Exhibit 10.33
MANUFACTURE, LICENSE AND
DISTRIBUTION AGREEMENT
BY AND BETWEEN
PERRIGO COMPANY OF SOUTH
CAROLINA, INC.
AND
SCOLR PHARMA, INC.
October 20,
2005
Confidential treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as [***]. A complete version of this
exhibit has been filed separately with the Securities and Exchange
Commission.
TABLE OF
CONTENTS
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Page
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1.
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DEFINITIONS.
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1
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2.
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LICENSE.
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4
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2.1
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Grant of License.
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4
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2.2
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Exclusivity.
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5
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2.3
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CDT Improvements.
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6
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2.4
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Documentation and Information.
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7
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2.5
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Use of Trademark.
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8
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2.6
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Sell-Through Period.
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8
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3.
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ROYALTY.
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8
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3.1
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Computation and Payment.
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8
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3.2
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Inspection of Books and Records.
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9
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3.3
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Resolution of Royalty Dispute.
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9
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3.4
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Step-Down of Royalty Obligation.
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9
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4.
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TERM.
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10
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5.
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ADDITIONAL PRODUCTS.
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10
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5.1
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Perrigo Right to Add to this Agreement
Additional Dietary Supplement Products Using CDT Rights.
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10
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5.2
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Initiated by Perrigo.
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11
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6.
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TECHNICAL ASSISTANCE.
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11
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7.
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REPRESENTATIONS AND WARRANTIES.
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11
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7.1
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Representations and Warranties by SCOLR
Pharma.
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11
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7.2
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Representations and Warranties by
Perrigo.
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13
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7.3
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Disclaimers.
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14
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8.
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INFRINGEMENT OF CDT RIGHTS BY THIRD
PARTIES.
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14
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9.
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INDEMNIFICATION; INSURANCE.
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15
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9.1
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SCOLR Pharma’s Indemnification
Obligations.
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15
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9.2
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Perrigo’s Indemnification
Obligations.
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15
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9.3
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Indemnification Procedures.
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15
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9.4
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Insurance.
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16
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10.
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TERMINATION.
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16
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10.1
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Termination for Material Breach.
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16
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10.2
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Termination for Bankruptcy.
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16
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11.
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CONFIDENTIALITY.
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17
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12.
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FORCE MAJEURE.
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17
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12.1
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Effects of Force Majeure.
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17
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12.2
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Notice of Force Majeure.
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17
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13.
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MISCELLANEOUS.
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18
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13.1
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Publicity.
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18
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13.2
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Independent Contractors.
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18
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13.3
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Assignment.
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18
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13.4
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Governing Law.
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19
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13.5
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No Implied Waiver.
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19
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13.6
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Notices.
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19
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13.7
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Amendments.
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20
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13.8
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Counterparts.
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20
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13.9
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Entire Agreement.
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20
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13.10
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Benefit; Binding Effect.
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20
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13.11
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Further Assurances.
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21
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13.12
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Severability.
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21
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13.13
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Headings.
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21
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13.14
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Remedies.
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21
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13.15
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Construction.
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21
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13.16
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Attorneys’ Fees.
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22
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Appendices:
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Appendix A
– List of Trademarks
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Appendix B
– List of Patents and Patent Applications
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Appendix C
– List of Products
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Appendix D
– Exceptions to Exclusivity
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- ii -
MANUFACTURE, LICENSE AND
DISTRIBUTION AGREEMENT
THIS LICENSE AGREEMENT
(this “ Agreement
”), is entered into as of October 20, 2005, by and
between Perrigo Company of South Carolina, Inc., a Michigan
corporation, with offices at 515 Eastern Avenue, Allegan, Michigan
49010 (“ Perrigo ”), and SCOLR Pharma,
Inc. , a Delaware corporation, with offices at 3625 132nd
Avenue SE, Suite 300, Bellevue, Washington 98006 (together with its
Affiliates, collectively, “ SCOLR Pharma
”).
Background
A. SCOLR Pharma is a specialty
pharmaceutical company that uses its proprietary drug delivery
technology to develop and formulate pharmaceutical and nutritional
products. SCOLR Pharma has developed dietary supplement products
that use its patented controlled delivery technology with certain
of those products presently being manufactured and distributed in
the United States by third parties.
B. Perrigo develops, manufactures,
markets, distributes and sells nutritional and dietary supplement
products.
