BEIGENE, LTD. : entry into a material definitive agreement, disclosure of FD regulations, other events, financial statements and exhibits (Form 8-K)


Article 1.01. The conclusion of an important definitive agreement.

On December 19, 2021, BeiGene Switzerland GmbH, a wholly-owned indirect
subsidiary of BeiGene, Ltd. (collectively, "BeiGene" or the "Company"), entered
into an Option, Collaboration and License Agreement (the "Collaboration
Agreement") with Novartis Pharma AG ("Novartis"), pursuant to which BeiGene has
granted Novartis an exclusive time-based option to receive an exclusive license
to develop, manufacture and commercialize BeiGene's investigational TIGIT
inhibitor ociperlimab in the United States, Canada, Mexico, member countries of
the European Union, the United Kingdom, Norway, Switzerland, Iceland,
Liechtenstein, Russia, and Japan (the "Licensed Territory").

Under the Collaboration Agreement, BeiGene will receive an upfront cash payment
of $300 million from Novartis and is eligible to receive an additional payment
of $600 million or $700 million upon exercise by Novartis of an exclusive
time-based option prior to mid-2023 or late-2023, respectively, subject to
receipt of required antitrust approval. Additionally, following option exercise,
BeiGene is eligible to receive up to $745 million upon the achievement of
regulatory approval milestones, $1.15 billion upon the achievement of sales
milestones, and tiered royalties based on percentages of annual net sales of
ociperlimab in the Licensed Territory ranging from the high-teens to
mid-twenties, with customary reductions in specified circumstances. Royalties
are payable on a country-by-country basis from the time of the first commercial
sale until the latest of the expiration of the last valid patent claim, the
expiration of regulatory exclusivity, or 10 years after the first commercial
sale of ociperlimab in the country of sale.

Under the Collaboration Agreement, during the option period, Novartis has agreed
to initiate, conduct and fund additional global clinical trials of ociperlimab
in combination with tislelizumab in selected tumor types and BeiGene has agreed
to expand enrollment in two ongoing trials. Additionally, following the option
exercise, the companies have agreed to jointly develop ociperlimab in the
Licensed Territory, with Novartis sharing development costs of global trials and
responsible for regulatory submissions after a transition period and for
commercialization upon regulatory approvals in the Licensed Territory. In
addition, both companies may conduct clinical trials globally to explore
potential combinations of ociperlimab with other cancer treatments. BeiGene will
initially be responsible for supplying ociperlimab to Novartis, with Novartis
having the right to conduct manufacturing for its use in the Licensed Territory
after successful transfer of the manufacturing process. Following approval,
BeiGene has agreed to provide 50% of the co-detailing and co-field medical
efforts in the United States, and has an option to co-detail up to 25% in Canada
and Mexico, in each case funded in part by Novartis. Each party retains the
worldwide right to commercialize its proprietary products in combination with
ociperlimab, as is the case with tislelizumab under the parties' existing
collaboration agreement. BeiGene retains the rights to manufacture and supply a
specified percentage of commercial supply of ociperlimab from its planned U.S.
manufacturing facility to be built in Hopewell, New Jersey.

The Collaboration Agreement contains customary representations, warranties and
covenants by BeiGene and Novartis. Unless earlier terminated, the agreement will
expire on a country-by-country basis upon the expiration of the royalty term in
such country. The Collaboration Agreement will expire in its entirety upon the
expiration of all applicable royalty terms under the agreement in all countries
in the Licensed Territory. The agreement may be terminated by Novartis upon 120
days' prior written notice if delivered before first commercial sale or 180
days' prior written notice if delivered following first commercial sale of
ociperlimab in the Licensed Territory, or by either party upon the other party's
bankruptcy or uncured material breach. BeiGene may terminate the agreement in
its entirety upon written notice if Novartis challenges the licensed BeiGene
patents. Either party may terminate the agreement in its entirety effective
immediately upon written notice to the other party (i) if the option terminates
or expires, or (ii) in the event that the license effective date has not
occurred within six months after the date of the Hart-Scott-Rodino Antitrust
Improvements Act filing, subject to extension.

The foregoing summary description of the Collaboration Agreement does not
purport to be complete and is subject to, and qualified in its entirety by, the
full text of the Collaboration Agreement, which the Company intends to file as
an exhibit to a subsequent periodic report or on an amendment to this Current
Report on Form 8-K.

