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Exhibit 10.35 [***] Certain confidential portions (indicated by brackets and
asterisks) have been omitted from this exhibit in accordance with the rules of
the Securities and Exchange Commission. AMENDMENT NO. 1 TO STRATEGIC
COLLABORATION AGREEMENT This AMENDMENT NO. 1 (this “Amendment”) to the Agreement
(as defined below) is entered into as of January 9, 2020 (the “Amendment
Effective Date”) by and between Nektar Therapeutics, a Delaware corporation,
headquartered at 455 Mission Bay Boulevard South, Suite 100, San Francisco, CA
94158 (“Nektar”) and Bristol-Myers Squibb Company, a Delaware corporation, with
offices at 430 E. 29th Street, 14th floor, New York, NY 10016 (“BMS”). Nektar
and BMS may be referred to herein individually as a “Party,” or collectively as
the “Parties.” RECITALS WHEREAS, the Parties have entered into a Strategic
Collaboration Agreement dated as of February 13, 2018 and effective as of April
3, 2018 (the “Agreement”); WHEREAS, the Parties have agreed to a revised version
of the Joint Development Plan that supersedes and replaces any prior versions
thereof, including the initial Joint Development Plan attached to the Agreement
as Schedule 3.1; WHEREAS, as a result of their agreement on a revised Joint
Development Plan, the Parties wish to amend the list of Collaboration Therapies
attached to the Agreement as Schedule 1.43; and WHEREAS, the Parties, pursuant
to Section 17.9 of the Agreement, wish to formalize their agreement on the
revised Joint Development Plan and agree on certain additional amendments
pursuant to the terms and conditions hereof. NOW, THEREFORE, in consideration of
the foregoing premises and the mutual promises and covenants contained herein,
the receipt and sufficiency of which is hereby acknowledged, the Parties agree
as follows: 1. DEFINITIONS The terms in this Amendment with initial letters
capitalized that are not defined herein shall have the meaning set forth in the
Agreement. 2. AMENDMENTS 2.1 Joint Development Plan (a) Pursuant to Sections
3.1(b), 3.6(b) and 3.6(c) of the Agreement, the Parties, on the basis of a
meeting of the JDC held on [***], and through other discussions held in
accordance with the Agreement have agreed to a revised Joint Development Plan.
The revised Joint Development Plan, effective as of the Amendment Effective
Date, is attached hereto as Appendix A. The Parties hereby waive the requirement
to have the revised Joint Development Plan attached hereto as Appendix A
approved at a meeting of the JDC. This revised Joint Development Plan replaces
and supersedes, as of the Amendment Effective Date, the initial Joint
Development Plan attached as Schedule 3.1 to the Agreement. (b) As a result of
their agreement on this revised Joint Development Plan, the Parties are hereby
released from any and all obligations or restrictions in respect of any of the
Initial Trials that are ACTIVE/102462316.2

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not listed in the revised Joint Development Plan attached hereto as Appendix A
(including relating to the conduct thereof). (c) Subject to Section 2.1(g), for
each of the Collaboration Studies contemplated in the revised Joint Development
Plan, Appendix A sets forth, for each Collaboration Study, either its Diligence
Date or a confirmation that the Diligence Date has been met, provided that such
Diligence Dates shall remain subject to Allowable Delays. (d) For purposes of
this Amendment and to the actual knowledge of BMS’ [***], BMS is not aware of
any circumstance that would justify to delay, on the basis of the application of
the Commercially Reasonable Efforts standard of the Agreement, the commencement
(and solely the commencement), by the applicable Diligence Date, of any of the
Collaboration Studies referred to in the Joint Development Plan attached as
Appendix A that has not started as of the Amendment Effective Date. For purposes
of this Amendment and to the actual knowledge of Nektar’s [***], Nektar is not
aware of any circumstance that would justify to delay, on the basis of the
application of the Commercially Reasonable Efforts standard of the Agreement,
the commencement (and solely the commencement), by the applicable Diligence
Date, of any of the Collaboration Studies referred to in the Joint Development
Plan attached as Appendix A that has not started as of the Amendment Effective
Date. (e) As a result of their agreement on the revised Joint Development Plan,
the Parties agree to a revised Schedule 1.43 (Collaboration Therapies) to the
Agreement. Such revised Schedule 1.43, attached hereto as Appendix C, replaces
and supersedes, as of the Amendment Effective Date, the initial version of
Schedule 1.43 attached to the Agreement. For clarity, as of the Amendment
Effective Date, the restrictions set forth in Section 7.3(d) of the Agreement
will no longer apply to any Collaboration Therapy that is not listed in the
revised Schedule 1.43 attached hereto as Appendix C. For additional clarity, the
restrictions set forth in Section 7.3(d) of the Agreement will apply to first
line non-small-cell lung cancer Collaboration Therapy even if there is, as of
the Amendment Effective Date, no Collaboration Study associated with that
Collaboration Therapy. (f) BMS shall have the right, at its sole discretion, to
terminate co-funding of its pro rata share of the Development Costs for the
Adjuvant Melanoma Collaboration Study by notice in writing to Nektar in the
event that the Metastatic Melanoma Collaboration Study fails to meet the primary
endpoint of progression-free survival (the “Adjuvant Melanoma Co-Funding
Termination Right”). In the event that any primary or co-primary endpoint is not
reached in the Metastatic Melanoma Collaboration Study, the Parties, with the
understanding that the health and welfare of patients is of foremost importance,
agree to meet and confer to discuss whether there is a need to inform patients,
physicians or study sites involved in the Adjuvant Melanoma Collaboration Study
of such endpoints not having been reached or other relevant information in the
Metastatic Melanoma Collaboration Study, and if so, the means and timeframe to
do so. In the event BMS duly exercises its Adjuvant Melanoma Co-Funding
Termination Right, Nektar shall have the right, in its sole discretion, to
continue the Adjuvant Melanoma Study as a Combined Therapy Independent Study
pursuant to the Agreement. (g) For the avoidance of doubt, notwithstanding
anything herein or in the Agreement to the contrary, nothing in this Amendment
or the Agreement should be read or construed as creating any obligation on
either Party to agree to conduct any Phase III Study or registrational Clinical
Trial of a [***]. The gating criteria included in Appendix A in this respect are
for guidance purposes only. [***] [***] Certain confidential portions (indicated
by brackets and asterisks) have been omitted from this exhibit in accordance
with the rules of the Securities and Exchange Commission. Page 2