C. This Agreement sets forth the
terms and conditions by which SCOLR Pharma will license its
patented controlled delivery technology and associated CDT
trademark to Perrigo for the manufacture, marketing, distribution,
sale, and use of specific dietary supplement products in the United
States, SCOLR Pharma will transition to Perrigo the manufacture,
marketing, distribution and sale of certain existing dietary
supplement products that use SCOLR Pharma’s controlled
delivery technology, and SCOLR Pharma will develop for Perrigo
additional dietary supplement products that use SCOLR
Pharma’s controlled delivery technology.
Agreement
In consideration of the premises and
of the mutual covenants and agreements set forth in this Agreement,
the Parties agree as follows:
1. DEFINITIONS . In addition
to any other definitions appearing in this Agreement, the following
words and phrases will, for purposes of this Agreement, have the
following meanings (with any word or phrase referred to in the
singular to include the plural and vice versa as the context
requires):
“Affiliate” means, with respect to any Person, any other
Person controlled by, controlling or under common control with such
Person, where control means more than fifty percent
(50%) ownership or voting rights or the power to direct
management or policy.
- 1 -
“CDT
Know-HoDDw” means
all confidential, technical, or proprietary information and
knowledge not generally known to the public (including information
and knowledge regarding inventions, discoveries, techniques,
systems, methods and processes of any type, technical data,
drawings, designs, manufacturing and other information), whether or
not patentable and whether or not in written form, that SCOLR
Pharma owns or possesses and that relates directly or indirectly to
(a) any Patent Right or any product, process or other matter
covered by any Patent Right, or (b) the design, development,
manufacture, testing, use or sale of any Product, but not including
the Patent Rights.
“CDT
Improvements” means
all inventions, discoveries, techniques, systems, methods,
processes, improvements, developments, enhancements and
modifications (whether or not patentable, commercially useful, or
reducible to writing or practice) that SCOLR Pharma, solely or
jointly with others, acquires, discovers, invents, originates,
makes, develops, conceives or has rights to, in whole or in party,
after the Effective Date, to the extent applicable to the Products,
including (a) any such invention or other item the practice of
which would fall within the scope of a claim of any Patent Right,
any CDT Know-How, any of the Other Rights, or any Product; and
(b) any such invention or other item which may be competitive
with operations or applications within the scope of any claim any
Patent Rights, any CDT Know-How, any of the Other Rights, or any
Product.
“CDT
Rights” means the
Patent Rights, the CDT Know-How, the Other Rights, and the CDT
Improvements.
“Contract
Year” of a
particular Product means the twelve (12) month period
beginning on the date of the First Commercial Sale of that Product
to its customers and each twelve (12) month period thereafter
beginning on the anniversary of such date.
“Dietary
Supplements” means
“dietary supplements” as defined in the Dietary
Supplement Health and Education Act of 1994.
“Effective
Date” means the
date of this Agreement.
“First Commercial
Sale” means the
first date on which Perrigo or a sublicensee transfers title,
rights to use or other rights in or to a Product to a third party
for monetary or other consideration or in a manner which otherwise
results in Net Profits.
“including” or any word or phrase of similar meaning means
“including, without limitation,” unless the context
requires otherwise or unless otherwise specified.
“Net
Profits” [***]
[***] Certain information on this
page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
- 2 -
[***]
“Net Sales
” for a particular Product,
means, for any period of calculation, the total amount invoiced by
Perrigo during that period to its customers for that Product (or
received by Perrigo in the absence of an applicable invoice) less
the sum of all overbills, excise, sales and other taxes imposed
upon the sale of that Product (to the extent invoiced by Perrigo,
but not taxes imposed on the income generated from such sales),
price protections, rebates, charge backs, cash discounts,
promotional allowances, off-invoice and bill back allowances,
volume rebates and allowances, freight, shipping and insurance
costs (to the extent such freight, shipping or insurance costs are
invoiced by Perrigo), and all other deductions, discounts, refunds,
credits and allowances paid or accrued during the period, including
cash discounts, refunds and credits for pricing errors, and Product
returns, rejections and recalls, all to the extent attributable to
that Product and all as determined in accordance with generally
accepted accounting principles (in the U.S.) consistently
applied.
“Other
Rights” means
(a) the trademarks identified in Appendix A
attached to this Agreement; (b) any other trademark or service
mark that is owned by SCOLR Pharma as of the Effective Date and
that relates directly or indirectly to any Patent Right, any CDT
Know-How or any Product; (c) any other Proprietary Right that
is owned by SCOLR Pharma as of the Effective Date (other than the
Patent Rights and the CDT Know-How) and that relates directly or
indirectly to any Patent Rights, any CDT Know-How, or any Product,
(d) any Proprietary Right that is developed or acquired by
SCOLR Pharma on or after the Effective Date (other than any such
right that becomes part of the Patent Rights, CDT Know-How, or the
CDT Improvements) and that relates directly or indirectly to any
Patent Right, any CDT Know-How, any CDT Improvement or any Product;
and (e) all goodwill of SCOLR Pharma associated with the
foregoing.
