Washington,
D.C. 20549
FORM
6-K
REPORT
OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of April 2007
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12 BGC Centre
28
The Esplanade
Perth
WA 6000
Australia
(Address
of principal executive offices)
(Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F).
Form
20-F
ý Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
ý
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
The
document attached as Exhibit 99.1 to this Report on Form 6-K is hereby
incorporated by reference herein and into the following registration statements:
(i) the Registrant's Registration Statement on Form F-3, Registration
No. 333-132776; (ii) the Registrant's Registration Statement on
Form F-3, Registration No. 333-132777; (iii) the Registrant's
Registration Statement on Form F-3, Registration No. 333-135428; (iv)
the Registrant's Registration Statement on Form F-3, Registration
No. 333-141083; and (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant,
pSivida Limited, has duly caused this report to be signed on its behalf by
the
undersigned, thereunto duly authorized.
Date:
April
26, 2007
PSIVIDA
LIMITED
By:
/s/
Michael J.
Soja
Michael
J. Soja
Vice
President, Finance and Chief Financial Officer
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Collaborative
Research and License Agreement, dated as of April 3, 2007, by and
among
pSivida Limited, pSivida Inc. and Pfizer Inc. (redacted pursuant
to a
confidential treatment
request)
|
CONFIDENTIAL
COLLABORATIVE
RESEARCH AND LICENSE AGREEMENT
Dated
as of April 3, 2007
Between
pSivida Limited
pSivida
Inc.
and
Pfizer
Inc.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
Confidential
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
Collaborative
Research and License Agreement (this “Agreement”)
dated
as of April 3, 2007 (the “Effective
Date”)
between pSivida, Inc., a Delaware corporation with offices located at 400
Pleasant Street, Watertown, Massachusetts 02472, pSivida Limited, ACN 009 232
026, a public limited liability corporation with offices located at Level 12,
BGC Centre, 28 The Esplanade, Perth WA 6000, Australia (together, “PSIVIDA”),
and
Pfizer Inc., a Delaware corporation with offices located at 235 East 42nd
Street, New York, New York, 10017, U.S.A. (“PFIZER”).
PSIVIDA and PFIZER are sometimes referred to herein individually as a
“Party”
and
collectively as the “Parties.”
WHEREAS,
PSIVIDA owns or otherwise controls certain patents, patent applications,
technology, know-how and scientific and technical information relating to
formulations for drug delivery and compatible devices, including Medidur™;
WHEREAS,
PSIVIDA has extensive expertise in designing and developing innovative
ophthalmic drug delivery systems;
WHEREAS,
PFIZER has extensive experience and expertise in the development and
commercialization of pharmaceutical products, and desires to acquire an
exclusive license in the Territory (as defined below) to such patents, patent
applications, technology, know how and scientific and technical information
and
enter into a collaborative research relationship with PSIVIDA; and
WHEREAS,
PSIVIDA desires to grant such license to PFIZER and to enter into such
collaborative research relationship with PFIZER.
NOW,
THEREFORE, in consideration of the mutual covenants and agreements provided
herein, PSIVIDA and PFIZER hereby agree as follows:
Section
1. DEFINITIONS.
For
purposes of this Agreement, the following definitions shall be
applicable:
1.1 “Accused
Device”
shall
have the meaning assigned to it in Section 8.4(b)(i).
1.2 “Additional
Investment”
shall
have the meaning assigned to it in Section 6.1(e).
1.3 “Affiliate”
means
any entity directly or indirectly controlled by, controlling, or under common
control with, a Party to this Agreement, but only for so long as such control
shall continue. For purposes of this definition, “control” (including, with
correlative meanings, “controlled by”, “controlling” and “under common control
with”) means (a) possession, direct or indirect, of the power to direct or cause
direction of the management or policies of an entity (whether through ownership
of securities or other ownership interests, by contract or otherwise), or (b)
beneficial ownership of at least 50% of the voting securities or other ownership
interest (whether directly or pursuant to any option, warrant or other similar
arrangement) or other comparable equity interests of an entity.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-2-
Confidential
1.4 “Alimera”
shall
mean Alimera Sciences, Inc.
1.5 “Alimera
Agreement”
shall
mean the Collaboration Agreement between Control Delivery Systems, Inc.
(presently, PSIVIDA) and Alimera dated as of February 11, 2005 as in existence
and effect as of the Effective Date.
1.6 “B&L”
shall
mean Bausch & Lomb Incorporated.
1.7 “B&L
Agreement”
shall
mean the Amended and Restated License Agreement between Control Delivery
Systems, Inc. (presently, PSIVIDA) and B&L dated as of December 9, 2003 as
in existence and effect on the Effective Date.
1.8 “BMP”
means
Beijing Med-Pharm Corp.
1.9 “BMP
Agreement”
means
the Exclusive Patent and Know How License Agreement by and among Psioncology
PTE. LTD., Beijing Med-Pharm Corp. and Psimedica Ltd. dated as of October 26,
2005, as amended and in existence and effect as of the Effective
Date.
1.10 “Business
Day”
means
a
day other than a Saturday, Sunday, or bank or other public holiday in New York,
New York or Boston, Massachusetts.
1.11 “Change
of Control”
means
that any of the following has occurred:
(a) any
Person or group that is a Large Pharmaceutical Company becomes the beneficial
owner, directly or indirectly, of fifty percent (50%) or more of the outstanding
Voting Stock or voting power over Voting Stock of (i) PSIVIDA or (ii) any one
or
more Persons which are direct or indirect parent holding companies of PSIVIDA
or
Affiliates controlling PSIVIDA (PSIVIDA, together with the Persons described
in
clause (ii), each hereinafter referred to, individually, as an “PSIVIDA Group
Company” and, collectively, as the “PSIVIDA Group Companies”); or
(b) any
PSIVIDA Group Company enters into an agreement with any Person or group that
is
a Large Pharmaceutical Company providing for the sale or disposition of all
or
substantially all of the assets of the PSIVIDA Group Companies, on a
consolidated basis, or all or substantially all of the assets of the PSIVIDA
Group Companies related to the Field, on a consolidated basis; or
(c) any
PSIVIDA Group Company enters into an agreement with any Person or group
providing for a merger, reorganization, consolidation or other similar
transaction (or series of related transactions) of any PSIVIDA Group Company
with such Person or any Affiliate of such Person, in each case, that is a Large
Pharmaceutical Company (other than with any of the PSIVIDA Group Company’s
wholly-owned subsidiaries) or with such group that contains a Large
Pharmaceutical Company, that results in the shareholders of the applicable
PSIVIDA Group Company immediately before the occurrence of such transaction
(or
series of transactions) beneficially owning less than a majority of the
outstanding Voting Stock or voting power over Voting Stock of the surviving
or
newly-created entity in such transaction (or series of transactions);
or
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-3-
Confidential
(d) a
change
in the board of directors of any PSIVIDA Group Company in which the individuals
who constituted the board of directors of such PSIVIDA Group Company at the
beginning of the two (2)-year period immediately preceding such change (together
with any other director whose election by the board of directors of such PSIVIDA
Group Company or whose nomination for election by the stockholders of such
PSIVIDA Group Company was approved by a vote of at least a majority of the
directors then in office either who were directors at the beginning of such
period or whose election or nomination for election was previously so approved)
cease for any reason to constitute a majority of the directors then in office;
or
(e) in
relation to Psivida Limited, (i) Psivida Limited becomes a Subsidiary of another
body corporate that is a Large Pharmaceutical Company, (ii) a business or
material assets of Psivida Limited or any of its Subsidiaries are sold to a
Person that is a Large Pharmaceutical Company, (iii) a Subsidiary ceases to
be a
Subsidiary of Psivida Limited; or (iv) there is a change in Control to a Person
that is a Large Pharmaceutical Company. For this paragraph (e), ‘Control’ has
the meaning in s50AA of the Corporations
Act 2001
(Cth)
and ‘Subsidiary’ has the meaning in s46 of the Corporations
Act 2001 (Cth);
or
(f) any
PSIVIDA Group Company enters into an agreement with any Person providing for
the
matters described in subsection (a), (b), (d) or (e) above.
For
purposes of this definition of “Change of Control” only: (A) references to any
PSIVIDA Group Company shall be deemed to include all successors in any merger,
consolidation, reorganization or similar transaction (or series of related
transactions) preceding any transaction (or series of related transactions)
described above; (B) “beneficial ownership” (and other correlative terms) means
beneficial ownership as defined in Rule 13d-3 under the United States Securities
and Exchange Act of 1934, as amended; it being understood and agreed that
“beneficial ownership” shall also include any securities which any Person or any
of such Person’s Affiliates has the right to acquire (whether such right is
exercisable immediately or only after the passage of time) pursuant to any
agreement, arrangement or understanding, or upon the exercise of conversion
rights, exchange rights, rights, warrants or options, or otherwise; (C) “group”
means group as defined in the Securities Exchange Act of 1934, as amended and
the rules of the Securities and Exchange Commission thereunder as in effect
on
the date hereof (“Exchange Act”); (D) “control” (including, with correlative
meanings, “controlled by”, “controlling” and “under common control with”) of an
entity means possession, direct or indirect, of (I) the power to direct or
cause
direction of the management and policies of such entity (whether through
ownership of securities or partnership or other ownership interests, by contract
or otherwise), or (II) at least fifty percent (50%) of the voting securities
(whether directly or pursuant to any option, warrant or other similar
arrangement) or other comparable equity interests of such entity; (E) “Large
Pharmaceutical Company” means (x) any pharmaceutical, biotechnology or
biopharmaceutical company that had at least one billion ($1,000,000,000) in
annual aggregate net sales of pharmaceutical products (based on data provided
by
IMS International, or, if such data is not available, such other reliable data
source as reasonably determined by Pfizer and reasonably agreed to by PSIVIDA),
(y) any one or more Persons that are direct or indirect parent holding companies
of subsidiaries of the pharmaceutical, biotechnology or biopharmaceutical
company described in clause (x) above, or (z) any Affiliate (as defined in
the
Exchange Act) of the pharmaceutical, biotechnology or biopharmaceutical company
described in clause (x) above; and “Voting Stock” means securities of any class
or series of a corporation, association or other entity, the holders of which
are ordinarily, in the absence of contingencies, entitled to vote generally
in
matters put before the shareholders or members of such corporation, association
or other entity.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-4-
Confidential
1.12 “Commence”
or
“Commencement”
when
used with respect to a clinical trial, means the first dosing of the first
patient for such trial.
1.13 “Commercially
Reasonable Efforts”
means
those efforts and resources consistent with the usual practice of PFIZER in
pursuing the development or commercialization of its own pharmaceutical products
that are of similar market potential as the Licensed Products, taking into
account all relevant factors including product labeling or anticipated labeling,
present and future market potential, past performance of Licensed Products
and
PFIZER’s own pharmaceutical products that are of similar market potential,
financial return, medical and clinical considerations, present and future
regulatory environment and competitive market conditions, all as measured by
the
facts and circumstances at the time such efforts are due.
1.14 “Competitive
Device”
shall
mean a [...]*
1.15 “Control”
or
“Controlled”
means,
with respect to any intellectual property right, that the Party owns or has
a
license to such intellectual property right and has the ability to grant the
other Party access, a license, or a sublicense (as applicable) to such
intellectual property right as provided herein, without violating the terms
of
any agreement or other arrangement with any Third Party existing at the time
such Party would be first required hereunder to grant the other party such
access, license or sublicense.
1.16 “Courts”
shall
have the meaning assigned to it in Section 15.2.
1.17 “[...]*
Condition
Indication”
means
either of the following indications in the Field: [...]*.
1.18 “Development
Plan”
shall
have the meaning assigned to it in Section 5.1.
1.19 “Device”
means
[...]*.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-5-
Confidential
1.20 “Device
Indication Field”
means
each of the following categories of indications in the Field (each such category
being a distinct Device Indication Field): [...]*.
1.21 "Escrow
Agreement" means the Escrow Agreement by and among pSivida Limited, PFIZER
and
Signature Bank, dated as of the Effective Date.
1.22 “Event
Milestone”
shall
have the meaning assigned to it in Section 6.1(a).
1.23 “Event
Milestone Payments”
means
the amounts set forth in Section 6.1(a) opposite the respective Event
Milestones.
1.24 “Faber”
means
Faber Research LLC.
1.25 “Faber
Agreement”
means
the License Agreement by and between Faber Research LLC and pSivida Limited
dated January 3, 2007 and as in existence and effect as of the Effective
Date.
1.26 “FDA”
means
the United States Food and Drug Administration or any successor agency
thereto.
1.27 “FDCA”
means
the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations
promulgated thereunder.
1.28 “Field”
means
the delivery of formulations for the treatment, control or prevention of any
ophthalmic diseases and conditions in humans or animals.
1.29 “Formulation”
means
a
solid, solution or suspension suitable for the ocular delivery of a PFIZER
Compound for use with the Device, and which contains a PFIZER
Compound.
1.30 “Generic
Compound”
means
a
composition of matter not included in clause (i) of the definition of PFIZER
Compound.
1.31 “Generic
Product”
means
any pharmaceutical product that (i) is sold by a Third Party that is not a
licensee or sublicensee of PFIZER or its Affiliates, or any of their licensees
or sublicensees, under a marketing authorization granted by a Regulatory
Authority to such Third Party, and (ii) contains the same PFIZER Compound as
an
active pharmaceutical ingredient as the relevant Licensed Product and (x) for
purposes of the United States, is approved in reliance on the prior approval
of
such Licensed Product as determined by the FDA, or (y) for purposes of a country
outside the United States, is approved in reliance on the prior approval of
such
Licensed Product as determined by the applicable Regulatory
Authority.
1.32 “Governmental
Authority”
means
any court, agency, department, authority or other instrumentality of any
national, state, county, city or other political subdivision.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-6-
Confidential
1.33 “IND”
means
an Investigational New Drug Application submitted under the FDCA or an analogous
application or filing with any analogous agency or Regulatory Authority outside
of the United States under any analogous foreign Law for the purposes of
obtaining permission to conduct human clinical studies.
1.34 “Indemnified
Party”
shall
have the meaning assigned to it in Section 14.4.
1.35 “Indemnifying
Party”
shall
have the meaning assigned to it in Section 14.4.
1.36 “Infringer”
has
the
meaning assigned to it in Section 8.4(b).
1.37 “Joint
Research Committee”
or
“JRC”
shall
have the meaning assigned to it in Section 2.1(a).
1.38 “Launch”
means
the first shipment of a Licensed Product in commercial quantities for commercial
sale by PFIZER, its Affiliates or its sublicensees to a Third Party in a country
in the Territory after receipt by PFIZER of the first Regulatory Approval (and,
in any country in which Price Approval is necessary or relevant for a majority
of the population to obtain access to pharmaceutical products, Price Approval)
for such Licensed Product in such country.
1.39 “Laws”
means
all laws, statutes, rules, regulations, orders, judgments and/or ordinances
of
any Governmental Authority.
1.40 “Licensed
Product”
means
any product containing or delivering a PFIZER Compound in any dosage form,
the
manufacture, sale, offer for sale, importation, or use of which (i) would be
covered by a Valid Claim, (ii) embodies or incorporates PSIVIDA Technology,
or
(iii) embodies or incorporates Program Technology. For the avoidance of doubt,
a
Licensed Product shall not include the following: (i) the “First Generation
Exclusive Licensed Product” and the “Vitrasert Licensed Product”, each as
defined under the B&L Agreement and (ii) the “First Product”, “Product” or
“Option Product” (to the extent PSIVIDA has granted a license covering such
Option Product pursuant to Section 5.8 of the Alimera Agreement), each as
defined under the Alimera Agreement.
1.41 “Litigation
Condition”
shall
have the meaning assigned to it in Section 14.4(a).
1.42 “Losses”
shall
have the meaning assigned to it in Section 14.2.
1.43 “Major
EU Countries”
means
the United Kingdom, Spain, Italy, France and Germany.
1.44 “Medidur
Device”
means
a
Device that falls under the definition of “Product” under the Alimera
Agreement.
1.45 “NDA”
means
a
New Drug Application or a Biological License Application filed with the FDA
in
accordance with the FDCA with respect to a pharmaceutical or biologic products
or an analogous application or filing with any Regulatory Authority outside
of
the United States (including any supra-national agency such as the European
Union) for the purpose of obtaining approval to market and sell a pharmaceutical
or biological product in such jurisdiction.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-7-
Confidential
1.46 “Net
Sales”
means
with respect to a Licensed Product, the gross amount invoiced by PFIZER, its
Affiliates and its sublicensees of such Licensed Product to Third Parties,
less,
without duplication, (i) bad debts related to such Licensed Product and (ii)
sales returns and allowances actually paid, granted or accrued, including,
trade, quantity and cash discounts and any other adjustments, including, those
granted on account of price adjustments, billing errors, rejected goods, damaged
or defective goods, recalls, returns, rebates, chargeback rebates,
reimbursements or similar payments granted or given to wholesalers or other
distributors, buying groups, health care insurance carriers or other
institutions, adjustments arising from consumer discount programs or other
similar programs, customs or excise duties, sales tax, consumption tax, value
added tax, and other taxes (except income taxes) or duties relating to sales,
any reductions of payment in respect of sales to the United States government,
any state government or any foreign government, or to any other Governmental
Authority, or with respect to any government-subsidized program or managed
care
organization (provided
that any
reductions, discounts or adjustments that apply collectively to multiple
products shall be allocated pro rata to the amounts invoiced for Licensed
Products), and freight and insurance (to the extent that PFIZER bears the cost
of freight and insurance for a Licensed Product). Net Sales shall be determined
from books and records maintained in accordance with generally acceptable
accounting principles in the United States, as consistently applied by PFIZER
with respect to sales of all its pharmaceutical or biologic
products.
1.47 “New
Device Indication Field”
means
a
Device Indication Field that is different than any Device Indication Field
to
which another Licensed Product that has previously undergone the relevant Event
Milestone is directed.
1.48 “Non-Sequential
Milestone”
shall
have the meaning assigned to it in Section 6.1(c).
1.49 “Other
Indication”
means
the following indication in the Field: [...]*.
1.50 “Patent
Costs”
means
the fees and costs associated with filing, prosecution and maintenance of Patent
Rights in the Territory.
