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SEC Company Response from Merck & Co., Inc. (MRK) (CIK 0000310158) (MRK) — Aug 5, 2011

Merck & Co., Inc. (MRK) (CIK 0000310158)
Date: Aug. 5, 2011 · CIK: 0000310158 · Accession: 0001193125-11-212044

AI Filing Summary & Sentiment

File numbers found in text: 001-06571

Referenced dates: July 8, 2011

Date
August 5, 2011
Author
Not clearly detected
Form
CORRESP
Company
Merck & Co., Inc. (MRK) (CIK 0000310158)

Letter

Via EDGAR Division of Corporation Finance Merck & Co., Inc. Form 10-K for the Fiscal Year Ended December 31, 2010, Filed February 28, 2011 Form 10-Q for the Quarterly Period Ended March 31, 2011, Filed May 9, 2011 File No. 001-06571

Dear Mr. Rosenberg:

We are submitting this letter in response to your comment letter dated July 8, 2011 addressed to Peter N. Kellogg, Executive Vice President and Chief Financial Officer relating to Form 10-K for the fiscal year ended December 31, 2010 and Form 10-Q for the quarterly period ended March 31, 2011. For ease of reference, we have repeated your comments prior to our responses.

Form 10-K for the Fiscal Year Ended December 31, 2010

Business

Research and Development, page 15

1. Regarding the chart of your current research pipeline at page 21, for each late stage research and development drug listed please provide us proposed disclosure to be included in future periodic reports showing the following:

•

The month and year the drug candidate entered phase III clinical development; and

•

Any significant patents associated with the drug candidates and the related expiration dates.

In response to the first part of the Staff’s comment, set forth below is the Company’s proposed disclosure to be included in future periodic filings, beginning with our second quarter Form 10-Q, that reflects the month and year drug candidates entered Phase III clinical development:

The chart below reflects the Company’s research pipeline as of July 29, 2011. Candidates shown in Phase III include specific products and the date such candidate entered into Phase III development.

CONFIDENTIAL TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-1)

Page 1 of 8

FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

Candidates shown in Phase II include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization in a given therapeutic area. Small molecules and biologics are given MK-number designations and for legacy Schering-Plough compounds SCH-number designations, and vaccine candidates are given V-number designations. Candidates in Phase I, additional indications in the same therapeutic area and additional claims, line extensions or formulations for in-line products are not shown.

Phase II

Phase III (Phase III entry date)

Under Review

Allergy

MK-8237 (SCH 900237), Immunotherapy(1)

Cancer

MK-0646 (dalotuzumab)

MK-7965 (SCH 727965) (dinaciclib)

Clostridium difficile Infection

MK-3415A

Contraception, Medicated IUS

MK-8342 (SCH 900342)

COPD

MK-7123 (SCH 527123) (navarixin)

Diabetes Mellitus

MK-3102

Hepatitis C

MK-5172

Insomnia

MK-3697

MK-6096

Osteoporosis

MK-5442

Overactive Bladder

MK-4618

Pneumoconjugate Vaccine

V114

Progeria

MK-6336 (SCH 066336) (lonafarnib)

Psoriasis

MK-3222 (SCH 900222)

Allergy

MK-7243 (SCH 697243), Grass pollen(1) (March 2008)

MK-3641 (SCH 039641), Ragweed(1) (September 2009)

Atherosclerosis

MK-0524A (extended-release niacin/

laropiprant) (U.S.) (December 2005)

MK-0524B (extended-release niacin/

laropiprant/simvastatin) (July 2007)

MK-0859 (anacetrapib) (May 2008)

Atrial Fibrillation

MK-6621 (vernakalant i.v.) (U.S.) (August 2003) (2)

Cervical Cancer

V503 (HPV vaccine (9 valent)) (September 2008)

COPD

MK-0877A (SCH 418131) (Zenhale) (EU) (August 2006)

Diabetes

MK-0431C (sitagliptin/pioglitazone) (September 2008)

Fertility

MK-8962 (SCH 900962) (corifollitropin alfa

injection) (U.S.) (July 2006)

Hepatitis C

MK-7009 (vaniprevir)(3) (June 2011)

Herpes Zoster

V212 (inactivated VZV vaccine) (December 2010)

Insomnia

MK-4305 (suvorexant) (December 2009)

Neuromuscular Blockade Reversal

MK-8616 (SCH 900616) (Bridion) (U.S.) (November 2005)

Osteoporosis

MK-0822 (odanacatib) (September 2007)

Parkinson’s Disease

MK-3814 (SCH 420814) (preladenant) (July 2010)

Pediatric Hexavalent Combination Vaccine

V419 (April 2011)

Sarcoma

MK-8669 (ridaforolimus) (October 2007)

Thrombosis

MK-5348 (SCH 530348) (vorapaxar) (September 2007)

Atherosclerosis

MK-0653C (ezetimibe/atorvastatin) (U.S.)

