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FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
EXHIBIT 16
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
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SUMMARY REPORT
AMERICAN GROUND ITAL IAN TALC
(Mathieu - AGIT 1615)
L
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NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
Distribution:
Dr. M. Gross
Mr. H. Hogan
Dr. J. R. Marvel ':"'(f--"~
ctrarv
Dr. R. L. Sundberg
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NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
SUMMARY REPORT
AMERICAN GROUND ITALIA~ TALC
(Mathieu - AGIT 1615)
Our stockpile of. Italian talc has been exhauted. Italian
talc imported in the raw rock form and subsequently ground by
Metropolitan Talc Co. has been approved for use in Shower to
Shower® Body Powder.
It has been assured that th~ primary source of the talc
has not changed and limited laboratory studies tend to confirm
the statement. The talc ground in the U.S. appears to be
.. '
slightly coarser, however, the slight increase in particle size
is of no practical significance. 'Long, term aging studies with
a similar Shower to Shower® formula indicate no change in aging
properties with the substitution of the u.S. ground talc.
Approximately 50 commercial batches have been produced by Kolmar
Labs using the new talc-without encountering any major problems.
A ,comprehensive report is ,attactel •..,..
Cff''.1.},ll~
,; R. Marvel
) .
,
,
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·e AMERICAN GROUND ITALIAN TALC
(Mathieu -AGIT 1615)
As st?t·ed in Mr. H. Hogan'sle-t.:ter of January 27, .1970, ....;.~.
320 ton~ of Italian talc will be required
.
for the
.
next produc-
tion run of Shower to Shower® Body 'Powder.· .with the use of
123 tons, the Johnson and Johnson, stock pile of Italian talc
will be depleted and additional supplies will be unavailable.
Charles Mathieu has the exclusive -rights to Ital:i~an talc and
has elected to import the talc in the rock form •• The talc
will then be ground in the Plainfield p1cmt of Metropolit.~n
Talc Co. Approval of Charles Mathieu '·s· 1615 AGIT (American
Ground Italian Talc) was requested ..
It has been assured by Mathieu' that the source, i.e.
mine, of the talc has not changed~ Bill A~hton visited the
·e Plainfield plant and found the·mil1ing.equipment to be similar
to the equipment used in Italy.He ·'also noticed the presence
of some foreign material in the talc :rock.Therefore, our'
evaluations have been limited to the 1) physical properties
associated with grinding, 2) absence of foreign·contaminants,
3) conformance to.existing raw material specifications, 4)
product performance, and·5) manufacturing· performance at
Kalmar Laboratories.
. .:.
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A. RAW MATERIAL
1) Confirmation of Source - Samples of talc ground in Italy
(regular) ~nd the U.S.A. (1615 -AGIT) were evaluated by D.T.~.
and x-ray difcfraction. The thermc;Jrarri:s, figure L were identi'Cal
except for t.he intensity at 700 o p.'which probably reflects a
difference in magnesium carbonate .level, 3.8%-U.S. versus 2.7%-
Italian ground in acid solubility. By X-ray diffraction the
same naturally occurring extraneous minerals (dolomite magnesite,
serpentine and tridymite) were found in both samples. This
data is in agreement with Mathieu's claim of no change in
source~
2) purity - Random samples obtained ,from the first shipment
supplied to Kolmar were evaluated microscopically by Mr.· R.
Rus~ell. The talc was similar to other Italian talc observed
previously without a significant amount of contamination.
Mr. Russell did observe the U.S. ground talc to be $lightly
coarser and confirmed this witha325 mesh wet screen analysis:
% Through 325 mesh
U.s. Ground #J026B 89.2
Italian Ground #4277lE 94.8
3) Particle Size Distribution and Surface Area - Three lots
(892913, 090215, and 185) received in December and our stand-
ard Italian talc were analyzed for particle size distribution.
As shown in figure 2, all three were slightly coarser than the
regular talc. The mean particl~ size and surface area measure-
ments are tabulated in Table I. The degree of increased.part-
,icle size appears to be of minor. importance.
