i
DEVELOPMENT AGREEMENT
BETWEEN
INEX PHARMACEUTICALS, INC.
AND
ENZON PHARMACEUTICALS, INC.
January 19, 2004
Development Agreement
Table of Contents
Article 1 Interpretation ................................................. 3
1.1 Definitions ..................................................... 3
1.2 Entire Agreement; Conflicts ..................................... 12
1.3 Governing Law ................................................... 12
1.4 Headings ........................................................ 12
1.5 Severability .................................................... 13
Article 2 Grant and Reservation of Rights ................................ 13
2.1 Grant of Licenses 10
2.2 Reservation of Rights ........................................... 13
2.3 *** .................................... Error! Bookmark not defined.
2.4 Sublicenses ..................................................... 14
Article 3 Milestone Payments for Development ............................. 15
3.1 Signing and Regulatory Milestone Payments ....................... 15
3.2 Withholding Taxes ............................................... 16
3.3 Late Payments ................................................... 17
Article 4 Development .................................................... 17
4.1 Development Activities in accordance with the Development Plan .. 17
4.2 Overview of Development ......................................... 18
4.3 Development Diligence ........................................... 18
4.4 Development Plans ............................................... 18
4.5 Reports on Development .......................................... 19
4.6 Attendance at Regulatory Meetings ............................... 19
4.7 Subcontractors .................................................. 19
Article 5 Development Responsibility and Funding ......................... 19
5.1 Shared Funding of Certain Development Costs ..................... 19
5.2 Development Clinical Activities ................................. 19
5.3 Post-Approval Clinical Activities ............................... 20
5.4 Regulatory Activities ........................................... 20
5.5 Filing of Regulatory Submissions ................................ 21
5.6 Technical and Manufacturing Support Activities .................. 21
5.7 Funding of Development Costs .................................... 21
5.8 Transition ...................................................... 22
5.9 Records ......................................................... 22
5.10 Audits .......................................................... 22
Article 6 Joint Steering Committee ....................................... 23
6.1 Joint Steering Committee ........................................ 23
6.2 Meetings of the Joint Steering Committee ........................ 24
6.3 Working Committees .............................................. 24
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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Article 7 Pharmacovigilance, DDMAC and Recalls ........................... 24
7.1 Regulatory Responsibilities ..................................... 24
7.2 Pharmacovigilance Agent ......................................... 25
7.3 Agency for DDMAC Activities ..................................... 26
7.4 Agent for Regulatory Authorities Generally ...................... 26
7.5 Recalls and Withdrawals of Product .............................. 26
Article 8 Additional Opportunities ....................................... 27
8.1 Pipeline Drug ................................................... 27
8.2 Legal Effect .................................................... 27
Article 9 Representations and Warranties ................................. 27
9.1 By Enzon ........................................................ 27
9.2 By Inex ......................................................... 28
9.3 Survival of Representations and Warranties ...................... 30
9.4 DISCLAIMER ...................................................... 30
Article 10 Intellectual Property Rights .................................. 30
10.1 Injunctive Relief ............................................... 30
10.2 Ownership of Pre-Existing Intellectual Property Rights .......... 31
10.3 Ownership of Intellectual Property Rights in the Product ........ 31
10.4 Ownership of Regulatory Approvals and Regulatory Submissions .... 31
10.5 Ownership of Intellectual Property Rights Outside the Development 31
Article 11 Termination ................................................... 32
11.1 Term ............................................................ 32
11.2 Renewal ......................................................... 32
11.3 Voluntary Termination ........................................... 32
11.4 Termination for Breach .......................................... 33
11.5 Termination upon Bankruptcy ..................................... 33
11.6 Survival of Obligations; Return of Confidential Information ..... 34
11.7 Additional Consequences of Termination .......................... 34
11.8 Termination on a Country by Country Basis ....................... 35
11.9 Termination of Related Agreements ............................... 35
Article 12 Miscellaneous ................................................. 36
12.1 Assignment ...................................................... 36
12.2 Counterparts .................................................... 36
12.3 Force Majeure ................................................... 36
12.4 Further Assurances .............................................. 37
12.5 International Sale of Goods Act ................................. 37
12.6 Modification .................................................... 37
12.7 No Agency ....................................................... 37
12.8 No Solicitation or Hiring of Employees .......................... 37
12.9 Non-Use of Names ................................................ 37
12.10 Notices ......................................................... 37
12.11 Publicity ....................................................... 39
12.12 No Third Party Beneficiaries .................................... 39
12.13 Waiver .......................................................... 40
12.14 Cross Default ................................................... 40
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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Development Agreement
This DEVELOPMENT AGREEMENT dated as of the 19th day of January, 2004 between
Inex Pharmaceuticals, Inc., a corporation duly incorporated pursuant to the laws
of Delaware, USA, having a registered office at Corporation Trust Center, 0000
Xxxxxx Xxxxxx, Xxxxxxxxxx, XX 00000 (hereinafter referred to as "Inex"), and
Enzon Pharmaceuticals, Inc., a corporation duly incorporated pursuant to the
laws of Delaware, having a principal place of business at 000 Xxxxx 000/000,
Xxxxxxxxxxx, Xxx Xxxxxx 00000, XXX (hereinafter referred to as "Enzon").
INTRODUCTION
A. Enzon is a pharmaceutical company with operations in research and
development, import, export, manufacture and sale of pharmaceutical products;
B. Inex is in the business of developing, manufacturing and selling certain
pharmaceutical products, including Vincristine Sulfate Liposomes Injection (as
further defined in this Agreement);
C. Of even date hereof, the Parties have entered into a Product Supply Agreement
for the supply from Inex to Enzon of Vincristine Sulfate Liposomes Injection,
and incidental thereto, the Parties must complete the development of Vincristine
Sulfate Liposomes Injection;
D. Inex and Enzon desire to set out in this Agreement the terms which will
govern the development of Vincristine Sulfate Liposomes Injection and to provide
for licenses for the right to develop, market and distribute Vincristine Sulfate
Liposomes Injection, which licenses are granted solely for the Parties' legal
protection and for the purpose of enabling Enzon to acquire rights to develop,
market, distribute and sell Inex's Vincristine Sulfate Liposomes Injection
product in the Territory for the Term;
E. The execution of this Agreement is ancillary to and a necessary pre-condition
for the establishment of both a market and a product for Inex's business with
respect to manufacturing and selling Vincristine Sulfate Liposomes Injection.
In consideration of the mutual covenants and promises contained in this
Agreement and other good and valuable consideration, and intending to be legally
bound, Inex and Enzon agree as follows:
Article 1 Interpretation
1.1 Definitions
Unless otherwise defined in this Agreement, capitalized terms used in this
Agreement shall have the meaning set out therefor in the Product Supply
Agreement. As used in this Agreement, the following terms, whether used in the
singular or plural, shall have the following meanings:
1.1.1 "Adverse Drug Event" will have the meaning set forth in Exhibit
1.1.1.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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1.1.2 "Affiliate" means any corporation, company, partnership, joint
venture or other person or entity which controls, is controlled by
or is under common control with a Party. For purposes of this
Section 1.1.1, "control" shall mean (a) in the case of corporate
entities, direct or indirect ownership of at least 50% of the
stock or shares (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction) entitled to vote for the election of directors or
otherwise having the power to vote on or direct the affairs of
such Party; and (b) in the case of non-corporate entities, direct
or indirect ownership of at least 50% of the equity interest or
the power to direct the management and policies of such
non-corporate entities.
1.1.3 "Agreement" means this Development Agreement including all
exhibits attached to this Agreement.
1.1.4 "Applicable Laws" means all applicable federal, provincial, state
and local laws, ordinances, rules and regulations of any kind
whatsoever in the Territory, including, without limitation,
pharmaceutical and environmental rules and regulations, including
cGMP Requirements, GCP Requirements, GLP Requirements and the
General Biological Products Standards of the FDA, and the Federal
Food, Drug and Cosmetic Act, as amended, or any successor act
thereto ("FDCA").
1.1.5 "Business Day" means any day other than a day which is a Saturday,
a Sunday or a statutory holiday in New York City, New York, USA.
1.1.6 "cGMP Requirements" shall mean the current Good Manufacturing
Practices standards required by the FDA, the TPD and the
equivalent Regulatory Authority elsewhere in the Territory, and
the applicable regulations, policies or guidelines of each of them
in effect for the manufacture and testing of pharmaceutical
materials, active ingredients, or excipients, as applicable.
1.1.7 "Clinical Activity" and "Clinical Activities" mean any one or more
of the activities associated with drug testing in humans,
including trial design and execution, payment of investigators',
institutional, and contractors' fees, drug distribution and
accountability, analytical testing, data management, statistical
analysis, adverse event reporting, and scientific publication,
performed or to be performed by the Parties or their
Representatives in pursuit of the Development of the Product or
post-Regulatory Approval commercialization of the Product.
1.1.8 "Code" or "Codes" means the Code on Interactions with Healthcare
Professionals promulgated by the Pharmaceutical Research and
Manufacturers of America (PhRMA) and the American Medical
Association (AMA) Guidelines on Gifts to Physicians from Industry,
as either of the foregoing may be amended from time to time.
1.1.9 "Commercially Reasonable Efforts" means efforts which are not less
than those efforts a Party makes with respect to other
pharmaceutical products in its portfolio (but, in any event, not
less than the efforts that would be exerted by a reasonably
prudent and diligent pharmaceutical company similarly situated and
seeking to accomplish similar objectives),
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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taking into account the product's market potential, level of
competition, number of prescribers and other relevant factors.
1.1.10 "Compendium Listing" means the listing in any two or more
publications or directories including Drugdex Information Service,
AHFS Drug Information, or US Pharmacopoeia Drug Information,
recognized by the US government for coverage under Medicaid,
Medicare or other like health insurance programs, for use of VSLI
in the treatment of Firstline NHL.
1.1.11 "Confidential Information" means:
(a) all proprietary information and materials, patentable or
otherwise, of a Party which is disclosed in writing by
or on behalf of such Party to the other Party and marked
as confidential or proprietary, including DNA sequences,
vectors, cells, substances, formulations, techniques,
methodology, equipment, data, reports, know-how,
preclinical and clinical trials and the results thereof,
sources of supply, patent positioning, marketing plans
and business plans, including any negative developments;
(b) any other information, oral or written, designated in
writing by the disclosing Party to the other Party as
confidential or proprietary within ten (10) days after
such disclosure, whether or not related to the making,
use, importing or selling of the Product; and
(c) the Data, the Inex Technology, the Regulatory Approvals
and Regulatory Submissions, and the Licensed Patents
(all of which are deemed to be Confidential Information
of Inex);
provided that Confidential Information shall not include such
information which:
(d) was known or used by the receiving Party or its
Affiliates prior to its date of disclosure to the
receiving Party, as evidenced by the prior written
records of the receiving Party or its Affiliates; or
(e) either before or after the date of the disclosure to the
receiving Party is lawfully disclosed to the receiving
Party or its Affiliates by an independent, unaffiliated
Third Party rightfully in possession of the Confidential
Information; or
(f) either before or after the date of the disclosure to the
receiving Party becomes published or generally known to
the public through no fault or omission on the part of
the receiving Party or its Affiliates; or
(g) the receiving Party can verify, by written
documentation, results from research and development by
the receiving Party or any of its Affiliates independent
of disclosure by the other Party thereof.