“Party”
when referring to the parties to
this Agreement means SCOLR Pharma or Perrigo or both of them, as
appropriate.
“Patent
Rights” means all
rights to (a) the patents and patent applications identified
in Appendix B attached to this Agreement, (b) any
other United States patent or patent application that is owned by
SCOLR Pharma as of the Effective Date and that relates directly or
indirectly to any CDT Know-How, any Product, or the design,
development, manufacture, testing or use of any Product; and
(c) any United States patent or patent application that is
filed or acquired by SCOLR Pharma on or after the Effective Date
and that relates directly or indirectly to any CDT Know-How, any
CDT Improvements, any Product, or the design, development,
manufacture, testing or use of any Product.
[***] Certain information on this
page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
- 3 -
“Perrigo Fiscal
Year” means a 52 or
53 week fiscal year of Perrigo ending on the Saturday closest to
June 30.
“Person”
means any individual, corporation,
partnership or other entity.
“Product”
means any of the Dietary Supplement
products listed on Appendix C attached to this
Agreement that use the CDT Rights or any additional Dietary
Supplement product using CDT Rights that is added to this Agreement
in accordance with the provisions of this Agreement. Products shall
not include any product which is not a Dietary
Supplement.
“Profit
Margin” of a
particular Product means, for any particular period of calculation,
the quotient resulting from the division of the Net Profits of that
Product for that period by the Net Sales of that Product for that
period, multiplied by 100 and expressed as a percentage.
“Project
Plan” means the
plan described in Section 2.2(b) below.
“Proprietary
Right” means any
patent application, patent, trademark, trade name, service mark,
trade secret, copyright or other intellectual property
right.
“Quarter”
means a Perrigo Fiscal year quarter
consisting of thirteen (13) weeks ending on a
Saturday.
“Sales and Marketing
Costs” for a
particular Product means, for any applicable period of calculation,
the amount equal to [***] of the Net Sales of that Product during
that period.
“Term”
has the meaning set forth in
Section 4 .
“U.S.”
means the United States of America
and all its territories, dependencies and possessions.
2. LICENSE.
2.1 Grant of License.
SCOLR Pharma grants to Perrigo during the Term of this Agreement as
to each particular Product the right and license to practice and
use the CDT Rights in the manufacture, marketing, distribution,
sale and use of the Products in the U.S., including the right to
manufacture or have manufactured, market, distribute and sell to
third parties. Perrigo shall have the right to sublicense the
foregoing rights to third parties, in a single tier only, to the
extent reasonably necessary to supplement the manufacturing and
distribution capabilities of Perrigo, subject to the prior approval
of SCOLR Pharma, which shall not be unreasonably
withheld.
[***] Certain information on this
page has been omitted and files separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
- 4 -
2.2 Exclusivity
.
(a) Except as set forth in this
Section 2.2 , the rights and license granted to Perrigo
in Section 2.1 are exclusive to Perrigo, and SCOLR
Pharma accordingly shall have no right (i) to practice or use
or license others to practice or use any of the CDT Rights for the
purpose of manufacturing, marketing, distributing, selling or using
any Product in the U.S., or (ii) to manufacture, have
manufactured, market, distribute, sell or use any Product in the
U.S. Such exclusivity shall not, however, apply with respect to:
(i) the exceptions set forth on Appendix D , or
(ii) use of Products by consumers.
(b) Such right and license granted
to Perrigo will, at the option of SCOLR Pharma exercisable by
written notice to Perrigo, become nonexclusive on a prospective
basis for a particular Product (but remain exclusive for all other
Products) if either
[***]
(ii) the Profit Margin of that
Product for any Contract Year for that Product, beginning with the
second Contract Year for that Product, is less than
[***].
For purposes of this Agreement, and
subject to any additional or conflicting provisions in the Project
Plan, (x) separate classes of trade include [***]. SCOLR
Pharma shall not, however, have the right to convert
Perrigo’s license with respect to a particular Product from
exclusive to nonexclusive if any of the events described in
subparts (i) or (ii) above occurs as a result of SCOLR
Pharma’s breach or default in performing or complying with
any covenant or obligation required to be
[***] Certain information on this
page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
- 5 -
performed or observed by SCOLR Pharma in this
Agreement or a Force Majeure Event. If Perrigo encounters any
difficulties in the development or manufacture of a Product that
Perrigo believes will prevent it from commencing distribution of a
Product in at least two (2) classes of trade within
six (6) months after Perrigo distribution is scheduled to
commence pursuant to the written Project Plan developed by the
Parties for that Product, Perrigo will notify SCOLR Pharma and keep
SCOLR Pharma reasonably informed of Perrigo’s efforts to
resolve such difficulties. Each Project Plan will require Perrigo
to use reasonable commercial efforts to market and distribute the
Product consistent with its business practice for similar products.
