[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
Exhibit 10.3

AMENDMENT NO. 1 CLINICAL AND COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT

This Amendment No. 1 (“Amendment No. 1”) is entered into by JAZZ PHARMACEUTICALS
IRELAND LIMITED (“JAZZ”) and BAXTER ONCOLOGY GmbH (“Baxter”) as of January 18,
2018 (“Amend No. 1 Effective Date”).
WHEREAS, Celator Pharmaceuticals, Inc. (“Celator”) and Baxter entered into that
certain Clinical and Commercial Manufacturing and Supply Agreement dated as of
December 22, 2010 (the “Agreement”);
AND WHEREAS, JAZZ acquired Celator effective July 12, 2016 and the Agreement was
assigned to JAZZ effective July 13, 2016;

AND WHEREAS, JAZZ and Baxter wish to amend certain provision(s) of the Agreement
to change (i) the purchasing of certain JAZZ-supplied Components, (ii) the
forecasting and (iii) the obligations to purchase/supply Product, among other
things;

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual
promises hereinafter set forth JAZZ and Baxter agree that the following
amendments shall be made to the Agreement as of the Amend No. 1 Effective Date:
1.All references to “Celator” under the Agreement are hereby amended to read
“JAZZ”.
2.Article 1 “DEFINITIONS”, the definitions for “Baxter-supplied Components”,
“Contract Year”, “JAZZ-supplied Components” and “Reservation Fees” are hereby
deleted and replaced with the following definitions:
“Baxter-supplied Components” shall mean those Components to be supplied by
Baxter as specified in the Product Master Plan.”
“Contract Year” shall mean the twelve (12) month period commencing on 3 August
2017 and each subsequent twelve (12) month period during the Commercial Term.”
“JAZZ-supplied Components” shall mean those Components to be supplied by JAZZ as
specified in the Product Master Plan.”
“Reservation Fees” shall be the fees payable by JAZZ for modification or
cancellation of a Firm Purchase Order as set forth in Section 4.4

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

3.Article 1 “DEFINITIONS”, the definitions for “DSPC”, “DSPG” and “Production
Price” are hereby deleted in their entirety.
4.Article 1 “DEFINTIONS”, the following will be added as a new definition
“Campaign”:
“Campaign” shall mean the running of at least [*] of Commercial Product in
sequence without interruption by a different product manufactured in the same
room which Campaign must result in at least the reduction of [*] of set up, [*]
of functional testing and [*] of cleaning post functional testing as compared to
the Production of a single Batch of Commercial Product.
5.Section 3.3 including subsection 3.3.1 “Components” are hereby deleted and
replaced with the following:
“3.3    Components. As set forth in the Product Master Plan, Jazz shall purchase
and supply Jazz-supplied Components which Jazz, at its sole cost and expense
(including, without limitation, shipping costs), shall supply to Baxter, in a
timely manner as set forth in Section 4.5 Component Delivery Delays. Baxter
shall procure, in a timely manner, and have available for Production of Product
Baxter-supplied Components, at its sole cost and expense (including, without
limitation, shipping costs), required to satisfy the terms of this Agreement. On
receipt of the Components, Baxter shall test such materials as set forth in the
Product Master Plan. If, notwithstanding such testing, Jazz determines to assert
a claim against a supplier of a Baxter-supplied Component because Jazz discovers
a defect in or adulteration of such Baxter-supplied Component that was not
discovered by Baxter, Baxter agrees to provide Jazz with all information
regarding such Baxter-supplied Component and the supplier thereof as Jazz shall
reasonably request and to cooperate with Jazz in the assertion of each such
claim.
3.3.1    Vendor/Supplier Qualification. The responsibility for vendor/supplier
qualification is set forth in the Quality Agreement.
3.3.2    Baxter-supplied Components. Unless otherwise set forth in a Product
Master Plan, Baxter will purchase the Baxter-supplied Components in sufficient
quantities and with a shelf life of more than [*] at the time of Baxter’s
purchase of such Baxter-supplied Components as is required to meet the greater
of (a) JAZZ’s forecasted demand for Product as set forth in the [*] JAZZ’s
Rolling Forecast, or (b) the minimum order quantity requirements as defined by
the third-party supplier.
3.3.2.1 Unused Baxter-supplied Components. Except in the event JAZZ previously
pays for unused Baxter-supplied Components as part of the Reservation Fees paid
to Baxter resulting from the cancellation or modification of a Firm Purchase
Order (as set out in Section 4.4), if any Baxter-supplied Component ordered in
accordance with Section 3.3.2 is not used within [*] of Baxter’s receipt of such
Component, JAZZ agrees to

