Written Communication Relating to an Issuer or Third Party (sc To-c)

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE TO

(Rule 14d-100)

TENDER OFFER STATEMENT UNDER SECTION 14(D)(1) OR 13(E)(1)

OF THE SECURITIES EXCHANGE ACT OF 1934

OCATA THERAPEUTICS, INC.

(Name of Subject Company (Issuer))

Laurel Acquisition Inc.

an indirect wholly-owned subsidiary of

Astellas Pharma Inc.

(Names of Filing Persons (Offerors))

Common Stock, $0.001 par value per share

(Title of Class of Securities)

67457L100

(CUSIP Number of Class of Securities (Underlying Common Stock))

Yoshihiko Hatanaka

President and Chief Executive Officer

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho, Chuo-ku

Tokyo 103-8411, Japan

+(81)-3-3244-3000

(Name, Address, and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Person)

Copies to:

Scott F. Smith, Esq.

Jack S. Bodner, Esq.

Covington & Burling LLP

The New York Times Building

620 Eighth Avenue

New York, NY 10018-1045

(212) 841-1000

Calculation of Filing Fee


Transaction Valuation*		Amount of Filing Fee**
N/A		N/A

*	Pursuant to General Instruction D to Schedule TO, a filing fee is not required in connection with this filing as it relates solely to preliminary communications made before the commencement of a tender offer.

¨	Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.


Amount Previously Paid:		Filing Party:
Form or Registration No.		Date Filed:

x	Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

Check the appropriate boxes below to designate any transactions to which the statement relates:

third-party tender offer subject to Rule 14d-1.

issuer tender offer subject to Rule 13e-4.

going-private transaction subject to Rule 13e-3.

amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer: ¨

This filing relates solely to preliminary communications made before the commencement of a tender offer for the outstanding common stock of Ocata Therapuetics, Inc. (“Ocata”) by Laurel Acquisition Inc. (the “Purchaser”), an indirect wholly-owned subsidiary of Astellas Pharma Inc. (“Astellas”) to be commenced pursuant to the Agreement and Plan of Merger, dated as of November 10, 2015, by and among Astellas, Purchaser and Ocata.

The following documents related to the proposed tender offer are attached as exhibits to this communication:

•

English translation of Press Release of Astellas Pharma Inc. filed with the Tokyo Stock Exchange and dated November 10, 2015;

•

Joint Press Release of Ocata Therapeutics, Inc. and Astellas Pharma Inc., dated November 10, 2015; and

•

English Translation of Investor Presentation of Astellas Pharma Inc., dated November 10, 2015.

Important Additional Information

The tender offer for the outstanding common stock of Ocata has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Ocata common stock, nor is it a substitute for the tender offer materials that Astellas and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. At the time the tender offer is commenced, Astellas will file a tender offer statement on Schedule TO with the SEC, and Ocata will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY OCATA’S STOCKHOLDERS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the tender offer statement and the solicitation/recommendation statement will be mailed to Ocata’s stockholders free of charge. A free copy of the tender offer statement and the solicitation/recommendation statement will also be made available to all stockholders of Ocata by contacting Ocata at info@ocata.com or by phone at (508) 756-1212. In addition, the tender offer statement and the solicitation/recommendation statement (and all other documents filed with the SEC) will be available at no charge on the SEC’s website: www.sec.gov, upon filing with the SEC.

Exhibit Index


Exhibit No.		Description

99.1		English translation of Press Release of Astellas Pharma Inc. filed with the Tokyo Stock Exchange and dated November 10, 2015.

99.2		Joint Press Release of Ocata Therapeutics, Inc. and Astellas Pharma Inc., dated November 10, 2015.

99.3		English Translation of Investor Presentation of Astellas Pharma Inc., dated November 10, 2015.


[English Translation of Japanese Press Release]		Exhibit 99.1

On November 10, 2015

Company Name: Astellas Pharma Inc.

Representative: Representative Director, President & CEO Yoshihiko Hatanaka

TSE Ticker: 4503

(URL:http://www.astellas.com/jp)

TSE First Section

Fiscal Year End: March

Contact: Vice President, Corporate Communications Masaaki Usui

Tel: +81-3-3244-3201

Astellas Entered into a Definitive Agreement to Acquire

Ocata Therapeutics and Plans Commencement of a Tender Offer

- New Step Forward in Ophthalmology with Cell Therapy Approach -

Astellas Pharma Inc. (Headquarters: Tokyo, Representative Director, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Ocata Therapeutics, Inc. (NASDAQ:OCATA, Headquarters: Massachusetts in the United States, President and CEO: Paul Wotton, “Ocata”), a biotechnology company in the United States, announced that today (Japan time) they have entered into a definitive agreement (the “Agreement”) under which Astellas will acquire Ocata.

