Document:

Exhibit 10.1

 

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

 

WORK ORDER NO. 4

 

THIS WORK ORDER NO. 4 is by and between RADIUS HEALTH, INC. (“RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”), and upon execution will be incorporated into the Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (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.

 

BA058

 

Peptide Sequence:  H-Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH2

 

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

 

Manufacturer will perform activities required for RADIUS’ filing of a new drug application (“NDA”) in the United States with the FDA and similar applications required by the European Medicines Agency (EMEA) and other Authorities, excluding authorities in Japan, for BA058 including, but not limited to, production of three (3) validation Batches.  These activities will provide for full process qualification and process validation and all required documentation necessary for regulatory submissions of the NDA to the FDA and the NDA equivalents to other Authorities.

 

Such work will be performed in accordance with Exhibits A and B of this Work Order plus such additional requirements as discussed below.  The Services are identified in terms of a particular numbered activity (each, an “Activity”).  All Services under this Work Order, including Manufacture of any Batches, will be conducted in compliance with standards suitable for an NDA filing by RADIUS.  All Batches will be Manufactured in compliance with cGMP, will conform to Specifications provided to Manufacturer prior to commencement of the applicable Batch, and the other requirements of the Agreement and this Work Order.  Except for Activities 1 and 6, Manufacturer will not proceed to a subsequent numbered Activity until it provides a report to RADIUS with the status of and results of the prior numbered Activity and RADIUS provides Manufacturer with written authorization to proceed to the next Activity.

 

Activity 1: Development Work: The objective for this Activity is to define the best conditions for the preparation of the BA058 peptide.  As a first step, Manufacturer will identify which parameters have influenced the unexpected high yield in the C2 campaign.  In addition, Manufacturer will investigate the chemistry to ensure repeatability/reproducibility of such results. The criteria to be evaluated and the deliverables to be provided are as set forth in Section 4 of Exhibit B.

 

Activity 2: Pre-qualification activities: Manufacturer will challenge the parameters identified as critical as a result of the performance of Activity 1 and identify working ranges for the parameters to ensure a robust process for upstream and downstream activities.  In addition, the studies identified in Section 5 of Exhibit B will have to be conducted on different steps of the process in order to define “holding points”.  If conducted on any intermediate products, all stability studies conducted by Manufacturer will be

 

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

 

1

 

conducted in accordance with the Manufacturer generated stability protocol to be approved by RADIUS in writing.

 

Activity 3: Qualification Campaign:  Manufacturer will not commence this Activity without the prior written consent of RADIUS.  Manufacturer will Manufacture a qualification Batch at a purification scale of NPW (net peptide weight) selected by RADIUS from the table in Exhibit A; however, the assembly and cleavage reaction that will lead to the crude will be performed at a scale of 180g NPW equivalent. The Batch will be Manufactured in a 20L SPPS reactor. An amount identified by RADIUS out of the crude that was Manufactured will be purified on an LC150 HPLC column and lyophilized in a GT10 lyophilizer. The excess of crude will be stored and will be purified by Manufacturer, if so requested by RADIUS in writing (“Additional Purification”). These activities are further described in Section 6 of Exhibit B.

 

Activity 4: Qualification Stability : Manufacturer will perform a stability study from samples of the Product Manufactured pursuant to Activity 3 in accordance with ICH requirements and the time points required by ICH requirements (at a minimum, the following time points:  0, 3, 6, 9, 12, 18, 24, 36 months). The study will be performed according to a stability protocol to be generated by Manufacturer and approved by RADIUS in writing.

 

Activity 5: Pre-validation activities:  Based on pre-qualification Batches (C1 and C2 which were previously Manufactured) and the qualification Batch (C3 — still to be produced), Manufacturer will prepare and deliver the reports and protocols identified in Section 8 of Exhibit B.

 

Activity 6: Analytical Methods Validation: Manufacturer will validate the analytical methods identified in Section 9 of Exhibit B and provide reports on the analytical methods. These Services described in this Activity will commence immediately. Completion dates are planned to allow the qualification Batch described in Activity 3 to be tested with the required methods validated in this Activity.  In any event, all methods will be validated before the commencement of Activity 7.

 

Activity 7: Validation Campaign:

 

Manufacturer will Manufacture and release three (3) Batches of Product at a scale of NPW (net peptide weight) selected by RADIUS from the table in Exhibit A; however, the assembly and cleavage reaction that will lead to the crude will be performed at a scale of 180g API equivalent. Manufacturer will commence Manufacture of a Batch only with the prior written consent of RADIUS.  The excess of crude will be stored and Additional Purification will be performed by Manufacturer, if so requested by RADIUS in writing. These activities are further described in Section 10 of Exhibit B.

 

Activity 8: Validation Reports:   Manufacturer will provide the following reports:

 

·                                          Upstream process validation reports

·                                          Downstream process validation report

 

Activity 9: Validation Stability: Manufacturer will perform a stability study from samples of the Product Manufactured pursuant to Activity 7 in accordance with ICH QIA requirements and the time points required by ICH requirements (at a minimum, the following time points:  0, 3, 6, 9, 12, 18, 24, 36 months). The study will be performed in according to a stability protocol to be generated by Manufacturer and approved by RADIUS in writing.

 

Activity 10: DMF Filing:  Manufacturer will prepare, submit to applicable Authorities identified by Radius, or to Radius for submission, and manage the Drug Master File (DMF) using information about processes, equipment, facilities, qualifications, controls and as needed.  Manufacturer will provide the DMF to Radius for review and approval prior to submission.

 

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

 

2

 

For each Batch of Product Manufactured under this Work Order, Manufacturer shall Manufacture, in accordance with cGMP and the Manufacturing Process, enough crude to yield 180 grams (or such other amount specified by Radius in writing) of Product.

 

The above requirements, including the yield requirements, and any additional requirements that are agreed by the parties as contemplated above, shall be deemed part of the Specifications for the Product for purposes of the Agreement.

 

a)                                                  Manufacturer will commence performance of this Work Order by the week of January 2, 2012. The deliverables will include regular updates (status reports, conference calls), as requested by RADIUS.   Release specifications will be provided by Radius, which for clarity shall be deemed part of the Specifications for the Product for purposes of the Agreement. Modifications may be required, as the development status changes, and shall be agreed by the parties in writing.

 

b)                                                 In the activities identified above, which may include Manufacturing Processes, Manufacturer Technology may be incorporated with the prior written consent of RADIUS.

 

c)                                                  A project team will be formed which will work closely with the team at RADIUS. The project team will include technical project leaders as well as the appropriate QC, QA, and Regulatory personnel. Communications with RADIUS will include teleconferences as needed.  Audits of the manufacturing plants and general customer visits may be scheduled as needed.

 

d)                                                 For further details, please refer to Exhibits A and B attached hereto.

 

3.                                      Completion:  Manufacturer will use commercially reasonable efforts to complete the Services no later than the following:

 

	
Activity   1: Development Work
    	
 
    	
Week   of March 19, 2012
    
	
Activity   2: Pre-qualification activities
    	
 
    	
Week   of May 28, 2012
    
	
Activity   3: Qualification Campaign
    	
 
    	
Week   of June 29, 2012
    
	
Activity   4: Qualification Stability
    	
 
    	
Stability   study to start by July 31, 2012 and continue according to protocol
    
	
Activity   5: Pre-validation activities
    	
 
    	
Week   of Sept 24, 2012
    
	
Activity   6: Analytical Methods Validation
    	
 
    	
Week   of May 30, 2012
    
	
Activity   7: Validation Campaign (Batch #1-3)
    	
 
    	
Batch   #1 and #2: Week of Dec 26, 2012. Batch #3: Week of Feb 11, 2013 (or 2 weeks   earlier, if small quantity has been requested).
    
