SEC Company Response from Merck & Co., Inc. (MRK) (CIK 0000310158) (MRK) — Apr 24, 2009
Merck & Co., Inc. (MRK) (CIK 0000310158)
Date: April 24, 2009 · CIK: 0000310158 · Accession: 0000950123-09-007180
AI Filing Summary & Sentiment
Referenced dates: April 13, 2009
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CORRESP
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CORRESP
Schering-Plough
2000 Galloping Hill Road
Kenilworth, NJ 07033 USA
Direct Dial: (908) 298-7119
Direct Fax: (908) 298-7303
Email: michael.pressman@spcorp.com
April 24,
2009
Jeffrey Riedler
Assistant Director
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re: Form 10-K for the fiscal year ended December 31, 2008
Dear Mr. Riedler,
Thank you for your letter dated April 13, 2009, commenting on Schering-Plough’s Form 10-K for
the fiscal year ended December 31, 2008. Your letter was directed to me, as Senior Counsel, by
Steven Koehler. Below please find Schering-Plough’s responses to your comments.
SEC Comment #1
We note that you are engaged in a joint venture with Merck & Co., Inc. in relation to the
development and commercialization of two cholesterol lowering drugs, VYTORIN and ZETIA. Please
revise your disclosure to provide a full description of the material terms of your joint venture
with Merck, to the extent this information has not been previously redacted by an appropriate grant
of confidential treatment by the Division of Corporation Finance. In particular, please quantify
and describe the amounts paid to date, aggregate potential milestones, royalty provisions, profit
sharing provisions and expiration provisions under your agreement.
Schering-Plough Response #1
We believe that the information requested by the Staff has been provided in Schering-Plough’s Form
10-K and that the Form 10-K accurately describes all the material provisions of the agreements with
Merck & Co, Inc. (Merck) in regard to the Merck/Schering-Plough Joint Venture (the “cholesterol
agreements”).
The cholesterol agreements were filed as exhibits and have been incorporated by reference into each
of Schering-Plough’s Forms 10-K since its 2002 Form 10-K (see
Exhibits 10(r), 10(s) and 10(t) to
Schering Plough’s 2008 Form 10-K). Accordingly, all terms of the contracts, except those subject
to confidential treatment, are included as part of Schering-Plough’s Form 10-K.
In the Business section of Schering-Plough’s 2008 Form 10-K, we provide overview information of the
cholesterol agreements. In particular, we disclose that:
•
The purpose of the cholesterol joint venture is to jointly develop, manage, and
commercialize certain products;
•
The agreement generally provides for equal sharing of development costs and for
co-promotion of approved products by each company; and
•
The geographic scope of the joint venture includes all
countries except for Japan.
The Business Section also directs the reader to Note 5 “Equity Income” under Item 8, “Financial
Statements, and Supplementary Data” of the Form 10-K for additional information regarding the terms
of the agreements with Merck. Note 5 “Equity Income” provides additional discussion of the
material aspects of the joint venture. In addition to the information already addressed in the
Business section, Note 5 provides that:
•
The cholesterol joint venture agreements provide for the sharing of operating income
generated by the joint venture based upon percentages that vary by product, sales level and
country;
•
In the U.S. market, Schering-Plough receives a greater share of the profits on the first
$300 million of annual ZETIA sales. Above $300 million of annual ZETIA sales, Merck and
Schering Plough generally share profits equally;
•
The companies agree annually to the minimum number of physician details by country and
either company’s share of the joint venture’s income from operations is subject to a
reduction if that company fails to perform a specified minimum number of physician details
in a particular country;
•
The companies bear the costs of their own general sales forces and commercial overhead
in marketing joint venture products around the world;
•
Costs of the joint venture that the companies contractually share are a portion of
manufacturing costs, specifically identified promotion costs (including direct-to-consumer
advertising and direct and identifiable out-of-pocket promotion) and other agreed upon
costs for specific services such as market support, market research, market expansion, a
specialty sales force and physician education programs; and
•
Certain specified research and development expenses are generally shared equally by
Schering-Plough and Merck.
In addition, the discussion of Equity income in Management’s Discussion and Analysis of Financial
Condition and Results of Operations also discusses financial terms of the agreements with Merck as
they relate to current year operating results. The disclosures in the financials statements and
Management’s Discussion and Analysis of Financial Condition and Results of Operations since
entering into the agreements have included descriptions of potential milestones and those
milestones recognized by Schering-Plough as well as profit sharing provisions. For instance, in
Schering-Plough’s 2005 Form 10-K, the company disclosed that “during 2005, 2004 and 2003, the
Company recognized milestones from Merck of $20 million, $7 million and $20 million, respectively.”