The board of directors of Astellas has approved today that pursuant to the Agreement Laurel Acquisition Inc. (“Laurel”), a wholly-owned subsidiary of Astellas US Holding Inc. (Headquarters: Illinois in the United States), will commence a tender offer for Ocata shares in cash (the “Tender Offer”).

Under the Agreement, Laurel aims to acquire all outstanding shares of common stock of Ocata, for a price of US$8.50 per share in cash. The offer price represents a premium of 79% to Ocata’s closing share price of US$4.75 on November 6, 2015. The all-cash transaction is valued at approximately US$379 million (total amount to purchase all outstanding common shares, options, warrants and other securities). The Tender Offer and the subsequent acquisition via the merger (the “Acquisition”) will be conducted in exchange for cash and are not conditioned on financing. The board of directors of Ocata has resolved to recommend that Ocata’s stockholders tender into the Tender Offer.

1.	Objectives of the Acquisition and the Tender Offer, etc.

(1)	Objectives of the Acquisition and the Tender Offer

Astellas is striving to create solid and resilient continuity of growth over the mid- to long-term through the pursuit of three main strategies – “Maximizing the Product Value”, “Creating Innovation”, “Pursuing Operational Excellence” in Astellas Strategic Plan 2015-2017 (“Strategic Plan”). Particularly in pursuit

of “Creating Innovation”, we are exploring new opportunities in addition to strengthening our capabilities to create innovative medicines. We’ve selected ophthalmology as one of new prioritized therapeutic areas for research besides muscle diseases and are promoting drug discovery research. We’re also proactively investing on regenerative medicine, especially cell therapy and next-generation vaccine as a part of initiatives to new technologies and modalities.

Ocata is a clinical stage biotechnology company focusing on the research and development of cell therapy in the field of ophthalmology. Ocata has strength in the fundamental technology that can establish differentiated cells from pluripotent stem cells and in the clinical development of cell therapy. Ocata’s most advanced retinal pigment epithelium (RPE) cell programs for the treatment of dry age-related macular degeneration and Stargardt’s macular degeneration are in clinical stage. Moreover, several cell therapy programs centering around ophthalmology are in research and pre-clinical stages.

The acquisition of Ocata is an important initiative for Astellas to achieve the goals of the Strategic Plan. Achieving the creation of innovative drugs via cell therapy will contribute to addressing the unmet medical needs of patients suffering from severe ophthalmic diseases. The strategic rationale of the Acquisition is as follows.

•

Establish a presence in ophthalmology

•

Establish a leading position in cell therapy by obtaining Ocata’s world-class capabilities

“We highly value Ocata’s R&D capabilities, including its world-leading researchers in cell therapy,” commented Yoshihiko Hatanaka, Representative Director, President and CEO, Astellas. “We’re confident that we will turn innovative science into value for patients through the creation of new value by combining both companies’ capabilities under ‘One Astellas,’ where Ocata will be taking a key role in Astellas’ R&D in ophthalmology and cell therapy.”

Paul Wotton, Ph.D., President and CEO, Ocata said, “I am impressed by the vision and commitment of Astellas and believe that with their global resources behind our regenerative platform, patients suffering from debilitating diseases like AMD and SMD will soon benefit from having access to regenerative medicine.”

(2)	Matters concerning material agreements between Laurel and the Ocata’s shareholders concerning tender into the Tender Offer

Ocata’s shareholders including Ocata’s directors and officers (in the aggregate, approximately 1.7% of total common shares outstanding) have agreed to tender the shares of common stock of Ocata that they hold into the Tender Offer.

(3)	Matters concerning the two-step acquisition

After the Tender Offer, Laurel will be merged with and into Ocata, and Ocata, as the surviving company, is expected to become Astellas’ consolidated subsidiary.

2.	Overview of the Tender Offer

(1)	Tender Offer Period (Plan)

The Tender Offer period will commence no later than November 25, 2015 and expire 20 business days after its commencement.

Possibility of the extension of the Tender Offer period by Ocata’s request:

If the Tender Offer conditions are not satisfied, Laurel may be required to extend the Tender Offer under certain circumstances; however, in no event will it be obligated to extend the Tender Offer period beyond May 9, 2016.