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2.2 Release and Waiver. EACH PARTY HEREBY FULLY AND IRREVOCABLY RELEASES AND
WAIVES ANY CLAIM, WHETHER KNOWN OR UNKNOWN, IT HAS OR MAY HAVE FROM THE
BEGINNING OF TIME TO THE AMENDMENT EFFECTIVE DATE AGAINST THE OTHER PARTY
ARISING OUT OF, OR RELATING TO, (A) ANY FAILURE BY SUCH OTHER PARTY TO CONDUCT
ANY OF THE INITIAL TRIALS OR (B) ANY OF THE INITIAL TRIALS NOT HAVING MET THEIR
DILIGENCE DATE, INCLUDING AS SET FORTH IN SECTION 3.2(A) OF THE AGREEMENT. 2.3
Additional Milestone Payments (a) Additional, Non-creditable Milestone Payment.
Within [***] following the achievement of the first patient, first visit in the
first Phase III Study of a Combined Therapy consisting of a Product and the BMS
Compound that is conducted as a Combined Therapy Collaboration Study (and not an
Independent Study) in adjuvant melanoma (the “Additional Melanoma Milestone”),
BMS shall pay, or cause to be paid, to Nektar an amount of twenty-five million
U.S. Dollars ($25,000,000) (the “Additional Melanoma Milestone Payment”). The
Additional Melanoma Milestone Payment payable pursuant to this Section 2.3(a)
will be non-refundable and non-creditable and is in addition to all other
payments that are, or may be due, to Nektar under the Agreement (as amended).
The Additional Melanoma Milestone Payment shall be payable only one time
regardless of the number of products that achieve such Additional Melanoma
Milestone and regardless of the number of Indications for which such Additional
Melanmoa Milestone is achieved. (b) Additional, Creditable Milestone Payments.
(i) Additional MIBC Milestone Payment. Within [***] following the achievement of
the first patient, first visit in the first Phase III Study of a Combined
Therapy consisting of a Product and the BMS Compound that is conducted as a
Combined Therapy Collaboration Study (and not an Independent Study) in Muscle
Invasive Bladder Cancer (the “Additional MIBC Milestone”), BMS shall pay, or
cause to be paid, to Nektar an amount of twenty-five million U.S. Dollars
($25,000,000) (the “Additional MIBC Milestone Payment”). The Additional MIBC
Milestone Payment payable pursuant to this Section 2.3(b)(i) will be
non-refundable, but will be fully creditable against any future Development
Milestone Payment(s) payable by BMS to Nektar pursuant to Section 9.2(b) of the
Agreement, until the full amount of such Additional MIBC Milestone Payment shall
have been applied to Development Milestone Payments. The Additional MIBC
Milestone Payment shall be payable only one time regardless of the number of
Products that achieve such Additional MIBC Milestone and regardless of the
number of Indications for which such Additional MIBC Milestone is achieved. (ii)
Within [***] following the achievement of the first patient, first visit in the
first Phase III Study of a Combined Therapy consisting of a Product and the BMS
Compound that is conducted as a Combined Therapy Collaboration Study (and not an
Independent Study) in First Line Non- Small-Cell Lung Cancer (the “Additional
Lung Milestone”), BMS shall pay, or cause to be paid, to Nektar an amount of
seventy-five million U.S. Dollars ($75,000,000) (the “Additional Lung Milestone
Payment”). The Additional Lung Milestone Payment payable pursuant to this
Section 2.3(b)(ii) will be non-refundable, but will be fully creditable against
any future Development Milestone Payment(s) payable by BMS to Nektar pursuant to
Section 9.2(b) of the Agreement, until the full amount of such Additional Lung
Milestone Payment shall have been applied to Development Milestone Payments. The
Additional Lung Milestone Payment shall be payable only one time regardless of
the number of Products that achieve such Additional Lung Milestone and
regardless of the number of Indications for which such Additional Lung Milestone
is achieved. For the avoidance of doubt, notwithstanding anything herein or in
the Agreement [***] Certain confidential portions (indicated by brackets and
asterisks) have been omitted from this exhibit in accordance with the rules of
the Securities and Exchange Commission. Page 3

