Document:

Exhibit 10.1

 

STRICTLY CONFIDENTIAL

 

Confidential Treatment Requested  Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

 

Change Order Form # 12

 

Change order under Agreement dated: Fourth Amendment to Development and Clinical Supplies Agreement dated March 2, 2011

 

Between:  Radius Health, Inc and 3M

 

Project Name: For the development of Radius’s BA-058 compound delivered via 3M’s Microstructured Transdermal Delivery System

 

Change requested by: Radius

Name: Mark Tomai

Company:  3M

Date:  03 Feb 2012

Description of change:

 

Radius has requested further development of a ready-to-coat formulation for preparation of sMTS supplies with increased stability compared to the current formulation.

 

OBJECTIVE

 

Optimize a new formulation for sMTS-BA058 to target a scalable formulation with a final configuration that provides 2 years stability under refrigerated conditions and 3 month stability at [*]C.

 

BACKGROUND

 

Initial experiments in using excipients to stabilize the sMTS-BA058 drug product show that certain excipients can dramatically increase the stability of the drug product.  These changes need to be investigated and evaluated with container-closure system (CCS) options.

 

PROCEDURE

 

1.              A composition and coatability study designed as a factorial experiment examining the effect of API concentration and different excipients.

 

2.              A drying study to determine the effect of a drying step on the performance of the trial formulations will be completed.  The study will be started concurrently with Step 1, as coated arrays are prepared.

 

3.              A study evaluating the potential for terminal sterilization of trial formulations will be completed.  Generally, the FDA requires proof that terminal sterilization is not feasible prior to giving approval of a product prepared by aseptic techniques.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Therefore, this study needs to be completed to support strategic planning for development of the commercial product.

 

DELIVERABLES

 

·                  Formulations designed for improved stability.

 

·                  Development report describing viability of terminal sterilization for sMTS-BA058.

 

TIMING

 

The required effort in hours, duration of the study in months, and expected end dates (assuming a 01 Mar 2012 start date) for the major tasks covered by this work plan are summarized in the table below.

 

	
Task
    	
 
    	
Estimated
   Effort
   (hours)
    	
 
    	
Estimated
    Duration
   (months)
    	
 
    	
End Date
    
	
Composition and   Coatability
    	
 
    	
[*]
    	
 
    	
3
    	
 
    	
20 May 2012
    
	
Terminal Sterilization   Evaluation
    	
 
    	
[*]
    	
 
    	
2
    	
 
    	
27 May 2012
    
	
Drying Study
    	
 
    	
[*]
    	
 
    	
4
    	
 
    	
20 Jul 2012
    

 

Total elapsed time estimated: 4 months

Total hours estimated: [*] hours

Total direct costs: ~ $40,000

 

In all other respects, the terms and conditions of the Agreement remain in full force and effect.

 

Requested task, dates and costs are approved by:

 

	
Company: Radius   Health, Inc
    	
 
    	
Company: 3M
    
	
Name: B. N. Harvey
    	
 
    	
Name: Mark Tomai
    
	
 
    	
 
    	
 
    
	
Signature: 
    	
/s/ B.N. Harvey
    	
 
    	
Signature: 
    	
/s/ Mark Tomai
    
	
Position: CFO
    	
 
    	
Position: Head of MTS   Business Development
    
	
 
    	
 
    	
 
    
	
Date (dd/mm/yy): 23/02/12
    	
 
    	
Date (dd/mm/yy): 23/02/12
    
					

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2Exhibit 10.2

 

EXECUTION VERSION

 

FIRST AMENDMENT TO LOAN AND SECURITY AGREEMENT

 

THIS FIRST AMENDMENT TO LOAN AND SECURITY AGREEMENT (this “Amendment”), dated as of February 27, 2012, by and among RADIUS HEALTH, INC., a Delaware corporation (“Borrower”), GENERAL ELECTRIC CAPITAL CORPORATION, in its capacities as agent (“Agent”) and a Lender (as defined below), and OXFORD FINANCE LLC, in its capacity as a Lender (as defined below).

