EXHIBIT 10.1
First Amendment to
Drug Product Production and Clinical Supply Agreement
     This First Amendment (the “Amendment”) is entered into and effective as of
June 25, 2007 (the “Amendment Date”) for the purpose of amending that certain
Drug Product Production and Clinical Supply Agreement dated August 15, 2006 (the
“Agreement”) by and between Altus Pharmaceuticals Inc., a Delaware corporation
(“Altus”), and Althea Technologies, Inc., a Delaware corporation (“Althea”).
Capitalized terms used but not otherwise defined herein shall have the meanings
provided in the Agreement.
     Whereas, the Parties had not reached agreement on a final Schedule 1
pursuant to Section 3.2 of the Agreement,
     Whereas, the Parties desire to resolve any differences and mutually agree
to a modified Schedule 1, along with related pricing and payment structure
changes to reflect changes to the expectations of the Parties and to facilitate
the efficient completion of the Project Plan; and
     Now, Therefore, in consideration of the mutual covenants contained herein
and other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties agree as follows:
1. Amendment and Restatement of Schedule 1. Schedule 1 to the Agreement is
hereby amended and restated to read in its entirety as set forth in Exhibit A to
this Amendment (the “Restated Schedule”). All references in Schedule 1 in the
Agreement, shall, as of the Amendment Date, be deemed to be references to the
Restated Schedule. The Parties acknowledge that the Restated Schedule includes
all activities to be performed under the Agreement through production of the
[***] Batch. The Parties agree that performances of the activities set forth on
the Restated Schedule, and substantial compliance with the timelines by the
Parties in the Restated Schedule are [***] of the Parties under the Agreement,
as amended by this Amendment. The Parties expect that the [***] Batches to be
produced pursuant to Section 4.1 of the Agreement will be completed no later
than [***], and Altus acknowledges that a [***] in such [***] will require one
or more change orders as described in paragraph 4 of this Amendment.
2. Work Performed As of the Amendment Date. The Parties agree that,
notwithstanding any provision of the Agreement or any other correspondence or
communication between the Parties to the contrary, the total amount due by Altus
for all work performed by Althea pursuant to the Agreement (other than the
facilities modification payment of [***] previously paid by Altus to Althea and
excluding work pursuant to the change orders referred to in Section 4 below) up
to and including the Amendment Date is [***]. Of such amount, Althea
acknowledges that it has already

1.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

received [***] (consisting of all payments due to Althea and paid by Altus
within [***] days of the Effective Date pursuant to Sections 5.2 ([***] and
[***]), 5.3 ([***]), 5.4 ([***]), and 5.5 ([***])). Altus further agrees to pay
upon execution of this Amendment:
     (a) an additional [***] in consideration for services performed by Althea
as of the Amendment Date; and
     (b) [***] for the first validation run for syringes (media fill), which was
conducted by Althea on [***].
3. Work Performed on or After the Amendment Date. Subject to paragraph 4 of this
Amendment, the Parties agree that, beginning as of the Amendment Date, all
additional work related to the specific activities described in the Restated
Schedule shall be paid as currently provided in the Agreement. For avoidance of
doubt, this includes the following activities more precisely described on the
Restated Schedule:
     (a) installation of the Equipment (including the skid), IQ, OQ and PQ
validation and cleaning validation under Section 3.3 of the Agreement;
     (b) Process technology transfer work under Section 3.4 of the Agreement,
including all necessary process documentation;
     (c) analytical methods technology transfer under Section 3.5 of the
Agreement;
     (d) validation runs under Section 3.6, and all work necessary to enable
Althea to perform the services outlined in Article 4 of the Agreement, except
for any work expressly required by the Agreement to be performed at Althea’s
cost; and
     (e) additional buffer runs at the prices set forth in Section 5.3 of the
Agreement in addition to the initial buffer run contemplated by Section 3.4 of
the Agreement.
4. Change Orders. Notwithstanding the provisions of paragraph 3 of this
Amendment:
     (a) the Parties acknowledge and agree that the work described in Contract
Change Order Nos. 6, 11, 13, 17 and 18 attached as Exhibit B to this Amendment
were not contemplated by the Agreement and that the payment amounts set forth in
the Agreement do not cover such work. Altus hereby approves each such change
order and all amounts payable to Althea as specified in each such change order
shall be due and payable within [***] days after receipt by Altus of an invoice
from Althea relating thereto; and
     (b) the Parties further acknowledge and agree that any additional change to
the Project Plan, or to Altus’ requirements with respect to Production of Drug
Product pursuant to Articles 3, 4 and 5 of the Agreement (including, without
limitation, [***] in addition to that specified by Althea as of the Amendment
Date), that Altus may propose

