Document:

Exhibit 10.16

 

DEVELOPMENT AND CLINICAL SUPPLIES AGREEMENT AMENDMENT NO. 1*

 

Radius Health Inc. (“RADIUS”) and 3M COMPANY (“3M”) and 3M INNOVATIVE PROPERTIES COMPANY (“3M IPC”) entered into the certain Development and Clinical Supplies Agreement (the “Agreement”) as of June 19, 2009 (“Effective Date”).

 

Pursuant to Paragraph 9.4 of the Agreement, the parties wish to enter into this Amendment No. 1 to the Agreement (“Amendment No. 1”) effective as of December 31, 2009 (“Amendment Date”).  Capitalized terms used in this Amendment No. 1 and not defined herein are used with the meanings ascribed to them in the Agreement.

 

NOW THEREFORE, in consideration of the mutual covenants and promises contained in this Amendment No. 1, the parties agree as follows:

 

1.  Change in Work Plan; Change in Price Structure.  The parties were required to undertake additional work not contemplated by the Work Plan concerning viscosity experiments with respect to the Product.  This additional work increased the costs to perform Stage 3 of the Work Plan above the Program Cost Estimate set forth in the Agreement.  The parties have conferred with respect to these incremental costs as well as the activities and pricing outlined in the Work Plan and have agreed that the costs for these viscosity experiments as well as all other activities outlined in the Work Plan, including but not limited to preclinical and clinical activities relating to the development and manufacturing of the [*] and [*] mcg doses, stability testing, information supporting manufacturing and regulatory filings, as well as on site training support for clinicians shall not exceed $1,325,000 in the aggregate.

 

2.  Ratification.  Except to the extent expressly amended by this Amendment No. 1, all of the terms, provisions and conditions of the Agreement are hereby ratified and confirmed and shall remain in full force and effect.  The term “Agreement”, as used in the Agreement, shall henceforth be deemed to be a reference to the Agreement as amended by this Amendment No. 1.

 

3.  General.  This Amendment No. 1 may be executed in counterparts, each of which will be deemed an original with all such counterparts together constituting one instrument.

 

[remainder of this page intentionally left blank]

 

* Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

 

1

 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 1 to be executed and duly delivered by their respective duly authorized officers, intending it to take effect as of the Amendment Date.

 

	
3M COMPANY
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Signed:
    	
/s/ James A. Vaughan
    	
 
    	
Dated:
    	
01/18/2010
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Printed: James A. Vaughan
    	
 
    	
Title: 3M Drug Delivery System   Division 
   Vice-President
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
3M INNOVATIVE PROPERTIES COMPANY
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Signed:
    	
/s/ Robert W. Sprague
    	
 
    	
Dated:
    	
January 13, 2010
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Printed: Robert W. Sprague
    	
 
    	
Title: Secretary
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
RADIUS HEALTH INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Signed:
    	
/s/ B.N. Harvey
    	
 
    	
Dated:
    	
2/24/10
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Printed: B. Nicholas Harvey
    	
 
    	
Title: Chief Financial Officer
    

 

2Exhibit 10.17

 

Second Amendment To Development and Clinical Supplies Agreement*

 

This Amendment, dated September 16, 2010 by and between 3M Company, and 3M Innovative Properties Company having a principal office at 3M Center, Building 275-3E-10, St. Paul, MN  55144-1000 (hereinafter “3M”), and Radius Health Inc. having a principal office at 300 Technology Square, Cambridge, MA (hereinafter “Radius”) amends the Development and Clinical Supplies Agreement dated June 19, 2009  (hereinafter “the Agreement”) as follows:

 

RECITALS:

 

A.           Whereas, 3M and Radius have previously entered into a Development and Clinical Supplies Agreement dated June 19, 2009 (“Agreement”) for the development and delivery of clinical supplies up through Phase II for a BA058 coated MTS  product (“Product”);

B.             Whereas,  Radius has conducted preclinical and clinical trials with Product; including a Phase Ia clinical trial with Product which rendered results that did not meet predetermined criteria;

C.             Whereas, Radius is willing to repeat the Phase Ia clinical trial with new Product made by 3M using a different, proprietary array material;

D.            Whereas, 3M is willing to manufacture new clinical supplies of Product at its own expense subject to the terms of this Amendment.

E.              Whereas, Radius also requires additional clinical supplies, including Phase Ib supplies.

F.              Whereas, 3M will have the capability or producing Phase II supplies by August 31, 2011 and will assume the capital expenditures costs for Phase II supplies;

G.             Whereas, all terms of the Agreement not explicitly amended by this Amendment shall remain in full force and effect.  To the extent not modified or defined by this Amendment, all capitalized and defined terms shall have the meaning ascribed to them in the Agreement.

 

NOW, THEREFORE, in consideration of the Recitals (which are incorporated herein) and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

1.               3M shall manufacture three (3) doses plus Placebo of Phase Ia/b clinical supplies of Product using 3M’s proprietary array material in quantities and for such uses as set forth below.  Phase Ia will be provided at 3M’s expense.  Included in the runs shall be small quantities of 200 mcg and Placebo (50 each) for preclinical studies. Such supplies shall be manufactured in September and October 2010 with a target release of approximately three (3) weeks after each run. The supplies will be manufactured in the following order: 100 mcg, Placebo, 200 mcg and 150 mcg. Production of the 100 mcg dose is targeted September 27, 2010, with the target release date on or before October 31, 2010. The Placebo is targeted to be released within a week or less afterwards. The 200 mcg and 150 mcg doses are targeted 

 

* Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

 

1

 

to be released one and two weeks after that, respectively. The preclinical supplies, 200 mcg and Placebo, are targeted to be released under quarantine by October 11 and October 18, 2011, respectively.

