Exhibit 10.1

***Text Omitted and Filed Separately with the Securities and Exchange

Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

AMENDMENT NO. 1 TO LICENSE AGREEMENT

This Amendment No. 1 (the “Amendment”) to that certain License Agreement dated
September 20, 2009 (the “Agreement”) is made and entered into effective as of
August 8, 2013 (the “Effective Date of the Amendment”), by and between
AstraZeneca AB, a Swedish corporation, with offices at S-151 85 Södertälje,
Sweden (“AstraZeneca”) and Nektar Therapeutics, a Delaware corporation, with
offices at 455 Mission Bay Boulevard South, San Francisco, California 94158 USA
(“Nektar”).

RECITALS

WHEREAS, the Parties have agreed to amend certain provisions of the Agreement as
provided in this Amendment;

NOW, THEREFORE, in consideration of the foregoing, the covenants and promises
contained in this Amendment and other good and valid consideration, the receipt
and sufficiency of which the Parties acknowledge, and in accordance with and
subject to the terms and conditions specified below, the Parties agree as
follows:

Amendment of the Agreement

The Parties hereby agree to amend the Agreement as of the Effective Date of the
Amendment as provided below. Capitalized terms used in this Amendment that are
not otherwise defined herein shall have the meanings provided in the Agreement.

 

  1. All references to “the Agreement” contained in any Section or subsection of
the Agreement shall mean “the Agreement as amended by this Amendment No. 1.”

 

  2. The following new definitions are added to Section 1 of the Agreement in
the appropriate alphabetical order:

“Approval Letter” means a letter from the FDA granting approval of the first
application for Health Registration Approval for the first Stand-Alone Product
as contemplated by 21 C.F.R. §314.105.

“Complete Response Letter” means a letter from the FDA stating it will not
approve the first application for a Health Registration Approval for the first
Stand-Alone Product as contemplated by 21 C.F.R. §314.110.

“CV Safety Study” means clinical trials or any other studies or activities
conducted in each case for the primary purpose of assessing the cardiovascular
safety of the first Stand-Alone Product, which any of the foregoing trials,
studies or activities individually or in the aggregate, are reasonably expected
to exceed $70 million in external costs to complete.

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EXECUTION VERSION

 

“FDA Acceptance” shall mean the date on which FDA notifies AstraZeneca that the
application for a Health Registration Approval for the first Stand-Alone Product
is accepted for review by the FDA.

 

  3. The following definition is deleted from Section 1 of the Agreement: “NDA
Acceptance Bonus Milestone.”

 

  4. Section 6.7(c) is deleted from the Agreement and replaced in its entirety
with the following:

“(c) Written Communications with FDA. Except as otherwise provided in
Section 6.7(f) with respect to communications to FDA concerning any
cardiovascular safety issues, AstraZeneca shall promptly provide Nektar with
copies of all written or electronic communications (other than communications
that are purely administrative in nature) forwarded or submitted by it or its
Affiliates to FDA with respect to any Licensed Product (provided that
AstraZeneca may redact any portions relating to aspects of any Combination
Product that are proprietary to AstraZeneca, its Affiliates or any Third Party
including any proprietary compounds or any other proprietary technology of
AstraZeneca, its Affiliates or any Third Party). Such communications shall be
provided by AstraZeneca to Nektar [***] of such forwarding or submission.
AstraZeneca shall promptly provide Nektar with copies of all written or
electronic communications received by it or its Affiliates from FDA (other than
communications that are purely administrative in nature) with respect to any
Licensed Product in the same form provided to AstraZeneca (provided that
AstraZeneca may redact any portions relating to aspects of any Combination
Product that are proprietary to AstraZeneca, its Affiliates or any Third Party
including any proprietary compounds or any other proprietary technology of
AstraZeneca, its Affiliates or any Third Party). Such communications shall be
provided by AstraZeneca to Nektar [***] of such receipt from FDA.”

 

  5. Section 6.7(d) is deleted from the Agreement and replaced in its entirety
with the following:

“(d) Meetings with FDA. AstraZeneca shall promptly provide Nektar with prior
written or email notice of all meetings, conference calls, outbound calls, and
any other discussions, whether scheduled or unscheduled, with the FDA regarding
any Licensed Product, which notice shall be provided [***] given the projected
date and time of such meeting, conference or discussion in order to give Nektar
[***] to attend or otherwise participate in such meeting, conference or
discussion as further described below. Subject to the

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

confidentiality provisions set forth under Article 11, and to the extent
permitted by the FDA, Nektar shall be entitled to have [***] of Nektar present,
with the opportunity to participate as appropriate and as reasonably agreed with
AstraZeneca, in any such meetings, conferences or discussions [***]. Nektar
acknowledges that AstraZeneca remains the lead party and ultimately responsible
for the direction of any and all regulatory interactions. It is assumed that
Nektar would actively participate in preparation for all formal FDA
interactions. AstraZeneca shall be required to use Commercially Reasonable
Efforts to take into account the schedules of the Nektar representatives in
scheduling such meetings, conferences or discussions. AstraZeneca shall promptly
forward to Nektar copies of all meeting minutes and summaries of all such
meetings, conferences and discussions with the FDA.”

