Exhibit 10.6

 

STRICTLY CONFIDENTIAL

 

AMENDMENT N°1 TO PHARMACEUTICAL DEVELOPMENT*
AGREEMENT

 

BETWEEN

 

BEAUFOUR IPSEN INDUSTRIE S.A.S., a French corporation incorporated under the
laws of France, located at rue d’Ethe Virton, 28100, France, duly represented by
Jean-Pierre Dubuc, President,

 

hereinafter referred to as “Ipsen”, on the one hand,

 

AND

 

RADIUS HEALTH Inc., a United States corporation incorporated under the laws of
the State of Delaware, United States, with its principal office at 300
Technology Square5th Floor, Cambridge, MA, USA and formerly known as
Nuvios, Inc., duly represented by Richard Lyttle, Chief Executive Officer,

 

hereinafter referred to as “Radius”, on the other hand.

 

WHEREAS

 

A.                                   Ipsen and Radius are parties to that
certain License Agreement dated September 27, 2005 (the “License Agreement”).

 

B.                                     Within the framework of the License
Agreement, Ipsen and Radius have entered into a pharmaceutical development
agreement to develop a multidose injection for BIM 44058 dated as of January 2,
2006 (the “Pharmaceutical Development Agreement”) pursuant to which Ipsen
performs certain research and development tasks and activities in view of
developing a new formulation of Licensed Compound and/or Licensed Product.

 

C.                                     Since (i) the work to be performed by
Ipsen has taken longer than originally planned in the Work Plan of the
Pharmaceutical Development Agreement and (ii) Radius wishes Ipsen to perform
additional work to the work initially set out in the Work Plan, Ipsen and Radius
have decided to further extend the duration and the scope of the Work Plan and
to provide for the consideration relating to such an extension under an
amendment to the Pharmaceutical Development Agreement (this “Amendment n°1”).

 

NOW, THEREFORE, in consideration of the premises and the performance of the
covenants herein contained, IT IS AGREED AS FOLLOWS:

 

1.                                       In this Amendment n°1, unless otherwise
expressly provided herein, the capitalized words and phrases shall have the same
meaning as in the Pharmaceutical Development Agreement.

 

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

 

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2.                                       The December 31, 2006 deadline
initially agreed upon for the performance by Ipsen or its subcontractors of all
the work set out in the Work Plan as it exists prior to this Amendment (the
“Original Work Plan”) and its payment by Radius, is extended to May 31, 2007.

 

For sake of clarity, any reference to the date of December 31, 2006 in
Article 10 of the Pharmaceutical Development Agreement which relates to the
performance of the Original Work Plan shall be replaced by and extended to
May 31, 2007. The budget agreed upon in respect to all the work described in the
Original Work Plan shall remain unchanged, except for the over overrun of €[*]
approved by Radius in Q4, 2006.

 

3.                                       The Work Plan is amended so as to
include the work described in Appendix A to this Amendment n°1 (the “Extended
Work Plan”), some of which is to be performed in 2007 and the rest in 2008. For
clarity, all references to the Work Plan in the Pharmaceutical Development
Agreement shall be deemed to include all work described in the Extended Work
Plan, as well as the work described in the Original Work Plan. Should Radius
wish Ipsen to perform any other work in addition to the 2007 and 2008 activities
described in the Extended Work Plan, Radius and Ipsen shall enter into a new
agreement or amendment.

 

4.                                       Payments:

 

(a) Subject to any modification of the budget included in the Extended Work Plan
to be prior agreed in writing by the parties by Mike Dey, Vice-President,
Pharmaceutical Development for Ipsen and by Nick Harvey, Chief Financial Officer
to Radius or by any other representative designated by the relevant Party, the
total amount to be paid by Radius to Ipsen in connection with the research
activities and tasks pursuant to the Extended Work Plan and this Amendment n°1
shall be as specified in the here attached Appendix B, that is to say:

 

(i) The total amount to be paid by Radius to Ipsen in connection with the 2007
activities described Appendix A shall be:

 

·                                          [*] euros ([*]€) for the additional
activities on Drug Substance;

 

·                                          [*] euros ([*]€) for additional
activities on Drug Product;

 

(ii) The total amount to be paid by Radius to Ipsen in connection with the 2008
activities described in Appendix A shall be:

 

·                                          [*] euros ([*]€) for the additional
activities on Drug Substance;

 

·                                          [*] euros ([*]€) for additional
activities on Drug Product;

 

Such total amount includes all costs in connection with such research
activities, including costs of materials, supplies, services, personnel,
subcontractors and overhead, regardless of whether such research activities are
performed by Ipsen or by a subcontractor or both. The budget included in the
Extended Work Plan as described in Appendix B to this Amendment shows the
breakdown by calendar quarter of such total amounts in Euros.

 

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

 

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(b) Ipsen shall invoice Radius no later than [*] days after the end of each
calendar quarter for the amount corresponding to actual FTE time spent as per
timesheets incurred plus actual external cost bills received and approved by
Ipsen during the elapsed quarter, as shall in each case be reported in
reasonable detail on the invoice annex. Radius shall make payment of each
invoice within [*] days after receipt thereof in Euros.

 

(c) Without the prior written consent of Radius, in no event shall Ipsen invoice
Radius for an amount due in respect of any calendar year that is greater than
the amount budgeted for such calendar year in the Extended Work Plan plus the
[*] percent ([*]%) limit defined in article 4(d) of this Amendment n°1. In
addition, and notwithstanding anything expressed or implied in this Agreement to
the contrary (including without limitation, the Extended Work Plan), in no event
shall Radius have any obligation to make payments to Ipsen pursuant to this
Amendment n°1 for any work done by Ipsen at any time after December 31, 2008
unless Radius shall have authorized in writing any such work.