Contraception

MK-8175A (SCH 900121) (Zoely) (NOMAC/E2) (EU) (U.S.)

Diabetes

MK-0431D (sitagliptin/simvastatin) (U.S.)

MK-0431A XR (sitagliptin/

extended-release metformin) (U.S.) (4)

Glaucoma

MK-2452 (tafluprost) (U.S.)

Footnotes:

(1) North American rights only.

(2) Vernakalant i.v. for atrial fibrillation started Phase III clinical trials in August 2003 sponsored by Cardiome in collaboration with Astellas.

(3) For development in Japan only.

(4) In July 2011, Merck received a Complete Response letter from the FDA.

CONFIDENTIAL TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-2)

Page 2 of 8

FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

In response to the second part of the Staff’s comment, set forth below is the proposed disclosure to be included in future 10-K filings within Item 1 “Business – Patents, Trademarks and Licenses”:

The Company has the following key U.S. patent protection for drug candidates in Phase III development:

Phase III Drug Candidate

Currently Anticipated Year of Expiration (in U.S.) (1)(2)(3)(4)

MK-7243 (SCH 697243)

N/A(5)

MK-3641 (SCH 039641)

N/A(5)

MK-0524A

MK-0524B

MK-0859

V503

2024 (compound) / 2026 (method of making/use)

MK-0877A (SCH 418131)

2020 (combination)

MK-0431C

2022 (compound) / 2026 (salt)

MK-8962 (SCH 900962)

MK-7009

V212

2016 (method of use)

MK-4305

MK-8616 (SCH 900616)

MK-0822

MK-3814 (SCH 420814)

V419

2020 (method of making/vectors)

MK-8669

MK-5348 (SCH 530348)

(1) Compound patent unless otherwise noted.

(2) Subject to any future patent term restoration of up to five years and six month pediatric market exclusivity, either or both of which may be available.

(3) Depending on the circumstances surrounding any final regulatory approval of the compound, there may be other listed patents or patent applications pending that could have relevance to the product as finally approved; the relevance of any such application would depend upon the claims that ultimately may be granted and the nature of the final regulatory approval of the product.

(4) Regulatory exclusivity tied to the protection of clinical data is complementary to patent protection, and in many cases may provide more efficacious or longer lasting marketing exclusivity than a compound’s patent estate. In the United States, the data protection generally runs 5 years from first marketing approval of a new chemical entity extended to 7 years for an orphan drug indication and 12 years from first marketing approval of a biological product.

(5) Twelve years of data exclusivity from first marketing approval is expected.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development, page 61

2. In order to help us evaluate your disclosure about the resources that you expend in your research and development activities, please provide us the composition of research and development expenses incurred during 2010 and 2009 other than those that you separately explain (i.e. IPR&D impairment, restructuring activities and the ARIAD agreement). In this regard, please provide us a break-out, if practicable, by development phase (i.e. preclinical versus clinical), by therapeutic class or by some other function/nature for which you report these costs internally.

In 2010, research and development (“R&D”) expenses were comprised of the costs associated within Merck Research Labs (“MRL”), our human health research and development division, certain costs from operating segments, including Pharmaceutical, Animal Health and Consumer Care, as well as from other

CONFIDENTIAL TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-3)

Page 3 of 8

FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

divisions responsible for production, general and administrative and depreciation. R&D expenses in 2010 also include in-process research and development impairment charges and research and development related restructuring charges. In 2010, expenses from MRL were approximately 54% of total research and development expense. In-process research and development impairment charges, research and development costs incurred by other divisions and research and development related restructuring charges were approximately 22%, 20% and 4%, respectively, of total research and development expense. Included in the 20% of research and development costs incurred by other divisions are items such as animal health research and development, certain clinical manufacturing performed by our manufacturing division and direct research and development facility costs including repairs and maintenance and depreciation. In 2009, expenses from MRL were approximately 55% of total research and development expense. Research and development costs incurred by other divisions and research and development related restructuring charges were approximately 41% and 4%, respectively, of total research and development expense. Included in the 41% of research and development costs incurred by other divisions are items such as two months of Schering Plough research and development, certain clinical manufacturing performed by our manufacturing division and direct research and development facility costs including repairs and maintenance and depreciation. Due to the timing and variability of certain research and development costs such as restructuring and in-process research and development impairments, MRL and the divisional research and development contribution to total research and development could vary significantly.

