall be subject to Avigen’s confidentiality
and non-use obligations under ARTICLE 7.
4.3
Ongoing Parkinson’s Trial . From the Effective Date
until such time as the IND for the Ongoing Parkinson Trial has been
effectively transferred to Genzyme as required pursuant to
Section 2.6, Avigen shall not take action to suspend or
terminate the Ongoing Parkinson’s Trial unless there arises a
safety issue or request from the FDA or IRB of a clinical
site.
4.4
Parkinson’s Disease Product
(a) Once
the IND for the Ongoing Parkinson’s Trial is transferred to
Genzyme, Genzyme shall:
(i) conduct
the Ongoing Parkinson’s Trial to completion in accordance
with its current protocol (subject to any amendments or updates
that may be required by the FDA or the IRB of any of the clinical
sites for the trial or that Genzyme in its prudent scientific or
business judgment deems necessary or advisable),
(ii) obtain
FDA review (a Type C or other similar meeting) of a protocol for a
subsequent Clinical Trial for a Current Parkinson’s Product
[*] .
(iii) if
Genzyme determines to submit a protocol for a subsequent Clinical
Trial for a Current Parkinson’s Product to the Recombinant
DNA Advisory Committee (“RAC”) for review, submit such
protocol to the RAC [*] , and
(iv) if the
RAC requests that Genzyme attend a meeting of the RAC to discuss
the protocol, obtain RAC review of the protocol [*]
provided that if [*] Genzyme shall [*] as an
[*] and [*] to [*] this meeting to be
[*] at the earliest possible date [*] .
(i) Within
[*] after the [*] Genzyme shall [*] in
[*] either [*] Avigen [*] or [*] the
[*] with respect to [*] to [*] to Avigen
[*] . Also, if Genzyme treats a patient in [*] of a
[*] (meaning [*] )) without a [*] then the
[*] .
(ii) The
term “FDA Decision” means, [*] if Genzyme does
not submit a protocol to the RAC as described in Section
4.4(a)(iii), the date of the FDA Type C or other similar meeting
with Genzyme to discuss the Ongoing Parkinson’s Trial results
and a proposed protocol for a subsequent Clinical Trial for a
Current Parkinson’s Product, [*] and the [*]
the date the RAC has held the meeting with Genzyme to discuss the
protocol.
(c) In
the case where the FDA (or the RAC, if Genzyme elects to submit a
protocol to the RAC as contemplated by Section 4.4(a)(iii) and does
so in a timely manner) [*] however, to be clear, anything
[*] provided that Genzyme has devoted Commercially
Reasonable and Diligent Efforts [*] feedback as required by
Section 4.4(a) and devotes Commercially
25.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
Reasonable and Diligent Efforts to
[*] in order for them to provide such feedback, the FDA
Decision will be the date of [*] If the FDA or RAC (if
Genzyme elects to submit a protocol to the RAC as contemplated by
Section 4.4(a)(iii) and does so in a timely manner) provides
Genzyme with a notice that [*] the FDA Decision will be the
date of such notice.
(d) If
the FDA or RAC [*] based on the information and data
produced by the Ongoing Parkinson’s trial, Genzyme
may:
|
(i)
|
[*] to
[*] to [*] pursuant to [*] of the Agreement,
or
|
(ii) Perform
further work, which may include an additional clinical trial, which
in Genzyme’s best scientific or business judgment, will
provide information and data that the FDA will deem sufficient to
approve a clinical protocol for a subsequent clinical trial of a
Current Parkinson’s Product following a Type C or similar
meeting (or a meeting with the RAC, if Genzyme elects to submit a
protocol to the RAC as contemplated by Section 4.4(a)(iii) and does
so in a timely manner), exercising Genzyme’s judgment in
making such decisions in accordance with the Commercially
Reasonable and Diligent Efforts standard and devoting Commercially
Reasonable and Diligent Efforts to such activities. In such case,
the FDA Decision will be the date of a subsequent Type C or other
similar meeting (or meeting with the RAC if Genzyme elects to
submit a protocol to the RAC as contemplated by Section 4.4(a)(iii)
and does so in a timely manner, whichever is later) that is
scheduled as soon as possible after the further work is performed
by Genzyme.
4.5
Commercialization . Genzyme shall use its Commercially
Reasonable and Diligent Efforts to promote (including without
limitation reasonable pre-marketing, advertising, education and
detailing), market, distribute, sell, and provide product support
for, each Product for which Genzyme obtains Regulatory Approval
and, if applicable, Pricing Approval. Genzyme may satisfy its
diligence obligations hereunder through its own efforts, and
through those of its Affiliates, Licensees, distributors and
subcontractors.
