Exhibit 10.1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Execution Version

 

AMENDMENT NO. 2 TO THE
LICENSE, MANUFACTURING AND SUPPLY AGREEMENT

 

This Amendment No. 2 to the License, Manufacturing and Supply Agreement (this
“Amendment”) by and between Nektar Therapeutics, a Delaware corporation with
offices at 455 Mission Bay Boulevard South, San Francisco, California 94158
(“Nektar”), successor by merger to Nektar Therapeutics AL, Corporation, an
Alabama corporation, and Ophthotech Corporation, a Delaware corporation with
offices at One Penn Plaza, Suite 1924, New York, NY 10119 (“Ophthotech”) is
effective as of February 11th, 2015 (“Effective Date of Amendment No. 2”).
 Capitalized terms used but not otherwise defined herein shall have the meanings
ascribed to such terms in the License, Manufacturing and Supply Agreement (the
“Agreement”) made effective as of September 30, 2006 by and between Nektar and
(OSI) Eyetech, Inc. (“OSI”), as amended by the Amendment No. 1 to the Agreement
effective as of April 5, 2012 by and between Nektar and Ophthotech.  Effective
July 27, 2007, OSI assigned to Ophthotech all of OSI’s right, title and interest
in and to the Agreement.  All references to Articles and Sections in this
Amendment refer to Articles and Sections of the Agreement.

 

WHEREAS, Section 4.3 of the Agreement provides for Ophthotech to submit rolling
forecasts and binding orders for REAGENT in full BATCH allocations of
approximately [**] grams;

 

WHEREAS, the parties desire to provide for the development by Nektar on behalf
of Ophthotech of a larger full BATCH allocation of approximately [**] grams;

 

WHEREAS, contemporaneously with this Amendment the parties have entered into
that certain Scope of Work No. 1 (“SOW #1”) pursuant to which Nektar is to
undertake a process validation campaign, including a stability study, for the
large scale manufacture of the REAGENT, as provided in SOW #1; and

 

WHEREAS, the parties hereto desire to amend certain provisions of the Agreement
relating to full BATCH allocation sizes and pricing of the REAGENT as set forth
herein.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the parties hereto, intending to be legally bound, hereby
agree as follows:

 

1.                                      Amendments to Agreement.

 

(a)                                 Article 1 of the Agreement is amended to
insert the following new definitions:

 

1.6.1 “COMMERCIAL REAGENT ORDER DATE” shall mean the date of OPHTHOTECH’s first
purchase order to NEKTAR for REAGENT for use in the manufacture of OPHTHOTECH’s
PRODUCT for commercial distribution.  Such purchase order shall be in full BATCH
allocation for LARGE SCALE BATCHES.  OPHTHOTECH shall note on such purchase

 

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

 

order that it memorializes the COMMERCIAL REAGENT ORDER DATE.

 

1.7.1 “COMPLETION DATE” shall mean the date to be mutually agreed by the parties
in writing upon which the services performed by NEKTAR under SOW #1 (and any
other scopes of work mutually agreed by the parties relating to process
development of LARGE SCALE BATCHES) have been successfully completed such that
LARGE SCALE BATCHES may be supplied by NEKTAR to OPHTHOTECH in compliance with
the provisions of this AGREEMENT and the QUALITY AGREEMENT.

 

1.31.1 “LARGE SCALE BATCH” shall mean a NEKTAR full BATCH allocation of REAGENT
of approximately [**] grams.

 

1.64.1 “SMALL SCALE BATCH” shall mean a NEKTAR full BATCH allocation of REAGENT
of approximately [**] grams.

 

(b)                                 Section 1.4 of the Agreement is hereby
amended to read in its entirety as follows:

 

“1.4 “BATCH” or “BATCHES” shall mean SMALL SCALE BATCHES and/or LARGE SCALE
BATCHES, as indicated by the context.”