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

pay Baxter [*] within [*] of the date of Baxter’s invoice. If the
Baxter-supplied Components paid for by JAZZ have not expired, such Components
can be booked on a JAZZ specific material number and used in the future for the
Production of Product, and in this case, Baxter will rebate the corresponding
cost of the Baxter-supplied Component previously paid for by JAZZ from the Batch
price.
3.3.2.2    Expired Baxter-supplied Components. Provided Baxter has met its
obligations regarding shelf-life under Section 3.3.2, if any quantities of a
Baxter-supplied Component ordered in accordance with Section 3.3.2 expire prior
to Baxter’s use of such Component in Production of Product, [*] the expired
Baxter-supplied Component and [*] the expired Component and [*].
3.3.2.3    Additional Baxter-supplied Components. The Parties agree it is the
intention of the Parties that Baxter provide additional Components for the
Production of JAZZ’s Commercial Product Vyxeos, which Components are currently
provided by JAZZ. Such additional Components include [*] (“Additional
Baxter-supplied Components”). Baxter must confirm, at JAZZ’s expense, the cGMP
compliance status of the suppliers of the Additional Baxter-supplied Components,
pursuant to Baxter’s requirements with respect new supplier qualification, prior
to Baxter providing any such Component. If Baxter begins to provide and use any
of these Additional Baxter-supplied Components in the Production of JAZZ’s
Commercial Product Vyxeos, the Purchase Price of such Commercial Product will
increase to include the cost of such Additional Baxter-supplied Components plus
[*] of the cost of the Additional Baxter-supplied Components (as a ‘service
fee’), which service fee will cover those activities as set forth in the Product
Master Plan. This Agreement will be amended to reflect such increased Purchase
Price in a revised Exhibit C. For the avoidance of doubt, once Baxter begins to
procure and use the Additional Baxter-supplied Components, such Components will
be considered Baxter-supplied Components and subject to this Section 3.3.2,
including subsections 3.3.2.1 and 3.3.2.2.”
6.Section 4.1 “Forecasts for Clinical Product”, the last sentence beginning with
“In the event Baster is unable to fill such open capacity…” is hereby deleted
and replaced with the following:
“In the event Baxter is unable to fill such open capacity, Baxter may charge
JAZZ a Reservation Fee as set forth in Section 4.4.”
7.Section 4.2 “Forecasts for Commercial Product” is hereby deleted and replaced
with the following:

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

“4.2    Forecasts for Commercial Product. Commencing no less than [*] prior to
the date of the Production of the first Batch of Commercial Product, and prior
to April 1 of each year thereafter, JAZZ will provide to Baxter in writing a
forecast for each calendar year during the remainder of the Term of JAZZ’s
estimated contract requirements for each Product (the “Long Range Forecast”).
The Long Range Forecast submitted by JAZZ will be for general planning purposes
only, and shall not be binding on JAZZ or Baxter. Commencing on 3 August 2017,
and prior to the tenth (10th) day of each month thereafter, JAZZ will provide to
Baxter in writing [*] rolling forecast, broken down by month, of JAZZ’s
estimated requirements for the Product (the “Rolling Forecast”). The first [*]
of each Rolling Forecast shall be [*] binding on JAZZ and Baxter, subject to
Section 4.2.1 (the “[*] Period”). JAZZ shall not decrease or increase quantities
of Product forecasted within the [*] Period without Baxter’s consent. The
remaining [*] months of the Rolling Forecast, i.e. months [*] through [*], shall
be non-binding.
4.2.1    Upon Baxter’s receipt of each Rolling Forecast, Baxter will compare the
quantities forecasted in the [*] Period to Baxter’s pro-rated Maximum Supply
Obligation for such period and to the previous Rolling Forecast submitted by
JAZZ. If: (i) the quantities forecasted in the [*] Period are equal to or less
than Baxter’s pro-rated Maximum Supply Obligation for such period, and provided
that JAZZ has not increased its forecasted quantities in comparison to month [*]
of the previous Rolling Forecast when it becomes month [*] of the [*] Period,
the quantities forecasted in the [*] Period shall be [*] binding on Baxter and
JAZZ; or (ii) such quantities forecasted in the [*] Period are greater than
Baxter’s pro-rated Maximum Supply Obligation for such period, Baxter will
confirm to JAZZ within [*] what quantities in excess of such pro-rated Maximum
Supply Obligation it is able to Produce, and such confirmed additional
quantities will also be [*] binding on Baxter and JAZZ (the “Binding [*]
Period”). If Baxter does not confirm its ability to Produce additional
quantities within such [*] period, Baxter shall be deemed to have so confirmed
and such additional quantities will be [*] binding on both Parties.”

8.Section 4.3 including Subsection 4.3.1 “Annual Obligation for Commercial
Product and Maximum Supply Obligation”, are hereby deleted and replaced with the
following:
“4.3    Annual Obligation for Commercial Product and Maximum Supply Obligation.
Jazz shall be obligated, upon receiving Regulatory Approval of the Product in
the United States or Europe, to purchase from Baxter a minimum number of Batches
of Commercial Product in each Contract Year during the Term of this Agreement
(the "Annual Obligation") as set forth in Exhibit A, which Annual Obligation
shall be prorated for any partial Contract Year. For the avoidance of doubt, in
each Contract Year JAZZ must order for delivery in such Contract Year the
greater of (i) the Annual Obligation or (ii) the binding portion of the Rolling
Forecasts for such Contract Year as set forth above in Section 4.2.1. Within [*]
after the end of each Contract Year, JAZZ shall pay Baxter for the difference
between the aggregate

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Purchase Price of Product actually ordered by JAZZ for delivery pursuant to
Section 4.2 in the Contract Year and the aggregate Purchase Price of the greater
of (i) the Annual Obligation or (ii) the binding portion of the Rolling
Forecasts. In any Contract Year during the Term of this Agreement, in no event
shall Baxter be obligated to Produce more than the number of Batches set forth
in Exhibit B ("Maximum Supply Obligation"); provided, however, Baxter will use
commercially reasonable efforts to provide additional Batches of Product if
requested by JAZZ. If changes (increase/decrease) in the annual order volume
require changes in equipment and/or process, Jazz will cover the costs of such
changes.”
4.3.1    At least [*] prior to the expiration of (i) the Commercial Initial Term
and (ii) each Commercial Renewal Term, the Parties, acting reasonably, shall
mutually agree upon JAZZ’s Annual Obligation and Baxter’s Supply Obligation for
the upcoming Commercial Renewal Term and such obligations shall be set forth in
an amended Exhibit A and Exhibit B to the Agreement. In the event the Parties
are unable to reach agreement on JAZZ’s Annual Obligation Commitment and
Baxter’s Supply Obligation for any Commercial Renewal Term, JAZZ’s Annual
Obligation and Baxter’s Supply Obligation for such Commercial Renewal Term shall
[*] or [*], as the case may be.
4.3.2    Notwithstanding the foregoing, with at least [*] prior notice, JAZZ may
request an increase in its Annual Obligation for a Contract Year; which, when
agreed to and confirmed in writing by Baxter with Baxter’s agreement and
confirmation not to be unreasonably withheld, will result in corresponding
increases in both JAZZ’s Annual Obligation and Baxter’s Maximum Supply
Obligation for such Contract Year. Exhibits A and B will be amended at that time
to reflect such increases.
9.Exhibit A “JAZZ’s ANNUAL OBLIGATION” and Exhibit B “BAXTER’s MAXIMUM SUPPLY
OBLIGATION” are hereby deleted in their entirety and replaced with the Exhibits
A and B attached to this Amendment No. 1.
10.Section 4.4 “Purchase Orders”, the second sentence only of the first
paragraph beginning “JAZZ shall not, without the written consent of Baxter,…” is
hereby deleted and replaced with the following sentence:
“JAZZ shall not, without the written consent of Baxter, designate a requested
pick-up date in a Purchase Order earlier than [*] from the date JAZZ submits the
Purchase Order.”
11.Section 4.4 “Purchase Orders”, the final two paragraphs beginning with “In
the event that JAZZ modifies or cancels a Firm Purchase Order…” are hereby
deleted and replaced with the following two paragraphs:
“In the event that JAZZ modifies or cancels a Firm Purchase Order through no
fault of Baxter, without Baxter’s written consent (which shall not be
unreasonable withheld or

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

delayed), Baxter may charge JAZZ [*] for each modified or cancelled Batch (a
“Reservation Fee”) [*]. The term “modifies” and “modified” herein shall mean
modification which prevents Baxter’s Production of a Batch within the scheduled
Production slot; provided, however, if the modification is insignificant and
Baxter is able to Produce the Batch according to such modification without any
material impact to its manufacturing schedule (e.g. Baxter left with open
capacity in its manufacturing schedule) and without preventing Baxter’s
manufacturing of any third party’s product, then Baxter will not charge JAZZ a
Reservation Fee.
JAZZ shall order full batches of Product on a single Purchase Order, either as
single batches or as part of a Campaign(s).”    
12.Section 4.5 “Component Delivery Delay” is hereby deleted and replaced with
the following:
“4.5    Component Delivery Delays. Timely delivery of JAZZ-supplied Components
shall mean that the respective Component and the documents required under the
Product Master Plan arrive at Baxter at least [*] business days prior to the
scheduled manufacturing date of such Product, as determined by the date set
forth in the Firm Purchase Order. Notwithstanding anything in this Agreement to
the contrary, in the event that Baxter receives such JAZZ-supplied Components
and associated cGMP documents for the Production of Product from JAZZ less than
[*] business days prior to the scheduled manufacturing date of such Product,
Baxter shall use commercially reasonable efforts to reschedule Batch within [*]
days after receipt. [*], Baxter may charge JAZZ a Reservation Fee as defined in
Section 4.4.”
13.Section 5.1 “Purchase Price” is hereby deleted and replaced with the
following:
“5.1    “Purchase Price. The price to be paid by JAZZ for the Production of
Product (the “Purchase Price”) shall be set forth in the Exhibit C. The Purchase
Price includes the cost of the Baxter-supplied Components. For each Batch of
Commercial Product Produced in a Campaign, the Purchase Price of each such Batch
will be reduced by the amount as set forth in Exhibit C.”
14.Section 5.2 “Production Price Adjustment for Commercial Product”, is hereby
deleted and replaced with the following:
“5.2    Purchase Price Adjustment for Commercial Product. On January 1, 2019,
Baxter shall adjust the Purchase Price of Commercial Product to reflect changes
in Baxter’s actual costs since the date on which the Production Price was last
established, but in an amount not to exceed [*] (i) the percentage increase in
the Index of Producer Prices of Industrial Products during the previous twelve
(12) month period as published by the Federal Statistical Office of Germany
(www.destatis.de) and (ii) [*]. Commencing on January 1, 2020 and on each
January 1 thereafter during the Term, Baxter shall adjust the Purchase Price of
Commercial Product in an amount not to exceed the percentage increase in the
Index of Producer Prices of Industrial Products

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

during the previously twelve (12) month period as published by the Federal
Statistical Office of Germany (www.destatis.de). In addition to the foregoing
increases, increases by third party suppliers in the price of Baxter-supplied
Components used in the Production of Product may also result in increases in the
Purchase Price. Written notification of all increases to the Purchase Price will
be sent by Baxter to JAZZ. In the event Baxter provides written notification to
JAZZ of a price increase due to third party supplier price increases, Baxter
will support this by providing supporting supplier verification, prior to
implementation of such increases.
15.Section 7.2.2B is hereby deleted and replaced with the following;
“7.2.2B     In the event Baxter agrees that Commercial Product is non-conforming
to the Product Requirements, or the laboratory or consultant determines that
such Commercial Product is non-conforming, JAZZ shall provide replacement
JAZZ-supplied Components, including API, and any other JAZZ supplied materials
to Baxter, at JAZZ’s expense, and Baxter shall replace such non-conforming
Commercial Product as soon as possible assuming sufficient JAZZ-supplied
Components, including API, and any other JAZZ supplied materials are available
or will be provided by JAZZ in due time to carry out the Production. Baxter is
not responsible to replace non-conforming Commercial Product in accordance with
this Section 7.2.2B, if such non-conformance arises out of, is caused by or
relates to any of the following:

[*]

In the event a Batch of Commercial Product is non-conforming, provided Baxter
has not already done so in accordance with Section 7.1.2 above, Baxter shall
duly investigate such non-conformity and the parties will mutually determine a
corrective action plan within [*] calendar days after the Parties determine or
agree that the Batch is non-conforming or such additional time as is reasonably
required if such investigation or plan requires data from sources other than
JAZZ or Baxter. If after such investigation, a root cause for such
nonconformance cannot be determined, the Parties shall refer the matter to a
mutually acceptable laboratory or consultant for investigation, whose
determination of root cause shall be binding upon the Parties and the costs of
such laboratory or consultant are to be borne by the Party who caused such
nonconformance. If such laboratory or consultant cannot determine a root cause
for such nonconformance [*].
16.Section 8.1 “Term” is hereby deleted and replaced with the following:
“8.1     Term.    Unless terminated pursuant to Section 8.2 herein, this
Agreement shall commence on the Effective Date and will continue until the
development and clinical Production have been completed, as described in the
Product Master Plan for clinical Production (the “Clinical Term”) and shall
continue in effect thereafter for commercial Production until the expiration of
the fifth (5th) Contract Year (the “Commercial Initial Term”). This Agreement
will be thereafter renewed automatically for further successive periods of three
(3) years each (each a “Commercial Renewal Term”) unless either JAZZ or Baxter
terminates the Agreement by giving the other Party