4.6
Regulatory Reporting . Beginning on the date that the
authority and responsibilities for the Current Regulatory Filings
are transferred by Avigen to Genzyme, as between the Parties,
Genzyme shall have sole responsibility for and control of such
transferred Regulatory Filings and all future Regulatory Filings
for the Products and all regulatory reporting that is required in
relation thereto with respect to periods beginning on such
date.
ARTICLE 5
PROTECTION OF INTELLECTUAL
PROPERTY
5.1
Filing, Prosecution and Maintenance of Patent
Rights
(a)
Patent Rights . Except as provided in subsection (b),
as between the Parties, Genzyme shall have sole responsibility for
and control over the filing, prosecution (including without
limitation conducting interferences and oppositions), and
maintenance, all at its sole expense, the Gene Therapy Patents.
Except as provided in any Upstream License or Other Gene Therapy
Agreement, Genzyme shall file, prosecute and maintain the Gene
Therapy Patents in a manner consistent with its general patent
practices and policies as in effect from time
26.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
to time. Avigen agrees to
(i) promptly execute such documents (or require its current
employees or consultants to execute such documents, and encourage
its former employees or consultants to execute such documents, as
applicable) and perform such acts as Genzyme may reasonably require
to enable Genzyme’s filing, prosecution and maintenance of
any and all Gene Therapy Patents and [*] . In response to
any reasonable requests from Avigen, Genzyme shall keep Avigen
reasonably informed of [*] related to the filing [*]
prosecution and maintenance of the Gene Therapy Patents.
It is understood and agreed that
with respect to any Gene Therapy Patents to which rights are
derived through an Upstream License or Other Gene Therapy
Agreement, Genzyme’s rights and obligations to file,
prosecute and maintain such Gene Therapy Rights under this ARTICLE
5 are subject to any applicable terms and conditions of the
relevant Upstream License or Other Gene Therapy
Agreement.
(b)
Maintenance of Certain Patents . Genzyme may elect to
[*] in a manner consistent with [*] as in effect from
time to time [*] subject to [*] with respect to any
Products [*] by such [*] to the full extent required
under [*]
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5.2
|
Infringement of Patent Rights
.
|
(a)
Action Against Infringement . Genzyme shall promptly deliver
Notice to Avigen of any alleged or threatened infringement of the
Gene Therapy Patents of which it becomes aware. Genzyme shall have
the right to prosecute any such infringement at its own and sole
expense. If Genzyme recovers any damages, by way of settlement or
otherwise, such recovery shall be used first to reimburse Genzyme
for its litigation expenses (including internal and expenses of
Avigen that are required to be reimbursed by Genzyme as described
below). Any remaining amounts from such recovery shall (i) to the
extent [*] , (ii) to the extent [*] and (iii)
the rest to be retained by Genzyme without any obligations to
Avigen with respect thereto. In the event Genzyme brings an
infringement action, Avigen shall cooperate fully in response to
Genzyme’s reasonable requests for assistance but at
Genzyme’s sole expense for all of Avigen’s reasonable
invoiced out-of-pocket expenses (including both internal and
external expenses), including, if required to bring such action,
the furnishing of a power of attorney.
(b)
Indispensable Party . If Genzyme reasonably determines that
Avigen (and/or its Affiliate) is an indispensable party to any
action brought by Genzyme pursuant to this Section 5.2, Avigen
hereby consents to be joined and agrees to use its reasonable
efforts to cause its Affiliate, as the case may be, to consent to
be joined. Avigen (or its Affiliate, as the case may be) shall bear
its own costs if it elects to be represented by separate counsel,
but Genzyme shall bear all other litigation costs, including
without limitation all of Avigen’s reasonable invoiced
out-of-pocket expenses, whether internal or external (other than
such costs of Avigen’s separate counsel).
(c)
Reimbursement of Internal Avigen Costs . Internal costs of
Avigen reimbursable pursuant to Section 5.2(a) or 5.2(b) are
limited to the [*] Time spent by an Avigen employee shall
not be eligible for reimbursement pursuant to Section 5.2(a) or
5.2(b) until Avigen has provided Genzyme with Notice of the annual
salary of the Avigen employee (the “Annual Salary”).
The amount Genzyme is required to reimburse Avigen with respect to
the
27.
* = confidential treatment requested; certain
confidential information, in the places marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
time spent by any Avigen employee
with respect to such infringement action will be calculated by
[*] .
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5.3
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Third Party Intellectual Property
.
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(a)
Notice . If the development, manufacture, use, import,
export, offer for sale or sale of any Product by or on behalf of
Genzyme, any of its Affiliates and Licensees results in a claim for
patent infringement or other violation of intellectual property
rights of any Thir