Exhibit 10.2.1

 

Execution Version

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

  

AMENDMENT #1 TO

MANUFACTURING AND SUPPLY AGREEMENT

 

THIS AMENDMENT #1 TO MANUFACTURING AND SUPPLY AGREEMENT (this “Amendment #1”)
dated the 12th day of December, 2017 (the “Amendment #1 Effective Date”) is made
by and between Intercept Pharma Europe Ltd., having a location at 2 Pancras
Square, Floor 1, London, United Kingdom N1C 4AG (“Intercept”), and PharmaZell
GmbH, a corporation organized under the laws of Germany (“PharmaZell”).
Intercept and PharmaZell are sometimes referred to herein individually as a
“Party” and collectively as the “Parties.”

 

WHEREAS, Intercept and PharmaZell previously entered into that certain
Manufacturing and Supply Agreement dated August 12, 2016 (the “Agreement”);

 

WHEREAS, the Parties desire to amend the Agreement on the terms and conditions
set forth in this Amendment #1.

 

NOW, THEREFORE, in consideration of the foregoing premises, the mutual promises
and covenants of the Parties contained herein, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties, intending to be legally bound, do hereby agree as follows:

 

1. Capitalized terms used but not defined in this Amendment #1 shall have the
meanings ascribed thereto in the Agreement.

 

2. With respect to the [**] validation campaign of API under the proposal dated
August 24, 2014 (the “Existing Work Order”), provided that PharmaZell has
provided to Intercept on or before the Amendment #1 Effective Date the
validation documentation for the Supplied Material and evidence that
approximately [**] of the Supplied Material that is the subject of such Existing
Work Order has been shipped to Intercept in accordance with the terms and
conditions of the Agreement, Intercept shall pay to PharmaZell on or before [**]
the amount of [**] as full and final payment for the Supplied Material that is
the subject of such Existing Work Order.

 

3. Notwithstanding the ordering, delivery dates and payment provisions set forth
in the Agreement or Work Order #1, with respect to the Supplied Material that is
the subject of Work Order #1 (“Campaign 1”), such Work Order will be amended and
replaced with the Work Orders attached to this Amendment #1 as Exhibit 1 and
Exhibit 2 and the following shall apply:

 

3.1The Parties agree that PharmaZell has achieved [**] Steps of the
Manufacturing Process and has invoiced Intercept for the same. Intercept shall
pay to PharmaZell on or before [**] the amount of [**] for the achievement of
[**] Steps of the Manufacturing Process as invoiced by PharmaZell.

 

3.2With respect to [**] Steps of the Manufacturing Process, in accordance with
the Agreement, this Amendment #1 and the Work Order attached hereto as Exhibit
1, PharmaZell shall Manufacture and invoice the Supplied Material that is the
subject of Campaign 1 based on a [**] Supplied Material order size at a price
per [**] equal to [**] (even though the Work Order attached hereto as Exhibit 1
is for [**] (subject to the [**] cap of Section 2.7(f) of the Agreement (i.e.,
Intercept shall have no obligation to purchase more than [**] of Campaign 1)))
in accordance with the terms and conditions of the Agreement with the expected
dates as follows:

 

Milestone Step of Manufacturing Process Percentage of total Purchase Price
Required Date of Completion of Step of Manufacturing Process [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]

 

The required Delivery Date for [**] is set forth in the Work Order attached
hereto as Exhibit 1.

 

3.3Upon the completion of the [**] Step of the Manufacturing Process, PharmaZell
shall divide the amount of [**] into [**], [**] of which shall be the “Campaign
1 Processed Amount” and [**] of which shall be the “Campaign 1 Stored Amount”.

 

(a)PharmaZell, in accordance with the terms and conditions of the Agreement,
this Amendment #1 and the Work Order attached hereto as Exhibit 2, shall process
and Manufacture the Campaign 1 Processed Amount into API, and upon completion,
shall provide the documentation and deliver to Intercept the API resulting from
the Campaign 1 Processed Amount. PharmaZell shall invoice Intercept for the
Campaign 1 Processed Amount in an amount equal to [**] of the total Purchase
Price for Campaign 1 (based on [**]). The required Delivery Date for the API
from the Campaign 1 Processed Amount is set forth in the Work Order attached
hereto as Exhibit 2.

 

 

 

 

(b)With respect to the Campaign 1 Stored Amount, such Campaign 1 Stored Amount
shall be considered “Intercept Material” and stored and handled by PharmaZell in
accordance with the terms and conditions of Sections 2.7(a)-(d) of the Agreement
and such additional storage and handling conditions as are set forth in the
Quality Agreement and the Work Order attached hereto as Exhibit 2. On or before
[**], Intercept shall notify PharmaZell that Intercept either desires PharmaZell
to (a) Manufacture the Campaign 1 Stored Amount into API and deliver such API to
Intercept in accordance with the terms and conditions of the Agreement or (b)
continue to store the Campaign 1 Stored Amount as Intercept Material beyond
[**].

