UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2014
ACTAVIS plc
(Exact name of registrant as specified in its charter)
Ireland | 000-55075 | 98-1114402 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1 Grand Canal Square, Docklands
Dublin 2, Ireland
(Address of Principal Executive Offices)
(862) 261-7000
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01. | Entry into a Material Definitive Agreement. |
On May 14, 2014, Watson Laboratories, Inc., an indirect wholly-owned subsidiary of Actavis plc (the Company) and Janssen Pharmaceuticals, Inc. (JPI) (f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc.) entered into an amendment (the Amendment) to the Supply Agreement (the Supply Agreement), dated as of November 1, 2010, by and between Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Watson Laboratories, Inc. Under the terms of the Supply Agreement, JPI manufactures and supplies the Company with all dosage strengths of the authorized generic version of Concerta® (methylphenidate hydrochloride extended-release tablets).
Pursuant to the Amendment, JPI will continue to manufacture and supply the Company with all dosage strengths of the authorized generic product, and the Company will continue to market and distribute the product in the United States. JPI will receive 50 percent of the net sales from the Companys product. The Amendment extends the expiration of the Supply Agreement from December 31, 2014 until December 31, 2017.
The foregoing description is qualified in its entirety by reference to the text of Amendment, which is attached as Exhibit 10.1 hereto and incorporated herein by reference. On May 15, 2014, the Company issued a press release announcing the Amendment, a copy of which is furnished herewith as Exhibit 99.1
Item 9.01 | Financial Statements and Exhibits. |
d. | Exhibits: |
10.1 | Amendment to Supply Agreement, effective as of May 14, 2014, by and between Janssen Pharmaceuticals, Inc. and Watson Laboratories, Inc. * | |
99.1 | Press Release of Actavis plc entitled Actavis Extends Exclusive Agreement to Distribute Authorized Generic Concerta® dated May 15, 2014. |
* | Confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: May 20, 2014
ACTAVIS plc | ||||
By: | /s/ David A. Buchen | |||
Name: | David A. Buchen | |||
Title: | Chief Legal Officer Global and Secretary |
EXHIBIT INDEX
Exhibit No. |
Description | |
10.1 | Amendment to Supply Agreement, effective as of May 14, 2014, by and between Janssen Pharmaceuticals, Inc. and Watson Laboratories, Inc. * | |
99.1 | Press Release of Actavis plc entitled Actavis Extends Exclusive Agreement to Distribute Authorized Generic Concerta® dated May 15, 2014. |
* | Confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Exhibit 10.1
Execution Version
Confidential portions of this Exhibit marked as [**] have been omitted pursuant to a
request for confidential treatment that has been filed separately with the Securities and Exchange Commission.
Amendment to Supply Agreement
This Amendment to the Supply Agreement (Amendment), effective as of May 14, 2014 (the Amendment Effective Date), amends that certain Supply Agreement, dated as of November 1, 2010 (the Agreement), by and between Ortho-McNeil-Janssen Pharmaceuticals, Inc., a Pennsylvania corporation ((n/k/a Janssen Pharmaceuticals, Inc.), Janssen) and Watson Laboratories, Inc., a Nevada corporation (Watson, and, together with Janssen, the Parties). All terms used herein and not defined shall have the meaning set forth in the Agreement.
WHEREAS, the Parties entered into the Agreement to allow Watson to exclusively sell the Products in the Territory in accordance with the terms set forth therein; and
WHEREAS, the Parties have determined to amend the Agreement to extend the term of the Agreement and the terms of the Purchase Price.
NOW, THEREFORE, for good and valuable consideration, the sufficiency of which is acknowledged herein, the Parties hereby agree as follows:
1. | Section 6.1 of the Agreement is hereby amended and restated in its entirety to read as follows: |
6.1 Term. The term of this Agreement shall commence on the date hereof and remain in effect for each Product hereunder until December 31, 2017, unless sooner terminated as expressly provided under the terms of this Agreement.