 

(c)                                  Section 4.3 is hereby amended to read in
its entirety as follows:

 

“4.3 Minimum Purchases and Rolling Forecast.  As soon as practicable after the
FIRST AMENDMENT DATE the PARTIES shall mutually agree upon the minimum purchase
requirements of OPHTHOTECH for the REAGENT for the [**] CALENDAR QUARTERS
immediately following the FIRST AMENDMENT DATE.  OPHTHOTECH shall, at least [**]
days prior to the commencement of the [**] and each CALENDAR QUARTER following
the FIRST AMENDMENT DATE, furnish NEKTAR with a rolling forecast of its
requirements of the REAGENT during the forthcoming [**] CALENDAR QUARTERS, with
the required quantities for the first [**] CALENDAR QUARTERS to be a binding
order for supply of the REAGENT and the forecast for the remaining [**] CALENDAR
QUARTERS to be an estimate only.  Prior to the COMPLETION DATE these quantities
shall be in full BATCH allocations for SMALL SCALE BATCHES.  Commencing with the
COMPLETION DATE and terminating on the COMMERCIAL REAGENT ORDER DATE, these
quantities shall be in full BATCH allocations for SMALL SCALE BATCHES, LARGE
SCALE BATCHES, or a combination of SMALL SCALE BATCHES and LARGE SCALE BATCHES,
in the discretion of OPHTHOTECH.  Following the COMMERCIAL REAGENT ORDER DATE,
all OPHTHOTECH rolling forecasts shall be in full BATCH allocations only for
LARGE SCALE BATCHES.  Notwithstanding the foregoing, (a) NEKTAR shall only be
bound to supply

 

2

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

 

up to [**] percent ([**]%) of the initial forecast for any CALENDAR QUARTER.  In
the event that OPHTHOTECH’s forecast exceeds [**] percent ([**]%) of the initial
forecast for any CALENDAR QUARTER, then the PARTIES will meet in good faith to
discuss how NEKTAR can meet the revised forecast, and (b) in no event shall
OPHTHOTECH purchase less than [**] percent ([**]%) of the initial forecast for
any CALENDAR QUARTER.”

 

(d)                                 Section 4.4 is hereby amended to add the
following language at the end of the existing Section 4.4:

 

“Prior to the COMPLETION DATE all OPHTHOTECH purchase orders shall be in full
BATCH allocations for SMALL SCALE BATCHES.  Commencing with the COMPLETION DATE
and terminating on the COMMERCIAL REAGENT ORDER DATE, all OPHTHOTECH purchase
orders shall be in full BATCH allocations for SMALL SCALE BATCHES, LARGE SCALE
BATCHES, or a combination of SMALL SCALE BATCHES and LARGE SCALE BATCHES, in the
discretion of OPHTHOTECH.  Following the COMMERCIAL REAGENT ORDER DATE, all
OPHTHOTECH purchase orders shall be in full BATCH allocations only for LARGE
SCALE BATCHES.”

 

(e)                                  A new Section 4.4.4 is added to the
Agreement to read in its entirety as follows:

 

“4.4.4.  OPHTHOTECH agrees to limit the quantities of REAGENT ordered from
NEKTAR to those necessary for (a) the production of PRODUCT during the [**]
month period following the delivery dates specified in OPHTHOTECH’s purchase
orders; plus (b) the maintenance by OPHTHOTECH (under OPHTHOTECH’s control at a
non-NEKTAR facility) of a reasonable quantity of safety stock of REAGENT to be
determined by OPHTHOTECH, in each case ((a) and (b)) rounded up to the NEKTAR
LARGE SCALE BATCH allocation.  The parties recognize that the process of
determining OPHTHOTECH’s requirements of REAGENT for use in the production of
PRODUCT and for the safety stock is a subjective one based on estimates of
market demand which may be proven by actual market demand not to be accurate. 
OPHTHOTECH will not be in breach of the foregoing merely because it
overestimates market demand for PRODUCT in good faith from time to time,
resulting in a temporary excess inventory of REAGENT.  If at any time OPHTHOTECH
experiences a temporary excess inventory of REAGENT which causes OPHTHOTECH to
materially reduce its forecasts or orders of REAGENT, then upon the written
request of NEKTAR, OPHTHOTECH agrees to make available to NEKTAR OPHTHOTECH’s
forecasts of market demand for the PRODUCT and other relevant OPHTHOTECH
documents and records which caused OPHTHOTECH to experience an excess inventory
of

 

3

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

 

REAGENT, so that NEKTAR may confirm the good faith basis for OPHTHOTECH’s
estimates of market demand for the PRODUCT.”

