EXHIBIT 10.5
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
INTELLECTUAL PROPERTY
ASSIGNMENT
AGREEMENT
BETWEEN
QLT USA, INC.
AND
ARIUS TWO, INC.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
TABLE OF CONTENTS
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Page
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ARTICLE I DEFINITIONS
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1
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Section 1.01
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Definitions
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1
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Section 1.02
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Defined Terms
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6
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Section 1.03
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No Amendment to License Definitions
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6
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ARTICLE II PURCHASE, SALE, ASSIGNMENT, AND
LICENSE
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6
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Section 2.01
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Purchase and Sales
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6
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Section 2.02
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Know-How License
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7
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Section 2.03
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Consideration
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7
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Section 2.04
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Termination of License Agreement
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7
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Section 2.05
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Expenses
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7
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ARTICLE III PATENT INFRINGEMENT
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8
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Section 3.01
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Infringement Claimed by Third
Parties
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8
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Section 3.02
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Indemnification of Seller
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8
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Section 3.03
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Indemnification of Buyer
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8
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Section 3.04
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Payment of Costs and Expenses
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8
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Section 3.05
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Termination of Obligations
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9
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ARTICLE IV CONFIDENTIALITY
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9
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Section 4.01
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Confidentiality
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9
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Section 4.02
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Disclosure of Agreement
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9
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ARTICLE V REPRESENTATIONS AND
WARRANTIES
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10
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Section 5.01
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Corporate Power
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10
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Section 5.02
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Due Authorization
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10
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Section 5.03
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Binding Obligation
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10
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Section 5.04
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Ownership of Purchased Assets
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11
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Section 5.05
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Patent Proceedings
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11
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Section 5.06
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Legal Proceedings
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11
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Section 5.07
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Limitation on Warranties
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11
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Section 5.08
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Limitation of Liability
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11
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ARTICLE VI COVENANTS
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12
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Section 6.01
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Access to Books and Records
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12
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CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
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Section 6.02
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Commercially Reasonable Efforts
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12
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Section 6.03
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Compliance
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12
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Section 6.04
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Further Actions
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12
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ARTICLE VII DELIVERIES
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13
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Section 7.01
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Deliveries By Seller
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13
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Section 7.02
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Deliveries By Buyer
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13
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ARTICLE VIII MISCELLANEOUS
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14
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Section 8.01
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Governing Law
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14
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Section 8.02
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Waiver
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14
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Section 8.03
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Severability
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14
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Section 8.04
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Notices
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14
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Section 8.05
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Independent Contractors
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15
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Section 8.06
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Rules of Construction
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15
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Section 8.07
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Publicity
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15
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Section 8.08
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Entire Agreement; Amendment
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15
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Section 8.09
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Headings
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16
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Section 8.10
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Waiver of Jury Trial
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16
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Section 8.11
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Counterparts
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16
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Section 8.12
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Assignment
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16
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Exhibit A
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-
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BEMA Patent
Rights
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Exhibit B
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-
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Guaranty
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Exhibit C
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-
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Patent and
Trademark Assignment Agreement
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Exhibit D
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-
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Patent and
Trademark Security Agreement
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Exhibit E
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-
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Secured
Promissory Note
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Exhibit F
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-
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Security
Agreement
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Exhibit G
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-
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Termination
Agreement
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CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
INTELLECTUAL PROPERTY ASSIGNMENT
AGREEMENT
This Intellectual Property
Assignment Agreement (the “Agreement”) is made as of
September 5, 2007 (the “Effective Date”) by and
between QLT USA, Inc. (formerly Atrix Laboratories, Inc.), a
Delaware corporation with its principal office at 2579 Midpoint
Drive, Fort Collins, CO 80525-4417 (“Seller”), and
Arius Two, Inc., a Delaware corporation with its principal office
at 2501 Aerial Center Parkway, Suite 205, Morrisville, NC 27560
(“Buyer”). Seller and Buyer are sometimes referred to
collectively herein as the “Parties” or singly as a
“Party.”
RECITALS
WHEREAS, Seller and Arius Pharmaceuticals, Inc.
(“Arius”) entered into that certain License Agreement
dated May 27, 2004, as amended July 14, 2005 and
August 2, 2006 (as amended, the “License
Agreement”); and
WHEREAS , Seller has agreed to sell to Buyer, and Buyer
has agreed to purchase from Seller the BEMA assets related
specifically to the United States.