 

W  I  T  N  E  S  S  E  T  H:

 

WHEREAS, Borrower, the lenders signatory thereto from time to time (each a “Lender” and, collectively, “Lenders”) and Agent are parties to that certain Loan and Security Agreement, dated as of May 23, 2011 (as amended, supplemented, replaced and otherwise modified from time to time, the “Loan Agreement”; capitalized terms used herein have the meanings given to them in the Loan Agreement except as otherwise expressly defined herein), pursuant to which Lenders and Agent have agreed to provide to Borrower certain loans in accordance with the terms and conditions thereof;

 

WHEREAS, Borrower, Lenders and Agent desire to amend certain provisions of the Loan Agreement as provided herein subject to the terms and conditions set forth herein;

 

NOW, THEREFORE, in consideration of the premises, the covenants and agreements contained herein, and other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Borrower, Lenders and Agent hereby agree as follows:

 

1.                                      AMENDMENT TO LOAN AGREEMENT.  Subject to the terms and conditions of this Amendment, including, without limitation, Section 6 of this Amendment, the Loan Agreement is hereby amended as of the First Amendment Effective Date (as defined below) as follows:

 

(a)          Section 6.2(c) of the Loan Agreement is hereby amended by:

 

(i)            adding the word “material” directly after the words “copies of all” and directly before the words “statements, reports and notices”;

 

(ii)           adding the word “material” directly after the words “and all” and directly before the words “documents filed with the Securities and Exchange Commission”;

 

(iii)          adding the following proviso to the end of clause (c):

 

“provided, that such material statements, reports and notices may be delivered electronically and, if so delivered, shall be deemed to have been delivered on the

 

 

date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the Internet at www.radiuspharm.com or on the SEC’s EDGAR system or any successor system thereto, and notifies Agent and each Lender of such posting via facsimile, overnight courier, electronic mail (to an e-mail address provided by Agent and the respective Lenders from time to time), or mail as provided in Section 10.2; provided, further, that the filing of any Form 10-K, Form 10-Q, Form 8-K or any proxy statements with the SEC shall be deemed material for purposes of this Section 6.2. ”

 

Section 6.3, Financial Statements, of the Loan Agreement is hereby amended by adding the following sentence to the end thereof:

 

“Notwithstanding anything herein to the contrary, documents required to be delivered pursuant to this Section 6.3 may be delivered electronically and, if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the Internet at www.radiuspharm.com or on the SEC’s EDGAR system or any successor system thereto, and notifies Agent and each Lender of such posting via facsimile, overnight courier, electronic mail (to an e-mail address provided by Agent and the respective Lenders from time to time), or mail as provided in Section 10.2. ”

 

2.             WAIVER. Subject to the conditions set forth in Section 3 below, Administrative Agent and Lenders hereby waive an Event of Default under Section 8.1(b) of the Loan Agreement solely as a result of (a) Borrower’s failure, prior to the date hereof, to deliver such statements, reports and notices required to be delivered pursuant to Section 6.2(c) of the Loan Agreement to the extent that such statements, reports and notices are, as of the date hereof, posted on the Borrower’s website or the SEC’s EDGAR system, and (b) Borrower’s failure to deliver copies of financial statements by the delivery method required by Section 6.3 of the Loan Agreement prior to the date hereof.

 

3.             CONDITIONS TO EFFECTIVENESS.  This Amendment shall become effective as of the date (the “First Amendment Effective Date”) upon which Agent shall notify Borrower in writing that each of the conditions specified below have been satisfied as determined in Agent’s sole discretion:

 

(a)           No Default or Event of Default shall have occurred and be continuing;

 

(b)           Agent shall have received one or more counterparts of this Amendment, duly executed, completed and delivered by Agent, each Lender and Borrower;

 

(c)           Borrower shall have paid all fees, costs and expenses due and payable as of the date hereof under the Loan Agreement and the other Debt Documents; and

 

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(d)           Agent shall have received all other documents and instruments as Agent or any Lender may reasonably deem necessary or appropriate to effectuate the intent and purpose of this Amendment.