2.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

will require a written change order signed by at least one of each Party’s
representatives on the Steering Committee (for change orders up to [***]) and a
written change order executed by both Parties (for change orders equal to or in
excess of [***]). If Altus proposes any such change, Althea shall submit a
written price proposal to Altus, which will note any delays that Althea
anticipates will result from such change, and Althea shall not be required or
authorized to implement such change unless and until the Parties agree in
writing on the price to be paid by Altus for such work.
     5. [***] to Compensation Structure. Altus acknowledges that processing of
additional change orders may result in significant administrative time and
expense on Althea’s part, and that project delays and/or price increases are
likely to result from additional change orders. Accordingly, if, at any time on
or after [***] days from the Amendment Date, [***] of the Steering Committee
determines in good faith that the pricing structure as outlined in the Agreement
and modified by paragraphs 3 and 4 of this Amendment (i.e., fixed fee plus
additional charges for change orders) is no longer [***] or [***] in light of
(i) [***] in the [***] resulting from circumstances outside [***] and/or (ii)
the [***] and/or [***] of change(s) to the Project Plan or Drug Product
requirements requested by Altus, such Steering Committee [***] shall so notify
the other Party’s representatives on the Steering Committee, and the Parties
shall promptly meet and consider in good faith an [***] of [***] the [***] to
Althea for its services under the Agreement.
6. Arrival and Functionality of Equipment; Delays.
     (a) In addition to the amounts specified above in this Amendment (or
specified in the Agreement and referenced in this Amendment), it is anticipated
the production skid and tanks required to manufacture the Drug Product arrived
at Althea’s facilities fully functional and operational, subject to customary
and reasonable adjustments in the installation and start up phase, in each case
as reasonably necessary for installation of such equipment and for manufacturing
of the Drug Product (“Operational”). If at any time it is determined [***]
(unless such [***]), [***] shall pay to Althea [***], but not more than [***],
for the period such [***] (the [***]). In such event, [***]. The payment of such
[***] shall not exceed the amount accrued from the date it is determined that
such [***] to the end of such [***] period. Altus shall be responsible for the
cost associated with the removal of such equipment from the Facility and the
subsequent return and replacement of such equipment to the Facility. [***] shall
meet and [***] shall reschedule the planned manufacturing activities pursuant to
the notice provisions of Section 4.1 of the Agreement.
     (b) All amounts payable to Althea under this paragraph 6 shall be due and
payable within [***] days after receipt of an invoice from Althea.
7. Facility Usage and Reservation. In addition to the amounts specified above in
this Amendment (or specified in the Agreement and referenced in this Amendment),
and in further consideration of resolving the Parties’ performance obligations
under the Restated Schedule, Altus shall pay to Althea [***] as follows:

3.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

     (a) [***] by [***];
     (b) [***] by [***];
     (c) [***] by [***]; and
     (d) [***] by [***];
In addition, in the event that Altus’ usage of the Facility extends beyond the
timeline set forth in the Restated Schedule (and such extension is due to Altus’
election or is otherwise directly and primarily caused by Altus or a third party
acting at Altus’ request or direction), such extension would be implemented
through one or more written change order(s) in accordance with Section 4(b)
above (it being understood that the daily and weekly rates for such extended
usage would be [***] set forth in the [***] and that such change order(s) would
allow for a [***], an associated [***], and related matters as set forth [***]).
For the avoidance of confusion, the Parties acknowledge that the production of
the [***] and [***] Batches as contemplated by Section 4.1 of the Agreement
shall not be deemed to constitute usage of the Facility beyond the timeline set
forth in the Restated Schedule for purposes of this Section 7, provided that
Altus has complied with the advance notice requirements of Section 4.1 with
respect to such Batches.
8. Success Bonus Payment. Altus confirms its obligation to pay the success bonus
payment provided for in, and in accordance with the terms of, Section 5.7 of the
Agreement, and the Parties acknowledge that they have mutually agreed to the
timeline set forth in the Restated Schedule for the purpose of Section 5.7;
provided that if Production of the first Batch has not been completed by [***]
and [***] or is [***], the success bonus payment specified in Section 5.7 of the
Agreement shall become immediately due and payable.
9. Steering Committee. Each Party shall appoint 3 members to the Steering
Committee. Altus confirms that its Steering Committee members are: [***], [***]
and [***]. Althea confirms that its Steering Committee members are: [***],
[***], and [***].
10. Effectiveness of Agreement. Except as specifically amended by this
Amendment, the terms and conditions of the Agreement shall remain in full force
and effect.
11. Counterparts. This Amendment may be executed in counterparts, each of which
shall be deemed an original document, and all of which, together with this
writing, shall be deemed one instrument.
[SIGNATURE PAGE FOLLOWS]

4.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

     In Witness Whereof, the Parties hereto have duly executed this Amendment as
of the Amendment Date.