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to the contrary, nothing in this Amendment or the Agreement should be read or
construed as creating any obligation on either Party to agree to conduct any
Phase III Study or registration Clinical Trial of the Combined Therapy in [***]
as a Combined Therapy Collaboration Study. 2.4 Combined Therapy Collaboration
Studies Expenses. Schedule 6.3 of the Agreement is replaced in its entirety by
the new version attached to this Amendment as Appendix D. 2.5 Right of Cross
Reference. Section 4.2(b)(v) of the Agreement is replaced in its entirety by the
following: “(v) to the extent necessary for the conduct of any Collaboration
Study or Independent Study or BMS’s filing of a BLA or supplemental BLA as set
forth in Section 10.1(b), providing BMS a Right of Cross-Reference to the
relevant Regulatory Documentation, provided that, such Right of Cross-Reference
shall terminate upon the expiration or termination of this Agreement for
purposes of conducting any new Clinical Trials, except that in the case of
termination for a Material Safety Issue pursuant to Section 16.4, such Right of
Cross-Reference shall remain in effect solely (A) to the extent necessary to
permit BMS to comply with any outstanding obligations required by a Regulatory
Authority and/or Applicable Law or (B) as necessary to permit BMS to continue to
dose subjects enrolled in each Collaboration Study or Independent Study through
completion of the applicable Protocol if required by the applicable Regulatory
Authority(ies) and/or Applicable Laws;” 2.6 Reimbursement for Opt-Out
Development Costs. Section 7.4 of the Agreement is replaced in its entirety by
the following: “7.4 Reimbursement for Opt-Out Development Costs. If a
Monotherapy Independent Study or Combined Therapy Independent Study results in
Regulatory Approval or a Label expansion of a BMS Asset or Nektar Asset
(including the Nektar Compound), the non-funding Party shall reimburse the
funding Party for the non-funding Party’s allocated share of Opt-Out Development
Costs incurred by the funding Party for the applicable Monotherapy Independent
Study or Combined Therapy Independent Study (using the principles set forth in
Sections 5.3(c)(i), 6.2 and 6.3) for which the non-funding Party would have been
responsible had such Independent Study been a Collaboration Study, plus an
amount equal to either (i) [***] of such reimbursement in the event that the
applicable Combined Therapy Independent Study studies the Combined Therapy of a
Product and the BMS Compound (whether or not other compounds are included in
such study), or (ii) [***] of such reimbursement in all other cases. Such
reimbursed Opt-Out Development Costs (and the [***] or [***], as applicable,
additional reimbursement for such Independent Study) shall be subject to the
reconciliation procedures set forth in Section 9.7 but shall not be subject to
the Development Cost Cap.” 2.7 Independent Studies. Appendix B hereto includes a
list of Independent Studies currently being conducted or planned to be initiated
by a Party. 2.8 [***] 2.9 [***] [***] Certain confidential portions (indicated
by brackets and asterisks) have been omitted from this exhibit in accordance
with the rules of the Securities and Exchange Commission. Page 4

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2.10 Governance. The Parties agree that Allowable Delays shall include the time
between the expiration of any contractually agreed timeframefor the provision by
one Party to the other Party of information, comments or Study Data and the
actual provision thereof. 3. PUBLICITY Upon execution of this Amendment, the
Parties will issue a press release the contents of which is as attached hereto
as Appendix E. The aforementioned press release will be issued within [***]
before the opening of U.S. based stock market trading on [***]. 4. MISCELLANEOUS
4.1 This Amendment shall become effective on the Amendment Effective Date. 4.2
Unless and to the extent expressly amended by this Amendment, all the terms and
conditions of the Agreement shall remain in full force and effect. 4.3 In the
event of a conflict between the terms of this Amendment (or any attachments
thereto) and the terms of the Agreement, the terms of this Amendment (including
its attachments) shall prevail. 4.4 The headings used in this Amendment have
been inserted for convenience of reference only and do not define or limit the
provisions hereof. 4.5 This Amendment may be signed in any number of
counterparts (facsimile and electronic transmission included), each of which
shall be deemed an original, but all of which shall constitute one and the same
instrument. 4.6 This Amendment and all claims relating to or arising out of this
Amendment or the breach thereof shall be governed and construed in accordance
with the internal laws of the State of New York, USA, excluding any choice of
law rules that may direct the application of the laws of another jurisdiction.
The United Nations Convention on Contracts for the International Sale of Goods
shall not apply to this Agreement. Further, Disputes arising out of this
Amendment, other than a JDC Dispute, JCC Dispute, JFC Dispute or JMC Dispute or
a Publication Dispute or a dispute as to whether a Material Safety Issue exists,
shall be resolved in accordance with Section 15.1 of the Agreement. No part of
this Amendment changes the rights and obligations of the Parties under Article
15 of the Agreement. 4.7 This Amendment and the Agreement (as amended by the
Amendment) constitute the entire understanding between the Parties with respect
to the subject matter hereof, and supersede all prior agreements whether oral or
written. No amendment, modification, waiver, release or discharge to this
Amendment or the Agreement shall be binding upon the Parties unless in writing
and duly executed by authorized representatives of both Parties. 4.8 This
Amendment has been prepared jointly and shall not be strictly construed against
either Party. No presumption as to construction of this Amendment shall apply
against either Party with respect to any ambiguity in the wording of any
provision(s) of this Amendment irrespective of which Party may be deemed to have
authored the ambiguous provision(s). (signature page follows) [***] Certain
confidential portions (indicated by brackets and asterisks) have been omitted
from this exhibit in accordance with the rules of the Securities and Exchange
Commission. Page 5

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IN WITNESS WHEREOF, the Parties, intending to be legally bound hereby, have
caused this Amendment to be executed by their duly authorized representatives as
of the Amendment Effective Date. For and on behalf of Nektar Therapeutics:
Signature: /s/ Howard W. Robin Title: President and CEO Date: 01/09/20 For and
on behalf of Bristol-Myers Squibb Company: Signature: /s/ Charles Bancroft
Title: Executive VP, Strategy and Business Development Date: 01/09/20 Signature
page to Amendment No. 1 to the Strategic Collaboration Agreement
ACTIVE/102462316.2