 

(f)                                   Section 7.5.1 and Section 7.5.2 are hereby
amended to read in their entirety as follows:

 

“7.5.1.  OPHTHOTECH shall pay to NEKTAR for the supply of the REAGENT shipped
complying with the SPECIFICATIONS and GMP, the prices in DOLLARS per unit of
REAGENT set forth in Part C of SCHEDULE III (“PURCHASE PRICE”).  As of
January for each year commencing with January of 2015, the initial annual
PURCHASE PRICE shall be based upon the quantity of grams to be shipped during
that year per the binding forecast and purchase orders then in the possession of
NEKTAR as of December of the prior year pursuant to Section 4.3 and
Section 4.4.  This price shall be used for shipments from January 1st through
[**] of the applicable year.  On [**], the total grams of REAGENT to be shipped
for the year to OPHTHOTECH (which will include purchase orders received by
NEKTAR from OPHTHOTECH and OPHTHOTECH’s binding forecast for the [**] calendar
quarters) will be calculated.  If the total binding quantity of grams to be
shipped for the year fall to a lower quantity tier as set forth in Part C of
SCHEDULE III, then an invoice to OPHTHOTECH will be generated based upon the
total grams shipped as of [**] multiplied by the difference between the initial
annual PURCHASE PRICE and the lower quantity tier price.  If the total binding
quantity of grams to be shipped for the year rise to a higher quantity tier as
set forth in Part C of SCHEDULE III, then either a credit memo or refund payment
(to be mutually agreed) will be issued to OPHTHOTECH based upon the total grams
shipped as of [**] multiplied by the difference between the initial annual
PURCHASE PRICE and the higher quantity tier price.  As of December 31st of the
applicable year, the final annual PURCHASE PRICE will be determined based on
actual shipments made during that year and any differences between the final
annual PURCHASE PRICE and the amounts previously invoiced will be either
invoiced or credited to OPHTHOTECH as applicable.  Any failure solely on the
part of NEKTAR to ship during that year, as required by the applicable purchase
orders or the binding forecast, shall be counted as an actual shipment made
during that year for the purposes of the determination of the final annual
PURCHASE PRICE.

 

7.5.2.  During [**] of each year commencing with [**] of 2015, NEKTAR shall
adjust the PURCHASE PRICE for the following calendar year as follows: (a) [**],
(b) Documented increases and decreases in NEKTAR’s cost of purchasing the raw
PEGylation component known as [**] that exceed the adjustment to the PURCHASE
PRICE provided in (a) shall [**].  NEKTAR agrees to provide to OPHTHOTECH such
additional documentation as may be reasonably requested by OPHTHOTECH
substantiating any such increase or decrease in the PURCHASE PRICE,

 

4

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

 

provided that nothing in this Section 7.5.2 shall require NEKTAR to disclose to
OPHTHOTECH any THIRD PARTY confidential information in breach of a
legally-binding confidentiality obligation of NEKTAR to such THIRD PARTY. 
NEKTAR shall notify OPHTHOTECH in writing of the adjustments made, the basis for
each adjustment, and the amount of the adjusted PURCHASE PRICE for the following
calendar year prior to [**] of each year.  In the event that OPHTHOTECH disputes
in writing any adjustment made by NEKTAR the parties will promptly appoint
representatives to resolve the dispute.  As used in this AGREEMENT, [**]”

 

(g)                                  Part C of Schedule III is hereby amended to
read in its entirely as follows:

 

“C.  REAGENT PRICES.  Pursuant to Section 7.5.1, OSI will pay to NEKTAR the
following prices for the REAGENT under this AGREEMENT:

 

Total grams purchased during calendar year

 

Price per Gram
(U.S. DOLLARS)

Less than [**]kg

 

[**]

Equal to or greater than [**]kg and less than [**]kg

 

[**]

Equal to or greater than [**]kg and less than [**]kg

 

[**]

Equal to or greater than [**]kg and less than [**]kg

 

[**]

Equal to or greater than [**]kg and less than [**]kg

 

[**]

Equal to or greater than [**]kg and less than [**] kg

 

[**]

Equal to or greater than [**]kg

 

[**]

 

The prices in the immediately preceding table shall become effective as of the
Effective Date of Amendment No. 2 and shall remain in effect, and be subject to
adjustment, as provided for in Section 7.5.2.”

