AND ANY OTHER PATENTS
OR KNOW-HOW OF ISIS OR ITS AFFILIATES, ARE HEREBY RETAINED BY ISIS OR ITS
AFFILIATES. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 2.1, ISIS WILL NOT BE DEEMED
BY ESTOPPEL OR IMPLICATION TO HAVE GRANTED ATLANTIC ANY LICENSE OR OTHER RIGHT
WITH RESPECT TO ANY INTELLECTUAL PROPERTY OF ISIS. NOTHING IN THIS AGREEMENT
WILL PREVENT ISIS FROM PRACTICING THE ALICAFORSEN PATENTS, THE ICAM-1 SPECIFIC
PATENTS, OR THE EXCLUDED MANUFACTURING IP FOR PRODUCTS OTHER THAN ALICAFORSEN
PRODUCTS.
ARTICLE 3 -
ATLANTIC PRODUCT DEVELOPMENT
SECTION 3.1
DEVELOPMENT/COMMERCIALIZATION/REGULATORY
RESPONSIBILITIES.
3.1.1
COMMERCIALLY REASONABLE EFFORTS. UNLESS ISIS EXERCISES ITS REVERSION
RIGHTS UNDER SECTION 11.2, ATLANTIC IS FULLY RESPONSIBLE FOR THE CONTINUED
DEVELOPMENT AND COMMERCIALIZATION OF ALICAFORSEN PRODUCTS AND WILL USE
COMMERCIALLY REASONABLE EFFORTS TO DEVELOP ALICAFORSEN PRODUCTS FOR ALL
COMMERCIALLY REASONABLE INDICATIONS, INCLUDING ALICAFORSEN PRODUCTS FOR THE
TREATMENT OF POUCHITIS AND TO MAKE ITS FIRST COMMERCIAL SALE OF AN ALICAFORSEN
PRODUCT FOR THE TREATMENT OF POUCHITIS IN THE USA AND EUROPE AS SOON AS
PRACTICABLE. ATLANTIC HEREBY ASSUMES ALL REGULATORY RESPONSIBILITIES IN
CONNECTION WITH ALICAFORSEN PRODUCTS, INCLUDING SOLE RESPONSIBILITY FOR ALL
RELATED REGULATORY DOCUMENTATION AND FOR OBTAINING ALL REGULATORY APPROVALS.
ATLANTIC WILL COMPLY WITH ALL APPLICABLE LAWS AND THE QUALITY STANDARD IN
CONNECTION WITH THE DEVELOPMENT AND COMMERCIALIZATION OF ALICAFORSEN PRODUCTS.
FOR THE AVOIDANCE OF DOUBT, ANY SUBLICENSEE THAT ENTERS INTO A SUBLICENSE WITH
ATLANTIC WILL USE COMMERCIALLY REASONABLE EFFORTS IN ACCORDANCE WITH THIS
AGREEMENT TO DEVELOP AND COMMERCIALIZE ANY ALICAFORSEN PRODUCTS THAT ARE THE
SUBJECT OF SUCH SUBLICENSE, AND ATLANTIC WILL ENSURE THAT SUCH EFFORTS ARE
UNDERTAKEN.
3.1.2
DEVELOPMENT PLAN. WITHOUT LIMITING ANY OF THE FOREGOING IN
SECTION 3.1.1, ATLANTIC WILL USE COMMERCIALLY REASONABLE EFFORTS TO IMPLEMENT
AND PERFORM THE INITIAL DEVELOPMENT PLAN APPROVED BY BOTH ATLANTIC AND ISIS AS
ATTACHED TO THIS AGREEMENT AS APPENDIX 4 (THE "INITIAL DEVELOPMENT PLAN"), WHICH
CONTAINS A GANTT CHART OF ATLANTIC'S GOOD-FAITH DEVELOPMENT PLAN FOR ALICAFORSEN
AS OF THE RESTATEMENT DATE WHICH SUPERSEDES ALL PREVIOUS
3
DEVELOPMENT PLANS.
ATLANTIC MAY UPDATE THE INITIAL DEVELOPMENT PLAN WITHIN 30
DAYS FOLLOWING THE RESTATEMENT DATE SO LONG AS (I) ANY SUCH UPDATE DOES NOT
CONSTITUTE A MATERIAL MODIFICATION OF, OR ADDITION TO, THE INITIAL DEVELOPMENT
PLAN, AND (II) ATLANTIC PROMPTLY PROVIDES ISIS WITH A COPY OF SUCH MODIFIED
INITIAL DEVELOPMENT PLAN WITH A SUMMARY/EXPLANATION OF ANY MODIFICATIONS
THERETO. FOLLOWING THE RESTATEMENT DATE, ATLANTIC WILL USE COMMERCIALLY
REASONABLE EFFORTS TO ARRANGE AND PARTICIPATE IN "ADVISORY" MEETINGS WITH THE
FDA AND EMEA (OR ANY OTHER REGULATORY AUTHORITY) AS SOON AS PRACTICABLE (EACH,
AN "ADVISORY MEETING"), AND FOLLOWING EACH SUCH ADVISORY MEETING, ATLANTIC WILL
PRESENT THE INFORMATION ARISING FROM SUCH MEETING(S) TO THE JDC TO, AMONG OTHER
THINGS, DISCUSS ANY NECESSARY MODIFICATIONS TO THE DEVELOPMENT PLAN.
THE
DEVELOPMENT PLAN WILL BE UPDATED AND MODIFIED ONLY AS DETERMINED BY THE JDC ON A
PERIODIC BASIS UNDER SECTION 3.2.1, INCLUDING FOLLOWING THE OCCURRENCE OF ANY
ADVISORY MEETINGS HELD BETWEEN ATLANTIC AND THE FDA AND/OR THE EMEA (OR ANY
OTHER REGULATORY AUTHORITY). NOTWITHSTANDING THE FOREGOING, ANY DEVELOPMENT PLAN
TO BE PERFORMED BY