                                     * * *

The representations and warranties and other statements in the Collaboration
Agreement (1) speak only as to the date on which they were made, and may be
modified or qualified by confidential schedules or other disclosures, agreements
or understandings among the parties, which the parties believe are not required
by the securities laws to be publicly disclosed, and (2) may be subject to a
different materiality standard than the standard that is applicable to
disclosures to investors. Moreover, it was advised that information concerning
the subject matter of the representations and warranties and other statements
made in the Collaboration Agreement would likely change after the execution date
of such agreement, and subsequent information may or may not be fully reflected
in the Company's public disclosures. Accordingly, investors should not rely upon
representations and warranties and other statements in the Collaboration
Agreement as factual characterizations of the actual state of affairs of the
Company. Investors should instead look to disclosures contained in the Company's
reports under the Securities Exchange Act of 1934, as amended (the "Exchange
Act").


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Article 7.01. FD Regulation Disclosure.

On December 20, 2021, the Company issued a press release announcing the
transactions described in this Current Report on Form 8-K. A copy of the press
release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and
shall not be deemed to be "filed" for purposes of Section 18 of the Exchange
Act, or otherwise subject to the liabilities of that section, nor shall it be
deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as expressly set forth by specific
reference in such filing or this Current Report.


Article 8.01. Other events.

On December 19, 2021, BeiGene Suzhou Co., Ltd., a wholly-owned indirect
subsidiary of BeiGene, Ltd. ("BeiGene Suzhou"), entered into a Market
Development Agreement (the "Market Development Agreement") with Beijing Novartis
Pharma Co., Ltd. ("Novartis Beijing"), pursuant to which BeiGene Suzhou will
obtain the right to market and promote five Novartis Beijing approved and
nationally reimbursed oncology products for an initial period of seven years in
China's broad markets, which include approximately 13,000 hospitals in cities
and counties with smaller populations, where roughly 500,000 people with cancer
receive their medical care. These products include: TAFINLAR® (dabrafenib), a
BRAF inhibitor, and MEKINIST® (trametinib), a MEK inhibitor, both approved for
the treatment of melanoma; VOTRIENT® (pazopanib), a VEGFR inhibitor for advanced
renal cell carcinoma; AFINITOR® (everolimus), an mTOR inhibitor, for advanced
renal cell carcinoma following progression on or after vascular endothelial
growth factor (VEGF)-targeted therapy; and ZYKADIA® (ceritinib), an ALK
inhibitor approved for ALK+ NSCLC. Under the agreement, BeiGene Suzhou is
eligible to receive certain payments calculated based on sales. The agreement
may be terminated by either party upon specified circumstances, including upon
the other party's bankruptcy or uncured material breach.


Article 9.01. Financial statements and supporting documents.

(d) Exhibits.

   Exhibit No.            Description

       99.1               Press Release titled "BeiGene Expands

Collaboration with Novartis to develop

                          and Commercialize BeiGene's TIGIT Inhibitor and 

Five Novartis Market

                          Oncology Medicines in China Broad Markets", 

issued by BeiGene, Ltd. to

                          December 20, 2021.

       104                The cover page from this Current Report on Form 8-K, formatted in Inline
                          XBRL


Forward-looking statements

This Current Report on Form 8-K and the materials furnished herewith contain
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and other federal securities laws, including
statements regarding the further advancement of, and anticipated clinical
development, regulatory milestones, and commercialization of ociperlimab; and
the option exercise by Novartis, the potential payments to be received by
BeiGene, the receipt of required antitrust approval, and the parties'
commitments and the potential benefits of the ociperlimab collaboration and
broad markets agreements. Actual results may differ materially from those
indicated in the forward-looking statements as a result of various important
factors, including the possibility that BeiGene will not realize the expected
benefits of the transactions; the possibility that BeiGene or Novartis will fail
to fully perform their respective obligations under the ociperlimab
collaboration and broad markets agreements; BeiGene's ability to demonstrate the
efficacy and safety of its drug candidates; the clinical results for its drug
candidates, which may not support further development or marketing approval;
actions of regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and marketing approval; BeiGene's ability to achieve
commercial success for its marketed medicines and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual property for
its medicines and technology; BeiGene's reliance on third parties to conduct
drug development, manufacturing and other services; BeiGene's limited experience
in obtaining regulatory approvals and commercializing pharmaceutical products
and its ability to obtain additional funding for operations and to complete the
development and commercialization of its drug candidates and achieve and
maintain profitability; and the impact of the COVID-19 pandemic on the Company's
clinical development, regulatory, commercial and other operations, as well as
those risks more fully discussed in the section entitled "Risk Factors" in
BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of
potential risks, uncertainties, and other important factors in BeiGene's
subsequent filings with the U.S. Securities and Exchange Commission. BeiGene
cautions you not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. BeiGene disclaims any obligation
to publicly update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any such
statements may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.

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