1.1.12 "Co-Promotion Agreement" means the Co-Promotion Agreement between
Inex and Enzon of even date herewith.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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1.1.13 "Data" has the meaning set out in Section 10.3.2.
1.1.14 "DDMAC Activities" mean all jointly agreed-to activities performed
or to be performed by one or both Parties in accordance with the
requirements of the Division of Drug Marketing, Advertising and
Communications, Center for Drug Evaluation and Research of the
FDA, and the Office of the Inspector General of the Department of
Health and Human Services of the United States.
1.1.15 "Development" means:
(a) all activities set forth in the Development Plan; and
(b) all activities necessary to obtain and maintain
Regulatory Approvals in each country in the Territory;
including Development Clinical Activities, Regulatory Activities
and Technical and Manufacturing Support Activities.
1.1.16 "Development Clinical Activities" has the meaning set out in
Section 5.2.
1.1.17 "Development Costs" means, with respect to Development of the
Product in respect of the Territory:
(a) the Development FTE Costs and Out-of-Pocket Costs
utilized or incurred by a Party in fulfilling its
obligations under the then-current Development Plan;
(b) all Development FTE Costs and Out of Pocket costs
incurred in excess of the budget in the then-current
Development Plan, provided that any such excess costs
have been approved in advance by the Joint Steering
Committee; and
(c) the Manufacturing Cost of Product produced for the
Development.
For greater certainty, Development Costs do not include
Commercialization Costs as defined in the Product Supply
Agreement.
1.1.18 "Development FTE" means a scientific or technical person employed
by a Party or a Party's Affiliates and assigned to work on
Development with such time and effort to constitute one person
working on Development on a full time basis consistent with normal
business and scientific practice (e.g., having appropriate
education, training and experience and working *** hours per year
of dedicated effort).
1.1.19 "Development FTE Costs" means the price of Development FTEs to be
used for the purposes of determining the costs incurred with
respect to personnel performing work on the Development in
accordance with the then-approved Development Plan. The price per
Development FTE shall initially be *** per Development FTE year or
pro-rata portion thereof incurred on the Development. The
Development FTE rate includes all the fully burdened cost of
salary, employee benefits, incidental materials, travel, lodging
and other expenses including support staff and direct and indirect
overhead for or associated with a Development FTE. On each
anniversary of the Effective Date, the FTE rate shall be
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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raised by a percentage equal to the percentage increase in the
Index (defined below) for the twelve (12) month period ending with
December of the calendar year immediately preceding such
anniversary date (such increase, the "CPI Increase"). For purposes
of this Agreement, the term "Index" shall mean the Consumer Price
Index for all Urban Consumers (CPI-U) - - U.S. City Average. All
Items (1982-1984 = 100), as published by the United States Bureau
of Labor Statistics, or if such index is no longer published, then
the index most comparable thereto.
1.1.20 "Development Plan" means the Development Plan for obtaining and
maintaining Regulatory Approvals for the Product in the Territory,
together with a corresponding budget accounting for the
anticipated Development Costs to be expended or incurred by each
Party in conducting the Development. The definitive Development
Plan adopted in accordance with Section 4.4 will form a part of
this Agreement.
1.1.21 "Dollar" and "$" means United States Dollars.
1.1.22 "Effective Date" means the date shown on page one of this
Agreement.
1.1.23 "Elan" means Elan Pharmaceuticals, Inc.
1.1.24 "Elan Consent" means the consent by Elan to the execution and
delivery of the Related Agreements and the subsequent grant of
manufacturing rights contemplated herein.
1.1.25 "Elan Improvements" has the meaning set out therefor in the Elan
License.
1.1.26 "Elan License" means the Amended and Restated License Agreement
made as of April 3, 2003 between Elan, IE Oncology Company Limited
and Inex Pharmaceuticals Corporation.
1.1.27 "Elan Patents" means the Patents set out in Exhibit 1.1.27.
1.1.28 "FDA" means the United States Food and Drug Administration or any
successor thereto.
1.1.29 "Field" means VSLI for all indications in humans.
1.1.30 "First Commercial Sale" means (a) with respect to a country in the
Territory, the first sale by Enzon, its sublicensees or Affiliates
for use, consumption or resale of the Product in such country
(excluding any sales for clinical trials, compassionate uses or
other non-commercial purposes) and (b) with respect to the
Territory, the First Commercial Sale in any country within the
Territory. A sale to a sublicensee or an Affiliate shall not
constitute a First Commercial Sale unless the sublicensee or
Affiliate is the end user of the Product.
1.1.31 "Firstline NHL" means the treatment of aggressive non-Hodgkin's
lymphoma in patients not previously treated for aggressive
non-Hodgkin's lymphoma.
1.1.32 "GCP Requirements" or "Good Clinical Practices" means the then
current standards for clinical trials for pharmaceuticals as
required by the FDA, the TPD and the equivalent Regulatory
Authority elsewhere in the Territory, and as applicable, the
policies and
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
8
guidelines of the International Conference on Harmonization in
effect for the clinical testing of pharmaceutical materials.
1.1.33 "GLP Requirements" or "Good Laboratory Practices" means the
current Good Laboratory Practices standards required by the FDA,
the TPD and the equivalent Regulatory Authority elsewhere in the
Territory in effect for the testing of pharmaceutical materials as
applied to raw materials and finished products.
1.1.34 "include" and "including" (and the like) means "including, without
limitation".
1.1.35 "IND" means an Investigational New Drug application in accordance
with the rules and regulations of the FDA.
1.1.36 "Inex Patents" means the Patents set out in Exhibit 1.1.36.
1.1.37 "Inex Technology" means all technical information and know-how
owned or controlled by Inex which relates to the Product and is
necessary or useful for the development and commercialization of
the Product, and shall include:
(a) as of the Effective Date, all biological, chemical,
pharmacological, toxicological, clinical, assay, control
and manufacturing data and any other information owned
or controlled by Inex and necessary or useful for the
development and commercialization of the Product;
(b) any Data referred to in Section 10.3; and
(c) any Data referred to in Section 12.3 of the Product
Supply Agreement.
1.1.38 "Intellectual Property Rights" means any rights to any Patents and
copyrights and registrations and applications for registration of
the foregoing rights, and trade secrets and moral rights.
"Intellectual Property Rights" do not include trademark, domain
name or trade name rights.
1.1.39 "Joint Steering Committee" means the committee formed pursuant to
Article 6. The Joint Steering Committee formed under this
Agreement shall be the same as the Joint Steering Committee formed
under the Product Supply Agreement.
1.1.40 "Licensed Patents" means the Patents owned or controlled by Inex
relating to VSLI, and necessary or useful for the development and
commercialization of the Product, and shall include:
(a) as of the Effective Date, the Inex Patents and the Elan
Patents;
(b) to the extent of Inex's legal right to grant rights to
same, as of the Effective Date, the Regents' Patents;
(c) any Patents on inventions referred to in Section 10.3;
and
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
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(d) any Patents on inventions referred to in Section 12.3 of
the Product Supply Agreement.
1.1.41 "NDA" means a New Drug Application in accordance with the rules
and regulations of the FDA.
1.1.42 "NHL" means non-Hodgkin's Lymphoma.
1.1.43 "not to be unreasonably withheld" and the like means not to be
unreasonably withheld or delayed.
1.1.44 "Out-of-Pocket Cost" means an out-of-pocket payment made by a
Party or its Representatives to a Third Party but only to the
extent such payment relates to costs which are incurred by a Party
or its Representatives with respect to fulfilling its obligations
under the Development Plan.
1.1.45 "Party" means Inex or Enzon and "Parties" means Inex and Enzon.
1.1.46 "Patent" means (a) all patent applications filed or having legal
force in any country; (b) all patents that have issued or in the
future issue therefrom, including without limitation utility,
model and design patents and certificates of invention; and (c)
all divisionals, continuations, continuations-in-part, reissues,
renewals, extensions (including supplemental protection
certificates), additions, registrations or confirmations to or of
any such patent applications and patents.
1.1.47 "Person" means and includes any individual, corporation,
partnership, firm, joint venture, syndicate, association, trust,
government body, and any other form of entity or organization.
1.1.48 "Permitted Exception" means any or all of the following:
(a) any termination of the license between ***and the *** by
either *** or the *** before or after the Effective
Date; or
(b) any inability of IE Oncology Company Limited or Inex to
grant sublicenses under the *** License, or the absence
of a consent to such sublicense from *** or the ***; or
(c) any inability of *** to grant Intellectual Property
Rights under the ***to IE Oncology Company Limited
("IE"), or of IE to grant such rights to Inex, or of
Inex to grant such rights to Enzon, which rights in each
case are at least co-extensive (within the Field and
within the Territory as defined in the Related
Agreements) with the scope of Intellectual Property
Rights under the *** purported to be granted by *** to
IE pursuant to the *** License;
or the like respecting the ***.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
10
1.1.49 "Pharmacovigilance" means all the activities associated with
maintaining an effective drug safety monitoring system and adverse
events reporting system in compliance with the requirements of
Regulatory Authorities.
1.1.50 "Post-Approval Clinical Activities" has the meaning set out in
Section 5.3.
1.1.51 "Prime Rate" means the prime or equivalent rate quoted by
Citibank, N.A. from time to time.
1.1.52 "Product" means VSLI.
1.1.53 "Product Supply Agreement" means the agreement for the supply of
the Product from Inex to Enzon entered into as of the Effective
Date.
1.1.54 "QA" means Quality Assurance, being that part of each management
system, within Inex and Enzon separately, having responsibility
for assuring the quality of the Product in respect of compliance
with Regulatory Requirements.
1.1.55 "Quality/Technical Agreement" has the meaning set out in the
Product Supply Agreement.
1.1.56 ***
1.1.57 "Regulatory Activity" and "Regulatory Activities" mean any one or
more of the regulatory activities to be performed by the Parties,
or their Representatives in pursuit of the Development of the
Product, including writing, translation, compilation,
notification, submission, filing, defense, maintenance and renewal
of Regulatory Approvals and payment of fees associated therewith,
and meeting with Regulatory Authorities.
1.1.58 "Regulatory Approvals" means all necessary and appropriate
regulatory approvals which must be obtained before placing the
Product on the market in the Field in any country in the Territory
in which such approval is required, including without limitation,
INDs, NDAs, and any other comparable terms as applicable with
regard to any such approvals in any other country in the
Territory.
1.1.59 "Regulatory Authority" or "Regulatory Authorities" means:
(a) the FDA, the TPD and any other like governmental
authorities, whether federal, provincial, state or
municipal, regulating the importation, distribution,
marketing and/or sale of therapeutic substances in the
Territory; and
(b) the corresponding governmental authorities, whether
federal, provincial, state or municipal, of each other
applicable jurisdiction outside the Territory in which
the Product will be developed, used or sold.