4) Lubricity - The esthetic property most likely to be effected
'by fineness would be lubricity. -U.S. ground talc sample 185
which had the lowest surface area was compared to the standard
Italian talc. Three talc samples, two of One talc and one
sample of the other talc, were given to ten individuals who were
asked to identify the correct pair. Judgements were based. upon,
Protected Document--Subject to Protective Order JNJAZ55_000002332
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
the talc's feel when rubbed between the fingers. The samples
were then reversed and a total of twenty judgements were ma~e.
Correct determinations, 40%, were "well below the level of
significance.
S) Conformanr.e to Specifications .~., The talc samples were
checked aga.l'ri~di; the Johnson and .Johnsor.. . speci fications for
Italian and Vermont talcsand the.U.S.P. specifications.
Recognizing that Italian talc ,al~ays .contains a higher carbonate
level than Vermont talc, the only. significant divergence in'
Table II is the fineness for lot'18S. The above data and the
attached Mathieu specification (98% minimum for 200 mesh)
indicates ~hat occasional batch~s -may fail to meet our spec-
ification limit for fineness although the difference 98 versus
98.5 is of a minor nature. 'Mat~ieuwas contacted relative to
fineness and recent batches have met our specifiactions,
Table Il.I.
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..,"'0FILED:
2. ..;
• . NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
~ NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
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SAMPLE: ' ! 'SIZE p~~' i' IRANGE '/0I'.JH/ RUN' NO.
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OPERATO.:dJ!
REMARKS
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III , FI~URE I DoT.A. ANALYSIS
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FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM
"'0 INDEX NO. 190002/2023
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It
NYSCEF
n DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
It
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3 FIGURE Ii
III
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in
l: Particle Size Distribution of Italian Tales
.g
III
~
6"
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It
n
~
10 Ground in Ita1y ~06839
III
~. A
a. - ,
~
B Ground in U.S. #185
20
C Ground in' u. S. #892913
.j..J
~o
o Ground in U. S. #090215,'
s::
Q)
u
H
Q)
p.., 40 I,
.... '" ~ ..... l. .....
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'~~
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-,-+ .50 j:
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.
100 80 60 50 40 30 20
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FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
TABLE I
Surface Area and Mean Particle Size of various Talc Samplp.s.
2
TALC LOT NO. SURFACE AREA (m. /g.)
Italian - AGIT 1615 892913 1.9
Italian - AGIT 1615 090215 2.3
Italian - AGIT 1615 185 1.7
Italian Standard 2.0-2.6
Vermont 1. 3-2.1
TALC LOT NO. Mean Parti~le Size
(micron)
Italian - AGIT 1615 892913 15.0
Italian - AGIT 1615 " 090215" 16.7
Italian -" AGIT 1615 185 12.5
Italian - Standard "" 06839 11. 3
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FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
TABLE II
ITAJ,IAN ':PALC AGIT 1615 CONFORMANCE TO SPECIFICATIONS
*vermont Talc Specification
**U.S.P.Talc Specification
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INDEX NO. 190002/2023
oFILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM
"'0
It
n NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
It
C-
O
o TABLE III
n
l:
3
III
::!.
in
l: LOT TO LOT CONFORMANCE TO SPECIFICATIONS FOR AGIT 1615 TALC,
.E rJl
III
!:l-
ei Date Shipment 2/24/70 2/27/70 ' 3/8/70 3/6/70 ,3/11/70
"'0
o
It Lot Number
I
,'f026B F024-A
I
F-025 C-002 C-004
!:l-
<'
III
o Moisture (N.M.T. 0.15%) 0.05 0.03 0.03 0.05 0.05
a.
~ solubility in Acid (N.M.T. 6%) 2.22 3.8 4.0 3.4 3 .. 3
3
Bulk Density (22-27 lbS./ft. ) 23.1 24.5 ' I 23.5 24.4 24.1
Fineness
,% Through 60 mesh (100) ,100 100 100 100 100
% Through 100 mesh (N.L.T. 99~7) 99.8 99:8 99.8 99.8 99'.8
.% Through 200 mesh (N.L.T. 98.5) 98.6 98.5 98.5 . 98.5 98..6
Los
c...
Z
c...