Similar to the Company’s overall management reporting structure, as discussed in Note 20 to the Company’s Form 10-K Segment Reporting, the research division manages its business with cross functional areas of expertise rather than by therapeutic class or phase of development. Examples of areas of expertise are global chemistry, pharmaceutical sciences, and epidemiology. Because these functional areas are multidisciplinary, the costs incurred by each area do not provide meaningful information to better understand the nature of research and development costs incurred by the research and development division.

Also, since the merger with Schering Plough in 2009, the organizational structure within MRL continues to evolve. Costs included in a particular functional area within MRL could differ from period-to-period making disclosures not comparable or meaningful.

Analysis of Liquidity and Capital Resources, page 75

3. You state on page 151 “at December 31, 2010, foreign earnings of $40.4 billion have been retained indefinitely by subsidiary companies for reinvestment.” You further state that “a large portion of the cash and investments are held in foreign jurisdictions.” Please provide proposed disclosure to be included in future periodic reports of the amount of cash and investments that are currently held by your foreign subsidiaries that are considered reinvested indefinitely and its expected effect on your liquidity and capital resources.

In response to the Staff’s comment, the Company proposes to include the following disclosure in future periodic filings beginning with our second quarter Form 10-Q:

At June 30, 2011, the total of worldwide cash and investments was $16.2 billion, including $14.0 billion of cash, cash equivalents and short-term investments and $2.2 billion of long-term investments. A substantial majority of these cash and investments, held by foreign subsidiaries, would be subject to significant tax payments if such cash and investments were repatriated. However, cash provided by operating activities in the United States continues to be the Company’s primary source of funds to finance domestic operating needs, capital expenditures, treasury stock purchases and dividends paid to shareholders.

CONFIDENTIAL TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-4)

Page 4 of 8

FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

Notes to the Consolidated Financial Statements

Note 12. Contingencies and Environmental Liabilities, page 124

4. Throughout your footnote you disclose for various litigation that unfavorable outcomes “could have a material adverse effect” on the Company’s financial position, liquidity and results of operations. For loss contingencies where you have made this assertion, please address the following:

•

Please provide us with proposed disclosure to be included in future periodic reports of the amount or range of reasonably possible loss, as that term is defined by ASC 450-20.

•

For those matters that you conclude that you cannot estimate an amount or range of reasonably possible loss, please provide us proposed disclosure to be included in future periodic reports in accordance with ASC 450-20 that makes this assertion. For those matters, also provide us an explanation of the procedures you undertake on a quarterly basis to attempt to develop an amount or range of reasonably possible loss.

In response to the Staff’s comment, the Company respectfully notes that in Note 12 the Company discloses that it cannot estimate the possible loss or range of loss with respect to Vioxx-related matters as follows:

The Company believes that it has meritorious defenses to the Vioxx Product Liability Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the “Vioxx Lawsuits”) and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the Vioxx Lawsuits not included in the Settlement Program. Other than the Vioxx Liability Reserve established with respect to the DOJ investigation noted above, the Company has not established any reserves for any potential liability relating to the Vioxx Lawsuits or the Vioxx Investigations. Unfavorable outcomes in the Vioxx Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

With respect to the Vytorin/Zetia (ENHANCE) litigation, the Company proposes to include the following disclosure in future periodic filings beginning with our second quarter Form 10-Q:

The Company believes that it has meritorious defenses to the ENHANCE Litigation and intends to vigorously defend against these lawsuits. The Company is unable to predict the outcome of these matters and at this time cannot reasonably estimate the possible loss or range of loss with respect to the ENHANCE Litigation. Unfavorable outcomes resulting from the ENHANCE Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

Lastly, the Company has evaluated its

Show Raw Text
CORRESP
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Response Letter

 FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

 Merck & Co., Inc.

One Merck Drive

 P.O. Box 100

Whitehouse Station, NJ 08889-0100

 CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT
AND HAVE BEEN MARKED WITH AN ASTERISK TO DENOTE WHERE OMISSIONS HAVE BEEN MADE. THE CONFIDENTIAL MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 August 5, 2011

 Via EDGAR

 Mr. Jim B. Rosenberg

 Senior Assistant Chief Accountant

Division of Corporation Finance

 U.S. Securities
and Exchange Commission

 100 F Street, N.E.

 Washington, D.C. 20549

RE:

Merck & Co., Inc.

