SAREPTA THERAPEUTICS, INC. (NASDAQ:SRPT) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
License Agreement
On July17, 2017, Sarepta Therapeutics, Inc. and Sarepta International C.V. (collectively, the “Company” or “Sarepta”) and BioMarin Leiden Holding BV, BioMarin Nederlands BV and BioMarin Technologies BV (collectively, “BioMarin”) executed a License Agreement (the “License Agreement”), to which BioMarin granted Sarepta a royalty-bearing, worldwide license under patent rights (“Licensed Patents”) and know-how (“Licensed Know-How”) controlled by BioMarin with respect to BioMarin’s Duchenne muscular dystrophy (“DMD”) program, which are potentially necessary or useful for the treatment of DMD, to practice and exploit the Licensed Patents and Licensed Know-How in all fields of use and for all purposes, including to develop and commercialize antisense oligonucleotide products that target one or more exons of the dystrophin gene to induce exon skipping, including eteplirsen (collectively, the “Products”).
The license granted by BioMarin to Sarepta under the terms of the License Agreement is exclusive, even as to BioMarin, with respect to the Licensed Patents, and is non-exclusive with respect to Licensed Know-How. Under the License Agreement, BioMarin has the option to convert the exclusive license under the Licensed Patents into a co-exclusive license (co-exclusive with BioMarin) (“BioMarin Co-Exclusive Option”).
Under the terms of the License Agreement, the Company is required to pay BioMarin an upfront payment of $15million, and BioMarin will be eligible to receive up to $20million from the Company per dystrophin gene exon (other than exon 51) targeted by one or more Products in specified regulatory milestones, as well as an additional $10million milestone, payable following the regulatory approval of eteplirsen by the European Medicines Agency. BioMarin will also be eligible to receive $15million from the Company upon the achievement of $650million in sales, as well as royalties segmented by specified geographic markets, in some of jurisdictions dependent on an the existence of a patent, ranging from four (4)to eight (8)digit percentages of net sales on a product-by-product and country-by-country basis.
Milestone and royalty payments are payable with respect to eteplirsen (an exon 51 skipping Product), casimersen (an exon 45 skipping Product), golodirsen (an exon 53 skipping Product) and other Products. For eteplirsen, casimersen and golodirsen, the royalty term will expire upon the end of 2023 in the United States, upon September30, 2024 in the European Union and no later than September30, 2024 in other countries provided certain conditions are met. For Products other than exon 45 skipping Products, exon 51 skipping Products and exon 53 skipping Products, the royalty term will end on a country-by country basis upon expiration of granted Licensed Patents covering the applicable Product. The royalties for all Products are subject to reduction upon BioMarin’s exercise of the BioMarin Co-Exclusive Option. All royalties are subject to further potential reductions, including for generic competition and, under specified conditions, for a specified portion of payments that the Company may become required to pay under third-party license agreements, subject to a maximum royalty reduction.
Unless earlier terminated, the License Agreement will expire upon the expiration of the last-to-expire royalty term. Either party may terminate the License Agreement in the event of the other party’s uncured material breach. BioMarin may also terminate the License Agreement on a Licensed Patent-by-Licensed Patent basis under specified circumstances relating to patent challenges by the Company.
Settlement Agreement
On July17, 2017, Sarepta, BioMarin, and The University of Western Australia on the one hand, and BioMarin on the other hand (collectively with the addition of Academisch Ziekenhuis Leiden (“AZL”), which has not yet executed the Settlement Agreement, the “Settlement Parties”), executed a Settlement Agreement to which all legal actions in the United States and certain legal actions in Europe (the “Actions”) would be stopped or withdrawn as between the Settlement Parties. Specifically, the terms of the Settlement Agreement require that existing efforts pursuing ongoing litigation and opposition proceedings would be stopped as between the Settlement Parties and the Settlement Parties would cooperate to withdraw the Actions before the European Patent Office (except for actions involving third parties), the U.S. Patent and Trademark Office, the U.S. Court of Appeals for the Federal Circuit and the High Court
of Justice of England and Wales, except for the cross-appeal of the Interlocutory Decision of the Opposition Division dated April15, 2013 of the European Patent Office of EP 1619249B1 (“EP ‘249 Appeal”) in which Sarepta will withdraw its appeal and BioMarin/AZL will continue with its appeal with Sarepta having oversight of the continued appeal by BioMarin/AZL.
Additionally, under the terms of the Settlement Agreement, the Settlement Parties agree to release each other and the customers, end-users, agents, suppliers, distributors, resellers, contractors, consultants, services and partners of Sarepta or BioMarin (as applicable) from claims and damages related to (i)the patent rights controlled by the releasing party that are involved in the Actions, (ii)with respect to the Company and UWA, its patent rights related to the patent rights involved in the Actions, and (iii)with respect to BioMarin and AZL, all of the Licensed Patents and Licensed Know-How.
Under the terms of the Settlement Agreement, the Company will pay BioMarin an upfront payment of $20million.
Conditions to Effectiveness of License and Settlement Agreements
The License and Settlement Agreements become effective if, within seven days of the execution date of the agreements, which is July24, 2017 (the “Deadline”), AZL (i)executes the settlement agreement and (ii)simultaneously provides a written consent to BioMarin’s execution of the License Agreement. If these conditions to effectiveness are not met by the Deadline, the Settlement Agreement and License Agreement become null and void.
The foregoing description of certain terms of the License Agreement and Settlement Agreement do not purport to be complete, is intended to be a summary of the material terms of such agreements and is qualified in its entirety by reference to complete text of each of the License Agreement and Settlement Agreement that Sarepta intends to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ended June30, 2017.
On July18, 2017, the Company issued a press release announcing the execution of the License and Settlement Agreements. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 1.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit Number |
Description |
| 99.1 | Press release, dated July18, 2017. |
Sarepta Therapeutics, Inc. ExhibitEX-99.1 2 d425893dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Sarepta Therapeutics and BioMarin Pharmaceutical Inc. Announce Execution of a Global Settlement and a License Agreement Resolving Exon Skipping Patent Litigation Agreement terms resolve global patent proceedings regarding Sareptas sale of EXONDYS 51® (eteplirsen) and future Duchenne muscular dystrophy (DMD) exon-skipping products CAMBRIDGE,…To view the full exhibit click here
About SAREPTA THERAPEUTICS, INC. (NASDAQ:SRPT)
Sarepta Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the discovery and development of ribonucleic acid (RNA)-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The Company, through its platform technologies, targets a range of diseases and disorders through RNA-targeted mechanisms of action. The Company is also developing therapeutics using its technology for the treatment of drug-resistant bacteria and infectious, rare and other human diseases. The Company’s lead Duchenne Muscular Dystrophy (DMD) product candidate, Eteplirsen, is an antisense phosphorodiamidate morpholino oligomer (PMO) therapeutic in Phase III clinical development for the treatment of individuals with DMD having an error in the gene coding for dystrophin that is amenable to skipping exon 51.