 

  6. A new Section 6.7(f) is added to the Agreement, as follows:

“(f) Communications to FDA concerning CV Safety Issue. Prior to approval of the
application for Health Registration Approval, AstraZeneca shall provide Nektar
with advance draft copies of all written or electronic communications and
presentations that AstraZeneca or its Affiliates intend to submit to FDA
relating to any cardiovascular safety issues (other than communications that are
purely administrative in nature). Prior to approval of the application for
Health Registration Approval, AstraZeneca shall provide Nektar with advance
draft written summaries of any communication that AstraZeneca or its Affiliates
intend to convey to FDA by telephone, teleconference or video conference
regarding any cardiovascular safety issues (other than communications that are
purely administrative in nature). AstraZeneca may redact any portions of any
copies or summaries provided under this clause (f) that relate to aspects of any
Combination Product that are proprietary to AstraZeneca, its Affiliates or any
Third Party including any proprietary compounds or any other proprietary
technology of AstraZeneca, its Affiliates or any Third Party. AstraZeneca shall
reasonably consider Nektar’s comments with respect to such draft communications
on any cardiovascular safety issues in good faith.”

 

  7. A new sentence is added at the end of Section 6.4(a) of the Agreement as
follows:

“Notwithstanding any other proviso or qualification in this Agreement to the
contrary and without limiting or qualifying AstraZeneca’s other obligations
hereunder, AstraZeneca hereby agrees to submit applications for Health
Registration Approval (in form and substance representing AstraZeneca’s
application of its Commercially Reasonable Efforts) for the first Stand-Alone
Product as follows: (a) to EMEA on or before [***] and not voluntarily withdraw
such submission to the EMEA or agree to any extension of the post-

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

submission review period until the EMEA has communicated its acceptance of such
application; and (b) to FDA on or before [***] and not voluntarily withdraw such
submission or agree to any extension of the post-submission review period until
FDA Acceptance.”

 

  8. Section 7.1(b) is deleted from the Agreement and replaced in its entirety
with the following:

“(b) with respect to the Stand-Alone Products containing NKTR-118 (which, for
clarity, include the Packaged 118 Opioid Product, but not Opioid Combination
Products, which are addressed in Section 7.1(c)):

(i) a payment of Seventy Million U.S. Dollars ($70,000,000) within five
(5) business days following FDA Acceptance;

(ii) a payment of Thirty-Five Million U.S. Dollars ($35,000,000) within [***]
following the earlier of (1) AstraZeneca receives an Approval Letter,
(2) AstraZeneca receives a Complete Response Letter which does not include a
request for a CV Safety Study; or (3) the effective date of AstraZeneca’s
termination of the Agreement in its entirety pursuant to the terms and
conditions of Section 18.4(a) for any reason permitted thereunder other than
pursuant to Section 18.4(a) subparagraph (d);

(iii) a payment of [***];

(iv) a payment of [***];

(v) a payment of [***];

(vi) a payment of [***];

(vii) a payment of [***];

(viii) a payment of [***];

(ix) a payment of [***];

(x) a payment of [***];

No payment in this Section 7.1(b) shall be made more than once irrespective of
the number of Stand-Alone Products that have achieved the milestone events set
forth in this Section 7.1(b), or the number of countries in which such milestone
events have been achieved.”

To account for the foregoing renumbering of Section 7.1(b), correspondingly,
Section 7.1(d) is hereby amended so that the reference to
Section 7.1(b)(v)-(ix) is modified to refer to Section 7.1(b)(vi)-(x).

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

  9. The following new Section 7.7(e) is hereby added to the Agreement:

“(e) Post-Approval Cardiovascular Study Royalty Reduction. If the FDA requires
AstraZeneca to conduct one or more post-approval cardiovascular safety clinical
or other studies or activities related to cardiovascular safety as a condition
to approval of the application for Health Registration Approval for the first
Stand-Alone Product, then the royalty rate otherwise payable by AstraZeneca
under Section 7.2(a)(i) will be reduced by two percentage points until such time
as the corresponding aggregate accumulated amount of such royalty payment
reduction is equal to a maximum of Thirty-Five Million U.S. Dollars
($35,000,000), provided further that in no event shall the aggregate accumulated
amount of such royalty payment reduction exceed thirty-three percent (33%) of
the external costs actually incurred by AstraZeneca to conduct such
post-approval studies or activities. AstraZeneca shall provide reasonable
documentation detailing the external costs incurred by it hereunder. The
reduction in this Section 7.7(e) shall not have the effect of reducing the
amount of any other step-down or reduction under Section 7.7 that would apply in
the absence of the application of this reduction.”