~
•
I~
o
o
o
o
IV
'"'"co
e e
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
B. PRODUCT PERFOfu~NCE
As a 'brief review, in January of1969'Shower to Shower®'
production was converted from formul~ 117 to formula 230. In
the fall ~:f:.·. J,.969, form\lla 263 was adopted. Formula 230 was,;:,o:;...:
an interim formulation having improved stability whic.h provided
time tode.ve.lop, age. and consumer test the ideal (stability)
formulation, formula 263. The formulations are compared below:
,Formula
In9'rec~Hent 62 117 230 263
I.F.F. Perfume 2751-a 0.2 0.3
I.F.F. Pe.rfume 3365-M .0.4
I.F.P. Pe rf1,lme. 3416-M 0.3
HexachlQrophen e 0.5 '. 0.5 0.5 0.1
Vermont T~lc qs. Ad 100· ,.:
·100
Italian Talc qs. Ad 100 100
1) Stab;i,;l,·ity ':"U. s. ground Italian talc (Metropolitan Talc Co.
e lots 86315-88715) was tested in the· formula 230 development
program. AfteJ:' f01;lr weeks at 120 o ·F.· the aging data indicated
a slight preference. (odor) for theU.• S~" ground talc. Long term
aging st.u<:lies were conducted with formula. 23l.(theperfumelevel
of formula 230 increase<:l to 0.4~ and the results are'pre~ented
below~
Triangular Difference Study*
Age Temperature % Difference Comments
36 weeks ··:45% . mixed
: .~ :
65 weeks 50% . mixed
*Comparison Of formula 231 odor.·prepared,·with either U. S.
ground Or regular Italian talc.
The. abti..,~data indicates thatnu-significant difference ':'n
odor was pres.ent. Although no long term data .is available with
formula 263 using the lI.S. ground talc, it is highly unlikely
~.' that the aging would be·more adverse with·formula 263.: The
latter formula contains g more stable perfume, 34l6M, . and a·
lower he.xachlorophene level.
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NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023
2) In vivo Antibact~rldl Activity - NO change in the.activity
_ of formula 230 was noted when the T.J.S. ground talc was sub-
stituted.
3) .Safety· Formula 230 using both tales were patch tested
and no diffeJ::ence was found. '.,..'.'
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C. PRODUCTION EXPERIENCE
One production bat.ch was prepared du:i:'ingthe week of
February 23 at Kolmar. Although the batch met all product
specification, the sifting (40 mEsh) and filling of the batch,
into drums L0quired almost twice as long. Examination of the'
last drum indicated the presence of string, bag fragments, and
other foreign material. A second batch supervised by Research
was prepared on March 2, 1970. The batch was normal in all
aspects. There was no excessive accumulation of foreign mat-
erial on the 40 mesh screen. It can be concluded that coinci-
dental with the first·test batch the screen had not been cleaned
and was clogged. Additional batches using the U.S. ground
talc have been normal in all aspects.
·e
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Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 EXHIBIT 16 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 f' I 2- b ~ 0 .- 'i) seA ~N G- ~ '- -" SUMMARY REPORT AMERICAN GROUND ITAL IAN TALC (Mathieu - AGIT 1615) L Protected Document--Subject to Protective Order JNJAZ55_000002328 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 Distribution: Dr. M. Gross Mr. H. Hogan Dr. J. R. Marvel ':"'(f--"~ ctrarv Dr. R. L. Sundberg Protected Document--Subject to Protective Order JNJAZ55_000002329 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 SUMMARY REPORT AMERICAN GROUND ITALIA~ TALC (Mathieu - AGIT 1615) Our stockpile of. Italian talc has been exhauted. Italian talc imported in the raw rock form and subsequently ground by Metropolitan Talc Co. has been approved for use in Shower to Shower® Body Powder. It has been assured that th~ primary source of the talc has not changed and limited laboratory studies tend to confirm the statement. The talc ground in the U.S. appears to be .. ' slightly coarser, however, the slight increase in particle size is of no practical significance. 