(2)	Type of Stock that is to be Acquired

Common Stock

(3)	Tender Offer Price

US $8.50 (8 Dollars and 50 Cents) per share of Common Stock

Note: Tender Offer Price has been determined through the negotiation with Ocata, considering projected earnings, the value of pipelines, potential market opportunities, the value of its technology, etc. and advised by the third party professional.

(4)	Capital Required for the Acquisition

Approximately $379 million

This amount is the sum of the acquisition of total common shares outstanding, outstanding options, outstanding warrants and other securities. Astellas has enough cash to consummate the Acquisition and the Acquisition is not conditioned on financing.

(5)	Conditions of Tender Offer

The Tender Offer is subject to customary closing conditions, including regulatory approvals and the tender of a majority of Ocata’s shares of common stock on a fully diluted basis.

3.	Minimum number of shares tendered

Laurel will consummate the Tender Offer in the event that a majority of Ocata’s shares of common stock on a fully diluted basis is tendered.

4.	Change in the number of shares of Ocata common stock that we own as a result of the Tender Offer

Percentage owned prior to the Tender Offer: 0%

Percentage owned after the Tender Offer: 100% (*)

*	This number is based on the situation where we are able to acquire 100% of Ocata’s Common Stock via the Tender Offer and subsequent merger.

5.	Ocata’s Overview



① Company name		Ocata Therapeutics, Inc.

② Address		33 Locke Drive, Marlborough, MA 01752, US

③ Representative’s title and name		President and CEO: Paul Wotton

④ Business		Research and development of new therapies for ophthalmic diseases in the field of regenerative medicine

⑤ Capital(Stockholders’ equity)		US $13,761,005 (as of September 30, 2015)

⑥ Date of establishment		Founded in 1994, changed its name to current one in 2014

⑦ Number of shares outstanding		42,300,462 shares of Common Stock (as of October 30, 2015)

⑧ Relationship between Ocata and Astellas

	Capital Relationship:	There is no capital relationship between Astellas and Ocata required to be disclosed.

	Personnel Relationship:	There is no personnel relationship between Astellas and Ocata required to be disclosed.

	Business Relationship:	There is no business relationship between Astellas and Ocata required to be disclosed.

	Applicable Relationships with Related Parties:	Ocata is not affiliated parties of Astellas.

⑨ Financial results in recent fiscal years

(THOUSANDS OF US DOLLARS)


	Fiscal Year ended December 2012			Fiscal Year ended December 2013			Fiscal Year ended December 2014
Sales		466			225			158
Net income		(34,584	)		(31,022	)		(34,749	)
Total assets		8,497			3,908			5,737
Net assets		(23,144	)		(22,534	)		(2,736	)

**	Cited from Form 10-K which Ocata submitted to the U.S. Securities and Exchange Commision (SEC).

6.	Financial Impact

The Tender Offer and consummation of the Acquisition are expected to have a minor impact on Astellas’ financial results for the fiscal year ending March 31, 2016.

7.	Financial Advisors and Legal Counsels

Citigroup Inc. is acting as exclusive financial advisor to Astellas and Covington & Burling LLP is acting as legal counsel.

Jefferies LLC is acting as exclusive financial advisor to Ocata and Goodwin Procter LLP is acting as legal counsel.

A detailed schedule of the Tender Offer will be announced on the SEC’s website (http://www.sec.gov).

Cautionary Statement Regarding Forward-Looking Statements

Any statements made in this communication that are not statements of historical fact, including statements about the expected timetable for completing the transaction and Astellas’ and Ocata’s beliefs and expectations and statements about Astellas’ proposed acquisition of Ocata, including the timing of and closing conditions to the acquisition, and the potential effects of the acquisition on both Astellas and Ocata are forward-looking statements that are based on management’s beliefs, certain assumptions and current expectations and should be evaluated as such. These statements may be identified by their use of forward-looking terminology such as the words “expects,” “projects,” “anticipates,” “intends” and other similar words. Forward-looking statements include statements that may relate to Astellas’ or Ocata’s plans, objectives, strategies, goals, future events, future revenues or performance, and other information that is not historical information. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, but are not limited to, general economic, business and market conditions and the satisfaction of the conditions to closing of the proposed transaction. For a more complete discussion of certain of the risks and uncertainties that could cause actual results to differ from those contained in the forward-looking statements with respect to Ocata, see the discussion of risks and uncertainties in Ocata’s annual report on Form 10-K for the fiscal year ended December 31, 2014, its most recent Quarterly Report on Form 10-Q, and other SEC filings. The forward-looking statements contained in this news release are made as of the date hereof, and neither Astellas nor Ocata undertakes any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise, except as required by law.