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APPENDIX A JOINT DEVELOPMENT PLAN (Effective as of January 9, 2020) Number Lead
Tumor Phase Patient Population Study Design Diligence Date Patients Party 3 1L
metastatic melanoma Bempeg + Nivo vs. Nivo 764 Achieved BMS Melanoma 3 Adjuvant
melanoma Bempeg + Nivo vs. Nivo 1100 [***] NKTR 3 1L metastatic RCC doublet
Bempeg + Nivo vs. TKI 600 Achieved NKTR Phase 1. Dose escalation cohort: Nivo +
6-20 [***] BMS Bempeg + axitinib Phase 2, gated study. Expansion cohort: Nivo +
Bempeg + Axitinib vs Nivo + Axitinib (gated upon RCC 80 [***] BMS 1/2/3 RCC
triplet acceptable safety profile from dose escalation (1) prior to initiation)
Phase 3, gated study. [***] 960 [***] BMS 2 1L metastatic UC Bempeg + Nivo 190
Achieved NKTR Bladder Muscle-invasive bladder Bempeg + Nivo vs Nivo 540 [***]
BMS 3 cancer 1/2A Pediatric study Bempeg + Nivo [***] [***] BMS Other 1 Safety
study - Japan Phase 1 Bempeg + Nivo 20 Achieved BMS 1 Safety study - [***]
Bempeg + Nivo [***] [***] BMS Bempeg = Bempegaldesleukin; Nivo = Nivolumab
PIVOT-02 – Parties have agreed to stop additional enrollment, continue to
provide patient follow up and conclude the study. [***] Certain confidential
portions (indicated by brackets and asterisks) have been omitted from this
exhibit in accordance with the rules of the Securities and Exchange Commission.

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APPENDIX B INDEPENDENT STUDIES (as of January 9, 2020) Tumor Study Lead Trial
Design End Point(s) FPFV Number of Patients Party Non-small cell lung PROPEL -
Nektar Bempeg + Pembrolizumab Safety, ORR Achieved Approximately 135 cancer
(NSCLC) NSCLC Phase 1/2 Non-small cell lung NSCLC Dose BMS Nivo + Bempeg 0.009
mg/kg vs. ORR [***] 180 cancer (NSCLC) Optimization Nivo + Bempeg 0.006 mg/kg
vs. Nivo + Phase 1/21 Ipi Multiple Solid Tumor Reveal Phase 1/2 Nektar NKTR-262
+ bempeg and in Safety, ORR Achieved Phase 1: Approximately 48 Indications
combination with Bempeg + Nivo Phase 2: Approximately 400 Squamous Cell Head
Phase 1/2 Pfizer Avelumab in combination with bempeg Safety, ORR, PSA Achieved
20-40 for each combination and Neck Cancer with or without talazoparib or
response rate enzalutamide Metastatic Colorectal and Prostate Cancer
Unresectable or Phase 2 Bioxcel BXCL701 in combination with avelumab Safety, ORR
[***] Approximately 52 Metastatic Pancreatic and bempeg Adenocarcinoma Locally
advanced or Phase 2 Vaccibody VB10.NEO or VB10.NEO plus bempeg Safety, ORR [***]
Approximately 50 metastatic solid tumors including melanoma, NSCLC, clear RCC,
urothelial cancer or SCCHN Sarcoma IST IST by Bempeg + Nivo ORR Achieved
Approximately 85 MSKCC [***] Bempeg = Bempegaldesleukin Ipi = Ipilimumab Nivo =
Nivolumab [***] Certain confidential portions (indicated by brackets and
asterisks) have been omitted from this exhibit in accordance with the rules of
the Securities and Exchange Commission.

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Execution Version APPENDIX C SCHEDULE 1.43 COLLABORATION THERAPIES No. Lines and
Indications MOAs / Targets* IL-2 + PD(L)-1 1 1L or later non-small-cell lung
cancer [***] 2 1L melanoma IL-2 + PD(L)-1 3 Adjuvant melanoma IL-2 + PD(L)-1
IL-2 + PD(L)-1 4 1L renal cell carcinoma [***] 5 1L bladder cancer IL-2 +
PD(L)-1 6 Muscle invasive bladder cancer IL-2 + PD(L)-1 * For purposes of this
Schedule: - PD-1 and PD-L1 are considered as the same mechanism of action
(“MOA”) for purposes of this Agreement; and - IL-2 refers to any IL-2 Agonist
[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

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Execution Version APPENDIX D SCHEDULE 6.3 COMBINED THERAPY COLLABORATION STUDY
DEVELOPMENT COST ALLOCATION Combined Therapy Collaboration Study Development
Cost Allocation: Combinations with Products Nektar BMS Third Party Doublet with
the BMS Compound or any other single BMS 32.5% 67.5% - Asset or Third Party
Asset sourced by BMS Doublet with any other Nektar Asset or Third Party Asset
82.5% 17.5% - sourced by Nektar Triplet with 2 BMS Assets (which may include the
BMS 22% 78% - Compound) [***] [***] [***] [***] [***] [***] [***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] In the event
that a Collaboration Study includes multi-arm comparative studies that draw on
more than one combination described in the above table (e.g., a doublet with a
BMS Compound plus a triplet with 1 BMS Asset plus 1 Nektar Asset) the
Development Cost allocations between Nektar and BMS shall be a blended rate
based [***]. Using the example from the prior sentence, [***] [***] Certain
confidential portions (indicated by brackets and asterisks) have been omitted
from this exhibit in accordance with the rules of the Securities and Exchange
Commission.

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Execution Version APPENDIX E Press Release (See attached)