	
Activity   8: Validation Reports
    	
 
    	
20   working days after completion of Validation Batch #3, or 20 days from date   requested by RADIUS
    
	
Activity   9: Validation Stability
    	
 
    	
Stability   study to start within one month of batch purification and continue according   to protocol
    
	
Activity   10: DMF Filing
    	
 
    	
Within   40 working days of date requested by RADIUS, but not earlier than 3.5 months   after the end of the Validation Campaign.
    

 

4.                                      Facilities.  The Services described above will be rendered at the Facility unless another facility of Manufacturer is indicated below:

 

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

 

3

 

Lonza S.A., Chausée de Tubize 297, B-1420 Braine l’Alleud, Belgium

 

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

 

None

 

6.                                      RADIUS Equipment.

 

None

 

7.                                      Manufacturer Representative.

 

Raimund Miller, Director, Sales and Business Development, Lonza Custom Manufacturing

 

8.                                      RADIUS Representative.

 

Louis Brenner, Senior Vice President and Chief Medical Officer

 

9.                                      Compensation.  The total compensation due Manufacturer for Services under this Work Order will not exceed €363,500 plus the applicable charges for Activities 3 and 7, as shown in Exhibit A.  The reduced prices for validation Batch #2 and #3 will apply, if validation Batches can be Manufactured simultaneously. The fees for the performance of the Activities described above are set forth below.

 

	
 
    	
 
    	
€
    
	
Activity   1: Development Work
    	
 
    	
[*]
    
	
Activity   2: Pre-qualification activities
    	
 
    	
[*]
    
	
Activity   3: Qualification Campaign
    	
 
    	
See   Exhibit A
    
	
Activity   4: Qualification Stability
    	
 
    	
[*]
    
	
Activity   5: Pre-validation activities
    	
 
    	
[*]
    
	
Activity   6: Analytical Methods Validation
    	
 
    	
[*]*
    
	
Activity   7: Validation Campaign, Batch #1-3
    	
 
    	
See   Exhibit A
    
	
Activity   8: Validation Reports
    	
 
    	
[*]
    
	
Activity   9: Validation Stability
    	
 
    	
[*]
    
	
Activity   10: DMF Filing
    	
 
    	
[*]
    

 

In addition, the prices for the Additional Purification, as described in Activity 3 and 7, are identified in Exhibit A.

 

To the extent that a regulatory approval process is substantially different from FDA or EMEA and requires additional effort as part of Activity 10, an additional fee may apply as may be agreed to in writing by the parties.

 

Invoicing: Compensation will be paid  in installments  as follows: Twenty percent (20%) of the fee listed above for an Activity (or in the case of Activity 3 and 7, the applicable Batch or Additional Purification) will be invoiced upon commencement of such Activity; the remaining fee for the Activity will be invoiced upon completion of all Services for such Activity including, but not limited, delivery to RADIUS of the resulting material, if applicable.

 

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

 

4

 

Expenses: Radius will be invoiced €22,500 for a stationary phase of an HPLC column used by Manufacturer in the Manufacture of the Product. This stationary phase will become the property of Radius upon payment to Manufacturer of the applicable invoice.

 

General: RADIUS and Manufacturer must agree in advance of either party making any change in the compensation due hereunder. Manufacturer will invoice RADIUS to the attention of Nick Harvey, SVP and CFO, 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 receipt of invoice.

 

10.                               Insurance will be provided as required by the Agreement.

 

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   
    	
/s/   Nick Harvey
    	
 
    	
By   
    	
/s/   Rachel Corder
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Print   Name
    	
Nick   Harvey
    	
 
    	
Print   Name 
    	
Rachel   Corder
    
	
Title
    	
CFO
    	
 
    	
Title   
    	
Senior   Legal Counsel
    
	
Date
    	
December 22,   2011
    	
 
    	
Date   
    	
December 23,   2011
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
By   
    	
/s/   John Eley
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Print   Name 
    	
John   Eley
    
	
 
    	
 
    	
Title   
    	
Legal   Counsel
    
	
 
    	
 
    	
Date
    	
December 23,   2011
    
								

 

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

 

5

 

Exhibit A

 

Pricing for Activity 3 and Activity 7

 

Pricing is identified below for several options which Radius may elect for the Activities identified below.

 

Activity 3, Qualification Campaign

 

	
 
    	
 
    	
First Purification (after synthesis at a scale of
   180g NPW equivalent)
    	
 
    	
Additional
   Purification
    	
 
    
	
 
    	
 
    	
50g
    	
 
    	
100g
    	
 
    	
150g
    	
 
    	
180g
    	
 
    	
50g
    	
 
    
	
Qualification Batch
    	
 
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    
	
per gram
    	
 
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    	
€
    	
[*
    	
]
    

 

Activity 7, Validation Campaign

 

	
 
    	
 
    	
First Purification (after synthesis at a scale of 180g NPW
    equivalent)
    	
 
    	
Additional
   Purification
    	
 
    
	
 
    	
 
    	
50g
    	
 
    	
100g
    	
 
    	
150g
    	
 
    	
180g
    	
 
    	
50g
    	
 
    
	
Validation Batch #1
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    
	
per gram
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    
	
Validation Batch #2
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    
	
per gram
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    
	
Validation Batch #3
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    
	
per gram
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    	
 
    	
€
    	
[*
    	
]
    

 

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

 

6

 

Exhibit B

 

Proposal

RADIUS

Product: BA-058

(Lonza Code: RDS-001)

Proposal for Pre-Validation and Validation Activities (Regulatory Roadmap)

(Version 1.7)

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

 

7

 

 

PROPOSAL

 

RADIUS

 

Product: BA-058

 

(Lonza Code: RDS-001)

 

Proposal for Pre-Validation and Validation Activities

 

[Regulatory Roadmap]

 

Version 1.5

 

July 20, 2010

 

September 29, 2010

 

October 6, 2010

 

October 13, 2010

 

October 18, 2010

 

October 25, 2010

 

October 18, 2011 (version 1.5)

 

October 21, 2011 (version 1.6)

 

December 05, 2011 (version 1.7)

 

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

 

8

 

CONFIDENTIAL

 

CONFIDENTIAL

 

This proposal contains information proprietary to Lonza Sales AG, and must not be copied or otherwise distributed other than for the purpose of review by RADIUS in accordance with the terms of our existing CDA.

 

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

 

9

 

	
Company: RADIUS
    	
 
    	
 
    	
 
    	
From:
    	
 
    	
Raimund   Miller 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Paul   Tastenhoye
    
	
To:   
    	
 
    	
 
    	
 
    	
Date: Oct.18,   2011
    	
 
    	
 
    
	
Maria Grunwald, PhD
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
E-mail:  
    	
 
    	
 
    	
 
    	
Page(s): 10
    	
 
    	
 
    
	
mgrunwald@radiuspharm.com
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Subject: Regulatory Roadmap
    	
 
    	
 
    	
 
    	
Copy:
    	
 
    	
 
    

 

Dear Maria,

 

On behalf of Lonza, we are pleased to provide you with our proposal for Pre-Validation and Validation Activities [Regulatory Roadmap] for your BA-058 (Lonza Code: RDS-001).

 

We would like to thank you for giving us the opportunity to quote for these activities. We sincerely hope that this proposal will win your confidence, as Lonza is highly committed to meet your requirements to the fullest extent.