 

	
 
    	
 
    	
100 mcg dose
    	
 
    	
150 mcg dose
    	
 
    	
200 mcg dose
    	
 
    	
Placebo
    
	
Study   supplies (Phase 1+7-day tox)
    	
 
    	
198
    	
 
    	
215
    	
 
    	
232
    	
 
    	
218
    
	
Extras
    	
 
    	
15
    	
 
    	
15
    	
 
    	
15
    	
 
    	
15
    
	
Retains
    	
 
    	
100
    	
 
    	
100
    	
 
    	
100
    	
 
    	
100
    
	
Release
    	
 
    	
55
    	
 
    	
55
    	
 
    	
55
    	
 
    	
40
    
	
Stability
    	
 
    	
140
    	
 
    	
140
    	
 
    	
140
    	
 
    	
0
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Needed   Arrays
    	
 
    	
508
    	
 
    	
525
    	
 
    	
542
    	
 
    	
373
    
	
Total   with 25% overage
    	
 
    	
635
    	
 
    	
656
    	
 
    	
678
    	
 
    	
466
    

 

2.                                       3M shall conduct a limited stability protocol on all three doses of the clinical supplies of Product.  The stability protocol shall include two storage conditions: 4C/ambient humidity with four (4) pulls (1,3,6, and 12 months), not including release, and 25C/60%RH with a single (1) pull at 1 month.  3M shall also conduct a limited stability protocol on the ready-to-coat (RTC) solutions for Phase 1a/b supplies.  The stability protocol shall include one storage condition: 4C/ambient humidity with five (5) pulls (1,2,3,4 and 6 months) for each solution. The RTC solution will also be tested prior to each manufacturing run for confirmation of formulation. 3M shall invoice Radius [*] Dollars ($[*]) per pull point for this stability testing at the conclusion of testing of the each pull.

 

3.                                       Upon request by 3M, Radius shall provide 3M with certain requested preclinical and clinical data generated by Radius under any previous Workplans; Radius shall not be required to provide preclinical or clinical data to 3M in the event and to the extent that the relevant data is being used or intended for use to support a patent application unless the parties mutually agree upon a method of disclosure that does not present a risk to the integrity of the applicable patent application.  3M shall have the right to use the preclinical and clinical data provided by Radius pursuant to this Section 3 (as well as any preclinical and clinical data previously provided to 3M by Radius) for purposes of marketing its MTS technology, so long as 3M does not disclose (i) the identity of Radius, (ii) the identity of BA058, or (iii) any information related to BA058 that would allow any third party to ascertain the identity of BA058, the therapeutic areas for which BA058 is useful for, including but not limited to the prevention and/or treatment of osteoporosis.  Before disclosing any Radius preclinical or clinical data provided pursuant to this Section 3 (as well as any preclinical and clinical data previously provided to 3M by Radius), 3M shall provide Radius with a draft of the portions of any proposed disclosure that contain such data no fewer than thirty (30) days prior to the 

 

* Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

 

2

 

planned disclosure date so that Radius may review the planned disclosure and confirm that it does not disclose any of the information covered by (i)-(iii).  3M shall comply with Radius’ reasonable request to delete references to information covered by (i)-(iii).  If there is a dispute regarding publications, such dispute shall be resolved by the parties and will include an undertaking by each party to propose scientifically meaningful equivalent disclosure that does not disclose the information covered by (i)-(iii).  It is specifically understood that disclosure of preclinical and/or clinical information to 3M under this Section 3 shall not alter its status (if applicable) as Radius Confidential Information.  It is further understood that after a disclosure has been approved by Radius under this Section 3 and approved that disclosure may be reused in the same format without resort to a separate review by Radius.  Radius also agrees to provide 3M with certain requested clinical data generated under any future Workplans upon Radius approval, which shall not be unreasonably withheld, and subject to the limitations set forth above with respect to data generated by Radius under previous Workplans.

 

4.                                       3M shall provide approximately seven hundred (700) Phase Ib supplies (included in the table above in (1)) 3M shall invoice Radius for such supplies on a time and material basis.  The estimated cost for the Phase Ib supplies is $85,000.

5.                                       3M shall provide proof to Radius that a DMF reference letter is on file. 3M shall provide Radius with an updated CMC section and finalized non-redacted copies of preclinical and clinical reports describing safety of the TAZ arrays, as well as any other information necessary for Radius regulatory filings.

6.                                       3M shall provide up to fifty (50) applicators for clinical use.

7.                                       The term of the Agreement shall be extended until June 19, 2013.

 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed in duplicate as of the date and year the last Party signs below.

 

ACCEPTED AND AGREED TO:

 

	
3M   COMPANY
    	
 
    	
Radius   Health, Inc.
    
	
 
    	
 
    	
 
    
	
By
    	
/s/   Jim A. Vaughan
    	
 
    	
By
    	
/s/   B.N. Harvey
    
	
Print   Name
    	
Jim   A. Vaughan
    	
 
    	
Print   Name 
    	
B.N.   Harvey
    
	
Title
    	
Division   VP & GM
    	
 
    	
Title
    	
CFO   and SVP
    
	
Date
    	
Sept.   22, 2010
    	
 
    	
Date
    	
16   Sept, 2010
    

 

 

3M INNOVATIVE PROPERTIES COMPANY

 

	
By
    	
/s/   Robert W. Sprague
    	
 
    

 

3

 

	
Print   Name
    	
Robert   W. Sprague
    	
 
    
	
Title
    	
Secretary
    	
 
    
	
Date
    	
9-20-2010
    	
 
    
	
 
    	
ACR   # 201004140
    	
 
    

 

4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}]]