2. | The chart describing the Purchase Price for a given Quarterly Period on Exhibit B of the Agreement is hereby amended and restated in its entirety as follows: |
Quarterly Period |
Purchase Price as a Percent of Purchaser Net Sales |
|||
Start Date June 30, 2011 |
[**] | % | ||
July 1, 2011 September 30, 2011 |
[**] | % | ||
October 1, 2011 December 31, 2011 |
[**] | % | ||
January 1, 2012 March 31, 2012 |
[**] | % | ||
April 1, 2012 December 31, 2014 |
[**] | % | ||
January 1, 2015 December 31, 2017 |
50 | % |
3. | For purposes of clarification, the remainder of Exhibit B shall remain unchanged, including the paragraph following the chart describing the Purchase Price and the Minimum Amounts (such Minimum Amounts calculated in accordance with the terms of the Agreement). |
4. | No Other Amendments. This Amendment shall be deemed to be a part of and incorporated into the Agreement. Except as expressly set forth in this Amendment, all of the terms and conditions of the Agreement shall remain unchanged and are ratified, confirmed in all respects and remain in full force and effect. This Amendment is for the sole benefit of the Parties hereto and nothing herein expressed or implied shall give or be deemed or construed to give to any other person any legal or equitable rights whatsoever. This Amendment may not be amended and no provision hereof may be waived or modified except in each case by an instrument in writing signed by each of the Parties. |
5. | Counterparts. This Amendment may be executed in any number of counterparts, each of which counterparts, when so executed and delivered, shall be deemed an original and all of which counterparts, when taken together, shall constitute one and the same instrument even if both Parties have not executed the same counterpart. Delivery of an executed counterpart of a signature page of this Amendment by facsimile transmission or other customary means of electronic transmission shall be effective as delivery of a manually executed counterpart hereof. |
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the Parties hereto have entered into this Amendment by their duly authorized representatives as of Amendment Effective Date.
JANSSEN PHARMACEUTICALS, INC. | ||
(formerly Ortho-McNeil-Janssen Pharmaceuticals, Inc.) | ||
/s/ Calvin Schmidt | ||
Name: | Calvin Schmidt | |
Title: | President, Internal Medicine | |
WATSON LABORATORIES, INC. | ||
/s/ R. Todd Joyce | ||
Name: | R. Todd Joyce | |
Title: | Chief Financial Officer |
Exhibit 99.1
NEWS RELEASE
CONTACTS: | Investors: | |||
Lisa DeFrancesco (862) 261-7152
Media: Charlie Mayr (862) 261-8030
David Belian (862) 261-8141 |
Actavis Extends Exclusive Agreement to Distribute Authorized Generic Concerta®
DUBLIN, IRELAND May 15, 2014 Actavis plc (NYSE: ACT) today announced that it has reached an agreement with Janssen Pharmaceuticals, Inc. (JPI) to continue supplying the authorized generic version of JPIs Concerta® (methylphenidate hydrochloride extended-release tablets).
Under the terms of the extended exclusive supply and distribution agreement which was first agreed to by the companies in November 2010 and due to expire on December 31, 2014 JPI will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic product, and Actavis will continue to market and distribute the product in the United States. JPI will receive 50 percent of the net sales from Actavis product. The extended agreement runs until December 31, 2017.
During the term of the agreement, Actavis may continue to pursue U.S. Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta® and may launch its own ANDA product at the conclusion of the exclusive supply agreement. Other terms of the agreement have not been disclosed.
Concerta® is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies. For the 12 months ending February 28, 2014, Concerta® had total U.S. brand and generic sales of approximately $1.4 billion, according to IMS Health data.
About Actavis
Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.
Actavis develops and manufactures generic, brand, branded generic, legacy brands and Over-the-Counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries. The Companys North American branded pharmaceuticals business is focused principally in the Womens Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in various stages of development. Actavis also has a portfolio of five biosimilar products in development in Womens Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.
For press release and other company information, visit Actavis Web site at http://www.actavis.com.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis current perspective of existing information as of the date of this release. It is important to note that Actavis goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis current expectations depending upon a number of factors, risks and uncertainties affecting Actavis business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers facilities, products and/or businesses; risks associated with potential claims that Actavis products infringe third party patents or other intellectual property rights; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plcs Annual Report on Form 10-K for the period ended December 31, 2013, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Concerta® is a registered trademark of ALZA Corporation.
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