 

Kind regards,

 

	

    	
 
    	

    
	
 
    	
 
    	
 
    
	
Raimund Miller
    	
 
    	
Eric   Bironneau
    
	
Director, Sales & BD
    	
 
    	
Head   of Business Development - Peptides
    
	
Lonza Inc.
    	
 
    	
Lonza   Sales Ltd.
    
	
Lonza Custom Manufacturing
    	
 
    	
Lonza   Custom Manufacturing
    

 

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

 

10

 

1) Introduction

 

The quotation provided herewith covers all activities which are required prior to NDA filing of the BA-058 peptide; these activities are in addition to the two development campaigns, C1 and C2 (50 g and 300 g respectively), which were already run and which supported Radius’ product requirements for Ph II and Ph III clinical trials. These regulatory road-map activities comprise the following steps:

 

·                  Development work

·                  Pre-qualification activities

·                  Qualification campaign at 50g NPW scale

·                  Pre-validation documentation

·                  Analytical methods validation

·                  Validation campaigns - 3 batches at 50g NPW scale

·                  Post-validation documentation

·                  Master validation report

·                  DMF Filing

 

2)  Peptide Sequence

 

H-Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH2

 

3)  Assumptions / Remarks

 

·                  The prices quoted are based on the yields and results obtained in the C2 campaign produced in 2010.

·                  The full SPPS strategy is the only strategy considered.

·                  The chemical assembly/cleavage process will be followed by two HPLC purifications (primary and secondary purifications) in order to meet the customer specifications. As a consequence, an expected final HPLC purity of the API > 97% will be obtained (by the FG1 method).

·                  Raw material prices: standard 2012 raw material prices were used in the cost calculations.

 

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

 

11

 

4)  Development Work (all quotations are in Euros €; (pro memoriam, as of Oct.14, ’11, the US $ / € exchange rate was 1.38)

 

·                  Objective: Define the best conditions for the preparation of BA-058 peptide.

 

First of all, Lonza will have to define clearly which parameters have influenced the unexpected high yield in the C2 campaign. Moreover, Lonza needs to investigate the chemistry to ensure repeatability / reproducibility of such results for future campaigns. Various criteria will have to be evaluated.

 

1.               Concerning raw materials:

 

·                  In order to achieve the same quality for future campaigns, Lonza will have to test different resin suppliers and qualify at least two of them.

·                  Specifications of the starting resin should then be modified in order to fit the defined parameters.

 

2.               Concerning process, Lonza will have to challenge the different steps.

 

·                  Loading:

 

a)             use of preloaded resin or in-house loading?

b)            working range of loading. It has to be defined in terms of productivity and quality of the resulting crude material.

 

·                  Assembly:

 

a)             Identification of critical impurities in the crude coming from mono deletion or double addition. This analysis will be performed based on impurities present in C1 and C2 materials.

 

·                  Cleavage:

 

a)             Define the best conditions of cleavage in order to minimize impurities linked to this step (almost 15% HPLC area for two impurities formed during this cleavage step).

 

·                  Purification:

 

a)              Assessment of the potential impact of upstream development work on the purification process.

b)             Development of UPLC method for in process control corresponding to FG1 method (analysis time reduction).

 

·                  Deliverables:

 

Upstream (7 to 8 weeks)

 

·                  Development work - experimental part     € [*]

·                  Process development report — Compilation of the process knowledge (C1, C2, and development work)   € [*]

 

Downstream (2 to 3 weeks)

 

·                  Development work - experimental part   € [*]

·                  Process development report — Compilation of the process knowledge (C1, C2, and development work) € [*]

 

In order to reach Radius target in terms of price and timing, it has been decided to reduce tests performed during this development work.

 

Quotation for development activities (in Euros €):  € 50,000 (Breakdown: see quotation for each activity; duration: almost 2.5 months with activities performed in parallel).

 

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

 

12

 

5) Pre-qualification Activities

 

·                  Objective: ensure we have a robust process by challenging parameters defined as critical for both upstream and downstream.

 

In order to ensure we have a robust process before running the qualification campaign, parameters defined as critical will have to be “challenged” in order to obtain a suitable working range for these parameters. Moreover, some stability studies will have to be conducted on different steps of the process in order to define “holding points”, such as:

 

For upstream part (2 weeks)     price € [*]

 

a)              stability of the peptide resin

b)             stability of the crude in neat TFA

c)              stability of the crude during evaporation step

d)             stability of the crude after precipitation

e)              stability of the crude during drying step

f)                stability of the crude upon storage, etc...

 

For downstream part (3 weeks)   price € [*].

Potential critical parameters such as column loading, gradient, chemical stability of fractions in purification and peptide concentration, tray volume, powder homogeneity in lyophilization will have to be assessed and challenged.

 

·                  Deliverables (4 weeks):

 

Upstream   € [*]

 

·                  Qualification parameter protocols

·                  Qualification parameter - experimental part

·                  Qualification parameter reports

·                  Definition of critical parameters Upstream

·                  Parameter List

·                  Robustness Testing

 

Downstream € [*]

 

·                  Qualification parameter protocols

·                  Qualification parameter experimental

·                  Qualification parameter reports

·                  Definition of critical parameters Downstream

·                  Parameter List

·                  Robustness Testing

 

Quotation for pre-qualification activities (in Euros €):  € 80,000 (Breakdown: 37.5% upstream, 62.5% downstream; duration: 9 weeks with activities performed in parallel).

 

By reducing development work, less experiment needed for this part of the roadmap.

Costs have been decreased accordingly.

 

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

 

13

 

6) Quotation for Qualification Campaign at 50g NPW scale (in Euros)

 

·                  Objective: Qualify the parameters defined as critical for both upstream and downstream for the preparation of BA-058 peptide.

 

Lonza will run the qualification campaign at a scale of 50g NPW; however, the assembly and cleavage reaction that will lead to the crude will be performed at a scale of 180g API equivalent, since this is the minimum scale at which the process can be validated later. The assembly will be performed in a 20L SPPS reactor. Only part of the crude (50g NPW out of 180g NPW) will be purified on an LC150 HPLC column and lyophilized in a GT10 lyophilizer. The excess of crude will be stored and can be purified later. Excellent 18M stability data of the crude are currently available.

 

The price is given for the first 50g NPW production (including the full cost of the crude at a scale of 180g NPW  API equivalent), as well is for the later processing of the excess crude (without crude processing cost and per 50g NPW API):

 

	
Quotation
    	
 
    	
First 50 g
   NPW
    	
 
    	
50 g Price
   without cost
   of crude
    	
 
    	
First
    100 g
   NPW
    	
 
    	
First 150g
   NPW
    	
 
    	
Full 180g
   NPW
    
	
Raw Materials
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*]
    
	
Production:
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
·      Crude (at scale of 180 g API equivalent)
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*]
    
	
·       Purification and Lyophilisation
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*]
    
	
QC/QA Release
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*]
    
	
Total   Quote
    	
 
    	
217,000
    	
 
    	
99,500
    	
 
    	
243,000
    	
 
    	
264,000
    	
 
    	
274,500
    
	
Price /   g
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*]
    

 

·                  Lead time: 14 weeks

·                  Deliverables: see point 8

·                  Following Lonza SOP a Development Manufacturing Report will be issued after qualification, considered as engineering batch. In case of no change between this batch and validation batches, this is possible after an equivalency report to use this batch as commercial supply. Moreover, this batch may be use for clinical trials as far as API specifications are met, as for C1 and C2 campaigns material.

