`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS,INC.,
`Petitioner,
`
`Vv.
`
`MERCK SERONOSA,
`Patent Owner.
`
`Case IPR2023-00049
`Patent 7,713,947
`
`Case IPR2023-00050
`Patent 8,377,903
`
`DECLARATION OF WILLEM DE WEERD
`IN SUPPORTOF EXHIBITS2048, 2049, 2050
`
`Merck 2067
`TWi v Merck
`
`IPR2023-00049
`
`Merck 2067
`TWi v Merck
`IPR2023-00049
`
`
`
`IPR2023-00049, JPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
`
`I, Willem de Weerd, declare as follows:
`
`l.
`
`I am an Authorized Representative of Merck Serono S.A.in Eysins,
`
`Switzerland. I submit this declaration in support of Merck Serono S.A.in the
`
`following Inter Partes Review proceedings: IPR2023-00049 and IPR2023-00050.
`
`2.
`
`Exhibit 2048is a true and accurate copy of a documenttitled “Product
`
`Development and License Agreement by and between IVAX International GMBH
`
`... and Ares Trading 8.A.” that was kept in the regular course of business by
`
`Merck Serono S.A.and its affiliates, including Ares Trading S.A.andits
`
`predecessor Serono International S.A. Exhibit 2048 is redacted. Those redactions
`
`narrowly protect the confidentiality ofpayment amounts andrelated financial
`
`information included in the agreementthat are not relevant to the issues in these
`
`proceedings.
`
`3.
`
`Exhibit 2049is a true and accurate copy of an email dated December
`
`17, 2003 with an attachmenttitled “Cladribine ... Briefing Document.” This email
`
`and the attached document were keptin the regular course ofbusiness by Merck
`
`Serono S.A. andits affiliates, including Ares Trading S.A. and its predecessor
`
`Serono International S.A.
`
`4.
`
`Exhibit 2050 is a true and accurate copy of a documenttitled “Oral
`
`Cladribine for MS Product[:] Meeting on 27 August 2003 in Amsterdam”that was
`
`kept in the regular course of business by Merck Serono S.A.andits affiliates,
`
`2
`
`
`
`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
`
`including Ares Trading S.A., and its predecessor Serono International S.A. Exhibit
`
`2050 is redacted. Those redactions narrowly protect privileged discussions with
`
`counsel presented earlier at the meeting.
`
`5.
`
`In signing this declaration, I understandthat the declaration will be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I acknowledgethat I may be
`
`subject to cross-examination in this case. If cross-examination is required of me,I
`
`will appear for cross-examination during the time allotted for cross-examination.
`
`6.
`
`I declare that all statements made herein of my knowledgearetrue,
`
`and that all statements made on information andbelief are believed to be true, and
`
`that these statements were made with the knowledgethat willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Co Dated: March 11, 2024
`
` Willem de Weerd
`
`By:
`
`Merck Serono S.A.
`TerreBonne Business Park ZO
`Route de Crassier 1
`CH 1262 Eysins
`Switzerland
`Tel: +41 79 338 3380
`Email: willem.de-weerd@merckgroup.com
`
`
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