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Exhibit 10.13(d)  


June 21,
2002 



Ms. Trudy
Briley

DSM Pharmaceuticals, Inc.

P.O. Box 1887

Greenville, NC 27835-1887 


        Re:    Amendment
No. 3 to Toll Manufacturing and Packaging Agreement 


Dear
Ms. Briley: 


        This
letter is to confirm our understanding concerning an amendment to be made with respect to the Toll Manufacturing and Packaging Agreement dated as of August 24, 1999, as
amended by Amendment No.1 dated July 3, 2001, and as further amended by Amendment No. 2 dated October 9, 2001 (the "Agreement"), between Cephalon, Inc. ("Cephalon") and DSM
Pharmaceuticals, Inc. ("DSM"). All terms not otherwise defined herein are used as defined in the Agreement. 



        The
purpose of this Amendment is to increase the minimum annual quantities of Product to be purchased by Cephalon and to increase the manufacturing capacity reserved by Catalytica for
the remainder of the Initial Term of the Agreement. The Agreement is hereby amended as follows: 



	1.
	Existing
Schedule F of the Agreement relating to Minimum Quantities shall be deleted in its entirety and replaced with the attached revised Schedule F.



	2.
	Except
as amended hereby, the Agreement remains in full force and effect. 




        If
the foregoing accurately reflects your understanding as to these matters, please indicate your agreement in the space provided below, and return one fully-executed original to me. 



	 	Very truly yours,
	

 	

/s/  ROBERT URBAN      
 Robert Urban

Vice President, Technical Operations





	Acknowledged and agreed to by:	 	 	 	 
	

DSM PHARMACEUTICALS, INC.	
 	

 	
 	

 
	

By:	
 	

/s/  WES WHEELER      
 Name: Wes Wheeler

Title: President & CEO	
 	

 	
 	

 




	**
	Certain
portions of this document have been omitted based upon a request for Confidential Treatment that has been filed with the Commission. The omitted portions have been filed
separately with the Commission. 





 
 
 

Schedule F
  
    Minimum Quantities    
  


The
minimum annual quantities to be purchased by CEPHALON and capacity to be reserved by DSM, are as follows for the remainder of the Initial Term of this Agreement: 



	Year
 
	 	Quantity
 

	2003	 	[**]
	2004 (until 8/24/04)	 	[**]





Pursuant
to Section 3.1, if the actual annual quantity exceeds the minimum annual quantity in any year by [**] percent [**] or less, this excess
will reduce the minimum annual quantity in the following year 


	**
	Certain
portions of this document have been omitted based upon a request for Confidential Treatment that has been filed with the Commission. The omitted portions have been filed
separately with the Commission. 


A-2









QuickLinks


Schedule F Minimum Quantities
<TABLE> <S> <C>

<ARTICLE> 5
       
<S>                             <C>
<PERIOD-TYPE>                   YEAR
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               DEC-31-1998
<CASH>                                         706,907
<SECURITIES>                                         0
<RECEIVABLES>                                  722,919
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                     0
<PP&E>                                      28,835,350
<DEPRECIATION>                              14,744,674
<TOTAL-ASSETS>                              32,971,969
<CURRENT-LIABILITIES>                        1,876,723
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                   (277,602)
<TOTAL-LIABILITY-AND-EQUITY>                32,971,969
<SALES>                                     14,746,766
<TOTAL-REVENUES>                            14,746,766
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                            13,125,628
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                           2,566,743
<INCOME-PRETAX>                            (1,369,601)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (1,369,601)
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                        0
        