 

7) Qualification stability: 0, 6, 12, 24, 36 months

 

€ 21,600

 

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

 

14

 

8) Pre-validation Activities

 

·                  Objective: prepare validation campaigns

 

·                  Deliverables:

 

·                  Update Process development report — Compilation of the process knowledge (pre-qualification and qualification batch)

·                  Master validation protocol

·                  Upstream and Downstream process validation protocols

 

·                  Cost:

 

·                  Process development report upstream

·                  Master validation protocol

·                  Upstream process validation protocol

 

·                  Process development report downstream

·                  Downstream process validation protocol

 

Quotation for pre-validation activities (in Euros €):  € 30,000

 

·                  Expected time needed: ± 20 working days (upstream and downstream activities in parallel).

 

9) Analytical Methods Validation

 

·                  These activities should start at least 6 months before the first batch of validation.

·                  Validation of analytical methods :

 

·                  Acetate and Trifluoroacetate content in API € [*]

·                  Water content € [*]

·                  GC-Headspace (complement to general method) € [*]

·                  Direct GC (complement to general method)  € [*]*

·                  Specific rotation  € [*]

·                  Peptide content (Nitrogen) € [*]

·                  HPLC for in-process control upstream and downstream (3 methods). Need for HPLC methods will be discussed with Radius.

·                  HPLC for in-process control downstream : 2 methods (FG1 and VG1) € [*] each method

·                  HPLC for in-process control upstream : 3 methods: loading € [*], short method cleavage € [*], long method cleavage € [*]

 

Quotation for analytical methods validation (in Euros €):  € 71,000

 

Additional testing (if needed):

 

· LCMS comparability:

 

LC-MS analysis by TG1 method: € [*] per sample

Comparability report: € [*]

 

· reference standard [assuming 2 lots and 250mg of each minimum]

 

Sequencing by ES/MS/CAD/MS: € [*] for 2 samples

Amino acid analysis: € [*] for 2 samples

 

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

 

15

 

Limit test for residual amino acids: € [*] for 2 samples

Secondary counter ions: € [*] for 2 samples

 

· Heavy metals (USP/EP level)

 

€ [900]* per test sample (same method as for lot 4AI1) + $ [*] for specific method validation (Sn, Cr, Hg, Pb, As, Cd per ICH guidelines)

 

· General properties:

 

Solubility: € [*] per test sample

pH: € [*] per test sample

isoelectric point: € [*] per test sample

 

10) Quotation for Validation Campaign at 50 g NPW scales (in Euros)

 

Lonza will  run do the validation campaign at a scale of 50g NPW; however, as for the qualification campaign, the assembly and cleavage reaction that will lead to the crude, will be performed at a scale of 180g API equivalent, since this is the minimum scale at which the process can be validated.

 

In order to make use of potential efficiencies, Radius asked for scenarios whereby validation batches V2 and V3 are performed in parallel. The quotes for these scenarios are presented in the table below:

 

·                  Validation batch 1 (V1) performed alone, no change in price

·                  Validation batches V2 and V3 performed in parallel in synthesis but not for purification

·                  2 releases in parallel for V2 and V3

 

The price is given for the first 50g NPW production (including the full cost of the crude at a scale of 180g NPW  API equivalent), as well is for the later processing of the excess crude (without crude processing cost and per 50g NPW API):

 

Validation 1:

 

	
Quotation
    	
 
    	
First 50 g
   NPW
    	
 
    	
50 g Price
   without cost
   of crude
    	
 
    	
First
    100 g
   NPW
    	
 
    	
First 150g
   NPW
    	
 
    	
Full 180g
   NPW
    	
 
    
	
Raw Materials
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Production:
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
·  Crude (at scale of 180 g API   equivalent)
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
·  Purification and   Lyophilisation
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
QC/QA Release
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Homogeneity Study
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Total Quote
    	
 
    	
226,750
    	
 
    	
99,500
    	
 
    	
252,750
    	
 
    	
273,750
    	
 
    	
284,250
    	
 
    
	
Price / g
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    

 

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

 

16

Validations 2 and 3:

 

	
Quotation
    	
 
    	
First 50 g
   NPW
    	
 
    	
50 g Price
   without cost
   of crude
    	
 
    	
First
    100 g
   NPW
    	
 
    	
First 150g
   NPW
    	
 
    	
Full 180g
   NPW
    	
 
    
	
Raw Materials
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Production:
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
·  Crude (at scale of 180 g API   equivalent)
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
·  Purification and   Lyophilisation
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
QC/QA Release
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Homogeneity Study
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    
	
Total Quote
    	
 
    	
209,000
    	
 
    	
97,750
    	
 
    	
235,000
    	
 
    	
256,000
    	
 
    	
266,500
    	
 
    
	
Price / g
    	
 
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    	
[*
    	
]
    

 

Lead time: 17 weeks (3 validation campaigns)

 

Total price for the 3 validation campaigns at 50 g:  1 x €226,750 + 2 x €209,000 = €644,750

 

Concerning homogeneity, this study in plates is performed during prequalification activities. In the case of the validation batches, defined as the most representative material compared to commercial batches, the homogeneity study is performed on bulk material during dispensing. This work will be done on all validation batches and will assay water content, acetonitrile content and acetate content (€9,750 per batch). This is the reason why validation batches are a bit more expensive than qualification batches.

 

No experience gain is expected between qualification and validation batches at that scale: same equipments, same scale.

 

11) Validation Reports

 

·                  Upstream process validation reports:               € [*] (20 working days)

·                  Downstream process validation report:           € [*] (20 working days)

 

Quotation for Validation reports:                    €22,500

 

12) Validation stability: ICH (0, 3, 6, 9, 12 etc. months)

 

€ 35,000 per batch

 

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

 

17

 

13) Stationary phase HPLC column

 

5kg of stationary phase of the HPLC column will be charged to Radius. This stationary phase is fully dedicated to BA-058 and cannot be used anymore for other products in case the RDS-001 project would stop for any reason. Therefore, it is now common practice at Lonza to sell the full amount of the phase directly to the customer at the start of a project. Once Radius has paid for it, it becomes Radius property.

 

€ 22,500€.

 

14) DMF Filing

 

Quotation for DMF filing: €40,000

 

15) Validity of Proposal

 

The validity of this proposal expires on December 31, 2011.

 

BK / RJM

07/20/10; 09/29/10; 10/06/10; 10/13/10; 10/18/10; 10/25/10.

 

PT/RJM

10/18/11; 10/21/11; 12/05/11

 

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

 

18EXHIBIT 10.1

 

AMENDED AND RESTATED
 EMPLOYMENT AGREEMENT

 

THIS AMENDED AND RESTATED EMPLOYMENT AGREEMENT (the “Agreement”), is dated as of December 28, 2011 (the “Effective Date”), between Mines Management, Inc., an Idaho corporation (the “Company”), and Glenn M. Dobbs (“Executive”).

 

W I T N E S S E T H   T H A T:

 

WHEREAS, the Company and Executive are parties to that certain Employment Agreement, dated August 7, 2007 (the “Prior Agreement”); and

 

WHEREAS, the Company and Executive wish to amend and restate the Prior Agreement; and

 

WHEREAS, the Company wishes to retain the services of Executive as President and Chief Executive Officer of the Company and Executive is willing to continue to make his services available to the Company on the terms and conditions herein provided.

