Exhibit 10.12

 

Execution Copy

 

DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT*

 

THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into
as of October 16, 2007 (the “Effective Date”) by and between RADIUS
HEALTH, INC., a Delaware corporation having an address at 300 Technology Square,
5th Floor, Cambridge, MA 02139 (together with its Affiliates, “RADIUS”) and
LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38,
CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”).

 

RECITALS:

 

WHEREAS, RADIUS desires to engage Manufacturer to perform certain Development or
Manufacturing Services (as those terms are defined below), on the terms and
conditions set forth below, and Manufacturer desires to perform such Services
for RADIUS.

 

AGREEMENT:

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants of the parties set forth in this Agreement, the parties hereto agree
as follows:

 

1.             Definitions.  Unless this Agreement expressly provides to the
contrary, the following terms, whether used in the singular or plural, have the
respective meanings set forth below:

 

1.1           “Affiliate” means, with respect to a party, any person or entity
which controls, is controlled by or is under common control with such party.  As
used in this Section, “control”  means (a) in the case of corporate entities,
direct or indirect ownership of at least fifty percent (50%) of the stock or
shares having the right to vote for the election of directors, and (b) in the
case of non-corporate entities, the direct or indirect power to manage, direct
or cause the direction of the management and policies of the non-corporate
entity or the power to elect at least fifty percent (50%) of the members of the
governing body of such non-corporate entity.

 

1.2           “Agreement” means this Development and Manufacturing Services
Agreement, together with all Appendices attached hereto, as amended from time to
time by the parties in accordance with Section 15.6, and all fully signed Work
Orders entered into by the parties.

 

1.3           “API/Drug Substance”  means the active pharmaceutical ingredient
identified on the applicable Work Order or any intermediate of such active
pharmaceutical ingredient.

 

1.4           “Applicable Law” means all applicable ordinances, rules,
regulations, laws, guidelines, guidances, requirements and court orders of any
kind whatsoever of any Authority, as amended from time to time, including
without limitation, cGMP (if applicable).

 

1.5           “Authority” means any government regulatory authority responsible
for granting approvals for the performance of Services under this Agreement or
for issuing regulations

 

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

 

CONFIDENTIAL

 

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pertaining to the Manufacture and/or use of Product in the intended country of
use, including, without limitation, the FDA.

 

1.6           “Batch” means a specific quantity of Product that is intended to
be of uniform character and quality, within specified limits, and is produced
during the same cycle of Manufacture as defined by the applicable Batch Record.

 

1.7           “Batch Documentation” has the meaning set forth in Section 6.2.

 

1.8           “Certificate of Analysis” means a document, signed by an
authorized representative of Manufacturer, describing Specifications for, and
testing methods applied to, Product, and the results thereof.

 

1.9           “Certificate of Compliance” means a document, signed by an
authorized representative of Manufacturer, certifying that a particular Batch
was Manufactured in accordance with cGMP (if applicable), all other Applicable
Law, and the Specifications.

 

1.10         “cGMP” means current good manufacturing practices applicable to the
Manufacture of Product promulgated by any Authority.

 

1.11         “Change Order” has the meaning set forth in Section 5.3.

 

1.12         “Confidential Information”  has the meaning set forth in
Section 10.

 

1.13         “Develop” or “Development” means the studies and other activities
conducted by Manufacturer under this Agreement to develop all or any part of a
Manufacturing Process including, without limitation, analytical tests and
methods, formulations and dosage forms.

 

1.14         “Equipment” means any equipment or machinery used by Manufacturer
in the Development and/or Manufacturing of Product, or the holding, processing,
testing, or release of Product.

 

1.15         “Facility” means the facilities of Manufacturer’s Affiliate Lonza
S.A., Chausée de Tubize 297, B-1420 Braine l’Alleud, Belgium, unless otherwise
identified in the applicable Work Order.

 

1.16         “FDA” means the United States Food and Drug Administration, and any
successor agency having substantially the same functions.

 

1.17         “FDCA” means the United States Federal Food, Drug and Cosmetic Act,
21 U.S.C.  §321 et seq., as amended from time to time.

 

1.18         “force majeure” has the meaning set forth in Section 15.3.

 

1.19         “Improvements” means all Technology and discoveries, inventions,
developments, modifications, innovations, updates, enhancements, improvements,
writings or rights (whether or not protectable under patent, trademark,
copyright or similar laws) that are

 

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conceived, discovered, invented, developed, created, made or reduced to practice
in the performance of Services under this Agreement.

 

1.20         “IND” means an Investigational New Drug application filed with the
FDA in accordance with Applicable Law.

 

1.21         “Manufacture” and “Manufacturing” means any steps, processes and
activities necessary to produce Product, including without limitation, the
manufacturing, processing, packaging, labeling, quality control testing,
release, storage or supply of Product.

 

1.22         “Manufacturer Indemnitee” has the meaning set forth in
Section 12.2.

 

1.23         “Manufacturer Technology” means the Technology of Manufacturer
(a) existing prior to the Effective Date, or (b) developed or obtained by or on
behalf of Manufacturer independent of this Agreement and without reliance upon
Confidential Information of RADIUS.

 

1.24         “Manufacturing Process” means any and all processes (or any step in
any process) used or planned to be used by Manufacturer to Manufacture Product,
consistent with the relevant Work Order and as evidenced in the Batch
Documentation or master Batch Documentation.

 

1.25         “Product” means any API/Drug Substance or drug product comprised of
API/Drug Substance, and any intermediates of the foregoing, in each case as
specified in the applicable Work Order, including, if applicable, bulk packaging
and/or labeling as provided in such Work Order.

 

1.26         “Quality Agreement” has the meaning set forth in Section 2.2.

 

1.27         “RADIUS Indemnitee” has the meaning set forth in Section 12.1.

 

1.28         “RADIUS Equipment” means the Equipment, if any, identified on the
applicable Work Order as being provided by RADIUS or purchased or otherwise
acquired by Manufacturer at RADIUS’ expense.

 

1.29         “RADIUS Materials” means the materials, and any intermediates or
derivatives thereof, identified in the applicable Work Order as being provided
by RADIUS including labels (if any) for Product.

 

1.30         “RADIUS Technology” means (a) RADIUS Materials, (b) Product and any
intermediates or derivatives thereof, (c) Specifications, and (d) the Technology
of RADIUS owned, developed or obtained by or on behalf of RADIUS prior to the
Effective Date, or developed or obtained by or on behalf of RADIUS independent
of this Agreement and without reliance upon the Confidential Information and
Technology of Manufacturer.

 

1.31         “Records” has the meaning set forth in Section 5.4(a).

 

1.32         “Representative” has the meaning set forth in Section 3.1.

 

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1.33         “Reprocess” and “Reprocessing” means introducing a Product back
into the process and repeating appropriate manipulation steps that are part of
the established Manufacturing Process.  Continuation of a process step after an
in-process control test show the process to be incomplete is not considered
reprocessing.

 

1.34         “Rework” and “Reworking” means subjecting a Product to one or more
processing steps that are different from the established Manufacturing Process.

 

1.35         “Services” means the Development, Manufacturing and/or other
services described in a Work Order entered into by the parties.