1.1.60 "Regulatory Requirements" means:
(a) Applicable Laws, rules, regulations, guidances, and the
Codes and Standards in respect of all activities of the
Parties and their permitted Representatives under
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
11
the Related Agreements, including guidances in respect
of quality control and QA procedures and processes,
manufacturing and production batch records (including
the Master Production Record), packaging, handling,
storage, delivery and retention of raw material and
Product samples and associated support data, and all
licenses, certificates, authorizations or requirements
from Regulatory Authorities; and
(b) the corresponding laws, rules, regulations and guidances
of each other applicable jurisdiction outside the
Territory in which such activities take place.
1.1.61 "Regulatory Submissions" means all submissions and filings made in
furtherance of obtaining and maintaining any Regulatory Approvals.
1.1.62 "Related Agreements" means, collectively, this Agreement, the
Product Supply Agreement, the Quality/Technical Agreement and the
Co-Promotion Agreement.
1.1.63 "Representatives" means, in respect of a Party, that Party's
Affiliates and their respective directors, officers, employees,
consultants, subcontractors, sublicensees, agents, representatives
and other persons acting under their authority.
1.1.64 "Standards" means the Accreditation Council for Continuing Medical
Education (ACCME) Standards for Commercial Support of Continuing
Medical Education, as they may be amended from time to time.
1.1.65 "Sublicensee" means a Third Party which is not an Affiliate of
Enzon and to whom Enzon has granted a sublicense for the purpose
of developing, using, selling, having sold, distributing,
importing or exporting the Product in one or more countries of the
Territory.
1.1.66 "Technical and Manufacturing Support Activity" or "Technical and
Manufacturing Support Activities" mean any one or more of the
activities to be performed by the Parties or their Representatives
in the area of analytical development, process development,
manufacturing, and quality control, in pursuit of manufacturing
scale-up and the Regulatory Approvals of the Product, including
the design, testing, analysis, qualification, and validation of
methods, equipment and/or processes.
1.1.67 "Term" has the meaning set out in Section 11.1.
1.1.68 "Territory" means Canada, Mexico and the USA.
1.1.69 "Third Party(ies)" means any Person other than Inex or Enzon or an
Affiliate of either of them.
1.1.70 "TPD" means the Therapeutic Products Directorate Organization of
Health Canada.
1.1.71 "Trademarks" means trademarks, trade names, and domain names
identified in Exhibit 1.1.71 and all applications and
registrations thereof in the Territory.
1.1.72 "USA" means the United States of America, including its
territories, possessions and the Commonwealth of Puerto Rico.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
12
1.1.73 "Valid Claim" means either:
(a) a claim of an issued and unexpired patent which has not
been held unenforceable, unpatentable or invalid by a
court or other governmental agency of competent
jurisdiction, and which has not been admitted to be
invalid or unenforceable through reissue, disclaimer or
otherwise; or
(b) a claim in a patent application, provided that if such
pending claim has not issued as a claim of an issued
patent within seven years after the national filing date
of such patent application in a country, such pending
claim shall not be a Valid Claim for purposes of this
Agreement.
In the event that a claim of an issued patent is held by a court
or other governmental agency of competent jurisdiction to be
unenforceable, unpatentable or invalid, and such holding is
reversed on appeal by a higher court or agency of competition
jurisdiction, such claim shall be reinstated as a Valid Claim
hereunder.
1.1.74 "Vincristine" means the chemical compound known as vincristine
sulfate.
1.1.75 "Vincristine Sulfate Liposomes Injection" or "VSLI" means
Vincristine encapsulated in sphingomyelin/cholesterol liposomes or
a kit for production of same.
1.2 Entire Agreement; Conflicts
The Parties hereby agree that, except as expressly modified hereby, the
following Articles of the Product Supply Agreement shall be part of this
Agreement as if set out herein: Sections 12.6 through 12.10 inclusive, Articles
13, 14, 15 and 16. This Agreement, together with the other Related Agreements,
constitutes the entire agreement between the Parties concerning the subject
matter hereof. In the event of a conflict between the terms and conditions set
out in any of the Related Agreements, the following agreements shall govern in
the following priority:
1.2.1 the Product Supply Agreement;
1.2.2 the Quality/Technical Agreement;
1.2.3 this Development Agreement; and
1.2.4 the Co-Promotion Agreement
1.3 Governing Law
This Agreement shall be governed by and construed in accordance with the laws of
Delaware in force therein without regard to its conflict of law rules.
1.4 Headings
The headings contained in this Agreement are for convenience of reference only
and shall not be considered in construing this Agreement. References to Articles
are references to Articles of this
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
13
Agreement and the Sections contained therein, and references to Sections are
references to Sections of this Agreement.
1.5 Severability
If a court or other tribunal of competent jurisdiction should hold any term or
provision of this agreement to be excessive, invalid, void or unenforceable, the
offending term or provision shall be deemed inoperative to the extent it
conflicts with such holding and shall be deemed to be modified to the extent
necessary to conform with such statute or rule of law, while still preserving,
to the extent practicable, the legitimate aims of the Parties, provided that the
remaining portions hereof shall remain in full force and effect. In the event
that the terms and conditions of this Agreement are materially altered as a
result of the above, the Parties will renegotiate the terms and conditions of
this Agreement to resolve any inequities.
Article 2 Grant and Reservation of Rights
2.1 Grant of Licenses
In furtherance of the Product Supply Agreement, and subject to the reservation
set forth in Section 2.2 of this Agreement, Inex hereby grants to Enzon:
2.1.1 an exclusive license for the Field in the Territory under the Inex
Patents;
2.1.2 subject to the terms, conditions and limitations set out in the
***, an exclusive sublicense for the Field in the Territory under
the ***;
2.1.3 subject to Section Error! Reference source not found., to the
extent of Inex's legal right to grant same, a non-exclusive
sublicense for the Field in the Territory under the ***;
2.1.4 an exclusive license for the Field in the Territory under the Inex
Technology; and
for the sole purpose of developing (solely in accordance with the Development
Plan), using, selling, having sold, offering for sale, distributing, importing
and exporting the Product for the Field in the Territory, including the right to
grant sublicenses under these rights in accordance with Section 2.4. Enzon shall
not use or exploit for any purpose of any Licensed Patents or Inex Technology
except as permitted in this Agreement.
2.2 Reservation of Rights
2.2.1 Except as otherwise expressly licensed to Enzon hereunder, Inex
may exploit the Licensed Patents and Inex Technology for any
purpose, including using, making, having made, selling, having
sold, distributing and importing the Product:
(a) outside the Territory;
(b) inside the Territory but outside the Field;
(c) inside the Territory and inside the Field, for the
purpose of sales to Enzon; and
(d) in accordance with Section 11.3.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
14
2.2.2 Inex retains the non-exclusive (non-sublicensable, except as
contemplated herein) right under the Licensed Patents and the Inex
Technology:
(a) to practice the Licensed Patents and the Inex Technology
for internal research purposes for the Field;
(b) to Co-Promote the Product in the Territory in accordance
with the Co-Promotion Agreement; and
(c) to undertake Development as contemplated herein.
2.2.3 For avoidance of doubt, Inex may exploit the Licensed Patents and
Inex Technology in any territory for any liposomal product which
does not contain Vincristine.
2.3 ***
2.4 Sublicenses
2.4.1 Enzon shall have the right to sublicense all the rights granted in
Section 2.1 to its Affiliates. Enzon hereby unconditionally
guarantees the performance of any such Affiliates hereunder as if
they were signatories to this Agreement to the extent the
performance or lack of performance is a breach of this Agreement.
A breach by any such Affiliate of any such obligation shall
constitute a breach by Enzon of this Agreement and shall entitle
Inex to exercise its rights hereunder, in addition to any other
rights and remedies to which Inex may be entitled.
2.4.2 Enzon shall also have the right to sublicense all the rights
granted in Section 2.1 to Third Parties, subject to the following:
(a) Prior to the execution of any sublicense, Enzon shall
provide Inex with at least the following information
with respect to each potential Sublicensee: (i) the
identity of the Sublicensee; (ii) the territory in which
the Product will be sold; and (iii) a copy of the draft
sublicense.
(b) Each sublicense shall contain covenants by the
Sublicensee for the benefit of Inex to observe and
perform similar terms and conditions to those in this
Agreement. All sublicenses granted by Enzon shall be
personal to the Sublicensee and shall not be further
sublicensable or assignable without the prior written
consent of Inex. Such sublicenses shall terminate upon
the termination of Enzon's rights granted herein unless
events of default are cured by Enzon or Sublicensee
within sixty (60) days after notification by Inex of
default and/or as provided by the terms of this
Agreement.
(c) Enzon may grant such sublicenses only with the prior
written consent of Inex, which shall not be unreasonably
withheld.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
15
(d) Unless otherwise agreed in the Elan Consent, Enzon may
grant such sublicenses only with the prior written
consent of Elan, which consent may be withheld in Elan's
absolute discretion.
(e) Any Sublicensee which wishes to grant a further
sublicense shall comply with the terms of this Section
as if the further sublicense were a sublicense
hereunder, including providing to Enzon and Inex the
information described in this Section with respect to
each potential sub-sublicensee, and obtaining the
consent referred to in this Section, prior to the
execution of any such sub-sublicense.
(f) In the event that Enzon becomes aware of a material
breach of any such sublicense by the Sublicensee, Enzon
shall promptly notify Inex of the particulars of same
and take all reasonable steps to enforce the terms of
such sublicense. Enzon shall remain responsible to Inex
for the compliance of each such Sublicensee with the
financial and other obligations due under this
Agreement. Upon the request of Inex, Enzon shall act
reasonably in considering any request of Inex for Enzon
to terminate such sublicense.
Article 3 Milestone Payments for Development
3.1 Signing and Regulatory Milestone Payments
As payments to facilitate the development of the Product and the establishment
of Inex's manufacturing and commercialization business, and as consideration for
the rights granted by Inex to Enzon under this Agreement, Enzon shall make the
following signing and regulatory milestone payments to Inex:
================================================================================
Milestone: Payment:
--------------------------------------------------------------------------------
3.1.1 Execution of the Product Supply Agreement, $12.0 million
this Agreement and the Co-Promotion Agreement
3.1.2 NDA Accelerated Approval ("AA") in the USA within $20.0 million
eighteen (18) months of completed NDA submission
date
3.1.3 *** $***
3.1.4 *** $***
3.1.5 *** $***
3.1.6 *** $***
3.1.7 *** $***
3.1.8 *** $***
3.1.9 *** $***
================================================================================
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
16
Provided that:
3.1.10 Enzon shall make the milestone payment referred to in Section
3.1.1 to Inex on execution and delivery of this Agreement by the
Parties, in payment for Inex's prior development work and other
rights granted herein;
3.1.11 Enzon shall make the milestone payments other than the ones
referred to in Sections 3.1.1 and Error! Reference source not
found. to Inex within thirty (30) days after achievement of each
milestone by a Party, or by an Affiliate or a Sublicensee;
3.1.12 Enzon shall make the milestone payments referred to in Section
Error! Reference source not found. to Inex on the dates set out
for occurrence of such milestone in Section Error! Reference
source not found.;
3.1.13 except for the payments set out in Section Error! Reference source
not found., each milestone payment hereunder shall be made only
one time, based upon the Product achieving a particular milestone
regardless of how many times such milestone is achieved;
3.1.14 only one of the three alternative milestone payments referred to
in Sections 3.1.2, Error! Reference source not found. and Error!