'Long, term aging studies with a similar Shower to Shower® formula indicate no change in aging properties with the substitution of the u.S. ground talc. Approximately 50 commercial batches have been produced by Kolmar Labs using the new talc-without encountering any major problems. A ,comprehensive report is ,attactel •..,.. Cff''.1.},ll~ ,; R. Marvel ) . , , Protected Document--Subject to Protective Order JNJAZ55_000002330 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 ·e AMERICAN GROUND ITALIAN TALC (Mathieu -AGIT 1615) As st?t·ed in Mr. H. Hogan'sle-t.:ter of January 27, .1970, ....;.~. 320 ton~ of Italian talc will be required . for the . next produc- tion run of Shower to Shower® Body 'Powder.· .with the use of 123 tons, the Johnson and Johnson, stock pile of Italian talc will be depleted and additional supplies will be unavailable. Charles Mathieu has the exclusive -rights to Ital:i~an talc and has elected to import the talc in the rock form •• The talc will then be ground in the Plainfield p1cmt of Metropolit.~n Talc Co. Approval of Charles Mathieu '·s· 1615 AGIT (American Ground Italian Talc) was requested .. It has been assured by Mathieu' that the source, i.e. mine, of the talc has not changed~ Bill A~hton visited the ·e Plainfield plant and found the·mil1ing.equipment to be similar to the equipment used in Italy.He ·'also noticed the presence of some foreign material in the talc :rock.Therefore, our' evaluations have been limited to the 1) physical properties associated with grinding, 2) absence of foreign·contaminants, 3) conformance to.existing raw material specifications, 4) product performance, and·5) manufacturing· performance at Kalmar Laboratories. . .:. Protected Document--Subject to Protective Order JNJAZ55_000002331 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 A. RAW MATERIAL 1) Confirmation of Source - Samples of talc ground in Italy (regular) ~nd the U.S.A. (1615 -AGIT) were evaluated by D.T.~. and x-ray difcfraction. The thermc;Jrarri:s, figure L were identi'Cal except for t.he intensity at 700 o p.'which probably reflects a difference in magnesium carbonate .level, 3.8%-U.S. versus 2.7%- Italian ground in acid solubility. By X-ray diffraction the same naturally occurring extraneous minerals (dolomite magnesite, serpentine and tridymite) were found in both samples. This data is in agreement with Mathieu's claim of no change in source~ 2) purity - Random samples obtained ,from the first shipment supplied to Kolmar were evaluated microscopically by Mr.· R. Rus~ell. The talc was similar to other Italian talc observed previously without a significant amount of contamination. Mr. Russell did observe the U.S. ground talc to be $lightly coarser and confirmed this witha325 mesh wet screen analysis: % Through 325 mesh U.s. Ground #J026B 89.2 Italian Ground #4277lE 94.8 3) Particle Size Distribution and Surface Area - Three lots (892913, 090215, and 185) received in December and our stand- ard Italian talc were analyzed for particle size distribution. As shown in figure 2, all three were slightly coarser than the regular talc. The mean particl~ size and surface area measure- ments are tabulated in Table I. The degree of increased.part- ,icle size appears to be of minor. importance. 4) Lubricity - The esthetic property most likely to be effected 'by fineness would be lubricity. -U.S. ground talc sample 185 which had the lowest surface area was compared to the standard Italian talc. Three talc samples, two of One talc and one sample of the other talc, were given to ten individuals who were asked to identify the correct pair. Judgements were based. upon, Protected Document--Subject to Protective Order JNJAZ55_000002332 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 the talc's feel when rubbed between the fingers. The samples were then reversed and a total of twenty judgements were ma~e. Correct determinations, 40%, were "well below the level of significance. S) Conformanr.e to Specifications .