 

NOW, THEREFORE, in consideration thereof and hereof, the parties hereto covenant and agree as follows:

 

Section 1                At Will Employment; Compensation.  The Company agrees to employ Executive from the Effective Date, in the full time capacity of President and Chief Executive Officer of the Company, with the responsibilities normally associated with such position, which employment shall continue until terminated as provided in Section 7 below (the “Term”).  Subject to the provisions of Section 7, but not withstanding any other provision hereof, the Company and Executive agree that Executive’s employment is “at will,” and either Executive or the Company may terminate Executive’s employment at any time, for any reason or no reason, with or without notice, warning or consent.  Beginning January 1, 2012, the Company will pay Executive for his services at an annual rate of Three Hundred Seventy Thousand Dollars ($370,000), payable in arrears, in equal installments, in accordance with standard Company practice, but in any event not less often than monthly, subject only to such payroll and withholding deductions as are required by law or authorized by Executive.  Executive shall also be entitled to participate in all employee benefit plans of the Company during the Term on the same terms and conditions as other employees similarly situated, subject to the Company’s right, in any event, to modify or terminate such plans.  The Company shall pay Executive’s individual medical and dental insurance premiums and shall provide paid monthly parking.  In addition, Executive shall be eligible to receive such stock options as may be approved, in its sole discretion, by the Compensation Committee of the Board of Directors of the Company (the “Board”) or by the Board. Executive’s performance will be evaluated annually or at such other times as determined by the Board.

 

Section 2                Office and Duties.  Executive shall serve as President and Chief Executive Officer of the Company, and if elected a director of the Company, as Chairman of the Board (so long

 

 

as Executive serves as a director and is so appointed by the Board) and perform duties customarily incident to such offices and all other duties as may from time to time be assigned to Executive by the Board. Executive shall devote substantially all of his business time, labor, skill, undivided attention, and best ability to the performance of his duties hereunder in a manner that will faithfully and diligently further the business and interests of the Company on a full time basis. Executive shall not directly or indirectly pursue any other business activity without the Company’s prior written consent. Executive agrees that he will travel as is reasonably necessary in the conduct of the Company’s business.

 

Section 3                Expenses.  Executive shall be entitled to reimbursement for expenses incurred by him in connection with the performance of his duties hereunder upon receipt of vouchers therefor in accordance with such procedures as the Company has heretofore or may hereafter establish.

 

Section 4                Vacation During Employment.  Executive shall be entitled to such reasonable vacation time as may be allowed by the Company in accordance with general practices established or to be established, but in any event not less than four (4) weeks of vacation during each twelve (12) month period plus usual statutory and other public holidays, the timing of such vacation to be mutually agreed upon between Executive and the Company.  The Company recommends that all employees take vacation, but if duties of Executive prevent him from taking said vacation, Executive shall be paid for any unused vacation at the end of each year. Unused vacation time will not be accrued and carried from year to year.

 

Section 5                Additional Benefits.  Nothing herein contained shall preclude Executive, to the extent he is otherwise eligible, from participation in any group insurance programs or other fringe benefit plans that the Company may hereafter, in its sole and absolute discretion, make generally available to its employees.

 

Section 6                Certain Definitions.  For purposes of this Agreement, the following words and phrases shall have the following meanings:

 

(a)           “Annual Compensation” shall be an amount equal to the sum of (i) Executive’s annual base salary from the Company and its subsidiaries at the rate in effect at the time of termination; and (ii) the amount of annual bonus, if any, paid by the Company to Executive for the year prior to the (A) termination of Executive’s employment (in the case of Annual Compensation determined for purposes of Section 7(d)) or (B) Change in Control event (in the case of Annual Compensation determined for purposes of Section 7(e)).

 

(b)           “Cause” shall mean termination by the Company of Executive due to:  (i) engaging in illegal conduct, including but not limited to fraud or embezzlement; (ii) being convicted of a felony; (iii) engaging in substance abuse which impairs Executive’s ability to perform the duties and obligations of his employment or causes harm to the reputation of the Company; (iv) the willful breach of Executive’s duties to the Company; (v) failure or refusal by Executive to follow reasonable directions given by the Board; or (vi) engaging in conduct which, in the sole opinion of management of the Company, is deemed to be detrimental to the Company.  Whether Cause exists for termination will be determined by the Company in its sole discretion.

 

2

 

(c)           A “Change in Control” shall be deemed to have occurred if any of the following occurs with respect to the Company:  (i) the direct or indirect sale or exchange in a single transaction or series of transactions by the shareholders of the Company of more than thirty five percent (35%) of the voting stock of the Company by an individual, an entity or a “group” as that term is defined in Section 13 of the Securities Exchange Act of 1934, as amended; (ii) a merger or consolidation to which the Company is a party and following which the shareholders of the Company do not have more than fifty percent (50%) of the voting stock of the resulting company (or its ultimate parent company); (iii) the sale, exchange, or transfer of all or substantially all of the assets of the Company; or (iv) a series of related Transactions (each of the items (i) through (iii) constituting a “Transaction”) wherein the shareholders of the Company immediately before the Transaction do not retain immediately after the Transaction, in substantially the same proportions as their ownership of shares of the Company’s voting stock immediately before the Transaction, direct or indirect beneficial ownership of more than fifty percent (50%) of the total combined voting power of the outstanding voting securities of the Company or, in the case of a Transaction involving the sale, exchange, or transfer of all or substantially all of the assets of the Company, the corporation or other business entity to which the assets of the Company were transferred (the “Transferee”), as the case may be.  For purposes of the preceding sentence, indirect beneficial ownership shall include, without limitation, an interest resulting from ownership of the voting securities of one or more corporations or other business entities which own the Company or the Transferee, as the case may be, either directly or through one or more subsidiary corporations or other business entities.  The Board shall have the right to determine whether multiple sales or exchanges of the voting securities of the Company or multiple Transactions are related, and its determination shall be final, binding and conclusive.  Notwithstanding the foregoing, a Change in Control shall not include (i) a distribution or transaction in which the voting stock of the Company or a parent or subsidiary is distributed to the shareholders of a parent of such entity or (ii) any change in ownership resulting from an underwritten public offering of the common stock or the stock of any parent or subsidiary shall not be deemed a Change in Control for any purpose hereunder.

 

(d)           The “Change in Control Date” shall be any date during the Term on which a Change in Control occurs.  Anything in this Agreement to the contrary notwithstanding, if Executive’s employment or status as an elected officer with the Company is terminated within sixty (60) days before the date on which a Change in Control occurs, and it is reasonably demonstrated that such termination (i) was at the request of a third party who has taken steps reasonably calculated or intended to effect a Change in Control or (ii) otherwise arose in connection with or anticipation of a Change in Control, then for all purposes of this Agreement the “Change in Control Date” shall mean the date immediately before the date of such termination.

 

(e)           “Code” shall mean the Internal Revenue Code of 1986, as amended.

 

(f)            “Disability,” for purposes of this Agreement, shall mean total disability as defined in any long-term disability plan sponsored by the Company in which Executive participates, or, if there is no such plan or such plan does not define such term, then it shall mean the physical or mental incapacity of Executive that prevents him from substantially performing the duties of President and Chief Executive Officer, and which incapacity has continued for a period of at least ninety (90) days, whether consecutive or not, in any three hundred sixty five (365) day period.