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Execution Version Jan 10, 2020 Nektar Therapeutics and Bristol-Myers Squibb
Amend Strategic Collaboration Agreement for bempegaldesleukin Plus Opdivo
(nivolumab) SAN FRANCISCO & NEW YORK--(BUSINESS WIRE)--Jan. 10, 2020-- Nektar
Therapeutics (Nasdaq:NKTR) and Bristol-Myers Squibb Company (NYSE:BMY) announced
today the companies have agreed to a new joint development plan to advance
bempegaldesleukin (bempeg) plus Opdivo (nivolumab) into multiple new
registrational trials. The revision to the strategic collaboration agreement
includes a new joint development plan under which Nektar and Bristol-Myers
Squibb will expand the active clinical development program for bempeg plus
nivolumab from three ongoing registrational trials in first-line metastatic
melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and
first-line metastatic renal cell carcinoma (RCC) to include two additional
registrational trials in adjuvant melanoma and in muscle-invasive bladder
cancer. In addition, a Phase 1/2 dose escalation and expansion study will be
initiated to evaluate bempeg plus nivolumab in combination with axitinib in
first-line RCC in order to support a future registrational trial. The costs for
these studies will be shared based upon the cost-sharing outlined in the terms
of the original collaboration agreement. Also as part of the new strategic
collaboration agreement, Bristol-Myers Squibb will independently conduct and
fund a Phase 1/2 dose optimization and expansion study in first-line
non-small-cell lung cancer with bempeg and nivolumab. “Bristol-Myers Squibb and
Nektar view bempeg as an important asset and IL-2 as an important target,” said
Fouad Namouni, M.D., head of oncology development, Bristol-Myers Squibb. “We
look forward to expanding the registrational program currently underway for
bempeg and are committed to the development of potential new combination
therapies to address the unmet needs of patients living with cancer.” “We are
pleased to move forward with this new set of registrational trials for bempeg,
including the addition of an important Phase 3 study in adjuvant melanoma which
builds on the existing metastatic melanoma study and our Breakthrough Therapy
Designation,” said Nektar President & CEO Howard W. Robin. “We now have a
comprehensive plan to target multiple indications and have the opportunity to
continue to collaborate on development with other companies in indications
outside of those in the BMS and Nektar joint development program.” About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is
designed to uniquely harness the body’s own immune system to help restore
anti-tumor immune response. By harnessing the body’s own immune system to fight
cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s
scientific expertise in the field of Immuno-Oncology, and includes a broad range
of clinical trials across all phases, including Phase 3, in a variety of tumor
types. To date, the Opdivo clinical

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Execution Version development program has treated more than 35,000 patients. The
Opdivo trials have contributed to gaining a deeper understanding of the
potential role of biomarkers in patient care, particularly regarding how
patients may benefit from Opdivo across the continuum of PD- L1 expression. In
July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive
regulatory approval anywhere in the world. Opdivo is currently approved in more
than 65 countries, including the United States, the European Union, Japan and
China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was
the first Immuno-Oncology combination to receive regulatory approval for the
treatment of metastatic melanoma and is currently approved in more than 50
countries, including the United States and the European Union. About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic
T-lymphocyte- associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of
T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4
with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell
activation and proliferation, including the activation and proliferation of
tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also
reduce T-regulatory cell function, which may contribute to a general increase in
T-cell responsiveness, including the anti-tumor immune response. On March 25,
2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg
monotherapy for patients with unresectable or metastatic melanoma. Yervoy is
approved for unresectable or metastatic melanoma in more than 50 countries.
There is a broad, ongoing development program in place for Yervoy spanning
multiple tumor types. U.S. FDA-APPROVED INDICATIONS FOR OPDIVO® OPDIVO®
(nivolumab) as a single agent is indicated for the treatment of patients with
unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with
YERVOY® (ipilimumab), is indicated for the treatment of patients with
unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the
treatment of patients with metastatic non-small cell lung cancer (NSCLC) with
progression on or after platinum-based chemotherapy. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on FDA-approved
therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab) is
indicated for the treatment of patients with metastatic small cell lung cancer
(SCLC) with progression after platinum-based chemotherapy and at least one other
line of therapy. This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the
treatment of patients with advanced renal cell carcinoma (RCC) who have received
prior anti-angiogenic therapy. OPDIVO® (nivolumab), in combination with YERVOY®
(ipilimumab), is indicated for the treatment of patients with intermediate or
poor risk, previously untreated advanced renal cell carcinoma (RCC). OPDIVO®
(nivolumab) is indicated for the treatment of adult patients with classical
Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous
hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after
3 or more lines of systemic therapy that includes autologous HSCT. This
indication is approved under accelerated approval based on overall response
rate. Continued approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.

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Execution Version OPDIVO® (nivolumab) is indicated for the treatment of patients
with recurrent or metastatic squamous cell carcinoma of the head and neck
(SCCHN) with disease progression on or after platinum-based therapy. OPDIVO®
(nivolumab) is indicated for the treatment of patients with locally advanced or
metastatic urothelial carcinoma who have disease progression during or following
platinum- containing chemotherapy or have disease progression within 12 months
of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor response rate
and duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in confirmatory
trials. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment
of adult and pediatric (12 years and older) patients with microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic
colorectal cancer (CRC) that has progressed following treatment with a
fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under
accelerated approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in
combination with YERVOY® (ipilimumab), is indicated for the treatment of adults
and pediatric patients 12 years and older with microsatellite instability-high
(MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC)
that has progressed following treatment with a fluoropyrimidine, oxaliplatin,
and irinotecan. This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the
treatment of patients with hepatocellular carcinoma (HCC) who have been
previously treated with sorafenib. This indication is approved under accelerated
approval based on tumor response rate and durability of response. Continued
approval for this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated
for the adjuvant treatment of patients with melanoma with involvement of lymph
nodes or metastatic disease who have undergone complete resection. U.S.
FDA-APPROVED INDICATIONS FOR YERVOY® (ipilimumab) YERVOY® (ipilimumab) is
indicated for the treatment of unresectable or metastatic melanoma in adults and
pediatric patients (12 years and older). YERVOY® (ipilimumab) is indicated for
the adjuvant treatment of patients with cutaneous melanoma with pathologic
involvement of regional lymph nodes of more than 1 mm who have undergone
complete resection, including total lymphadenectomy. IMPORTANT SAFETY
INFORMATION WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in
severe and fatal immune-mediated adverse reactions. These immune-mediated
reactions may involve any organ system; however, the most common severe
immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis
(including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The
majority of these immune-mediated reactions initially manifested during
treatment; however, a minority occurred weeks to months after discontinuation of
YERVOY.