</TABLE>
<TABLE> <S> <C>

<PAGE>
 
<ARTICLE> 5
<MULTIPLIER> 1,000
       
<S>                             <C>                     <C>
<PERIOD-TYPE>                   12-MOS                   12-MOS
<FISCAL-YEAR-END>                          OCT-31-1997             OCT-31-1996
<PERIOD-START>                             NOV-01-1996             NOV-01-1995
<PERIOD-END>                               OCT-31-1997             OCT-31-1996
<CASH>                                           1,190                   5,867
<SECURITIES>                                         0                       0
<RECEIVABLES>                                   53,011                  57,524
<ALLOWANCES>                                     (350)                   (398)
<INVENTORY>                                     87,299                 121,710
<CURRENT-ASSETS>                               150,150                 189,833
<PP&E>                                          95,766                 104,043
<DEPRECIATION>                                (50,846)                (47,580)
<TOTAL-ASSETS>                                 316,258                 373,182
<CURRENT-LIABILITIES>                           94,294                 101,962
<BONDS>                                         74,245                  74,188
<PREFERRED-MANDATORY>                                0                       0
<PREFERRED>                                      5,000                   5,000
<COMMON>                                             0                       0
<OTHER-SE>                                    (30,503)                (20,962)
<TOTAL-LIABILITY-AND-EQUITY>                   373,258                 373,182
<SALES>                                        468,173                 462,406
<TOTAL-REVENUES>                               468,173                 462,406
<CGS>                                          424,967                 419,476
<TOTAL-COSTS>                                  467,499                 476,842
<OTHER-EXPENSES>                                     0                       0
<LOSS-PROVISION>                                     0                       0
<INTEREST-EXPENSE>                              13,228                  13,858
<INCOME-PRETAX>                               (12,554)                (28,294)
<INCOME-TAX>                                   (3,013)                 (8,683)
<INCOME-CONTINUING>                                  0                       0
<DISCONTINUED>                                       0                       0
<EXTRAORDINARY>                                      0                       0
<CHANGES>                                            0                       0
<NET-INCOME>                                   (9,541)                (19,611)
<EPS-PRIMARY>                                        0                       0
<EPS-DILUTED>                                        0                       0
        

</TABLE>
<TABLE> <S> <C>

<PAGE>
<ARTICLE> 5
<RESTATED>

<S>                             <C>
<PERIOD-TYPE>                   YEAR
<FISCAL-YEAR-END>                          DEC-31-1995
<PERIOD-START>                             JAN-01-1995
<PERIOD-END>                               DEC-31-1995
<CASH>                                               0
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                     0
<PP&E>                                               0
<DEPRECIATION>                                       0
<TOTAL-ASSETS>                                       0
<CURRENT-LIABILITIES>                                0
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                           0
<TOTAL-LIABILITY-AND-EQUITY>                         0
<SALES>                                     15,482,111
<TOTAL-REVENUES>                            15,482,111
<CGS>                                        5,944,113
<TOTAL-COSTS>                                5,944,113
<OTHER-EXPENSES>                            19,136,446
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (9,023,854)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (9,023,854)
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                   (1.39)


</TABLE>
Editorial Note on Subpart A of Part 876
Editorial Note: Nomenclature changes to part 876 appear at 73 FR 35341, June 23, 2008.

§ 876.1 Scope. ( a ) This part sets forth the classification of gastroenterology-urology devices intended for human use that are in commercial distribution.
( b ) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.
( c ) To avoid duplicative listings, a gastroenterology-urology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.
( d ) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
( e ) Guidance documents referenced in this part are available on the Internet at *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm ..*
[52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987, as amended at 69 FR 77623, Dec. 28, 2004; 78 FR 18233, Mar. 26, 2013]
# C_2016136EN.01002902.xml

| 18.4.2016 | EN | Official Journal of the European Union | C 136/29 |
| --- | --- | --- | --- |

18.4.2016

EN

Official Journal of the European Union

C 136/29

---

Judgment of the General Court of 1 March 2016 — Secop v Commission

(Case T-79/14) (1)

1

((State aid - Rescuing firms in difficulty - Aid in the form of a State guarantee - Decision declaring the aid compatible with the internal market - Failure to initiate the formal investigation procedure - Serious difficulties - Procedural rights of the interested parties))

(2016/C 136/41)

Language of the case: German

Parties

Parties

Applicant: Secop GmbH (Flensburg, Germany) (represented by: U. Schnelle and C. Aufdermauer, lawyers)

Applicant:

Defendant: European Commission (represented by: L. Armati, T. Maxian Rusche and R. Sauer, acting as Agents)

Defendant:

Re:

Re:

Action for annulment of Commission Decision C(2013) 9119 final of 18 December 2013, concerning State aid SA.37640 — Rescue aid for ACC Compressors SpA — Italy.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the action; |
| --- | --- |

1.