Reference source not found. will be paid;
3.1.15 payment shall not be owed for a milestone which is not reached;
3.1.16 except as expressly set out in this Agreement, each payment shall
be made without setoff, deduction or similar right;
3.1.17 with the exception of payment referred to in Section 3.1.9, which
is creditable in accordance with its terms, any milestone payment
described herein shall be non-refundable and non-creditable
against any other payment due from Enzon to Inex under this
Agreement;
3.1.18 ***
3.1.19 ***
3.1.20 ***
3.1.21 ***
3.1.22 ***
3.2 Withholding Taxes
The Parties contemplate that there will be no payment or withholding by Enzon of
taxes on any payments made by Enzon to Inex pursuant to this Agreement. In the
event that either Party takes any action, or if the circumstances applicable to
either Party change with the result that taxes must be paid or withheld on the
payments due pursuant to this Agreement, then such taxes shall be borne by such
Party. Without limiting the generality of the foregoing:
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
17
3.2.1 if Enzon assigns or sublicenses its rights hereunder, undergoes a
reorganization or otherwise changes its structure, or changes its
domicile, and thereafter taxes must be paid or withheld on the
payments hereunder, such payments shall be grossed up so that Inex
receives the actual amounts set out in this Agreement; and
3.2.2 if Inex assigns or sublicenses its rights hereunder, undergoes a
reorganization or otherwise changes its structure, or changes its
domicile, and thereafter taxes must be paid or withheld on the
payments hereunder, then such tax or withholding payments shall be
deducted from the amounts set forth herein, and Enzon shall assist
Inex as may be reasonably required, including providing proof of
such payment of such tax payment, in order to allow Inex to claim
the benefit of, exemption from or repayment such tax payment, as
may be applicable; and
3.2.3 in the event that payment or withholding by Enzon of taxes becomes
necessary on any payments made by Enzon to Inex pursuant to this
Agreement when neither Section 3.2.1 nor Section 3.2.2 applies,
then such tax or withholding payments shall be deducted from the
amounts set forth herein, and Enzon shall assist Inex as may be
reasonably required, including providing proof of such payment of
such tax payment, in order to allow Inex to claim the benefit of,
exemption from or repayment such tax payment, as may be
applicable.
Notwithstanding the foregoing, if Inex is able to credit the grossed up portion
of any payment made by Enzon pursuant to Section 3.2.1 against taxes payable by
Inex, or gain exemption from or repayment of such tax payment, Inex will
promptly pay the equivalent of the benefit received by Inex to Enzon.
3.3 Late Payments
Any payment by Enzon or Inex that is not paid on or before the date such payment
is due under this Agreement shall bear interest at a rate equal to the lesser
of:
3.3.1 Prime Rate plus *** per year, or
3.3.2 the maximum rate permitted by law;
calculated based on the number of days that payment is delinquent.
Article 4 Development
4.1 Development Activities in accordance with the Development Plan
Inex and Enzon will undertake Development as set out in the Development Plan and
as amended from time to time by the Parties in accordance with this Article 4.
Subject to Sections 5.2 and 5.8, from the Effective Date until the Parties'
agreement to the terms of the definitive Development Plan, Inex and Enzon will
undertake the Development acting reasonably. If either Party fails to perform
its responsibilities under the Development Plan (the "Non-performing Party")
after reasonable notice of such failure from the other Party (the "Performing
Party"), the Performing Party's sole remedy shall be that the Performing Party
may assume conduct of such responsibilities and the Development Plan shall be
amended to reflect such change. The cost of any such responsibilities so assumed
shall be borne by the Parties as set out in this Agreement.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
18
4.2 Overview of Development
The Parties intend to work cooperatively to pursue the Development in accordance
with the terms of this Agreement. Unless otherwise set out in this Agreement,
the Parties will conduct the Development as directed by the Joint Steering
Committee and in conformance with the Development Plan. The Parties shall
collaborate closely, through the Joint Steering Committee, to assign
responsibility for conducting the various aspects of such Development. Unless
otherwise agreed by the Parties, the Parties will conduct the activities
assigned to them in the Development Plan.
4.3 Development Diligence
4.3.1 Inex shall make its third submission to the FDA for an NDA for the
Product as soon as reasonably possible.
4.3.2 Each of the Parties, directly and through its permitted
Representatives, shall use Commercially Reasonable Efforts to
Develop the Product for the USA and Canada, including carrying out
its respective responsibilities under the Development Plan,
including to:
(a) conduct or cause to be conducted the necessary and
appropriate clinical trials as necessary to obtain and
maintain Regulatory Approvals for the Product; and
(b) prepare, file and prosecute or cause to be prepared,
filed and prosecuted the Regulatory Submissions for the
Product in the USA and Canada.
4.3.3 Each of the Parties, directly and through its permitted
Representatives, shall perform the Development in compliance with
Regulatory Requirements.
4.3.4 Each Party shall ensure none of its Representatives who
participate in any activities under the Related Agreements:
(a) is or has been suspended, debarred or disqualified by
the FDA;
(b) has been convicted of any offence that would form the
basis for any debarment; or
(c) is or has been subject to any proceedings for the
suspension, disqualification or debarment of such Party
or any Representative of such Party.
4.4 Development Plans
4.4.1 Within ninety (90) days after the Effective Date, the Joint
Steering Committee shall prepare, review and submit to the Parties
for approval a detailed Development Plan for the Development of
the Product.
4.4.2 Development of the Product shall be conducted by the Parties in
conformance with the Development Plan.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
19
4.4.3 The Development Plan may be updated by the Joint Steering
Committee and the Parties as provided herein.
4.4.4 At a minimum, the Development Plan as amended from time to time
shall describe the specific activities to be performed in the
Territory for a twelve (12) month period, with a summary of
development activities to be performed thereafter. The Development
Plan will be reviewed on at least a semi-annual basis by the Joint
Steering Committee to update the specific activities to be
performed for the rolling twelve (12) month period, as well as to
reflect the revised Development as the Joint Steering Committee
reasonably determines to be necessary or useful. Notwithstanding
the above, no amendment to any Development Plan shall be construed
to be final unless it has been made in accordance with the
provisions of Article 6.
4.5 Reports on Development
Each Party will keep the other Party fully informed on the progress of the
Development in respect of the Territory, using reasonable reporting requirements
mutually established by the Parties. As a minimum requirement, the Joint
Steering Committee shall receive and review and approve quarterly progress
reports.
4.6 Attendance at Regulatory Meetings
Each Party will inform the other Party of planned meetings between its
representatives and governmental or Regulatory Authorities regarding Regulatory
Approvals and Regulatory Submissions for the Product in the Territory and, where
appropriate to do so, make reasonable efforts to include the other Party in such
meetings.
4.7 Subcontractors
Either Party may subcontract to any of its Representatives any of its
obligations in respect of the Development with the consent of the other Party,
such consent not to be unreasonably withheld; provided however, that the
subcontracting Party shall be responsible for the performance of its
Representatives and shall remain fully responsible and obligated to the other
Party for all activities undertaken by its Representatives.
Article 5 Development Responsibility and Funding
5.1 Shared Funding of Certain Development Costs
Each Party shall bear the initial responsibility for funding all Development
Costs required to support the conduct of all such Party's responsibilities in
pursuit of Regulatory Approvals for the Product in the Territory in accordance
with the Development Plan, subject to allocation and reimbursement for such
expenses in accordance with this Article 5.
5.2 Development Clinical Activities
5.2.1 Subject to Section 5.2.2, Enzon will fund 50%, and Inex 50% of
Development Costs for all the following Clinical Activities (the
"Development Clinical Activities"):
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confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
20
(a) obtaining and maintaining Regulatory Approval for the
first label claim for the Product in each country in the
Territory, including any FDA mandated Phase III
confirmatory trials for the first label claim if VSLI
receives NDA Accelerated Approval in the USA;
(b) any jointly agreed-to trials designed to obtain
additional Regulatory Approvals for the Product in the
Territory;
(c) all Phase II clinical trials for the Product ongoing as
of the Effective Date, a listing of which is set out in
Exhibit 5.2.1(c); and
(d) all jointly agreed-to trials sponsored by either of the
Parties to explore new indications or dosing regimens
for the Product.
5.2.2 Notwithstanding anything herein to the contrary, Enzon's
contribution to Development Costs for Development Clinical
Activities under this Section 5.2 from the Effective Date through
June 30, 2004 shall be limited to *** of the first *** of
Development Costs incurred. Inex shall pay *** of the Development
Costs incurred during this period in excess of ***, if any.
5.3 Post-Approval Clinical Activities
Enzon will be responsible for and fund *** of the costs for all the following
Clinical Activities (the "Post-Approval Clinical Activities"):
5.3.1 Clinical Activities typically associated with post-Regulatory
Approval commercialization, including Phase IV clinical trials and
post-Regulatory Approval Compendium Listings;
5.3.2 physician-sponsored studies; and
5.3.3 any Clinical Activities undertaken by the Parties not required by
a Regulatory Authority in order to obtain any Regulatory Approval
or as a condition of obtaining or maintaining a Regulatory
Approval.
5.4 Regulatory Activities
5.4.1 The Parties will coordinate their activities with each other with
respect to the overall regulatory strategy for the Product in the
Territory, and with respect to Inex's overall regulatory strategy
for the Product outside the Territory.
5.4.2 Inex will have primary responsibility for Regulatory Activities in
the Territory, with Enzon's input and advice.
5.4.3 Enzon will fund ***, and Inex *** of all Development Costs for
Regulatory Activities associated with obtaining and maintaining
Regulatory Approval for the Product in the Territory.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
21
5.5 Filing of Regulatory Submissions
5.5.1 Inex or an Affiliate of Inex designated by Inex shall be named as
the applicant for all Regulatory Submissions and holder of all
Regulatory Approvals in all countries, including the countries in
the Territory, and all such Regulatory Approvals and Regulatory
Submissions shall be owned as set out in Section 10.4.
5.6 Technical and Manufacturing Support Activities
5.6.1 Each Party will have responsibility for Technical and
Manufacturing Support Activities in the Territory as set out in
the Development Plan, with input and advice from the other Party.
5.6.2 Enzon will fund ***, and Inex *** of all Development Costs
including Costs for Technical and Manufacturing Support Activities
and the following additional activities, if mutually agreed upon,
shall be Technical and Manufacturing Support Activities:
(a) manufacturing scale up activities;
(b) the contracting of secondary suppliers and testing
laboratories;
(c) the establishment of secondary manufacturing sites; and
(d) the establishment of secondary suppliers and/or
alternate sources of raw materials.
5.7 Funding of Development Costs
5.7.1 From and after the Effective Date, in respect of each calendar
quarter in which Development Costs are incurred, the Parties shall
bear their proportionate share of Development Costs as set out in
this Article.
5.7.2 Within twelve Business (12) Days after of the end of each calendar
quarter, each Party shall provide the other Party with a
reasonably detailed invoice setting forth such Party's Development
Costs.
5.7.3 Such invoices shall be accompanied by appropriate documentation
("Supporting Documentation"), including a listing of expenditures
in reasonably specific detail to support the Party's determination
of the actual Development Costs incurred in conducting Development
work during such calendar quarter.