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Execution Version Assess patients for signs and symptoms of enterocolitis,
dermatitis, neuropathy, and endocrinopathy, and evaluate clinical chemistries
including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level,
and thyroid function tests, at baseline and before each dose. Permanently
discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for
severe immune-mediated reactions. Immune-Mediated Pneumonitis OPDIVO can cause
immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients
for signs with radiographic imaging and for symptoms of pneumonitis. Administer
corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue
for Grade 3 or 4 and withhold until resolution for Grade 2. In patients
receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have
occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In
patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated
pneumonitis occurred in 6% (25/407) of patients. In RCC patients receiving
OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4%
(24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with
YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of
patients. In Checkmate 205 and 039, pneumonitis, including interstitial lung
disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated
pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3
(n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO can cause
immune-mediated colitis. Monitor patients for signs and symptoms of colitis.
Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4
colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently
discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When
administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently
discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO
monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In
patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune- mediated colitis
occurred in 26% (107/407) of patients including three fatal cases. In RCC
patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis
occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving
OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7%
(8/119) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe,
life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus,
peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%)
patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%)
developed intestinal perforation, 4 (0.8%) died as a result of complications,
and 26 (5%) were hospitalized for severe enterocolitis. Immune-Mediated
Hepatitis OPDIVO can cause immune-mediated hepatitis. Monitor patients for
abnormal liver tests prior to and periodically during treatment. Administer
corticosteroids for Grade 2 or greater transaminase elevations. For patients
without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for
Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer
corticosteroids if AST/ALT is within normal limits at baseline and increases to
>3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to
3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if
AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10
times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if
AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times
the ULN. In patients receiving OPDIVO monotherapy,

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Execution Version immune-mediated hepatitis occurred in 1.8% (35/1994) of
patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg,
immune-mediated hepatitis occurred in 13% (51/407) of patients. In RCC patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune- mediated hepatitis
occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving
OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8%
(10/119) of patients. In Checkmate 040, immune-mediated hepatitis requiring
systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO. In
a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal
hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations
>3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure
in 0.2% and hospitalization in 0.4%. Immune-Mediated Neuropathies In a separate
Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1
case of severe (Grade 3) peripheral motor neuropathy were reported.
Immune-Mediated Endocrinopathies OPDIVO can cause immune-mediated hypophysitis,
immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1
diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis,
signs and symptoms of adrenal insufficiency, thyroid function prior to and
periodically during treatment, and hyperglycemia. Administer hormone replacement
as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis.
Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis.
Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for
Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency.
Administer hormone-replacement therapy for hypothyroidism. Initiate medical
management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and
permanently discontinue for Grade 4 hyperglycemia. In patients receiving OPDIVO
monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients
receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9%
(36/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1
mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC
patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated
hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO
monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In
patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency
occurred in 5% (21/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg
with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients.
In MSI- H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg,
adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients
receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in
hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred
in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients
receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis
resulting in hypothyroidism occurred in 22% (89/407) of patients.
Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of
OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1
mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22%
(119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients
receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving
OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in
hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in
12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes
occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg
with YERVOY 3 mg/kg,

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Execution Version diabetes occurred in 1.5% (6/407) of patients. In RCC patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547)
of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe to
life-threatening immune-mediated endocrinopathies (requiring hospitalization,
urgent medical intervention, or interfering with activities of daily living;
Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism,
and some had additional concomitant endocrinopathies such as adrenal
insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were
hospitalized for severe endocrinopathies. Immune-Mediated Nephritis and Renal
Dysfunction OPDIVO can cause immune-mediated nephritis. Monitor patients for
elevated serum creatinine prior to and periodically during treatment. Administer
corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for
Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine.
In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal
dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO
1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction
occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg
with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in
4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg
with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in
1.7% (2/119) of patients. Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer
corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently
discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold
OPDIVO and refer the patient for specialized care for assessment and treatment;
if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy,
immune-mediated rash occurred in 9% (171/1994) of patients. In patients
receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in
22.6% (92/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY
1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In
MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg,
immune-mediated rash occurred in 14% (17/119) of patients. In a separate Phase 3
study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune- mediated
dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash
complicated by full thickness dermal ulceration, or necrotic, bullous, or
hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%)
patient died as a result of toxic epidermal necrolysis. 1 additional patient
required hospitalization for severe dermatitis. Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with
neurologic symptoms may include, but not be limited to, consultation with a
neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with
new-onset moderate to severe neurologic signs or symptoms and evaluate to rule
out other causes. If other etiologies are ruled out, administer corticosteroids
and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients
receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of
patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of
exposure despite discontinuation of OPDIVO and administration of
corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg
with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred
in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after
approximately 4 months of exposure. Encephalitis occurred in

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Execution Version one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg
with YERVOY 1 mg/kg after 15 days of exposure. Other Immune-Mediated Adverse
Reactions Based on the severity of the adverse reaction, permanently discontinue
or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate,
initiate hormone-replacement therapy. Across clinical trials of OPDIVO
monotherapy or in combination with YERVOY, the following clinically significant
immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of
patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis,
iritis, pancreatitis, facial and abducens nerve paresis, demyelination,
polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome,
hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis,
sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),
motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic
syndrome. If uveitis occurs in combination with other immune-mediated adverse
reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been
observed in patients receiving OPDIVO and may require treatment with systemic
steroids to reduce the risk of permanent vision loss. Infusion Reactions OPDIVO
can cause severe infusion reactions, which have been reported in <1.0% of
patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4
infusion reactions. Interrupt or slow the rate of infusion in patients with
Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion,
infusion-related reactions occurred in 6.4% (127/1994) of patients. In a
separate study in which patients received OPDIVO monotherapy as a 60-minute
infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2%
(8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368)
and 1.4% (5/369) of patients, respectively, experienced adverse reactions within
48 hours of infusion that led to dose delay, permanent discontinuation or
withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg
every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients.
In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related
reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions
occurred in 4.2% (5/119) of patients. Complications of Allogeneic Hematopoietic
Stem Cell Transplantation Fatal and other serious complications can occur in
patients who receive allogeneic hematopoietic stem cell transplantation (HSCT)
before or after being treated with a PD-1 receptor blocking antibody.
Transplant-related complications include hyperacute graft-versus- host-disease
(GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after
reduced intensity conditioning, and steroid-requiring febrile syndrome (without
an identified infectious cause). These complications may occur despite
intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients
closely for evidence of transplant-related complications and intervene promptly.
Consider the benefit versus risks of treatment with a PD-1 receptor blocking
antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity Based on
their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective contraception
during treatment with an

