In het jaarverslag 2017 is Perrigo opvallend voorzichtig over de rechtszaak tegen Alychlo NV ("Alychlo") en Holdco I BE NV ("Holdco"). De onderneming stelt letterlijk: 'There can be no
assurance that our Claim will be successful, and Sellers deny liability for the Claim."
1. Perrigo Company plc - Item 8
Note 16
171
Tysabri®
Product Liability Lawsuits
We and our collaborator Biogen are co-defendants in product liability lawsuits arising out of the occurrence
of Progressive Multifocal Leukoencephalopathy, a serious brain infection, and serious adverse events, including
deaths, which occurred in patients taking Tysabri®
. Each co-defendant would be responsible for 50% of losses and
expenses arising out of any Tysabri®
product liability claims. During calendar year 2016, one case in the U.S. was
settled and two others were dismissed with prejudice. In 2017, seven other cases were dismissed with prejudice.
While we intend to vigorously defend the remaining lawsuits, management cannot predict how these cases will be
resolved. Adverse results in one or more of these lawsuits could result in substantial judgments against us.
Claim Arising from the Omega Acquisition
On December 16, 2016, we and Perrigo Ireland 2 brought an arbitral claim ("Claim") against Alychlo NV
("Alychlo") and Holdco I BE NV ("Holdco") (together the Sellers) in accordance with clause 26.2 of the Share
Purchase Agreement dated November 6, 2014 ("SPA") and the rules of the Belgian Centre for Arbitration and
Mediation ("CEPANI"). Our Claim relates to the accuracy and completeness of information about Omega provided
by the Sellers as part of the sale process, the withholding of information by the Sellers during that process and
breaches of Sellers’ warranties. We are seeking monetary damages from the Sellers. The Sellers served their
respective responses to the Claim on February 20, 2017. In its response, Alychlo has asserted a counterclaim for
monetary damages contending that we breached the duty of good faith in performing the SPA. There can be no
assurance that our Claim will be successful, and Sellers deny liability for the Claim. We deny that Alychlo is entitled
to any relief (including monetary relief) under the counterclaim. The arbitration proceedings are confidential as
required by the SPA and the rules of the CEPANI.
NOTE 17 - COLLABORATION AGREEMENTS AND OTHER CONTRACTUAL ARRANGEMENTS
We actively collaborate with other pharmaceutical companies to develop, manufacture and market certain
products or groups of products. These types of agreements are common in the pharmaceutical industry. We may
choose to enter into these types of agreements to, among other things, leverage our or others’ scientific research
and development expertise or utilize our extensive marketing and distribution resources. Terms of the various
collaboration agreements may require us to make or receive milestone payments upon the achievement of certain
product research and development objectives and pay or receive royalties on the future sale, if any, of commercial
products resulting from the collaboration. Milestone and up-front payments made are generally recorded in research
and development expense if the payments relate to drug candidates that have not yet received regulatory approval.
Milestone and up-front payments made related to approved drugs will generally be capitalized and amortized to cost
of goods sold over the economic life of the product. Royalties received are generally reflected as revenues, and
royalties paid are generally reflected as cost of goods sold. We enter into a number of collaboration agreements in
the ordinary course of business. Although we do not consider these arrangements to be material, the following is a
brief description of notable agreements entered into during the years ended December 31, 2016 and June 27, 2015.
We did not enter into any collaborative arrangements during the the six months ended December 31, 2015.
Year Ended December 31, 2017
In December 2017, we entered into a collaboration agreement with a generic pharmaceutical development
company, pursuant to which the parties will collaborate in the ongoing development and commercialization of a
generic injectable product. We will provide assistance including preparing and filing the product ANDA, and be
responsible for commercializing the product. As part of the agreement, we paid a $2.5 million milestone payment on
the effective date of the agreement. The $2.5 million fee is reported in Research and development on the
consolidated financial statements. We will make additional payments if regulatory approval is obtained and certain
other development milestones are achieved. These contingent milestone payments could total $14.5 million in
aggregate. There can be no assurance that any such products will be approved by the FDA on the anticipated
schedule or at all.