QUALITY AGREEMENT for the Manufacture of an application system pre-filled with abaloparatide in a solution, by and between RADIUS HEALTH, INC. and VETTER PHARMA-FERTIGUNG GMBH & CO. KG

“Appendix” shall mean an appendix attached to this QA.

“Complaint” shall mean a complaint received from a user, customer or any Authority regarding the Product.

“Deviation” shall mean, after final assessment of Vetter Pharma, any deviation which was planned to occur and/or that did occur during the Manufacture of the Product which (i) has not affected (“Minor Deviation”); (ii) may impact (“Major Deviation”); or (iii) impacts (“Critical Deviation”) the quality of the Product, as set forth in more detail in Article 11 of this QA.

“Facility” shall mean the warehouse and/or the manufacturing facilities of Vetter Pharma, used for the Manufacture and located in or near Ravensburg or Langenargen, Germany.

“Product” shall mean the Cartridge, the Pen and/or the Finished Product, as the context requires.

“QA” shall mean this quality agreement and its Appendices.

“QP” or “Qualified Person”, and “Vetter QP” and “Radius QP”, shall have the respective meanings as set forth in Article 8.

“Recall” shall mean actions taken by Radius to remove the Product from the market.

“Records” shall mean records supporting the documentation listed in Appendix 3 and all other Services performed hereunder.

“Regulatory Approvals” shall mean any and all approvals, consents, clearances, permissions and registrations to be obtained from the applicable Authority, and maintained, by Radius, for Vetter Pharma to Manufacture, and for use by Radius for commercial purposes, including use in clinical trials, or import, export, distribution, marketing, promoting or selling the Product.

Radius shall provide the Radius Materials to the Facility, together with any available manufacturers’ quality certificates, other data, documentation and/or information as may be required by law, any applicable Authority or as Vetter Pharma may reasonably request. Radius shall perform risk assessments for the Radius Materials, and Vetter shall perform risk assessments for the Vetter Materials, respectively, per the EU GMP Guidelines on the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use, according to Appendix 5. With respect to the Radius Materials, Vetter Pharma shall have performed, at the Facility, an incoming inspection in accordance with the Specifications.

As required by cGMP, Radius must audit the API manufacturing site, on a routine basis, to verify compliance with EU GMP Part II or ICH Q7; provided, however, Radius shall involve Vetter Pharma in the planning of such audits, the findings and the CAPAs, and Radius shall provide a copy of the audit report to Vetter Pharma (as well as a related GMP certificate for Vetter Pharma to be able to present to any Authority, as required).

Vetter Pharma shall provide the Vetter Materials, as well as all labour, materials and equipment (other than Radius Equipment) necessary to perform the Manufacture. The Vetter Materials shall be sampled in accordance with the SOPs, and inspected and tested in accordance with the Specifications, it being agreed that such testing shall be performed in accordance with validated test methods on qualified and calibrated equipment if such testing should be required. Upon completion of the inspection and testing and release by Vetter Pharma, such Vetter Materials may be used for the Manufacture. Any additional inspection or testing shall be subject to the prior written agreement by and between the Parties.

The Radius Materials and the Vetter Materials, and the processes associated with Manufacturing of the Product, shall be evaluated by Vetter Pharma in accordance with Appendix 5, to prevent cross contamination and to ensure compliance with TSE (transmissible spongiform encephalopathy) regulatory guidance (Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 current version)). New products or materials that are introduced into the Facility will be evaluated by Vetter Pharma in accordance with Article 10 below. On the basis of pharmacological and/or toxicological data of each new product introduced to the Facility, health based exposure limits shall be calculated, as required under the applicable EU GMP guidelines and Directives, and an evaluation and specification of measures for the manufacturing of the new product shall be performed. New products and materials introduced into the Facility will be processed and stored in compliance with SOPs, and cGMP. Vetter Pharma shall submit a change request for review and/or approval by Radius in accordance with Article 10 below, if any new product or material, which is outside of the matrix of existing products, will be introduced into the Facility, and if the equipment used for the manufacturing or processing of the new product or material will also be used for the Manufacturing or processing of the Product. Vetter Pharma does not manufacture beta-lactams, cephalosporins, cytotoxic compounds, pesticides and herbicides. For all new products introduced to the Facility, a risk assessment shall be performed on the basis of their pharmacological and/or toxicological properties, and suitable measures (e.g. containment) for the manufacturing of the new products shall be specified.