The Parties acknowledge acceptance and agreement of a Project Plan
for Glucosamine/Chondroitin. If the Parties have failed to agree
upon a Project Plan for any other Product within sixty (60)
days following the Effective Date (or, for Products added to this
Agreement following the Effective Date, within thirty (30)
days following the date of such addition), either Party may
thereafter terminate this Agreement with respect to such Product
upon written notice to the other Party provided that the Parties
have not agreed upon a Project Plan for such Product before such
written notice of termination is given.
(c) If the rights and license
granted to Perrigo becomes nonexclusive with respect to a Product
as provided in this Section 2.2 , then SCOLR Pharma
shall promptly notify Perrigo of and extend to Perrigo the benefit
of any terms that SCOLR Pharma may include in a subsequent license
entered into during the one year period following the date upon
which the rights became nonexclusive, of any CDT Rights with
respect to that Product with any other Person that are more
favorable to the licensee than the terms of this Agreement. SCOLR
Pharma shall permit an independent certified public accounting firm
selected by Perrigo and reasonably acceptable to SCOLR Pharma to
review, at Perrigo’s expense, the relevant books and records
of SCOLR Pharma to verify SCOLR Pharma’s compliance with this
Section 2.2(c) , provided that such firm shall execute
a confidentiality agreement in a form reasonably acceptable to
SCOLR Pharma.
2.3 CDT Improvements
.
(a) SCOLR Pharma shall disclose and
communicate to Perrigo in writing, as soon as reasonably practical,
any material CDT Improvement acquired, discovered, invented,
originated, made or conceived on or after the Effective Date, and,
at Perrigo’s request, shall provide Perrigo with all
documentation and other information in whatever form stored
(written, electronic or otherwise) that is necessary or desirable
to enable Perrigo to practice and use such CDT Improvement in
connection with the manufacture, marketing, sale, distribution or
use of any Product. All CDT Improvements shall automatically be
included, on a royalty-free basis and without additional
consideration, within the scope of the license granted pursuant to
this Agreement.
(b) Notwithstanding
Section 2.3(a) , SCOLR shall have no obligation to
develop CDT Improvements or apply such CDT Improvements to the
Products. If, however, during the Term of this Agreement as to a
particular Product, SCOLR Pharma desires to apply a material CDT
Improvement to any Dietary Supplement that is or would
be
- 6 -
competitive with such Product (a
“Competitive Dietary Supplement” ), then before
SCOLR Pharma enters into any arrangement with any Person that
involves the application of that CDT Improvement to a Competitive
Dietary Supplement, or engages in any discussions with any Person
concerning any such arrangement, or SCOLR Pharma itself undertakes
to apply that CDT Improvement to a Competitive Dietary Supplement,
SCOLR Pharma (i) shall promptly notify Perrigo in writing of
such CDT Improvement, the Competitive Dietary Supplement, and the
particular Product or Products with which the Competitive Dietary
Supplement would compete and provide Perrigo with any information
concerning such CDT Improvement that Perrigo may reasonably
request, and (b) shall give Perrigo a period of
thirty (30) days (or such longer period mutually agreed upon
by the Parties in writing) after Perrigo’s receipt of such
notice and requested information to determine whether Perrigo is
interested in discussing entering into an arrangement with SCOLR
Pharma for the application of that CDT Improvement to one or more
such Products. If Perrigo notifies SCOLR Pharma in writing before
the expiration of such thirty (30) day period that Perrigo is
interested in discussing that opportunity with SCOLR Pharma, then a
new period of thirty (30) days (or such longer period as the
Parties may mutually agree in writing) will start on the date of
Perrigo’s notice to SCOLR Pharma to allow Perrigo and SCOLR
Pharma to discuss the possibility of a mutually acceptable
agreement between them for the application of that CDT Improvement
to one or more such Products and during that additional
thirty (30) day (or agreed upon longer) period, SCOLR Pharma
will continue to refrain from entering into any arrangement with
any Person that involves the application of that CDT Improvement to
a Competitive Dietary Supplement, and from engaging in any
discussions with any Person concerning any such arrangement, and
from itself undertaking to apply that CDT Improvement to a
Competitive Dietary Supplement. If Perrigo does not notify SCOLR
Pharma in writing before the expiration of the first
thirty (30) day (or agreed upon longer) period described above
that Perrigo is interested in discussing with SCOLR Pharma the
possibility of entering into an agreement for the application of
that CDT Improvement to one or more such Products or if Perrigo
provides such notice to SCOLR Pharma but at the end of the second
thirty (30) day (or agreed upon longer) period described above
Perrigo and SCOLR Pharma are not able to successfully conclude
negotiations of such an agreement, then SCOLR Pharma shall be free
to enter into an arrangement with any other Person that involves
the application of such CDT Improvement to such Competitive Dietary
Supplements.