Form 10-K for the Fiscal Year Ended December 31, 2010, Filed February 28, 2011

Form 10-Q for the Quarterly Period Ended March 31, 2011, Filed May 9, 2011

File No. 001-06571

 Dear Mr. Rosenberg:

 We are submitting this letter in response to your comment letter dated July 8, 2011 addressed to Peter N. Kellogg, Executive Vice President and Chief Financial Officer relating to Form 10-K for the
fiscal year ended December 31, 2010 and Form 10-Q for the quarterly period ended March 31, 2011. For ease of reference, we have repeated your comments prior to our responses.

 Form 10-K for the Fiscal Year Ended December 31, 2010

 Business

Research and Development, page 15

1.
Regarding the chart of your current research pipeline at page 21, for each late stage research and development drug listed please provide us proposed disclosure to
be included in future periodic reports showing the following:

•

 The month and year the drug candidate entered phase III clinical development; and

•

 Any significant patents associated with the drug candidates and the related expiration dates.

In response to the first part of the Staff’s comment, set forth below is the Company’s proposed disclosure to be included in future periodic
filings, beginning with our second quarter Form 10-Q, that reflects the month and year drug candidates entered Phase III clinical development:

The chart below reflects the Company’s research pipeline as of July 29, 2011. Candidates shown in Phase III include specific products and the
date such candidate entered into Phase III development.

 CONFIDENTIAL
TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-1)

 Page 1 of 8

 FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

Candidates shown in Phase II include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization
in a given therapeutic area. Small molecules and biologics are given MK-number designations and for legacy Schering-Plough compounds SCH-number designations, and vaccine candidates are given V-number designations. Candidates in Phase I, additional
indications in the same therapeutic area and additional claims, line extensions or formulations for in-line products are not shown.

 Phase II

 Phase III (Phase III entry date)

 Under Review

 Allergy

 MK-8237 (SCH 900237), Immunotherapy(1)

 Cancer

MK-0646 (dalotuzumab)

 MK-7965 (SCH 727965) (dinaciclib)

 Clostridium difficile Infection

MK-3415A

 Contraception,
Medicated IUS

 MK-8342 (SCH 900342)

 COPD

 MK-7123 (SCH 527123) (navarixin)

Diabetes Mellitus

MK-3102

 Hepatitis
C

 MK-5172

Insomnia

MK-3697

MK-6096

Osteoporosis

MK-5442

 Overactive
Bladder

 MK-4618

Pneumoconjugate Vaccine

V114

Progeria

 MK-6336 (SCH
066336) (lonafarnib)

 Psoriasis

 MK-3222 (SCH 900222)

 Allergy

 MK-7243 (SCH 697243), Grass pollen(1) (March 2008)

 MK-3641 (SCH 039641), Ragweed(1) (September 2009)

Atherosclerosis

MK-0524A (extended-release niacin/

 laropiprant) (U.S.) (December 2005)

 MK-0524B (extended-release
niacin/

 laropiprant/simvastatin) (July 2007)

 MK-0859 (anacetrapib) (May 2008)

 Atrial Fibrillation

MK-6621 (vernakalant i.v.) (U.S.) (August 2003) (2)

Cervical Cancer

 V503
(HPV vaccine (9 valent)) (September 2008)

 COPD

 MK-0877A (SCH 418131) (Zenhale) (EU) (August 2006)

 Diabetes

MK-0431C (sitagliptin/pioglitazone) (September 2008)

 Fertility

 MK-8962 (SCH 900962) (corifollitropin alfa

injection) (U.S.) (July 2006)

Hepatitis C

 MK-7009
(vaniprevir)(3) (June 2011)

 Herpes Zoster

V212 (inactivated VZV vaccine) (December 2010)

 Insomnia

 MK-4305 (suvorexant) (December 2009)

Neuromuscular Blockade Reversal

 MK-8616 (SCH 900616) (Bridion) (U.S.) (November 2005)

 Osteoporosis

MK-0822 (odanacatib) (September 2007)

 Parkinson’s Disease

 MK-3814 (SCH 420814) (preladenant) (July
2010)

 Pediatric Hexavalent Combination Vaccine

 V419 (April 2011)

 Sarcoma

MK-8669 (ridaforolimus) (October 2007)

 Thrombosis

 MK-5348 (SCH 530348) (vorapaxar) (September
2007)

 Atherosclerosis

 MK-0653C (ezetimibe/atorvastatin) (U.S.)