1.51 “Patent
Rights”
shall
mean all patents and patent applications, whether domestic or foreign, including
all continuations, continuations-in-part, divisionals, provisionals and
renewals, and letters of patent granted with respect to any of the foregoing,
patents of addition, supplementary protection certificates, registration or
confirmation patents and all reissues, re-examination and extensions thereof.
In
all cases, inventorship will be determined in accordance with U.S.
law.
1.52 “Person”
means
an individual, corporation, partnership, company, joint venture, unincorporated
organization, limited liability company or partnership, sole proprietorship,
association, bank, trust company or trust, whether or not legal entities, or
any
Governmental Authority.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-8-
Confidential
1.53 “PSIVIDA
Confidential Information”
means
all information relating to Devices, PSIVIDA Technology or PSIVIDA Program
Technology, as well as any other information regarding the technology, business
and operations of PSIVIDA, that is or has been disclosed (whether orally or
in
writing) by PSIVIDA to PFIZER or its Affiliates to the extent that such
information is not (i) as of the date of disclosure to PFIZER, known to PFIZER
or its Affiliates; or (ii) disclosed in published literature, or otherwise
generally known to the public through no breach by PFIZER of this Agreement;
or
(iii) obtained by Pfizer or its Affiliates from a Third Party free from any
obligation of confidentiality to PSIVIDA; or (iv) independently developed by
PFIZER or its Affiliates without use of the PSIVIDA Confidential Information;
or
(v) in the reasonable opinion of legal counsel, required to be disclosed under
Law; provided
that, in
the case of (v), PFIZER provides PSIVIDA prior notice (to the extent
practicable) of such disclosure and agrees to cooperate, at the request and
sole
expense of PSIVIDA, with PSIVIDA’s efforts to preserve the confidentiality of
such information.
1.54 “PSIVIDA
Patent Rights”
means
(i) all Patent Rights directed to the Device or Formulations which are owned,
licensed or otherwise Controlled by PSIVIDA as of the Effective Date or at
any
time during the Term (other than Program Patent Rights), including the Patent
Rights listed in Exhibit
A
and any
Patent Rights that may issue from, or claim priority to or through, the
applications listed on Exhibit
A,
and
(ii) in addition to the drug delivery Patent Rights described in clause (i),
[...]*.
1.55 “PSIVIDA
Program Patent Rights”
shall
have the meaning assigned to it in Section 8.1(c).
1.56 “PSIVIDA
Program Technology”
shall
have the meaning assigned to it in Section 8.1(c).
1.57 “PSIVIDA
Research Costs”
means
the actual costs expended by PSIVIDA during any calendar year for the Research
Program in accordance with the Research Plan, such amounts to be limited to
amounts budgeted by the JRC under Section 2.1(e), including personnel costs
at a
rate of [...]* per year per full-time employee, payments to Third
Parties[...]*.
1.58 “PSIVIDA
Technology”
means
any Technology owned or otherwise Controlled by PSIVIDA as of the Effective
Date
or at any time during the Term, other than Program Technology; [...]*.
1.59 “PSIVIDA
Trademarks”
means
the mark, MedidurTM.
1.60 “PFIZER
Compound”
means
(i) any composition of matter, [...]* that is specifically or generically
claimed in composition of matter claims in any patent and/or patent application
owned, licensed or otherwise Controlled by PFIZER as of the Effective Date
or
during the Term of this Agreement, and (ii) Generic Compounds that [...]*.
A
PFIZER Compound shall not include a corticosteroid or an Option Compound for
which Alimera has exercised the Alimera Compound Option (as defined in the
Alimera Agreement) under Section 5.8.3 of the Alimera Agreement.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-9-
Confidential
1.61 “PFIZER
Confidential Information”
means
all information relating to PFIZER Compounds, Formulations, Licensed Products
or
PFIZER Program Technology, as well as any other information regarding the
technology, business and operations of PFIZER, that is or has been disclosed
(whether orally or in writing) by PFIZER to PSIVIDA or its Affiliates to the
extent that such information is not (i) as of the date of disclosure known
to
PSIVIDA or its Affiliates; or (ii) disclosed in published literature, or
otherwise generally known to the public through no breach by PSIVIDA of this
Agreement or (iii) obtained by PSIVIDA or its Affiliates from a Third Party
free
from any obligation of confidentiality to PFIZER; or (iv) independently
developed by PSIVIDA or its Affiliates without use of the Pfizer Confidential
Information; or (v) in the reasonable opinion of legal counsel, required to
be
disclosed under Law; provided that, in the case of (v), PSIVIDA provides PFIZER
prior notice (to the extent practicable) of such disclosure and agrees to
cooperate, at the request and sole expense of PFIZER, with PFIZER’s efforts to
preserve the confidentiality of such information.
1.62 “PFIZER
Quarter”
means
each of the four (4) thirteen (13) week periods (i) with respect to the United
States, commencing on January 1 of any calendar year, and (ii) with respect
to
any country in the Territory other than the United States, commencing on
December 1 of any calendar year.
1.63 “PFIZER
Patent Rights”
means
all Patent Rights owned or otherwise Controlled by PFIZER as of the Effective
Date or at any time during the Term, including such rights with respect to
PFIZER Proprietary Compounds (other than Program Patent Rights).
1.64 “PFIZER
Program Patent Rights”
shall
have the meaning assigned to it in Section 8.1(c).
1.65 “PFIZER
Program Technology”
shall
have the meaning assigned to it in Section 8.1(c).
1.66 “PFIZER
Proprietary Compound”
means
any composition of matter included in clause (i) of the definition of PFIZER
Compound.
1.67 “PFIZER
Technology”
means
any technology and know-how owned, licensed or otherwise Controlled by PFIZER
as
of the Effective Date or at any time during the Term (including as related
to
PFIZER Proprietary Compounds), other than Program Technology.
1.68 “Phase
I/II Clinical Study”
means
a
clinical study, other than a Phase III Clinical Study, that is intended to
test
the safety or effectiveness of a Licensed Product for a specific indication
in
patients with the disease or condition under study, including first in human
studies to the extent is intended to test such effectiveness.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-10-
Confidential
1.69 “Phase
II(b) Clinical Study”
means
a
Phase II Clinical Study that is intended to establish the dosing regimen for
use
in a Phase III Clinical Study of a Licensed Product for a specific
indication.
1.70 “Phase
III Clinical Study”
means
a
clinical study intended to meet the requirements for approval of an NDA for
a
Licensed Product.
1.71 “Price
Approval”
means,
in any country where a Governmental Authority authorizes reimbursement for,
or
approves or determines pricing for, pharmaceutical products, receipt (or, if
required to make such authorization, approval or determination effective,
publication) of such reimbursement authorization or pricing approval or
determination (as the case may be).
1.72 “Program
Patent Rights”
means
all Patent Rights that cover Program Technology and include PSIVIDA Program
Patent Rights and PFIZER Program Patent Rights.
1.73 “Program
Technology”
means
Technology that is or was (a) invented by officers, employees or agents of,
or
consultants to, PSIVIDA or any of its Affiliates, alone or jointly with Third
Parties, in the course of performing the Research Plan during the Research
Term,
(b) jointly invented by officers, employees or agents of, or consultants to,
both PSIVIDA and PFIZER or any of their respective Affiliates or sublicensees,
in each case, alone or jointly with Third Parties, in the course of performing
the Research Plan during the Research Term, (c) invented by officers, employees
or agents of, or consultants to, PFIZER or any of its Affiliates or
sublicensees, alone or jointly with Third Parties, in the course of performing
the Research Plan during the Research Term or (d) acquired by purchase, license,
assignment or other means from Third Parties by PSIVIDA or any of its
Affiliates, by PSIVIDA and PFIZER or any of their respective Affiliates or
by
PFIZER or any of its Affiliates, in each case, alone or jointly with Third
Parties, in order for such Party (or Parties) to perform the Research Plan
during the Research Term. In all cases, inventorship shall be determined
according to United States law.
1.74 “Redacted
Agreement”
shall
have the meaning assigned to it in Section 9.4.
1.75 “Regulatory
Approval”
means
any and all approvals, with respect to any jurisdiction, or authorizations
(other than Price Approvals) of a Regulatory Authority, that are necessary
for
the commercial manufacture, distribution, use, marketing or sale of a
pharmaceutical product in such jurisdiction.
1.76 “Regulatory
Authority”
means,
in respect of a particular country or jurisdiction, the Governmental Authority
having responsibility for granting Regulatory Approvals in such country or
jurisdiction.
1.77 “Representatives”
shall
have the meaning assigned to it in Section 14.1(a).
1.78 “Research
Costs”
shall
have the meaning assigned to it in Section 3.3.
1.79 “Research
Plan”
shall
have the meaning assigned to it in Section 3.1.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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1.80 “Research
Program”
means
the program under which research under Section 3 will be conducted during the
Research Term, which program includes the Research Plan.
1.81 “Research
Records”
shall
have the meaning assigned to it in Section 3.4.
1.82 “Research
Term”
means
a
term beginning on the Effective Date and ending on at the Commencement of the
first Phase III Clinical Study for the first Licensed Product.
1.83 “Reserved
Interests”
shall
have the meaning assigned to it in Section 16.2.
1.84 “Royalty
Term”
means,
on a country-by-country and Licensed Product-by-Licensed Product basis, the
period commencing upon Launch of a Licensed Product in a country and ending
upon
the later to occur of: (i) the date on which such Licensed Product is no longer
covered by a Valid Claim in such country; and (ii) [...]* years from the date
of
Launch of such Licensed Product in such country.
1.85 “[...]*
Patent
Rights”
means
the Patent Rights listed on Exhibit
H.
1.86 “Sales
Milestone Payments”
means
the amounts set forth in Section 6.2.
1.87 “Security
Agreement”
means
the Security Agreement attached as Exhibit
I.
1.88 “Stock
Purchase Agreement”
means
the Stock Purchase Agreement, dated as of the Effective Date, between Pfizer
Inc. and pSivida Limited.
1.89 “Subsequent
Indication Licensed Product”
means
a
Licensed Product that contains a PFIZER Compound that is different than the
PFIZER Compound contained in any Licensed Product for which PFIZER had been
required to pay the relevant Event Milestone, and that is developed with the
purpose of receiving Regulatory Approval in a New Device Indication
Field.
1.90 “Technology”
means
all inventions, materials, technology, data, technical and scientific
information, know-how, expertise and trade secrets that are used in connection
with a Device, PFIZER Compounds or Formulation, including any improvements
to
the Device, PFIZER Compounds or Formulations and intellectual property rights
embodying any of the foregoing, but excluding any Patent Rights.
1.91 “Term”
means
the period of time commencing on the Effective Date and ending on the earlier
of
(a) the last to expire Royalty Term or (b) the effective date of termination
of
this Agreement pursuant to Section 13.1.
1.92 “Territory”
means
the entire world.
1.93 “Third
Party”
means
any person or entity other than PFIZER, PSIVIDA, or any of their respective
Affiliates.
1.94 “Third
Party Claim”
shall
have the meaning assigned to it in Section 14.4.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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1.95 “UKRF
Licenses”
means
the licenses by and between PSIVIDA and the University of Kentucky Research
Foundation set forth in Exhibit
E.
1.96 “UKRF
Technology”
means
the technology licensed under UKRF Licenses.
1.97 “UKRF
Patent Rights”
means
the Patent rights licensed under UKRF Licenses.
1.98 “Valid
Claim”
means
any claim from (a) an issued and unexpired patent included within the PSIVIDA
Patent Rights or Program Patent Rights that has not been revoked or held
unenforceable or invalid by a final decision of a court or other Governmental
Authority of competent jurisdiction, unappealable or unappealed within the
time
allowed for appeal or that has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue or disclaimer or otherwise; or (b)
a
patent application included within the PSIVIDA Patent Rights or Program Patent
Rights; provided however, that such a claim from a patent application has not
been canceled, withdrawn, or abandoned [...]*. If a claim of a patent
application ceases to be a Valid Claim under item (b) because of the passage
of
time and later issues as part of a patent within item (a), then it shall again
be considered to be a Valid Claim effective as of the earlier of the grant,
allowance or issuance of such patent.
1.99 “[...]*
Condition Indication”
means
any of the following indications in the Field: [...]*.
1.100 Construction.
Except
where expressly stated otherwise in this Agreement, the following rules of
interpretation apply to this Agreement: (i) “include”, “includes” and
“including” are not limiting and mean include, includes and including, without
limitation; (ii) definitions contained in this Agreement are applicable to
the
singular as well as the plural forms of such terms; (iii) references to an
agreement, statute or instrument mean such agreement, statute or instrument
as
from time to time amended, modified or supplemented; (iv) references to a person
are also to its permitted successors and assigns; (v) references to an
“Article”, “Section”, “Exhibit” or “Schedule” refer to an Article or Section of,
or any Exhibit or Schedule to, this Agreement unless otherwise indicated; (vi)
the word “will” shall be construed to have the same meaning and effect as the
word “shall”; (vii) the word “any” shall mean “any and all” unless otherwise
indicated by context and (viii) references to “dollars” or “$” shall refer to
United States Dollars.
Section
2. Management
of the Research Program
2.1 Joint
Research Committee.
(a) The
Research Program established by this Agreement shall be overseen by a joint
research committee composed of two (2) representatives from each Party (the
“Joint
Research Committee”
or
“JRC”). An alternate member designated by a Party may serve temporarily in the
absence of a permanent member of the JRC for such Party. Each Party shall
designate one of its representatives as a co-chair of the JRC. The co-chairs
of
the JRC shall be jointly responsible for setting the agenda for each meeting,
and each co-chair will be responsible for chairing alternating JRC meetings.
From time to time, the JRC may establish subcommittees or subordinate committees
(that may or may not include members of the JRC itself) to oversee particular
projects or activities, and such subcommittees or subordinate committees shall
be constituted and shall operate as the JRC agrees. After the end of the
Research Term, the JRC shall be disbanded.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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The
members of the JRC initially shall be:
PFIZER
Appointees: [...]*
PSIVIDA
Appointees: [...]*
(b) All
decisions of the JRC made pursuant to this Agreement shall be made by consensus;
provided, however, that in the event of a disagreement between PFIZER and
PSIVIDA, subject to Sections 2.1(c) and (d) below and except with respect to
Section 2.4(g), the PFIZER co-chair of the JRC shall have the final
decision-making authority.
(c) Any
changes to the Research Plan that materially expand PSIVIDA’s obligations,
require PSIVIDA to materially increase its efforts, materially alter the nature
of the services provided by PSIVIDA shall require the unanimous consent of
the
JRC. If the JRC fails to reach unanimous consent regarding any such change
to
the Research Plan, then the obligations of PSIVIDA shall not be increased and
the nature of the services provided by PSIVIDA shall not be altered.
(d) If
any
aspect of a supplement to the Research Plan approved by the JRC, if performed,
would violate Section 2 of the BMP Agreement, Sections 4.1, 5.1, 5.4 and 5.8
of
the Alimera Agreement or Sections 2.1, 2.3, 2.4 and 2.5 of the B&L
Agreement, such aspect shall not become a part of the Research Plan regardless
of whether the JRC has approved such designation.
(e) The
approval of the budget for the Research Costs shall require the unanimous
consent of the JRC.
2.2 Meetings.
The JRC
shall hold meetings at such times and places as shall be determined by the
co-chairs of the JRC (it being expected that any in-person meetings will
alternate between the appropriate offices of each Party), but in no event shall
such meetings be held less frequently than once every calendar quarter during
the Research Term. The JRC may:
(a) conduct
meetings in person, by videoconference or by telephone conference;
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(b) invite
other personnel of the Parties to attend meetings of the JRC as appropriate
to
the agenda for such meeting, after giving advance notice to the other
Party;
(c) act
without a meeting if, prior to such action, a consent thereto is signed by
the
co-chairs of the JRC; and
(d) by
unanimous consent, amend or expand upon the foregoing procedures for its
internal operation.
2.3 Minutes.
At each
meeting, the JRC shall elect a secretary who will prepare minutes after each
meeting, reporting in reasonable detail the actions taken by the JRC during
such
meeting, issues requiring resolution, and resolutions of previously reported
issues. Such minutes are to be reviewed and, if reasonably complete and
accurate, signed by one JRC member from each Party. The secretary shall revise
such minutes as necessary to obtain such signatures.
2.4 JRC
Functions and Powers.
The
research activities of the Parties under the Research Plan shall be managed
by
the JRC only to the extent set forth herein (unless otherwise mutually agreed
in
writing by the Parties). The JRC shall foster the collaborative relationship
between the Parties in order to assist each Party in fulfilling its obligations
under the Research Plan, and shall in particular:
(a) encourage
and facilitate ongoing cooperation and information exchange between the
Parties;
(b) monitor
the progress of the Research Program and the Parties’ diligence in carrying out
their responsibilities thereunder; provided, however, that the JRC shall not
have the authority to make any determination that either Party is in breach
of
its obligations under the Research Plan;
(c) subject
to Section 2.1(c) and (d), prepare any amendments to the Research Plan, if
the
JRC should determine that any such amendments are necessary;
(d) set
priorities, allocate tasks and coordinate activities between the Parties, in
each case as required to perform the Research Program;
(e) perform
such other functions as appropriate to further the purposes of the Research
Plan
as mutually determined by the Parties;
(f) discuss
issues relating to the designation of PFIZER Compounds;
(g) subject
to Section 2.1(e), approve the budgets for Research Costs; and
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(h) except
as
set forth in Sections 2.4(c), the JRC shall have no power to amend this
Agreement and shall have only such powers as are specifically delegated to
it in
this Agreement.
2.5 Independence.
Subject
to the terms of this Agreement, the activities and resources of each Party
shall
be managed by such Party, acting independently and in its individual capacity.
The relationship between PSIVIDA and PFIZER is that of independent contractors
and neither Party shall have the power to bind or obligate the other Party
in
any manner, other than as is expressly set forth in this Agreement. PSIVIDA
and
PFIZER are not joint venturers, partners, principal and agent, employer and
employee, and have no other relationship other than independent contracting
parties.
Section
3. Conduct
of the Research Program
3.1 Research
Plan.