                              Altus Pharmaceuticals Inc.       Althea
Technologies, Inc.
 
                           
By:
  /s/ Sheldon Berkle       By:   /s/ W. Alan Moore            
 
                           

  Name:  Sheldon Berkle         Name:  W. Alan Moore            

  Title: President and Chief Executive Officer         Title: Executive Vice
President and
          Chief Business Officer            

5.

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

Exhibit A
Amended and Restated Schedule 1

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

ALTU-238 Project Plan
[***]

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

Exhibit B
Change Orders Submitted as of the Amendment Date

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

(ALTHEA TECHNOLOGIES, INC. LOGO) [b66164apb6616400.gif]
Contract Change Order No. 6
Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing
Page 1 of 1

             
To: [***]
    Change Order No: 6    
Manager, Contract Manufacturing
    Change Order Date: 05-02-07    
Altus Pharmaceuticals Inc.
         
125 Sidney Street
         
Cambridge, MA 02139-4807
         
 
    Althea Contact: [***]    
Telephone No: [***]
    Office: [***]    
Fax No: (617) 299-2899
    Fax: [***]    
Email: [***]@altus.com
    Email: [***]@altheatech.com    

                                                                               
            Change Order Description     Qty       Unit Price       Total Price
                                                           
 
                                 
 
      [***]         [***]         [***]      
[***]
                                 
 
                                 
[***]
                                 
 
                                 
[***]
                                 
[***]
                                 
[***]
                                 
[***]
                                 
 
                                                         
TOTAL
                          [***]                            

Pursuant to the terms and conditions of the Drug Product Production and Clinical
Supply Agreement dated August 16, 2006 by and between Altus Pharmaceuticals,
Inc. and Althea Technologies, Inc. Signatures below acknowledge agreement with
the quotation description of services.

             
ALTUS PHARMACEUTICALS, INC
      ALTHEA TECHNOLOGIES, INC.    
 
           
 
           
 
           
PRINT NAME
      PRINT NAME    
 
           
 
           
TITLE
      TITLE    
 
           
 
           
SIGNATURE
      SIGNATURE    
 
           
 
           
DATE
      DATE    
 
           
 
           
ALTUS PURCHASE ORDER NUMBER
           

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

(ALTHEA TECHNOLOGIES, INC. LOGO) [b66164apb6616400.gif]
Contract Change Order No. 11
Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing
Page 1 of 1

             
To: [***]
    Change Order No: 11    
Manager, Contract Manufacturing
    Change Order Date: 06-06-07    
Altus Pharmaceuticals Inc.
         
125 Sidney Street
         
Cambridge, MA 02139-4807
         
 
    Althea Contact: [***]    
Telephone No: [***]
    Office: [***]    
Fax No: (617) 299-2899
    Fax: [***]    
Email: [***]@altus.com
    Email: [***]@altheatech.com    

                                                                               
            Change Order Description     Qty       Unit Price       Total Price
                                                           
 
                                 
 
      [***]         [***]         [***]      
 
                                 
[***]
                                 
 
                                 
[***]
                                 
 
                                 
[***]
      [***]         [***]         [***]      
 
                                 
[***]
                                 
[***]
                                 
 
                                                         
TOTAL
                          [***]                            

Pursuant to the terms and conditions of the Drug Product Production and Clinical
Supply Agreement dated August 16, 2006 by and between Altus Pharmaceuticals,
Inc. and Althea Technologies, Inc. Signatures below acknowledge agreement with
the quotation description of services.

             
ALTUS PHARMACEUTICALS, INC
      ALTHEA TECHNOLOGIES, INC.    
 
           
 
           
 
           
PRINT NAME
      PRINT NAME    
 
           
 
           
TITLE
      TITLE    
 
           
 
           
SIGNATURE
      SIGNATURE    
 
           
 
           
DATE
      DATE    
 
           
 
           
ALTUS PURCHASE ORDER NUMBER
           

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

(ALTHEA TECHNOLOGIES, INC. LOGO) [b66164apb6616400.gif]
Contract Change Order No. 13
Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing
Page 1 of 1

             
To: [***]
    Change Order No: 13    
Manager, Contract Manufacturing
    Change Order Date: 06-06-07    
Altus Pharmaceuticals Inc.
         