~., The talc samples were checked aga.l'ri~di; the Johnson and .Johnsor.. . speci fications for Italian and Vermont talcsand the.U.S.P. specifications. Recognizing that Italian talc ,al~ays .contains a higher carbonate level than Vermont talc, the only. significant divergence in' Table II is the fineness for lot'18S. The above data and the attached Mathieu specification (98% minimum for 200 mesh) indicates ~hat occasional batch~s -may fail to meet our spec- ification limit for fineness although the difference 98 versus 98.5 is of a minor nature. 'Mat~ieuwas contacted relative to fineness and recent batches have met our specifiactions, Table Il.I. Protected Document--Subject to Protective Order JNJAZ55_000002333 ..,"'0FILED: 2. ..; • . NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 ~ NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 [ o SAMPLE: ' ! 'SIZE p~~' i' IRANGE '/0I'.JH/ RUN' NO. I o n l: 3 III ::!. in , , :rrAt./Il1'1 TALC- (L(.S. (;,ROIANP) " ", J,..oT, !lFo;1'!-1l I I i REF. ~/,.,/...! ..,IL~j'/ !I GAS 1. I1Jz- 2• 'lbs o/in 2, DA~E #0 - l: .E III !:l. - o \, "'0: o I ORIGIN: " ;: PROG PROG. 0 MODE RATE .Lf)U:kn PRESSURE VACUUM --- mm i OPERATO.:dJ! REMARKS It 'r !:l., <' III , FI~URE I DoT.A. ANALYSIS °1 A.' ~ . ,'-' I ~ ' '\ " I I. ,I \ "\ I ' \ ! II ' . " \. "" _ ,r, ! I " ',' , , , '" ___-:_ .._.....__..~,_ :.. ' c::::::: ,"" g-- ~ 'ta., . " . ," f'( ,C; 'f'Q'Ut>I d 'i ......... ..-. .... --~.. . . . . -..... _.. """ "", , ' ,.' I -~ . ~ 1~cJ', 'U.,'O.G~-u.I4~~ ..... lI , i ; t iI i....... ", I " \,' ....~ ,! " r JL,j 11 I it. II :1 'I I 'J 11'1 '1'1'1 !I 'I 'I II 'I :Ll~ c... Z c... . 0 .. . . , ..... , 50 100 150 , .a__ 20\) ." \ .2 5( _. ~ ~__ I~ 0,/ ' , , 100, ,200 , ;JVV ~vu . :xJU o ~/f.;.,.''~"" ., " . 'I , " ·1'·'· .'". ·1·'·"·,' 'I, ~., '"I '_L'·"·"" I'·"··· "'I" ;"", " ,(" , . "~, '."" .., ,,., r, I oS o \"~ " I ., I . I, . ' , ' I o o IV 100 ,200 ,300' 400 " ,_00 ,,'. GOO . , 700 . BqO .... ...,JO --'0-00 '"'" .... FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM "'0 INDEX NO. 190002/2023 o It NYSCEF n DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 It a. o o n l: 3 FIGURE Ii III :::l ';'" in l: Particle Size Distribution of Italian Tales .g III ~ 6" "'0 o o :.: It n ~ 10 Ground in Ita1y ~06839 III ~. A a. - , ~ B Ground in U.S. #185 20 C Ground in' u. S. #892913 .j..J ~o o Ground in U. S. #090215,' s:: Q) u H Q) p.., 40 I, .... '" ~ ..... l. ..... I' .j..J ,.c: '~~ .. ljl, -,-+ .50 j: " I {[)I ~ .- .. Q) :> -.-II, 6 (i): II ;, , ' ... "'- ·1Ji I'd ~i ~: '1(iJi Ei: ' ~I liJ) ~~' B(i)I '~ ... ......._._- ' 9{») ~=l, -~---:t. I .' ## '-:OJ 1, ' ,,'~ .i j i I • I •• • il, • • i II . 100 80 60 50 40 30 20 10 8 6 5 4 3 Microns 2 ,1 c... Z c... ~ I'" o o o o e' e o IV '"'"'" e FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 TABLE I Surface Area and Mean Particle Size of various Talc Samplp.s. 2 TALC LOT NO. SURFACE AREA (m. /g.) Italian - AGIT 1615 892913 1.9 Italian - AGIT 1615 090215 2.3 Italian - AGIT 1615 185 1.7 Italian Standard 2.0-2.6 Vermont 1. 3-2.1 TALC LOT NO. Mean Parti~le Size (micron) Italian - AGIT 1615 892913 15.0 Italian - AGIT 1615 " 090215" 16.7 Italian -" AGIT 1615 185 12.5 Italian - Standard "" 06839 11. 