The
Parties shall conduct the Research Program according to the research plan (as
supplemented or amended from time to time, the “Research Plan”). In the event of
an inconsistency or disagreement between the Research Plan and this Agreement,
the terms of this Agreement shall prevail. The objective of the Research Program
is to develop [...]*, and (2) Formulations for ocular [...]* in the
Field.
(a) Development
[...]*.
PSIVIDA will have primary responsibility for developing [...]* under a Research
Plan described under Exhibit B-1.
(b) Development
[...]*
for
PFIZER Compounds.
Subject
to the terms and conditions of this Section 3.1(b) and except as restricted
by
Section 2 of the BMP Agreement, Sections 2.1 and 2.5 of the B&L Agreement
and Sections 4.1, 5.1 and 5.8 of the Alimera Agreement, PSIVIDA and PFIZER
shall
conduct the Research Plan throughout the Research Term during which, from time
to time, PFIZER will submit a PFIZER Compound or another composition of matter
that is not claimed in composition of matter claims in issued, valid and
unexpired Third Party Patent Rights and a proposed supplement to the Research
Plan to PSIVIDA for [...]*
for use
in the Field and associated development [...]*. All technology related [...]
developed in the course of performing the Research Plan will become part of
Program Technology. The initial Research Plan will relate to the PFIZER
Compounds listed in Exhibit B-2 hereto. For sake of clarification, PFIZER
Compounds listed in Exhibit B-2 as of the Effective Date are specifically
licensed hereunder.
(c) Proposals
for Development for PFIZER Compounds.
(i) With
respect to any composition of matter under subsection (b) that PFIZER proposes
a
supplement to the Research Plan during the period prior to February 11, 2008,
PFIZER shall send written notice of its intention to propose as a supplement
to
the Research Plan to PSIVIDA. PSIVIDA will have ten (10) days to respond in
writing that Alimera has exercised its Alimera Compound Option (as defined
in
the Alimera Agreement) to such composition of matter under Section 5.8 of the
Alimera Agreement. In the event that PSIVIDA responds to PFIZER within such
period that Alimera has rights in such composition of matter, PFIZER will not
be
permitted to propose a supplement to the Research Plan for such composition
of
matter. In the event that PSIVIDA responds to PFIZER within such period that
Alimera has not exercised its Alimera Option with respect to such composition
of
matter, or does not respond to PFIZER within such ten day period, PFIZER may
proceed to supplement the Research Program with respect to such composition
of
matter, and such composition of matter shall, upon finalization by the JRC,
become part of the Research Program. On and after February 11, 2008, PFIZER
may
propose to the JRC any PFIZER Compound(s) or other composition of matter(s)
pursuant to subsection (b) to supplement the Research Plan without first
complying with the procedures set forth in this subsection.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(ii) A
proposed supplement to the Research Plan submitted by PFIZER will be reviewed
and finalized by the JRC. Any supplement to the Research Plan finalized by
the
JRC will be attached to Exhibit B-2. Each new Research Plan supplement shall
be
appended to Exhibit B-2 and made part of this Agreement.
(iii) PSIVIDA
agrees that, subject to Section 2.1(c) and (d), during the Research Term, PFIZER
can add any PFIZER Compound or other composition of matter that is not claimed
in composition of matter claims in issued, valid and unexpired Third Party
Patent Rights to the Research Program for any indication within the Field
without restriction.
(d) Extension
of Research Term.
PFIZER
may extend the Research Program in its sole discretion by one year by giving
written notice at least 60-days before the end of the initial Research
Term.
(e) Limitations.
Notwithstanding anything to the contrary herein, PSIVIDA’s obligation to perform
under the Research Plan, including, but not limited to, any supplements to
the
Research Plan, shall be subject to PSIVIDA’s work load with respect to other
compositions of matter previously submitted under the Research
Plan.
3.2 Conduct
of Research.
The
Parties shall conduct the Research Program in compliance in all material
respects with the requirements of applicable Laws and the Parties will use
reasonably diligent efforts to achieve the objectives of the Research Program
and the Research Plan efficiently and expeditiously. Each Party shall promptly
inform the other about all inventions within Program Technology that are made
in
the performance of the Research Plan. For the avoidance of doubt, PSIVIDA shall
have no obligation to undertake any development activity for the Device or
Licensed Products other than those allocated to it in the Research Plan and
included in the budget for the Research Costs.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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3.3 Research
Costs.
Starting for the calendar year 2008 and until the Commencement of a Phase III
Clinical Study for the first Licensed Product, PFIZER shall pay PSIVIDA at
a
rate [...]* in consideration of PSIVIDA’s costs in performing the Research
Program (the “Research
Costs”).
PFIZER shall pay the Research Costs in four equal installments by wire transfer,
in accordance with the wire instructions set forth in Exhibit
F,
each
such payment to be made within ten (10) days after the beginning of each PFIZER
Quarter and the first of such payments being made during the first PFIZER
Quarter of 2008. In addition to the foregoing payments, at the end of each
PFIZER Quarter in which PFIZER has paid Research Costs in accordance with this
Section 3.3, PSIVIDA shall bill PFIZER for the amount, if any, by which the
PSIVIDA Research Costs incurred by PSIVIDA in performing its obligations under
the Research Plan exceed the Research Costs paid by PFIZER during such PFIZER
Quarter. PFIZER shall pay the amount billed by PSIVIDA within thirty (30) days
after its receipt of such invoice.
3.4 Records.
Each
Party shall maintain complete and accurate records of all work conducted under
the Research Program and all results, data and developments made pursuant to
its
efforts under the Research Program (collectively, the “Research
Records”).
Such
Research Records shall reflect work done and results achieved in the performance
of the Research Program in sufficient detail and in a manner appropriate for
patent and regulatory purposes. Subject to bona fide confidentiality obligations
to a Third Party, each Party shall have the right to request copies of such
Research Records of the other Party at reasonable times and upon reasonable
notice to the extent necessary or useful for such Party to conduct its research
or perform its other obligations under this Agreement, or to secure or enforce
patents licensed under this Agreement.
3.5 Reports.
During
the Research Term, each Party shall report to the JRC no less than once per
calendar quarter, and such reports shall consist of a written progress report
summarizing the work performed under the Research Plan since the previous
report. The JRC shall define the format and the nature of the content of such
quarterly reports, which format and nature shall be adopted by both
Parties.
3.6 Termination
of Research Program.
The
Research Program and the Research Plan shall automatically terminate on the
effective date of any termination of this Agreement pursuant to Section 13.1.
In
addition, either Party may terminate the Research Program and the Research
Plan
if the other Party has materially breached its obligations under Article 3
of
this Agreement or under the Research Plan, such termination to be effective
thirty (30) days after the breaching Party’s receipt of a notice from the
non-breaching Party to such effect; provided
that if
the breaching Party has cured such breach prior to the expiration of such thirty
(30)-day period, then the Research Program and Research Plan shall remain in
effect pursuant to the terms thereof. As a result of any termination in
accordance with this Section 3.6, Article 2, Article 3, the Research Program
and
the Research Plan shall cease to be in effect and neither Party shall have
any
further obligations with respect thereto.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Section
4. LICENSES.
4.1 License
to PFIZER.
Subject
to the terms of this Agreement and except to the extent rights granted hereunder
were granted under Section 2 of the BMP Agreement, Sections 2.1.1 or 2.1.2
of
the B&L Agreement, or under Sections 4.1, 5.1, 5.4 and 5.8 of the Alimera
Agreement, or include rights that PSIVIDA is otherwise obligated not to convey
to a third party under Sections 2.3, 2.4 and 2.5of the B&L Agreement, or
under Sections 4.1, 5.1, 5.4 and 5.8 of the Alimera Agreement, PSIVIDA hereby
grants, and shall cause its Affiliates to grant, to PFIZER, and PFIZER hereby
accepts:
(a) (i)
an
exclusive (even as to PSIVIDA and its Affiliates), royalty-bearing worldwide
license, with the right to sublicense, under the PSIVIDA Technology, the PSIVIDA
Program Technology, and the PSIVIDA Confidential Information and (ii) an
exclusive (even as to PSIVIDA and its Affiliates), royalty-bearing worldwide
sublicense, with a right of further sublicense, under the UKRF Technology,
in
each case to make, have made, use, sell or import Licensed Products, Devices
and
Formulations in the Territory in the Field;
(b) (i)
an
exclusive (even as to PSIVIDA and its Affiliates), royalty-bearing worldwide
license, with the right to sublicense, under the PSIVIDA Patent Rights, and
the
PSIVIDA Program Patent Rights and (ii) an exclusive (even as to PSIVIDA and
its
Affiliates), royalty-bearing worldwide sublicense, with a right of further
sublicense, under the UKRF Patent Rights, in each case to make, have made,
use,
sell or import Licensed Products, Devices and Formulations in the Territory
in
the Field; and
(c) a
non-exclusive sublicense, without a right to further sublicense, to use the
PSIVIDA Trademarks with the Licensed Products, Devices and Formulations in
the
Territory in the Field. PFIZER shall cause to appear on all items bearing a
PSIVIDA Trademark such legends, markings and notices as may be required by
applicable law or reasonably requested by PSIVIDA to establish, perfect, defend
or exploit the proprietary character of the PSIVIDA Trademarks. PFIZER shall
not
grant, attempt to grant or record anywhere, a security interest in a PSIVIDA
Trademark. PSIVIDA hereby assigns and will assign any goodwill associated with
its use of the PSIVIDA Trademarks to PFIZER. PFIZER ACKNOWLEDGES AND AGREES
THAT
THE PSIVIDA TRADEMARKS ARE PROVIDED ON AN “AS IS” BASIS AND THAT PSIVIDA MAKES
NO REPRESENTATIONS AND EXTENDS NO WARRANTIES WHATSOEVER, EXPRESS, IMPLIED OR
STATUTORY, WITH RESPECT THERETO INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTIES OF TITLE, VALIDITY, ENFORCEABILITY OR NON-INFRINGEMENT. PSIVIDA
is
not obligated to (i) file any application for registration of the PSIVIDA
Trademarks, or to secure any rights in the PSIVIDA Trademarks, (ii) to maintain
the PSIVIDA Trademarks, or (iii) to police or pursue (including for
infringement) any Third Parties using the PSIVIDA Trademarks.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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In
the
event that during the Term, any rights of BMP, B&L or Alimera in the first
paragraph of this Section 4.1 that has been excluded from the grant to PFIZER,
or PSIVIDA is no longer restricted under the sections of the BMP Agreement,
B&L Agreement and the Alimera Agreement referenced in this Section 4.1,
PFIZER shall thereafter have rights to Licensed Products within the Field to
the
same extent it has rights granted under Sections 4.1(a) and (b) above. PSIVIDA
shall notify PFIZER within thirty (30) days of any termination of such rights
of
BMP, Alimera and B&L, as the case may be, under their respective
agreements.
4.2 Licenses
and Sublicenses to PSIVIDA Parties.
Subject
to the terms of this Agreement, during the Term, PFIZER grants, and shall cause
its Affiliates to grant, to PSIVIDA the following fully paid, royalty-free,
worldwide licenses and sublicenses, under PFIZER’s interest and PSIVIDA hereby
accepts:
(a) a
non-exclusive license or sublicense, as applicable, without the right to
sublicense or further sublicense (other than solely to the extent required
to
perform research under and contemplated by the Research Plan), respectively,
in
and to the PFIZER Technology, the PFIZER Confidential Information, the PSIVIDA
Technology, the PSIVIDA Confidential Information and the PFIZER Program
Technology solely to the extent necessary or useful to make, have made, use,
or
import the Licensed Products, and Devices and Formulations for use in and with
the Licensed Products, in the Territory solely for purposes of performing its
obligations under the Research Plans; and
(b) a
non-exclusive license or sublicense, as applicable, without the right to
sublicense or further sublicense (other than solely to the extent required
to
perform research under and contemplated by the Research Plan), respectively,
in
and to the PFIZER Patent Rights, the PSIVIDA Patent Rights, PSIVIDA Program
Patent Rights and the PFIZER Program Patent Rights to make, have made, use,
or
import the Licensed Products, and Devices and Formulations for use in and with
the Licensed Products in the Territory solely for purposes of performing its
obligations under the Research Plan.
Other
than as specifically provided in this Section 4.2 and in the license grant
set
forth in Sections 4.3(b), PSIVIDA does not have, and nothing in this Agreement
shall be construed to grant any license, interest or right to use any PFIZER
Technology, PFIZER Confidential Information, PFIZER Patent Rights, PFIZER
Program Technology and PFIZER Program Patent Rights.
4.3 Non-Exclusive
License.
Without
limiting any of the licenses granted in 4.1:
(a) To
the
extent permitted by the BMP Agreement, Alimera Agreement and the B&L
Agreement, PSIVIDA grants to PFIZER a non-exclusive, irrevocable, royalty-free,
perpetual license in the Territory, with the right to sublicense to Affiliates,
to use for all research purposes the PSIVIDA Technology, PSIVIDA Program
Technology, and PSIVIDA Confidential Information, in each case disclosed during
the Term to PFIZER by PSIVIDA or its Affiliates; and
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(b) PFIZER
grants to PSIVIDA a non-exclusive, irrevocable, royalty-free, perpetual license
in the Territory, with the right to sublicense to Affiliates, to use for all
research purposes the PFIZER Technology, PFIZER Program Technology and PFIZER
Confidential Information, in each case disclosed during the Term to PSIVIDA
by
PFIZER or its Affiliates.
4.4 Notwithstanding
anything in Section 4.1 or any other provision of this Agreement, (i) the
Parties agree and acknowledge that, under the BMP Agreement, the B&L
Agreement and the Alimera Agreement, PSIVIDA has granted certain rights to
BMP,
B&L and Alimera, respectively, both exclusively and nonexclusively, and has
agreed not to grant certain licenses or other rights to third parties; and
(ii)
to the extent any rights granted hereunder have been granted under the BMP
Agreement, the B&L Agreement or the Alimera Agreement or are restricted
pursuant to a covenant not to convey under the B&L Agreement or the Alimera
Agreement, such rights shall not be and are not granted to PFIZER under this
Agreement, except as provided in the last paragraph of Section 4.1.
Section
5. DEVELOPMENT,
REGULATORY APPROVALS AND MARKETING.
5.1 PFIZER
Development Plan.
PFIZER
shall have the exclusive right and responsibility to prepare and implement
a
development plan for any PFIZER Compounds and Licensed Products (the
“Development
Plan”).
A
draft Development Plan shall be provided to PSIVIDA and PFIZER shall give due
consideration to all suggestions and comments of PSIVIDA in relation thereto.
All decisions with respect to the creation, modification and implementation
of
the Development Plan shall be made by PFIZER.
5.2 Development
Reports.
During
the period beginning after the delivery by PFIZER to PSIVIDA of the initial
Development Plan for a Licensed Product pursuant to Section 5.1 [...]* to
PSIVIDA regarding the development of such Licensed Product, including any
material changes to the Development Plan.
5.3 Records.
During
the Term, PFIZER will prepare and maintain accurate records and books relating
to the progress and status of its activities under the Development Plan and
otherwise in relation to the development of Licensed Products.
5.4 Diligence.
PFIZER
will use Commercially Reasonable Efforts to develop, seek Regulatory Approval
for and commercialize at least one Licensed Product [...]*.
5.5 Regulatory
Affairs.
PFIZER
shall determine all regulatory plans and strategies for the Licensed Products,
and will own and be responsible for preparing, seeking, submitting and
maintaining all regulatory filings and Regulatory Approvals for all Licensed
Products, including preparing all reports necessary as part of a regulatory
filing or Regulatory Approval. [...]*
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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5.6 Manufacture
and Supply.
PSIVIDA
shall be responsible for the manufacture of all clinical supplies of Devices
and
Formulations in accordance with the Research Plan for each PFIZER Compound.
PFIZER shall be responsible for the manufacture of all commercial supplies
of
each PFIZER Compound, Formulation and each Licensed Product.
5.7 Commercialization/Pricing.
PFIZER
shall be solely responsible for marketing, promoting, selling, distributing
and
determining pricing and other terms of sale for all Licensed
Products.
5.8 Disclosure
of Technology.
(a) Within
thirty (30) days after the Effective Date, and from time-to-time throughout
the
Term, and during the Term at PFIZER’s reasonable request, but in no event later
than ten (10) days following such request, PSIVIDA will disclose to PFIZER
or
its designated Affiliates, all documentation, manuals, tangible materials,
protocols, SOPs or software embodying PSIVIDA Technology and PSIVIDA Program
Technology that is reasonably necessary or useful to PFIZER to develop,
manufacture, register, or market Licensed Products and efficiently practice
the
licenses under this Agreement, including such information from Third Parties
to
the extent permitted under any applicable agreements.
(b) In
addition, from time to time and as soon as practicable, but in no event later
than three (3) months following the Effective Date, PFIZER shall have the right
to have two (2) employees trained at PSIVIDA’s US facilities at least annually
during the Research Term in all aspects of manufacture and development of the
Devices and Formulations, it being understood that PFIZER may request that
PSIVIDA train different employees every year; provided, if there are
modifications, improvements or advancements to the Device, PSIVIDA shall train
PFIZER’s employees upon PFIZER’s reasonable request at PSIVIDA’s US facility.
All costs incurred by PFIZER or reasonable costs incurred by PSIVIDA in
complying with the subsection shall be fully reimbursed by PFIZER.
Section
6. FEES
AND ROYALTIES.
6.1 Event
Milestone Payments and Stock Purchase Agreements.