 

4.             REAFFIRMATION OF DEBT DOCUMENTS.  By executing and delivering this Amendment, Borrower hereby expressly (i) reaffirms, ratifies and confirms its Obligations under the Loan Agreement, the Notes and the other Debt Documents, (ii) agrees that this Amendment shall be a “Debt Document” under the Loan Agreement and (iii) agrees that the Loan Agreement, the Notes and each other Debt Document shall remain in full force and effect following any action contemplated in connection herewith.

 

5.             REAFFIRMATION OF GRANT OF SECURITY INTEREST IN COLLATERAL.  Borrower hereby expressly reaffirms, ratifies and confirms its obligations under the Loan Agreement, including its mortgage, grant, pledge and hypothecation to the Agent for the benefit of the Agent and each Lender, of the lien on and security interest in, and all of its right, title and interest in, all of the Collateral.

 

6.             NO OTHER AMENDMENTS OR WAIVERS.  Except for the amendment set forth in Section 1 of this Amendment, the Loan Agreement and the other Debt Documents shall remain unchanged and in full force and effect. The waiver in this Amendment is applicable only to the specific matters set forth in Section 2 above for the time period specified therein, and does not constitute a future waiver or consent nor a consent to anything other than the matters expressly set forth herein. Nothing in this Amendment is intended, or shall be construed, to constitute a novation or an accord and satisfaction of any Loan Party’s Obligations under or in connection with the Loan Agreement and any other Debt Document or to modify, affect or impair the perfection or continuity of Agent’s security interest in, (on behalf of itself and Lenders) security titles to or other liens on any Collateral for the Obligations.

 

7.             REPRESENTATIONS AND WARRANTIES; LIENS; NO DEFAULT, NO CONFLICT.  Borrower hereby represents, warrants and covenants with and to the Agent and Lenders as follows: (i) all of the representations and warranties set forth in the Debt Documents continue to be true and correct in all material respects as of the date hereof, except to the extent such representations and warranties by their terms expressly relate only to a prior date (in which case such representations and warranties shall be true and correct as of such prior date); (ii) there are no Defaults or Events of Default that have not been waived or cured; (iii) Agent has and shall continue to have valid, enforceable and perfected first-priority liens, subject only to Permitted Liens, on and security interests in the Collateral and all other collateral heretofore granted by Borrower to Agent, for the benefit of the Agent and each Lender, pursuant to the Debt Documents or otherwise granted to or held by Agent, for the benefit of the Agent and each Lender; (iv) the agreements and obligations of Borrower contained in the Debt Documents and in this Amendment constitute the legal, valid and binding obligations of Borrower, enforceable against Borrower in accordance with their respective terms, except as the enforceability thereof may be limited by bankruptcy, insolvency or other similar laws of general application affecting the enforcement of creditors’ rights or by the application of general principles of equity; and (v) the execution, delivery and performance of this Amendment by Borrower will not violate any law, rule, regulation or order or contractual obligation or

 

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organizational document of such Loan Party and will not result in, or require, the creation or imposition of any lien, claim or encumbrance of any kind on any of its properties or revenues.

 

8.             ADVICE OF COUNSEL.  Each of the parties represents to each other party hereto that it has discussed this Amendment with its counsel.

 

9.             SEVERABILITY OF PROVISIONS.  In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any applicable jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

 

10.          RELEASE.

 

(a)           In consideration of the agreements of Lenders contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Borrower, on behalf of itself and its successors, assigns, and other legal representatives, hereby fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Lenders, and their successors and assigns, and their present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers, attorneys, employees, agents and other representatives (Lenders and all such other persons being hereinafter referred to collectively as the “Releasees” and individually as a “Releasee”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies, agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set-off, demands and liabilities whatsoever (individually, a “Claim” and collectively, “Claims”) of every name and nature, known or unknown, suspected or unsuspected, both at law and in equity, which Borrower, or any of its successors, assigns, or other legal representatives may now or hereafter own, hold, have or claim to have against the Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time on or prior to the day and date of this Amendment, including, without limitation, for or on account of, or in relation to, or in any way in connection with any of the Loan Agreement, or any of the other Debt Documents or transactions thereunder or related thereto.