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Execution Version OPDIVO- or YERVOY- containing regimen and for at least 5
months after the last dose of OPDIVO. Increased Mortality in Patients with
Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and
Dexamethasone In clinical trials in patients with multiple myeloma, the addition
of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased
mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1
blocking antibody in combination with a thalidomide analogue plus dexamethasone
is not recommended outside of controlled clinical trials. Lactation It is not
known whether OPDIVO or YERVOY is present in human milk. Because many drugs,
including antibodies, are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants from an OPDIVO-containing
regimen, advise women to discontinue breastfeeding during treatment. Advise
women to discontinue breastfeeding during treatment with YERVOY and for 3 months
following the final dose. Serious Adverse Reactions In Checkmate 037, serious
adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3
and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most
frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients
receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate
aminotransferase, and increased lipase. In Checkmate 066, serious adverse
reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4
adverse reactions occurred in 41% of patients receiving OPDIVO. The most
frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving
OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In
Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions
leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and
36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more
frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm
(n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus
YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%),
colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 017 and 057,
serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418).
The most frequent serious adverse reactions reported in ≥2% of patients
receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural
effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious
adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most
frequent serious adverse reactions reported in at least 2% of patients receiving
OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusions, and dehydration.
In Checkmate 025, serious adverse reactions occurred in 47% of patients
receiving OPDIVO (n=406). The most frequent serious adverse reactions reported
in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia,
diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions
occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients
receiving sunitinib. The most frequent serious adverse reactions reported in ≥2%
of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute
kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated
with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate
205 and 039, adverse reactions leading to discontinuation occurred in 7% and
dose delays due to adverse reactions occurred in 34% of patients (n=266).
Serious adverse reactions occurred in 26% of patients. The most frequent serious
adverse reactions reported in ≥1% of patients were pneumonia, infusion-related
reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash.
Eleven patients died from causes other than disease progression: 3 from adverse
reactions within 30 days of the last OPDIVO dose, 2 from infection

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Execution Version 8 to 9 months after completing OPDIVO, and 6 from
complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions
occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious
adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia,
dyspnea, respiratory failure, respiratory tract infection, and sepsis. In
Checkmate 275, serious adverse reactions occurred in 54% of patients receiving
OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of
patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small
intestine obstruction, and general physical health deterioration. In Checkmate
142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse
reactions occurred in 47% of patients. The most frequent serious adverse
reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events,
abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040,
serious adverse reactions occurred in 49% of patients (n=154). The most frequent
serious adverse reactions reported in ≥2% of patients were pyrexia, ascites,
back pain, general physical health deterioration, abdominal pain, and pneumonia.
In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of
OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse
reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased
lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO- treated
patients. Common Adverse Reactions In Checkmate 037, the most common adverse
reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066,
the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs
dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs
25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most
common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were
fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus
(39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%),
cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection
(23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067,
the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue
(59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%),
cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased
appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and
vomiting (20%). In Checkmate 017 and 057, the most common adverse reactions
(≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain,
cough, dyspnea, and decreased appetite. In Checkmate 032, the most common
adverse reactions (≥20%) in patients receiving OPDIVO (n=245) were fatigue
(45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%),
nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate
025, the most common adverse reactions (≥20%) reported in patients receiving
OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs
38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea
(25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back
pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most
common adverse reactions (≥20%) reported in patients treated with OPDIVO plus
YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs
25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs
11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia
(23% vs 16%), decreased appetite (21% vs 29%), dyspnea (20% vs 21%), and
vomiting (20% vs 28%). In Checkmate 205 and 039, the most common adverse
reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper
respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%),
pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus
(20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients
receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than
investigator’s choice. In Checkmate 275, the most common adverse reactions
(≥20%) reported in patients receiving OPDIVO (n=270) were fatigue

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Execution Version (46%), musculoskeletal pain (30%), nausea (22%), and decreased
appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as
a single agent, the most common adverse reactions (≥20%) were fatigue (54%),
diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%),
musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation
(20%), and upper respiratory tract infection (20%). In Checkmate 142 in
MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse
reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%),
musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%),
rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the
most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were
fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%),
diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In
Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-
treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue
(57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain
(32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%),
upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The
most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis
(6%), and hepatitis (3%). In a separate Phase 3 study of YERVOY 3 mg/kg, the
most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg
were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis
(8%). Please see U.S. Full Prescribing Information for OPDIVO and YERVOY,
including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
Checkmate Trials and Patient Populations Checkmate 037–previously treated
metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma;
Checkmate 067–previously untreated metastatic melanoma, as a single agent or in
combination with YERVOY; Checkmate 017–second-line treatment of metastatic
squamous non-small cell lung cancer; Checkmate 057–second-line treatment of
metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell
lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate
214–previously untreated renal cell carcinoma, in combination with YERVOY;
Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or
metastatic squamous cell carcinoma of the head and neck; Checkmate
275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal
cancer, as a single agent or in combination with YERVOY; Checkmate
040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.
About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical
company whose mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter,
YouTube, Facebook, and Instagram. Celgene and Juno Therapeutics are wholly owned
subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred to as,
Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers
Squibb company. About the Bristol-Myers Squibb and Ono Pharmaceutical
Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical
Co., Bristol-Myers Squibb expanded its territorial rights to develop and
commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where
Ono had retained all rights to the compound at the time. On July 23, 2014, Ono
and Bristol-Myers Squibb further expanded the companies’

