TO EACH
ALICAFORSEN PRODUCT.
IN ADDITION, IN CONNECTION WITH ANY REPORTED SERIOUS
ADVERSE EVENT, ATLANTIC WILL PROVIDE ISIS (PROMPTLY FOLLOWING SUCH EVENT AND
PRIOR TO ANY COMMUNICATION WITH A REGULATORY AUTHORITY OR ETHICS COMMITTEE) IN A
MUTUALLY ACCEPTABLE FORMAT, THE FOLLOWING PATIENT DATA WHERE IT IS REASONABLY
AVAILABLE TO ATLANTIC ONCE INFORMED OF A SERIOUS ADVERSE EVENT AND ANY OTHER
DATA ATLANTIC REASONABLY DEEMS RELEVANT TO THE ISIS DATABASE: (A) BASIC
STATISTICS (INCLUDING AGE, RACE, GENDER, WEIGHT, HEIGHT); (B) MEDICAL HISTORY;
(C) CONCURRENT MEDICATION USAGE; (D) PARTICULARS OF THE EVENT (VERBATIM TERM,
MEDDRA TERM & SYSTEM ORGAN CLASS, ONSET DATE, RESOLUTION DATE, RELATION TO
ALICAFORSEN PRODUCT, SEVERITY/SERIOUSNESS, OUTCOME); (E) DOSING HISTORY (DATES,
QUANTITY OF ALICAFORSEN PRODUCT ADMINISTERED, METHOD OF ADMINISTRATION); (F)
CHEMISTRY AND HEMATOLOGY LAB TESTS; AND (G) OCULAR PRESSURE.
FOR CLARITY,
ATLANTIC SHALL BE RESPONSIBLE FOR ALL SAFETY AND/OR PHARMACOVIGILANCE MATTERS
RELATING TO OR ARISING FROM THE DEVELOPMENT AND COMMERCIALIZATION OF THE
ALICAFORSEN PRODUCTS AND FOR MAKING ALL ADVERSE EVENT REPORTS TO THE RELEVANT
REGULATORY AUTHORITIES AT THE TIMES AND IN THE MANNER IT DEEMS APPROPRIATE TO
COMPLY WITH ALL APPLICABLE LAWS.
SECTION 3.4
REPORTS. ATLANTIC AGREES TO KEEP ISIS INFORMED WITH RESPECT TO
ACTIVITIES AND PROGRESS WITH THE FURTHER DEVELOPMENT AND COMMERCIALIZATION OF
ALICAFORSEN PRODUCTS, AND AGREES TO PROVIDE TO THE JDC EVERY SIX MONTHS A
SUMMARY OF SUCH ACTIVITIES AND PROGRESS.
SECTION 3.5
SUPPLY OF EXISTING ALICAFORSEN API.
3.5.1
ISIS AGREES TO SUPPLY ATLANTIC WITH A QUANTITY OF ALICAFORSEN API
THAT IS IN ISIS' POSSESSION AS OF THE EFFECTIVE DATE, REASONABLY SUFFICIENT TO
OBTAIN REGULATORY APPROVAL FOR AN ALICAFORSEN PRODUCT FOR POUCHITIS (BUT NOT TO
EXCEED [***] KG) IN THE USA [***], IN ACCORDANCE WITH A CLINICAL TRIAL PROGRAM
DESIGNED BY ATLANTIC AND DISCUSSED BY THE JDC.
3.5.2
ATLANTIC AND ISIS AGREE THAT, TO THE EXTENT AVAILABLE FROM THE
STOCKS OF ALICAFORSEN API IN ISIS' POSSESSION AS OF THE EFFECTIVE DATE, ANY
OTHER QUANTITIES OF ALICAFORSEN API REQUIRED BY ATLANTIC FOR THE DEVELOPMENT 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; ONCE SUCH EXISTING STOCKS OF ALICAFORSEN API WITH GREATER THAN [***]
*** CONFIDENTIAL TREATMENT REQUESTED
3
months of shelf life have been exhausted, additional quantities of Alicaforsen
API may be acquired from Isis on the terms of Section 3.6.
3.5.3
ALL ALICAFORSEN API ORDERED BY ATLANTIC PURSUANT TO SECTION 3.5 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 3.5; (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
EFFECTIVE DATE, (III) HAVE AT LEAST [***] MONTHS SHELF LIFE REMAINING WHEN
DELIVERED, AND WILL BE ACCOMPANIED BY A