 

  10. Section 7.10(a) is deleted from the Agreement and replaced in its entirety
with the following:

(a) [***].

 

  11. The following new Section 7.20 is hereby added to the Agreement:

“7.20 “Loan Upon Termination. Solely in the event that AstraZeneca terminates
this Agreement with respect to the United States or in its entirety pursuant to
Section 18.4(a) subparagraph (d), the amount paid by AstraZeneca pursuant to
Section 7.1(b)(i) (the FDA Acceptance milestone) (i.e., $70,000,000) shall be
converted into a secured loan granted by AstraZeneca under a loan agreement,
security agreement and such any other applicable related agreements
substantially on the terms set forth in Exhibit I of this Agreement and
otherwise on reasonable and customary terms. The Parties shall negotiate in good
faith such definitive agreements commencing following the Effective Date of the
Amendment and such agreements shall be finalized and executed no later than
[***] thereafter.”

 

  12. The following new subparagraph (d) is added at the end of the first
sentence of Section 18.4(a) of the Agreement:

“, or (d) FDA issues a Complete Response Letter or other written document that
requires the pre-approval submission of one or more CV Safety Studies (provided
the aggregate cost threshold in the definition is met) as a condition of initial
approval of the application for the Health Registration Approval for

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

the first Stand-Alone Product (a “CV Study Reason”), provided, that AstraZeneca
shall have the right to terminate the Agreement in its entirety (or if elected
by AstraZeneca, solely with respect to the United States) for a CV Study Reason
only upon written notice delivered to Nektar on or before the end of the [***]
period immediately following notification of the CV Study Reason from FDA.
Section 18.4(a) subparagraph (d) is not intended to limit or otherwise modify
any other termination rights of AstraZeneca or Nektar under this Agreement.”

 

  13. Exhibit I. Exhibit I to this Amendment No. 1 is hereby added as a new
Exhibit I to the Agreement.

 

  14. Miscellaneous

 

  a. Temporary Suspension of Termination Rights. AstraZeneca agrees that it will
not exercise any of its termination rights that it may have under the Agreement
prior to a decision by each of FDA and EMEA on the acceptance for filing of the
application for Health Registration Approval submitted by AstraZeneca for the
first Stand-Alone Product as provided in Section 6.4(a).

 

  b. Disclosure. The Parties agree and acknowledge that the terms and conditions
of this Amendment will be disclosed by Nektar in a Current Report on Form 8-K
under the Securities Exchange Act of 1934 (“Exchange Act”) within four
(4) business days following the Effective Date of the Amendment and a conformed
copy of this Amendment will be filed as an exhibit to one or more of Nektar’s
Exchange Act filings; provided, however, that Nektar will comply with
Section 11.5 of the Agreement, including but not limited to the preparation of
redactions, and Nektar shall redact the dates specified in Paragraph 7 of this
Amendment.

 

  c. Full Force and Effect. Except as expressly amended by this Amendment, the
Agreement shall remain unchanged and continue in full force and effect as
provided therein.

 

  d. Entire Agreement of the Parties. This Amendment and the Agreement
constitute the complete final and exclusive understanding and agreement of the
Parties with respect to the subject matter of the Agreement, and supersede any
and all prior or contemporaneous negotiations, correspondence, understandings
and agreements, whether oral or written, between the Parties respecting the
subject matter of the Agreement; other than that certain letter agreement
between the Parties dated of even date herewith, which for clarity remains in
full force and effect.

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

 

  e. Counterparts. This Amendment may be executed in multiple counterparts, each
of which shall be deemed an original, but all of which together shall constitute
one and the same instrument. One or more counterparts of this Amendment may be
executed and/or exchanged by facsimile or other electronic means (such as in pdf
format), and such execution and/or exchange shall be legally binding for all
purposes.

 

  f. Other. Section 2 and 20 of the Agreement shall apply to this Amendment,
mutatis mutandis.

[Signature Page Follows]

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment in by their
authorized representatives as of the Effective Date of the Amendment.

SIGNED ON BEHALF OF

ASTRAZENECA AB

 

By:  

[***]

Name:  

[***]

Title:  

[***]

SIGNED ON BEHALF OF

NEKTAR THERAPEUTICS

 

By:  

[***]

Name:  

[***]

Title:  

[***]

[Signature Page to Amendment No. 1]

 

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

Exhibit I

Loan Terms

Capitalized terms have the meaning set forth in the License Agreement (as
defined below).

