On January 9, 2019 Puma Biotechnology, Inc. (the "Company") reported that it has entered into a License Agreement (the "Agreement") with Knight Therapeutics Inc. ("Knight") (Filing, 8-K, Puma Biotechnology, JAN 9, 2019, View Source [SID1234532676]).

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Pursuant to the Agreement, the Company granted to Knight, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds (the "Licensed Product") in Canada (the "Territory"), (ii) to seek and maintain regulatory approvals for the Licensed Products in the Territory and (iii) to manufacture the Licensed Products anywhere in the world solely for the development and commercialization of the Licensed Products in the Territory for human use, subject to the terms of the Agreement and a supply agreement to be negotiated and executed by the parties.

Under the terms of the Agreement, the Company will be solely responsible for the manufacturing and supply of the Licensed Products to Knight, but under limited circumstances Knight may obtain the right to manufacture the Licensed Products under the supply agreement.

The Agreement sets forth the parties’ respective obligations with respect to the commercialization of the Licensed Products. Within the Territory, the Company will be solely responsible for obtaining the regulatory approval for the indication of extended adjuvant treatment of HER2-positive early stage breast cancer ("Initial Indication") and Knight will use commercially reasonable efforts to prepare, file and manage regulatory filings for any other indications in the field of human use. Promptly after obtaining the regulatory approval for the Initial Indication in the Territory, the Company will transfer such regulatory approval to Knight, and Knight will own and hold any regulatory approvals for the Licensed Products in the Territory in its name.

Pursuant to the Agreement, the Company is entitled to upfront and development milestones of up to US$2.0 million, and sales milestone payments of up to CAN$7.0 million, payable upon achievement of the milestone events specified in the Agreement. Furthermore, the Company is entitled to receive significant double digit royalties calculated as a percentage of net sales of the Licensed Products in the Territory.

The term of the Agreement continues, on a Licensed Product-by-Licensed Product basis, until the later of (i) the expiration or abandonment of the last valid claim of the licensed patents that covers such Licensed Product in the Territory, or (ii) the earlier of (x) the time when generic competitors to such Licensed Product have achieved seventy percent (70%) or more market share in the Territory based on unit volume, or (y) ten (10) years following the date of first commercial sale of such Licensed Product in the Territory. The Agreement may be terminated by either party if the other party commits a material breach, subject to a customary cure period, or if the other party is insolvent. Knight may terminate the agreement with ninety (90) days’ written notice in the event either party or both parties receive any written claim alleging that the manufacture or commercialization of the Licensed Products in the Territory infringes, misappropriates, or otherwise violates any intellectual property rights of a third party. The foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.

On January 9, 2019 Selexis SA, a pioneering life sciences company and a global leader in mammalian cell line generation technology, reported that it has signed additional commercial license agreements (CLAs) with Agenus Inc., (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, and adoptive cell therapies (Press release, Selexis , JAN 9, 2019, View Source [SID1234532600]).1 Under the new CLAs, Agenus will leverage Selexis’ modular SUREtechnology Platform for the rapid, stable, and cost-effective production of its therapeutic proteins.

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"It’s gratifying to have the opportunity to play a part in Agenus’ mission to redefine cancer treatment by advancing promising new biologics for individuals living with cancer," said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. "The Selexis team has a notable track record of success in helping our partners overcome protein-expression challenges and advance products rapidly and safely through the clinic to the market where they can be made available to patients in need."

The Selexis SUREtechnology Platform improves the way mammalian cells are used in the discovery, development and manufacturing of recombinant proteins and drugs. The platform provides key significant advantages over traditional approaches, enabling: speed, high-yield, stability and flexibility.

"Our fully integrated capabilities, from early discovery of protein therapeutics to GMP manufacturing, allows us to rapidly produce and clinically test promising new drug candidates thereby delivering innovation with speed. A critical step in this process is the in-house development of commercially viable cell-lines expressing novel and complex proteins," said Alex Duncan, PhD, chief technology officer at Agenus. "We have successfully used the Selexis’ platform to drive our lead anti-CTLA4 (AGEN1884) and anti-PD1 (AGEN2034) programs, and are excited to partner with them to advance our novel single agent and multi-specific antibody programs."

On January 8, 2019 CSPC Pharmaceutical Group Ltd. agreed to acquire Hong Kong-based Yong Shun Technology Development for about 252.9 million yuan (Press release, CSPC Pharmaceutical, JAN 8, 2019, View Source [SID1234605494]). CSPC unit Dragon Merit Holdings Ltd. will acquire all issued shares of Yong Shun, subject to certain conditions. CSPC said the deal is in line with its strategy to seek acquisition targets with strong research and development capabilities in the biopharmaceutical drug market. As of Jan. 7, US$1 was equivalent to 6.85 yuan.

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On January 8, 2019 Heat Biologics, Inc. is presented the corporate presentations (Presentation, Heat Biologics, JAN 8, 2019, View Source [SID1234532569]).

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On January 8, 2019 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the sale of its residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to OMERS, the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, for $65 million (Press release, ImmunoGen, JAN 8, 2019, View Source [SID1234532585]).

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"ImmunoGen played a key role in the generation and early development of Kadcyla, the first ADC approved for the treatment of HER2-positive breast cancer, and we are pleased to see the continued progress of this important therapy in the market," said Mark Enyedy, President and Chief Executive Officer. "As ImmunoGen evolves into a fully-integrated company with our proprietary portfolio, this transaction further strengthens our balance sheet as we execute on our strategic priorities and work to deliver more good days to people living with cancer."

This transaction entails the sale of the residual interest held by ImmunoGen from a prior transaction with Immunity Royalty Holdings, L.P. (IRH). In 2015, ImmunoGen announced a $200 million non-dilutive royalty transaction through which ImmunoGen sold the right to receive 100% of the royalty revenue on Kadcyla commercial sales to an undisclosed threshold amount, subject to certain conditions. Once the applicable threshold was met, ImmunoGen would receive 85% of the Kadcyla royalty revenue and the original purchaser would receive 15% for the remaining term of the royalty. With this transaction, OMERS now owns 100% of ImmunoGen’s rights to receive Kadcyla royalties.

MTS Health Partners, L.P. acted as exclusive financial advisor to ImmunoGen and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as special transactional counsel to ImmunoGen.

ABOUT KADCYLA ROYALTIES

Genentech, a member of the Roche Group, developed Kadcyla (ado-trastuzumab emtansine) using ADC technology licensed from ImmunoGen under a 2000 agreement established between the companies. This agreement entitles ImmunoGen to receive royalties ranging from 3-5% on Kadcyla sales in countries where ImmunoGen holds valid patents covering Kadcyla, and 2% in countries without relevant ImmunoGen patents. ImmunoGen is entitled to receive royalties on commercial Kadcyla sales in each country for ten years after the launch of Kadcyla in that country. This period extends to twelve years for each country in which ImmunoGen has valid claims in relevant patents on the tenth anniversary of the commercial launch of Kadcyla in that country.

ABOUT OMERS

Founded in 1962, OMERS is one of Canada’s largest defined benefit pension plans, with more than $95 billion in net assets, as at December 31, 2017. It invests and administers pensions for almost half a million members from municipalities, school boards, emergency services, and local agencies across Ontario. OMERS has employees in Toronto and other major cities across North America, the U.K., Europe, Asia, and Australia – originating and managing a diversified portfolio of investments in public markets, private equity, infrastructure, and real estate. For more information, please visit www.omers.com.