 

2.                                      Miscellaneous.  The parties hereto
hereby confirm and agree that, except as amended hereby, the Agreement remains
in full force and effect and is a binding obligation of the parties hereto. 
This Amendment may be executed in counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.

 

[Signature page follows]

 

5

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

 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 2 to be
executed by their duly authorized representatives as of the Effective Date of
Amendment No. 2.

 

OPHTHOTECH CORPORATION

 

NEKTAR THERAPEUTICS

 

 

 

 

 

By:

/s/ Douglas Brooks

 

By:

/s/ Maninder Hora

 

 

 

 

 

Name:

Douglas Brooks

 

Name:

Maninder Hora

 

 

 

 

 

Title:

VP Manufacturing Development

 

Title:

Sr VP, Pharm Dev & Mfg Ops

 

6

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

 

SCOPE OF WORK #l

 

This Scope of Work No. 1 (“SOW #1”) is entered into as of February 18, 2015 (the
“Effective Date of SOW #1”) by and between Nektar Therapeutics, a Delaware
corporation and successor to Shearwater Corporation (“NEKTAR”) and Ophthotech
Corporation, a Delaware corporation (“OPHTHOTECH”) pursuant to that License,
Manufacturing and Supply Agreement dated September 30, 2006, as amended by
Amendment No. 1 to License, Manufacturing and Supply Agreement effective as of
April 5, 2012 (collectively, the “AGREEMENT”) between the PARTIES.  This SOW #1
incorporates all the terms and conditions of the Agreement, and describes the
Services to be provided by NEKTAR to OPHTHOTECH for the fees set forth herein. 
Capitalized terms used in this SOW #1 and not defined herein shall have the
meanings ascribed in the Agreement.

 

Nektar Project Code:
50000050

 

Services:

 

Following receipt by NEKTAR of the OPHTHOTECH Purchase Order for such Services,
NEKTAR will undertake the Process Demonstration and Validation Campaigns
including a stability study in accordance with the Stability Synopsis, attached
hereto as Attachment 1, for large scale PEG2NHS40K manufactured by NEKTAR and
sold to OPHTHOTECH pursuant to the AGREEMENT for use in the production of
Fovista and/or research purpose.

 

Validation Campaign Key Deliverables:

 

Project Duration For Demonstration and Validation Campaigns: [**] months, to
commence upon receipt by NEKTAR of OPHTHOTECH’s Purchase Order

 

Process assessment reports per stage (one intermediate and final product)

 

Master Batch Records including packaging with new Product Codes (one
intermediate and final product)

 

Validation Protocols and Reports to include comparability assessment per stage
(one intermediate and final product)

 

Approximately [**] g of PEG2NHS40K engineering batch, produced in the
demonstration campaign, manufactured and tested under cGMP conditions.

 

[**] validation batches of PEG2NHS40K, approximately [**] g each, produced
during the process validation campaign, manufactured and tested under cGMP
conditions.

 

Quality Target for the engineering and validation batches: Per proposed
acceptance criteria for optimized large scale process for PEG2NHS40K (Attachment
2 and Attachment 3)

 

Batch Certificate (including Certificate of Analysis, CoA)

 

BSE/TSE certificate

 

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

 

The engineering and [**] validation batches for large scale PEG2NHS40K will only
be released after all executed batch records, all validation reports, and CoA
for large scale PEG2NHS40K have been reviewed and released by Nektar
Therapeutics QA.

 

Shipment of the batches shall have less than [**]% of its initial shelf-life as
of the completion of its manufacture remaining.

 

Stability Study Key Deliverables

 

Stability program for PEG2NHS40K including [**]-cycle freeze/thaw study per ICH
guidelines (Attachment 1)

 

Project Manager:

 

[**]

 

Time Frame:

 

The term of this SOW #1 shall commence on the Effective Date of SOW #1 and shall
continue until Services are completed.