 

1.36         “Specifications” means the list of tests, references to any
analytical procedures and appropriate acceptance criteria which are numerical
limits, ranges or other criteria for tests described in order to establish a set
of criteria to which Product at any stage of Manufacture should conform to be
considered acceptable for its intended use that are provided by or approved by
RADIUS, as such specifications are amended or supplemented from time to time by
RADIUS in writing.

 

1.37         “Technology” means all methods, techniques, trade secrets,
copyrights, know-how, data, documentation, regulatory submissions,
specifications and other intellectual property of any kind (whether or not
protectable under patent, trademark, copyright or similar laws).

 

1.38         “Work Order” means a written work order, substantially in the form
attached hereto as Appendix A, for the performance of Services by Manufacturer
under this Agreement.

 

2.             Engagement of Manufacturer.

 

2.1           Services and Work Orders.  From time to time, RADIUS may wish to
engage Manufacturer to perform Services for RADIUS.  Such Services will be set
forth in a Work Order.  Each Work Order will be appended to this Agreement and
will set forth the material terms for the project, and may include the scope of
work, specified Services, Specifications, deliverables, estimated timelines,
milestones (if any), quantity, budget, payment schedule and such other details
and special arrangements as are agreed to by the parties with respect to the
activities to be performed under such Work Order.  No Work Order will be
effective unless and until it has been agreed to and signed by authorized
representatives of both parties.  Documents relating to the relevant project,
including without limitation Specifications, proposals, quotations and any other
relevant documentation, will be attachments to the applicable Work Order and
incorporated in the Work Order by reference.  Each fully signed Work Order will
be subject to the terms of this Agreement and will be incorporated herein and
form part of this Agreement.  Manufacturer will perform the Services specified
in each fully signed Work Order, as amended by any applicable Change Order(s),
and in accordance with the terms and conditions of such Work Order and this
Agreement.  Notwithstanding the foregoing, nothing in this Agreement will
obligate either party to enter into any Work Order under this Agreement.

 

2.2           Quality Agreement.  If appropriate or if required by Applicable
Law, the parties will also agree upon a Quality Agreement containing quality
assurance provisions for the Manufacture of Product (“Quality Agreement”), which
agreement will also be attached to the applicable Work Order and incorporated by
reference in the Work Order.

 

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2.3           Conflict Between Documents.  If there is any conflict,
discrepancy, or inconsistency between the terms of this Agreement and any Work
Order, Quality Agreement, purchase order, or other form used by the parties, the
terms of this Agreement will control.

 

3.             Project Performance.

 

3.1           Representatives.  Each party will appoint a representative having
primary responsibility for day-to-day interactions with the other party for the
Services (each, a “Representative”), who will be identified in the applicable
Work Order.  Each party may change its Representative by providing written
notice to the other party in accordance with Section 15.3; provided that
Manufacturer will use reasonable efforts to provide RADIUS with at least [*]
([*]) days prior written notice of any change in its Representative for the
Services.  Except for notices or communications required or permitted under this
Agreement, which will be subject to Section 15.3, or unless otherwise mutually
agreed by the parties in writing, all communications between Manufacturer and
RADIUS regarding the conduct of the Services pursuant to such Work Order will be
addressed to or routed directly through the parties’ respective Representatives.

 

3.2           Communications.  The parties will hold project team meetings via
teleconference or in person, on a periodic basis as agreed upon by the
Representatives.  Manufacturer will make written reports to RADIUS as specified
in the applicable Work Order.

 

3.3           Subcontracting.  Manufacturer may not subcontract with any third
party to perform any of its obligations under this Agreement without the prior
written consent of RADIUS.  Manufacturer will be solely responsible for the
performance of any permitted subcontractor, and for costs, expenses, damages, or
losses of any nature arising out of such performance as if such performance had
been provided by Manufacturer itself under this Agreement.  Manufacturer will
cause any such permitted subcontractor to be bound by, and to comply with, the
terms of this Agreement, as applicable, including without limitation, all
confidentiality, quality assurance, regulatory and other obligations and
requirements of Manufacturer set forth in this Agreement.

 

3.4           Duty to Notify.  If Manufacturer, at any time during the term of
this Agreement, has reason to believe that it will be unable to perform or
complete the Services, Manufacturer will promptly notify RADIUS thereof. 
Compliance by Manufacturer with this Section 3.4 will not relieve Manufacturer
of any other obligation or liability under this Agreement.

 

4.             Materials and Equipment.

 

4.1           Supply of Materials.  Unless the parties otherwise agree in a Work
Order, Manufacturer will supply, in accordance with the relevant approved raw
material specifications, all materials to be used by Manufacturer in the
performance of Services under a Work Order other than the RADIUS Materials
specified in such Work Order.  RADIUS or its designees will provide Manufacturer
with the RADIUS Materials.  Manufacturer agrees (a) to account for all RADIUS
Materials, (b) not to provide RADIUS Materials to any third party without the
express prior written consent of RADIUS, (c) not to use RADIUS Materials for any
purpose other than

 

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

 

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conducting the Services, including, without limitation, not to analyze,
characterize, modify or reverse engineer any RADIUS Materials or take any action
to determine the structure or composition of any RADIUS Materials unless
required pursuant to a signed Work Order, and (d) to destroy or return to RADIUS
all unused quantities of RADIUS Materials according to RADIUS’ written
directions.

 

4.2           Ownership of Materials.  RADIUS will at all times retain title to
and ownership of the RADIUS Materials, Product, any intermediates (and
components thereof), and any work in process at each and every stage of the
Manufacturing Process.  Manufacturer will provide within the Facility an area or
areas where the RADIUS Materials, Product, any intermediates (and components
thereof), and any work in process are segregated and stored in accordance with
the Specifications and cGMP (if applicable), and in such a way as to be able at
all times to clearly distinguish such materials from products and materials
belonging to Manufacturer, or held by it for a third party’s account. 
Manufacturer will at all times take such measures as are required to protect the
RADIUS Materials, Product, any intermediates (and components thereof), and any
work in process from risk of loss or damage at all stages of the Manufacturing
Process.  Manufacturer will ensure that RADIUS Materials, Product, any
intermediates (and components thereof), and any work in process are free and
clear of any liens or encumbrances.  Manufacturer will immediately notify RADIUS
if at any time it believes any Product or RADIUS Materials have been damaged,
lost or stolen.

 

4.3           Supply of Equipment.  Unless otherwise agreed in a Work Order,
Manufacturer will supply all Equipment necessary to perform the Services.

 

5.             Development and Manufacture of Product.

 

5.1           Resources; Applicable Law.  Manufacturer will comply with all
Applicable Law in performing Services.

 

5.2           Facility.

 

(a)           Performance of Services.  Manufacturer will perform all Services
at the Facility, provide all staff necessary to perform the Services in
accordance with the terms of the applicable Work Order and this Agreement, and
hold at such Facility all Equipment, RADIUS Equipment, RADIUS Materials and
other items used in the Services.  Manufacturer will not change the location of
such Facility or use any additional facility for the performance of Services
under this Agreement without at least [*] ([*]) days prior written notice to,
and prior written consent from, RADIUS, which consent will not be unreasonably
withheld or delayed (it being understood and agreed that RADIUS may withhold
consent pending satisfactory completion of a quality assurance audit and/or
regulatory impact assessment of the new location or additional facility, as the
case may be).  Manufacturer will maintain, at its own expense, the Facility and
all Equipment required for the Manufacture of Product in a state of repair and
operating efficiency consistent with the requirements of the cGMP (if
applicable) and all Applicable Law.