3 Protected Document--Subject to Protective Order JNJAZ55_000002336 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 TABLE II ITAJ,IAN ':PALC AGIT 1615 CONFORMANCE TO SPECIFICATIONS *vermont Talc Specification **U.S.P.Talc Specification Protected Document--Subject to Protective Order JNJAZ55_000002337 INDEX NO. 190002/2023 oFILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM "'0 It n NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 It C- O o TABLE III n l: 3 III ::!. in l: LOT TO LOT CONFORMANCE TO SPECIFICATIONS FOR AGIT 1615 TALC, .E rJl III !:l- ei Date Shipment 2/24/70 2/27/70 ' 3/8/70 3/6/70 ,3/11/70 "'0 o It Lot Number I ,'f026B F024-A I F-025 C-002 C-004 !:l- <' III o Moisture (N.M.T. 0.15%) 0.05 0.03 0.03 0.05 0.05 a. ~ solubility in Acid (N.M.T. 6%) 2.22 3.8 4.0 3.4 3 .. 3 3 Bulk Density (22-27 lbS./ft. ) 23.1 24.5 ' I 23.5 24.4 24.1 Fineness ,% Through 60 mesh (100) ,100 100 100 100 100 % Through 100 mesh (N.L.T. 99~7) 99.8 99:8 99.8 99.8 99'.8 .% Through 200 mesh (N.L.T. 98.5) 98.6 98.5 98.5 . 98.5 98..6 Los c... Z c... ~ • I~ o o o o IV '"'"co e e FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 B. PRODUCT PERFOfu~NCE As a 'brief review, in January of1969'Shower to Shower®' production was converted from formul~ 117 to formula 230. In the fall ~:f:.·. J,.969, form\lla 263 was adopted. Formula 230 was,;:,o:;...: an interim formulation having improved stability whic.h provided time tode.ve.lop, age. and consumer test the ideal (stability) formulation, formula 263. The formulations are compared below: ,Formula In9'rec~Hent 62 117 230 263 I.F.F. Perfume 2751-a 0.2 0.3 I.F.F. Pe.rfume 3365-M .0.4 I.F.P. Pe rf1,lme. 3416-M 0.3 HexachlQrophen e 0.5 '. 0.5 0.5 0.1 Vermont T~lc qs. Ad 100· ,.: ·100 Italian Talc qs. Ad 100 100 1) Stab;i,;l,·ity ':"U. s. ground Italian talc (Metropolitan Talc Co. e lots 86315-88715) was tested in the· formula 230 development program. AfteJ:' f01;lr weeks at 120 o ·F.· the aging data indicated a slight preference. (odor) for theU.• S~" ground talc. Long term aging st.u<:lies were conducted with formula. 23l.(theperfumelevel of formula 230 increase<:l to 0.4~ and the results are'pre~ented below~ Triangular Difference Study* Age Temperature % Difference Comments 36 weeks ··:45% . mixed : .~ : 65 weeks 50% . mixed *Comparison Of formula 231 odor.·prepared,·with either U. S. ground Or regular Italian talc. The. abti..,~data indicates thatnu-significant difference ':'n odor was pres.ent. Although no long term data .is available with formula 263 using the lI.S. ground talc, it is highly unlikely ~.' that the aging would be·more adverse with·formula 263.: The latter formula contains g more stable perfume, 34l6M, . and a· lower he.xachlorophene level. Protected Document--Subject to Protective Order JNJAZ55_000002339 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 2) In vivo Antibact~rldl Activity - NO change in the.activity _ of formula 230 was noted when the T.J.S. ground talc was sub- stituted. 3) .Safety· Formula 230 using both tales were patch tested and no diffeJ::ence was found. '.,..'.' Protected Document--Subject to Protective Order JNJAZ55_000002340 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 101 RECEIVED NYSCEF: 07/10/2023 C. PRODUCTION EXPERIENCE One production bat.ch was prepared du:i:'ingthe week of February 23 at Kolmar. Although the batch met all product specification, the sifting (40 mEsh) and filling of the batch, into drums L0quired almost twice as long. Examination of the' last drum indicated the presence of string, bag fragments, and other foreign material. A second batch supervised by Research was prepared on March 2, 1970. The batch was normal in all aspects. There was no excessive accumulation of foreign mat- erial on the 40 mesh screen. It can be concluded that coinci- dental with the first·test batch the screen had not been cleaned and was clogged. Additional batches using the U.S. ground talc have been normal in all aspects. ·e Protected Document--Subject to Protective Order JNJAZ55_000002341