0001193125-16-610583.txt : 20160602 0001193125-16-610583.hdr.sgml : 20160602 20160602083037 ACCESSION NUMBER: 0001193125-16-610583 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160601 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160602 DATE AS OF CHANGE: 20160602 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36172 FILM NUMBER: 161691185 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 d203652d8k.htm 8-K 8-K

 

 

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): June 1, 2016

 

 

ARIAD Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36172   22-3106987

(State or other jurisdiction

of incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

26 Landsdowne Street, Cambridge,

Massachusetts

  02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 494-0400

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

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 June 1, 2016, ARIAD Pharmaceuticals, Inc. (“ARIAD”) completed the previously announced sale of its European operations to Incyte Corporation (“Incyte”) and entered into the previously announced license agreement granting Incyte exclusive rights to develop and commercialize Iclusig® (ponatinib) in Europe and other select countries. At closing, ARIAD received from Incyte a payment of approximately $140 million, which is subject to customary post-closing adjustments (the “Purchase Price”).

In the transaction, ARIAD sold all of the outstanding shares of ARIAD Pharmaceuticals (Luxembourg) S.a r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in Europe, including ARIAD Pharmaceuticals (Europe) S.a r.l. (“ARIAD Europe”), to Incyte’s wholly-owned subsidiary, Incyte Europe S.a r.l. (“Incyte Europe”), pursuant to a Share Purchase Agreement (the “Share Purchase Agreement”), entered into on May 9, 2016, among ARIAD, ARIAD’s wholly-owned subsidiary ARIAD Pharmaceuticals (Cayman) L.P., Incyte (as guarantor) and Incyte Europe. The Share Purchase Agreement includes a standstill provision that precludes Incyte from acquiring more than a specified percentage of shares of ARIAD’s common stock or from taking certain other actions intended to acquire or influence control of ARIAD without the consent of ARIAD’s board of directors for a specified period following the date of the agreement, subject to certain customary exceptions.

In connection with the closing under the Share Purchase Agreement, on June 1, 2016, ARIAD, ARIAD Europe and Incyte (as guarantor) entered into the previously agreed upon Amended and Restated Buy-in License Agreement (the “License Agreement”). ARIAD Europe and Incyte Europe are collectively referred to in the remainder of this Item 1.01 as “Incyte Europe.” Under the terms of the License Agreement, Incyte Europe was granted an exclusive license to develop and commercialize Iclusig® (ponatinib) in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia (the “Territory”). ARIAD will be eligible to receive from Incyte Europe tiered royalties of between 32% and 50% on net sales of Iclusig in the Territory. The royalties will be subject to adjustment for certain events including events related to the expiration of statutory or regulatory exclusivity periods for the commercialization of Iclusig in the Territory. In addition, ARIAD will be eligible to receive up to $135 million in potential development and regulatory milestones for Iclusig in new oncology indications in the Territory, together with additional milestones for non-oncology indications, if approved, in the Territory (the “Milestones”). Incyte Europe has agreed to contribute up to $7 million in each of 2016 and 2017 to fund ARIAD’s OPTIC and OPTIC-2L clinical trials (the “Development Costs”).

The terms of the License Agreement also include an option (the “Option”) for a potential future acquirer of ARIAD to purchase the European development and commercialization rights to Iclusig from Incyte Europe, subject to certain conditions. Upon exercise of the Option, ARIAD’s acquirer would be required to make a payment to Incyte Europe equivalent to the Purchase Price and any Milestones or Development Costs payments made by Incyte Europe to ARIAD and an additional payment based upon the last 12 months of Iclusig sales booked by Incyte Europe in the Territory. Incyte Europe also would be eligible to receive royalties of between 20% to 25% of net sales of Iclusig in the Territory by an acquirer of ARIAD following the effective date of the purchase of the European development and commercialization rights to Iclusig. The Option cannot be exercised before two years nor after the sixth year from the date of the License Agreement. Following exercise of the Option, there is a further transition period of up to one year before the provision can be made effective.

ARIAD and Incyte will establish a joint steering committee and joint commercialization committee to oversee product development and commercialization of Iclusig in the Territory, including oversight of any development or commercialization plan. Decisions by the joint committees must generally be resolved by consensus, with the exception of specified matters for which either ARIAD or Incyte has ultimate decision making authority.