 

Radius shall pay for all work in respect of which Ipsen has entered into legally
binding commitments with subcontractors and which occurs before December 31,
2008, that may not be cancelled by Ipsen without incurring penalties, provided
that all of such work is within the framework of the Extended Work Plan and the
cost of such work is within the budget included in the Extended Work Plan.

 

The remaining samples from stability studies will be made available for Radius
to ship to Radius nominated contract laboratory by December 31, 2008. Should
Radius request in writing that Ipsen conduct work on Radius behalf, Ipsen will
be under no obligation to conduct such work.

 

(d)           Notwithstanding any overruns which have been approved by Radius
with respect to work under the Original Work Plan, should external costs
incurred by Ipsen in relation to the performance of 2007 or 2008 activities
described in the Extended Work Plan be more than as specified in Appendix B
hereby attached for such activities, Radius shall reimburse Ipsen such
additional costs up to a maximum of [*] percent ([*]%) of the relevant annual
amount described in Appendix B for the performance of the specific tasks that
resulted in such additional costs. In addition, should internal costs incurred
by Ipsen in relation to performance of the Work Plan be more than as specified
in Exhibit B due to an increase in the number of FTE’s required (but not the
cost per FTE), Radius shall reimburse Ipsen such additional costs up to a
maximum of [*] percent ([*]%) of the relevant annual amount described in
Appendix B for the performance of the specific tasks that resulted in such
additional costs. In either case, any reimbursement of costs in excess of such
percentage will have to be prior agreed by Radius and, in the absence of any
such prior agreement by Radius, shall be the responsibility of Ipsen. Ipsen
shall use all reasonable efforts to avoid any such cost overruns. For clarity,
the maximum [*]% adjustment permitted in 2007 will be of [*] ([*]) euros and in
2008 of [*] ([*]) euros. Any reimbursement of costs in excess of such percentage
will have to be prior agreed by Radius and, absent any such prior agreement by
Radius, shall be the responsibility of Ipsen.

 

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

 

3

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5.                                       This Amendment n°1 shall enter into
force retroactively upon its signature as of January 1st, 2007 and shall remain
in full force and in effect until complete performance of the Extended Work Plan
or termination of the Pharmaceutical Development Agreement in accordance with
its terms.

 

6.                                       All other terms and conditions of the
Pharmaceutical Development Agreement shall remain in full force and effect and
shall apply to this Amendment n°1 which is made part of the Pharmaceutical
Development Agreement.

 

7.                                       This Amendment n°1 shall be governed
by, interpreted and construed in accordance with the laws of the State of New
York, U.S.A., without regard to the conflicts of law principles, and shall not
be governed by the United Nations Conventions of International Contracts on the
Sale of Goods (the Vienna Convention).

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly
executed by their respective duly authorized representatives:

 

 

Date:   July 16, 2007

 

Date: 29.06.07

 

 

 

SIGNED by B.N. Harvey

 

SIGNED by Jean-Pierre Dubuc

 

 

 

/s/ B.N. Harvey

 

/s/ Jean-Pierre Dubuc

on behalf of
RADIUS HEALTH Inc.

 

as President of
BEAUFOUR IPSEN INDUSTRIE S.A.S.

 

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APPENDIX A

 

EXTENDED WORK PLAN

 

 

BA058: DEVELOPMENT PLAN

 

OF READY TO USE PEN INJECTION

 

FOR PHASE II

 

 

 

ADDITIONAL ACTIVITIES - 2007 & 2008

 

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APPENDIX B

 

EXTENDED WORK PLAN

 

I.              2007 BUDGET

 

I.1           DRUG SUBSTANCE

 

Additional test on batch 01- 402
(residual solvents, TFA and optical rotation)

 

External cost*

 

[*]€

Stability study of batch 01- 402

 

Internal cost — FTE**
[*]

 

[*]€

Retest of reference material

 

Internal cost — FTE**
[*]

 

[*]€

Total

 

 

 

[*]€

 

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* Subcontracting of Additional test on batch 01- 402 at EXPANSIA + shipment
** FTE rates at [*]€

 

1.2          DRUG PRODUCT

 

FTE

 

FTE cost*

 

External cost**

 

Total

[*] + [*] (μbio)

 

[*]€

 

[*]€

 

[*]€

 

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* FTE rates at [*]€
** Subcontracting of sterility test at VETTER + shipment

 

1.3          QUARTERLY BREAKDOWN FOR EXTENDED WORK PLAN ACTIVITIES  PERFORMED IN
2007

 

 

 

2007

 

2007

 

In K€

 

Q1

 

Q2

 

Q3

 

Q4

 

Total

 

External Costs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

Internal Costs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

FTEs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

Total Costs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

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

 

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II.            2008 BUDGET

 

II. 1.        DRUG SUBSTANCE

 

Stability study of batch 01- 402

 

Internal cost — FTE**
[*]

 

[*]€

Total

 

 

 

[*]€

 

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** FTE rates at [*]€

 

11.2        DRUG PRODUCT

 

FTE

 

FTE cost *

 

External cost**

 

Total

[*] + [*] (μbio)

 

[*]€

 

[*]€

 

[*]€

 

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* FTE rates at [*]€

** Subcontracting of sterility test at VETTER + shipment

 

11.3        QUARTERLY BREAKDOWN FOR EXTENDED WORK PLAN ACTIVITIES PERFORMED IN
2008

 

 

 

2008

 

2008

 

 

 

Q1

 

Q2

 

Q3

 

Q4

 

Total

 

External costs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

Internal costs (Drug Substance)

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

Internal costs (Drug Product)

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

FTEs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

Total costs

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

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

 

7

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