NOW, THEREFORE
, in consideration of the foregoing
recitals and the mutual covenants and agreements contained herein,
the Parties hereto, intending to be legally bound, do hereby agree
as follows:
AGREEMENT
ARTICLE I
DEFINITIONS
Section 1.01
Definitions . The following terms as used in this
Agreement shall have the meaning set forth below:
“ Affiliate ”
means an individual, trust, business trust, joint venture,
partnership, corporation, association or any other entity which
owns, is owned by or is under common ownership with, a Party. For
the purposes of this definition, the term “owns”
(including, with correlative meanings, the terms “owned
by” and “under common ownership with”) as used
with respect to any Party, shall mean the possession (directly or
indirectly) of more than 50% of the outstanding voting securities
of a corporation or comparable equity interest in any other type of
entity.
“ Applicable Laws
” means all applicable laws, rules, regulations and
guidelines that may apply to the performance of either
Party’s obligations under this Agreement.
“ Assumed Liabilities
” means all obligations and liabilities arising out of
Buyer’s ownership of the Purchased Assets, whether arising
prior to or after the Effective Date; except for such obligations
and liabilities for which Seller is obligated to indemnify Buyer
under Section 3.03 of this Agreement.
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ BEMA ” means
Seller’s proprietary bioerodible, mucoadhesive multi-layer
polymer film.
“ Claims ” shall
mean and include all past, present and future disputes, claims,
controversies, demands, rights, obligations, liabilities, actions
and causes of action of every kind and nature.
“ Combination Product
” means a Worldwide Product (as defined below) that is sold
together with any other products and/or services at a unit price,
whether packaged together or separately with another pharmaceutical
product or other device, equipment, instrumentation, or other
components (other than solely containers or packaging exclusively
for the Worldwide Product).
“ Commercially Reasonable
Efforts ” shall mean, except as otherwise explicitly set
forth in this Agreement, those efforts consistent with the exercise
of prudent scientific and business judgment, as applied to products
having comparable market potential within the relevant product
lines of that Party and generally accepted practices in the
pharmaceutical industry. “Comparable market potential”
shall be fairly determined by a Party in good faith and without
limitation may be based upon market size, price, competition,
patent rights, product liability issues and general marketing
parameters.
“ Competent Authorities
” means, collectively, all governmental entities, foreign or
domestic, responsible for the regulation of medicinal products
intended for human use.
“ Confidential
Information ” means any confidential or proprietary
information of a Party, whether in oral, written, graphic or
electronic form. Confidential Information shall not include any
information which the receiving Party can prove by competent
evidence:
(a) is now, or hereafter becomes,
through no act or failure to act on the part of the receiving
Party, generally known by or available to the public;
(b) is known by the receiving Party
at the time of receiving such information, as evidenced by its
written records maintained in the ordinary course of
business;
(c) is hereafter furnished to the
receiving Party by a Third Party, as a matter of right and without
restriction on disclosure;
(d) is independently developed by
the receiving Party, as evidenced by its written records maintained
in the ordinary course of business, without knowledge of, and
without the aid, application or use of, the disclosing
Party’s Confidential Information; or
(e) is the subject of a written
permission to disclose provided by the disclosing Party.
2
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Control ” means
the possession of the ability to assign to Buyer as provided for
herein without violating the terms of any agreement or other
arrangement with any Third Party.
“ Encumbrance ”
means any lien, pledge, hypothecation, mortgage, security interest,
encumbrance, equitable interest, preference, right of possession,
lease, tenancy, license, proxy, covenant, order, option, right of
first refusal or preemptive right, whether arising out of an
obligation to pay any taxes or otherwise.
“ BEMA Know-How ”
means all Know-How related to BEMA or any Product which is under
the Control of Seller as of the Effective Date, including, but not
limited to, data and documentation of clinical trials,
pharmacological, toxicological, clinical, assay, control, and
manufacturing data, techniques, processes, methods, or systems, and
any other information relating to BEMA, excluding the BEMA Patent
Rights.
“ Marks ” means
all right, title, and interest in “BEMA” or any
additional trademarks or service marks owned by Seller with respect
to the BEMA Technology, alone or accompanied by any logo or design
and any non-English language equivalents in figure, sound or
meaning, whether registered or not, including but not limited to
any and all such rights in the Territory existing solely under
common law, statute, or similar bases not requiring explicit
government notice or registration.
“ BEMA Patent Rights
” means all Patent Rights claiming BEMA or any Improvement,
or which are necessary, useful, or appropriate to develop,
manufacture, or commercialize Products, and under the Control of
Seller as of the Effective Date, which shall include but not be
limited to the patents and patent applications listed on Exhibit
A .
“ BEMA Technology
” means the BEMA Patent Rights and the BEMA
Know-How.
“ Books and Records
” means, in whatever media, any and all books and records,
reports and accounts and data in connection with or related to any
Product, BEMA Technology, or Marks, or any research, development,
or other activities primarily related to the foregoing (including
but not limited to those related to filing, prosecution, and/or
maintenance of the BEMA Patent Rights).
“ US Patent Term
” means, on a Product-by-Product basis, the period of time
ending on the expiration of the last to expire of the BEMA Patent
Rights covering such Product in the Territory.