(a) In
consideration of the rights granted hereunder, and subject to the terms and
conditions of this Agreement, PFIZER shall pay to PSIVIDA the amount set forth
in the table below opposite the corresponding event milestone (each an
“Event
Milestone”)
within
thirty (30) days after the occurrence of such Event Milestone:
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-22-
Confidential
|
Event
Milestone
|
Event
Milestone Payment
|
|
Commencement
of first Phase I/II Clinical Study for the first Licensed Product
to
Commence a Phase I/II Clinical Study, subject to reduction to the
extent
Pfizer purchases shares under the Stock Purchase Agreement or the
Second
Stock Purchase Agreement, as the case may be, and under the terms
and
conditions set forth in Exhibit
L.
|
$[...]*
million
|
|
Commencement
of first Phase II(b) Clinical Study for the first Licensed Product
to
Commence a Phase II(b) Clinical Study.
|
$[...]*
million
|
|
Commencement
of first Phase III Clinical Study for the first Licensed Product
to
Commence a Phase III Clinical Study.
|
$[...]*
million
|
|
Date
of acceptance by FDA of PFIZER’s first NDA for the first Licensed Product
in the United States to have an NDA accepted in the United
States.
|
$[...]*
million
|
|
Launch
of the first Licensed Product in the United States.
|
$[...]*
million
|
|
Launch
of the first Licensed Product in the first three Major EU Countries.
|
$[...]*
million
|
(b) In
consideration of the rights granted hereunder, and subject to the terms and
conditions of this Agreement, PFIZER shall also pay to PSIVIDA the amount set
forth in the table below opposite the corresponding Event Milestone no later
than thirty (30) days following the occurrence of such Event
Milestone:
|
Event
Milestone
|
Event
Milestone Payment
|
|
Commencement
of Phase III Clinical Study for any Subsequent Indication Licensed
Product.
|
$[...]*
million
|
|
Date
of acceptance by FDA of PFIZER’s NDA for any Subsequent Indication
Licensed Product in the United States.
|
$[...]*
million
|
|
Launch
of any Subsequent Indication Licensed Product in the United
States.
|
$[...]*
million
|
|
Launch
of any Subsequent Indication Licensed Product in the first three
Major EU
Countries.
|
$[...]*
million
|
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(c) For
the
avoidance of doubt, if at any time an Event Milestone (a “Non-Sequential
Milestone”)
occurs
prior to the occurrence of all Event Milestones set forth in the rows preceding
such Non-Sequential Milestone in the table set forth in subsection (a) or
subsection (b) above, as applicable, PFIZER shall pay to PSIVIDA the sum of
(i)
all Event Milestone Payments associated with Event Milestones in rows preceding
the Non-Sequential Event Milestone which have not otherwise been paid by PFIZER,
other than an Event Milestone on Launch, and (ii) the Event Milestone Payment
associated with the Non-Sequential Milestone. In addition, for the avoidance
of
doubt, there shall be a maximum of three sets of Event Milestones for Licensed
Products in total, one for each Device Indication Field.
(d) Simultaneously
with the execution of this Agreement, PFIZER and PSIVIDA Limited will enter
into
a Stock Purchase Agreement, pursuant to which, PFIZER will make an investment
in
ordinary shares of Psivida Limited, in the amount of US$5 million, subject
to
the terms and conditions set forth therein.
(e) PFIZER
may invest an additional (x) US$ [...]* million (the “Additional
Investment”)
and
(y) up to a maximum of US$ [...]* million (such additional amount under this
clause (y) to be fully creditable against the Phase I/II Clinical Study Event
Milestone for the first Licensed Product to Commence a Phase I/II Clinical
Study) pursuant to the terms and conditions set forth in Exhibit L.
6.2 Sales
Milestone Payments.
In
addition to the Event Milestone Payments, in consideration of the rights granted
hereunder, and subject to the terms and conditions of this Agreement, PFIZER
shall pay to PSIVIDA the following one-time payments (each, a “Sales
Milestone Payment”)
when
aggregate Net Sales of all Licensed Products in a calendar year in the Territory
first reach the respective thresholds indicated below:
|
Annual
Net Sales in the Territory
|
Sales
Milestone Payment
|
|
Net
Sales in a calendar year exceed $[...]* million
|
$[...]*
million
|
|
Net
Sales in a calendar year exceed $[...]* billion
|
$[...]*
million
|
|
Net
Sales in a calendar year exceed $[...]* billion
|
$[...]*
million
|
|
Net
Sales in a calendar year exceed $[...]* billion
|
$[...]*
million
|
PFIZER
shall make any Sales Milestone Payment payable with respect to a calendar year
within sixty (60) days after the end of such calendar year, and such payment
shall be accompanied by a report identifying the Licensed Products, the relevant
countries, Net Sales of each Licensed Product for each such country, and the
amount payable to PSIVIDA. All such reports shall be kept confidential by
PSIVIDA and not disclosed to any other party, other than PSIVIDA’s accountants
which shall be obligated to keep such information confidential, and such
information and reports shall only be used for purposes of this
Agreement.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
6.3 Royalty
Payments.
In
addition to the payments under Sections 6.1 and 6.2, in consideration of the
rights granted hereunder, and subject to the terms and conditions of this
Agreement, PFIZER shall pay to PSIVIDA, with respect to each Licensed Product,
an amount equal to [...]*% of Net Sales for the portion of Net Sales of such
Licensed Product in a calendar year in the Territory.
Notwithstanding
the foregoing, (i) for Net Sales based on sales of a Licensed Product in the
United States, any payments owed with respect to sales of such Licensed Product
pursuant to this Section 6.3 shall be reduced by [...]* percent ([...]*%)
[...]*for the remainder of the applicable Royalty Term if a Generic Product
is
available in the United States, any such reduction to be prorated appropriately
for the then-current PFIZER Quarter; (ii) for Net Sales based on sales of a
Licensed Product in a country in the Territory other than the United States,
any
payments owed with respect to sales of such Licensed Product in such country
pursuant to this Section 6.3 shall be reduced by [...]* percent ([...]*%),
such
reduction to be prorated appropriately for the then-current PFIZER Quarter,
for
so long as and at any time that a Generic Product is available in such country;
and (iii) for Net Sales based on sales of a Licensed Product in any country
in
the Territory, payments owed with respect to sales of such Licensed Product
pursuant to this Section 6.3 shall be reduced to an amount equal to [...]*%
of
Net Sales for the portion of Net Sales of such Licensed Product in such country
for so long as and at any time that the following events occur or are in
existence: (a) a Competitive Device is being marketed in that country and (b)
clause (i) and (ii) of this Section 6.3 do not otherwise apply. The Parties
agree and acknowledge that the payment of royalties by PFIZER to PSIVIDA for
sales in a country in which there is no Valid Claim covering the applicable
Licensed Product shall represent consideration for the license to PSIVIDA
Technology granted by PSIVIDA to PFIZER in Section 4.1.
6.4 Duration
of Royalty Payments.
Payments under Section 6.3 shall continue until the expiration of the Royalty
Term in each country in the Territory for such Licensed Product. Thereafter,
on
a Licensed Product-by-Licensed Product basis, to the extent such rights have
not
been exclusively licensed or restricted under a covenant not to convey under
the
BMP Agreement, the Alimera Agreement or the B&L Agreement, PFIZER shall have
a non-exclusive, royalty-free, perpetual, irrevocable, worldwide license, with
the right to sublicense, under the PSIVIDA Technology and PSIVIDA Program
Technology.
6.5 Notices
of Termination.
In the
event that a Party has given the other Party any notice of termination of this
Agreement as allowable under Section 13 no further payments under Section 6.1
shall become due following the date of such notice.
Section
7. ACCOUNTING
AND PROCEDURES FOR PAYMENT.
7.1 Inter-Company
Sales.
Sales
between or among PFIZER, its Affiliates or sublicensees shall not be subject
to
royalties under Section 6. PFIZER shall be responsible for the payment of
royalties on Net Sales by its Affiliates or sublicensees to Third
Parties.
7.2 Currency.
All
royalty payments shall be computed and paid in United States dollars. For the
purposes of determining the amount of any Sales Milestone Payments or royalties
due for the relevant PFIZER Quarter, the amount of Net Sales in any foreign
currency shall be converted into United States dollars in a manner consistent
with PFIZER’s normal practices used to prepare its audited financial reports;
provided
that
such practices use a widely accepted source of published exchange
rates.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-25-
Confidential
7.3 Royalty
Payments.
PFIZER
shall make royalty payments to PSIVIDA with respect to each PFIZER Quarter
within sixty (60) days after the end of such PFIZER Quarter, and each payment
shall be accompanied by a report identifying the Licensed Product, each
applicable country, Net Sales for each such country, and the amount payable
to
PSIVIDA, as well as the computation thereof and the basis of any reductions
allowable under Section 6.3. Said reports shall be kept confidential by PSIVIDA
and not disclosed to any other party, other than PSIVIDA’s certified public
accountants which shall be obligated to keep such information confidential,
and
such information and reports shall only be used for purposes of this Agreement.
Said reports shall be considered PFIZER Confidential Information.
7.4 Method
of Payments.
Each
payment hereunder shall be made by electronic transfer in immediately available
funds via either a bank wire transfer, an ACH (automated clearing house)
mechanism, or any other means of electronic funds transfer, at PFIZER’s
election, to the bank account specified in Exhibit
F,
or to
such other bank account as PSIVIDA shall designate in a notice at least five
(5)
Business Days before the payment is due. All payments under this Agreement
shall
bear interest from the fifteenth (15th) day after the date due until paid at
a
rate equal to the thirty (30)-day United States dollar LIBOR rate in effect
on
the date that payment was due, as published by The Financial Times.
7.5 Inspection
of Records.
PFIZER
shall, and shall cause its Affiliates and sublicensees to, keep accurate books
and records setting forth gross sales of each Licensed Product, Net Sales of
each Licensed Product, and amounts payable hereunder to PSIVIDA for each such
Licensed Product. PFIZER shall permit, and shall cause its Affiliates and
sublicensees to permit, PSIVIDA, independent certified public accountants
employed by PSIVIDA and reasonably acceptable to PFIZER, to examine such books
and records at any reasonable time, upon reasonable notice, but not later than
[...]* years following the rendering of the corresponding royalty reports
pursuant to Section 7.3. The foregoing right of examination may be exercised
only once during each twelve (12)-month period of the Term. PFIZER may require
such accountants to enter into a reasonably acceptable confidentiality
agreement, and in no event shall such accountants disclose to PSIVIDA any
information, other than such as relates to the accuracy of the corresponding
royalty reports pursuant to Section 7.3. The opinion of said independent
accountants regarding such reports and related payments shall be binding on
the
Parties, other than in the case of manifest error. PSIVIDA shall bear the cost
of any such examination and review; provided
that if
the examination shows an underpayment of royalties of more than ten percent
(10%) of the amount due for the applicable period, then PFIZER shall promptly
reimburse PSIVIDA for all costs incurred in connection with such examination.
PFIZER shall promptly pay to PSIVIDA the amount of any underpayment of royalties
revealed by an examination. Any overpayment of royalties by PFIZER revealed
by
an examination shall be fully-creditable against future royalty payments under
6.3.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-26-
Confidential
7.6 Royalty
Report.
Upon
the expiration of the [...]* period following the rendering of a royalty report
pursuant to Section 7.3, such report shall be binding on the Parties, and PFIZER
and its Affiliates shall be released from any liability or accountability with
respect to royalties for the period covered by such report.
7.7 Tax
Matters.
(a) VAT.
It is
understood and agreed between the Parties that any payments made by PFIZER
under
this Agreement are inclusive of any value added or similar tax imposed upon
such
payments.
(b) Tax
Cooperation.
The
Parties agree to cooperate and produce on a timely basis any tax forms or
reports, including an IRS Form W-8BEN, reasonably requested by the other party
in connection with any payment made by PFIZER to PSIVIDA under this Agreement.
Each Party further agrees to provide reasonable cooperation to the other Party,
at the other Party’s expense, in connection with any official or unofficial tax
audit or contest relating to payments made by PFIZER to PSIVIDA under this
Agreement.
(c) Withholding
Tax Matters.
In
addition, in the event any of the payments made by PFIZER pursuant to Section
6
become subject to withholding taxes under the Laws of any jurisdiction, PFIZER
shall deduct and withhold the amount of such taxes for the account of PSIVIDA
to
the extent required by Law, such payment to PSIVIDA shall be reduced by the
amount of taxes deducted and withheld, and PFIZER shall pay the amount of such
taxes to the proper Governmental Authority in a timely manner and promptly
transmit to PSIVIDA an official tax certificate or other evidence of such tax
obligations, together with proof of payment from the relevant Governmental
Authority of all amounts deducted and withheld sufficient to enable PSIVIDA
to
claim such payment of taxes. [...]*. Any such withholding taxes required under
applicable Law to be paid or withheld shall be an expense of, and borne solely
by, PSIVIDA. PFIZER will provide PSIVIDA with reasonable assistance, at
PSIVIDA’s expense, to enable PSIVIDA to recover such taxes as permitted by
Law.
Section
8. PATENTS
AND INFRINGEMENT.
8.1 Ownership.
(a) PSIVIDA
Technology and Patent Rights.
Subject
to the terms and conditions of this Agreement, PSIVIDA or its Affiliates Control
all PSIVIDA Confidential Information and PSIVIDA Technology and all PSIVIDA
Patent Rights, except to the extent limited by the terms of the Alimera
Agreement, including, but not limited to, Sections 4.1, 5.1, 5.4 and 5.8
thereof, the B&L Agreement, including, but not limited to, Sections 2.1,
2.3, 2.4 and 2.5 thereof and the BMP Agreement, including Section 2
thereof.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(b) PFIZER
Technology and Patent Rights.
Subject
to the terms and conditions of this Agreement, PFIZER or its Affiliates Control
all PFIZER Confidential Information, PFIZER Technology, and PFIZER Patent
Rights.
(c) Program
Technology and Patent Rights.
In the
course of performing the Research Plan during the Research Term, PSIVIDA and
PFIZER contemplate the invention of Program Technology and Program Patent
Rights. PFIZER shall have sole ownership of any Program Technology and Program
Patent Rights to the extent they relate to (in the case of Program Technology)
or specifically claim (in the case of Program Patent Rights) (i) the Device
with
[...]* (respectively, “PFIZER
Program Technology”
and
“PFIZER
Program Patent Rights”),
regardless of the identity of the inventors. PSIVIDA shall have sole ownership
of Program Technology and Program Patent Rights to the extent they relate to
(in
the case of Program Technology) or claim (in the case of Program Patent Rights)
(I) improvements to the Device that [...]* (II) methods of manufacture or
monitoring the Device other than with respect to [...]* (III) the Device with
any composition of matter [...]* and (IV) method of use claims that are not
included under Section 8.1(c)(iv) (respectively, “PSIVIDA
Program Technology”
and
“PSIVIDA
Program Patent Rights”),
regardless of the identity of the inventors. For the avoidance of doubt, (A)
Program Technology and Program Patent Rights shall not include CDS Improvements
(as defined in the Alimera Agreement) and (B) notwithstanding any activities
under the Research Plan, PSIVIDA Patent Rights shall not be converted into
Program Patent Rights and PSIVIDA Program Patent Rights shall not be converted
into PFIZER Program Patent Rights.
(d) Cooperation.
PSIVIDA
and PFIZER shall cooperate and use reasonable efforts to file, prosecute and
maintain Patent Rights, including PSIVIDA Patent Rights, PSIVIDA Program Patent
Rights, PFIZER Patent Rights and PFIZER Program Patent Rights, licensed to
the
Parties under this Agreement to fully preserve the rights of both Parties.
For
example, the Parties will cooperate to develop filing strategies, such as filing
patent applications owned by each Party on the same day where
appropriate.
8.2 Off-Label
Use.
(a) Notwithstanding
anything to the contrary herein and subject to the obligations of PSIVIDA under
this Agreement, the Faber Agreement, the BMP Agreement, Sections 2.1.1 and
2.1.2
of the B&L Agreement and Sections 4.1, 5.1, 5.4 and 5.8 of the Alimera
Agreement, PSIVIDA shall not have the right under the PSIVIDA Technology, the
PSIVIDA Patent Rights, the PSIVIDA Program Technology or the PSIVIDA Program
Patent Rights to make, have made, use, sell, import or service products that
(A)
contain or incorporate (x) a Generic Compound that has been studied in animals
pursuant to terms and conditions of the Research Plan unless such Generic
Compound was the subject of prior (i.e., before such Generic Compound was
studied in animals under the Research Plan) pre-clinical animal studies by
PSIVIDA or (y) a PFIZER Proprietary Compound or (B) use a Device that could
reasonably be used to deliver a composition of matter into the eye of a patient
during an office visit through an incision smaller than that required for a
20
gauge needle.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(b) Without
limiting the obligations in Section 8.2(a), in the event a product that
incorporates or utilizes PSIVIDA Patent Rights, PSIVIDA Technology, PSIVIDA
Program Patent Rights or PSIVIDA Program Technology is sold by PSIVIDA or its
Affiliates, or any of its licensees or sublicensees, under a marketing
authorization granted by a Regulatory Authority to PSIVIDA for a use outside
the
Field and has annual unit sales in the Field in any country in the Territory
equal to an amount greater than [...]*% of the annual unit sales of a Licensed
Product in such country (unit sales based on data provided by IMS International
or if such data is not available from IMS International, such other reliable
data source as reasonably determined by PFIZER and reasonably agreed by
PSIVIDA), such product sold by PSIVIDA shall be designated a “Generic Product”
under this agreement and royalties shall be reduced with respect to such country
for the relevant Licensed Product with which it competes in compliance with
Section 6.3 hereof.
8.2A Use
by
PFIZER.
(a) PFIZER
agrees that PFIZER will not (1) grant a license to any Affiliate or Third Party
under the PFIZER Program Technology or the PFIZER Program Patent Rights to
make,
have made, use, offer to sell, sell, or import any devices or products [...]*
outside the Field in the Territory, and (2) itself use PFIZER Program Technology
or the PFIZER Program Patent Rights to make, have made, use, offer to sell,
sell, or import any devices or products [...]* outside the Field in the
Territory.
(c) PFIZER
agrees that PFIZER will not (1) grant a license to any Affiliate or Third Party
under the PSIVIDA Technology, the PSIVIDA Program Technology, the PSIVIDA Patent
Rights or the PSIVIDA Program Patent Rights to make, have made, use, offer
to
sell, sell, or import any devices or products [...]* outside the Field in the
Territory, and (2) itself use the PSIVIDA Technology, the PSIVIDA Program
Technology, the PSIVIDA Patent Rights or the PSIVIDA Program Patent Rights
to
make, have made, use, offer to sell, sell, or import any devices or products
[...]* outside the Field in the Territory.
(d) [...]*
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-29-
Confidential
8.3 Prosecution
and Maintenance of PSIVIDA Patent Rights and PSIVIDA Program Patent Rights
in
the Territory.