While Schering-Plough discloses the milestones recognized pursuant to the agreement, milestones in
the agreement have not been, individually or in the aggregate,
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material to Schering-Plough. Other provisions of the cholesterol agreements, such as the treatment
of Research and Development expenses have also been disclosed. For instance in the discussion of
the Equity income in Schering-Plough’s 2007 Form 10-K, we disclosed that “Schering-Plough could be
entitled to receive reimbursements of its future research and development expenses of up to $105
million.” In the 2008 discussion of Equity income we disclose that a $105 million reimbursement was
paid to Schering-Plough in 2008. There are no additional potential milestones pursuant to the
cholesterol agreements.
The Staff comment asks us to disclose the profit sharing provisions of the contract.
Schering-Plough’s current disclosure states that once annual ZETIA sales exceed $300 million the
companies generally share profits equally. More detailed or specific disclosure of the profit
sharing provisions could overwhelm the material elements of the disclosure. The agreement covers
profit sharing provisions for numerous countries, and many are subject to differing profit sharing
arrangements, none of which materially affect overall profit sharing. Providing disclosure of each
such provision would provide an overwhelming level of detail, without providing a corresponding
benefit.
In addition, the staff requests that we disclose the expiration provisions of the agreement. The
agreement has standard termination provisions covering bankruptcy, material breach of contract and
change of control. In Schering-Plough’s Strategic Alliances disclosure in Schering-Plough’s 2008
Form 10-K (page 35), we disclose that entering into potential strategic arrangements with third
parties could result in VYTORIN and ZETIA being acquired by Merck. We also refer readers to Exhibit
10(r) of the 2008 Form 10-K for the text of the change of control provisions. We will add the
following bolded disclosure to our 2009 First Quarter Form 10-Q discussion of Strategic Alliances:
In addition, any potential strategic alternatives may be impacted by the change of control
provisions in those arrangements, which could result in VYTORIN and ZETIA being acquired by
Merck or REMICADE reverting back to Centocor. The change in control provision relating to
VYTORIN and ZETIA is included in the contract with Merck, filed as Exhibit 10(r) to
Schering-Plough’s 2008 10-K, and the change of control provision relating to REMICADE is
contained in the contract with Centocor, filed as Exhibit 10(v) to Schering-Plough’s 2008
10-K. In addition, the VYTORIN and ZETIA agreements provide for the right to terminate due
to bankruptcy of the other party or material breach by the other party of its of
obligations. The REMICADE agreement provides for the right to terminate the agreement due to
insolvency or bankruptcy of the other party or material breach by the other party of its
obligations.
SEC Comment #2
We note that you have entered into agreements with Centocor, Inc. in relation to the licensing and
manufacturing of REMICADE. Please revise your disclosure to provide a full description of the
material terms of your agreements with Centocor, to the extent this information has not been
previously redacted by an appropriate grant of confidential treatment by the Division of
Corporation Finance. In particular, please quantify and describe the amounts paid to date,
aggregate potential milestones, royalty provisions, profit sharing provisions and expiration
provisions under your agreement. Please be advised that it appears the grant of confidential
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treatment with respect to the original Distribution Agreement with Centocor, dated April 3, 1998,
has expired.
Schering-Plough Response #2
We believe that the information requested by the Staff has been provided in Schering-Plough’s Form
10-K and that Schering-Plough’s Form 10-K accurately describes all the material provisions of the
1998 distribution agreement and 2007 amendment (collectively, “the agreements”) with Centocor,
Inc., a Johnson and Johnson Company (Centocor) relating to the distribution of REMICADE.
The agreements were filed as exhibits and are incorporated by reference into Schering-Plough’s
Forms 10-K. The original 1998 agreement was filed with Schering-Plough’s 2004 Form 10-K/A and the
2007 amendment to the agreement was filed with Schering-Plough’s December 21, 2007 Form 8-K, and
appear as Exhibits 10(u), and 10(v), respectively, to Schering Plough’s 2008 Form 10-K.