5.7.4 If the invoices and Supporting Documentation (as verified by the
Joint Steering Committee) demonstrate that one Party, in
completing tasks assigned for such quarter under the Development
Plan (but excluding tasks each Party is to perform at its own
expense hereunder) has borne more of the Development Costs than
the share set out for such Party in this Article 5, then within 30
days after the exchange of invoices and Supporting Documentation,
there shall be an accounting and payment between the Parties to
bring the Development Costs incurred by them respectively during
such quarter into conformity with this Article 5.
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confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
22
5.7.5 Each Party shall use Commercially Reasonable Efforts to comply
with the applicable budget for each activity set out in the
Development Plan for such Party during the each calendar year. In
the event that a Party incurs any Development FTE Costs for a
particular activity that exceed the amount budgeted therefor, such
event shall not be considered a breach of this Agreement by such
Party, but the other Party shall not be responsible for funding
any such excess amount, unless otherwise agreed to in writing by
the Parties. If a Party believes that completion of the assigned
Development tasks will exceed the portion of such budget that is
allocated for such Party's efforts, such Party will contact the
Joint Steering Committee promptly after such determination in
order to initiate discussion by the Joint Steering Committee of
such matter and appropriate means of resolving same.
5.8 Transition
From the Effective Date until the Parties' agreement to the terms of the
definitive Development Plan, Inex and Enzon will fund their respective shares of
Development Costs incurred as contemplated by this Agreement. If the Parties
fail to agree on the terms of the definitive Development Plan within 90 days of
the Effective Date, until the terms of the definitive Development Plan are
determined, the Parties shall fund their respective shares of Development Costs
incurred by the Parties, acting reasonably. Notwithstanding the foregoing, after
the Effective Date, in the absence of a definitive Development Plan agreed upon
by the Parties, no more than an aggregate of US$*** in Development Costs will be
incurred without the review of the Joint Steering Committee and the agreement of
the Parties.
5.9 Records
Both Parties shall keep full, true and accurate books of accounts and other
records containing all information and data which may be necessary to ascertain
and verify:
5.9.1 the Development Costs incurred by each of them and their
respective Representatives for a period of three (3) years after
the completion of the Development; and
5.9.2 any other amount payable hereunder for a period of three (3) years
after the completion of the Term.
5.10 Audits
5.10.1 During the Development and for a period of one (1) year following
the completion of the Development, Enzon shall have the right from
time to time (not to exceed once during each calendar year) to
have either its internal financial audit personnel or an
independent firm of accountants (i.e., a certified public
accountant or like person reasonably acceptable to Inex) inspect
the books, records and supporting data of Inex referred to in
Section 5.9. Such independent firm of accountants shall perform
these audits at Enzon's expense upon reasonable prior notice and
during Inex's regular business hours, and shall agree as a
condition to such audit to maintain the confidentiality of all
information disclosed or observed in connection with such audit
and to disclose to Enzon only whether Inex has complied with its
obligations under this Agreement with respect to Development
Costs. If the result of such audit demonstrates an overpayment or
underpayment, there shall be a prompt (but in no event more than
60 days after
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confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
23
completion of the audit) accounting between the parties to
reconcile such overpayment or underpayment. If the result of such
audit demonstrates an overpayment by Enzon of *** or more, Inex
shall pay Enzon the reasonable costs of such audit.
5.10.2 During the Term and for a period of one (1) year thereafter, Inex
shall have the right from time to time (not to exceed once during
each calendar year) to have either its internal financial audit
personnel or an independent firm of accountants (i.e., a certified
public accountant or like person reasonably acceptable to Enzon)
inspect the books, records and supporting data of Enzon referred
to in Section 5.9. Such independent firm of accountants shall
perform these audits at Inex's expense upon reasonable prior
notice and during Enzon's regular business hours, and shall agree
as a condition to such audit to maintain the confidentiality of
all information disclosed or observed in connection with such
audit and to disclose to Inex only whether Enzon has complied with
its obligations under this Agreement with respect to the payment
of money owing pursuant to this Agreement. If the result of such
audit demonstrates an overpayment or underpayment, there shall be
a prompt (but in no event more than 60 days after completion of
the audit) accounting between the parties to reconcile such
overpayment or underpayment. If the result of such audit
demonstrates an underpayment of *** or more, Enzon shall pay Inex
the reasonable costs of such audit.
5.10.3 The provisions of Sections 5.10.1 and 5.10.2 are based on the
assumption that the net flow of payments under Section 5.7 will be
from Enzon to Inex. If this assumption proves incorrect, the
provisions of Sections 5.10.1 and 5.10.2 will be deemed modified
to permit an appropriate accounting between Inex and Enzon to
correct for any underpayment or overpayment by Inex.
Article 6 Joint Steering Committee
6.1 Joint Steering Committee
6.1.1 As of the Effective Date of this Agreement, the Joint Steering
Committee shall be formed and shall be constituted of four
representatives from each Party. The members of the Joint Steering
Committee as of the Effective Date are as set forth on Exhibit
6.1. The Chairperson of the Joint Steering Committee at the first
meeting of the Joint Steering Committee shall be an Enzon member
of the Joint Steering Committee, and thereafter, the Chairperson
will alternate at each meeting between a representative of Inex
and a representative of Enzon. The Chairperson shall be
responsible for issuing an agenda for the meeting, conducting and
chairing the meeting and preparing the minutes for the meeting,
and such other tasks as assigned by the committee. The Joint
Steering Committee shall meet regularly at least quarterly during
the period when Development in respect of the Territory is
occurring, or more frequently if necessary.
6.1.2 Each Party shall bear its own expenses associated with its
participation in the Joint Steering Committee and its
administration and oversight of the activities contemplated by the
Agreement. Such expenses shall not be included in Development
Costs.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
24
6.2 Meetings of the Joint Steering Committee
6.2.1 The Joint Steering Committee should meet at least once per year at
the location of Inex or an Affiliate of Inex, and once per year at
a location of Enzon or an Affiliate of Enzon. All other meetings
of the Joint Steering Committee may occur by telephone, video
conference or other acceptable means or location if requested by a
Party. The Joint Steering Committee shall oversee all Development
activities of the Parties under this Agreement, including
coordinating the overall strategy for Development. The Joint
Steering Committee shall have the responsibilities as set forth
generally in Exhibit 6.1. Each Party may appoint its
representatives to the Joint Steering Committee and other members
of its project team at its discretion. It is the intent of the
Parties to assign responsibilities for the various operational
aspects of the Development Plan to those portions of their
respective organizations which have the appropriate resources,
expertise and responsibility for such functions. The Joint
Steering Committee shall act only as a body making recommendations
to the Parties, and neither Party is bound by any recommendation
of the Joint Steering Committee. The members of the Joint Steering
Committee shall attempt, in good faith, to reach consensus on all
matters before the committee and make a consensus recommendation
to the Parties. In the event that the Joint Steering Committee
cannot make a consensus recommendation to the Parties which is
acceptable to the Parties, either Party may refer the matter for
resolution in accordance with the terms of Article 16 of the
Product Supply Agreement.
6.2.2 The Joint Steering Committee shall cause there to be recorded
reasonably detailed minutes of its meetings. The Party providing
the chairperson of each meeting shall be responsible for preparing
draft minutes of such meeting and distributing same to the other
members of the committee within five Business Days after such
meeting. If the other Party desires to revise the draft minutes it
will provide comments on such minutes within ten Business Days
after receiving the minutes. If such comments are provided,
members of the Joint Steering Committee designated by each Party
shall confer promptly and in good faith to resolve such comments
and finalize the minutes. If the members of the Joint Steering
Committee are unable to finalize the minutes within 30 days after
the date of the meeting, either Party may refer the matter for
resolution in accordance with the terms of Article 16 of the
Product Supply Agreement.
6.3 Working Committees
The Joint Steering Committee may establish working committees to manage actively
the Development. Such working committees will conduct at a minimum quarterly
planning and review meetings as well as ad hoc meetings as necessary. The
primary method of meeting will be teleconference. Responsibilities of the
working committees may include overseeing the planning and monitoring of the
clinical development process and the regulatory and commercialization processes.
Article 7 Pharmacovigilance, DDMAC and Recalls
7.1 Regulatory Responsibilities
Inex will be responsible for maintaining and fulfilling all Regulatory
Requirements with respect to the Product that are imposed upon Inex as the
manufacturer and holder of the Regulatory Approvals. Subject
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
25
to the other express terms of the Related Agreements, Enzon and its designees
will have sole responsibility for the advertising and other promotion of the
Product and for maintaining and fulfilling all Regulatory Requirements with
respect to the Product that are imposed upon Enzon as the advertiser, marketer
and distributor thereof.
7.2 Pharmacovigilance Agent
7.2.1 Unless the Parties agree to establish the agency referred to in
Section 7.2.2 on an accelerated basis, Inex shall be responsible
for performing Pharmacovigilance in respect of all pre-Regulatory
Approval Clinical Activities (in addition to all other Regulatory
Activities for which Inex is responsible). Until this agency is
established, if Enzon receives any information of any type
whatsoever that may constitute a complaint regarding the Product
or indicates that the Product in any way relates to an Adverse
Drug Event, then it will record the information set forth on
Exhibit 1.1.1 and transmit the completed form to Inex as soon as
possible, and in any event at least in time to allow Inex to meet
its reporting obligations under Regulatory Requirements. Inex will
then report the Adverse Drug Event in accordance with Regulatory
Requirements, and provide Enzon with a copy(ies) of all
documentation provided to Regulatory Authorities in respect of
such complaint or Adverse Drug Event. Further, until this agency
is established, if Inex receives any information of any type
whatsoever that may constitute a complaint regarding the Product
or indicates that the Product in any way relates to an Adverse
Drug Event, then it will record the information set forth on
Exhibit 1.1.1, provide a copy of the completed form to Enzon (if
possible, prior to submitting it to Regulatory Authorities) and
report the Adverse Drug Event in accordance with Regulatory
Requirements.
7.2.2 After Regulatory Approval of the Products by a Regulatory
Authority (or sooner if and to the extent agreed to by the
Parties), Enzon shall be appointed by Inex as Inex's agent with
respect to the regulatory dossier for the Product in the Field in
the Territory for the sole purpose of conducting
Pharmacovigilance. After this agency has been established, Enzon
shall manage and carry out on behalf of Inex all relevant
communications and relations with Regulatory Authorities to the
extent related to Pharmacovigilance with respect to the Product.