(a) Filing,
Prosecution, and Maintenance of PSIVIDA Patent Rights.
PSIVIDA
shall have primary responsibility for and control over the preparation, filing,
prosecution, and maintenance of PSIVIDA Patent Rights and the PSIVIDA Program
Patent Rights in the Territory. PSIVIDA shall have the authority to select
patent counsel, and to determine the form and content of such prosecution
documents and to make all decisions regarding whether to file, prosecute and
maintain patents and patent applications, and in which countries to do so.
PSIVIDA shall be [...]* of the Patent Costs associated with the PSIVIDA Patent
Rights and the PSIVIDA Program Patent Rights. PSIVIDA shall keep PFIZER
reasonably informed regarding the status of each patent or patent application
included within the PSIVIDA Patent Rights and the PSIVIDA Program Patent Rights
and shall provide PFIZER with copies of all official correspondence (including,
but not limited to, applications, office actions, responses, etc.) relating
to
prosecution and maintenance of these patent rights. PFIZER shall have the right
to review all pending patent applications and other proceedings, and to make
recommendations to PSIVIDA regarding the prosecution of such patent rights;
provided that all final decisions regarding the prosecution and maintenance
of
such PSIVIDA Patent Rights and PSIVIDA Program Patent Rights shall be made
by
PSIVIDA. Notwithstanding the foregoing, with respect to the PSIVIDA Program
Patent Rights, PSIVIDA agrees to act in good faith (i) to cooperate and
coordinate with PFIZER, as reasonably requested, on the prosecution and
maintenance of such PSIVIDA Program Patent Rights, including with respect to
when to file patent applications and (ii) to not take any action that would
impinge, impede or otherwise limit PFIZER from obtaining the broadest available
claims included within the definition of PFIZER Program Patent Rights in the
Territory.
(b) Abandonment
of PSIVIDA Patent Rights or PSIVIDA Program Patent Rights.
PSIVIDA
may, at its sole discretion, abandon any patent or pending patent application,
on a country-by-country and patent-by-patent or application-by-application
basis, within the PSIVIDA Patent Rights and PSIVIDA Program Patent Rights.
PSIVIDA shall not abandon prosecution or maintenance of any PSIVIDA Patent
Rights or PSIVIDA Program Patent Rights in the Territory without notifying
PFIZER in a timely manner of PSIVIDA’s intention and reason therefor and
providing PFIZER with reasonable opportunity to comment upon such abandonment
and to assume responsibility for prosecution or maintenance of such PSIVIDA
Patent Rights and/or PSIVIDA Program Patent Rights. In the event that PSIVIDA
abandons prosecution or maintenance of PSIVIDA Patent Rights or PSIVIDA Program
Patent Rights in any country in the Territory, PFIZER may assume prosecution
responsibility for such Patent Rights in that country; provided, however, that
such abandoned PSIVIDA Patent Rights or PSIVIDA Program Patent Rights shall
be
excluded from the definition of Valid Claim for the purposes of the Royalty
Term. The cancellation or amendment of a claim or claims during the prosecution
of a patent application, or during a reissue or reexamination proceeding with
respect to an issued patent, within the PSIVIDA Patent Rights or PSIVIDA Program
Patent Rights shall not in and of itself constitute a discontinuance or
abandonment under this section. Notwithstanding the foregoing, PFIZER’s rights
under this Section 8.3(b) with respect to PSIVIDA Patent Rights shall be subject
to rights granted to BMP under the BMP Agreement, including the rights set
forth
in Section 15 thereof, to Faber under the Faber Agreement, including Section
4.1
thereof, to Alimera under the Alimera Agreement, including the rights set forth
in Section 7.1 and 7.2 thereof, and to B&L under the B&L Agreement,
including the rights set forth in Article 9 thereof.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-30-
Confidential
(c) Information
Disclosure; Cooperation.
Subject
to any limitations imposed by the confidentiality obligations set forth in
the
BMP Agreement, Faber Agreement, Alimera Agreement and the B&L Agreement,
PSIVIDA shall disclose and make available to PFIZER all material information
controlled by PSIVIDA that is reasonably necessary for PFIZER to perform its
obligations and to exercise its rights under this Article 8. All such
information shall be disclosed to PFIZER reasonably promptly after it is first
developed or learned or its significance is first appreciated. PSIVIDA agrees
to
cooperate with PFIZER with respect to the preparation, filing, prosecution
and
maintenance of patents and patent applications pursuant to this Article
8.
8.4 Enforcement
of PSIVIDA Patent Rights and PSIVIDA Program Patent Rights.
(a) Notification.
During
the Term, each of the Parties shall promptly notify the other in the event
they
learn of any known infringement or suspected infringement of any of the PSIVIDA
Patent Rights or PSIVIDA Program Patent Rights that cover a Licensed Product
and
shall provide the other Party with all available evidence supporting said
infringement or suspected infringement.
(b) Enforcement.
[...]*,
but not the obligation, to initiate or prosecute an infringement or other
appropriate suit or action against any Third Party who at any time has infringed
or is suspected of infringing (an “Infringer”),
any
of the PSIVIDA Patent Rights or PSIVIDA Program Patent Rights covering a
Licensed Product. [...]* sufficient advance notice of its intent to file said
suit and the reasons therefore, and shall provide [...]* with an opportunity
to
make suggestions and comments regarding such filing; provided, however, that
[...]* shall provide any such comments sufficiently in advance of any filing
dates to allow for consideration by [...]*, and further provided that it shall
be within [...]* sole discretion whether to incorporate such suggestions or
comments. [...]* shall keep [...]* reasonably informed of the status and
progress of the litigation. [...]* shall have the sole and exclusive right
to
select counsel for any such suit and action and shall pay all expenses of the
suit, including, but not limited to, attorneys’ fees and court costs. If [...]*
has not taken legal action or been successful in obtaining cessation of the
infringement within (a) ninety (90) days from the date of notice by either
Party
under Section 8.4(a); or (b) thirty (30) days after [...]* notifies [...]*
that
[...]* would like to move for injunctive relief; or (c) ten (10) days before
the
expiration of a period of time set by applicable Law in which action must be
taken with respect to the alleged infringement (e.g., as may be required under
the Hatch-Waxman Act and 35 USC §271), then, subject to the rights with respect
to the PSIVIDA Patent Rights granted to BMP under the BMP Agreement, including
Section 17 thereof, to Faber under the Faber Agreement, including 4.2 thereof,
to Alimera under the Alimera Agreement, including Section 7.6 thereof, and
to
B&L under the B&L Agreement, including Article 10 thereof, [...]* shall
have the right to bring suit against an Infringer at [...]* own expense.
[...]*
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
[...]*
(c) Upon
request of the other Party, either Party shall join as a party to or shall
commence the suit on behalf of the other Party if required for standing, at
the
other Party’s expense, and shall offer reasonable assistance to the other Party
in connection therewith at its own expense. Any damages, royalties, settlement
fees or other consideration for infringement resulting from such suit shall
be
distributed as follows: (i) first, each Party shall be reimbursed for its
reasonable out-of-pocket costs paid in connection with the proceeding; and
(ii)
thereafter, PFIZER will receive [...]* and PSIVIDA will receive [...]* of any
damages, royalties, settlement fees or other consideration. Neither Party shall
settle any such action or otherwise consent to an adverse judgment in any such
action that adversely affects the rights or interests of the other Party under
this Agreement, including, without limitation, issues of validity of the PSIVIDA
Patent Rights or PSIVIDA Program Patent Rights, without the prior written
consent of the other Party.
(d) UKRF.
If
neither Party commences actions or proceedings against Infringers or
unauthorized users of any PSIVIDA Patent Rights that have been licensed from
UKRF within the time periods specified above, UKRF shall, at its expense, have
the right to initiate and pursue such action and receive all resulting
benefits.
8.5 Prosecution
and Maintenance of PFIZER Patent Rights and PFIZER Program Patent Rights in
the
Territory.
(a) Filing,
Prosecution and Maintenance of Patents.
PFIZER
shall have primary responsibility for and control over the preparation, filing,
prosecution, and maintenance of PFIZER Patent Rights and the PFIZER Program
Patent Rights in the Territory. PFIZER may elect to prosecute the PFIZER Patent
Rights and/or the PFIZER Program Patent Rights using in-house counsel or may
select outside patent counsel to do so, which election shall be at PFIZER’s sole
discretion. PFIZER shall have sole discretion to determine the form and content
of such prosecution documents and to make all decisions regarding whether to
file, prosecute and maintain patents and patent applications, and in which
countries to do so. PFIZER shall be [...]* of the Patent Costs associated with
the PFIZER Patent Rights and the PFIZER Program Patent Rights. PFIZER shall
keep
PSIVIDA reasonably informed regarding the status of each patent or patent
application included within the PFIZER Program Patent Rights and shall provide
PSIVIDA with copies of all official correspondence (including, but not limited
to, applications, office actions, responses, etc.) relating to prosecution
and
maintenance of these patent rights. PSIVIDA shall have the right to review
all
pending patent applications and other proceedings, and to make recommendations
to PFIZER regarding the prosecution of such PFIZER Program Patent Rights;
provided that all final decisions regarding the prosecution and maintenance
of
such patent rights shall be made by PFIZER. Notwithstanding the foregoing,
with
respect to the PFIZER Program Patent Rights, PFIZER agrees to act in good faith
(i) to cooperate and coordinate with PSIVIDA, as reasonably requested, on the
prosecution and maintenance of such PFIZER Program Patent Rights, including
with
respect to when to file patent applications and (ii) to not take any action
that
would impinge, impede or otherwise limit PSIVIDA from obtaining the broadest
available claims included within the definition of PSIVIDA Program Patent Rights
in the Territory.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(b) Abandonment.
PFIZER
may, at its sole discretion, abandon any patent or pending patent application,
on a country-by-country and patent-by-patent or application-by-application
basis, within the PFIZER Patent Rights and the PFIZER Program Patent Rights.
PFIZER shall not abandon prosecution or maintenance of any PFIZER Program Patent
Rights in the Territory without notifying PSIVIDA in a timely manner of PFIZER’s
intention and reason therefore and providing PSIVIDA with reasonable opportunity
to comment upon such abandonment.
(c) Information
Disclosure; Cooperation.
PFIZER
shall disclose and make available to PSIVIDA all material information controlled
by PFIZER that is reasonably necessary for PSIVIDA to perform its obligations
and to exercise its rights under this Article 8. All such information shall
be
disclosed to PSIVIDA reasonably promptly after it is first developed or learned
or its significance is first appreciated. PFIZER agrees to cooperate with
PSIVIDA with respect to the preparation, filing, prosecution and maintenance
of
patents and patent applications pursuant to this Article 8.
8.6 Enforcement
of PFIZER Patent Rights and PFIZER Program Patent Rights.
(a) Notification.
During
the Term, each of the Parties shall promptly notify the other in the event
they
learn of any known infringement or suspected infringement of any of the PFIZER
Patent Rights, PFIZER Program Patent Rights that cover a Licensed Product and
shall provide PFIZER with all available evidence supporting said infringement
or
suspected infringement.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(b) Enforcement.
PFIZER
shall have the exclusive right, but not the obligation, to initiate or prosecute
an infringement or other appropriate suit or action against any Infringer of
the
PFIZER Patent Rights or the PFIZER Program Patent Rights covering a Licensed
Product. With respect to any suit against an Infringer of a PFIZER Program
Patent Right, PFIZER shall give PSIVIDA sufficient advance notice of its intent
to file said suit and the reasons therefore, and shall provide PSIVIDA with
an
opportunity to make suggestions and comments regarding such filing; provided,
however, that PSIVIDA shall provide any such comments sufficiently in advance
of
any filing dates to allow for consideration by PFIZER, and further provided
that
it shall be within PFIZER’s sole discretion whether to incorporate such
suggestions or comments. PFIZER shall keep PSIVIDA reasonably informed of the
status and progress of the litigation. PFIZER shall have the sole and exclusive
right to select counsel for any such suit and action and shall pay all expenses
of the suit, including, but not limited to, attorneys’ fees and court costs. For
the avoidance of doubt, in the event PFIZER does not initiate or prosecute
an
infringement against an Infringer of a PFIZER Patent Right or a PFIZER Program
Patent Right, PSIVIDA shall not have the right to bring such
action.
(c) Upon
request of the other Party, either Party shall join as a party to the suit,
or
shall commence the suit on behalf of the other Party if required for standing,
at the other Party’s expense, and shall offer reasonable assistance to the other
Party in connection therewith at its own expense. Any damages, royalties,
settlement fees or other consideration for infringement resulting from such
suit
shall be distributed as follows: (i) first, each Party shall be reimbursed
for
its reasonable out-of-pocket costs paid in connection with the proceeding;
and
(ii) thereafter, PFIZER will receive [...]* and PSIVIDA will receive [...]*
of
any damages, royalties, settlement fees or other consideration. Neither Party
shall settle any such action or otherwise consent to an adverse judgment in
any
such action that adversely affects the rights or interests of the other Party
under this Agreement, including, without limitation, issues of validity of
the
PFIZER Program Patent Rights, without the prior written consent of the other
Party.
8.7 Patent
Term Extension.
PFIZER
shall have the exclusive right to seek, at PFIZER’s expense, patent term
extensions or supplemental patent protection, including supplementary protection
certificates, in any country in the Territory in relation to each of the
Licensed Products and under any of the PFIZER Patent Rights and PFIZER Program
Patent Rights. Subject to the rights of Alimera under Section 7.6 of the Alimera
Agreement and B&L under Section 10 of the B&L Agreement, PFIZER shall
have the right to seek, at PFIZER’s expense, a patent term extension or
supplemental patent protection, including supplementary protection certificate,
in any country in the Territory in relation to each of the Licensed Products
under any one patent under the PSIVIDA Patent Rights. PFIZER shall also have
the
right to seek, at PFIZER’s expense, a patent term extension or supplemental
patent protection, including supplementary protection certificates, in any
country in the Territory in relation to each of the Licensed Products under
any
one patent under the PSIVIDA Program Patent Rights. [...]*
For the
avoidance of doubt, any extension or supplemental protection obtained by PFIZER
in compliance with the foregoing shall be included in the definition of Valid
Claim for the purposes of the Royalty Term. PFIZER and PSIVIDA shall cooperate
in connection with all such activities, and PFIZER, its agents and attorneys
will give due consideration to all timely suggestions and comments of PSIVIDA
regarding any such activities; provided that all final decisions shall be made
by PFIZER.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
8.8 Orange
Book Listings.
With
respect to filings in the FDA Orange Book (and foreign equivalents) for issued
patents for a Licensed Product for which PFIZER applies for or holds an NDA,
PFIZER shall have the exclusive right and shall be solely responsible at its
expense for fulfilling its obligations under applicable law to list any
applicable PSIVIDA Patent Rights, PSIVIDA Program Patent Rights, PFIZER Patent
Rights, and PFIZER Program Patent Rights. PFIZER will be solely responsible
for
any such filings and listings, and for any and all decisions with respect to
such filings and listings.
8.9 Patent
Invalidity Claim with Respect to PSIVIDA Patent Rights and PSIVIDA Program
Patent Rights.
During
the Term, each of the Parties shall promptly notify the other in the event
of
any legal or administrative action by any Third Party against a PSIVIDA Patent
Right or a PSIVIDA Program Patent Right of which it becomes aware, including
any
nullity, revocation, reexamination or compulsory license proceeding. [...]*
shall have the first right, but not the obligation, to defend against any such
action involving a PSIVIDA Patent Right or a PSIVIDA Program Patent Right,
[...]*.
8.10 Patent
Invalidity Claim with Respect to PFIZER Patent Rights and PFIZER Program Patent
Rights.
During
the Term, each of the Parties shall promptly notify the other in the event
of
any legal or administrative action by any Third Party against a PFIZER Patent
Right or a PFIZER Program Patent Right of which it becomes aware, including
any
nullity, revocation, reexamination or compulsory license proceeding. PFIZER
shall have the first right, but not the obligation, to defend against any such
action involving a PFIZER Patent Right or a PFIZER Program Patent Right, in
its
own name, and the costs of any such defense shall be at PFIZER’s expense.
PSIVIDA, upon request of PFIZER, agrees to join in any such action and to
cooperate reasonably with PFIZER; provided that PFIZER shall promptly reimburse
all out-of-pocket expenses (including reasonable counsel fees and expenses)
actually incurred by PSIVIDA in connection with such cooperation. [...]* PFIZER,
upon request of PSIVIDA, agrees to join in any such action and to cooperate
reasonably with PSIVIDA; provided that PSIVIDA shall promptly reimburse all
out-of-pocket expenses (including reasonable counsel fees and expenses) actually
incurred by PFIZER in connection with such cooperation. For the avoidance of
doubt, in the event PFIZER does not defend against any such action involving
PFIZER Patent Rights, PSIVIDA shall not have the right to defend such
action.
8.11 Notification
of Third Party Claim.
Each
Party shall promptly report in writing to the other Party during the Term of
this Agreement any claim or allegation by any Third Party that the development
or commercialization of any Device, Formulation or Licensed Product infringes
the intellectual property rights of any Third Party and shall provide the other
Party with all available evidence supporting said infringement or suspected
infringement.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(a) Responsibility.