Radius shall keep Vetter Pharma informed of any Product-related requirements of the FDA and/or EMA (other than generally applicable requirements of cGMP), and/or any legislation, rules and regulations as well as practices of any Authority other than the FDA and/or EMA, including any changes in any of the foregoing requirements, including those pertaining to Radius Materials, which may reasonably be expected to affect the Product and/or the Services. Radius shall specifically inform Vetter Pharma of the effect of any such r

Radius and Vetter Pharma shall mutually agree upon the Specifications, written documentation of which shall be referred to in Appendix 2 and be signed by duly authorized representatives, respectively, of Radius and Vetter Pharma. Radius shall ensure that the Specifications comply with the Regulatory Approvals and that the Product complies with Applicable Laws.

Changes to the Specifications requested by Vetter Pharma or Radius shall be subject to the change control procedures set forth in this QA and in the SOPs. Any changes to the Specifications shall be approved by Radius and Vetter Pharma in writing prior to implementation.

Vetter Pharma agrees to Manufacture the Product in accordance with the Standard, including as described in Appendix 5. Radius shall provide Product-specific technical support as required. Radius may, subject to the Regulatory Approvals, use the Product in clinical trials or for commercial purposes (including trade or samples); provided, however, such Product conforms to the Specifications, cGMP and the other requirements as set forth in this QA, including as in the preceding sentence.

Radius shall provide Vetter Pharma with the information necessary to identify or determine the shelf-life and expiry date applicable to each Batch which information shall be set forth or referred to in Appendix 2.

Any special request of Radius for re-packaging, re-labeling, or similar services, in respect of the Product shall be accepted by Vetter Pharma in writing, subject to prior agreement by and between the Parties clarifying the technical conditions and related issues.

Each Party shall store and transport the Radius Materials, the Vetter Materials, the Product and samples of any thereof, as set forth in the Specifications.

For each Batch of the Product, Vetter Pharma shall provide Radius with electronic copies of the documentation as set forth in Appendix 3. Upon prior written request, Vetter Pharma shall provide Radius with copies, preferably in the form of electronic documents, of the underlying Records supporting the documentation listed in Appendix 3. Vetter Pharma shall provide English translations of German documents at Radius’ request. These supporting documents shall also be made available for review by Radius or any Authority, during normal business hours, at the Facility.

Vetter Pharma shall take and keep reference samples from each Batch of Cartridges (filled and visually inspected) as set forth in the separately and mutually agreed sampling plan, all in accordance with the Specifications. Such reference samples are kept for each Batch of Cartridges, for at least [*] past the expiration date of the Product, and in quantity allowing for at least two (2) complete re-analyses of the Product. Vetter Pharma shall take and keep reference and retention samples from each Batch of Finished Product as required by cGMP. Such retention samples are kept for each Batch of Finished Product, for at least [*] past the expiration date of the Finished Product and in quantity allowing for at least two (2) complete re-analyses of the Finished Product.

Vetter Pharma shall have the right, but not the obligation, to take and keep samples from each Batch of the Product (for example for investigation, request from Authorities, etc). If Vetter Pharma should decide to take such samples, Vetter Pharma shall inform Radius thereof in writing.

Vetter Pharma shall maintain the Records for at least [*] unless a longer retention period is required by Applicable Law. Vetter Pharma shall notify Radius at least [*] calendar days prior to any destruction of such records listed in Appendix 3. Radius may request in writing, within [*] calendar days after receipt of such notification from Vetter Pharma, that the records shall be sent to Radius. If Vetter Pharma does not receive any such written request within such time period, after confirmed receipt at Radius, such records may be destroyed.