Accordingly, all terms of the contracts, except those subject to confidential treatment, are
included as part of Schering-Plough’s 2008 Form 10-K
In the Business section of Schering-Plough’s 2008 Form 10-K, we provide overview information of the
agreements which cover all material terms of the contracts. In particular, we disclose that:
•
REMICADE is licensed from and manufactured by Centocor;
•
During 2005, Schering-Plough exercised an option under its contract with Centocor for
license rights to develop and commercialize golimumab;
•
Schering-Plough has exclusive marketing rights to both products outside the U.S., Japan
and certain Asian markets;
•
In December 2007, Schering-Plough and Centocor revised their distribution agreement
regarding the development, commercialization and distribution of both REMICADE and
golimumab, extending Schering-Plough’s exclusive rights to market REMICADE to match the
duration of Schering-Plough’s exclusive marketing rights for golimumab;
•
Effective upon regulatory approval of golimumab in the EU, Schering-Plough’s marketing
rights for both products will extend for 15 years after the first commercial sale of
golimumab within the EU;
•
Centocor will receive a progressively increased share of profits on Schering-Plough’s
distribution of both products in the Schering-Plough marketing territory between 2010 and
2014, and the share of profits will remain fixed thereafter for the remainder of the term;
•
REMICADE marketing rights and the profit sharing arrangement for the products are all
conditioned on approval of golimumab being granted prior to September 1, 2014;
•
Schering-Plough may independently develop and market golimumab for a Crohn’s disease
indication in its territories, with an option for Centocor to participate;
•
Schering-Plough and Centocor agreed to utilize an autoinjector device in the
commercialization of golimumab and further agreed to share its development costs.
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Information regarding the agreements is also provided in Note 14 “Product License” under Item 8,
“Financial Statements, and Supplementary Data. Note 14 also includes additional disclosure that
Schering-Plough made an upfront payment of $21 million for rights to the auto-injector.
The Staff asks that we disclose all material milestone payments. Pursuant to the 2007 amendment,
all material milestones with respect to REMICADE have been satisfied and there are no milestone
payments with respect to the development and commercialization of golimumab. There are remaining
potential milestone payments with respect to the auto-injector, but the amounts are not material.
The Staff asks that we disclose all material royalty provisions of the agreements. The 2007
amendment provides the base percentage Contribution Income Split that will be in effect if
golimumab receives EU approval:
Contribution Income Split
Agreement Year
S-P
Centocor
2010
60
%
40
%
2011
58
%
42
%
2012
55
%
45
%
2013
52
%
48
%
2014
50
%
50
%
Alsubsequent years
50
%
50
%
In response to the Staff’s comment, we will provide the following (or substantially similar) bolded
disclosure regarding the profit split in the “License Arrangement with Centocor” section of our
Management’s Discussion and Analysis of Financial Condition and Results of Operations for the 2009
First Quarter Form 10-Q:
REMICADE is prescribed for the treatment of inflammatory diseases such as rheumatoid
arthritis, early rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing
spondylitis, plaque psoriasis and ulcerative colitis. REMICADE is Schering-Plough’s second
largest marketed pharmaceutical product line (after the cholesterol franchise). REMICADE is
licensed from and manufactured by Centocor, Inc., a Johnson & Johnson company. During 2005,
Schering-Plough exercised an option under its contract with Centocor for license rights to
develop and commercialize golimumab, a fully human monoclonal antibody which has been filed
for approval in Europe. Schering-Plough has exclusive marketing rights to both products
outside the U.S., Japan and certain Asian markets. In December 2007, Schering-Plough and
Centocor revised their distribution agreement regarding the development, commercialization
and distribution of both REMICADE and golimumab, extending Schering-Plough’s rights to
exclusively market REMICADE to match the duration of Schering-Plough’s exclusive marketing
rights for golimumab. Effective upon regulatory approval of golimumab in the EU,
Schering-Plough’s marketing rights for both products will now extend for 15 years after the
first commercial sale of golimumab within the EU. After operating expenses and subject to
certain adjustments, Schering-Plough currently is entitled to receive an
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approximately 60 percent share of profits on Schering-Plough’s distribution in the Schering
Plough marketing territory. Beginning in 2010, subject to the approval of golimumab within
the EU, share of profits will change over time to a 50 percent share of profits by 2014 for
both products and the share of profits will remain fixed thereafter for the remainder of the
term. The changes to the duration of REMICADE marketing rights and the profit sharing
arrangement for the products are all conditioned on approval of golimumab being granted
prior to September 1, 2014. Schering-Plough may independently develop and market golimumab
for a Crohn’s disease indication in its territories, with an option for Centocor to
participate. In addition, Schering-Plough and Centocor agreed to utilize an autoinjector
device in the commercialization of golimumab and further agreed to share its development
costs.
While the percentage of the split is provided, the provisions addressing the underlying details of
how the Contribution Income Split is calculated were accorded confidential treatment by the
Commission on February 26, 2004 and Schering-Plough has sub