ISIS MAINTAINS A DATABASE THAT INCLUDES INFORMATION REGARDING THE
TOLERABILITY OF ITS DRUG COMPOUNDS, INDIVIDUALLY AND AS A CLASS, INCLUDING
INFORMATION DISCOVERED DURING PRE-CLINICAL AND CLINICAL DEVELOPMENT (THE "ISIS
DATABASE").
IN AN EFFORT TO MAXIMIZE UNDERSTANDING OF THE SAFETY PROFILE AND
PHARMACOKINETICS OF ISIS COMPOUNDS, ATLANTIC WILL COOPERATE IN CONNECTION WITH
POPULATING THE ISIS DATABASE. ATLANTIC WILL PROVIDE ISIS WITH INFORMATION
CONCERNING TOXICOLOGY, PHARMACOKINETICS, SAFETY PHARMACOLOGY STUDY(IES), SERIOUS
ADVERSE EVENTS AND OTHER SAFETY INFORMATION RELATED TO EACH ALICAFORSEN PRODUCT
AS SOON AS PRACTICABLE FOLLOWING THE DATE SUCH INFORMATION IS AVAILABLE TO
ATLANTIC (BUT NOT LATER THAN 30 DAYS AFTER ATLANTIC'S RECEIPT OF SUCH
INFORMATION). 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. ATLANTIC WILL DELIVER ALL SUCH
INFORMATION TO ISIS FOR THE ISIS DATABASE TO: ISIS PHARMACEUTICALS, INC. 1896
RUTHERFORD ROAD, CARLSBAD, CALIFORNIA 92008, ATTENTION: CHIEF MEDICAL OFFICER
(OR TO SUCH OTHER ADDRESS/CONTACT DESIGNATED IN WRITING BY ISIS). 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.
3.3.2.
From time to time, Isis utilizes the information in the Isis
Database to conduct analyses to keep Isis and its partners informed regarding
class generic properties of antisense oligonucleotides, including with respect
to safety. As such, if and when Isis identifies safety or other related issues
that Isis reasonably believes may be relevant to an Alicaforsen Product or the
gene target, ICAM-1 (including any potential class-related toxicity), Isis will
promptly inform Atlantic of such issues and, if requested, provide the data
supporting Isis' conclusions. In addition, if Isis becomes aware of any serious
adverse events related to Alicaforsen or ICAM-1, Isis will promptly inform
Atlantic. Isis will deliver all such information to Atlantic to: Atlantic
Pharmaceuticals Limited, Maple House, Birdbrook, Halstead, CO9 4BB, UK,
Attention: Chief Medical Officer (or to such other address/contact designated in
writing by Atlantic).
5
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 (INCLUDING WITH RESPECT TO THE
ACTIVITIES OF ATLANTIC'S AFFILIATES AND SUBLICENSEES), AND AGREES TO PROVIDE TO