 

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

 

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(b)           Validation.  Manufacturer will be responsible for performing all
validation of the Facility, Equipment and cleaning and maintenance processes
employed in the Manufacturing Process in accordance with cGMP, Manufacturer’s
internal SOPs, the applicable Quality Agreement, Applicable Law, and in
accordance with any other reasonable validation procedures established by RADIUS
and made known in writing to Manufacturer.  Manufacturer will also be
responsible for ensuring that all such validated processes are carried out in
accordance with their terms.

 

(c)           Licenses and Permits.  Manufacturer will be responsible for
obtaining, at its expense, any Facility or other licenses or permits, and any
regulatory and government approvals necessary for the performance of Services by
Manufacturer under this Agreement.  At RADIUS’ request, Manufacturer will
provide RADIUS with reasonable copies of all such approvals and submissions to
Authorities, and RADIUS will have the right to use any and all information
contained in such approvals or submissions in connection with regulatory
approval and/or commercial development of Product.

 

(d)           Access to Facility.  Upon prior notice, Manufacturer will permit
RADIUS or its duly authorized representatives, such representatives having to
enter into a reasonable separate confidentiality agreement with Manufacturer, to
reasonably observe and consult with Manufacturer during the performance of
Services under this Agreement, including without limitation the Manufacturing of
any Batch of Product.  Manufacturer also agrees that RADIUS and its duly
authorized agents, upon prior notice, will have reasonable access, during
operational hours and during active Manufacturing, to inspect the Facility and
Manufacturing Process to ascertain compliance by Manufacturer with the terms of
this Agreement, including, without limitation, inspection of (i) the Equipment
and materials used in the performance of Services, (ii) the holding facilities
for such materials and Equipment, and (iii) all Records relating to such
Services and the Facility.  RADIUS will also have the right, at its expense, to
reasonably conduct “mock” pre-approval audits upon prior notice to Manufacturer,
and Manufacturer agrees to cooperate with RADIUS in such “mock audits.”

 

5.3           Changes to Work Orders, Manufacturing Process and Specifications.

 

(a)           Changes to Work Orders.  If the scope of work of a Work Order
changes, especially the estimated timelines, then the applicable Work Order may
be amended as provided in this Section 5.3(a).  If a required modification to a
Work Order is identified by RADIUS, or by Manufacturer, the identifying party
will notify the other party in writing as soon as reasonably possible. 
Manufacturer will provide RADIUS with a change order containing a description of
the required modifications and their effect on the scope, fees and estimated
timelines specified in the Work Order (“Change Order”) and will use reasonable
efforts to do so within ten (10) business days of receiving or providing such
notice, as the case may be.  No Change Order will be effective unless and until
it has been signed by authorized representatives of both parties.  If RADIUS
does not approve such Change Order, and has not terminated the Work Order, but
requests the Work Order to be amended to take into account the modification,
then the parties will use reasonable efforts to agree on a Change Order that is
mutually acceptable.  If practicable, Manufacturer will continue to work on the
existing Work Order during any such negotiations, provided such efforts would
facilitate the completion of the work envisioned in the

 

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proposed Change Order, but will not commence work in accordance with the Change
Order until it is authorized in writing by RADIUS.

 

(b)           Process/Specifications Changes.  Any change or modification to the
Manufacturing Process or Specifications for any Product must be approved in
advance by both parties and will be made in accordance with the change control
provisions of the applicable Quality Agreement.  Any such change or modification
can result in lower or higher costs, and the parties herewith agree to enter
into good-faith negotiations concerning any such price deviation; provided,
however, that RADIUS will not be responsible for any increase in price unless
agreed in writing by RADIUS.

 

5.4           Record and Sample Retention.

 

(a)           Records.  Manufacturer will keep complete and accurate records
(including without limitation reports, accounts, notes, data, and records of all
information and results obtained from performance of Services) of all work done
by it under this Agreement, in form and substance as specified in the applicable
Work Order, the applicable Quality Agreement, and this Agreement (collectively,
the “Records”).  Manufacturer will not transfer, deliver or otherwise provide
any such Records to any party other than RADIUS, without the prior written
approval of RADIUS.  Upon prior notice, Records will be available at reasonable
times for inspection, examination and copying by or on behalf of RADIUS.  All
original Records of the Development and Manufacture of Product under this
Agreement will be retained and archived by Manufacturer in accordance with cGMP
(if applicable) and Applicable Law, but in no case for less than a period of [*]
([*]) years following completion of the applicable Work Order.  Upon RADIUS’
request, Manufacturer will promptly provide RADIUS with copies of such Records. 
[*] ([*]) years after completion of a Work Order, all of the aforementioned
records will be sent to RADIUS or RADIUS’ designee; provided, however, that
RADIUS may elect to have such records retained in Manufacturer’s archives for an
additional period of time at a reasonable charge to RADIUS.  For the avoidance
of doubt, RADIUS herewith takes note that certain Records are written in French
as the Facility is in Belgium.  RADIUS shall pay all costs incurred with any
translation of such Records requested by RADIUS.

 

(b)           Sample Retention.  Manufacturer will take and retain, for such
period and in such quantities as may be required by cGMP (if applicable) and the
applicable Quality Agreement, samples of Product from the Manufacturing Process
produced under this Agreement.  Further, Manufacturer will submit such samples
to RADIUS, upon RADIUS’ written request.

 

5.5           Regulatory Matters.

 

(a)           Regulatory Approvals.  RADIUS will be responsible for obtaining,
at its expense, all regulatory and governmental approvals and permits necessary
for RADIUS’ use of any Product Developed and/or Manufactured under this
Agreement, including, without limitation, IND submissions and any analogous
submissions filed with the appropriate Authority of a country other than the
United States.  Manufacturer will be responsible for providing

 

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

 

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RADIUS with all supporting data and information relating to the Development
and/or Manufacture of Product reasonably necessary for obtaining such approvals,
including, without limitation, all Records, raw data, reports, authorizations,
certificates, methodologies, Batch Documentation, raw material specifications,
SOPs, standard test methods, Certificates of Analysis, Certificates of
Compliance and other documentation in the possession or under the control of
Manufacturer relating to the Development and Manufacture of Product (or any
component thereof).

 

(b)           Regulatory Inspections.  Manufacturer will permit RADIUS or its
agents to be present and participate in any visit or inspection by any Authority
of the Facility (to the extent it relates in any way to any RADIUS Product) or
the Manufacturing Process.  Manufacturer will give as much advance notice as
possible to RADIUS of any such visit or inspection.  Manufacturer will provide
to RADIUS a copy of any report or other written communication received from such
Authority in connection with such visit or inspection, and any written
communication received from any Authority relating to any RADIUS Product, the
Facility (if it relates to or affects the Development and/or Manufacture of
Product) or the Manufacturing Process, within [*] ([*]) hours after receipt
thereof, and will consult with RADIUS before responding to each such
communication.  Manufacturer will provide RADIUS with a copy of its final
responses within [*] ([*]) business days after submission thereof.