A qualified person (“Qualified Person”, or “QP”) of Vetter Pharma shall, in accordance with EU GMP Volume 4 Annex 16, confirm that the Batch of the Product has been Manufactured in accordance with cGMP and the Specifications, in accordance with SOPs, that is subject to audit by Radius. Such QP (also, “Vetter QP”) shall issue a Certificate of Conformity in accordance with the latest version of Appendix 1 of Annex 16, and shall make sure that the Product is Released, to Radius.

Then Radius shall review the Records listed in Appendix 3 that are pertinent to the Product and any other records relevant to the Product that Radius shall require to complete its review, and Radius shall perform the final certification and release of the Product for the purposes intended by Radius. No Product shall be Released until all testing required by the Specifications has been successfully performed.

If required by cGMP, the QP of Radius (also, “Radius QP”) shall certify Batches, after review of the Records and any other documentation, and Release confirmation by the Vetter QP. Shipment ([*] )of Product intended for markets requiring release by a QP shall occur after certification has been provided by the Radius QP. Shipment ([*])of Product prior to certification by the Radius QP may be performed for individual Batches on an exceptional basis, in accordance with a protocol, or SOPs, that is approved by both the Vetter QP and the Radius QP.

Shipment ([*])of the Product, and/or samples thereof, from the Facility by Radius, shall be in accordance with the Supply Agreement.

Radius shall have the right to conduct inspections of such areas of the Facility used for the Manufacture, upon reasonable written notice and during normal business hours, [*], which inspection shall not exceed the duration of [*] business days, except in the event of any critical concern with respect of the quality of the Product. All audit teams of Radius, each member of which shall explicitly be bound in writing by confidentiality obligations at least as restrictive as those agreed in the Supply Agreement, shall at all times be accompanied by members of the Facility personnel and not be divided into more than[*].

Vetter Pharma shall permit Radius (or its agents, subject to the obligations of Section 9(1) of this QA), to the extent not prohibited by Applicable Law, to be present and participate in any pre-approval inspection by any Authority of the Facility or the Manufacturing Process, to the extent any such inspection relates to the Product (and is not a general cGMP audit of the Facility, even if such general cGMP inspection also relates to the Product); provided, however, such presence shall be limited to presence in the inspection room during the initial discussion, daily wrap-up discussions and the final discussions. Vetter Pharma shall give as much advance notice as possible to Radius of any such pre-approval inspection.

Vetter Pharma shall provide Radius with 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 product, the Facility or the Manufacturing Process to the extent any such communication relates to the Product (and is not generally related to cGMP, even if such communication generally related to cGMP inspection also relates to the Product but does not impact Product quality), within [*] business days after receipt. The Parties shall consult each other in an effort to arrive at a mutually acceptable answer to any such communication or request or procedure for taking other

Radius shall not submit documents to any Authority with respect to the Services performed at the Facility without prior review by Vetter Pharma; provided, however, that if Vetter Pharma does not provide comments within [*] business days of receipt thereof from Radius, or within a longer, but reasonable period, requested in writing by Vetter Pharma within such initial [*] business day period, as may be reasonably required to evaluate facts as may be necessary to provide such comments, Radius may submit such documents. The Parties shall assist each other in responding to any questions or other requests from any Authority with respect to the Product or the Manufacture and shall provide reasonably required information or data within adequate timelines, but in no event later than requested by such Authority. Upon receipt of any such information, the Parties shall consult each other in an effort to arrive at a mutually acceptable answer to such question or request or procedure for taking other appropriate action; provided, however, that nothing contained herein shall be construed as restricting the right of either Party to make a timely report of such matter to any Authority or take other action that it deems to be appropriate or required by Applicable Law. Each Party shall have the right to disclose any such information to an Authority to the extent reasonably required or requested by such Authority in connection with a filing, inspection or otherwise; provided, however, Radius agrees not to submit information, such as documents or data to any Authority with respect to[*], without prior review and written approval of Vetter Pharma, all to the maximum reasonable extent while in compliance with said legal requirement and the provisions of this QA.

Vetter Pharma shall use a documented system of procedures for the control of changes to the Vetter Materials, the Radius Materials, the Equipment, the Facility, the Manufacturing processes, the Specifications and/or to suppliers that could affect the Product. Any and all such changes that may affect or that do affect the Product quality or requiring submission to a Authority shall be reviewed and approved in writing by Radius and Vetter Pharma prior to implementation. Unless otherwise agreed in writing, Radius and Vetter Pharma shall, respectively, respond to the other Party on a change request within [*] business days. Vetter Pharma shall not unreasonably withhold its approval of changes requested by Radius; provided, however, Vetter Pharma may take into account such factors as capacity of the Facility, technical capability, production commitments and similar business factors. Radius shall not unreasonably withhold its approval of changes requested by Vetter Pharma; provided, however, Radius may take into account cGMP, prior commitments to Authorities, any applicable legislation, rules and regulations, implementation and compliance costs, submission requirements to Authorities and any other information that is pertinent to an objective assessment of the proposed change.

Changes, to the Master Batch Record that may affect or that do affect the quality of the Product or the Specifications or requiring submission to a Authority, shall be translated into the English language, communicated to Radius in writing and shall require written approval of each of the Parties prior to implementation. All other changes to the Master Batch Record shall be communicated to Radius in writing at least [*] business days prior to the change being effective. If Radius objects to Vetter Pharma’s impact assessment, Radius will have [*] business days to respond in writing. A summary of changes made during the review period shall be made when providing the Annual Product Quality Review. The requirements of the change control process shall not apply to the following types of changes, because these are not relevant to GMP:

Correction of typing errors and grammar

Adaptation of page and line breaks

Adaptation of part designations and Master Batch Record page header regarding pharmaceutical non-relevant information, e.g. Radius product codes

Adaptation of layout without changes of position numbers

Amendments regarding information documented in the Batch record but not pre-defined in the Master Batch Record, e.g. existing definitions multiplied such as stamping fields to document the sterilization

Replacement of alphanumeric SOPs’ numbers with the current five-digit SOPs’ numbers

Vetter Pharma shall have no obligation to follow the foregoing change control procedures in the event that the Product is not Manufactured at the Facility for more than[*]. If the Product is not Manufactured for more than[*], the Manufactring process will be re-evaluated according to SOPs, and the updated Specifications shall be approved by the Radius QP prior to any subsequent Manufacture. Any dispute regarding a change shall be settled in accordance with the Supply Agreement.

Solely with respect to any Product-related re-qualification of processes, packaging, analytical methods, cleaning and equipment, Radius and Vetter Pharma shall mutually agree upon a documented re-qualification process to achieve compliance with cGMP and the responsibilities set forth in Appendix 5. Radius shall review and approve such documentation within [*] business days of any written request to do so. The respective documentation will be provided by Vetter Pharma to Radius in English.

The suppliers of Vetter Materials shall at appropriate intervals be re-qualified by Vetter Pharma as required by cGMP. Such re-qualification shall be performed in accordance with the applicable methods listed in the Specifications, and shall include a full testing of the Vetter Materials by an external laboratory or other qualified third party. Upon request by Radius, Vetter Pharma shall provide results of such re-qualification. Changes in the approval status of the suppliers shall be provided by Vetter Pharma to Radius.

The Parties shall mutally agree on the reporting period for the APQR. Vetter Pharma shall provide the approved APQR report to Radius no later than [*] calender days following expiration of the preceding reporting period; provided, however, if changes to such report should be required, Vetter Pharma shall issue one updated version. Prior to issuance of the APQR report, Radius may request data or other information that will be referenced in the report.

The layout and structure of the respective report shall be in accordance with the SOPs, including, but not limited to, the following categories of information to be evaluated and reported:

Summary of all Batches Manufactured during review period (including rejected, reworked, and reprocessed lots)

Summary of any changes pertaining to the Product and process including Master Batch Records, Product-related processing equipment, Manufacturing area, chemical and microbiological test methods, in-process controls, visual inspection, packaging materials, raw materials

Summary of Major Deviations and Critical Deviations investigations including corrective and preventive actions taken

Summary of the Continued Process Verification (CPV), which includes a review of critical in-process controls and Product results

A review of all Batches, Manufacture of which failed to meet the Standard, and their investigationQualification status of relevant major Product-related equipment and utilities information applicable during review period

Summary of stability studies results

Summary of quality-related complaints and recalls and the investigations then performed

A review of the provisions of this QA to ensure up-to-date status

Summary of visual inspection of reference samples

Statement that “All these data prove that the Manufacture of the Product is in compliance with the current Good Manufacturing Practices as described in Parts 210/211 of Title 21 of the Code of Federal regulations and in the EU-GMP-Guides”

Any Product intended by Radius to be registered, marketed, sold, used and/or shipped to the United States of America shall comply with the requirements regarding combination products, as referred to and set forth in the Code of Federal Regulations (also, “CFR”). As the sponsor, it is the responsibility of Radius to ensure any such overall compliance. Radius shall have all required documents, processes and systems in place required to ensure any such compliance.

Vetter Pharma shall support Radius in the efforts of Radius demonstrating Radius’ compliance with the Applicable Laws relating to combination products, by Vetter Pharma maintaining certain procedures and systems as applicable to the Manufacture, as set forth in Appendix 5. Radius shall, during its regular audits, review the suitability and effectiveness of such procedures and systems.

To enable Vetter Pharma to provide such assistance, Radius shall provide Vetter Pharma with all information required and/or reasonably requested by Vetter Pharma.

In accordance with section 4.4(a) of 21 CFR Part 4, the quality requirements under the Code of Federal Regulations for co-packaged and single-entity combination products, which each of the Parties agrees is applicable to the Product, can be satisfied by Radius in one of two ways:

Under section 4.4(a)(1), a manufacturer can demonstrate compliance with each applicable regulation in its entirety (e.g., with all of the drug cGMPs and the QS regulation, for a drug-device combination product);

under section 4.4(a)(2), if the combination product is subject to the drug cGMPs and QS regulation, these two sets of requirements can be met by demonstrating compliance with (1) either the drug cGMPs or QS regulation; or (2) those provisions specified in section 4.4(b) from the other of these two sets of regulations.

It is hereby agreed by and between the Parties that the Product shall be Manufactured at the Facility of Vetter Pharma in accordance with the Standard, which includes the Specifications. Radius shall ensure that the Specifications are and shall be in accordance with the provisions of 21 CFR Part 4, section 4.4(a)(2) and therefore comply with cGMP and with the provisions of the QS regulation of 21 CFR Part 820 to the extent necessary to comply with subsection 4.4(b)(1) of 21 CFR Part 4.

(signed) /s/ Afshin Hosseiny        

Name: Dr. Afshin Hosseiny

Title: Qualified Person

(signed) /s/ Oliver Kurz        

Name: Oliver Kurz

Title: Vice President Quality Assurance

Declaration of conformity “For Human Use”

Analysis certificate regarding the Product analysis (transferred from change to commercial)

Deviation reports with Batch reference

List of all Minor Deviations, Major Deviations, and Critical Deviations, with Batch reference, in table format, and planned Deviations

Complete copy of the Manufacturing Records, including in-process-control Batch reports

Declaration of conformity “For Human Use”

Analysis certificate regarding the Product analysis (transferred from change to commercial)

Deviation reports, with Batch reference

List of all Minor Deviations, Major Deviations, and Critical Deviations, with Batch reference in table format, and planned Deviations

Material parts list, for each stage of Manufacture

Yield calculation, for each stage of Manufacture

Records of the weighing system

In-process-control Batch reports

Overall reconciliation of visual inspection rejects by type and the AQL random-sample check of visual inspection

Cold-chain documentation for 2–8°C Products, if a specification of the total interruption time has been agreed upon in a separate written document and is available