PFIZER
shall have the initial right, but not the obligation, to defend any suit or
action initiated by any Third Party alleging solely that a Licensed Product
developed or commercialized hereunder has infringed, or is suspected of
infringing any Third Party intellectual property rights. Upon PFIZER’s request,
PSIVIDA shall join such suit or action and shall offer reasonable assistance
to
PFIZER in connection therewith at PFIZER’s expense. PFIZER shall give PSIVIDA
advance notice of its intent to defend any said suit and shall provide PSIVIDA
with an opportunity to make suggestions and comments regarding such defense;
provided, however, that PSIVIDA shall provide any such comments sufficiently
in
advance of any filing dates to allow for consideration by PFIZER, and further
provided that it shall be within PFIZER’s sole discretion whether to incorporate
such suggestions or comments. PFIZER shall keep PSIVIDA reasonably informed
of
the status and progress of the litigation. PFIZER shall have the sole and
exclusive right to select counsel for any such suit and action and shall pay
all
expenses of the suit, including, but not limited to, attorneys’ fees and court
costs. PFIZER shall have the right to settle any such litigation and shall
specifically have the right, whether or not litigation commences, to negotiate
a
license or other rights from any Third Party authorizing the use of Third Party
intellectual property rights in connection with the Licensed Products; provided,
however, that PFIZER shall not settle any such action, or otherwise consent
to
an adverse judgment in any such action, or make any admission in any such
license and negotiation that adversely affects the rights or interests of
PSIVIDA under this Agreement, including, without limitation, issues of validity
of the PSIVIDA Patent Rights or PSIVIDA Program Patent Rights, without the
prior
written consent of PSIVIDA. Any such license shall be at arm’s length and
otherwise on terms and conditions as may be deemed appropriate in the reasonable
business judgment of PFIZER. PFIZER shall provide PSIVIDA with a copy of any
such license promptly after its execution.
(b) If
PFIZER
does not defend a claim, suit or proceeding as set forth above within ninety
(90) days of the date PFIZER was reasonably aware or notified of the Third
Party
claim alleging infringement (or within such shorter period as may be necessary
for submitting or filing a response), then PSIVIDA may, in its sole discretion,
elect to defend such claim, suit or proceeding, using counsel of its own choice
and the provisions of Section 8.11(a) shall apply as if the term “PSIVIDA” were
changed to “PFIZER” and the term “PFIZER” were changed to
“PSIVIDA”.
8.12 Third
Party Royalty Obligations.
If
PFIZER (a) reasonably determines in good faith that, in order to avoid
infringement of any patent not licensed hereunder, it is reasonably necessary
to
obtain a license from a Third Party in order to make, use, sell, offer for
sale,
supply, cause to be supplied, or import a Licensed Product in a country in
the
Territory (excluding any license that is solely required by PFIZER to make,
use,
sell, offer for sale, supply, cause to be supplied, or import a PFIZER Compound
in such country), and to pay a royalty or other consideration under such license
(including in connection with the settlement of a patent infringement claim),
or
(b) shall be subject to a final court or other binding order or ruling requiring
any payments, including the payment of a royalty to a Third Party patent holder
in respect of sales of any Licensed Product in a country in the Territory,
then,
without limiting PSIVIDA’s obligations under Section 14.1(a), the amount of
PFIZER’s royalty payments under Section 6.3 with respect to Net Sales for such
Licensed Product in such country shall be reduced by [...]* of the amount
payable by PFIZER to such Third Party, [...]*.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-36-
Confidential
Section
9. CONFIDENTIALITY;
PUBLICATION.
9.1 Confidential
Information.
(a) PFIZER
and PSIVIDA each agree that during the Term and for five (5) years after the
Term, it will keep confidential, and will cause its Affiliates to keep
confidential, all of the other party’s Confidential Information that is
disclosed to it, or to any of its Affiliates. PFIZER and PSIVIDA each agree
to
take such action, and to cause its Affiliates to take such action, to preserve
the confidentiality of PSIVIDA Confidential Information and PFIZER Confidential
Information, respectively, as it would customarily take to preserve the
confidentiality of its own similar types of confidential
information.
(b) Each
of
PFIZER, PSIVIDA and their respective Affiliates agree (i) to use PSIVIDA
Confidential Information and PFIZER Confidential Information, respectively,
only
as expressly permitted in this Agreement and (ii) not to disclose PSIVIDA
Confidential Information and PFIZER Confidential Information, respectively,
to
any Third Parties under any circumstance without the prior consent of the other
Party, except as expressly permitted in this Agreement.
(c) Notwithstanding
anything to the contrary in this Section 9, PFIZER may disclose PSIVIDA
Confidential Information (i) to Governmental Authorities (a) to the extent
desirable to obtain or maintain INDs or Regulatory Approvals for any Formulation
or Licensed Product within the Territory for use in the Field, and (b) in order
to respond to inquiries, requests or investigations relating to this Agreement;
(ii) to outside consultants, contractors, advisory boards, managed care
organizations, and non-clinical and clinical investigators, in each case to
the
extent desirable to develop, register or market any PFIZER Compound, Formulation
or Licensed Product; provided that PFIZER shall obtain the same confidentiality
obligations from such Third Parties as it obtains with respect to its own
similar types of confidential information; (iii) in connection with filing
or
prosecuting Patent Rights or trademark rights as permitted by this Agreement,
(iv) in connection with prosecuting or defending litigation as permitted by
this
Agreement, (v) in connection with or included in scientific
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
-37-
Confidential
presentations
and publications relating to PFIZER Compounds, Formulations or Licensed
Products, including abstracts, posters, journal articles and the like, and
(vi)
to the extent necessary or desirable in order to enforce its rights under this
Agreement. Notwithstanding anything to the contrary in this Section 9, PSIVIDA
may disclose PFIZER Confidential Information to: (i) Governmental Authorities
in
order to respond to inquiries, requests or investigations relating to this
Agreement; (ii) to the extent necessary or desirable in order to enforce its
rights under this Agreement; (iii) in connection with filing or prosecuting
Patent Rights or trademark rights as permitted by this Agreement and (iv) in
connection with prosecuting or defending litigation as permitted by this
Agreement. PSIVIDA further agrees that it will not, and will cause its
Representatives not to, share any PFIZER Confidential Information with (x)
any
Affiliate that becomes an Affiliate in connection with a Change of Control
or
(y) any Representatives of PSIVIDA who become Representatives in connection
with
such Change of Control (except for purposes of this Section 9.1, the definition
of Change of Control shall be read omitting all references to “that is a Large
Pharmaceutical Company” or “that contains a Large Pharmaceutical Company”
appearing therein and shall be construed accordingly). If any such Change of
Control of PSIVIDA occurs, PSIVIDA shall promptly notify PFIZER, share with
PFIZER the polices and procedures it plans to implement in order to protect
the
confidentiality of PFIZER Confidential Information prior to such implementation
and make any adjustments to such policies and procedures that are reasonably
requested by PFIZER. In addition, either Party may disclose the terms of this
Agreement to any investors or potential investors, lenders, and other potential
financing sources, or to a Third Party in connection with a merger or
acquisition or proposed merger or acquisition or a license or proposed licenses
of the technology or intellectual property licensed hereunder, and to
Affiliates, attorneys, accountants, stockholders, investment bankers, advisers
or other consultants of the foregoing, in each case provided that the Person
to
which such disclosure is made is obligated by written agreement to keep such
information confidential on essentially the same terms as set forth herein
and
to use such Confidential Information solely to evaluate such investment,
financing, acquisition, merger or license.
9.2 Publication.
PSIVIDA
shall not, and shall cause, its Affiliate and its Affiliates’ employees,
consultants, contractors, licensees and agents not to publish or present any
information with respect to any PFIZER Compounds, formulations related thereto
or Licensed Products without PFIZER’s prior written consent (which may be
withheld in its sole and final discretion), except as may be required by Law
or
legal proceedings.
9.3 Publicity.
The
public announcement of the execution of this Agreement is set forth on
Exhibit
C
attached
hereto and shall be promptly disseminated following the execution of this
Agreement by both Parties. Except as set forth in Section 9.2, a Party may
not
make any public statement (written or oral), including in analyst meetings,
concerning the terms of, or events related to, this Agreement or concerning
any
PFIZER Compound or concerning a
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
Licensed
Product, except where such statement: (a) is required by Law or legal
proceedings, (b) is required to be contained in PSIVIDA or PFIZER financial
statements prepared in accordance with generally acceptable accounting
principles in the United States, (c) concerns one of the events described in
Schedule
9.3(c);
provided
that
PSIVIDA may only make a public statement concerning the events described in
Schedule
9.3(c)
as
follows: (i) jointly with PFIZER, (ii) with PFIZER’s prior approval of the text
of such statement and in compliance with the other provisions of this Section
9.3 or (iii) after PFIZER has made a public statement with respect thereto,
so
long as PSIVIDA’s public statement is consistent therewith; (d) has been
announced previously in accordance with this Section 9.3, or (e) has been
announced previously by either Party, so long as in the case of clause (d)
or
(e), such public statement is consistent with such previously announced
statement. In the case of any public statement (written or oral) that is
required by Law or legal proceedings, each Party shall (i) use commercially
reasonable efforts to obtain confidential treatment of financial and trade
secret information, and (ii) if reasonably practicable under the circumstances,
give the other Party sufficient advance notice of the text so that such Party
will have the opportunity to comment upon the statement, and give due
consideration to any such comments in the final statement.
9.4 Filing,
Registration or Notification of the Agreement.
If a
Party determines that it is required by Law to publicly file, register or notify
this Agreement with a Governmental Authority, such Party shall (i) initially
file a copy of this Agreement excluding, at a minimum, the provisions redacted
from the form of Agreement in Exhibit
D
attached
hereto (the “Redacted
Agreement”),
(ii)
request, and use commercially reasonable efforts to obtain, confidential
treatment of all terms redacted from this Agreement, as reflected in the
Redacted Agreement, for a period of at least ten (10) years, (iii) permit the
other Party to review and approve such request for confidential treatment and
any subsequent correspondence with respect thereto at least five (5) Business
Days prior to its submission to such Governmental Authority, (iv) promptly
deliver to the other party any written correspondence received by it or its
representatives from such Governmental Authority with respect to such
confidential treatment request and promptly advise the other party of any other
communications between it or its representatives with such Governmental
Authority with respect to such confidential treatment request, (v) upon the
written request of the other Party, request an appropriate extension of the
term
of the confidential treatment period, and (vi) if such Governmental Authority
requests any changes to the redactions set forth in the Redacted Agreement,
use
commercially reasonable efforts to support the redactions in the Redacted
Agreement as originally filed and shall not agree to any changes to the Redacted
Agreement without first discussing such changes with the other Party and taking
the other Party’s comments into consideration when deciding whether to agree to
such changes. Each Party shall be responsible for its own legal and other
external costs in connection with any such filing, registration or
notification.
Section
10. REPRESENTATIONS
AND WARRANTIES.
10.1 PSIVIDA
Representations and Warranties.
As of
the Effective Date, PSIVIDA hereby represents and warrants to PFIZER as
follows:
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Confidential
(a) PSIVIDA
has the corporate power and authority to execute and deliver this Agreement
and
to perform its obligations hereunder, and the execution, delivery and
performance of this Agreement by PSIVIDA have been duly and validly authorized
and approved by proper corporate action on the part of PSIVIDA, and PSIVIDA
has
taken all other action required by Law, its certificate of incorporation,
by-laws or other organizational documents or any agreement to which it is a
party or to which it may be subject required to authorize such execution,
delivery and performance. Assuming due authorization, execution and delivery
on
the part of PFIZER, this Agreement constitutes a legal, valid and binding
obligation of PSIVIDA, enforceable against PSIVIDA in accordance with its
terms.
(b) The
execution and delivery of this Agreement by PSIVIDA and the performance by
PSIVIDA contemplated hereunder does not and will not violate any Laws or any
order of any court or Governmental Authority.
(c) [...]*,
the patents encompassed within the PSIVIDA Patent Rights as of the Effective
Date, are, or, upon issuance, will be, valid and enforceable patents and no
Third Party (i) is infringing any such patents relating to the Medidur Device
or
a bioerodible form of the Medidur Device as of the Effective Date or (ii) has
challenged the extent, validity or enforceability of such patents (including
by
way of example through the institution or written threat of institution of
interference, nullity or similar invalidity proceedings before the United States
Patent and Trademark Office or any analogous foreign entity).
(d) To
the
knowledge of PSIVIDA, the manufacture, use, sale, offer for sale, supply or
importation by PSIVIDA or PFIZER (or their respective Affiliates) of the Medidur
Device would not infringe any claim of any issued patent of any Third Party
or,
if and when issued, any claim within any published patent application of any
Third Party.
(e) Exhibit
A
contains
a complete and correct list of all patents and patent applications owned by
or
otherwise Controlled by PSIVIDA (and indicating which entity owns or Controls
each patent and patent application and which are owned and which are Controlled)
relating to the Device.
(f) Except
as
set forth in Exhibit
G,
PSIVIDA
is the sole legal and beneficial owner of all the PSIVIDA Patent Rights and
PSIVIDA Technology, free of any lien, encumbrance, charge, security interest,
mortgage or other similar restriction, and no person, firm, corporation,
governmental agency, or other entity (including any Affiliate of PSIVIDA) has
any right, interest or claim in or to, and neither PSIVIDA nor any of its
Affiliates has entered into any agreement granting to any Third Party (including
any academic, governmental organization or agency) any right, interest or claim
in or to, any PSIVIDA Patent Rights or PSIVIDA Technology. PSIVIDA has not
received any written request pursuant to Section 5.8.2 of the Alimera Agreement
with respect to any of the PFIZER Compounds listed by PFIZER in Exhibit B-2.
PSIVIDA has not received any written notice from Alimera pursuant to Section
5.8.1 of the Alimera Agreement indicating Alimera’s intention to exercise the
Alimera Compound Option (as defined under the Alimera Agreement).
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(g) The
UKRF
Licenses as heretofore delivered by PSIVIDA to PFIZER represent the complete
agreements and understandings between UKRF and PSIVIDA relating to the PSIVIDA
Patent Rights and PSIVIDA Technology which are the subject of the UKRF Licenses.
Each of the agreements and understandings related to UKRF Licenses is listed
in
Exhibit
K.
The
UKRF Licenses have not been modified, supplemented or amended, other than by
amendments thereto provided to PFIZER prior to the execution date of this
Agreement. Except for the UKRF Licenses, there are no agreements to which
PSIVIDA or any of its Affiliates is a party pursuant to which PSIVIDA or any
of
its Affiliates has a license, or an option to obtain a license, or holds an
immunity from suit, with respect to patents which (i) are pending, applied
for,
granted or registered as of the Effective Date, and (ii) but for PSIVIDA’s
rights under such agreements, could be asserted by Third Parties to be infringed
by the distribution, use, or sale of Devices. PSIVIDA has previously delivered
to PFIZER all of its agreements with any Third Parties regarding supply and
manufacture of all goods and services relating to Devices, none of which have
been modified, supplemented or amended; and (ii) the UKRF License is in full
force and effect, all payments to date required to be made thereunder by PSIVIDA
have been made, and PSIVIDA is in compliance in all respects with its respective
obligations thereunder. [...]*.
(h) The
Faber
Agreement, BMP Agreement, Alimera Agreement and the B&L Agreement as
heretofore delivered by PSIVIDA to PFIZER represent the complete agreements
and
understanding between Faber and PSIVIDA, BMP and PSIVIDA, Alimera and PSIVIDA
and B&L and PSIVIDA, respectively. None of the Faber Agreement, BMP
Agreement, Alimera Agreement or the B&L Agreement has been modified,
supplemented or amended, other than by amendments thereto provided to PFIZER
prior to the execution date of this Agreement, and list of such agreements
and
understandings is listed in Exhibit
K.
(i) Except
for the agreements listed on Exhibit
J,
PSIVIDA
is not a party to any agreement or understanding with any Third Parties with
respect to the manufacture or sale of Devices as they may relate to Licensed
Products.
(j) Except
as
set forth in the UKRF Licenses and the B&L Agreement, none of the PSIVIDA
Patent Rights or PSIVIDA Technology have been licensed or otherwise made
available (including pursuant to any immunity from suit arrangement) to PSIVIDA
or any of its Affiliates from a Third Party.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(k) PSIVIDA
has heretofore disclosed to PFIZER all material scientific and technical
information in PSIVIDA’s possession and Control and all information relating to
safety and efficacy known to it or its Affiliates prior to the Effective Date
with respect to the Medidur Device.
(l) PSIVIDA
has heretofore disclosed to PFIZER all material correspondence and contact
information between PSIVIDA and the FDA and any other Governmental Authorities
prior to the Effective Date regarding the Medidur Device.
(m) Neither
the execution and delivery of this Agreement nor the performance hereof by
PSIVIDA requires PSIVIDA to obtain any permits, authorizations or consents
from
any Governmental Authority (other than any Regulatory Approvals relating to
the
performance of the Research Plan or manufacture of clinical supply) or from
any
other person, firm or corporation, and such execution, delivery and performance
will not result in the breach of or give rise to any right of termination,
rescission, renegotiation or acceleration under, or trigger any other rights
under, any agreement or contract to which PSIVIDA is a party or to which it
may
be subject that relates to the PSIVIDA Patent Rights, the PSIVIDA Technology
or
the Device.
(n) There
is
no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
summons, subpoena, inquiry or investigation of any nature, civil, criminal,
regulatory or otherwise, in law or in equity, pending or, to the knowledge
of
PSIVIDA, threatened against PSIVIDA, any of its Affiliates, in each case in
connection with the PSIVIDA Patent Rights, the PSIVIDA Technology, the Device
or
relating to the transactions contemplated by this Agreement.
10.2 PFIZER
Representations and Warranties.
As of
the Effective Date, PFIZER hereby represents and warrants to PSIVIDA as
follows:
(a) PFIZER
has the corporate power and authority to execute and deliver this Agreement
and
to perform its obligations hereunder, and the execution, delivery and
performance of this Agreement by PFIZER have been duly and validly authorized
and approved by proper corporate action on the part of PFIZER, and PFIZER has
taken all other action required by Law, its certificate of incorporation or
by-laws, or any agreement to which it is a party or to which it may be subject,
required to authorize such execution, delivery and performance. Assuming due
authorization, execution and delivery on the part of PSIVIDA, this Agreement
constitutes a legal, valid and binding obligation of PFIZER, enforceable against
PFIZER in accordance with its terms.
(b) The
execution and delivery of this Agreement by PFIZER and the performance by PFIZER
contemplated hereunder does not and will not violate any Laws or any order
of
any court or Governmental Authority.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(c) Neither
the execution and delivery of this Agreement nor the performance hereof by
PFIZER requires PFIZER to obtain any permits, authorizations or consents from
any Governmental Authority (other than any regulatory approvals relating to
the
manufacture, use, importation or sale of any Devices, Formulations or Licensed
Product) or from any other person, firm or corporation, and such execution,
delivery and performance will not result in the breach of or give rise to any
right of termination under any agreement or contract to which PFIZER is a party
or to which it may be subject, except for those breaches or rights that would
not adversely affect the ability of PFIZER to perform its obligations under
this
Agreement.