 

5.6           Waste Disposal.  The generation, collection, storage, handling,
transportation, movement and release of hazardous materials and waste generated
in connection with the Services will be the responsibility of Manufacturer at
Manufacturer’s sole cost and expense.  Without limiting other applicable
requirements, Manufacturer will prepare, execute and maintain, as the generator
of waste, all licenses, registrations, approvals, authorizations, notices,
shipping documents and waste manifests required under Applicable Law.

 

5.7           Safety Procedures.  Manufacturer will be solely responsible for
implementing and maintaining health and safety procedures for the performance of
Services and for the handling of any materials or hazardous waste used in or
generated by the Services.  Manufacturer, in consultation with RADIUS, will
develop safety and handling procedures for API/Drug Substance and Product;
provided, however, that RADIUS will have no responsibility for Manufacturer’s
health and safety program.  Should such safety and handling procedures
materially deviate from Manufacturer’s existing health and safety program and
require additional investment on the part of Manufacturer, the parties shall
agree in writing in advance on reasonable charges to RADIUS for such procedures.

 

5.8           Technology Transfer.  If RADIUS elects to Manufacture Product, or
to have Product Manufactured by a third party, then Manufacturer will provide to
RADIUS, or its designee, all Manufacturing information, including, without
limitation, documentation, technical assistance, materials and cooperation by
appropriate employees of Manufacturer as RADIUS or its designee may reasonably
require in order to Manufacture Product.  RADIUS will compensate Manufacturer
for such assistance at the hourly-rate(s) set forth in the applicable Work
Order, or such other reasonable rate(s) as the parties may agree in writing.  If
such a move or replication of

 

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

 

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Manufacture of Product involves Manufacturer Technology incorporated into the
Manufacturing Process pursuant to the express terms of any relevant Work Order,
the parties will negotiate in good-faith in order to determine a reasonably
royalty fee or other reasonable consideration to be paid to Manufacturer by
RADIUS for the right to continue to use such Manufacturer Technology.

 

6.             Testing and Acceptance Process.

 

6.1           Testing by Manufacturer.  The Product to be Manufactured under
this Agreement will be Manufactured in accordance with cGMP, unless otherwise
stated in the Work Order, and the Manufacturing Process approved by RADIUS. 
Each Batch of Product will be sampled and tested by Manufacturer against the
Specifications, and the quality assurance department of Manufacturer will review
the records relating to the Manufacture of the Batch and will assess if the
Manufacture has taken place in compliance with cGMP (if applicable) and the
Manufacturing Process.

 

6.2           Provision of Records.  If, based upon such tests, a Batch of
Product conforms to the Specifications and was Manufactured according to cGMP
(if applicable) and the Manufacturing Process, then a Certificate of Compliance
will be completed and approved by the quality assurance department of
Manufacturer.  This Certificate of Compliance, a Certificate of Analysis and the
Specifications (collectively, the “Batch Documentation”, excluding any batch and
master batch records) for each Batch of Product will be delivered to RADIUS by a
reputable overnight courier or by registered or certified mail, postage prepaid,
return receipt required to verify delivery date.  Upon reasonable request,
Manufacturer will also deliver to RADIUS all raw data, reports, authorizations,
certificates, methodologies, raw material specifications, SOPs, standard test
methods, and other documentation in the possession or under the control of
Manufacturer relating to the Manufacture of each Batch of Product.  If RADIUS
has not received all such Batch Documentation at the time of receipt of the
Batch, RADIUS will notify Manufacturer in writing.  If RADIUS requires
additional copies of such Batch Documentation, these will be provided by
Manufacturer to RADIUS at cost.

 

(a)           Review of Batch Documentation; Acceptance.  RADIUS will review the
Batch Documentation for each Batch of Product and may test samples of the Batch
of Product against the Specifications.  For the avoidance of doubt, RADIUS
herewith takes note that certain parts of the Batch Documentation will be
written in French as the Facility is in Belgium.  RADIUS shall pay all costs
incurred with any translation of such Records requested by RADIUS.  RADIUS will
notify Manufacturer in writing of its acceptance or rejection of such Batch
within [*] ([*]) weeks of receipt of the complete Batch Documentation relating
to such Batch.  During this review period, the parties agree to respond
promptly, but in any event within [*] ([*]) days, to any reasonable inquiry by
the other party with respect to such Batch Documentation.  RADIUS has no
obligation to accept a Batch if such Batch does not comply with the
Specifications and/or was not Manufactured in compliance with cGMP (if
applicable) and the Manufacturing Process.

 

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

 

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6.3           Disputes.  In case of any disagreement between the parties as to
whether Product conforms to the applicable Specifications or cGMP (if
applicable), the quality assurance representatives of the parties will attempt
in good faith to resolve any such disagreement and RADIUS and Manufacturer will
follow their respective SOPs to determine the conformity of the Product to the
Specifications and cGMP (if applicable).  If the foregoing discussions do not
resolve the disagreement in a reasonable time (which will not exceed [*] ([*])
days), a representative sample of such Product will be submitted to an
independent testing laboratory mutually agreed upon by the parties for tests and
final determination of whether such Product conforms with such Specifications. 
The laboratory must meet cGMP (if applicable), be of recognized standing in the
industry, and consent to the appointment of such laboratory will not be
unreasonably withheld or delayed by either party.  Such laboratory will use the
test methods contained in the applicable Specifications.  The determination of
conformance by such laboratory with respect to all or part of such Product will
be final and binding on the parties.  The fees and expenses of the laboratory
incurred in making such determination will be paid by the party against whom the
determination is made.

 

6.4           Product Non-Compliance and Remedies.  If a Batch of Product fails
to conform to the Specifications due to the fault of Manufacturer or was not
Manufactured in compliance with cGMP (if applicable) and the Manufacturing
Process, then Manufacturer will, at RADIUS’ sole option:

 

(a)           refund in full the fees and expenses paid by RADIUS for such
Batch, including the costs of RADIUS Materials used in the Manufacture of such
Batch; or

 

(b)           at Manufacturer’s cost and expense, including the costs of RADIUS
Materials used in the Manufacture of such Batch, produce a new Batch of Product
as soon as reasonably possible; or

 

(c)           Rework or Reprocess the Product, at Manufacturer’s cost and
expense, so that the Batch can be deemed to have been Manufactured in compliance
with cGMP (if applicable) and the Manufacturing Process, and to conform to
Specifications.

 

Moreover, the parties will meet to discuss, evaluate and analyze the reasons for
and implications of the failure to comply with cGMP (if applicable) and/or the
Manufacturing Process and will decide whether to proceed with or to amend the
applicable Work Order, or to terminate such Work Order.

 

6.5           Disposition of Non-Conforming Product.  The ultimate disposition
of non-conforming Product will be the responsibility of RADIUS’ quality
assurance department and RADIUS’ expense.

 

7.             Shipping and Delivery.

 

7.1           Shipping; Delivery.  Manufacturer agrees not to ship Product to
RADIUS or its designee until it has received a written approval to ship from
RADIUS.  Manufacturer will

 

--------------------------------------------------------------------------------

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

 

11

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ensure that each Batch will be delivered to RADIUS’ designee, (a) on the
estimated delivery date and to the destination designated by RADIUS in writing,
and (b) in accordance with the instructions for shipping given to Manufacturer
by RADIUS and packaging specified by RADIUS in the applicable Work Order or as
otherwise agreed to by the parties in writing.  Delivery terms will be FCA the
Facility (Incoterms 2000).  A bill of lading will be furnished to RADIUS with
respect to each shipment.  For the avoidance of doubt, RADIUS will reimburse
Manufacturer for any packaging materials that are outside of the packaging
normally used by Manufacturer for like products as the Product.

 

8.             Price and Payments.

 

8.1           Price.  The price of Product and/or the fees for the performance
of Services will be set forth in the applicable Work Order.

 

8.2           Invoice.  Upon performance of Services and/or release of
Batch(es), such release to be conducted exclusively by Manufacturer,
Manufacturer will invoice RADIUS according to the payment schedule in the
applicable Work Order.  Payment of undisputed invoices will be due [*] ([*])
days after date of Manufacturer’s invoice.  Any undisputed invoices that remain
unpaid by RADIUS after the aforementioned timeframe shall be subject to a late
payment charge of [*] % ([*] percent) per [*] for each [*] that the payment
remains outstanding in Manufacturer’s accounts.

 

8.3           Payments.  RADIUS will make all payments pursuant to this
Agreement by check or wire transfer to a bank account designated in writing by
Manufacturer.  All payments under this Agreement will be made in Euros (EUR).

 

8.4           Financial Records.  Manufacturer will keep accurate records of all
Services performed and invoice calculations, and, upon the request of RADIUS,
will permit an independent accountant appointed by RADIUS to examine such
records upon prior notice and during normal business hours for the purpose of
verifying the correctness of all such calculations.

 

8.5           Taxes.  Duty, sales, use or excise taxes imposed by any
governmental entity that apply to the provision of Services will be borne by
RADIUS (other than taxes based upon the income of Manufacturer).

 

9.             Intellectual Property Rights.

 

9.1           RADIUS Technology.  All rights to and interests in RADIUS
Technology will remain solely in RADIUS and no right or interest therein is
transferred or granted to Manufacturer.  Manufacturer acknowledges and agrees
that it does not acquire a license or any other right to RADIUS Technology
except for the limited purpose of carrying out its duties and obligations under
this Agreement and that such limited, non-exclusive, license will expire upon
the completion of such duties and obligations or the termination or expiration
of this Agreement, whichever is the first to occur.

 

--------------------------------------------------------------------------------

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

 

12

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9.2           Manufacturer Technology.  All rights to and interests in
Manufacturer Technology will remain solely in Manufacturer and no right or
interest therein is transferred or granted to RADIUS.  RADIUS acknowledges and
agrees that it will not acquire a license or any other right to Manufacturer
Technology except as otherwise set forth in this Agreement.  If RADIUS wishes to
move or replicate the Manufacture of Product, where the relevant Manufacturing
Process involves Manufacturer Technology incorporated into the Manufacturing
Process pursuant to the express terms of any relevant Work Order, the parties
will negotiate in good-faith in order to determine a reasonably royalty fee or
other reasonable consideration to be paid to Manufacturer by RADIUS for the
right to continue to use such Manufacturer Technology.

 

9.3           Improvements.  Manufacturer agrees that all Improvements will be
the sole and exclusive property of RADIUS and are hereby assigned to RADIUS (or
its designee) without additional compensation to Manufacturer.  Manufacturer
will take such steps as RADIUS may reasonably request (at RADIUS’ expense) to
vest in RADIUS (or its designee) ownership of the Improvements.

 

9.4           Non-Exclusive License.  RADIUS agrees to grant to Manufacturer a
non-exclusive, perpetual, fully paid-up, worldwide license, with the right to
sub-license, to use Improvements that relate solely to Manufacturer Technology
or the Confidential Information of Manufacturer, in the manufacture of products
that do not contain an API/Drug Substance or derivative that is the subject of a
Work Order under this Agreement or that use other Confidential Information of
RADIUS.

 

9.5           Patent Filings.  RADIUS will have the exclusive right and option,
but not the obligation, to prepare, file, prosecute, maintain and defend at its
sole expense, any patents that claim and/or cover the Improvements.  If RADIUS
declines to file and prosecute any patent applications, or maintain any patents,
relating to Improvements, it will give Manufacturer reasonable notice to this
effect and, thereafter, Manufacturer may, upon written notice to RADIUS, file
and prosecute such patent applications and/or maintain such patents, in the name
of RADIUS and at Manufacturer’s sole expense.

 

10.           Confidentiality.

 

10.1         Definition.  As used in this Agreement, “Confidential Information” 
means any scientific, technical, trade or business information which is given by
one party to the other under this Agreement or any confidentiality agreement
entered into in contemplation of this Agreement and which is treated by the
disclosing party as confidential or proprietary, or which is developed by one
party for the other under the terms of this Agreement.  The disclosing party
will, to the extent practical, use reasonable efforts to label or identify as
confidential, at the time of disclosure all such Confidential Information that
is disclosed in writing or other tangible form.  Confidential Information of
Manufacturer includes, but is not limited to, Manufacturer Technology, whether
or not labeled confidential.  Confidential Information of RADIUS includes, but
is not limited to, RADIUS Technology and Improvements, whether or not labeled
confidential.

 

13

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10.2         Obligations.  Each party agrees (a) to keep confidential the
Confidential Information of the other party, (b) not to disclose the other
party’s Confidential Information to any third party without the prior written
consent of such other party, and (c) to use such Confidential Information only
as necessary to fulfill its obligations or in the reasonable exercise of rights
granted to it under this Agreement; provided, however, that the foregoing
obligations shall not apply to Confidential Information that is (i) in
possession of the receiving party at the time of disclosure, as reasonably
demonstrated by written records and without obligation of confidentiality,
(ii) later becomes part of the public domain through no fault of the receiving
party, (iii) received by the receiving party from a third party without
obligation of confidentiality, or (iv) developed independently by the receiving
party without use of, reference to, or reliance upon the disclosing party’s
Confidential Information by individuals who did not have access to Confidential
Information.  Notwithstanding the foregoing, a party may disclose
(y) Confidential Information of the other party to its Affiliates, and to its
and their directors, employees, consultants, and agents in each case who have a
specific need to know such Confidential Information and who are bound by a like
obligation of confidentiality and restriction on use, and (z) Confidential
Information of the other party to the extent such disclosure is required to
comply with Applicable Law or the rules of any stock exchange or listing entity,
or to defend or prosecute litigation; provided, however, that the receiving
party provides prior written notice of such disclosure to the disclosing party
and takes reasonable and lawful actions to avoid or minimize the degree of such
disclosure.  Moreover, RADIUS may disclose Confidential Information of
Manufacturer relating to the Development and/or Manufacture of Product to
entities with whom RADIUS has (or may have) a marketing and/or development
collaboration or to bona fide actual or prospective underwriters, investors,
lenders or other financing sources or to potential acquirors of the business to
which this Agreement relates, and who in each case have a specific need to know
such Confidential Information and who are bound by a like obligation of
confidentiality and restrictions on use.

 

10.3         Public Statements.  Except to the extent required by Applicable Law
or the rules of any stock exchange or listing entity, neither party will make
any public statements or releases concerning this Agreement or the transactions
contemplated by this Agreement, or use the other party’s name in any form of
advertising, promotion or publicity, without obtaining the prior written consent
of the other party, which consent will not be unreasonably withheld or delayed.

 

11.           Representations and Warranties.

 

11.1         Manufacturer’s Representations and Warranties.  Manufacturer
represents and warrants to RADIUS that:

 

(a)           it has the full power and right to enter into this Agreement and
that there are no outstanding agreements, assignments, licenses, encumbrances or
rights of any kind held by other parties, private or public, inconsistent with
the provisions of this Agreement;

 

(b)           the Services will be performed with requisite care, skill and
diligence, in accordance with Applicable Law and industry standards, and by
individuals who are appropriately trained and qualified;

 

14

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(c)           to the best of its knowledge, the Services will not infringe the
intellectual property rights of any third party and it will promptly notify
RADIUS in writing should it become aware of any claims asserting such
infringement;

 

(d)           at the time of delivery to RADIUS, the Product Manufactured under
this Agreement (i) will have been Manufactured in accordance with cGMP (if
applicable) and all other Applicable Law, the Manufacturing Process, the
applicable Quality Agreement, and Specifications, and (ii) will not be
adulterated or misbranded under the FDCA or other Applicable Law; and

 

(e)           it has not been debarred, nor is it subject to a pending
debarment, and that it will not use in any capacity in connection with the
Services any person who has been debarred pursuant to section 306 of the FDCA,
21 U.S.C.  § 335a, or who is the subject of a conviction described in such
section.  Manufacturer agrees to notify RADIUS in writing immediately if
Manufacturer or any person who is performing Services is debarred or is the
subject of a conviction described in section 306, or if any action, suit, claim,
investigation, or proceeding is pending, or to the best of Manufacturer’s
knowledge, is threatened, relating to the debarment or conviction of
Manufacturer or any person performing Services.

 

11.2         RADIUS Representations and Warranties.  RADIUS represents and
warrants to Manufacturer that:

 

(a)           it has the full power and right to enter into this Agreement and
that there are no outstanding agreements, assignments, licenses, encumbrances or
rights held by other parties, private or public, inconsistent with the
provisions of this Agreement, and

 

(b)           to the best of its knowledge, the use of RADIUS Technology as
contemplated in the Services will not infringe the intellectual property rights
of any third party and that it will promptly notify Manufacturer in writing
should it become aware of any claims asserting such infringement.

 

11.3         Disclaimer of Other Representations and Warranties.  EXCEPT AS
EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS
OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT
NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
OR NON-INFRINGEMENT.

 

12.           Indemnification.

 

12.1         Indemnification by Manufacturer.  Manufacturer will indemnify,
defend and hold harmless RADIUS, its Affiliates and their respective officers,
directors, employees and agents (each a “RADIUS Indemnitee”) from and against
any and all losses, damages, liabilities or expenses (including reasonable
attorneys fees and other costs of defense) (collectively, “Losses”)  in
connection with any and all actions, suits, claims or demands that may be
brought or instituted against any RADIUS Indemnitee by any third party based on,
arising out of, or resulting from, any (a) breach by Manufacturer of its
representations, warranties or covenants under this

 

15

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Agreement, or (b) negligent act or omission or the willful misconduct of any
Manufacturer Indemnitees in performing obligations under this Agreement.

 

12.2         Indemnification by RADIUS.  RADIUS will indemnify, defend and hold
harmless Manufacturer, its Affiliates and their respective officers, directors,
employees and agents (each a “Manufacturer Indemnitee”) from and against any and
all Losses in connection with any and all actions, suits, claims or demands that
may be brought or instituted against any Manufacturer Indemnitee by any third
party based on, or arising out of, or resulting from (a) the use of the Product,
except to the extent that such Losses are within the scope of the
indemnification obligation of Manufacturer under Section 12.1, (b) any breach by
RADIUS of its representations, warranties or covenants under this Agreement, or
(c) any negligent act or omission or the willful misconduct of any RADIUS
Indemnitees in performing obligations under this Agreement.

 

12.3         Procedures.  Each party agrees to notify the other party within [*]
([*]) days of receipt of any claims made for which the other party might be
liable under Section 12.1 or 12.2, as the case may be.  Subject to Section 12.4,
the indemnifying party will have the right to defend, negotiate, and settle such
claims.  The party seeking indemnification will provide the indemnifying party
with such information and assistance as the indemnifying party may reasonably
request, at the expense of the indemnifying party.  The parties understand that
no insurance deductible will be credited against losses for which a party is
responsible under this Section 12.

 

12.4         Settlement.  Neither party will be responsible or bound by any
settlement of any claim or suit made without its prior written consent;
provided, however, that the indemnified party will not unreasonably withhold or
delay such consent.  If a settlement contains an absolute waiver of liability
for the indemnified party, and each party has acted in compliance with the
requirements of Section 12.3, then the indemnified party’s consent will be
deemed given.  Notwithstanding the foregoing, Manufacturer will not agree to
settle any claim on such terms or conditions as would impair RADIUS’ ability or
right to Manufacture, market, sell or otherwise use Product, or as would impair
Manufacturer’s ability, right or obligation to perform its obligations under
this Agreement.

 

12.5         Limitation of Liability.  NOTWITHSTANDING ANYTHING IN THIS
AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF THIS
AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY.  THIS LIMITATION WILL
APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT APPLY TO DAMAGES
RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NON-USE
IMPOSED UNDER SECTION 10 OR ITS INDEMNIFICATION OBLIGATIONS UNDER THIS
SECTION 12.

 

--------------------------------------------------------------------------------

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

 

16

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13.           Insurance.

 

13.1         Manufacturer Insurance.  Manufacturer will secure and maintain in
full force and effect throughout the term of this Agreement (and for at least
[*] ([*]) years thereafter for claims made coverage), insurance with coverage
and minimum policy limits set forth as follows:

 

(a)           Comprehensive General Liability and Personal Injury, including
coverage for contractual liability assumed by Manufacturer and coverage for
Manufacturer’s independent contractor(s), with per occurrence limits of at least
[*] dollars ($[*]) each and a general aggregate limit of [*] dollars ($[*]);

 

(b)           Products Liability, exclusive of the coverage provided by the
Comprehensive General Liability policy, with an aggregate limit of at least [*]
dollars ($[*]); and

 

(c)           “All Risk” Property, valued at replacement cost, covering loss or
damage to the Facility and RADIUS’ property and materials in the care, custody,
and control of Manufacturer.

 

13.2         Evidence of Insurance.  Upon request, Manufacturer will furnish to
RADIUS a certificate from an insurance carrier (having a minimum AM Best rating
of A) demonstrating the insurance requirements set forth above.  [*] ([*]) days
prior written notice will be given to RADIUS of cancellation or any material
change in the policies.

 

13.3         Insurance Information.  Manufacturer will comply, at RADIUS’
expense, with reasonable requests for information made by RADIUS’ insurance
provider representative(s), including permitting such representative(s) to
inspect the Facility during operational hours and upon reasonable notice to
Manufacturer.  In regard to such inspections, the representative(s) will adhere
to such guidelines and policies pertaining to safety and non-disclosure as
Manufacturer may reasonably require.

 

14.           Term and Termination.

 

14.1         Term.  This Agreement will take effect as of the Effective Date
and, unless earlier terminated pursuant to this Section 14, will expire on the
later of (a) [*] ([*]) years from the Effective Date, or (b) the completion of
Services under the last Work Order executed by the parties prior to the second
anniversary of the Effective Date.  The term of this Agreement may be extended
by RADIUS continuously for additional [*] ([*]) year periods upon written notice
to Manufacturer at least [*] ([*]) days prior to the expiration of the then
current term.

 

14.2         Termination by RADIUS.  RADIUS will have the right, in its sole
discretion, to terminate this Agreement and/or any Work Order (a) upon [*] ([*])
days prior written notice to Manufacturer, or (b) immediately upon written
notice if (i) in RADIUS’ reasonable judgment, Manufacturer is or will be unable
to perform the Services in accordance with the agreed upon timeframe and/or
budget set forth in the applicable Work Order, or (ii) Manufacturer fails to

 

--------------------------------------------------------------------------------

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

 

17

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obtain or maintain any material governmental licenses or approvals required in
connection with the Services.

 

14.3         Termination by Either Party.  Either party will have the right to
terminate this Agreement or any signed Work Orders that are pending by written
notice to the other party, upon the occurrence of any of the following:

 

(a)           the other party files a petition in bankruptcy, or enters into an
agreement with its creditors, or applies for or consents to the appointment of a
receiver or trustee, or makes an assignment for the benefit of creditors, or
becomes subject to involuntary proceedings under any bankruptcy or insolvency
law (which proceedings remain undismissed for [*] ([*]) days);

 

(b)           the other party fails to start and diligently pursue the cure of a
material breach of this Agreement within [*] ([*]) days after receiving written
notice from the other party of such breach; or

 

(c)           a force majeure event that will, or continues to, prevent
performance (in whole or substantial part) of this Agreement or any pending Work
Order for a period of at least [*] ([*]) days.  In the case of a force majeure
event relating to a pending Work Order, the right to terminate will be limited
to such Work Order.

 

14.4         Effect of Termination.  Manufacturer will, upon receipt of a
termination notice from RADIUS, promptly cease performance of the applicable
Services and will take all reasonable steps to mitigate the out-of-pocket
expenses incurred in connection therewith.  In particular, Manufacturer will use
its best efforts to:

 

(a)           immediately cancel, to the greatest extent possible, any third
party obligations;

 

(b)           promptly inform RADIUS of any irrevocable commitments made in
connection with any pending Work Order(s) prior to termination;

 

(c)           promptly return to the vendor for a refund all unused, unopened
materials in Manufacturer’s possession that are related to any pending Work
Order; provided that RADIUS will have the option, but not the obligation, to
take possession of any such materials;

 

(d)           promptly inform RADIUS of the cost of any remaining unused,
unreturnable materials ordered, or work in progress pursuant to any pending Work
Order(s), and either deliver such materials to RADIUS (or its designee) or
properly dispose of them, as instructed by RADIUS, upon which Manufacturer shall
invoice RADIUS for any such associated costs; and

 

(e)           perform only those services and activities mutually agreed upon by
RADIUS and Manufacturer as being necessary or advisable in connection with the
close-out of any pending Work Order(s).

 

--------------------------------------------------------------------------------

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

 

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14.5         Return of Materials/Confidential Information.  Upon the expiration
or termination of this Agreement, each party will promptly return all
Confidential Information of the other party that it has received pursuant to
this Agreement, provided however that Manufacturer is allowed to keep one copy
of such Confidential Information for archival purposes only.  Manufacturer will
also promptly return all RADIUS Materials, RADIUS Equipment, retained samples,
data, reports and other property, information and/or know-how in recorded form
that was provided by RADIUS, or developed in the performance of the Services,
that are owned by or licensed to RADIUS.

 

14.6         Inventories.  Upon expiration or termination of this Agreement or a
pending Work Order, RADIUS (a) will purchase from Manufacturer any existing
inventories of Product conforming to the Specifications and Manufactured in
accordance with cGMP (if applicable) and the Manufacturing Process, at the price
for such Product set forth in the applicable Work Order, and (b) may either
(i) purchase any Product in process held by Manufacturer as of the date of the
termination, at a price to be mutually agreed (it being understood that such
price will reflect, on a pro rata basis, work performed and non-cancelable
out-of-pocket expenses actually incurred by Manufacturer with respect to the
Manufacture of such in-process Product), or (ii) direct Manufacturer to dispose
of such material at RADIUS’ cost.

 

14.7         Payment Reconciliation.  Within [*] ([*]) days after the close-out
of a Work Order, Manufacturer will provide to RADIUS a written itemized
statement of all work performed by it in connection with the terminated Work
Order, an itemized breakdown of the costs associated with that work, and a final
invoice for that Work Order.  If RADIUS has pre-paid to Manufacturer more than
the amount in a final invoice then Manufacturer agrees to promptly refund that
money to RADIUS, or to credit the excess payment toward another existing or
future Work Order, at the election of RADIUS.

 

14.8         Survival.  Expiration or termination of this Agreement for any
reason will not relieve either party of any obligation accruing prior to such
expiration or termination or of any rights and obligations of the parties that
by their terms survive termination or expiration of this Agreement or of any
Work Order, including, without limitation, Sections 1, 2.3, 4, 5.2(c), 5.2(d),
5.4, 5.5, 5.6, 5.7, 5.8, 6, 9 through 13, 14.4, 14.5, 14.6, 14.7, 14.8 and 15,
and the provisions of the applicable Quality Agreement.

 

15.           Miscellaneous.

 

15.1         Independent Contractor.  All Services will be rendered by
Manufacturer as an independent contractor and this Agreement does not create an
employer-employee relationship between RADIUS and Manufacturer.  Manufacturer
will not in any way represent itself to be a partner or joint venturer of or
with RADIUS.

 

15.2         Force Majeure.  Except as otherwise expressly set forth in this
Agreement, neither party will have breached this Agreement for failure or delay
in fulfilling or performing any term of this Agreement when such failure or
delay is caused by or results from causes

 

--------------------------------------------------------------------------------

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

 

19

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beyond the reasonable control of the affected party, including, without
limitation, fire, floods, embargoes, shortages, epidemics, quarantines, war,
acts of war (whether war be declared or not), insurrections, riots, civil
commotion, strikes, acts of God or acts, omissions, or delays in acting, by any
governmental authority (“force majeure”).  The party affected by any event of
force majeure will promptly notify the other party, explaining the nature,
details and expected duration thereof.  Such party will also notify the other
party from time to time as to when the affected party reasonably expects to
resume performance in whole or in part of its obligations under this Agreement,
and to notify the other party of the cessation of any such event.  A party
affected by an event of force majeure will use its reasonable efforts to remedy,
remove, or mitigate such event and the effects thereof with all reasonable
dispatch.  If a party anticipates that an event of force majeure may occur, such
party will notify the other party of the nature, details and expected duration
thereof.  Upon termination of the event of force majeure, the performance of any
suspended obligation or duty will promptly recommence.

 

15.3         Notices.  All notices must be written and sent to the address or
facsimile number identified below or in a subsequent notice.  All notices must
be given (a) by personal delivery, with receipt acknowledged, (b) by facsimile
followed by hard copy delivered by the methods under (c) or (d), (c) by prepaid
certified or registered mail, return receipt requested, or (d) by prepaid
recognized next business day delivery service.  Notices will be effective upon
receipt or at a later date stated in the notice.

 

If to Manufacturer, to:

Lonza Ltd

 

Legal Department

 

Muenchensteinerstrasse 38

 

CH-4002 Basel

 

Switzerland

 

 

 

Facsimile number: +41 61 316 83 14

 

 

If to RADIUS, to:

Chief Financial Officer

 

Radius Health, Inc.

 

300 Technology Square, 5th Floor

 

Cambridge, MA 02139

 

15.4         Assignment.  This Agreement may not be assigned or otherwise
transferred by either party without the prior written consent of the other
party; provided, however, that RADIUS may, without such consent, but with notice
to the Manufacturer, assign this Agreement, in whole or in part, (a) in
connection with the transfer or sale of all or substantially all of its assets
or the line of business or Product to which this Agreement relates, (b) to a
successor entity or acquirer in the event of a merger, consolidation or change
of control, (c) to any Affiliate, or (d) to any licensee of RADIUS’ rights to
the relevant Product.  Any purported assignment in violation of the preceding
sentence will be void.  Any permitted assignee will assume the rights and
obligations of its assignor under this Agreement.

 

15.5         Entire Agreement.  This Agreement, including the attached
Appendices and any fully-signed Work Orders, each of which are incorporated
herein, constitute the entire agreement between the parties with respect to the
specific subject matter hereof and all prior agreements

 

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with respect thereto are superseded.  Each party hereto confirms that it is not
relying on any representations or warranties of the other party except as
specifically set forth herein.

 

15.6         No Modification.  This Agreement and and/or any Work Order or
Quality Agreement may be changed only by a writing signed by authorized
representatives of both parties.

 

15.7         Severability; Reformation.  Each provision in this Agreement is
independent and severable from the others, and no restriction will be rendered
unenforceable because any other provision may be invalid or unenforceable in
whole or in part.  If the scope of any restrictive provision in this Agreement
is too broad to permit enforcement to its full extent, then such restriction
will be reformed to the maximum extent permitted by law.

 

15.8         Governing Law.  This Agreement will be construed and interpreted
and its performance governed by the laws of the State of New York, USA, without
regard to any choice of law principle that would dictate the application of the
law of another jurisdiction.  The application of the 1980 United Nations
Convention on Contracts for the International Sale of Goods is hereby
specifically excluded.

 

15.9         Arbitration.  Any dispute which may arise between the parties in
relation to this Agreement shall be settled amicably between the parties.  If,
contrary to expectation, no amicable settlement can be reached, both parties
hereto agree to settle the dispute by arbitration in accordance with the
rules and regulations of the International Chamber of Commerce.  The number of
arbitrators shall be three, the seat of the arbitration shall be in New York,
New York, USA and the language that the proceedings are held in shall be
English.  The decision or award rendered by the arbitrator shall be final and
non-appealable, and judgment may be entered upon it in any court of competent
jurisdiction.

 

15.10       Waiver.  No waiver of any term, provision or condition of this
Agreement in any one or more instances will be deemed to be or construed as a
further or continuing waiver of any other term, provision or condition of this
Agreement.  Any such waiver, extension or amendment will be evidenced by an
instrument in writing executed by an officer authorized to execute waivers,
extensions or amendments.

 

15.11       Counterparts.  This Agreement may be executed in any number of
counterparts, each of which will be deemed an original and all of which together
will constitute one and the same instrument.

 

15.12       Headings.  This Agreement contains headings only for convenience and
the headings do not constitute or form a part of this Agreement, and should not
be used in the construction of this Agreement.

 

15.13       No Benefit to Third Parties.  The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the parties hereto and their successors and permitted assigns, and they will not
be construed as conferring any rights on any other persons.

 

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.

 

RADIUS HEALTH, INC.

LONZA SALES LTD

 

 

 

 

 

 

 

 

 

 

By:

/s/ B.N. Harvey

 

By:

/s/ Daniel Burgin / Y. Kesch

 

 

 

 

 

Print Name:

B. Nicholas Harvey

 

Print Name:

Daniel Burgin / Y. Kesch

 

 

 

 

 

Title:

CPO

 

Title:

Director Director Sales & BD / legal counsel

 

 

 

 

 

Date:

October 16, 2007

 

Date:

October 9, 2007

 

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APPENDIX A

SAMPLE WORK ORDER

 

THIS WORK ORDER is by and between RADIUS HEALTH, INC. (“RADIUS”) and [FULL
MANUFACTURER NAME] (“Manufacturer”), and upon execution will be incorporated
into the Development and Manufacturing Services Agreement between RADIUS and
Manufacturer dated [EFFECTIVE DATE OF AGREEMENT] (the “Agreement”).  Capitalized
terms in this Work Order will have the same meanings as set forth in the
Agreement.

 

RADIUS hereby engages Manufacturer to provide Services, as follows:

 

1.             API/Drug Substance and Product.

 

Describe the specific API/Drug Substance(s) and Product(s).

 

2.             Services.  Manufacturer will render to RADIUS the following
Services:

 

Describe the specific Services to be conducted by Manufacturer (summarize) or
attach Manufacturer’s proposal.  If Manufacturer Technology is to be
incorporated in any Manufacturing Process, expressly indicate that here.

 

3.             Facilit(ies).  The Services described above will be rendered at
the Facility unless another facility of Manufacturer is indicated below:

 

Include alternate Facility address(es).

 

4.             RADIUS Materials.  RADIUS will provide to Manufacturer the
following materials to be used by Manufacturer to perform the Services:

 

Describe specific materials being provided by RADIUS to Manufacturer.

 

5.             RADIUS Equipment.

 

Include any equipment that will be provided by RADIUS to Manufacturer to be used
by Manufacturer in performance of the Services.

 

6.             Manufacturer Representative.          Name and Title

 

7.             RADIUS Representative.                    Name and Title

 

8.             Compensation.  The total compensation due Manufacturer for
Services under this Work Order is INSERT WRITTEN AMOUNT (numerical amount). 
Such compensation will be paid INSERT PAYMENT SCHEDULE OR REFERENCE PROPOSAL. 
RADIUS and Manufacturer must agree in advance of either party making any change
in compensation.  Manufacturer will invoice RADIUS to the attention of INSERT
NAME for Services rendered under this Agreement.  Manufacturer will invoice
RADIUS for all amounts due under this Work Order.  All undisputed payments will
be made by RADIUS within thirty (30) days of date of invoice.

 

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9.             [Quality Agreement.  The provisions of the Quality Agreement,
attached hereto as Attachment 1, are incorporated herein by reference.]

 

All other terms and conditions of the Agreement will apply to this Work Order.

 

WORK ORDER AGREED TO AND ACCEPTED BY:

 

RADIUS HEALTH, INC.

 

LONZA SALES LTD

 

 

 

 

 

 

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

Print Name:

 

 

Print Name:

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

 

 

 

Date:

 

 

Date:

 

 

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