 Contraception

MK-8175A (SCH 900121) (Zoely) (NOMAC/E2) (EU) (U.S.)

 Diabetes

 MK-0431D (sitagliptin/simvastatin) (U.S.)

MK-0431A XR (sitagliptin/

 extended-release metformin) (U.S.) (4)

 Glaucoma

MK-2452 (tafluprost) (U.S.)

 Footnotes:

(1)  North American rights
only.

 (2) Vernakalant i.v. for atrial fibrillation started Phase III clinical
trials in August 2003 sponsored by Cardiome in collaboration with Astellas.

 (3)  For development in Japan only.

 (4)  In July 2011, Merck received a Complete Response letter from the FDA.

 CONFIDENTIAL
TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-2)

 Page 2 of 8

 FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

 In response to the second part of the Staff’s comment, set forth below is the proposed disclosure
to be included in future 10-K filings within Item 1 “Business – Patents, Trademarks and Licenses”:

 The Company has the
following key U.S. patent protection for drug candidates in Phase III development:

 Phase III Drug Candidate

 Currently Anticipated Year of Expiration (in U.S.) (1)(2)(3)(4)

MK-7243 (SCH 697243)

N/A(5)

MK-3641 (SCH 039641)

N/A(5)

MK-0524A

2023

MK-0524B

2023

MK-0859

2027

V503

2024 (compound) / 2026 (method of making/use)

MK-0877A (SCH 418131)

2020 (combination)

MK-0431C

2022 (compound) / 2026 (salt)

MK-8962 (SCH 900962)

2018

MK-7009

2027

V212

2016 (method of use)

MK-4305

2029

MK-8616 (SCH 900616)

2021

MK-0822

2024

MK-3814 (SCH 420814)

2021

V419

2020 (method of making/vectors)

MK-8669

2023

MK-5348 (SCH 530348)

2024

(1)
 Compound patent unless otherwise noted.

(2)
 Subject to any future patent term restoration of up to five years and six month pediatric market exclusivity, either or both of which may be available.

(3)
 Depending on the circumstances surrounding any final regulatory approval of the compound, there
may be other listed patents or patent applications pending that could have relevance to the product as finally approved; the relevance of any such application would depend upon the claims that ultimately may be granted and the nature of the final
regulatory approval of the product.

(4)
 Regulatory exclusivity tied to the protection of clinical data is complementary to patent protection, and in many cases may provide more efficacious or longer lasting marketing exclusivity than a
compound’s patent estate. In the United States, the data protection generally runs 5 years from first marketing approval of a new chemical entity extended to 7 years for an orphan drug indication and 12 years from first marketing approval of a
biological product.

(5)
 Twelve years of data exclusivity from first marketing approval is expected.

 Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development, page 61

2.
In order to help us evaluate your disclosure about the resources that you expend in your research and development activities, please provide us the composition of
research and development expenses incurred during 2010 and 2009 other than those that you separately explain (i.e. IPR&D impairment, restructuring activities and the ARIAD agreement). In this regard, please provide us a break-out, if
practicable, by development phase (i.e. preclinical versus clinical), by therapeutic class or by some other function/nature for which you report these costs internally.

 In 2010, research and development (“R&D”) expenses were comprised of the costs associated within Merck Research Labs (“MRL”), our human health research and development division,
certain costs from operating segments, including Pharmaceutical, Animal Health and Consumer Care, as well as from other

 CONFIDENTIAL
TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-3)

 Page 3 of 8

 FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

divisions responsible for production, general and administrative and depreciation. R&D expenses in 2010 also include in-process research and development impairment charges and research and
development related restructuring charges. In 2010, expenses from MRL were approximately 54% of total research and development expense. In-process research and development impairment charges, research and development costs incurred by other
divisions and research and development related restructuring charges were approximately 22%, 20% and 4%, respectively, of total research and development expense. Included in the 20% of research and development costs incurred by other divisions are
items such as animal health research and development, certain clinical manufacturing performed by our manufacturing division and direct research and development facility costs including repairs and maintenance and depreciation. In 2009, expenses
from MRL were approximately 55% of total research and development expense. Research and development costs incurred by other divisions and research and development related restructuring charges were approximately 41% and 4%, respectively, of total
research and development expense. Included in the 41% of research and development costs incurred by other divisions are items such as two months of Schering Plough research and development, certain clinical manufacturing performed by our
manufacturing division and direct research and development facility costs including repairs and maintenance and depreciation. Due to the timing and variability of certain research and development costs such as restructuring and in-process research
and development impairments, MRL and the divisional research and development contribution to total research and development could vary significantly.