 

(b)           Borrower understands, acknowledges and agrees that the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release.

 

(c)           Borrower agrees that no fact, event, circumstance, evidence or transaction which could now be asserted or which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above.

 

11.          FURTHER ASSURANCES.  Borrower hereby agrees that at any time and from time to time, at the expense of Borrower, it will promptly execute and deliver all further instruments and documents, and take all further action, that may be necessary or that

 

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Agent or Lenders may reasonably request, in connection with this Amendment, or to enable them to exercise and enforce their rights and remedies under this Amendment, the Loan Agreement and the other Debt Documents.

 

12.          COSTS AND EXPENSES.  Borrower shall be responsible for the payment of all fees, costs and expenses incurred by Agent and Lenders in connection with the preparation and negotiation of this Amendment, including, without limitation, any and all fees and expenses of Agent’s in-house and outside counsel. All fees, costs and expenses shall be due and payable upon demand of Agent, and if not paid promptly upon such demand, all such fees, costs and expenses shall become part of the Obligations.

 

13.          REFERENCE TO THE EFFECT ON THE LOAN AGREEMENT.

 

(a)           Upon the effectiveness of this Amendment, each reference in the Loan Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Loan Agreement as modified by this Amendment.

 

(b)           The execution, delivery and effectiveness of this Amendment shall not, except as expressly provided in this Amendment, operate as a waiver of any right, power or remedy of Agent or any Lender, nor constitute a waiver of any provision of the Loan Agreement or any other documents, instruments and agreements executed or delivered in connection with the Loan Agreement.

 

14.          GOVERNING LAW.  THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO CONTRACTS MADE AND PERFORMED IN SUCH STATE WITHOUT REGARD TO THE PRINCIPLES THEREOF REGARDING CONFLICTS OF LAWS.

 

15.          SUCCESSORS/ASSIGNS.  This Amendment shall bind, and the rights hereunder shall inure to, the respective successors and assigns of the parties hereto, subject to the provisions of the Debt Documents.

 

16.          HEADINGS.  Section headings in this Amendment are included for convenience of reference only and shall not constitute a part of this Amendment for any other purpose.

 

17.          ENTIRE AGREEMENT.  The Loan Agreement and the other Debt Documents as and when amended through this Amendment embody the entire agreement between the parties hereto relating to the subject matter thereof and supersede all prior agreements, representations and understandings, if any, relating to the subject matter thereof.

 

18.          COUNTERPARTS.  This Amendment may be executed in multiple counterparts, each of which shall be deemed to be an original and all of which when taken together shall constitute one and the same instrument. Delivery of an executed signature page of

 

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this Amendment by facsimile transmission or electronic transmission shall be as effective as delivery of a manually executed counterpart hereof.

 

[Signature Pages to Follow]

 

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IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to Loan and Security Agreement to be duly executed and delivered as of the day and year specified at the beginning hereof.

 

 

	
 
    	
BORROWER:
    
	
 
    	
 
    
	
 
    	
RADIUS HEALTH, INC.
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ B. N.   Harvey
    
	
 
    	
Name:
    	
B. N.   Harvey
    
	
 
    	
Title:
    	
CFO
    

 

[Signatures Continue on Following Page]

 

S-1

 

	
 
    	
AGENT AND   LENDER:
    
	
 
    	
 
    
	
 
    	
GENERAL ELECTRIC CAPITAL CORPORATION
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Jacqueline   K. Blechinger
    
	
 
    	
Name:
    	
Jacqueline   K. Blechinger
    
	
 
    	
Title:
    	
Duly   Authorized Signatory
    

 

[Signatures Continue on Following Page]

 

S-2

 

	
 
    	
LENDER:
    
	
 
    	
 
    
	
 
    	
OXFORD FINANCE, LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Mark Davis
    
	
 
    	
Name:
    	
Mark Davis
    
	
 
    	
Title:
    	
Vice President - Finance, Secretary &   Treasurer
    

 

[End of Signature Pages]

 

S-3

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