Important Additional Information

OCATA’S STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

Exhibit 99.2

Astellas to Acquire Ocata Therapeutics

- New Step Forward in Ophthalmology with Cell Therapy Approach -

Tokyo and Massachusetts, November 10, 2015—Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Ocata Therapeutics, Inc. (NASDAQ: OCAT, President and CEO: Paul Wotton, “Ocata”), a biotechnology company focused on the research and development of new therapies in the field of regenerative medicine, primarily cell therapy addressing unmet medical needs in ophthalmology patients, announced today that they have entered into a definitive agreement. Under the agreement, Astellas will acquire Ocata through Laurel Acquisition Inc., a wholly-owned subsidiary of Astellas US Holding, Inc. (“Laurel”). The boards of directors of both Astellas and Ocata have unanimously approved the agreement.

Pursuant to the agreement, Laurel will commence a tender offer for all outstanding shares of common stock of Ocata, for a price of US$8.50 per share in cash (the “Tender Offer”). Promptly upon successful completion of the Tender Offer, Laurel will be merged into Ocata, and any remaining shares of common stock of Ocata will be canceled and converted into the right to receive the offer price (except for shares held by stockholders who properly demand appraisal rights under Delaware law). The board of directors of Ocata has resolved to recommend that Ocata’s stockholders tender into the Tender Offer.

Each of the directors and executive officers of Ocata entered into support agreements with Astellas and Laurel, pursuant to which such directors and officers, among other things, agreed to tender the shares of common stock of Ocata that they hold into the Tender Offer. Shares held by these directors and officers represent, in the aggregate, approximately 1.7% of the share of common stock of Ocata outstanding on this date.

The acquisition of Ocata represents the coming together of two companies with significant accomplishments and a shared commitment to development innovative therapies that address the unmet medical needs of patients suffering from severe ophthalmic diseases. The acquisition also represents a step toward achieving Astellas’ Strategic Plan 2015-2017.

Further, acquiring Ocata will enable Astellas to establish a presence in ophthalmology and a leading position in cell therapy.

“We highly value Ocata’s R&D capabilities, including its world-leading researchers in cell therapy,” commented Yoshihiko Hatanaka, President and CEO, Astellas. “We’re confident that we will turn innovative science into value for patients through the creation of new value by combining both companies’ capabilities under ‘One Astellas,’ where Ocata will be taking a key role in Astellas’ R&D in ophthalmology and cell therapy.”

Financial Details and Closing Conditions

Consummation of the transaction is subject to customary closing conditions, including antitrust approvals and the tender of a majority of Ocata’s shares of common stock on a fully diluted basis. The offer price represents a premium of 79% to Ocata’s closing share price of US$4.75 on November 6, 2015. The all-cash transaction is valued at approximately US$379 million including the purchase of all common shares, options, warrants and other securities. The Tender Offer period is expected to commence no later than November 25, 2015, and will expire 20 business days after its commencement, unless otherwise extended. If the Tender Offer conditions are not satisfied, Astellas may be required to extend the Tender Offer under certain circumstances; however, in no event will Astellas be obligated to extend the Tender Offer beyond May 9, 2016.

The Tender Offer and consummation of the acquisition is expected to have a minor impact on Astellas’ financial results for the fiscal year ending March 31, 2016.

Citigroup Inc. is acting as exclusive financial advisor to Astellas and Covington & Burling LLP is acting as legal counsel.

Jefferies LLC is acting as exclusive financial advisor to Ocata and Goodwin Procter LLP is acting as legal counsel.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.

About Ocata

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of new therapies in the field of regenerative medicine. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information on Ocata, please visit www.ocata.com.

Cautionary Statement Regarding Forward-Looking Statements

for the fiscal year ended December 31, 2014, its most recent Quarterly Report on Form 10-Q, and other SEC filings. The forward-looking statements contained in this news release are made as of the date hereof, and neither Astellas nor Ocata undertakes any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise, except as required by law.

Important Additional Information

Contacts:

Astellas Pharma Inc.

Corporate Communications

TEL: 03-3244-3201 FAX: 03-5201-7473

http://www.astellas.com/en

U.S Media Contact

Marjorie Moeling

TEL: 224-205-5205 MOBILE: 847-682-7471

Marjorie.moeling@astellas.com

Ocata Therapeutics, Inc.

Investors: