Exhibit 10.33

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

FIRST AMENDMENT OF AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT

THIS FIRST AMENDMENT OF AMENDED AND RESTATED MANUFACTURING AND SERVICES
AGREEMENT (the “Amendment”) is made as of February 18, 2019 (the “Effective
Date”) by and between Paratek Pharmaceuticals, Inc., a corporation existing
under the laws of Delaware, with an address at 75 Park Plaza, 4th Floor, Boston,
MA 02116 (“Paratek”) and CIPAN ̵̶ Companhia Industrial Produtora de
Antibióticos, S.A., a corporation organized and existing under the laws of
Portugal with an address at Rua da Estação, no42, 2600-726 Castanheira do
Ribatejo, Portugal (“CIPAN”, collectively referred to herein with Paratek as the
“Parties” and each, a “Party”). Capitalized terms used, but not otherwise
defined, herein shall have the meanings set forth in the Agreement.

WHEREAS, Paratek and CIPAN are parties to that certain Manufacturing and
Services Agreement, dated November 2, 2016 (as amended on October 18, 2017, the
“Original Agreement”) and that Original Agreement was subsequently amended and
restated by the Parties on April 18, 2018 (the “Agreement”);

WHEREAS, Pursuant to the Agreement, (a) CIPAN is obligated to manufacture
Minocycline HCI dihydrate meeting the Specifications (“Minocycline”) and crude
Omadacycline meeting the Specifications (“Crude Omadacycline” and, collectively
with Minocycline, the “Products”, and each, a “Product”) for Paratek and (b) in
exchange for technology and financial assistance from Paratek to CIPAN;

WHEREAS, the Parties now desire to amend the Agreement as set forth in this
Amendment;

NOW THEREFORE, the Parties agree as follows:

 

1.

First Amendment to the Agreement. The Agreement is amended and modified as
follows:

 

a.

Section 7.1 is hereby amended and restated to read in its entirety as follows:

 

i.

Delivery.  All Products shall be delivered [***].  CIPAN will notify Paratek at
least ten (10) Business Days prior to any shipment of Product.  CIPAN is
responsible for the arrangement of transport of Products from the Facility to
the shipping destination specified in the purchase order.  [***] All Products
shall be suitably prepared and packed for shipment in suitable containers in
accordance with sound commercial practices to ensure that Products are delivered
in an undamaged condition. CIPAN shall mark the relevant purchase order number
on each container and enclose an itemized packing list with such number with the
shipment.  CIPAN shall hold title to and bear all risk of loss or damage to
Products and Materials prior to

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

such item’s delivery to Paratek or its designee hereunder.  Time is of the
essence for all deliveries of Products.  CIPAN shall ensure that all Product
held in storage is stored in accordance with the Specifications until delivery
to Paratek under this Agreement and that all storage areas meet cGMP
requirements.  In the event of any delay in delivery of Product from the
delivery date on the applicable purchase order for such Product, if such delay
is: [***], unless, in each case ((a) and (b)), such delay is due to a Force
Majeure Event causing a worldwide shortage of the applicable Materials, in which
case Article 17 shall apply.

 

b.

The following new Section 7.2 shall be added, and the numbering of the
subsequent sections of Agreement shall be updated accordingly:

 

i.

Minocycline.  CIPAN shall ensure that all Minocycline held in storage is stored
in accordance with the Specifications until such Minocycline is manufactured
into Crude Omadacycline and delivered to Paratek or its designee and that all
storage areas meet cGMP requirements. For the avoidance of doubt, Paratek shall
not hold title to or bear any risk of loss or damage to any Minocycline prior to
such Minocycline being manufactured into Crude Omadacycline and such Crude
Omadacycline being delivered to Paratek in accordance with Section 7.1 (or, if
such Minocycline is not to be manufactured into Crude Omadacycline under this
Agreement, prior to delivery to Paratek of such Minocycline in accordance with
Section 7.1).

 

c.

Section 8.1 is hereby amended and restated to read in its entirety as follows:

 

i.

Supply Price.  The prices of Products to be sold to Paratek during the Term are
set forth in Exhibit A attached hereto (and, with respect to Crude Omadacycline,
shall be based on the annual volume of each such Product ordered by Paratek),
subject to adjustment as set forth in Sections 2.8.1, 7.1, 8.2 and 8.3 (such
price for a Product, the “Supply Price” for such Product). [***] The Supply
Price per kilogram invoiced by CIPAN to Paratek for Minocycline during any
rolling [***] shall be the [***]. The Supply Price for Minocycline shall comply
with this Section 8.1 as of the Effective Date. For the avoidance of doubt, the
Supply and Quality Committee will not have any responsibilities relating to the
Supply Price matters unless such responsibilities are expressly provided in
clause (f) of Section 4.3 of this Agreement.

-2-

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

d.

Section 8.4 is hereby amended and restated to read in its entirety as follows:

 

i.

Payment.  Subject to the terms of this Section 8.4, CIPAN shall invoice Paratek
for Products on or after the Approval Date and shall only charge Paratek for
Products that are shipped to Paratek or Paratek’s designee pursuant to this
Agreement. Each invoice submitted to Paratek will include [***] as mutually
agreed upon by the Parties. Except as expressly specified in this Section 8.4,
Paratek shall pay CIPAN for all supplied quantities of conforming Products
within [***] from the date of invoice receipt; provided that in the event that
Paratek submits a purchase order to CIPAN for Minocycline to be used in the
Manufacture of Crude Omadacycline by CIPAN under this Agreement, (A) CIPAN shall
issue an invoice to Paratek for such purchase order following the Approval Date
for such Minocycline for an amount equal to [***] of the Supply Price of the
Crude Omadacycline ordered by Paratek to incorporate such Minocycline and
Paratek shall pay CIPAN such invoiced amount within [***] from the date of
invoice receipt and (B) following the delivery of such Crude Omadacycline to
Paratek, CIPAN shall issue an invoice to Paratek for the remaining Supply Price
of such Crude Omadacycline and Paratek shall pay CIPAN for all supplied
quantities of conforming Crude Omadacycline within [***] from the date of
invoice receipt. In this Agreement, unless expressly otherwise stated, all
references to money or payments means US Dollars and all payments made hereunder
shall be made in that currency.  Notwithstanding anything to the contrary in
this Agreement, pending resolution regarding any disagreement between the
Parties as to conformance of a Product to the requirements of this Agreement or
the Quality Agreement, Paratek is not obligated for any payment with respect to
any Product Paratek believes to be non-conforming.

 

e.

Exhibit A to the Agreement is hereby deleted in its entirety and replaced with
Exhibit A attached to this Amendment.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

2.

General Provisions.  Unless specifically modified or changed by the terms of the
Amendment, all terms and conditions of the Agreement and the Quality Agreement,
between the Parties, dated as of November 2, 2016 (as may be amended from time
to time, “Quality Agreement”) shall remain in full force and effect and shall
apply fully as described and set forth in the Agreement and Quality Agreement,
respectively. In the event of any express conflict or inconsistency between the
Amendment, on one hand, and the Agreement or Quality Agreement on the other
hand, the terms and conditions of the Amendment shall control.  This Amendment,
the Quality Agreement and the Agreement constitute the entire understanding
among the parties regarding subject matters contained therein and herein and
supersede all prior negotiations, commitments, agreements and understandings
among them on such subject matters.  This Amendment may be executed in any
number of counterparts, either by original or facsimile counterpart, each such
counterpart shall be deemed to be an original instrument, and all such
counterparts together shall constitute but one agreement.  This Amendment and
all acts and transactions pursuant hereto and the rights and obligations of the
parties hereto shall be governed, construed and interpreted in accordance with
the law of [***], without regard to the conflict of laws principles thereof.

 

-4-

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

IN WITNESS WHEREOF, the duly authorized representatives of the Parties have
executed this Amendment as of the Effective Date.

 

 

PARATEK PHARMACEUTICALS, INC.

By:

 

/s/ Jason Burdette

Name:

 

Jason Burdette

Title:

 

Sr. Vice President of Technical Operations

 

 

CIPAN Companhia Industrial Produtora de AntibiÓticos, S.A.

By:

 

/s/ Teresa Alves

Name:

 

Teresa Alves

Title:

 

CEO

 

 

[Signature Page to Amendment]

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT

REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXHIBIT A

Prices

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

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[***]