2.4 Documentation and
Information . As soon as practical after the execution of
this Agreement, but in any event within ten (10) days
thereafter, or, in the case of any Product added to this Agreement
pursuant to Section 5.1 or Section 5.2 ,
when such Product is added to this Agreement, SCOLR Pharma shall
provide Perrigo with copies of all documentation containing the CDT
Know-How and Other Rights and all patent applications included in
the Patent Rights and all other information reasonably requested by
Perrigo regarding the practice and use of the CDT Rights in
connection with the manufacture, marketing, sale, distribution or
use of any Product, including documentation and information
sufficient to enable Perrigo to manufacture the Products and to
practice and use the CDT Rights in connection with the manufacture,
marketing, sale, distribution, or use of any Product.
- 7 -
2.5 Use of Trademark .
To the extent allowed by law, Perrigo agrees to prominently display
the CDT Controlled Delivery Technology trademark on the principal
display panel of Perrigo’s packaging of the Product that it
markets and sells where appropriate and permitted by
Perrigo’s particular customer. Perrigo shall comply at all
times with SCOLR Pharma’s applicable trademark usage
guidelines.
2.6 Sell-Through
Period . The rights and license granted to Perrigo in
Section 2.1 shall continue on a non-exclusive basis for
a period of twelve (12) months after any expiration or
termination of this Agreement with respect to a Product other than
a termination by SCOLR Pharma pursuant to Section 10.1
by reason of a material breach or default by Perrigo, in order for
Perrigo to sell through its existing inventory and related
packaging materials of such Product or Products and to provide for
an orderly transition for its customers.
3. ROYALTY .
3.1 Computation and
Payment . Commencing on the date of Perrigo’s First
Commercial Sale of a Product and continuing thereafter during the
Term of this Agreement as to that Product, Perrigo will pay SCOLR
Pharma in the manner described below a royalty on Perrigo’s
sales of that Product in the amount equal to [***] of
Perrigo’s Net Profits of the Product. Within thirty (30)
days after the end of each Quarter (or an initial partial Quarter)
during this period, (a) Perrigo will furnish SCOLR Pharma with
a report stating for each Product the amount of Perrigo’s Net
Sales for such Quarter (including the number of tablets sold for
each Product and the customers to whom the tablets were sold), the
Net Profits for such Quarter, and the royalty for such Quarter,
together with such other information as SCOLR Pharma may reasonably
request, and (b) except as set forth below in this
Section 3.1 , Perrigo will pay SCOLR Pharma the royalty
for that Quarter as reflected in the report. If the date of the
First Commercial Sale of a Product by Perrigo is later than the
first day of a Quarter, then the period covered by the first report
and the first royalty payment for that Product will begin on the
date of the First Commercial Sale of that Product by Perrigo and
will end on the last day of the first complete Quarter following
the date of the First Commercial Sale of that Product by Perrigo.
The Parties shall share equally in the manner described below the
risk of and the loss resulting from any amount that Perrigo
invoices to its customers for any Product becoming uncollectible
and being written off by Perrigo. Perrigo will notify SCOLR Pharma
when Perrigo has any such write-offs, and Perrigo will recover
SCOLR Pharma’s share of such write-offs by setting such
amount off against and reducing the amount of royalty otherwise
payable to SCOLR Pharma for that Quarter for that Product or any
other Product, and if SCOLR Pharma’s share of such write-offs
is not paid in full to Perrigo in this way during that Quarter,
then such excess amount shall be carried forward to succeeding
Quarters and set off against the amount of royalty otherwise
payable to SCOLR Pharma for such Quarters. SCOLR Pharma shall not,
however, have any obligation to repay Perrigo for any royalty
previously paid as a result of such write-offs.
[***] Certain information on this
page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.
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3.2 Inspection of Books and
Records . During the one (1) year period following the
close of each Perrigo Fiscal Year, but not more frequently than
once per Perrigo Fiscal Year, Perrigo shall permit an independent
certified public accounting firm selected by SCOLR Pharma, and
reasonably acceptable to Perrigo, to have access, during normal
business hours and upon reasonable prior notic