(d) There
is
no action, claim, demand, suit, proceeding, arbitration, grievance, citation,
summons, subpoena, inquiry or investigation of any nature, civil, criminal,
regulatory or otherwise, in law or in equity, pending or, to the knowledge
of
PFIZER, threatened against PFIZER or any of its Affiliates relating to the
transactions contemplated by this Agreement.
10.3 Disclaimer
of Warranty.
EXCEPT
AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO COMPOUNDS, DEVICES,
FORMULATIONS, LICENSED PRODUCTS, PSIVIDA PATENT RIGHTS, OR PSIVIDA TECHNOLOGY.
EXCEPT AS OTHERWISE PROVIDED IN THIS SECTION 10, EACH PARTY EXPRESSLY DISCLAIMS
ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.
Section
11. ADDITIONAL
COVENANTS.
11.1 Except
to
the same extent that this Agreement may be assigned under Section 16.8, PSIVIDA
shall not (and shall cause its Affiliates not to) sell, assign or otherwise
transfer to any person any PSIVIDA Patent Rights, PSIVIDA Program Patent Rights,
any PSIVIDA Technology, PSIVIDA Program Technology (or agree to do any of the
foregoing). Except for grants of licenses or other similar rights by PSIVIDA
outside the Field to Third Parties to the extent consistent with this Agreement
and except to the extent incurred or permitted to exist under the agreements
set
forth on Exhibit
G
as of
the date hereof, PSIVIDA hereby covenants and agrees that PSIVIDA shall not
incur or permit to exist (and shall cause each of its Affiliates not to incur
or
permit to exist), with respect to any PSIVIDA Patent Rights, PSIVIDA Program
Patent Rights, PSIVIDA Technology, PSIVIDA Program Technology, any lien,
encumbrance, charge, security interest, mortgage, liability or other restriction
(including in connection with any indebtedness).
11.2 PSIVIDA
(a) shall not execute or otherwise permit, and shall cause its Affiliates to
refrain from executing or otherwise permitting, any amendment, modification,
consent or waiver to the UKRF Licenses, the Faber Agreement, the BMP Agreement,
the Alimera Agreement or the B&L Agreement in a manner that would adversely
affect the rights of PFIZER hereunder, without the prior written consent of
PFIZER, (b) shall not make any election or exercise any right or option (or
omit
to take any action) which would, and shall cause its Affiliates to refrain
from
making any election or exercising any right or option (or omitting to take
any
action) which would, terminate or relinquish in whole or in part any right
under
a UKRF License, (c) shall comply, and shall cause its Affiliates to comply
in
all material respects, with all of its, and its Affiliates’ obligations under
the UKRF Licenses, the Faber Agreement, the BMP Agreement, the Alimera Agreement
and the B&L Agreement, (d) shall take, and shall cause its Affiliates to
take, such actions as shall be necessary to keep in full force and effect the
UKRF Licenses, and (e) shall give prompt notice to PFIZER, together with a
detailed summary of outstanding issues if PFIZER so requests, of any notice
received from the Third Party, of any actual or alleged defaults, breaches,
violations, proposed amendments or proposed modifications of, or any proposed
waivers under, any of the UKRF Licenses by any of the parties
thereto.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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11.3 Each
of
PSIVIDA and PFIZER shall conduct, and shall use reasonable efforts to cause
its
Affiliates to conduct, all its activities contemplated under this Agreement
in
accordance with all applicable Laws of the country in which such activities
are
conducted.
11.4 Irrespective
of whether or not the Additional Investment is made under the terms of the
Stock
Purchase Agreement or the Second Stock Purchase Agreement, as the case may
be,
as soon as PSIVIDA is permitted under its current agreements with Third Parties,
PSIVIDA will enter into the Security Agreement. [...]*. PSIVIDA will not enter
into any financing, incur any indebtedness or enter into any other agreement
or
arrangement with a Third Party that would prohibit or otherwise prevent PSIVIDA
from executing and delivering the Security Agreement, or the grant the security
interest provided thereunder. Notwithstanding the foregoing, PSIVIDA shall
not
be obligated to enter into the Security Agreement if PSIVIDA satisfies all
conditions precedent to the Additional Investment set forth in the Stock
Purchase Agreement or the Second Stock Purchase Agreement, as the case may
be,
and Exhibit
L
of this
Agreement and PFIZER elects not to make the Additional Investment.
11.5 Subject
to any confidentiality obligations of PSIVIDA under agreements with Third
Parties, from and after the date hereof and during the Term of this Agreement,
PSIVIDA shall, upon reasonable notice from PFIZER, provide PFIZER and its agents
and representatives with reasonable access, at mutually agreed to times during
regular business hours, to (a) all information concerning Devices, Formulations,
Licensed Products, PSIVIDA Patent Rights and/or PSIVIDA Technology, and (b)
all
employees of PSIVIDA who possess any information described in clause (a) of
this
Section 11.5. Any information obtained by PFIZER during such visits shall be
treated as PSIVIDA Confidential Information.
11.6 [...]*
Section
12. TERM.
This
Agreement shall be effective as of the Effective Date and shall, unless earlier
terminated in accordance with Section 13, remain in effect until the expiration
of the last-to-expire Royalty Term.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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Section
13. TERMINATION.
13.1 Termination
Rights.
This
Agreement may be terminated as follows:
(a) If
either
PFIZER or PSIVIDA materially breaches or materially defaults in the performance
or observance of any of its respective obligations under this Agreement, and
such breach or default is not cured within ninety (90) days after the giving
of
written notice by the other Party specifying such breach or default, then such
other Party shall have the right to terminate this Agreement by providing the
breaching Party written notice within ten (10) days following the expiration
of
such ninety (90)-day period (such termination to be effective upon receipt
of
such termination notice). For the purpose of this Section 13.1(a), a material
breach or material default shall include a material inaccuracy in any warranty
or representation contained herein.
(b) If
either
Party is generally unable to meet its debts when due, or makes a general
assignment for the benefit of its creditors, or there shall have been appointed
a receiver, trustee or other custodian for such Party for all or a substantial
part of its assets, or any case or proceeding shall have been commenced or
other
action taken by or against such Party in bankruptcy or seeking the
reorganization, liquidation, dissolution or winding-up of such Party or any
other relief under any bankruptcy, insolvency, reorganization or other similar
act or Law, and any such event shall have continued for sixty (60) days
undismissed, unstayed, unbonded and undischarged, then the other Party may,
upon
notice to such Party, terminate this Agreement, such termination to be effective
upon such Party’s receipt of such notice. If any of the following events occur
in relation to Psivida Limited:
(i) (involuntary
winding up)
if:
(A) an
application is filed for the winding up of Psivida Limited (a ‘winding up
application’) and the winding up application is not dismissed or withdrawn
within 10 Business Days of the filing of the winding up application;
or
(B) an
order
is made for the winding up of Psivida Limited and the winding up is not stayed
indefinitely or terminated within 10 Business Days of the making of the winding
up order;
(ii) (voluntary
winding up)
if
Psivida Limited passes a resolution for its winding up;
(iii) (receiver)
if a
receiver, receiver and manager, controller (as defined in section 9 of the
Corporations
Act 2001
(Cth)), or analogous person is appointed to any property of Psivida
Limited;
*
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Securities and Exchange Commission pursuant to a confidential treatment
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(iv) (provisional
liquidator)
if a
provisional liquidator is appointed to Psivida Limited;
(v) (administration)
if:
(A) Psivida
Limited is placed into administration (as defined in section 9 of
the
Corporations Act 2001
(Cth)) or enters into a deed of company arrangement (as defined in section
9 of
the Corporations
Act 2001
(Cth)); or
(B) Psivida
Limited takes any step towards placing Psivida Limited into administration
or
towards entering into a deed of company arrangement;
(vi) (insolvency)
if
Psivida Limited:
(A) advises
PFIZER that it is financially unable to proceed with or meet any of its
obligations under this Contract;
(B) without
the prior written consent (not to be unreasonably withheld) of PFIZER, suspends
payment of its debts, other than as the result of a failure to pay a debt or
claim which is the subject of a genuine dispute;
(C) is
or
states that it is unable to pay its debts as and when they fall due and payable;
or
(D) is
taken
to fail to comply with a statutory demand in accordance with section 459F of
the
the Corporations
Act
2001
(Cth);
(vii) (compromise
or arrangement)
Psivida
Limited, without the consent of the other party:
(A) takes
any
steps toward entering into, or enters into, any compromise or arrangement with
one or more of its creditors under part 5.1 of the the Corporations
Act
2001
(Cth); or
(B) makes
any
assignment or enters into any arrangement or composition generally for the
benefit of one or more of its creditors;
(viii) (execution)
execution is levied against the party by a creditor; or
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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(ix) (analogous
event)
if any
event happens in Australia or any other country or territory in respect of
Psivida Limited which is analogous to any of the events or circumstances
referred to otherwise in this definition,
except
in
the case of (i) through (ix) above where this takes place as part of a solvent
reconstruction, amalgamation, merger or consolidation or similar
transaction.
(c) At
any
time and for any reason, PFIZER, upon sixty (60) days’ written notice to
PSIVIDA, shall have the right, at PFIZER’s sole discretion, to terminate this
Agreement, such termination to be effective upon the expiration of such sixty
(60)-day period.
(d) If,
pursuant to the terms and conditions of the Escrow Agreement, Pfizer exercises
the First Termination Option or the Second Termination Option, as each such
term
is defined under the Escrow Agreement.
(e) In
order
to ensure the smooth transition of the development and/or commercialization
of
any Licensed Product from PFIZER to PSIVIDA or a Third Party designated by
PSIVIDA, promptly after receipt by PSIVIDA of such written notice,
representatives of PFIZER and PSIVIDA will meet to negotiate in good faith
the
terms of a transition plan with respect to all then-current as well as planned
activities relating to Devices.
13.2 Accrued
Obligations.
Expiration or termination of this Agreement for any reason (x) shall be without
prejudice to PSIVIDA’s right to receive all royalties accrued under Section 6.3
prior to the effective date of such termination and to any other remedies that
either Party may otherwise have and (y) shall not release a Party hereto from
any indebtedness, liability or other obligation incurred hereunder by such
Party
prior to the date of termination or expiration.
13.3 Effect
of Termination.
(a) Upon
any
termination of this Agreement pursuant to Section 13.1, all licenses and rights
granted herein to PFIZER shall terminate.
(b) In
addition, if PFIZER terminates this Agreement under Section 13.1(c) other than
for reasons related to the safety of any Device, or PSIVIDA terminates this
Agreement under Section 13.1(a) or 13.1(b) (but in no event if (x) any such
termination results, arises from or relates to, or is deemed to result, arise
from or relate to, by operation of law or otherwise, any termination or deemed
termination hereof that occurs during the course of any bankruptcy or other
insolvency proceeding involving PSIVIDA or (y) PSIVIDA rejects this Agreement
pursuant to Sections 363, 365 or 1123 of Title 11 of the United States Code,
as
amended), PFIZER shall, promptly after such termination, (i) transfer to PSIVIDA
ownership of all regulatory filings and Regulatory Approvals that solely relate
to the Device, (ii) deliver to PSIVIDA all pre-clinical and clinical data and
information in PFIZER’s possession or control solely related to the Device,
including for clarity manufacturing data, if any (subject to the last sentence
of this Section 13.3), in the same form in which PFIZER maintains such data;
and
(iii) deliver to PSIVIDA, in the same form in which PFIZER maintains such items,
copies of all reports, records, regulatory correspondence and other materials
in
PFIZER’s possession or control solely related to the Device, including, if
applicable, any information contained in the global safety database established
and maintained by PFIZER; provided that the Parties agree that any good faith
failure by PFIZER to provide immaterial data, information, reports, records,
correspondence or other materials to PSIVIDA shall not be a breach of PFIZER’s
obligations under this Section 13.3. It is understood that upon any termination,
PSIVIDA will not obtain any rights to PFIZER Compounds, PFIZER Patent Rights,
PFIZER Technology, PFIZER Program Patent Rights or PFIZER Program
Technology.
*
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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(c) Following
termination of this Agreement pursuant to Section 13.1: each of PFIZER and
PSIVIDA shall, upon request of the other Party, return or destroy all PSIVIDA
Confidential Information and PFIZER Confidential Information, respectively,
disclosed to it pursuant to this Agreement, including all copies and extracts
of
documents, as promptly as practicable following receipt of such request, except
that one (1) copy may be kept for the purpose of complying with continuing
obligations under this Agreement.
13.4 Bankruptcy.
All
rights and licenses granted under or pursuant to this Agreement by PSIVIDA
are,
and shall otherwise be deemed to be, for purposes of Article 365(n) of the
U.S.
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Article 101 of the U.S. Bankruptcy Code. The Parties agree that PFIZER, as
licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the U.S. Bankruptcy Code. The
Parties further agree that, in the event of the commencement of any proceeding
by or against PSIVIDA under the U.S. Bankruptcy Code, PFIZER shall be entitled
to a complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property, and,
if
not already in its possession, PSIVIDA shall promptly deliver to PFIZER all
such
intellectual property and all embodiments of such intellectual property (a)
upon
PFIZER’s request any time following commencement of any such proceeding, unless
PSIVIDA elects to continue to perform all of its obligations under this
Agreement or (b) if not delivered under (a) above, upon PFIZER’s request any
time following the rejection of this Agreement by or on behalf of
PSIVIDA.
13.5 Change
of Control.
PSIVIDA
shall notify PFIZER promptly, but in no event later than five (5) Business
Days,
following approval by PSIVIDA’s board of directors of any transaction that
constitutes a Change of Control (excluding any Change of Control under Section
1.11(e)(ii) relating to a Subsidiary of Psivida Limited or under
Section1.11(e)(iii)),. PFIZER shall have the right upon sixty (60) days’ notice
following any such Change of Control, to elect that any one or more of the
following shall be deleted, in whole or in part, from this Agreement: Sections
2.1-2.4, 3.1-3.5, 5.1, 5.2, 5.3, 5.5 and 5.6 and the Research Plan. If PFIZER
makes any election as provided in this Section 13.5 to delete any Section,
each
of the Parties hereto will enter into an appropriate and customary written
amendment and no Party shall have any further obligations with respect to any
such deleted Section. In the event that a transaction that constitutes a Change
of Control is approved by PSIVIDA’s board of directors but is not consummated,
any Section deleted by Pfizer pursuant to the foregoing shall immediately and
automatically be reinstated upon notice thereof by PSIVIDA to PFIZER. For the
avoidance of doubt, PFIZER shall be entitled, in its sole discretion, to make
the elections provided for in this Section 13.5 upon each occurrence of a Change
of Control.
*
Confidential information has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment
request.
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13.6 Breach
Remedy.
If an
event occurs that gives rise to a right of termination by PFIZER under Section
13.1(a) (as a result of an uncured breach by PSIVIDA) and if PFIZER elects
not
to terminate this Agreement, PFIZER may elect that any one or more of the
following shall be deleted, in whole or in part, from this Agreement: Sections
2.1-2.4, 3.1-3.5, 5.1, 5.2, 5.3 5.5 and 5.6 and the Research Plan. If PFIZER
makes any election as provided in this Section 13.6 to delete any Section,
each
of the Parties hereto will enter into an appropriate and customary written
amendment and no Party shall have any further obligations with respect to any
such deleted Section.
Section
14. INDEMNIFICATION.
14.1 Indemnification.
(a) PSIVIDA
will indemnify, defend and hold PFIZER and PFIZER’s Affiliates, and their
respective directors, officers and employees (collectively, “Representatives”),
harmless from any and all Losses (as defined below) incurred by any of them
and
which are not covered by an insurance policy as a result of:
(i) the
breach of any covenant, warranty or representation made by PSIVIDA under this
Agreement;
(ii) the
negligence, recklessness, or willful misconduct of PSIVIDA or any of its
Affiliates; or
(iii) any
acts
or omissions of PSIVIDA or any of its Affiliates in connection with the
research, development or commercialization of products containing Devices prior
to or after the Effective Date or following termination in whole or in part
of
this Agreement and the reversion of the applicable rights hereunder to PSIVIDA
in accordance with Section 13.3.
PSIVIDA
shall only be obligated to so indemnify, defend and hold PFIZER harmless to
the
extent that such Losses do not arise from the negligence, recklessness or
willful misconduct of PFIZER.
*
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(b) PFIZER
will indemnify, defend and hold PSIVIDA and PSIVIDA’s Representatives, harmless
from any and all Losses incurred by any of them and which are not covered by
an
insurance policy as a result of:
(i) the
breach of any covenant, warranty or representation made by PFIZER under this
Agreement;
(ii) the
negligence, recklessness, or willful misconduct of PFIZER or any of its
Affiliates;
(iii) any
acts
or omissions of PFIZER or any of its Affiliates in connection with the research,
development or commercialization of PFIZER Compounds, Formulations, Devices
or
Licensed Products prior to or after the Effective Date; or
(iv) use
of
any PFIZER Compound, Formulation or Licensed Product by a Third
Party.
PFIZER
shall only be obligated to so indemnify, defend and hold PSIVIDA harmless to
the
extent that such Losses do not arise from the negligence, recklessness or
willful misconduct of PSIVIDA.
14.2 Losses.
For
purposes of this Agreement, “Losses”
shall
mean any and all costs, expenses, claims, losses, liabilities, damages, fines,
royalties, governmental penalties or punitive damages, deficiencies, interest,
settlement amounts, awards, and judgments, including any and all reasonable,
out-of-pocket costs and expenses properly incurred as a result of a Third Party
claim (including reasonable, out-of-pocket attorneys’ fees and all other
expenses reasonably incurred in investigating, preparing or defending any
litigation or proceeding, commenced or threatened), in each case, net of any
insurance recovery received as a result of such Loss.