“ Ex-US Purchase
Agreement ” means that certain Intellectual Property
Assignment Agreement, dated August 2, 2006, between the
Parties.
“ Ex-US BEMA Patent
Rights ” means all Patent Rights assigned to Buyer
pursuant to the Ex-US Purchase Agreement.
“ Ex-US Product ”
means individually and collectively any product which would
infringe one or more valid claims of the Ex-US BEMA Patent
Rights.
3
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Territory ”
means the United States.
“ FDA ” means the
Food and Drug Administration, the governmental entity responsible
in the United States for the regulation of medicinal products
intended for human use.
“ GAAP ” means
generally accepted accounting principles of the United States
consistently applied on a basis consistent throughout the periods
indicated and consistent with each other.
“ Governmental Approval
” means all permits, licenses and authorizations, including
but not limited to, import permits and Marketing Authorizations
required by any Competent Authority as a prerequisite to the
manufacturing, marketing or selling of the Product for human
therapeutic use.
“ Guaranty ”
means that certain Guaranty to be executed by BioDelivery Sciences
International, Inc. (“BDSI”), owner of all of the
outstanding capital stock of Buyer, in the form attached hereto as
Exhibit B .
“ Improvement ”
means any and all developments, inventions or discoveries directly
relating to the BEMA Technology developed or acquired by, or under
the Control of, a Party at any time prior to or following the
Effective Date and shall include, but not be limited to, such
developments intended to enhance the safety and/or efficacy of any
Product.
“ Know-How ”
means all know-how, trade secrets, inventions, data, processes,
techniques, procedures, compositions, devices, methods, formulas,
protocols and information, whether or not patentable, which are not
generally publicly known, including, without limitation, all
chemical, biochemical, toxicological, and scientific research
information, whether in written, graphic or video form or any other
form or format.
“ Marketing
Authorization ” means all necessary and appropriate
regulatory approvals, including but not limited to, variations
thereto, and Pricing and Reimbursement Approvals to put a Product
on the market in a particular jurisdiction.
“ Net Sales ”
means the gross amounts invoiced by Buyer, its Affiliates or
sublicensees for sales of the Worldwide Product by Buyer, its
Affiliates, or its sublicensees, as applicable, to a Third Party in
a bona fide arm’s length transaction, less the following
items: *** . Net Sales shall not include any sales or
transfers of Worldwide Products by Buyer or its Affiliates to
Affiliates or sublicensees pursuant to manufacturing or
distribution agreements where such Affiliate or sublicensee will
ultimately sell such Worldwide Product and such amounts received in
connection with sale will be included in Net Sales.
A Worldwide Product shall be
considered sold when billed out or invoiced. Components of Net
Sales shall be determined in the ordinary course of business in
accordance with historical practice and using the accrual method of
accounting in accordance with GAAP.
In the event Buyer transfers
Worldwide Product to a Third Party in a bona fide arm’s
length transaction, for consideration, in whole or in part, other
than cash or to a Third Party in
4
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
other than a bona fide arm’s length
transaction, the Net Sales price for such Worldwide Product shall
be deemed to be the standard invoice price then being invoiced by
Buyer in an arms length transaction with similar customers. The Net
Sales of a Combination Product shall be calculated as if the
invoiced sales price for a Product included within the Combination
Product is *** . In the event that Buyer includes a
Worldwide Product as part of a single bundled sale of separate
products with separately stated prices, the Net Sales attributable
to such Worldwide Product shall be the higher of ***
.
“ Patent and Trademark
Assignment Agreement ” means the Patent and Trademark
Assignment Agreement executed by Seller in the form attached hereto
as Exhibit C .
“ Patent and Trademark
Security Agreement ” means that certain Patent and
Trademark Security Agreement between Buyer and Seller in the form
attached hereto as Exhibit D .
“ Patent Rights ”
means all rights under patents and patent applications, and any and
all patents issuing therefrom (including utility, model and design
patents and certificates of invention), together with any and all
substitutions, extensions (including supplemental protection
certificates), registrations, confirmations, reissues, divisionals,
continuations, continuations-in-part, re-examinations, renewals and
foreign counterparts of the foregoing, and all improvements,
supplements, modifications or additions.
“ Pricing and Reimbursement
Approvals ” means any pricing and reimbursement approvals
which may or must be obtained before placing a Product on the
market in a particular jurisdiction.
“ Product ” means
a Product, as defined in the License Agreement, excluding an Ex-US
Product.