 

(c)In the event that Intercept requires PharmaZell to Manufacture the Campaign 1
Stored Amount into API, Intercept shall issue a new Work Order by [**] for such
Manufacturing and specify the requested Delivery Date therefor (it being
understood that with respect to the Delivery Date for the API to be Manufactured
from the Campaign 1 Stored Amount, Intercept shall have the right to specify a
Delivery Date that is [**] months after the issuance of such Work Order). Upon
the delivery of the API resulting from the Campaign 1 Stored Amount, PharmaZell
shall invoice Intercept for the remaining percentage of the Purchase Price (at a
price per [**] of [**]) in accordance with the Agreement based on the amount of
API actually delivered (taking into account the total amount of API delivered
from the Campaign 1 Processed Amount and the Campaign 1 Stored Amount).

 

(d)In the event that Intercept requires PharmaZell to continue to store the
Campaign 1 Stored Amount, (i) PharmaZell shall continue to store such Campaign 1
Stored Amount until the earlier of (x) the expiration or termination of the
Agreement or (y) such time as Intercept requires PharmaZell to Manufacture the
Campaign 1 Stored Amount into API, and (ii) PharmaZell shall invoice Intercept
for [**] of the Purchase Price based on an expected yield conversion of [**]
from [**] to API, (subject to a cap of [**] of API). At any time during the
Term, Intercept may issue a Work Order with a requested Delivery Date for
PharmaZell to Manufacture the Campaign 1 Stored Amount into API (it being
understood that with respect to the Delivery Date for the API to be Manufactured
from the Campaign 1 Stored Amount, Intercept shall have the right to specify a
Delivery Date that is [**] months after the issuance of such Work Order). Upon
the delivery of the API resulting from the Campaign 1 Stored Amount, PharmaZell
shall invoice Intercept for the remaining percentage of the Purchase Price in
accordance with the Agreement based on the amount of API actually delivered
(taking into account the amount of API delivered from the Campaign 1 Processed
Amount and the Campaign 1 Stored Amount). If Intercept has not required
PharmaZell to Manufacture the Campaign 1 Stored Amount into API prior to the
expiration or termination of the Agreement, upon the written direction of
Intercept, PharmaZell shall either deliver such Campaign 1 Stored Amount to
Intercept or its designee or destroy such Campaign 1 Stored Amount.

 

 2 

 

 

4. On the Amendment Effective Date, Intercept is hereby issuing the Work Orders
for [**] of API, with the Work Order attached as Exhibit 3 for the manufacture
of such campaign through [**] and the Work Order attached hereto as Exhibit 4
for the manufacture of [**] into API. Notwithstanding the ordering, delivery
dates and payment provisions set forth in the Agreement, with respect to the API
that is the subject of the Work Orders attached hereto as Exhibit 3 and Exhibit
4 (“Campaign 2”), the following shall apply:

 

4.1With respect to the [**] Steps of the Manufacturing Process, PharmaZell shall
Manufacture and invoice the Supplied Material that is the subject of Campaign 2
based on a [**] Supplied Material order size (subject to the [**] cap of Section
2.7(f) of the Agreement (i.e., Intercept shall have no obligation to purchase
more than [**] of Campaign 2) in accordance with the terms and conditions of the
Agreement and the below table:

 

Milestone Step of Manufacturing Process Percentage of total Purchase Price
Required Date of Completion of Step of Manufacturing Process [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]

 

The required Delivery Date for the [**] from the Campaign 2 Processed Amount is
set forth in the Work Order attached hereto as Exhibit 3.

 

4.2Upon the completion of the [**] Step of the Manufacturing Process, PharmaZell
shall divide the amount of [**] into [**], [**] of which shall be the “Campaign
2 Processed Amount” and [**] of which shall be the “Campaign 2 Stored Amount”.

 

(a)PharmaZell, in accordance with the terms and conditions of the Agreement,
this Amendment #1 and the Work Order attached hereto as Exhibit 4 shall process
and Manufacture the Campaign 2 Processed Amount into API, and upon completion,
shall provide the documentation and deliver to Intercept the API resulting from
the Campaign 2 Processed Amount. PharmaZell shall invoice Intercept for the
Campaign 2 Processed Amount in amount equal to [**] of the total Purchase Price
for Campaign 2 (based on [**]). The required Delivery Date for the API from the
Campaign 2 Processed Amount is set forth in the Work Order attached hereto as
Exhibit 4.

 

 3 

 

 

(b)With respect to the Campaign 2 Stored Amount, such Campaign 2 Stored Amount
shall be considered “Intercept Material” and shall be stored and handled by
PharmaZell in accordance with the terms and conditions of Sections 2.7(a)-(d) of
the Agreement and such additional storage and handling conditions as are set
forth in the Quality Agreement and the Work Order attached hereto as Exhibit 4.
On or before [**], Intercept shall notify PharmaZell that Intercept either
desires PharmaZell to (a) Manufacture the Campaign 2 Stored Amount into API and
deliver such API to Intercept in accordance with the terms and conditions of the
Agreement or (b) continue to store the Campaign 2 Stored Amount as Intercept
Material beyond [**]; provided that the [**] date shall be extended day-for-day
for every day that PharmaZell delivers the [**] beyond the Delivery Date for
such [**] set forth in the Work Order attached as Exhibit 3.