Inex shall be entitled to participate in all negotiations and
discussions between Enzon and Regulatory Authorities relating to
Pharmacovigilance with respect to the Product. Without limiting
the generality of the foregoing, after this agency has been
established, if Inex receives any information of any type
whatsoever that may constitute a complaint regarding the Product
or indicates that the Product in any way relates to an Adverse
Drug Event, then it will record the information set forth on
Exhibit 1.1.1 and transmit the completed form to Enzon as soon as
possible, and in any event at least in time to allow Enzon to meet
its reporting obligations under Regulatory Requirements. Enzon
will then report the Adverse Drug Event in accordance with
Regulatory Requirements, and provide Inex with a copy(ies) of all
documentation provided to Regulatory Authorities in respect of
such complaint or Adverse Drug Event. Further, after this agency
has been established, if Enzon receives any information of any
type whatsoever that may constitute a complaint regarding the
Product or indicates that the Product in any way relates to an
Adverse Drug Event, then it will record the information set forth
on Exhibit 1.1.1, provide a copy of the completed form to Inex (if
possible, prior to submitting it to Regulatory Authorities) and
report the Adverse Drug Event in accordance with Regulatory
Requirements.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
26
7.3 Agency for DDMAC Activities
7.3.1 Inex hereby appoints Enzon as its agent for the Product in the
Field in the Territory for the sole purpose of conducting all
DDMAC Activities in the USA and the foreign equivalents in the
remainder of the Territory.
7.3.2 Enzon shall perform the DDMAC Activities in the USA and the
foreign equivalents in the remainder of the Territory in
compliance with Regulatory Requirements.
7.3.3 Enzon will perform all DDMAC Activities in the USA and the foreign
equivalents in the remainder of the Territory and subject to
Section 7.1, be responsible for all post-approval
Pharmacovigilance activities, and assume all the costs associated
therewith.
7.3.4 In each country for which Inex is the holder of the Regulatory
Approval, Enzon shall regularly inform Inex of Enzon's DDMAC
Activities and foreign equivalents and obtain Inex's prior consent
to Enzon's DDMAC Activities and foreign equivalents and plans
respecting any of them. In the event Enzon informs Inex of its
DDMAC Activities, foreign equivalents and plans, and does not
receive a written objection from Inex within 10 Business Days,
Inex shall be deemed to have consented to such activities and
plans.
7.4 Agent for Regulatory Authorities Generally
7.4.1 Nothing in Section 7.1 or this Section 7.4 precludes Inex from
appointing an agent for Regulatory Authorities for products other
than the Product, or for territories outside the Territory.
7.4.2 All activities, communications and relations as well as Enzon's
role as agent for Regulatory Authorities shall be performed by
Enzon in close coordination with Inex, as holder of the Regulatory
Approvals.
7.4.3 In respect of all of the foregoing under Section 7.1 or this
Section 7.4, except as required by Regulatory Requirements and
except for those reporting requirements which have timeliness
requirements that make it impossible to seek and obtain Inex's
consent prior to making such report, any communications with
Regulatory Authorities by Enzon under Section 7.1 or this Section
7.4 are subject to the consent of the Inex, such consent not to be
unreasonably withheld.
7.5 Recalls and Withdrawals of Product
7.5.1 If Inex or Enzon will be required or requested by any Regulatory
Authority to recall any Product for any reason, or should Enzon
decide voluntarily to withdraw any Product:
(a) Enzon will be responsible for co-coordinating such
recall or withdrawal;
(b) Enzon shall pay the costs and expenses of such recall or
withdrawal, subject to recovery of some or all of same
in accordance with the terms of Section 7.5.2;
(c) unless Inex is liable for such costs and expenses in
accordance with the terms of Section 7.5.2, Enzon will
remain responsible to Inex for the Purchase Price for
27
such Product and will reimburse Inex for all of the
reasonable costs and expenses actually incurred by Inex
in connection with such recall or withdrawal including,
but not limited to, administration of the recall or
withdrawal and such other reasonable costs as may be
reasonably related to the recall or withdrawal; and
(d) both Parties will cooperate fully with one another in
connection with any such recall or withdrawal.
7.5.2 if a recall or withdrawal is due to Inex's negligence, willful
misconduct or breach of this Agreement or Inex's failure to
Manufacture the Product in conformity with the Specifications or
the provisions of the Product Supply Agreement or the
Quality/Technical Agreement, Inex will reimburse Enzon for all of
Enzon's reasonable costs and expenses actually incurred by Enzon
in connection with the recall or withdrawal, including the
Purchase Price for the recalled or withdrawn Product, costs of
retrieving Product already delivered to customers, costs and
expenses Enzon is required to pay for notification, shipping and
handling charges, destruction or return of the defective Product
or Product and such other reasonable costs as may be reasonably
related to the recall or withdrawal.
7.5.3 If the Parties are unable to agree on whether or not a recall or
withdrawal is due to Inex's negligence, willful misconduct or
breach of this Agreement, either Party may refer the matter for
resolution pursuant to Article 16 of the Product Supply Agreement.
Article 8 Additional Opportunities
8.1 Pipeline Drug
For a reasonable period after the Effective Date, the Parties will make good
faith efforts to work together to identify and secure rights to one other
oncology or hematology product from within or to be added to Enzon's current
pipeline. The Parties' intention is that the development and commercialization
of such new product in the Territory would be on the basis of a 50:50 funding
and profit sharing split.
8.2 Legal Effect
The matters set forth in this Article 8 constitute merely an expression of the
desire of the Parties to negotiate with each other regarding the terms of an
agreement regarding the subject matter of this Article 8, and nothing in this
Article 8 will have any legal or binding effect unless set out in writing in a
separate agreement and signed by the duly authorized representatives of the
Parties.
Article 9 Representations and Warranties
9.1 By Enzon
Enzon hereby represents and warrants to Inex that, as of the Effective Date:
9.1.1 Enzon has full legal right, power and authority to execute,
deliver and perform its obligations under the Related Agreements;
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
28
9.1.2 the execution, delivery and performance by Enzon of the Related
Agreements does not contravene or constitute a default under any
provision of Applicable Law or its articles or by-laws (or
equivalent documents) or of any judgment, injunction, order,
decree or other instrument binding upon Enzon;
9.1.3 all licenses, consents, authorizations and approvals, if any,
required for the execution, delivery and performance by Enzon of
the Related Agreements have been obtained and to the best
knowledge of Enzon are in full force and effect and all conditions
thereof have been complied with, and, except for appropriate
disclosure regarding the Related Agreements under the Securities
Exchange Act of 1934, as amended, no other action by or with
respect to, or filing with, any governmental authority or any
other person or entity is required in connection with the
execution, delivery and performance by Enzon of the Related
Agreements;
9.1.4 except for the Permitted Exception, to the best knowledge of
Enzon, the exploitation by Enzon of the rights granted to Enzon
hereunder in pursuit of the Development, Manufacture and
Commercialization of the Product do not infringe the Intellectual
Property Rights of any Third Party;
9.1.5 assuming each is a valid, binding and enforceable agreement of
Inex, each of the Related Agreements constitutes a valid and
binding agreement of Enzon, enforceable against Enzon in
accordance with its terms, except as such enforceability may be
limited by bankruptcy, insolvency, moratorium or creditors' rights
generally;
9.1.6 the execution, delivery and performance by Enzon of each Related
Agreement does not and will not conflict with or result in a
material breach of any of the terms and provisions of any Third
Party agreement of Enzon entered into as of the Effective Date;
9.1.7 except for the Permitted Exception, Enzon is not aware of any
impediment, including without limitation any Third Party agreement
of Enzon, which would prevent Enzon from performing its
obligations under the Related Agreements;
9.1.8 Enzon will not enter into any Third Party agreement after the
Effective Date which, in any way, will limit its ability to
perform all of the obligations undertaken by Enzon under the
Related Agreements; and
9.1.9 except for Intellectual Property Rights owned by Elan and licensed
to Enzon, Enzon does not own or control any Intellectual Property
Rights which could be asserted against Inex for Inex's performance
under the Related Agreements, or which could be infringed by the
developing, using, selling, having sold, distributing and
importing of the Product in the Territory.
9.2 By Inex
Inex hereby represents and warrants to Enzon that, as of the Effective Date:
9.2.1 Inex has full legal right, power and authority to execute, deliver
and perform its obligations under the Related Agreements;
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
29
9.2.2 the execution, delivery and performance by Inex of the Related
Agreements does not contravene or constitute a default under any
provision of Applicable Law or its articles or by-laws (or
equivalent documents) or of any judgment, injunction, order,
decree or other instrument binding upon Inex;
9.2.3 all licenses, consents, authorizations and approvals, if any,
required for the execution, delivery and performance by Inex of
the Related Agreements, including the Elan Consent, have been
obtained and, except for the Permitted Exception, to the best
knowledge of Inex, are in full force and effect and all conditions
thereof have been complied with, and, except for appropriate
disclosure regarding the Related Agreements required by any stock
exchange having authority, except for the Permitted Exception, to
the best knowledge of Inex no other action by or with respect to,
or filing with, any governmental authority or any other person or
entity is required in connection with the execution, delivery and
performance by Inex of the Related Agreements;
9.2.4 except for the Permitted Exception, and the rights granted by Inex
outside the Field or outside the Territory, Inex is the exclusive
owner or licensee of all legal and beneficial right, title and
interest in and to the Licensed Patents;
9.2.5 except for the Permitted Exception, Inex has the rights to the
Elan Patents necessary to grant the sublicenses granted in the
Related Agreements and the Elan License has not been breached by
Inex or its Affiliates or, to the best knowledge of Inex, by Elan
and its Affiliates;
9.2.6 except for rights granted by Inex outside the Field or outside the
Territory, Inex is the sole and exclusive owner or licensee of the
Inex Technology, free and clear of any lien, claim or encumbrance
or rights of any other person or entity;
9.2.7 except for the Permitted Exception, to the best knowledge of Inex,
the exploitation by Enzon of the rights granted to Enzon under the
Related Agreements in pursuit of the Development, Manufacture and
Commercialization of the Product do not infringe the Intellectual
Property Rights of any Third Party;
9.2.8 assuming each is a valid, binding and enforceable agreement of
Enzon, each of the Related Agreements constitutes a valid and
binding agreement of Inex, enforceable against Inex in accordance
with its terms, except as such enforceability may be limited by
bankruptcy, insolvency, moratorium or creditors' rights generally;
9.2.9 the execution, delivery and performance by Inex of the Related
Agreements does not and will not conflict with or result in a
material breach of any of the terms and provisions of any Third
Party agreement of Inex entered into as of the Effective Date;
9.2.10 except for the Permitted Exception, Inex is not aware of any
impediment, including without limitation any Third Party agreement
of Inex, which would prevent Inex from performing its obligations
under the Related Agreement;
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
30
9.2.11 Inex will not enter into any Third Party agreement after the
Effective Date which, in any way, will limit its ability to
perform all of the obligations undertaken by Inex under the
Related Agreements;
9.2.12 except for the Licensed Patents and Inex Technology, Inex does not
own or control any Intellectual Property Rights which could be
asserted against Enzon for Enzon's performance under the Related
Agreements, or which could be infringed by the developing, using,
selling, having sold, distributing and importing of the Product in
the Territory; and
9.2.13 at the time delivered to Enzon, all Product:
(a) will fully conform to the Regulatory Requirements, the
Specifications and the Master Production Record; and
(b) will not, as the result of Inex's undertakings or
failure to perform its undertakings as set out in this
Agreement, be adulterated or misbranded within the
meaning of Section 501[351] and 502[352] of the Federal
Food, Drug and Cosmetic Act, as amended, and the
regulations issued thereunder or within the meaning of
any applicable state or local law, the adulteration and
misbranding provisions of which are similar to the
Federal Food, Drug and Cosmetic Act.