“ Purchased Assets
” means (i) the Marks, (ii) BEMA Technology,
(iii) Books and Records, (iv) all Government Approvals
(as defined in the License Agreement) and appropriate
correspondence, clearance or transfer letters, or any other form of
authorization, license, permit, or the like from regulatory
authorities with respect to Government Approvals, to the extent not
previously assigned to Buyer under the License Agreement, and
(v) any and all benefits, privileges, causes of action, and
remedies relating to any of the foregoing, whether before or
hereafter accrued, including, without limitation, all rights in, to
and under applications for, filings, registrations or renewals, and
rights to apply for, file, register, maintain, extend or renew any
of the foregoing and the right to bring actions for past, present
or future infringement of or otherwise enforce any of the foregoing
and to settle and retain the proceeds of such actions (including,
without limitation, all causes of actions relating to any of the
foregoing, claims and demands or other rights accruing with respect
to any of the foregoing, or arising from any infringement of the
BEMA Technology and the Marks, before or after the Effective Date),
and any and all other rights corresponding thereto throughout the
world.
“ Secured Promissory
Note ” means that certain secured promissory note made by
Buyer in favor of Seller in the form attached hereto as
Exhibit E , the terms and conditions of which are
incorporated herein by reference.
5
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
“ Security Agreement
” means that certain Security Agreement between Buyer and
Seller in the form attached hereto as Exhibit F
.
“ Third Party ”
means any entity other than: (a) Seller, (b) Buyer or
(c) an Affiliate of Seller or Buyer.
“ United States ”
or “US” means the United States of America, its
territories and possessions, including the Commonwealth of Puerto
Rico.
“ Worldwide Product
” means, collectively, all Ex-US Products and
Products.
Section 1.02 Defined
Terms . Each of the following terms is defined in the
Section set forth opposite such term below:
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Agreement
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Preamble
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Arius
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Recitals
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Assumed Liabilities
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Section 2.01
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Buyer
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Preamble
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CDC
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Recitals
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Closing Cash Payment
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Section 2.03(a)
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Effective Date
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Preamble
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Indemnified Party
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Section 3.04
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Indemnifying Party
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Section 3.04
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License Agreement
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Recitals
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Loss
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Section 3.02
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Party(ies)
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Preamble
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Purchase Price
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Section 2.03
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Seller
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Preamble
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Third Party Claim
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Section 3.01
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Section 1.03 No Amendment
to License Definitions . The definition of certain
terms above which are also separately defined above shall not in
any way alter, amend, or be used to interpret the definitions
established under the License Agreement.
ARTICLE II
PURCHASE, SALE, ASSIGNMENT, AND
LICENSE
Section 2.01 Purchase and
Sales . Subject to the terms and conditions set forth in
this Agreement, effective on the Effective Date, Seller hereby
conveys, assigns, and transfers to Buyer, and Buyer hereby acquires
from Seller, for the Purchase Price, free and clear of all
Encumbrances, the Purchased Assets and shall assume, pay,
discharge, and perform all Assumed Liabilities. For a period of
three months following the Effective Date, Seller will cooperate
with Buyer, as reasonably requested by Buyer and at Buyer’s
expense, which expense shall be commercially reasonable and
documented, in effecting the transfer of the Marks to Buyer and
enabling Buyer to file registrations, applications therefor, or
equivalent formal legal recognition of, or rights with respect to,
the Marks in Buyer’s name in the Territory, and Buyer shall
own all right, title, and interest thereto in the
Territory.
6
CONFIDENTIAL TREATMENT
REQUESTED
WITH RESPECT TO CERTAIN
PORTIONS HEREOF
DENOTED WITH
“***”
Section 2.02 Know-How
License . To the extent any BEMA Know-How or Improvement
cannot be severed from Know-How related to technology or
intellectual property other than BEMA Technology and assigned to
Buyer as contemplated by this Agreement, Seller hereby grants to
Buyer an exclusive, perpetual, royalty-free, fully-paid license in
the Territory, with rights of sublicense, under and to such
Know-How and Improvements (to the extent not claimed in any BEMA
Patent Rights and concerning or related to BEMA (and not any
technology other than BEMA)) made, obtained, or Controlled by
Seller and related Books and Records to use, develop, market,
advertise, promote, distribute, offer for sale, sell, export and
import, manufacture, and have manufactured Products, provided that,
following the expiration of the US Patent Term, such license shall
be non-exclusive, fully-paid, perpetual and
royalty-free.
Section 2.03
Consideration . As consideration for the Purchased
Assets, Buyer shall pay to Seller total consideration of $7,000,000
(the “Purchase Price”). The Purchase Price shall be
payable as follows:
(a) $3,000,000 (the “Closing
Cash Payment”), by wire transfer of immediately available
funds on the Effective Date to an account designated by Seller;
and
(b) $4,000,000, as evidenced by a
secured promissory note, to Seller as follows:
(i) $2,000,000, within ten
(10) business days after the initial Governmental Approval of
a Product in the United States; and
(ii) $2,000,000, the first time that
cumulative Net Sales