 

3

 

(g)           “Good Reason” means any of the following actions or omissions of the Company without the consent of Executive:

 

(i)            the assignment to Executive of any duties inconsistent in any material respect with Executive’s position (including status, offices, titles and reporting requirements, authority, duties or responsibilities), or any other action that results in a material diminution in such position, authority, duties, or responsibilities, excluding for this purpose an isolated or inadvertent action not taken in bad faith;

 

(ii)           a material reduction by the Company in Executive’s base salary as increased from time to time after the date hereof;

 

(iii)          a failure by the Company to maintain plans providing benefits at least as beneficial as those provided by any benefit or compensation plan (including, without limitation, any incentive compensation plan, bonus plan or program, retirement, pension or savings plan, life insurance plan, health and dental plan or disability plan) in which Executive is now participating, or any action taken by the Company that would adversely affect Executive’s participation in or reduce Executive’s opportunity to benefit under any of such plans or deprive Executive of any material fringe benefit now enjoyed by him where such failure or action results in a material negative change to Executive; provided, however, that a reduction in benefits under the Company’s tax-qualified retirement, pension, or savings plans or its life insurance plan, health and dental plan, disability plans or other insurance plans, which reduction applies generally to all participants in the plans shall not constitute “Good Reason”;

 

(iv)          the Company’s requiring Executive, without Executive’s written consent, to be based at any office or location in excess of fifty (50) miles from his office location, except for travel reasonably required in the performance of Executive’s responsibilities;

 

(v)           any failure by the Company to obtain the assumption of the obligations contained in this Agreement by any successor as contemplated in Section 14 of this Agreement; or

 

(vi)          any material breach of this Agreement by the Company.

 

Notwithstanding the foregoing definition of Good Reason, Executive cannot terminate his employment hereunder for Good Reason unless (x) Executive notifies the Compensation Committee or the Board in writing of the condition (or conditions) which Executive believes constitutes (or constitute) a Good Reason condition under (i) through (vi) above within thirty (30) days from the date of the initial occurrence of such condition (a “Good Reason Notice”), (y) the Company fails to cure, correct or mitigate the Good Reason condition within thirty (30) days of receipt of a Good Reason Notice so that the Good Reason condition no longer exists or Executive agrees, in writing, that after modification or accommodation made by the Company such condition shall not constitute a Good Reason condition, and (z) Executive terminates his employment within sixty (60) days of the Good Reason Notice.

 

4

 

(h)           “Protection Period” means the period beginning on the Change in Control Date and ending on the one year anniversary of the Change in Control Date.

 

Section 7                Termination of Employment.

 

(a)           Notwithstanding any other provision of this Agreement, Executive’s employment may be terminated:

 

(i)            by Executive upon ninety (90) days written notice;

 

(ii)           by the Company upon thirty (30) days written notice, without Cause;

 

(iii)          by the Company, with notice to Executive, for Disability;

 

(iv)          in the event of Executive’s death during the Term, provided that the Company’s obligation to pay further compensation hereunder shall cease forthwith, except that Executive’s estate shall be entitled to receive an amount equal to one-twelfth (1/12) of Executive’s then current annual base salary for a period of three (3) months beginning with the pay period immediately after Executive’s death shall have occurred and payable on regular payroll dates; or

 

(v)           by the Company, at any time for Cause.

 

(vi)          Upon the termination of Executive’s employment pursuant to this Section 7(a), this Agreement shall automatically terminate, except as otherwise provided herein.

 

(b)           In the event that Executive’s employment is terminated pursuant to Section 7(a)(i), (ii), (iii), (iv) or (v) or Section 7(e), Executive shall receive an amount equal to Executive’s full base salary and vacation pay (for vacation not taken) accrued but unpaid through the date of termination at the rate in effect at the time of the termination.

 

(c)           Subject to Section 7(f), in the event that Executive’s employment is terminated pursuant to Section 7(a)(ii) or (iii) or Section 7(e), in addition to the amounts specified in Section 7(b):

 

(i)            shares, options, or other forms of securities issued by the Company and beneficially owned by Executive (whether granted before or after the date of this Agreement) that are unvested, restricted, or subject to any similar restriction shall vest automatically on the termination date and shall be exercisable by Executive or Executive’s personal representative in accordance with the terms of the applicable Company stock option plan and restrictions shall lapse; and

 

(ii)           the Company shall pay the premium for Executive’s continuation coverage for health benefits provided by the Company for a period of up to twenty-four (24) months following the date of termination.  Such continuation coverage shall be in the form of COBRA continuation coverage for so long as Executive is eligible for COBRA continuation

 

5

 

coverage, and thereafter shall be in the form of health insurance coverage substantially similar to the coverage then offered to employed executives of the Company.

 

(d)           Subject to Section 7(f), in the event that Executive’s employment is terminated pursuant to Section 7(a)(ii) or if Executive terminates his employment for Good Reason, in addition to the amounts specified in Section 7(b) and the benefits provided in Section 7(c), the Company shall pay to Executive in a lump sum in cash on the sixty-first (61st) day following the date of termination of Executive’s employment (the “Payment Trigger Date”), a severance amount equal to Executive’s Annual Compensation.

 

(e)           Benefits upon Termination During a Protection Period.  Subject to Section 7(f), if during a Protection Period, Executive’s employment is terminated by the Company other than for Cause, for Disability or other than as a result of Executive’s death, or if Executive terminates his employment for Good Reason during the Protection Period, the Company shall pay to Executive in a lump sum in cash, on the sixty-first (61st) day following the date of termination of Executive’s employment (the “Protection Period Payment Trigger Date”), a severance amount equal to three (3) times Executive’s Annual Compensation.  For the avoidance of doubt, Executive shall be entitled to the payment of a severance amount under Section 7(d) or 7(e) but not both.

 

(f)            In order to receive any payment or other consideration set forth in Section 7(c)(i) or (ii), 7(d), or Section 7(e), Executive must, within twenty-two (22) days (or such longer period as may be required by law) following the Payment Trigger Date or Protection Period Payment Trigger Date, as applicable, sign a Severance and Release Agreement substantially in the form attached hereto as Exhibit A, and such Severance and Release Agreement must not have been revoked by Executive.

 

Section 8                Gross-Up Benefits.  Anything in this Agreement to the contrary notwithstanding, in the event it shall be determined that any payment or distribution by the Company to or for the benefit of Executive (whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise, but determined without regard to any additional payments required under this Section 8 (a “Payment”) would be subject to the excise tax imposed by Section 4999 of the Code, or any interest or penalties are incurred by Executive with respect to such excise tax that are not due to Executive’s actions or inactions (such excise tax, together with any such interest and penalties, are hereinafter collectively referred to as the “Excise Tax”), then Executive shall be entitled to receive an additional payment (a “Gross-Up Payment”) in an amount such that after payment by Executive of all taxes imposed upon the Gross-Up Payment (including any federal, state, and local income taxes, employment taxes under Section 3101(b) of the Code, and Excise Taxes, and assuming that the highest marginal income tax rate or rates applicable to Executive apply to the Gross-Up Payment), Executive retains an amount of the Gross-Up Payment equal to the Excise Tax imposed upon the Payments.  In the event that Executive is entitled to a Gross-Up Payment, the following shall apply:

 

(a)           All determinations required to be made, including whether and when a Gross-Up Payment is required and the amount of such Gross-Up Payment, shall be made by a nationally recognized certified public accounting firm selected by the Company (the “Accounting Firm”).  The Accounting Firm shall be requested to provide detailed supporting calculations both to the Company

 

6

 

and to Executive within fifteen (15) business days of the receipt of notice that there has been a Payment.  All fees and expenses of the Accounting Firm shall be borne solely by the Company.  Any Gross-Up Payment shall be paid by the Company to Executive within five (5) days of the receipt of the Accounting Firm’s determination, but in no event later than the last day of the taxable year following the taxable year in which the Excise Tax is incurred.  Any determination by the Accounting Firm shall be binding upon the Company and Executive.  As a result of uncertainty in the application of Sections 280G and 4999 of the Code, it is possible that Gross-Up Payments that will not have been made by the Company should have been made (an “Underpayment”).  In the event the Company exhausts its remedies pursuant to the following subparagraph and Executive is thereafter required to make a payment of any Excise Tax, the Accounting Firm shall be requested to determine the amount of the Underpayment that has occurred and any such Underpayment shall be promptly paid by the Company to Executive, but in no event later than the last day of the taxable year following the taxable year in which the Excise Tax is incurred.