 

License Agreement:    License Agreement, dated as of September 20, 2009, by and
between the Lender and
the Borrower, as amended by Amendment No. 1 to License Agreement, dated as of
August 8, 2013 (the “License Agreement”). Borrower:    Nektar.

Guarantors:

  

All of Nektar’s existing and future domestic subsidiaries.

Lender:    AstraZeneca and/or one or more of its affiliates. Facility:    $70
million milestone payment under Section 7.1(b)(i) of the License Agreement (the
date of such milestone payment, the “Milestone Date”), which shall convert to a
secured term loan if and when the Lender exercises its right to terminate the
License Agreement pursuant to Section 18.4(a), subparagraph (d) thereof (the
“Facility”). The date of such conversion is referred to herein as the
“Conversion Date.” Maturity Date:    January 15, 2018 or Royalty Term Date, as
applicable. Amortization:    If the Lender terminates the License Agreement in
its entirety pursuant to Section 18.4(a), subparagraph (d) thereof, the Facility
shall be amortized as follows:   

January 15, 2015:

  $10 million plus accrued interest for the period commencing on such
termination date.   

January 15, 2016:

  $10 million plus accrued interest for the period following the immediately
preceding payment date.   

January 15, 2017:

  $20 million plus accrued interest for the period following the immediately
preceding payment date.   

January 15, 2018:

  $30 million plus accrued interest for the period following the immediately
preceding payment date.   

If the Lender terminates the License Agreement only with respect to the United
States, the Facility shall be repaid (first accrued interest and then principal)
by offsetting 50% of the royalties payable (not including milestone payments) by
the Lender to the Borrower under the License Agreement, and any amounts that

 

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EXECUTION VERSION

 

    

remain outstanding after the end of the royalty term for the first Stand Alone
Product as determined under Section 7.9(a) of the License Agreement, whether due
to termination of the License Agreement or the expiration of such term (“Royalty
Term Date”), shall become due and payable within [***] days of the Royalty Term
Date; provided that if the Royalty Term Date is prior to January 15, 2018 and
such
aggregate remaining outstanding amount exceeds $10 million, then such amount
shall be instead be payable pursuant to the amortization schedule set forth
above
until fully paid (it being understood that (i) if the remaining amount on a
given
amortization date is less than the amount set forth above for such date, such
lesser
amount will be due and (ii) if the remaining amount on the Royalty Term Date is
greater than the amounts set forth above for all future payment dates, then the
amount of such excess shall be paid within [***] days of the Royalty Term Date).

 

The Borrower, at its option, may prepay the Facility at any time without premium
or penalty.

Interest Rate:    4.5% per annum, compounded annually, which shall accrue from
and after the Conversion Date. Security:    Secured by all rights of the
Borrower and its affiliates under the License Agreement (the “Collateral”), the
grant of such security interest to be effective on the Milestone Date.
Representations and Warranties:                        Representations and
Warranties are limited to the following: (i) corporate existence and good
standing and corporate power and authority, (ii) execution, delivery and
enforceability of the definitive documentation for the transaction, (iii) no
material violation of law, material contracts, other material indebtedness or
organizational documents arising from this transaction, (iv) no required
governmental or third party approvals or consents for this transaction, and (v)
perfected security interest in the Collateral (subject to the existing lien in
favor of the Company’s Senior Secured Notes due 2017). Financial Covenants:   
None. Covenants:    Affirmative Covenants are limited to the following: Borrower
agrees (with respect to itself and its subsidiaries) to (i) deliver annual
financial statements and notices of default under the Facility, (ii) deliver
compliance certificates an annual basis confirming there is no material breach
of any representation or warranty listed above, (iii) comply with contracts and
laws, except as would not reasonably be expected to have a material adverse
effect, (iv) remain in good corporate standing other than would not reasonably
be expected to have a material adverse effect, (v) with respect to the Borrower
and its domestic subsidiaries, not merge, consolidate or sell all/substantially
all assets (unless the successor is organized under one of the states of the
U.S. or the District of Columbia, or there would be no adverse legal or tax
consequences to the Lender, and the successor assumes obligations under the
Facility), and (vi) not transfer to any third party any of the Collateral or the
assets underlying the Collateral. Events of Default:    Events of Default are
limited to the following: (i) nonpayment of principal or interest due under the
Facility following [***] day cure period, (ii) the representations or warranties
listed above proving to be materially incorrect on the Conversion Date and on
any repayment date, (iii) breach of any covenant in

 

10

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Commission. Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

EXECUTION VERSION

 

   the Facility, subject to [***] day cure period, (iv) failure to maintain
perfected security interest in Collateral, (v) bankruptcy or inability to pay
debts when due, and (vi) default under other material indebtedness, and (vii)
change of control without a guaranty or assumption of the Facility by the
acquiring company. Governing Law and Forum:                                New
York.

 

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