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Execution Version strategic collaboration agreement to jointly develop and
commercialize multiple immunotherapies – as single agents and combination
regimens – for patients with cancer in Japan, South Korea and Taiwan. About
Nektar Therapeutics Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly-owned R&D pipeline of investigational medicines in oncology,
immunology and pain as well as a portfolio of approved partnered medicines.
Nektar is headquartered in San Francisco, California, with additional operations
in Huntsville, Alabama and Hyderabad, India. Further information about the
company and its drug development programs and capabilities may be found online
at http://www.nektar.com. About Bempegaldesleukin (BEMPEG, NKTR-214) Bempeg is
an investigational, first-in-class, CD122-preferential IL-2 pathway agonist
designed to provide rapid activation and proliferation of cancer-killing immune
cells, known as CD8+ effector T cells and natural killer (NK) cells, without
over activating the immune system. The agent is designed to stimulate these
cancer-killing immune cells in the body by targeting CD122-specific receptors
found on the surface of these immune cells. CD122, which is also known as the
Interleukin-2 receptor beta subunit, is a key signaling receptor that is known
to increase proliferation of these effector T cells.1 In clinical and
preclinical studies, treatment with bempegaldesleukin resulted in expansion of
these cells and mobilization into the tumor micro- environment.2,3
Bempegaldesleukin has an antibody-like dosing regimen similar to the existing
checkpoint inhibitor class of approved medicines. Bristol-Myers Squibb Forward
Looking Statements This press release contains “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and commercialization
of pharmaceutical products and the collaboration with Nektar Therapeutics. All
statements that are not statements of historical facts are, or may be deemed to
be, forward-looking statements. Such forward-looking statements are based on
historical performance and current expectations and projections about our future
financial results, goals, plans and objectives and involve inherent risks,
assumptions and uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that are
difficult to predict, may be beyond our control and could cause our future
financial results, goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks, assumptions,
uncertainties and other factors include, among others, that the expected
benefits of, and opportunities related to, the collaboration with Nektar
Therapeutics may not be realized by Bristol-Myers Squibb or may take longer to
realize than anticipated and that Opdivo, in combination with bempegaldesleukin,
may not achieve their primary study endpoints or receive regulatory approval for
the indications described in this release in the currently anticipated timeline
or at all and, if approved, whether such combination treatment for such
indications described in this release will be commercially successful. No
forward-looking statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and uncertainties
that affect Bristol-Myers Squibb’s business and market, particularly those
identified in the cautionary statement and risk factors discussion in
Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December
31, 2018, as updated by our subsequent Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this document are made
only as of the date of this document and except as otherwise required by
applicable law, Bristol-Myers Squibb undertakes no obligation to publicly update
or revise any forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.

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Execution Version Nektar Therapeutics Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking statements which can be
identified by words such as: "will," "move forward," "plan" and similar
references to future periods. Examples of forward- looking statements include,
among others, statements we make regarding the therapeutic potential of
bempegaldesleukin ("bempeg") in combination with nivolumab, and the availability
of results and outcomes from studies of the therapies based on bempeg
combinations. Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on our current
beliefs, expectations and assumptions regarding the future of our business,
future plans and strategies, anticipated events and trends, and other future
conditions. Because forward-looking statements relate to the future, they are
subject to inherent uncertainties, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control. Our actual
results may differ materially from those indicated in the forward-looking
statements. Therefore, you should not rely on any of these forward- looking
statements. Important factors that could cause our actual results to differ
materially from those indicated in the forward-looking statements include, among
others: (i) our statements regarding the therapeutic potential of bempeg are
based on preclinical and clinical findings and observations; (ii) bempeg is
currently in clinical development and the risk of failure remains high and
failure can unexpectedly occur at any stage for one or more of the cancer
indications being studied prior to regulatory approval due to lack of sufficient
efficacy, safety considerations or other factors that impact drug development;
(iii) data reported from ongoing preclinical and clinical trials are necessarily
interim data only and the final results will change based on continuing
observations; (iv) scientific discovery of new medical breakthroughs is an
inherently uncertain process and the future success of potential of bempeg is
therefore very uncertain and unpredictable; (v) the timing of the commencement
or end of clinical studies and the availability of clinical data may be delayed
or unsuccessful due to regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, changing standards of care, evolving
regulatory requirements, clinical trial design, clinical outcomes, delays caused
by our collaboration partners, and enrollment competition; (vi) patents may not
issue from our patent applications for our drug candidates, patents that have
issued may not be enforceable, or additional intellectual property licenses from
third parties may be required; and (vii) certain other important risks and
uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 7, 2019. Any forward-looking
statement made by us in this press release is based only on information
currently available to us and speaks only as of the date on which it is made. We
undertake no obligation to update any forward-looking statement, whether written
or oral, that may be made from time to time, whether as a result of new
information, future developments or otherwise. References: 1. Boyman, J., et
al., Nature Reviews Immunology, 2012, 12, 180-190. 2. Charych, D., et al., Clin
Can Res; 22(3) February 1, 2016 3. Diab, A., et al., Journal for ImmunoTherapy
of Cancer 2016, 4(Suppl 1): P369 For Bristol-Myers Squibb Media: media@bms.com
609-252-3345

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Execution Version Investors: Tim Power, 609-252-7509, timothy.power@bms.com Nina
Goworek, 908-673-9711, ngoworek@celgene.com For Nektar Investors: Vivian Wu of
Nektar Therapeutics 628-895-0661 Media: Dan Budwick of 1AB 973-271-6085
dan@1abmedia.com  

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