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

written notice of intent to terminate at least twenty-four months prior to the
expiration of the Commercial Initial Term or prior to the expiration of the
Commercial Renewal Term, as applicable. The Commercial Initial Term and the
Commercial Renewal Term(s) are collectively referred to herein as the
“Commercial Term”. The Clinical Term and the Commercial Term are collectively
referred to as the “Term”.
17.Section 8.5 “Payment on Termination of Commercial Production”, all references
to “Production Price” in Section 8.5 are hereby changed to “Purchase Price”.
18.The following is hereby added to the Agreement as a new Section 8.7.2:
“8.7.2    If at any time during the Term JAZZ requests Baxter’s assistance to
help JAZZ set up a secondary supplier to manufacture Product, the Parties will
in good faith and acting reasonably, mutually agree at that time, in writing, if
and to what extent Baxter will assist.
19.Section 12.2 “Baxter Warranty”, the first sentence is hereby deleted and
replaced with the following:
“Baxter represents and warrants that (i) it shall Produce all Product in
accordance with cGMP and (ii) subject to Section 7.2.2B(i), all Commercial
Product shall meet Product Specifications.”
20.Capitalized terms used herein that are not defined herein shall have the
defined meaning set forth in the Agreement.
21.Except as modified by this Amendment No. 1, the terms of the Agreement shall
continue in full force and effect.
22.This Amendment No. 1 may be executed in counterparts and all of such
counterparts taken together shall be deemed one and the same instrument. Any
photocopy, facsimile, or pdf of the executed Amendment No. 1 shall constitute an
original.

{Signatures on Next Page}

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

IN WITNESS WHEREOF, the parties have caused this Amendment No. 1 to be duly
authorized, executed, and delivered as of the Amendment No. 1 Effective Date.

BAXTER ONCOLOGY GmbH
 
JAZZ PHARMACEUTICALS IRELAND LIMITED
 
 
By:
/s/ Dr Sven Remmerbach
 
By:
/s/ Aoife Campbell
Title:
Director BDCM
 
Title:
VP, Strategy & Corporate Development
 
 
 
 
 
 
 
 
 
 
And
 
 
 
 
 
 
 
 
 
 
 
 
 
 
By:
/s/ Jurgen Fleischer
 
 
 
Title:
Director Human Resources & EHS
 
 
 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

EXHIBIT A
JAZZ’s ANNUAL OBLIGATION

Contract Years
 
Annual Obligation
Contract Year One
 
[*]
Contract Year Two
 
[*]
Contract Year Three
 
[*]
Contract Year Four
 
[*]
Contract Year Five
 
[*]

Note: For any Commercial Renewal Term, the parties will mutually agree upon an
Annual Obligation as set forth in Section 4.3.1.

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

EXHIBIT B
BAXTER’S MAXIMUM SUPPLY OBLIGATION

Contract Year
 
Maximum Supply Obligation
Contract Year One
 
[*]
Contract Year Two
 
[*]
Contract Year Three
 
[*]
Contract Year Four
 
[*]
Contract Year Five
 
[*]

Note: For any Commercial Renewal Term, the parties will mutually agree upon
Baxter’s Maximum Supply Obligation as set forth in Section 4.3.1.

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

EXHIBIT C
PURCHASE PRICE
BAXTER shall charge JAZZ for Product as set forth in the table below plus any
occurring Value-Added Taxes (if applicable) (ready for shipment).
Clinical / Commercial Batches
Batch size
Number of batches
Purchase Price per Batch (includes the cost of the Baxter-supplied Components
Up to [*]
See Exhibit A of the Agreement for the manufacturing of commercial batches

[*]
Campaign Manufacturing
At least [*] in sequence as defined in the Agreement*

[*]

[*]

The Purchase Price includes Baxter costs for keeping the suppliers of
Baxter-supplied Components in an adequate state of qualification.
Associated Batch specific costs: Batch specific selection of sterile filters and
bioburden filters and the costs of such filters, including without limitation
the testing of such filters, will be set forth in the Product Master Plan.

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.