 

Project Pricing Detail:

 

Project Price Summary Cost Estimates:

 

ARTICLE I.  Price Summary

 

PEG2NHS40K Large Scale Demonstration Campaign

 

Production preparation, process optimization including reports

 

 

Stability study including freeze/thaw

 

[**]

Engineering batch per cGMP(a),(b)

 

[**]

Subtotal (USD)

 

[**]

 

PEG2NHS40K Large Scale Validation Campaign

 

[**] validation batches per cGMP(a),(b),(c)

 

[**]

Subtotal (USD)

 

[**]

Project Total Price (USD)

 

[**]

 

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

(a) Pricing assumption at [**] g per batch at $[**]/g for volume equal to or
greater than [**] kg for 2015.
(b) Shipment upon QA release and finalization of validation report.
(c) Invoice at time of shipment for each batch based on actual grams shipped at
the price per gram per the applicable pricing tier.

 

Payment(s) and Schedule For PEG2NHS40K Large Scale Demonstration Campaign
including Reports:

 

Initial payment of [**]% of the total price at time of the Purchase Order

 

2

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

 

Another [**]% of the total price at time of the completion of process assessment
report for the intermediate

 

Another [**]% of the total price at time of the completion of process assessment
report for the large scale PEG2NHS40K

 

Another [**]% of the total price at time of the completion of validation
manufacturing process and reporting for the intermediate

 

Another [**]% of the total price at time of the completion of validation
manufacturing process and reporting for large scale PEG2NHS40K

 

The balance will be invoiced upon QA release of the large scale PEG2NHS40K
demonstration and validation batches

 

Invoices will be issued by NEKTAR whenever a payment is due from OPHTHOTECH for
Production Preparation and Process Optimization.  Full payment shall be made by
OPHTHOTECH to NEKTAR within [**] days of receipt of each of NEKTAR’s invoices. 
All payments to NEKTAR shall be made by wire transfer payable to NEKTAR’s bank
and bank account noted below (or to such other bank or bank account of which
NEKTAR shall notify OPHTHOTECH in writing from time to time).  NEKTAR shall
reference OPHTHOTECH’s Purchase Order number on any and all NEKTAR invoices
associated with this SOW #1.  NEKTAR shall not commence Services pursuant to
this SOW #1 until NEKTAR has received OPHTHOTECH’s corresponding Purchase Order.

 

Nektar Tax ID # 94-3134940
Nektar Bank Account Information:
[**]
Account No. [**]
Routing No. [**]
Swift Code (international wires) [**]

 

All payments by OPHTHOTECH shall reference the NEKTAR invoice number.

 

This SOW #1 may be executed in separate counterparts, and by facsimile or
electronically, each of which when so executed and delivered shall be a
legally-binding original and all such counterparts shall together constitute one
and the same instrument, binding on all PARTIES, notwithstanding that each of
the PARTIES may have signed different counterparts.  The PARTIES agree that
delivery of an executed counterpart signature hereof by facsimile transmission,
by electronic mail in “portable document format” (“.pdf’) form, or by any other
electronic means intended to preserve the original graphic and pictorial
appearance of a document, will have the same effect as physical delivery of the
paper document bearing the original signature.

 

IN WITNESS WHEREOF, the authorized representatives of the PARTIES have executed
this SOW #1 as of the Effective Date of SOW #1.

 

3

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

 

NEKTAR THERAPEUTICS

 

OPHTHOTECH CORPORATION

 

 

 

Signature:

/s/ Maninder Hora

 

Signature:

/s/ David Guyer

Print Name: Maninder Hora

 

Print Name: David Guyer

Title: Sr VP, Pharm Dev & Mfg Ops

 

Title: CEO

 

4

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

 

Attachment 1

 

Stability Synopsis

 

 

 

Time (month)

 

Conditions

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]° C

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]° C

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]° C/[**]%RH

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

 

[**]

 

Freeze Thaw Study

 

Conditions

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]° C

 

[**]

 

[**]

 

[**]

 

[**]

 

 

Freeze-Thaw stability samples will be removed from the [**]°C chamber per
defined schedule, labeled appropriately and allowed to warm to room temperature
on laboratory bench (minimum [**], maximum [**]).  Samples will then be returned
to the [**]°C chamber for a minimum of [**].  All freeze-thaw samples will be
tested in the same analytical sequence.