 

(b)           Executive shall notify the Company in writing of any assertion by any taxing authority that, if successful, would require the payment by the Company of an Underpayment.  Such notification shall be given as soon as practicable, but no later than ten (10) business days after Executive is informed of such assertion.  Executive shall apprise the Company of the nature of such assertion and provide copies of all letters, notices, etc. regarding the assertion, and written summaries of any statements made to Executive or by Executive in connection with the assertion.  Executive shall not pay any amount asserted to be due prior to the expiration of the 30-day period following the date on which Executive gives such notice to the Company (or such shorter period ending on the date that any payment of taxes with respect to such assertion is due).  If the Company notifies Executive in writing prior to the expiration of such period that the Company desires to contest such assertion, Executive shall:

 

(i)            give the Company any information reasonably requested by the Company relating to such assertion,

 

(ii)           take such action in connection with contesting such assertion as the Company shall reasonably request in writing from time to time, including, without limitation, accepting legal representation with respect to such assertion by an attorney reasonably selected by the Company,

 

(iii)          cooperate with the Company in good faith in order effectively to contest such assertion, and

 

(iv)          permit the Company to participate in any proceedings relating to such assertion;

 

provided, however, that the Company shall bear and pay directly all costs and expenses (including additional interest and penalties) incurred in connection with such contest, and shall indemnify and hold Executive harmless, on an after-tax basis, for any Excise Tax and income and employment tax (including interest and penalties) imposed as a result of such representation and payment of costs and expenses, which amounts shall be paid no later than the last day of the taxable year following the taxable year in which such amounts are incurred.  The Company shall control all proceedings taken

 

7

 

in connection with such contest, and, at its sole discretion, may pursue or forgo any and all administrative appeals, proceedings, hearings and conferences with the applicable taxing authority in respect of such assertion and may, at its sole discretion, either direct Executive to pay the tax asserted and sue for a refund or contest the claim in any permissible manner, and Executive agrees to prosecute such contest to a determination before any administrative tribunal, in a court of initial jurisdiction and in one or more appellate courts, as the Company shall determine; provided, however, that, if the Company directs Executive to pay such claim and sue for a refund, the Company shall advance the amount of such payment to Executive, on an interest-free basis, and shall indemnify and hold Executive harmless, on an after-tax basis, from any Excise Tax and income and employment tax (including interest or penalties) imposed with respect to such advance or with respect to any imputed income in connection with such advance, which indemnified amounts shall be paid no later than the last day of the taxable year following the taxable year in which such amounts are incurred; and provided, further, that any extension of the statute of limitations relating to payment of taxes for the taxable year with respect to which such contested amount is claimed to be due is limited solely to such contested amount.  Furthermore, the Company’s control of the contest shall be limited to issues with respect to which the Gross-Up Payment would be payable hereunder, and Executive shall be entitled to settle or contest, as the case may be, any other issue raised by the Internal Revenue Service or any other taxing authority.

 

(c)           If, after the receipt by Executive of a Gross-Up Payment or an amount advanced by the Company, Executive becomes entitled to receive any refund with respect to the Excise Tax to which such Gross-Up Payment relates or with respect to such claim, Executive shall (subject to the Company’s complying with the requirements of this section, if applicable) promptly pay to the Company the amount of such refund (together with any interest paid or credited thereon after taxes applicable thereto).  If, after the receipt by Executive of an amount advanced by the Company pursuant to this section, a determination is made that Executive shall not be entitled to any refund with respect to such claim and the Company does not notify Executive in writing of its intent to contest such denial of refund prior to the expiration of 30 days after such determination, then such advance shall be forgiven and shall not be required to be repaid and the amount of such advance shall offset, to the extent thereof, the amount of Gross-Up Payment required to be paid.

 

Section 9                Code Section 409A.

 

(a)           The intent of the parties is that payments and benefits under this Agreement comply with or be exempt from Internal Revenue Code Section 409A and the regulations and guidance promulgated thereunder (collectively “Code Section 409A”) and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted and operated to be in compliance therewith.  In no event whatsoever shall the Company be liable for any additional tax, interest or penalty that may be imposed on Executive by Code Section 409A or damages for failing to comply with Code Section 409A.  If Executive notifies the Company that Executive has received advice of tax counsel with expertise in Code Section 409A that any provision of this Agreement would cause Executive to incur any additional tax or interest under Code Section 409A (with specificity as to the reason therefor) or the Company independently makes such determination, the Company and Executive shall take commercially reasonable efforts to reform such provision to try to comply with or be exempt from Code Section 409A through good faith modifications to the minimum extent reasonably appropriate to conform with Code Section 409A, provided that any such modifications

 

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shall not materially increase the cost or liability to the Company.  To the extent that any provision hereof is modified in order to comply with or be exempt from Code Section 409A, such modification shall be made in good faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to Executive and the Company of the applicable provision without violating the provisions of Code Section 409A.

 

(b)           Executive shall have no right to designate the date of any payment hereunder.

 

(c)           Notwithstanding any other payment schedule provided herein to the contrary, if Executive is deemed on the date of termination to be a “specified employee” within the meaning of that term under Code Section 409A(a)(2)(B), then with regard to any payment that is considered deferred compensation under Code Section 409A payable on account of a “separation from service,” such payment shall be made on the date which is the earlier of (A) the expiration of the six (6)-month period measured from the date of such “separation from service” of Executive, and (B) the date of Executive’s death (the “Delay Period”) to the extent required under Code Section 409A.  Upon the expiration of the Delay Period, all payments delayed pursuant to this Section (whether they would have otherwise been payable in a single sum or in installments in the absence of such delay) shall be paid to Executive in a lump sum, and all remaining payments due under this Agreement shall be paid or provided in accordance with the normal payment dates specified for them herein.

 

(d)           For purposes of compliance with Code Section 409A, (i) all expenses or other reimbursements under this Agreement shall be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred by Executive, (ii) any right to reimbursement or in kind benefits is not subject to liquidation or exchange for another benefit, and (iii) no such reimbursement, expenses eligible for reimbursement, or in-kind benefits provided in any taxable year shall in any way affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year.

 

(e)           Notwithstanding any other provision to the contrary, in no event shall any payment under this Agreement that constitutes “deferred compensation” for purposes of Code Section 409A be subject to offset by any other amount unless otherwise permitted by Code Section 409A.

 

(f)            To the extent necessary to avoid the imposition of additional tax, interest or penalty under Code Section 409A, “termination,” “termination of employment,” “termination of Executive’s employment” and similar terms, where used in this Agreement, shall mean the occurrence of a “separation from service” as such term is defined in Treas. Reg. § 1.409A-1(h).

 

(g)           Each payment of “deferred compensation” for purposes of Code Section 409A contemplated by this Agreement shall be a separate payment, and a separately identified and determinable payment, for purposes of Code Section 409A.