9.3 Survival of Representations and Warranties
The representations and warranties contained herein shall survive the execution,
delivery and performance of this Agreement by the Parties, notwithstanding any
investigation at any time made by or on behalf of any Party or Parties.
9.4 DISCLAIMER
EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS CONTAINED IN THIS
AGREEMENT, NEITHER Inex NOR ENZON MAKES, AND EACH HEREBY EXPRESSLY DISCLAIMS,
ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR
IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR VALIDITY OR SCOPE OR NON-INFRINGEMENT OF
ANY INTELLECTUAL PROPERTY RIGHTS.
Article 10 Intellectual Property Rights
10.1 Injunctive Relief
Each party acknowledges the competitive and technical value of the Licensed
Patents and Inex Technology, and the sensitive and confidential nature of the
Confidential Information and agrees that monetary damages alone will be
inadequate to protect the other party's interests against any actual or
threatened material breach of this Agreement. Accordingly, each party consents
to the granting of specific performance and injunctive or other equitable relief
to the other party in respect of any actual or threatened breach of this
Agreement, without proof of actual damages.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
31
10.2 Ownership of Pre-Existing Intellectual Property Rights
Any Intellectual Property Rights or trademark rights owned by either Party prior
to the Effective Date shall remain solely owned by such Party.
10.3 Ownership of Intellectual Property Rights in the Product
All Intellectual Property Rights arising from and during the course of the
Development, including all Intellectual Property Rights:
10.3.1 to all inventions arising from and during the course of the
Development;
10.3.2 to all data, information, know-how and results and the like
created as part of the Development (the "Data"); and
10.3.3 relating to the Product or improvements thereto or the process for
manufacturing the Product;
shall be solely owned by Inex or its designee, regardless of:
10.3.4 which Party(ies) created or invented the same; and
10.3.5 whether or not such Intellectual Property Rights are required to
obtain and maintain Regulatory Approvals;
and shall be licensed to Enzon hereunder as Licensed Patents and Inex Technology
without additional consideration or formality during the Term. Without limiting
the generality of the foregoing, any Elan Improvements made by Enzon, or its
Representatives, regardless of whether or not arising from and during the course
of the Development, shall be solely owned by Elan and sublicensed (within the
Field and within the Territory) without additional consideration to Enzon
through Inex on the terms set out in this Section. Enzon shall cooperate, and
shall cause its Representatives to cooperate, with Inex and Elan, at Elan's
expense, in perfecting Elan's ownership and other proprietary rights in respect
of any Elan Improvements and Enzon hereby assigns same to Elan and shall execute
and deliver, and cause its Representatives to execute and deliver, to Elan any
documents that Elan may reasonably require with respect thereto. If at any time
Elan does not exercise its rights under this Section, such rights may be
exercised by Inex as if Inex were Elan under this Section.
10.4 Ownership of Regulatory Approvals and Regulatory Submissions
Notwithstanding the terms of Section 10.3:
10.4.1 Inex or its Representatives will own all Regulatory Approvals and
Regulatory Submissions made as part of the Development in respect
of the Product in the Territory and all Intellectual Property
Rights in same; and
10.4.2 Inex or its Representatives may use all Data and Regulatory
Approvals and Regulatory Submissions, in Inex or its
Representative's efforts to register and commercialize the Product
outside the Territory and inside the Territory but outside the
Field.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
32
10.5 Ownership of Intellectual Property Rights Outside the Development
Except as otherwise provided in Sections 10.3 and 10.4, each Party shall have
and retain sole and exclusive title to all inventions, discoveries and know-how
which are made, conceived, reduced to practice or generated by its
Representatives. For greater certainty, Intellectual Property Rights or
inventions or creations generated outside the Development and without access to
the other Party's Confidential Information shall not be licensed hereunder or
included in the Licensed Patents or Inex Technology.
Article 11 Termination
11.1 Term
This Agreement shall become effective on the Effective Date and, unless earlier
terminated as provided for herein, shall expire, on a country-by-country basis,
upon the later of:
11.1.1 expiration of the last to expire of the Licensed Patents
containing Valid Claims covering the Product in such country in
the Territory; and
11.1.2 fifteen years from the date of the First Commercial Sale in that
country;
and such period shall be the "Term" under this Agreement.
11.2 Renewal
On or before six months before the expiration of this Agreement in accordance
with its terms, Enzon may notify Inex in writing that Enzon wishes to renew this
Agreement. In the event that Enzon so notifies Inex, the Parties will negotiate
in good faith for the extension of the Term. If the Parties have not reached
agreement in writing to extend the Term on or before the expiry of the Term,
this Section 11.2 shall be of no further force or effect.
11.3 Voluntary Termination
11.3.1 In the event that Enzon does not have a significant interest in
obtaining or maintaining Regulatory Approval of and marketing
Product in any country of the Territory, Enzon shall promptly
notify Inex in writing. If Inex requests in writing that Enzon
indicate whether or not Enzon has an interest in obtaining or
maintaining Regulatory Approval of and marketing Product in a
country(ies) of the Territory, within thirty (30) days thereafter
Enzon shall notify Inex in writing as to whether or not Enzon has
such an interest. In the event that:
(a) Enzon notifies Inex that it does not have a significant
interest in obtaining or maintaining Regulatory Approval
of and marketing Product in any country(ies) of the
Territory; or
(b) Enzon does not respond in writing within thirty (30)
days of Enzon's receipt of Inex's query;
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
33
(c) Inex may terminate all licenses granted to Enzon
pursuant to this Agreement in respect of such
country(ies) of the Territory, and such country(ies)
shall no longer form part of the Territory.
11.3.2 Enzon may terminate this Agreement in its entirety at any time by:
(a) providing Inex ninety (90) days prior written notice of
Enzon's intention to terminate;
(b) paying all outstanding obligations due to Inex,
including Enzon's portion of all non-cancelable
Development Costs incurred by Inex and its Affiliates
pursuant to the Related Agreements as of the date of
termination; and
(c) paying a termination fee of two million dollars
($2,000,000), unless such termination is effected after
12 months from the Effective Date but prior to Inex
completing its NDA submission to the FDA for the
Product.
(d) All amounts due hereunder shall be paid by Enzon to Inex
within ten (10) days of termination, without reduction,
except as agreed in writing between the parties.
11.4 Termination for Breach
Each Party shall be entitled to terminate this Agreement and the licenses
granted hereunder to the other Party by written notice to the other Party in the
event that the other Party shall be in material default of any of its
obligations hereunder, and shall fail to remedy any such default within ninety
(90) days after notice thereof by the non-breaching Party. Any such notice shall
specifically state that the non-breaching Party intends to terminate this
Agreement in the event that the breaching Party shall fail to remedy the
default. Any such notice shall set out expressly the actions required of the
breaching Party to remedy the default. If such default is not corrected, the
non-breaching Party shall have the right to terminate this Agreement by giving
written notice to the Party in default provided the notice of termination is
given within six (6) months of the default and prior to correction of the
default.
11.5 Termination upon Bankruptcy
11.5.1 This Agreement may be terminated by a Party by providing written
notice to the other Party upon:
(a) the bankruptcy, liquidation or dissolution of the other
Party;
(b) the filing of any voluntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of
the other Party; or
(c) the filing of any involuntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of
the other Party which is not dismissed within one
hundred twenty (120) days after the date on which it is
filed or commenced.
11.5.2 Notwithstanding the foregoing, either Party may seek the waiver of
the operation of Section 11.5.1 in advance of any event giving
rise to a right of termination under Section 11.5.1(b), and,
provided that:
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
34
(a) the requesting Party is in good standing and not in
breach of any of the terms of the Related Agreements;
(b) the requesting Party is in reasonable financial
condition; and
(c) the Party whose consent is sought will not be prejudiced
by granting such waiver,
the Party whose consent is sought will not unreasonably withhold
its consent to such waiver. Such waiver may be revocable in the
event of a material adverse change in circumstances related to the
requesting Party not contemplated at the time of granting the
waiver.
11.6 Survival of Obligations; Return of Confidential Information
11.6.1 Upon any termination of this Agreement pursuant to this Article
11, neither Party shall be relieved of any obligations incurred
prior to such termination.
11.6.2 Upon any termination of this Agreement pursuant to this Article
11, the licenses granted in Section 2.1 will forthwith terminate.
11.6.3 Notwithstanding any termination of this Agreement, the obligations
of the Parties under Article 1, Sections 5.9 and 5.10, Article 9,
Article 10, Article 11 and Article 12, as well as under any other
provisions which by their nature are intended to survive any such
termination, shall survive and continue to be enforceable. 11.6.4
Upon any termination of this Agreement pursuant to this Article
11, except as contemplated hereby, each Party shall promptly
return to the other Party all written Confidential Information,
and all copies thereof (except for one archival copy to be
retained by a person designated by such Party (who shall not make
such Confidential Information generally available to employees or
other representatives of such Party) for the purpose of confirming
which information to hold in confidence hereunder), of the other
Party which is not covered by a license surviving such
termination.
11.7 Additional Consequences of Termination
11.7.1 On or before the effective date of termination of this Agreement,
except as otherwise set forth herein:
(a) Enzon shall promptly deliver to Inex a copy of all Data
and such other information, materials (including
biological materials) and documents in Enzon's
possession or control arising from the development of
the Product under this Agreement, including, without
limitation, the Development, provided that Inex shall be
responsible for any reasonable associated Out-of-Pocket
Costs associated with transferring same;
(b) Enzon shall pay its share of the Development Costs as
determined in accordance with Article 5, including all
non-cancelable Development Costs reasonably committed to
by Inex and its Affiliates prior to the termination of
the Agreement;
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
35
(c) in the event that such termination occurs before the
payment of all of the milestone payments referred to in
Section Error! Reference source not found., then,
concurrently with such termination, Enzon shall pay to
Inex the next such payment, pro-rated so that such
payment is reduced by the proportion of the year
remaining prior to the date for such payment as of the
effective date of such termination;
(d) Enzon's right to use the Data pursuant to Section 10.4.2
will forthwith terminate;
(e) all licenses and sublicenses granted pursuant to this
Agreement shall forthwith terminate;
(f) Enzon shall:
(i) use all reasonable endeavors to take all steps and
execute all documents reasonably necessary to
assign and/or transfer or permit reference to (to
the extent legally permissible in the relevant
country) all Regulatory Approvals and Regulatory
Submissions arising from the development of the
Product under this Agreement, including, without
limitation, the Development, in Enzon's name or in
the name of Enzon's Affiliates or Sublicensees, to
Inex or its designee;
(ii) provide to Inex or its designee copies of or
access to all correspondence, meeting minutes and
any other written information exchanged between
Enzon and any Regulatory Authority(ies) regarding
such Regulatory Approvals and Regulatory
Submissions;
(iii) in the event that no such assignment and/or
transfer and/or reference pursuant to Section
11.7.1(f)(i) may legally be made, then Enzon shall
forthwith surrender such Regulatory Approvals and
Regulatory Submissions for cancellation; and
(iv) upon Inex's request, Enzon shall within the same
period deliver to Inex or its designee any and all
documents relating to Regulatory Approvals and
Regulatory Submissions in its possession or
control arising from the Development that are
reasonably required in order to file, obtain or
maintain Regulatory Approvals for the Product.
