United states securities and exchange commission

Table of Contents
20
AbbVie, Inc.
We have a collaboration agreement with AbbVie 
for the development and commercialization of 
ZINBRYTA in MS. Under this agreement, we and 
AbbVie conduct ZINBRYTA co-promotion activities in 
the U.S., E.U. and Canadian territories, and we are 
responsible for all manufacturing and research and 
development activities.
For information on the Article 20 Procedure of 
ZINBRYTA and resulting impairment of ZINBRYTA 
related assets, please read Note 20, Collaborative 
and Other Relationships, to our consolidated financial 
statements included in this report.
Acorda Therapeutics, Inc.
We have a collaboration and license agreement 
with Acorda to develop and commercialize products 
containing fampridine, such as FAMPYRA, in markets 
outside the U.S. We are responsible for all regulatory 
activities and the future clinical development of 
related products in those markets.
Alkermes
We have an exclusive license and collaboration 
agreement with Alkermes to develop and 
commercialize BIIB098, an oral MMF prodrug in Phase 
3 development for the treatment of relapsing forms of 
MS.
Applied Genetic Technologies Corporation
We have a collaboration agreement with Applied 
Genetic Technologies Corporation (AGTC) to develop 
gene-based therapies for multiple ophthalmic 
diseases. This collaboration is focused on the 
development of a clinical-stage candidate for X-linked 
Retinoschisis (XLRS) and a preclinical candidate for 
the treatment of X-linked Retinitis Pigmentosa (XLRP), 
for which we were granted worldwide 
commercialization rights. This agreement also 
provides us with options to early stage discovery 
programs in two ophthalmic diseases and one non-
ophthalmic condition.
Bristol-Myers Squibb Company
We have an exclusive license agreement with 
BMS for the development and commercialization of 
BIIB092. Under this agreement, we received 
worldwide rights to BIIB092 and are responsible for 
the full development and global commercialization of 
BIIB092 in AD and PSP. 
Eisai Co., Ltd.
We have a collaboration agreement with Eisai to 
jointly develop and commercialize E2609 and 
BAN2401, two Eisai product candidates for the 
treatment of AD. Eisai serves as the global 
operational and regulatory lead for both E2609 and 
BAN2401 and all costs, including research, 
development, sales and marketing expenses, are 
shared equally between us and Eisai. Following 
marketing approval in major markets, we will co-
promote E2609 and BAN2401 with Eisai and share 
profits equally. 
We also have the Aducanumab Collaboration 
Agreement with Eisai for the joint development and 
commercialization of aducanumab. Under the 
Aducanumab Collaboration Agreement, the two 
companies will co-promote aducanumab with a region-
based profit split and we will continue to lead the 
ongoing Phase 3 development of aducanumab. 
We and Eisai will co-promote AVONEX, TYSABRI 
and TECFIDERA in Japan in certain settings and Eisai 
will distribute AVONEX, TYSABRI, TECFIDERA and 
PLEGRIDY in India and other Asia-Pacific markets, 
excluding China.
Genentech (Roche Group)
We have a collaboration agreement with 
Genentech which entitles us to certain financial and 
other rights with respect to RITUXAN, GAZYVA, 
OCREVUS and other anti-CD20 product candidates. 
Ionis Pharmaceuticals, Inc.
We have an exclusive, worldwide option and 
collaboration agreement with Ionis relating to the 
development and commercialization of up to three 
gene targets, and an exclusive, worldwide option and 
collaboration agreement with Ionis under which both 
companies are responsible for the development and 
commercialization of SPINRAZA for the treatment of 
SMA. 
We also have research collaboration agreements 
with Ionis, under which both companies perform 
discovery level research and will develop and 
commercialize new ASO drug candidates for the 
treatment of SMA and additional antisense and other 
therapeutics for the treatment of neurological 
disorders.
Neurimmune
We have a collaboration and license agreement 
with Neurimmune for the development and 
commercialization of antibodies for the treatment of 
AD, including aducanumab. Under this agreement, we 
are responsible for the development, manufacturing 
and commercialization of all licensed products.

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Samsung Bioepis
We and Samsung Biologics established a joint 
venture, Samsung Bioepis, to develop, manufacture 
and market biosimilar pharmaceuticals. We also have 
an agreement with Samsung Bioepis to 
commercialize, over a 10-year term, three anti-TNF 
biosimilar product candidates in specified E.U. 
countries and, in the case of BENEPALI, Japan. Under 
this agreement, we are manufacturing and 
commercializing BENEPALI, an etanercept biosimilar 
referencing ENBREL, and FLIXABI, an infliximab 
biosimilar referencing REMICADE. 
In addition to our joint venture and 
commercialization agreement with Samsung Bioepis, 
we license certain of our proprietary technology to 
Samsung Bioepis in connection with Samsung 
Bioepis' development, manufacture and 
commercialization of its biosimilar products. We also 
provide technical development and technology 
transfer services to Samsung Bioepis, and 
manufacture clinical and commercial quantities of 
bulk drug substance of Samsung Bioepis' biosimilar 
products.
University of Pennsylvania
We have a collaboration and alliance with the 
University of Pennsylvania (UPenn) to advance gene 
therapy and gene editing technologies. The 
collaboration is primarily focused on the development 
of therapeutic approaches that target the eye, skeletal 
muscle and the central nervous system. The alliance 
is also focused on the research and validation of next-
generation gene transfer technology using adeno-
associated virus gene delivery vectors and exploring 
the expanded use of genome editing technology as a 
potential therapeutic platform.
Regulatory
Our current and contemplated activities and the 
products, technologies and processes that result from 
such activities are subject to substantial government 
regulation.
Regulation of Pharmaceuticals
Product Approval and Post-Approval Regulation in 
the U.S.
APPROVAL PROCESS
Before new pharmaceutical products may be 
sold in the U.S., preclinical studies and clinical trials 
of the products must be conducted and the results 
submitted to the FDA for approval. With limited 
exceptions, the FDA requires companies to register 
both pre-approval and post-approval clinical trials and 
disclose clinical trial results in public databases. 
Failure to register a trial or disclose study results 
within the required time periods could result in 
penalties, including civil monetary penalties. Clinical 
trial programs must establish efficacy, determine an 
appropriate dose and dosing regimen, and define the 
conditions for safe use. This is a high-risk process 
that requires stepwise clinical studies in which the 
candidate product must successfully meet 
predetermined endpoints. The results of the 
preclinical and clinical testing of a product are then 
submitted to the FDA in the form of a Biologics 
License Application (BLA) or a New Drug Application 
(NDA). In response to a BLA or NDA, the FDA may 
grant marketing approval, request additional 
information or deny the application if it determines 
the application does not provide an adequate basis 
for approval.
Product development and receipt of regulatory 
approval takes a number of years, involves the 
expenditure of substantial resources and depends on 
a number of factors, including the severity of the 
disease in question, the availability of alternative 
treatments, potential safety signals observed in 
preclinical or clinical tests and the risks and benefits 
of the product as demonstrated in clinical trials. The 
FDA has substantial discretion in the product approval 
process, and it is impossible to predict with any 
certainty whether and when the FDA will grant 
marketing approval. The agency may require the 
sponsor of a BLA or NDA to conduct additional clinical 
studies or to provide other scientific or technical 
information about the product, and these additional 
requirements may lead to unanticipated delay or 
expense. Furthermore, even if a product is approved, 
the approval may be subject to limitations based on 
the FDA's interpretation of the existing pre-clinical or 
clinical data. 

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