125 Sidney Street
         
Cambridge, MA 02139-4807
         
 
    Althea Contact: [***]    
Telephone No: [***]
    Office: [***]    
Fax No: (617) 299-2899
    Fax: [***]    
Email: [***]@altus.com
    Email: [***]@altheatech.com    

                                                                               
            Change Order Description     Qty       Unit Price       Total Price
                                                           
 
                                 
 
      [***]         [***]         [***]      
 
                                 
[***]
                                 
 
                                 
[***]
                                 
[***]
                                 
 
                                                         
TOTAL
                          [***]                            

Pursuant to the terms and conditions of the Drug Product Production and Clinical
Supply Agreement dated August 16, 2006 by and between Altus Pharmaceuticals,
Inc. and Althea Technologies, Inc. Signatures below acknowledge agreement with
the quotation description of services.

             
ALTUS PHARMACEUTICALS, INC
      ALTHEA TECHNOLOGIES, INC.    
 
           
 
           
 
           
PRINT NAME
      PRINT NAME    
 
           
 
           
TITLE
      TITLE    
 
           
 
           
SIGNATURE
      SIGNATURE    
 
           
 
           
DATE
      DATE    
 
           
 
           
ALTUS PURCHASE ORDER NUMBER
           

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

(ALTHEA TECHNOLOGIES, INC. LOGO) [b66164apb6616400.gif]
Contract Change Order No. 17
Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing
Page 1 of 1

             
To: [***]
    Change Order No: 17    
Manager, Contract Manufacturing
    Change Order Date: 06-06-07    
Altus Pharmaceuticals Inc.
         
125 Sidney Street
         
Cambridge, MA 02139-4807
         
 
    Althea Contact: [***]    
Telephone No: [***]
    Office: [***]    
Fax No: (617) 299-2899
    Fax: [***]    
Email: [***]@altus.com
    Email: [***]@altheatech.com    

                                                                               
            Change Order Description     Qty       Unit Price       Total Price
                                                           
 
                                 
 
      [***]         [***]         [***]      
 
                                 
[***]
                                 
 
                                 
[***]
                                 
[***]
                                 
[***]
                                 
[***]
                                 
[***]
                                 
[***]
                                 
 
                                                         
TOTAL
                          [***]                            

Pursuant to the terms and conditions of the Drug Product Production and Clinical
Supply Agreement dated August 16, 2006 by and between Altus Pharmaceuticals,
Inc. and Althea Technologies, Inc. Signatures below acknowledge agreement with
the quotation description of services.

             
ALTUS PHARMACEUTICALS, INC
      ALTHEA TECHNOLOGIES, INC.    
 
           
 
           
 
           
PRINT NAME
      PRINT NAME    
 
           
 
           
TITLE
      TITLE    
 
           
 
           
SIGNATURE
      SIGNATURE    
 
           
 
           
DATE
      DATE    
 
           
 
           
ALTUS PURCHASE ORDER NUMBER
           

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.

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

 

(ALTHEA TECHNOLOGIES, INC. LOGO) [b66164apb6616400.gif]
Contract Change Order No. 18
Altus Pharmaceuticals, Inc. ALTU-238 Phase III Manufacturing
Page 1 of 1

             
To: [***]
    Change Order No: 18    
Manager, Contract Manufacturing
    Change Order Date: 06-06-07    
Altus Pharmaceuticals Inc.
         
125 Sidney Street
         
Cambridge, MA 02139-4807
         
 
    Althea Contact: [***]    
Telephone No: [***]
    Office: [***]    
Fax No: (617) 299-2899
    Fax: [***]    
Email: [***]@altus.com
    Email: [***]@altheatech.com    

                                                                               
            Change Order Description     Qty       Unit Price       Total Price
                                                           
 
                                 
 
      [***]         [***]         [***]      
[***]
                                 
 
                                 
[***]
                                 
[***]
                                 
 
                                 
 
                                                         
TOTAL
                          [***]                            

Pursuant to the terms and conditions of the Drug Product Production and Clinical
Supply Agreement dated August 16, 2006 by and between Altus Pharmaceuticals,
Inc. and Althea Technologies, Inc. Signatures below acknowledge agreement with
the quotation description of services.

             
ALTUS PHARMACEUTICALS, INC
      ALTHEA TECHNOLOGIES, INC.    
 
           
 
           
 
           
PRINT NAME
      PRINT NAME    
 
           
 
           
TITLE
      TITLE    
 
           
 
           
SIGNATURE
      SIGNATURE    
 
           
 
           
DATE
      DATE    
 
           
 
           
ALTUS PURCHASE ORDER NUMBER
           

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO THE COMPANY’S APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT.