(
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`Flexpen
`
`Component details & proposed
`assembly sequence
`
`J
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`DCA0000559
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`Highly Confidential -Outside Attorneys' Eyes Only
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`1
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`SANOFI 2321
`Mylan v. Sanofi
`IPR2018-01679
`IPR2018-01680
`IPR2018-01682
`
`
`
`Flexpen - complete assembly
`
`Section A - A
`
`Project:
`Title:
`Description:
`Issue:
`Date:
`Document code:
`
`HM26 -Flexpen
`Complete assembly
`30 CAD images illustrating the main components and assembly arrangement, as well as the key specification elements.
`A
`18.02.03
`HM26rep043
`
`05/09/02 HM26007
`
`Highly Confidential — Outside Attorneys Eyes Only
`
`DCA0000560
`
`2
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`
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`Flexpen - exploded assembly
`
`6
`
`No. Name
`
`Material Type
`
`Filler
`
`Post Moulding Operations
`
`Volume cm.
`
`Cap
`2 Cartridge holder
`3 Bearing
`4 Leadscrew nut
`5 Leadscrew
`6 Body
`7 Dose dial
`8 Drive sleeve
`9 Limiting nut
`10 Limiting nut sleeve
`11 Clicker
`12 Dose button
`
`Polypropylene
`Polypropylene
`Polypropylene
`Polypropylene
`Polypropylene
`Polypropylene
`Acetal
`Acetal
`Polypropylene
`Polypropylene
`Acetal
`Polypropylene
`
`Tampo printing of vol. indication numbers
`
`20% Talc
`
`Tampo printing of indication arrow
`Laser marking of dose numbers (white)
`
`3.907
`1.452
`0.12
`0.418
`0.576
`3.326
`2.857
`0.512
`0.115
`0.974
`0.34
`0.546
`
`9
`
`Project:
`Title:
`Description:
`Issue:
`Date:
`Document code:
`
`HM26 -Flexpen
`Exploded assembly
`3D CAD images illustrating the main components and assembly arrangement, as well as the key specification elements.
`A
`18.02.03
`HM26rep043
`
`12
`
`Highly Confidential — Outside Attorneys' Eyes Only
`
`DCA0000561
`
`3
`
`
`
`12.imiting nut sleeve + limiting nut = Sub-assembly B
`
`Flexpen - proposed assembly sequence
`
`1 1,
`
`o,c 1.11 Body = Sub-a,,crnbly A
`
`Process number: 3
`Descnpbon:
`Sub-assembly A + Sub-assembly B = Sub-assembly C
`The keyway feature, en the limiting nut must align with the Spline in the dose
`Notes:
`
`Process number: 0
`Description:
`Sub-assembly C + dicker = Sub-assembly D
`Notes:
`This retains Sub-assemkty B.
`
`Project:
`
`Description:
`Issue:
`Date:
`Document code.
`
`HM26 — Flexpen
`Assembly sequence illustrations
`3D CAD images illustrating the proposed assembly sequence and operations required.
`A
`18.02.03
`HM26rep043
`
`Highly Confidential — Outside Attorneys Eyes Only
`
`DCA0000562
`
`4
`
`
`
`•
`
`Process number: 6
`Desambon:
`Sub-assembly E • Bearing = Sub-assembly F
`Notes:
`Sutton is pressed to align the components.
`
`5C
`
`artridge • Cartridge Holder = Sub-assembly E
`
`[ Process number:
`
`Descnpnon:
`Notes:
`
`7
`Sub-assembly F • Leadscrew Nut = Sub-assembly G
`The snap feab.res must align.
`
`Project:
`Title:
`Description:
`Issue:
`Date:
`Document code:
`
`HM26 - Flexpen
`Assembly sequence illustrations
`3D CAD images illustrating the proposed assembly sequence and operations required.
`A
`18.02.03
`HM26rep043
`
`Process number:
`Desenpbon:
`Notes:
`
`IS
`Load screw • Drive sleeve = Sub-assembly 14
`The flats must align between the two tom:co-rents.
`There is no locatcrt feature to posttcrt the lead screw axially for further assembly. It must be held in posdlon.
`
`Highly Confidential — Outside Attorneys Eyes Only
`
`DCA0000563
`
`5
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`
`
`Process number:
`Deuription:
`Notes:
`
`9
`Sub-assembly G + Sub-assembly II = Sub-assembly I
`Sup-assemb:y H IS handled in this manner to allow tne ratchet feature to aagn, and the lead urew to thread.
`
`Process number:
`Descriptor,:
`Notes:
`
`10
`Sub-assembly Ow Sub-assembly I = Sub-assembly
`The keyway in the dnye sseeye must aagn with the ears on the finish lead screw.
`
`I
`
`number:
`rProcess
`DeSCOpt1017:
`Noes:
`
`k
`
`11 and 12
`Dose Button • Label • Sub-aseembly 3 . Sub-assembly K
`Two assembly steps are shown sn the llustratqns.
`'Mesa pecceues are used to tclentiy the insulin type.
`
`i
`
`Pmeese number:
`Description:
`Notes:
`
`13
`Cap + Sub-assembly I< = Final assembly
`
`Project:
`Title:
`Description:
`Issue:
`Date:
`Document code:
`
`HM26 — Flexpen
`Assembly sequence illustrations
`3D CAD images Illustrating the proposed assembly sequence and operations required.
`A
`18.02.03
`HM26rep043
`
`Highly Confidential — Outside Attorneys Eyes Only
`
`DCA0000564
`
`6
`
`
