ISIS AND THE JDC EVERY SIX MONTHS A SUMMARY OF SUCH ACTIVITIES AND PROGRESS. IN
ACCORDANCE WITH SECTION 3.2.1, DURING THE PERIOD ATLANTIC HAS A RIGHT OF FIRST
NEGOTIATION UNDER SECTION 4.1, ISIS AGREES TO KEEP ATLANTIC INFORMED WITH
RESPECT TO ISIS' ACTIVITIES AND PROGRESS WITH THE FURTHER DEVELOPMENT AND
COMMERCIALIZATION OF FOLLOW-ON PRODUCTS BY PROVIDING A SUMMARY OF ANY SUCH
ACTIVITIES AT MEETINGS OF THE JDC.
SECTION 3.5
[NOT USED]
SECTION 3.6
SUPPLY OF EXISTING ALICAFORSEN API.
3.6.1
ISIS AGREES TO SUPPLY ATLANTIC WITH A QUANTITY OF ALICAFORSEN API
THAT IS IN ISIS' POSSESSION AS OF THE RESTATEMENT DATE, REASONABLY SUFFICIENT TO
OBTAIN REGULATORY APPROVAL FOR AN ALICAFORSEN PRODUCT FOR POUCHITIS (BUT NOT TO
EXCEED [***] KG) IN THE USA OR EUROPE [***], IN ACCORDANCE WITH A CLINICAL TRIAL
PROGRAM SET FORTH IN THE DEVELOPMENT PLAN.
FOR THE AVOIDANCE OF DOUBT, THE
[***] KG OF ALICAFORSEN API SUPPLIED BY ISIS PRIOR TO THE RESTATEMENT DATE HAS
BEEN SUPPLIED [***].
3.6.2
ATLANTIC AND ISIS AGREE THAT, TO THE EXTENT AVAILABLE FROM THE
STOCKS OF ALICAFORSEN API IN ISIS' POSSESSION AS OF THE RESTATEMENT DATE, ANY
OTHER QUANTITIES OF ALICAFORSEN API REQUIRED BY ATLANTIC FOR THE DEVELOPMENT AND
COMMERCIALIZATION OF ALICAFORSEN PRODUCT MAY BE PURCHASED FROM ISIS IN A MINIMUM
ORDER SIZE OF [***]KG AT A COST OF [***] DOLLARS ($[***]) PER GRAM UNTIL SUCH
STOCKS HAVE BEEN EXHAUSTED.
AS OF THE RESTATEMENT DATE, ISIS HAS APPROXIMATELY
(I) [***] KILOGRAMS OF ALICAFORSEN API AVAILABLE FOR SALE, AND (II) [***]
KILOGRAMS OF ALICAFORSEN API IN QUARANTINE WITH THE POSSIBILITY OF RELEASE FROM
SUCH QUARANTINE IF CERTAIN QUALIFICATION STUDY(IES) ARE PERFORMED (E.G., A
BRIDGING TOXICOLOGY STUDY).
ISIS WILL HOLD SUCH ALICAFORSEN API IN QUARANTINE
FOR A PERIOD OF [***] ([***]) YEARS AFTER THE RESTATEMENT DATE FOR THE BENEFIT
OF ATLANTIC. IF ATLANTIC HAS THE NECESSARY STUDY(IES) PERFORMED, AT ATLANTIC'S
EXPENSE, AND SUCH ALICAFORSEN API IS SUCCESSFULLY RELEASED FROM QUARANTINE IN
ACCORDANCE WITH CGMP, ISIS WILL SELL SUCH [***] KILOGRAMS OF ALICAFORSEN API TO
ATLANTIC AT A COST OF [***] DOLLARS ($[***]) PER GRAM.
3.6.3
ALL ALICAFORSEN API ORDERED BY ATLANTIC PURSUANT TO SECTION 3.6 WILL
BE SHIPPED BY ISIS TO ATLANTIC, EXW (INCOTERMS 2000) ISIS' PREMISES, TO THE
DESTINATION SPECIFIED IN WRITING BY ATLANTIC.
ALL TRANSPORTATION AND INSURANCE
COSTS ARE THE SOLE RESPONSIBILITY OF ATLANTIC.
ISIS WARRANTS THAT EACH SUCH
AMOUNT OF ALICAFORSEN API SUPPLIED BY ISIS PURSUANT TO SECTION 3.6; (I) WILL
HAVE BEEN MANUFACTURED IN ACCORDANCE WITH CGMP, (II) MEETS THE SPECIFICATION FOR
ALICAFORSEN API SET OUT IN THE REGULATORY DOCUMENTATION EXISTING AT THE
RESTATEMENT DATE, (III) HAVE AT LEAST [***] MONTHS SHELF LIFE REMAINING WHEN
DELIVERED, AND WILL BE ACCOMPANIED BY A CERTIFICATE OF ANALYSIS.
SECTION 3.7
PRODUCT MANUFACTURING RESPONSIBILITY.
EXCEPT AS
OTHERWISE PROVIDED IN THIS AGREEMENT, ATLANTIC ACKNOWLEDGES AND AGREES THAT IT
IS SOLELY RESPONSIBLE FOR THE MANUFACTURING OF ALICAFORSEN PRODUCT AND
ALICAFORSEN API, INCLUDING, WITHOUT LIMITATION, MANAGEMENT OF THE OVERALL
MANUFACTURING STRATEGY AND TACTICS, CMC WORK, VALIDATION ACTIVITIES
6
AND BATCHES, FORMULATION, CONTRACT MANUFACTURER SELECTION FOR FINISHED