Dismisses the action;

| 2. | Orders Secop GmbH to pay the costs. |
| --- | --- |

2.

Orders Secop GmbH to pay the costs.

---

(1)  OJ C 85, 22.3.2014.

1

---
SAT Report

PMN Number: P-10-0246

SAT Date: 5/21/2010

Print Date: 4/20/2011

Related cases: CBI: Yes

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 1

 Persistence Bioaccum Toxicity Comments

3 31

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: LUNG OVERLOAD; ONCO; IMMUNOTOX; MUTA (UNCERT)

Summary of Assessment:

 Fate:

Fate Summary: P-10-0246

FATE: 

Solid with MP = Dec. 499 C (M)

S < 0.001 mg/L at 25 C (E)

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 0-90 via sorption

Time for complete ultimate aerobic biodeg > mo
Sorption to soils/sediments = low - v.strong

PBT Potential: P3B3

*CEB FATE: Migration to ground water = negl – rapid

Direct photolysis will be negl - rapid

Indirect photolysis will be negl - rapid

 Health:

 Health Summary: Expect poor absorption via all routes (pchem/analog). 

Concern for lung toxicity if inhaled based on lung overload for poorly soluble particulates. Also 

concern for oncogenicity and immunotoxicity based on carbon nanomaterials. Uncertain 

concern for mutagenicity.

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value *

daphnid _ chronic value *

algal _ chronic value *

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for nonionic polymers; SAR 

chemical class = polymer-nonionic-carbon; MW > 1,000,000; pH7; effective concentrations 

based on 100% active ingredients and nominal concentrations; hardness <180.0 mg/L as 

CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs nonionic polymers

SAR Class polymer-nonionic-carbon 

allotrope

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916
<TABLE> <S> <C>



<ARTICLE> 5
<LEGEND>
THE SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AS OF SEPTEMBER 30, 1997 AND FROM THE STATEMENT OF OPERATIONS FOR THE
NINE MONTHS ENDED SEPTEMBER 30, 1997 AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1997
<PERIOD-END>                               SEP-30-1997
<CASH>                                         505,024
<SECURITIES>                                    75,000
<RECEIVABLES>                                    1,812
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                     0<F1>
<PP&E>                                      10,505,298
<DEPRECIATION>                                       0<F2>
<TOTAL-ASSETS>                              11,282,710
<CURRENT-LIABILITIES>                                0<F1>
<BONDS>                                      5,236,104
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                   5,755,403
<TOTAL-LIABILITY-AND-EQUITY>                11,282,710
<SALES>                                      1,518,297
<TOTAL-REVENUES>                             1,532,611
<CGS>                                                0
<TOTAL-COSTS>                                1,065,392
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                             333,978
<INCOME-PRETAX>                                 26,617
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                             26,617
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                    26,617
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                        0
<FN>
<F1>THE PARTNERSHIP HAS AN UNCLASSIFIED BALANCE SHEET; THEREFORE, THE VALUE IS $0.
<F2>THIS INFORMATION IS NOT DISCLOSED IN THE PARTNERSHIP'S FORM 10-Q FILING.
</FN>
        

</TABLE>
# C_2014175EN.01005601.xml

| 10.6.2014 | EN | Official Journal of the European Union | C 175/56 |
| --- | --- | --- | --- |

10.6.2014

EN

Official Journal of the European Union

C 175/56

---

Action brought on 24 March 2014 — ZZ v Parliament

(Case F-26/14)

2014/C 175/80

Language of the case: French

Parties

Parties

Applicant: ZZ (represented by: L. Levi, C. Bernard-Glanz and A. Tymen, lawyers)

Applicant:

Defendant: European Parliament

Defendant:

Subject-matter and description of the proceedings

Subject-matter and description of the proceedings

Application for annulment of the decision rejecting the request for assistance submitted by the applicant in respect of psychological harassment.