 

PACKAGING REQUIREMENTS

 

Samples will be packaged as described below.  The samples will be packaged under
Argon and stored under argon atmosphere.

 

Primary Container

[**]

 

 

Secondary Container

[**]

 

TEST LIST and ACCEPTANCE CRITERIA

 

Stability samples will be tested per the methods outlined.  All methods used in
this study will be evaluated per the proposed acceptance criteria for optimized
large scale process.  Stability data will be evaluated based on the typical
ranges for the product and summarized in the final stability report.  A
stability protocol will be issued for this study.

 

Ref

 

Document

 

Title

1

 

N/A

 

Determination of appearance and color

2

 

H-PAM-0158

 

The Determination of the Molecular Weight & PDI and Impurities of PEG2NHS40KP/E
by GFC

 

5

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

 

Ref

 

Document

 

Title

3

 

H-PAM-0161

 

The Determination of [**] in PEG2NHS40KP/E

 

6

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

 

Attachment 2

 

Large Scale Optimized Process Validation Proposed Acceptance Criteria
(mBTC Intermediate)

 

Parameters

 

Ophthotech Small Scale
Specifications

 

Small Scale
(In Process Control)

 

Large Scale Optimized
Process
Validation Proposed
Acceptance Criteria

 

Remark

 

% Substitution

 

[**]

 

[**]

 

[**]

 

 

 

IPA-BTC

 

[**]

 

[**]

 

[**]

 

 

 

Mn

 

[**]

 

[**]

 

[**]

 

 

 

Polydispersity

 

[**]

 

[**]

 

[**]

 

[**]

 

Identity by NMR

 

[**]

 

[**]

 

[**]

 

 

 

Appearance

 

[**]

 

[**]

 

[**]

 

 

 

Color

 

[**]

 

[**]

 

[**]

 

 

 

Additional Notes

 

[**]

 

[**]

 

[**]

 

 

 

 

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

 

Attachment 3

 

Large Scale Optimized Process Validation Proposed Acceptance Criteria
(PEG2NHS40K Final Product)

 

Parameters

 

Ophthotech Small Scale
Specifications

 

Large Scale SPC Data
(Average Value Per
Current Process)

 

Large Scale Optimized
Process Validation
Proposed Acceptance
Criteria

 

Remark

Appearance

 

[**]

 

[**]

 

[**]

 

[**]

Color

 

[**]

 

[**]

 

[**]

 

[**]

Identity NMR

 

[**]

 

[**]

 

[**]

 

[**]

Molecular Weight (GPC)

 

[**]

 

[**]

 

[**]

 

[**]

Polydispersity

 

[**]

 

[**]

 

[**]

 

[**]

% purity

 

[**]

 

[**]

 

[**]

 

[**]

Impurities

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

Total Impurities

 

[**]

 

[**]

 

[**]

 

[**]

Organic Volatile Impurities

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

2

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

 

Parameters

 

Ophthotech Small Scale
Specifications

 

Large Scale SPC Data
(Average Value Per
Current Process)

 

Large Scale Optimized
Process Validation
Proposed Acceptance
Criteria

 

Remark

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

 

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

Endotoxin

 

[**]

 

[**]

 

[**]

 

[**]

Extended Characterization

 

 

 

 

 

 

 

 

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

[**]

 

[**]

 

[**]

 

[**]

 

[**]

 

3

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

 

OPHTHOTECH

Purchase Order

 

 

PO #:

01-0261

 

PO Date:

17 February 2015

 

Contact:

[**]

 

Phone:

[**]

 

Code:

7611.06

 

To:

Invoice

 

 

Nektar Therapeutics

Ophthotech Corp.

[**] Contracts Administration

214 Carnegie Center, Suite 302

1112 Church Street

Princeton, NJ 08540

Huntsville, AL 35801

 

Phone: [**]

[**]

 

Tel: [**]

 

Fax: [**]

 

Per SOW #1 and the 2015 pricing letter (dated 05Dec14) and the September 30,
2006 License,Manufacturing and Supply agreement between Nektar Therapeutics and
OSI Eyetech, as now assigned to Ophthotech Corporation (as amended).