 Similar to the Company’s overall management reporting structure, as discussed in Note 20 to the Company’s Form 10-K Segment Reporting, the research division manages its business with
cross functional areas of expertise rather than by therapeutic class or phase of development. Examples of areas of expertise are global chemistry, pharmaceutical sciences, and epidemiology. Because these functional areas are multidisciplinary, the
costs incurred by each area do not provide meaningful information to better understand the nature of research and development costs incurred by the research and development division.

 Also, since the merger with Schering Plough in 2009, the organizational structure within MRL continues to evolve. Costs included in a particular functional area within MRL could differ from
period-to-period making disclosures not comparable or meaningful.

 Analysis of Liquidity and Capital Resources, page 75

3.
You state on page 151 “at December 31, 2010, foreign earnings of $40.4 billion have been retained indefinitely by subsidiary companies for
reinvestment.” You further state that “a large portion of the cash and investments are held in foreign jurisdictions.” Please provide proposed disclosure to be included in future periodic reports of the amount of cash and investments
that are currently held by your foreign subsidiaries that are considered reinvested indefinitely and its expected effect on your liquidity and capital resources.

 In response to the Staff’s comment, the Company proposes to include the following disclosure in future periodic filings beginning with our second quarter Form 10-Q:

At June 30, 2011, the total of worldwide cash and investments was $16.2 billion, including $14.0 billion of cash, cash equivalents and short-term
investments and $2.2 billion of long-term investments. A substantial majority of these cash and investments, held by foreign subsidiaries, would be subject to significant tax payments if such cash and investments were repatriated. However,
cash provided by operating activities in the United States continues to be the Company’s primary source of funds to finance domestic operating needs, capital expenditures, treasury stock purchases and dividends paid to shareholders.

 CONFIDENTIAL
TREATMENT REQUESTED BY MERCK & CO., INC. (MRK-2011A-4)

 Page 4 of 8

 FOIA CONFIDENTIAL TREATMENT REQUEST

BY MERCK & CO., INC. PURSUANT TO 17 C.F.R. § 200.83

 Notes to the Consolidated Financial Statements

Note 12. Contingencies and Environmental Liabilities, page 124

4.
Throughout your footnote you disclose for various litigation that unfavorable outcomes “could have a material adverse effect” on the Company’s
financial position, liquidity and results of operations. For loss contingencies where you have made this assertion, please address the following:

•

 Please provide us with proposed disclosure to be included in future periodic reports of the amount or range of reasonably possible loss, as that
term is defined by ASC 450-20.

•

 For those matters that you conclude that you cannot estimate an amount or range of reasonably possible loss, please provide us proposed disclosure
to be included in future periodic reports in accordance with ASC 450-20 that makes this assertion. For those matters, also provide us an explanation of the procedures you undertake on a quarterly basis to attempt to develop an amount or range of
reasonably possible loss.

 In response to the Staff’s comment, the Company respectfully notes that in Note 12 the
Company discloses that it cannot estimate the possible loss or range of loss with respect to Vioxx-related matters as follows:

 The
Company believes that it has meritorious defenses to the Vioxx Product Liability Lawsuits, Vioxx Shareholder Lawsuits and Vioxx Foreign Lawsuits (collectively, the “Vioxx Lawsuits”) and will vigorously defend
against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at
this time cannot reasonably estimate the possible loss or range of loss with respect to the Vioxx Lawsuits not included in the Settlement Program. Other than the Vioxx Liability Reserve established with respect to the DOJ investigation
noted above, the Company has not established any reserves for any potential liability relating to the Vioxx Lawsuits or the Vioxx Investigations. Unfavorable outcomes in the Vioxx Litigation could have a material adverse effect
on the Company’s financial position, liquidity and results of operations.

 With respect to the Vytorin/Zetia (ENHANCE) litigation,
the Company proposes to include the following disclosure in future periodic filings beginning with our second quarter Form 10-Q:

 The Company
believes that it has meritorious defenses to the ENHANCE Litigation and intends to vigorously defend against these lawsuits. The Company is unable to predict the outcome of these matters and at this time cannot reasonably estimate the possible loss
or range of loss with respect to the ENHANCE Litigation. Unfavorable outcomes resulting from the ENHANCE Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

Lastly, the Company has evaluated its