Form of order sought

Form of order sought

The applicant claims that the Tribunal should:

| — | annul the implied decision rejecting the applicant’s request for assistance of 13 February 2013; |
| --- | --- |

—

annul the implied decision rejecting the applicant’s request for assistance of 13 February 2013;

| — | annul the decision of 18 December 2013 rejecting the applicant’s complaint of 26 August 2013; |
| --- | --- |

—

annul the decision of 18 December 2013 rejecting the applicant’s complaint of 26 August 2013;

| — | grant the applicant damages such as to compensate for the harm suffered of EUR 7 500 in respect of material harm and EUR 50 000 in respect of non-material harm; |
| --- | --- |

—

grant the applicant damages such as to compensate for the harm suffered of EUR 7 500 in respect of material harm and EUR 50 000 in respect of non-material harm;

| — | order the Parliament to pay the costs. |
| --- | --- |

—

order the Parliament to pay the costs.

---
Editorial Note on Part 872
Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008.

§ 872.3220 Facebow. ( a ) *Identification.* A facebow is a device intended for use in denture fabrication to determine the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator (§ 872.3150) and thereby aiding correct placement of artificial teeth into a denture base.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]
§ 803.10 Generally, what are the reporting requirements that apply to me? ( a ) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows: ( 1 ) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event: ( i ) Submit reports of device-related deaths to us and to the manufacturer, if known, or
( ii ) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
( 2 ) Submit annual reports (described in § 803.33) to us.
( b ) If you are an importer, you must submit reports (described in subpart D of this part), as follows: ( 1 ) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event: ( i ) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
( ii ) Submit reports of device-related malfunctions to the manufacturer.
( 2 ) [Reserved]
( c ) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows: ( 1 ) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.
( 2 ) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of: ( i ) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
( ii ) A reportable event for which we made a written request.
( 3 ) Submit supplemental reports if you obtain information that you did not submit in an initial report.
<TABLE> <S> <C>

<ARTICLE>                     5
<LEGEND>
THE SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED FINANCIAL STATEMENTS OF LADISH CO., INC. AS OF AND FOR THE
SIX MONTHS ENDED JUNE 30, 2000 AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER>                                   1,000

<S>                             <C>
<PERIOD-TYPE>                   6-MOS
<FISCAL-YEAR-END>                              DEC-31-2000
<PERIOD-START>                                 JAN-01-2000
<PERIOD-END>                                   JUN-30-2000
<CASH>                                         899
<SECURITIES>                                   0
<RECEIVABLES>                                  36,219
<ALLOWANCES>                                   340
<INVENTORY>                                    54,122
<CURRENT-ASSETS>                               91,428
<PP&E>                                         161,031
<DEPRECIATION>                                 69,820
<TOTAL-ASSETS>                                 199,230
<CURRENT-LIABILITIES>                          54,232
<BONDS>                                        0
<PREFERRED-MANDATORY>                          0
<PREFERRED>                                    0
<COMMON>                                       143
<OTHER-SE>                                     79,681
<TOTAL-LIABILITY-AND-EQUITY>                   199,230
<SALES>                                        112,266
<TOTAL-REVENUES>                               112,266
<CGS>                                          95,290
<TOTAL-COSTS>                                  4,944
<OTHER-EXPENSES>                               86
<LOSS-PROVISION>                               0
<INTEREST-EXPENSE>                             974
<INCOME-PRETAX>                                11,144
<INCOME-TAX>                                   2,006
<INCOME-CONTINUING>                            9,138
<DISCONTINUED>                                 0
<EXTRAORDINARY>                                0
<CHANGES>                                      0
<NET-INCOME>                                   9,138
<EPS-BASIC>                                  0.69
<EPS-DILUTED>                                  0.66


</TABLE>