 

Invoices submitted against this PO will be paid within [**] days of receipt.

 

Item

 

Quantity

 

Description

 

Unit Price

 

Total Price

 

 

 

 

 

PEG2NHS40K Large Scale Demonstration Campaign

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

1

 

Production, Preparation, process optimization including reports

 

[**]

 

[**]

 

 

 

 

 

Stability Study including freeze/thaw

 

[**]

 

[**]

 

2

 

[**] g

 

Engineering batch per cGMP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shipment upon QA release and finalization of validation report.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PEG2NHS40K Large Scale Validation Campaign

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

[**]g

 

Validation Batches per cGMP

 

[**]

 

[**]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shipment upon QA release and finalization of validation report.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Invoice at time of shipment for each batch based on actual grams shipped at the
price per gram per the applicable pricing tier.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.              Please send two copies of your invoice.

 

Subtotal

 

$

 [**]

 

2.              Enter this order in accordance with the prices, terms, delivery
dates, and specifications listed above.

 

Tax

 

 

 

3.              Please notify us immediately if you are unable to ship/deliver
as specified.

 

Total

 

$

 [**]

 

 

Authorized Signature(s)

/s/ David Guyer

 

Name/Title

David Guyer, CEO

Date:

17 February 2015

 

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This order is not valid unless it is signed. Please acknowledge receipt of this
order.

 

2

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AMENDMENT NO. 3 TO THE
LICENSE, MANUFACTURING AND SUPPLY AGREEMENT

 

This Amendment No. 3 to the License, Manufacturing and Supply Agreement (this
“Amendment”) by and between Nektar Therapeutics, a Delaware corporation with
offices at 455 Mission Bay Boulevard South, San Francisco, California 94158
(“Nektar”), successor by merger to Nektar Therapeutics AL, Corporation, an
Alabama corporation, and Ophthotech Corporation, a Delaware corporation with
offices at One Perm Plaza, Suite 1924, New York, NY 10119 (“Ophthotech”) is
effective as of April 27, 2015 (“Effective Date of Amendment No. 3”). 
Capitalized terms used but not otherwise defined herein shall have the meanings
ascribed to such terms in the License, Manufacturing and Supply Agreement (the
“Agreement”) made effective as of September 30, 2006 by and between Nektar and
(OSI) Eyetech, Inc. (“OSI”), as amended by the Amendment No. 1 to the Agreement
effective as of April 5, 2012 by and between Nektar and Ophthotech and Amendment
No. 2 to the Agreement effective as of February 11, 2015 between Nektar and
Ophthotech.  Effective July 27, 2007, OSI assigned to Ophthotech all of OSI’s
right, title and interest in and to the Agreement.  All references to Articles
and Sections in this Amendment refer to Articles and Sections of the Agreement.

 

WHEREAS, the parties hereto desire to amend certain provisions of the Agreement
relating to diligence obligations of Ophthotech.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the parties hereto, intending to be legally bound, hereby
agree as follows:

 

1.             Amendment to Agreement.  Section 3.7 is hereby amended by
replacing each of the two occurrences of “December 31, 2016” with “June 30,
2018”, and by replacing “December 31, 2017” with “June 30, 2019”.

 

2.             Miscellaneous.  The parties hereto hereby confirm and agree that,
except as amended hereby, the Agreement remains in full force and effect and is
a binding obligation of the parties hereto.  This Amendment may be executed in
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

[Signature page follows]

 

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IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 3 to be
executed by their duly authorized representatives as of the Effective Date of
Amendment No. 3.

 

OPHTHOTECH CORPORATION

 

NEKTAR THERAPEUTICS

 

 

 

By:

/s/ Michael G. Atieh

 

By :

/s/ Maninder Hora

 

 

 

Name:

Michael G. Atieh

 

Name:

Maninder Hora

 

 

 

Title:

Executive VP/Chief Financial

 

Title:

Sr. V.P., Pharm Dev. & Mfg Ops.

 

& Business Officer

 

 

 

 

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