 

(c)In the event that Intercept requires PharmaZell to Manufacture the Campaign 2
Stored Amount into API, Intercept shall issue a new Work Order for such
Manufacturing by the later of [**] or [**], and specify the requested Delivery
Date therefor (it being understood that with respect to the Delivery Date for
the API to be Manufactured from the Campaign 2 Stored Amount, Intercept shall
have the right to specify a Delivery Date that is [**] months after the issuance
of such Work Order). Upon the delivery of the API resulting from the Campaign 2
Stored Amount, PharmaZell shall invoice Intercept for the remaining percentage
of the Purchase Price in accordance with the Agreement based on the amount of
API actually delivered (taking into account the total amount of API delivered
from the Campaign 2 Processed Amount and the Campaign 2 Stored Amount).

 

(d)In the event that Intercept requires PharmaZell to continue to store the
Campaign 2 Stored Amount, (i) PharmaZell shall continue to store such Campaign 2
Stored Amount until the earlier of (x) the expiration or termination of the
Agreement or (y) such time as Intercept requires PharmaZell to Manufacture the
Campaign 2 Stored Amount into API, and (ii) PharmaZell shall invoice Intercept
for [**]of the Purchase Price based on an expected yield conversion of [**] from
[**] to API (subject to a cap of [**] of API). At any time during the Term,
Intercept may issue a Work Order with a requested Delivery Date for PharmaZell
to Manufacture the Campaign 2 Stored Amount into API (it being understood that
with respect to the Delivery Date for the API to be Manufactured from the
Campaign 2 Stored Amount, Intercept shall have the right to specify a Delivery
Date that is [**] months after the issuance of such Work Order). Upon the
delivery of the API resulting from the Campaign 2 Stored Amount, PharmaZell
shall invoice Intercept for the remaining percentage of the Purchase Price in
accordance with the Agreement based on the amount of API actually delivered
(taking into account the amount of API delivered from the Campaign 2 Processed
Amount and the Campaign 2 Stored Amount). If Intercept has not required
PharmaZell to Manufacture the Campaign 2 Stored Amount into API prior to the
expiration or termination of the Agreement, upon the written direction of
Intercept, PharmaZell shall either deliver such Campaign 2 Stored Amount to
Intercept or its designee or destroy such Campaign 2 Stored Amount.

 

 4 

 

 

5. The Parties acknowledge and agree that, notwithstanding anything to the
contrary contained in Section 2.2(b) of the Agreement, the issuance of the Work
Orders attached hereto for Campaign 1 has satisfied Intercept’s Minimum Annual
Requirement for Calendar Year 2017 and the issuance of the Work Orders attached
hereto for Campaign 2 has satisfied Intercept’s Minimum Annual Requirement for
Calendar Year 2018, and Intercept shall have no further obligations to order any
quantities of Supplied Material for delivery in either Calendar Year 2017 or
Calendar Year 2018.

 

6. Schedule 2.2(b) of the Agreement is hereby deleted.

 

7. Schedule 2.7(e) of the Agreement is hereby replaced in its entirety with the
Schedule 2.7(e) attached to this Amendment #1 as Appendix 1.

 

8. Except as specifically amended hereby, the Agreement remains in full force
and effect.

 

9. The Governing Law and Dispute Resolution provisions contained in Sections
10.6 and 10.7 of the Agreement shall apply to any disputes under this Amendment
#1 as if fully set forth herein.

 

10. This Amendment #1 may be executed in any number of counterparts, each of
which shall be deemed to be an original, and all of which, taken together, shall
constitute one and the same instrument. Delivery of an executed counterpart of a
signature page of this Amendment #1 (and each amendment, modification and waiver
in respect of it) by facsimile or other electronic transmission shall be as
effective as delivery of a manually executed original counterpart of each such
instrument.

 

11. This Amendment #1 shall be written and executed in, and all other
communications under or in connection with this Amendment #1 shall be in, the
English language. Any translation into any other language shall not be an
official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.

 

Signature Page to Follow

 

 5 

 

 

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment #1 to be
effective as of the last date of signature below.

  

INTERCEPT PHARMA EUROPE LTD. 

  PHARMAZELL GmbH           By: /s/ Daniel Hood   By: /s/ Dr. Wolfgang Burger  
        Name: Daniel Hood   Name: Dr. Wolfgang Burger           Title:
Authorized Signatory   Title: VP Business Development           Date: December
12, 2017   Date: December 12, 2017  

  

 

 

Signature Page to Amendment #1 to Manufacturing and Supply Agreement

 

 

 

APPENDIX 1

 

Schedule 2.7(e)

 

Standard Yields

 

[**]