 

Section 10             Proprietary Information.  Executive hereby grants to the Company all right, title, and interest in and to any information concerning discoveries; methods; business plans and practices; enterprises; explorations; mining information; plant design, location, or operation; works made for hire; or any other information affecting the business operations of the Company and any

 

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invention, discovery, or improvement conceived or reduced to practice in connection with the services performed hereunder (“Proprietary Information”).  Executive will keep signed, witnessed, and dated written records of all such inventions, discoveries, or improvements; will furnish the Company promptly with complete information in respect thereof and will do all things necessary to protect the interests of the Company therein.

 

Section 11             Confidentiality.  Executive shall not, either during the period of Executive’s employment with the Company or thereafter, reveal or disclose to any person outside the Company or use for Executive’s own benefit or for the benefit of any third party, without the Company’s specific written authorization, whether by private communication or by public address or publication or otherwise, any information not already lawfully available to the public concerning the Company or the Company’s equity securities, including any Proprietary Information, whether or not supplied by the Company, and whether or not made, developed, and/or conceived by Executive or by others in the employ of the Company.  All originals and copies of any of the foregoing, relating to the business of the Company, however and whenever produced, shall be the sole property of the Company, not to be removed from the premises or custody of the Company without in each instance first obtaining written consent or authorization of the Company.  Upon the termination of Executive’s employment in any manner or for any reason, Executive shall promptly surrender to the Company all copies of any of the foregoing, together with any other documents, materials, data, information, and equipment belonging to or relating to the Company’s business and in his possession, custody, or control, and Executive shall not thereafter retain or deliver to any other person, any of the foregoing or any summary or memorandum thereof.

 

Section 12             Notices.  All notices and other communications hereunder shall be in writing and shall be deemed to have been given when delivered or three (3) days after mailing if mailed by first-class, registered, or certified mail, postage prepaid, addressed (a) if to Executive: Glenn M. Dobbs, 22820 E. Clearwater Lane, Liberty Lake, Washington 99019, and (b) if to the Company: Chief Financial Officer, Mines Management, Inc., 905 W. Riverside Ave. Suite 311, Spokane, WA 99201, or to such other person(s) or address(es) as the Company shall have furnished to Executive in writing.

 

Section 13             Survival.  The rights and obligations of the parties hereto arising under Sections 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 and 23 shall survive the termination or cancellation of this Agreement for any reason.

 

Section 14             Assignability.  If the Company shall be merged with, or consolidated into any other corporation, or in the event that it shall sell and transfer substantially all of its assets to another corporation, the terms of this Agreement shall inure to the benefit of, and be assumed by, the corporation resulting from such merger or consolidation, or to which the Company’s assets shall be sold and transferred.  This Agreement shall not be assignable by Executive, but it shall be binding upon and, to the extent provided in Section 7(a)(iv), shall inure to the benefit of, his heirs, executors, administrators, and legal representatives.

 

Section 15             Entire Agreement.  This Agreement contains the entire agreement between the Company and Executive with respect to the subject matter hereof and there have been no oral or other agreements of any kind whatsoever as a condition precedent or inducement to the signing of

 

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this Agreement or otherwise concerning this Agreement or the subject matter hereof. This Agreement supersedes and replaces any prior agreements, promises, or understandings between the Company and Executive, including the Prior Agreement.

 

Section 16             Expenses.  Each party shall pay its or his own expenses incident to the performance or enforcement of this Agreement, including all fees and expenses of its counsel for all activities of such counsel undertaken pursuant to this Agreement, except as otherwise herein specifically provided.

 

Section 17             Equitable Relief.  Executive recognizes and agrees that the Company’s remedy at law for any breach of the provisions of Sections 10 and 11 hereof would be inadequate, and he agrees that for breach of such provisions, the Company shall, in addition to such other remedies as may be available to it at law or in equity or as provided in this Agreement, be entitled to injunctive relief and to enforce its rights by an action for specific performance to the extent permitted by law.  If Executive engages in any activities prohibited by this Agreement or fails to satisfy Executive’s obligations under this Agreement, he agrees to pay over to the Company all compensation, remunerations or property of any sort received in connection with such prohibited activities; such payment shall not impair any rights or remedies of the Company or obligations or liabilities of Executive that such parties may have under this Agreement or applicable law.

 

Section 18             Waivers and Further Agreements.  Any waiver of any terms or conditions of this Agreement shall not operate as a waiver of any other breach of such terms or conditions or any other term or condition, nor shall any failure to enforce any provision hereof operate as a waiver of such provision or of any other provision hereof, unless it, by its own terms, explicitly provides to the contrary, nor shall it be construed to effect a continuing waiver of the provision being waived and no such waiver in any instance shall constitute a waiver in any other instance or for any other purpose or impair the right of the party against whom such waiver is claimed in all other instances or for all other purposes to require full compliance with such provision.  Each of the parties hereto agrees to execute all such further instruments and documents and to take all such further action as the other party may reasonably require in order to effectuate the terms and purposes of this Agreement.

 

Section 19             Amendments.  This Agreement may not be amended, nor shall any waiver, change, modification, consent, or discharge be effected except by an instrument in writing executed by or on behalf of the party against whom enforcement of any such waiver, change, modification, consent, or discharge is sought.

 

Section 20             Severability.  If any provision of this Agreement shall be held or deemed to be, or shall in fact be, invalid, inoperative, or unenforceable as applied to any particular case in any jurisdiction or jurisdictions, or in all jurisdictions or in all cases, because of the conflict of any provision with any constitution or statute or rule of public policy or for any other reason, such circumstance shall not have the effect of rendering the provision or provisions in question invalid, inoperative, or unenforceable in any other jurisdiction or in any other case or circumstance or of rendering any other provision or provisions herein contained invalid, inoperative, or unenforceable to the extent that such other provisions are not themselves actually in conflict with such constitution, statute, or rule of public policy, but this Agreement shall be reformed and construed in any such jurisdiction or case as if such invalid, inoperative, or unenforceable provision had never been

 

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contained herein and such provision reformed so that it would be valid, operative, and enforceable to the maximum extent permitted in such jurisdiction or in such case.

 

Section 21             Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

Section 22             Section Headings.  The headings contained in this Agreement are for reference purposes only and shall not in any way affect the meaning or interpretation of this Agreement.

 

Section 23             General Provisions.

 

(a)           Executive further agrees that his obligations under Sections 10 and 11 of this Agreement shall be binding upon him irrespective of the duration of his employment by the Company, the reasons for any cessation of his employment by the Company, or the amount of his compensation and shall survive the termination of this Agreement (whether such termination is by the Company, by Executive, upon expiration of this Agreement or otherwise).

 

(b)           Executive represents and warrants to the Company that he is not now under any obligations to any person, firm, or corporation, and has no other interest that is inconsistent or in conflict with this Agreement, or that would prevent, limit or impair, in any way, the performance by him of any of the covenants or duties in his employment.

 

Section 24             Gender.  Whenever used herein, the singular number shall include the plural, the plural shall include the singular, and the use of any gender shall include all genders.

 

Section 25             Governing Law.  This Agreement shall be governed by and construed and enforced in accordance with the law of Washington.  Venue for any action arising from or in connection with this Agreement shall be in Spokane County, Washington.

 

Signature Page Follows.

 

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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.

 

	
 
    	
MINES MANAGEMENT, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   James H. Moore
    
	
 
    	
Name:
    	
James   H. Moore
    
	
 
    	
Title:
    	
Chief   Financial Officer
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
EXECUTIVE:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
/s/   Glenn M. Dobbs
    
	
 
    	
Glenn   M. Dobbs
    

 

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