11.8 Termination on a Country by Country Basis
In the event of termination of this Agreement in respect of one or more
country(ies) in the Territory pursuant to Section 11.3.1, then Sections 11.6 and
11.7 shall apply in respect of the country(ies) to which such termination
applies.
11.9 Termination of Related Agreements
In the event of termination of this Agreement, the Related Agreements shall
terminate with immediate effect, subject to any continuing or surviving
obligations as set forth in each such Related Agreement.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
36
Article 12 Miscellaneous
12.1 Assignment
12.1.1 The rights and obligations set out in this Agreement are personal
to each Party and for this reason, except as expressly set out in
this Agreement, this Agreement will not be assignable by either
Party in whole or in part, nor will either Party subcontract any
of its obligations hereunder without the prior written consent of
the other Party, which consent shall not be withheld or delayed
unreasonably; provided, however, that the restriction contained
herein will in no way limit the rights of either Party to:
(a) assign or subcontract any right or obligation hereunder
to any of its Affiliates; or
(b) appoint as its agent for any purpose of this Agreement
any such Affiliate; or
(c) assign any right or obligation hereunder to any person
or entity that:
(i) purchases all or substantially all of its assets
to which this Agreement relates or
(ii) purchases all or substantially all of the stock of
either Party; or
(iii) acquires or is combined with either Party in a
merger or some other form of business combination.
12.1.2 This Agreement will be binding upon and will enure to the benefit
of the parties hereto and to any permitted assignee or successor
of either party.
12.1.3 Subject to other provisions of this Section 12.1, if one Party
validly assigns or subcontracts any or all of its obligations
hereunder, such assigning or subcontracting Party agrees to remain
bound by all of its responsibilities and obligations hereunder.
12.1.4 Any and all assignments of this Agreement or any interest herein
not made in accordance with this Section 12.1 will be void ab
initio.
12.2 Counterparts
This Agreement may be executed in any number of counterparts, each of which
shall be deemed an original but all of which together shall constitute one and
the same instrument.
12.3 Force Majeure
In the event that either Party is prevented from performing or is unable to
perform any of its obligations under this Agreement due to any act of God; fire;
casualty; flood; war; strike; lockout; failure of public utilities; injunction
or any act, exercise, assertion or requirement of governmental authority;
epidemic; destruction of production facilities; riots; insurrection; failure of
transportation; inability to procure or use materials; or any other cause beyond
the reasonable control of the Party invoking this Section 12.3 if such Party
shall have used its reasonable efforts to avoid such occurrence, such Party
shall give notice to the other Party in writing promptly, and thereupon the
affected Party's performance shall be excused and the
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
37
time for performance shall be extended for the period of delay or inability to
perform due to such occurrence.
12.4 Further Assurances
Each Party hereto agrees to execute, acknowledge and deliver such further
instruments and do all such further acts as may be necessary or appropriate to
carry out the purposes and intent of this Agreement.
12.5 International Sale of Goods Act
The Parties acknowledge and agree that the International Sale of Goods Act and
the United Nations Convention on Contracts for the International Sale of Goods
have no application to this Agreement.
12.6 Modification
No waiver, alteration or modification of any of the provisions hereof shall be
binding unless made in writing and signed by the Parties by their respective
officers thereunto duly authorized.
12.7 No Agency
Nothing herein shall be deemed to constitute either Party as the agent or
Representative of the other Party, or both Parties as joint venturers or
partners for any purpose. Inex shall be an independent contractor, not an
employee or partner of Enzon, and the manner in which Inex renders its services
under this Agreement shall be within Inex's sole discretion. Neither Party shall
be responsible for the acts or omissions of the other Party, and neither Party
will have authority to speak for, represent or obligate the other Party in any
way without prior written authority from the other Party.
12.8 No Solicitation or Hiring of Employees
During the Development and for one year thereafter, neither Inex nor Enzon
shall, without the prior consent of the other Party, solicit the employment of
or hire any person who during the course of employment with the other Party was
involved with activities under the Development Plan and who when solicited or to
be hired is a current employee of the other Party.
12.9 Non-Use of Names
Except as otherwise expressly set out in this Agreement, neither Party shall use
the name of the other Party, nor any adaptation thereof, in any advertising,
promotional or sales literature without prior written consent obtained from such
other Party in each case (which consent shall not be unreasonably withheld or
delayed).
12.10 Notices
Any notice or other communication in connection with this Agreement must be in
writing and if by mail, by registered mail, return receipt requested, and shall
be effective when delivered to the addressee at the address listed below or such
other address as the addressee shall have specified in a notice actually
received by the addressor.
If to Inex:
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
38
Inex Pharmaceuticals, Inc.
c/o Corporation Trust Center
0000 Xxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
Attention: President and CEO
With copies to:
Inex Pharmaceuticals Corporation
000-0000 Xxxxxxxx Xxxxxxx
Xxxxxxx, Xxxxxxx Xxxxxxxx
Xxxxxx X0X 0X0
Fax: 000-000-0000
Attention: Sr. V.P. Commercial Operations, and
With a copy to:
Inex Pharmaceuticals Corporation
000-0000 Xxxxxxxx Xxxxxxx
Xxxxxxx, Xxxxxxx Xxxxxxxx
Xxxxxx X0X 0X0
Fax: 000-000-0000
Attention: Business Development
and: Lang Xxxxxxxx
0000-0000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
Xxxxxx X0X 0X0
Fax: 000-000-0000
Canada V6E 4N7
Attention: Xxx Xxxxxx
and:
Farris, Vaughan, Xxxxx & Xxxxxx
2600 - 000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
Xxxxxx X0X 0X0
Fax: 000-000-0000
Attention: Xxxxx Xxxxxx
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
39
If to Enzon:
Enzon Pharmaceuticals, Inc.
000 Xxxxx 000/000
Xxxxxxxxxxx, Xxx Xxxxxx, XXX 00000
Fax: 000.000.0000
Attention: V.P. Business Development
with a copy to:
Enzon Pharmaceuticals, Inc.
000 Xxxxx 000/000
Xxxxxxxxxxx, XX 00000
Attention: General Counsel
Fax: 000.000.0000
12.11 Publicity
Except as required by law, stock exchange or Regulatory Authority:
12.11.1 neither Party, nor any of its Affiliates, shall originate any
publicity, news release or other public announcement, written or
oral, relating to this Agreement or the existence of an
arrangement between the Parties, without the prior written
approval of the other Party and agreement upon the nature and text
of such announcement or disclosure, which approval shall not be
unreasonably withheld;
12.11.2 the Party desiring to make any such public announcement or other
disclosure shall inform the other Party of the proposed
announcement or disclosure in reasonably sufficient time prior to
public release, and shall provide the other Party with a written
copy thereof, in order to allow such other Party to comment upon
such announcement or disclosure; and
12.11.3 notwithstanding the foregoing, the Parties agree that the press
release set out as an Exhibit to the Product Supply Agreement
shall be released by the Parties upon execution and delivery of
this Agreement by both Parties.
12.12 No Third Party Beneficiaries
Except as expressly set out in this Agreement, nothing in this Agreement is
intended to or shall confer upon any Third Part any legal or equitable right,
benefit or remedy of any nature whatsoever.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
40
12.13 Waiver
The waiver by either Party of a breach or a default of any provision of this
Agreement by the other Party shall not be construed as a waiver of any
succeeding breach of the same or any other provision, nor shall any delay or
omission on the part of either Party to exercise or avail itself of any right,
power or privilege that it has or may have hereunder operate as a waiver of any
right, power or privilege by such Party.
12.14 Cross Default
A breach of or default under any of the Related Agreements other than the
Co-Promotion Agreement shall constitute a breach of and default under all the
Related Agreements.
IN WITNESS WHEREOF, the Parties hereto have caused this Development Agreement to
be executed as a sealed instrument in their names by their properly and duly
authorized officers or representatives.
Inex Pharmaceuticals, Inc.
By: /s/ Xxxxx X. Main
---------------------------
Name: Xxxxx X. Main
Title: President & CEO
Enzon Pharmaceuticals, Inc.
By: /s/ Xxxxxx X. Xxxxxxx
---------------------------
Name: Xxxxxx X. Xxxxxxx
Title: Chairman & CEO
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
41
Exhibit 1.1.1: Adverse Drug Event
ADVERSE DRUG EVENT FORM
An Adverse Drug Event shall mean any noxious, unintended, or untoward
medical occurrence in a patient or clinical investigation subject
associated with the use of a medicinal or investigational product, whether
or not related to the medicinal or investigational product.
This Form must be completed and faxed to the Regulatory Authorities (with
a copy provided to the other Party)::
a) Immediately, or not later than 24 hours following receipt of any
information relating to an Adverse Drug Event; and
b) No later than two (2) business days following receipt of any information
relating to a product complaint.
Complaint Date:__________________________
Complaint received by:___________________ Title:________________________
Manner complaint received in: Oral |_| Written |_| Faxed |_|
Other:_________________
Complainant's name:__________________ Phone:___________ Fax: _____________
Clinic's name:_________________ Phone:_____________ Fax:__________________
Clinic's Address:_________________________________________________________
Product Name: ___________ Lot number: ___________ Expiry Date: ___________
Description of Product Complaint or Adverse Drug Event:___________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
42
Exhibit 1.1.27: ***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
43
Exhibit 1.1.36: ***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
44
Exhibit 5.2.1(c): Ongoing Phase II Clinical Trials
***
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
45
Exhibit 6.1: Joint Steering Committee Responsibilities
The members of the Joint Steering Committee as of the Effective Date are:
For Enzon:
Xxxx Xxxxxxx, VP - Clinical
Xxxxxx Xxxxxx, VP - Sales & Marketing
Xxxxxxxxx Xxxxxxxx, VP - Regulatory
Xxxx Xxxxxxx, VP - Business Development
For Inex:
Xxx XxxXxxx, Senior VP, Commercial Opoerations
Xxxxxxxxx Xxxxxxx, Senior VP, Clinical and Regulatory Affairs
Xxxx Xxxxxxxxxxx, VP Finance and CFO
Xxxxx Xxxxx, Director, Project Management
The Joint Steering Committee shall have responsibilities including:
1. review amendments to the Development Plan and submit same to the Parties
for review and approval;
2. establish working committees to conduct work under the Development Plan;
3. assign responsibility for conducting all needed Development work
appropriately between the Parties, including providing for subcontractors
to perform certain tasks if desirable;
4. oversee all Development activities, including the review and approval as
appropriate, of all reports on the progress of Development;
5. coordinate the overall strategy for Development and commercialization;
6. meet quarterly, circulate agendas at least one (1) week in advance of each
quarterly meeting, and circulate minutes of meetings within two (2) weeks
following each meeting;
7. verify the reports of Development Costs;
8. such other duties and responsibilities as may be agreed upon by the
Parties; and
9. be the primary contact point between the Parties regarding the transfer of
information and the discussion of each Party's efforts to conduct
Development.
*** Indicates the omission of confidential material pursuant to a request for
confidential treatment made in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended. The Confidential material is being filed
separately with the Secretary to the Securities and Exchange Commission.