Unless terminated earlier in accordance with its provisions, the License Agreement will continue in effect on a country-by-country basis until the latest to occur of (1) the expiration date of the composition patent in the relevant country, (2) the expiration of any regulatory marketing exclusivity period or other statutory designation that provides similar exclusivity for the commercialization of Iclusig in such country and (3) the seventh anniversary of the first commercial sale of Iclusig in such country; and thereafter, in the


absence of generic competition, for a specified period of time in which Incyte Europe will be obligated to pay royalties at a reduced rate. The License Agreement may be terminated in its entirety by Incyte Europe for convenience on twelve months notice after the third anniversary of the date of the License Agreement. The License Agreement may also be terminated by either party under certain other circumstances, including material breach, force majeure and bankruptcy or insolvency of the other party.

The foregoing descriptions of the Share Purchase Agreement and the License Agreement do not purport to be complete and are qualified in their entirety by reference to the full agreements, which ARIAD intends to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ending June 30, 2016.

Except for their status as contractual documents between the parties, the Share Purchase Agreement and License Agreement are not intended to provide factual information about the respective parties. The representations and warranties contained in each of these agreements were made only for purposes of each such agreement and as of the dates specified therein, were solely for the benefit of the respective parties to such agreements, and may be subject to limitations agreed to by the contracting parties, including being qualified by disclosures between the parties. These representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreements instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Accordingly, they should not be relied upon by investors as statements of factual information.

 

Item 8.01. Other Events.

On June 2, 2016, ARIAD issued a press release announcing the completion of the previously announced sale of its European operations to Incyte and the effectiveness of the License Agreement described under Item 1.01 of this Current Report on Form 8-K. A copy of the press release is being filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference in this Current Report on Form 8-K.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) The following exhibits are filed with this report:

 

Exhibit No.

  

Description

99.1    Press Release, dated June 2, 2016, issued by ARIAD Pharmaceuticals, Inc.


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.

 

ARIAD Pharmaceuticals, Inc.

/s/ Manmeet S. Soni

     Manmeet S. Soni
     Executive Vice President,
     Chief Financial Officer and Treasurer

Date: June 2, 2016


Exhibit Index

 

Exhibit No.

  

Description

99.1    Press Release, dated June 2, 2016, issued by ARIAD Pharmaceuticals, Inc.
EX-99.1 2 d203652dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO       News Release

 

 

ARIAD COMPLETES THE SALE OF ITS EUROPEAN OPERATIONS AND OUT-LICENSE OF EUROPEAN RIGHTS TO ICLUSIG®

~Divestiture to Incyte Strengthens Financial Position

~ARIAD Receives $140 Million Upfront Payment, $135 million to be Received in Potential Oncology Milestones, Tiered Royalty Payments of Between 32% and 50%

Cambridge, MA, June 2, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has completed the sale of its European operations to Incyte Corporation and entered into the previously announced license agreement for Incyte to exclusively license Iclusig® (ponatinib) in Europe and other select countries.

ARIAD transferred all rights to its EU operations to Incyte, which has acquired all shares of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in the licensed territory, for a payment to ARIAD at the closing of approximately $140 million (subject to customary post-closing adjustments). In addition, Incyte has now been granted an exclusive license to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

“With the closing of this transaction, we have completed a key outcome from our strategic review,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “This agreement puts ARIAD in a strong financial position. It will allow us to focus our resources on our promising R&D initiatives and our efforts to achieve the full commercial potential of Iclusig and brigatinib, if approved, in the highly valuable U.S. market, while also maintaining future strategic flexibility through the buy-back provision for the licensed Iclusig rights.”

In connection with the closing of the Incyte transaction, the previously disclosed amendments to ARIAD’s royalty financing agreement with PDL BioPharma, Inc. (PDL), entered into on May 9, 2016, became effective. ARIAD and PDL agreed to amend the agreement to, among other things, include net sales of Iclusig made by Incyte in the calculation of net sales under the PDL agreement and to restructure ARIAD’s option to receive additional funding so that ARIAD may require PDL to fund up to an additional $40 million (instead of the original $100 million) in July 2017, rather than between January and July 2016.

Baker & McKenzie LLP represented ARIAD in the Incyte transaction, and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. represented ARIAD in the PDL transaction.

About Iclusig® (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.


In the U.S., Iclusig is a kinase inhibitor indicated for the:

 

    Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

 

    Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

 

    Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.

 

    Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

 

    Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Click here to view the EU Dear Healthcare Provider Letter (PDF).


About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is an orphan oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat orphan cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

Forward-Looking Statements

This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to the statements made by Mr. Panayiotopoulos, are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to, our ongoing strategic review, our ability to successfully commercialize and generate profits from sales of Iclusig and our product candidates, if approved; competition from alternative therapies; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.


Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

 

CONTACTS:    For Investors    For Media     
  

Manmeet S. Soni

   Liza Heapes   
  

Manmeet.soni@ariad.com

   Liza.heapes@ariad.com   
  

(617) 503-7298

   (617) 620-4888   

###

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