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`Allergan and Saint Regis Mohawk Tribe Announce
`Agreements Regarding RESTASIS® Patents
`
`Sep 8, 2017
`
`The Tribe Is Filing Motion to Dismiss Inter Partes Review of RESTASIS Patents Based on its Sovereign Immunity
`
`DUBLIN, IRELAND –September 8, 2017– Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and the Saint
`Regis Mohawk Tribe today announced that the Tribe now owns all Orange Book-listed patents for RESTASIS® (Cyclosporine
`Ophthalmic Emulsion) 0.05%, and that Allergan has been granted exclusive licenses in the patents related to the product. The
`Tribe, a recognized sovereign tribal government, is (cid:210)ling a motion to dismiss the ongoing inter partes review (IPR) of the
`RESTASIS® patents based on their sovereign immunity from IPR challenges.The agreement with the Tribe has no impact on
`the pending abbreviated new drug application (ANDA) patent litigations regarding the RESTASIS® patent family which recently
`completed a (cid:210)ve-day trial in Federal District Court in Marshall, Texas.
`
`“The Saint Regis Mohawk Tribe and its counsel approached Allergan with a sophisticated opportunity to strengthen the
`defense of our RESTASIS® intellectual property in the upcoming inter partes reviewproceedings before the Patent Trial and
`Appeal Board,” said Bob Bailey, Allergan’s Chief Legal O(cid:213)cer. “Allergan evaluated this approach closely, with expert counsel in
`patent and sovereign immunity law.This included a thorough review of recent case law such as Covidien LP v. University of
`Florida Research Foundation Inc. and Neochord, Inc. v. University of Maryland, in which the PTAB dismissed IPR proceedings
`against the universities based upon their claims of sovereign immunity. We are impressed with the Tribe’s thoughtful and
`enterprising approach, which will allow them to achieve their goals of self-reliance and help them address the most urgent
`needs in their community.”
`
`In a uni(cid:210)ed statement about the agreement with Allergan, the Saint Regis Mohawk Tribal Council stated, “This is a viable and
`sound opportunity for the Saint Regis Mohawk Tribe to enter into the patent, technology and research sector as part of our
`overall economic diversi(cid:210)cation strategy. We realize that we cannot depend solely on casino revenues and, in order for us to
`be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne
`community; such as housing, employment, education, healthcare, cultural and language preservation.”
`
`Under the terms of the agreement, the Tribe will receive $13.75 million upon execution of the agreement. Additionally, the
`Tribe will be eligible to receive $15 million in annual royalties.
`
`The patents transferred to the Tribe include United States Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930
`and 9,248,191. The patents are listed in the Orange Book for RESTASIS® and expire on August 27, 2024.
`
`About Allergan plc
`
`https://www.srmt-nsn.gov/news/2017/allergan-and-saint-regis-mohawk-tribe-announce-agreements-regarding-restasis-patents
`
`MYLAN - EXHIBIT 1157
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`10/13/2017
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`Allergan and Saint Regis Mohawk Tribe… | Saint Regis Mohawk Tribe
`
`Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new
`industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded
`pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
`
`Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical
`aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
`
`Allergan is an industry leader in Open Science, a model of research and development, which de(cid:210)nes our approach to
`identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built
`one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs
`currently in development.
`
`Allergan’s success is powered by our more than 18,000 global colleagues’ commitment to being Bold for Life. Together, we
`build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is
`right.
`
`With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare
`providers and patients to deliver innovative and meaningful treatments that help people around the world live longer,
`healthier lives every day.
`
`For more information, visit Allergan’s website at (http://www.allergan.com/)www.Allergan.com
`(http://www.Allergan.com).
`
`About Saint Regis Mohawk Tribe:
`
`The Saint Regis Mohawk Tribal Council is the duly elected and U.S. federally recognized government of the Saint Regis Mohawk
`People.
`
`For more information, visit the Saint Regis Mohawk Tribe’s website at (http://www.srmt-nsn.gov/)www.srmt-nsn.gov
`(http://www.srmt-nsn.gov).
`
`Forward-Looking Statement
`
`Statements contained in this press release that refer to future events or other non-historical facts are forward-looking
`statements that re(cid:211)ect Allergan’s current perspective on existing trends and information as of the date of this release. Actual
`results may di(cid:215)er materially from Allergan’s current expectations depending upon a number of factors a(cid:215)ecting Allergan’s
`business. These factors include, among others, the di(cid:213)culty of predicting the timing or outcome of FDA approvals or actions, if
`any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products;
`di(cid:213)culties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public (cid:210)lings with the
`Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended
`December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly
`required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
`
`O(cid:213)ce Of Technology Research And Patents FAQS (https://www.srmt-nsn.gov/_uploads/site_(cid:210)les/O(cid:213)ce-of-Technology-
`Research-and-Patents-FAQs.pdf)
`
`Working Together Today to Build a Better Tomorrow
`Ska’tne ionkwaio’te ón:wa wenhniserá:te ne sén:ha aioianerénhake ne
`enióhrhen’ne
`
`Saint Regis Mohawk Tribe
`412 State Route 37
`Akwesasne, NY 13655
`Phone: 518-358-2272 Fax: 518.358.3203
`
`Saint Regis Mohawk Health Service
`Phone: 518.358.3141 Fax: 518.358.6245
`
`
`(https://www.facebook.com/SaintRegisMohawkTribe
` (https://twitter.com/srm_tribe)
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`Allergan and Saint Regis Mohawk Tribe… | Saint Regis Mohawk Tribe
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