14.3 Insurance.
Each
Party shall maintain, and shall cause its Affiliates and each sublicensee
conducting activities under this Agreement to maintain, at such Party’s, an
Affiliate’s, or sublicensee’s sole expense, appropriate product liability
insurance coverage in amounts reasonably determined by the Party from time
to
time but at least sufficient to insure against claims which may arise from
the
performance of obligations or exercise of rights granted under this Agreement
or
from indemnification obligations under this Article 14, but in no event shall
a
Party’s insurance coverage be in an amount less than $5,000,000 per occurrence
and $10,000,000 annual aggregate. The policy of insurance shall contain a
provision of non-cancellation except upon the provision of thirty (30) days
notice to the other Party. The policy of insurance with respect to any Licensed
Product that would, absent the licenses herein, infringe a Valid Claim under
a
patent licensed under one or more of the UKRF Licenses shall contain an
endorsement naming UKRF, and the University of Kentucky (and its Board of
Trustees, agents, officers, and employees) as additional insureds. Each Party
shall maintain such insurance commencing on the Effective Date and for so long
as it continues to research, produce, develop, manufacture, distribute, sell
or
use the Products, and thereafter for so long as each Party maintains insurance
for itself covering such manufacture or sales.
*
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Securities and Exchange Commission pursuant to a confidential treatment
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14.4 Defense
Procedures; Procedures for Third Party Claims.
In the
event that any Third Party (in no event to include any Affiliate of any of
the
Parties) asserts a claim with respect to any matter for which a Party (the
“Indemnified
Party”)
is
entitled to indemnification hereunder (a “Third
Party Claim”),
then
the Indemnified Party shall promptly notify the Party obligated to indemnify
the
Indemnified Party (the “Indemnifying
Party”)
thereof; provided,
however,
that no
delay on the part of the Indemnified Party in notifying the Indemnifying Party
shall relieve the Indemnifying Party from any obligation hereunder unless (and
then only to the extent that) the Indemnifying Party is prejudiced
thereby.
(a) The
Indemnifying Party shall have the right, exercisable by notice to the
Indemnified Party within ten (10) Business Days after receipt of notice from
the
Indemnified Party of the commencement of or assertion of any Third Party Claim,
to assume direction and control of the defense, litigation, settlement, appeal
or other disposition of the Third Party Claim (including the right to settle
the
claim solely for monetary consideration) with counsel selected by the
Indemnifying Party and reasonably acceptable to the Indemnified Party; provided
that (i) the Indemnifying Party has sufficient financial resources, in the
reasonable judgment of the Indemnified Party, to satisfy the amount of any
adverse monetary judgment that is sought, (ii) the Third Party Claim seeks
solely monetary damages and (iii) the Indemnifying Party expressly agrees in
writing that as between the Indemnifying Party and the Indemnified Party, the
Indemnifying Party shall be solely obligated to satisfy and discharge the Third
Party Claim in full (the conditions set forth in clauses (i), (ii) and (iii)
above are collectively referred to as the “Litigation Conditions”).
(b) Within
ten (10) Business Days after the Indemnifying Party has given notice to the
Indemnified Party of its exercise of its right to defend a Third Party Claim,
the Indemnified Party shall give notice to the Indemnifying Party of any
objection thereto based upon the Litigation Conditions. If the Indemnified
Party
reasonably so objects, the Indemnified Party shall continue to defend the Third
Party Claim, at the expense of the Indemnifying Party, until such time as such
objection is withdrawn. If no such notice is given, or if any such objection
is
withdrawn, the Indemnifying Party shall be entitled, at its sole cost and
expense, to assume direction and control of such defense, with counsel selected
by the Indemnifying Party and reasonably acceptable to the Indemnified Party.
During such time as the Indemnifying Party is controlling the defense of such
Third Party Claim, the Indemnified Party shall cooperate, and shall cause its
Affiliates and agents to cooperate upon request of the Indemnifying Party,
in
the defense or prosecution of the Third Party Claim, including by furnishing
such records, information and testimony and attending such conferences,
discovery proceedings, hearings, trials or appeals as may reasonably be
requested by the Indemnifying Party. In the event that the Indemnifying Party
does not satisfy the Litigation Conditions or does not notify the Indemnified
Party of the Indemnifying Party’s intent to defend any Third Party Claim within
ten (10) Business Days after notice thereof, the Indemnified Party may (without
further notice to the Indemnifying Party) undertake the defense thereof with
counsel of its choice and at the Indemnifying Party’s expense (including
reasonable, out-of-pocket attorneys’ fees and costs and expenses of enforcement
or defense). The Indemnifying Party or the Indemnified Party, as the case may
be, shall have the right to join in (including the right to conduct discovery,
interview and examine witnesses and participate in all settlement conferences),
but not control, at its own expense, the defense of any Third Party Claim that
the other Party is defending as provided in this Agreement.
*
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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(c) The
Indemnifying Party shall not, without the prior consent of the Indemnified
Party, enter into any compromise or settlement that commits the Indemnified
Party to take, or to forbear to take, any action. The Indemnified Party shall
have the sole and exclusive right to settle any Third Party Claim, on such
terms
and conditions as it deems reasonably appropriate, to the extent such Third
Party Claim involves equitable or other non-monetary relief, but shall not
have
the right to settle such Third Party Claim to the extent such Third Party Claim
involves monetary damages without the prior written consent of the Indemnifying
Party. Each of the Indemnifying Party and the Indemnified Party shall not make
any admission of liability in respect of any Third Party Claim without the
prior
consent of the other Party, and the Indemnified Party shall use reasonable
efforts to mitigate losses arising from the Third Party Claim.
14.5 Disclaimer
of Liability for Consequential Damages.
IN NO
EVENT SHALL ANY PARTY OR ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE UNDER THIS
AGREEMENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER
IN
CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, INCLUDING
LOSS OF PROFITS OR REVENUE, SUFFERED BY PFIZER, PSIVIDA OR ANY OF THEIR
RESPECTIVE REPRESENTATIVES, EXCEPT TO THE EXTENT OF ANY SUCH DAMAGES PAID TO
A
THIRD PARTY IN CONNECTION WITH A THIRD PARTY CLAIM; PROVIDED
THAT
THIS SECTION SHALL NOT RELIEVE EITHER PARTY FROM ITS PAYMENT OBLIGATIONS UNDER
THIS AGREEMENT.
14.6 SOLE
REMEDY.
EXCEPT
AS EXPRESSLY PROVIDED IN THIS AGREEMENT AND EXCEPT FOR ANY EQUITABLE REMEDIES
THAT MAY BE AVAILABLE TO A PARTY, INDEMNIFICATION PURSUANT TO THIS SECTION
14
SHALL BE
THE SOLE AND EXCLUSIVE REMEDY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER
LEGAL THEORY) AVAILABLE TO PSIVIDA OR PFIZER FOR THE MATTERS COVERED
THEREIN.
Section
15. GOVERNING
LAW AND JURISDICTION.
15.1 Governing
Law.
This
Agreement shall be governed by and construed in accordance with the substantive
laws of the State of New York, without regard to conflicts of law
rules.
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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15.2 Jurisdiction.
With
the exception of those matters referred for resolution by independent
accountants under Section 7.5, in the event of any controversy, claim or
counterclaim arising out of or relating to this Agreement, the Parties shall
first attempt to resolve such controversy or claim through good faith
negotiations for a period of not less than thirty (30) days following
notification of such controversy or claim to the other Party. If such
controversy or claim cannot be resolved by means of such negotiations during
such period, then such controversy or claim shall be resolved by the United
States District Court for the Southern District of New York or a local court
sitting in New York, New York (collectively, the “Courts”).
Each
Party (a) irrevocably submits to the exclusive jurisdiction in the Courts for
purposes of any action, suit or other proceeding relating to or arising out
of
this Agreement and (b) agrees not to raise any objection at any time to the
laying or maintaining of the venue of any such action, suit or proceeding in
any
of the Courts, irrevocably waives any claim that such action, suit or other
proceeding has been brought in an inconvenient forum and further irrevocably
waives the right to object, with respect to such action, suit or other
proceeding, that such Court does not have any jurisdiction over such party.
In
the event of any action, suit or other proceeding pursuant to this Section
15.2,
either Party may effect service of process by providing a complaint and/or
summons or other court filing to the other Party pursuant to Section 16.10.
Any
defenses based on adequacy of service of process, other than breach of Section
16.10 are waived.
Section
16. MISCELLANEOUS.
16.1 Force
Majeure.
Neither
Party hereto shall be liable to the other Party (except for payment obligations
set forth in this Agreement, each of which shall remain in effect) for any
losses or damages attributable to a default in or breach of this Agreement
that
is the result of war (whether declared or undeclared), acts of God, revolution,
acts of terror, fire, earthquake, flood, pestilence, riot, enactment or change
of Law (following the Effective Date), accident(s), labor trouble, or shortage
of or inability to obtain material equipment or transport or any other cause
beyond the reasonable control of such Party; provided
that if
such a cause occurs, then the Party affected will promptly notify the other
Party of the nature and likely result and duration (if known) of such cause
and
use commercially reasonable efforts to reduce the effect. If the event lasts
for
a period of longer than three (3) months, the Parties shall meet and discuss
appropriate remedial measures.
16.2 Reserved
Rights; Non-Exclusivity.
(a) All
rights and interests not expressly granted to PFIZER are reserved by PSIVIDA
(the “Reserved
Interests”)
for
itself, its Affiliates and partners (other than PFIZER) and other licensees
and
sublicensees, including, but not limited to, the rights to use, enter into
agreements or grant licenses under the PSIVIDA Patent Rights, PSIVIDA Program
Patent Rights, PSIVIDA Technology, PSIVIDA Program Technology or any other
technology owned or controlled by PSIVIDA to make, have made, use, offer to
sell, sell, have sold and import products (other than Licensed Products in
the
Field for so long as PFIZER has a license to such Licensed Products under this
Agreement) (the “Reserved
Interests”).
It
shall not be a breach of this Agreement, including Section 3.2, for PSIVIDA,
acting directly or indirectly, to exploit its Reserved Interests in any manner
anywhere in the Territory, whether or not such activity is competitive with
the
activities of PFIZER, subject to PSIVIDA’s obligation under the Research Program
and under Sections 8.2 and 9.1, including the research, development and
commercialization or licensing to others to research, develop and commercialize
products (other than Licensed Products in the Field for so long as PFIZER has
a
license to such Licensed Products under this Agreement).
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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(b) Except
as
otherwise expressly provided in this Agreement, for the avoidance of doubt,
PFIZER shall be free to use, enter into an agreement with and grant licenses
to
any Third Party or Third Parties under the PFIZER Patent Rights, the PFIZER
Program Patent Rights, the PFIZER Technology or the PFIZER Program Technology
or
any other technology owned, licensed or Controlled by PFIZER to research,
develop and commercialize any and all products inside the Field, and it shall
not be a breach of this Agreement, including Sections 3.2 and 5.4, for PFIZER,
acting directly or indirectly, to engage in any activities competitive with
the
activities of PSIVIDA, subject to its obligations under Sections 8.2A and 9.1,
including the research, development and commercialization of products and other
drug delivery devices.
16.3 Sublicensing.
PFIZER
shall have the right to grant sublicenses under the licenses granted pursuant
to
Section 4, provided, however, that any such sublicense shall not be inconsistent
with the terms and conditions of this Agreement and that PFIZER shall be
responsible for the operations of any sublicensee relative to this Agreement
as
if such operations were carried out by PFIZER itself, including (without
limitation) the payment of any royalties provided for hereunder, regardless
of
whether the terms of any sublicense provide for such amount to be paid by the
sublicensee directly to PSIVIDA.
16.4 Severability.
If and
solely to the extent that any provision of this Agreement shall be invalid
or
unenforceable, or shall render this entire Agreement to be unenforceable or
invalid, such offending provision shall be of no effect and shall not affect
the
validity of the remainder of this Agreement or any of its provisions;
provided,
however,
the
Parties shall use their respective reasonable efforts to replace the invalid
provisions in a manner that best accomplishes the original intentions of the
Parties.
16.5 Waivers.
Any
term or condition of this Agreement may be waived at any time by the Party
that
is entitled to the benefit thereof, but no such waiver shall be effective unless
set forth in a written instrument duly executed by or on behalf of the Party
or
Parties waiving such term or condition. Neither the waiver by any Party of
any
term or condition of this Agreement nor the failure on the part of any Party,
in
one or more instances, to enforce any of the provisions of this Agreement or
to
exercise any right or privilege, shall be deemed or construed to be a waiver
of
such term or condition for any similar instance in the future or of any
subsequent breach hereof. All rights, remedies, undertakings, obligations and
agreements contained in this Agreement shall be cumulative and none of them
shall be a limitation of any other remedy, right, undertaking, obligation or
agreement.
*
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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16.6 Entire
Agreements; Amendments.
This
Agreement sets forth the entire agreement and understanding between the Parties
as to the subject matter hereof and supersedes all agreements or understandings,
verbal or written, made between PSIVIDA and PFIZER before the date hereof with
respect to the subject matter hereof, including the Confidentiality Agreement
between the parties, dated February 2, 2007, and the Feasibility Study Agreement
dated December 22, 2006. All PSIVIDA Confidential Information disclosed to
PFIZER prior to the Effective Date will be deemed to have been disclosed
pursuant to this Agreement. None of the terms of this Agreement shall be
amended, supplemented or modified except in writing signed by the
Parties.
16.7 Survival.
The
provisions of Sections 4.3 (Non-Exclusive License), 5.5 (Regulatory Affairs),
7.5 (Inspection of Records), 8.2A (Use by Pfizer), 9.1(a) (Confidentiality),
13.3 (Effect of Termination), 14 (Indemnification), and 15 (Governing Law and
Jurisdiction), as well as any other Sections or defined terms referred to in
such Sections or necessary to give them effect shall survive termination or
expiration of this Agreement and remain in force until discharged in full.
Furthermore, any other provisions required to interpret and enforce the Parties’
rights and obligations or to wind up their outstanding obligations under this
Agreement shall survive to the extent required.
16.8 Assignment.
Neither
this Agreement nor any rights or obligations of either Party to this Agreement
may be assigned or otherwise transferred by either Party without the consent
of
the other Party; provided,
however,
either
Party may, without such consent, assign this Agreement, in whole or in part:
(i)
to any of its respective Affiliates; provided however, that PSIVIDA shall not
be
permitted to assign or otherwise transfer PSIVIDA Patent Rights or PSIVIDA
Program Patent Rights to any Affiliate that is not a U.S. Person; (ii) to any
transferee of substantially all of the assets or stock of such Party’s entire
business or such Party’s ophthalmic business, (iii) in connection with a Change
of Control of such Party (except for purposes of this Section 16.8, the
definition of Change of Control shall be read omitting all references to “that
is a Large Pharmaceutical Company” or “that contains a Large Pharmaceutical
Company” appearing therein and shall be construed accordingly); or (iv) to any
sublicensee as permitted under this Agreement; provided
that
such assigning Party shall remain jointly and severally liable with such
Affiliate in respect of all obligations so assigned.
Any
purported assignment in violation of this Section 16.8 shall be void. Any
permitted assignee shall assume all obligations of its assignor under this
Agreement.
16.9 Independent
Contractor.
The
relationship between PSIVIDA and PFIZER is that of independent contractors.
PSIVIDA and PFIZER are not joint venturers, partners, principal and agent,
employer and employee, and have no other relationship other than independent
contracting parties.
16.10 Notices.
Each
communication and document made or delivered by one party to another under
this
Agreement shall be made in the English language. All notices, consents,
approvals, requests or other communications required hereunder given by one
Party to the other hereunder shall be in writing and made by registered or
certified air mail, facsimile, express overnight courier or delivered personally
to the following addresses of the respective Parties:
*
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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|
If
to PSIVIDA:
|
PSIVIDA
Inc.
400
Pleasant Street
Watertown,
MA 02472
Attention:
President
Fax:
(617) 926-5050
|
|
with
a copy to:
|
PSIVIDA
Inc.
400
Pleasant Street
Watertown,
MA 02472
Attention:
General Counsel
Fax:
(617) 926-5050
|
|
with
a copy to:
|
Ropes
& Gray LLP
One
International Place
Boston,
MA 02110
Attention:
Susan Galli, Esq.
|
|
If
to PFIZER:
|
PFIZER
Global R&D Headquarters
50
Pequot Avenue
New
London, CT 06320
Attn.:
Head of Research, PGRD
Copy
to: General Counsel, PGRD
|
|
Invoices
should be sent to the attention of Phil McGurk at the following
address:
|
|
Pfizer
Inc/NASS
Attn:
Philip McGurk
PO
Box 341804
Bartlett,
TN 38184-1804
|
Notices
hereunder shall be deemed to be effective (a) upon receipt if personally
delivered, (b) on the tenth (10th) Business Day following the date of mailing
if
sent by registered or certified air mail; (c) on the second (2nd) Business
Day
following the date of transmission or delivery to the overnight courier if
sent
by facsimile or overnight courier. A Party may change its address listed above
by sending notice to the other Party in accordance with this Section
16.10.
16.11 Third
Party Beneficiaries.
None of
the provisions of this Agreement shall be for the benefit of or enforceable
by
any Third Party, including any creditor of either party. No Third Party shall
obtain any right under any provision of this Agreement or shall by reason of
any
such provision make any claim in respect of any debt, liability or obligation
(or otherwise) against either Party.
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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16.12 Binding
Effect.
This
Agreement shall be binding upon and inure to the benefit of the parties hereto
and their respective heirs, successors and permitted assigns.
16.13 Counterparts.
This
Agreement may be executed in any two or more counterparts, each of which, when
executed, shall be deemed to be an original and all of which together shall
constitute one and the same document.
16.14 Headings.
Headings in this Agreement are included herein for ease of reference only and
shall have no legal effect. References to the parties, Sections, Schedules,
and
Exhibits are to the parties, Sections, Schedules and Exhibits to and of this
Agreement unless otherwise specified.
IN
WITNESS WHEREOF the parties hereto have caused this Agreement to be executed
by
their duly authorized officers upon the date set out below.
|
PSIVIDA
LIMITED
|
PFIZER
INC.
|
|
By:
______________________________
|
By:
______________________________
|
|
Name:
|
Name:
|
|
Title:
|
Title:
|
|
PSIVIDA,
INC.
|
|
|
By:
______________________________
|
|
|
Name:
|
|
|
Title:
|
*
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Securities and Exchange Commission pursuant to a confidential treatment
request.
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