OF EXPIRATION OF EITHER THIS
AGREEMENT OR THE MANUFACTURING AGREEMENT.
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, INCLUDING MANAGEMENT
OF THE OVERALL MANUFACTURING STRATEGY AND TACTICS, FORMULATION, CONTRACT
MANUFACTURER SELECTION FOR FINISHED PRODUCT, ASSOCIATED AUDITS, AND STABILITY
TESTING.
ARTICLE 4 -
SECOND GENERATION ICAM-1 PRODUCTS
SECTION 4.1
SECOND GENERATION ICAM-1 ASO DRUG CANDIDATE LICENSE.
4.1.1
CANDIDATE POOL.
IMMEDIATELY FOLLOWING RECEIPT OF A NOTICE FROM
ATLANTIC REQUESTING ISIS TO COMMENCE THE WORK (SUCH NOTICE TO BE GIVEN WITHIN
[***] OF THE GRANT OF REGULATORY APPROVAL IN THE USA OF AN ALICAFORSEN PRODUCT
FOR THE TREATMENT OF POUCHITIS, BUT IN NO EVENT WILL SUCH NOTICE BE GIVEN LATER
THAN [***] AFTER THE EFFECTIVE DATE), ISIS AGREES TO, AT ITS SOLE COST AND
EXPENSE, COMMENCE IN VITRO SCREENING IN ACCORDANCE WITH A WRITTEN WORK PLAN TO
BE MUTUALLY AGREED UPON BY BOTH PARTIES (THE "WORK PLAN"), TO ATTEMPT TO
DISCOVER BETWEEN [***] AND [***] SECOND GENERATION ICAM-1 ASO DRUG CANDIDATES
(THE "CANDIDATE POOL") (THE "SECOND GENERATION ICAM-1 RESEARCH PROGRAM").
ISIS
AGREES TO USE COMMERCIALLY REASONABLE EFFORTS AND THE QUALITY STANDARD WHEN
DISCHARGING ANY OF ITS OBLIGATIONS UNDER THE WORK PLAN AND WILL KEEP OR CAUSE TO
BE KEPT WRITTEN LABORATORY NOTEBOOKS AND OTHER RECORDS AND REPORTS OF ITS
PROGRESS WITH THE WORK PLAN AND ITS ACTIVITIES UNDER THE WORK PLAN IN SUFFICIENT
DETAIL AND IN A GOOD SCIENTIFIC MANNER FOR ALL PURPOSES INCLUDING PATENT
PURPOSES.
ISIS WILL REPORT ITS PROGRESS WITH THE SECOND GENERATION ICAM-1
RESEARCH PROGRAM TO THE JDC.
4.1.2
CANDIDATE SELECTION.
ISIS WILL PROVIDE ATLANTIC WITH WRITTEN NOTICE
AND ANY SUPPORTING IN VITRO DATA AT SUCH TIME AS THE CANDIDATE POOL IS AVAILABLE
FOR CONSIDERATION BY ATLANTIC (THE "NOTICE"). ATLANTIC MUST NOTIFY ISIS, IN
WRITING WITHIN [***] FOLLOWING THE NOTICE, THAT (I) IT HAS ELECTED TO DEVELOP A
SECOND GENERATION ICAM-1 PRODUCT AND NOMINATE ONE OF THE CANDIDATES FROM THE
CANDIDATE POOL AS THE LEAD SECOND GENERATION ICAM-1 ASO DRUG CANDIDATE, AND (II)
IT AGREES TO PROMPTLY ESTABLISH, IN GOOD FAITH, A SIGNIFICANT DEVELOPMENT
PROGRAM PURSUANT TO A WRITTEN DEVELOPMENT PLAN TO BE SET BY ATLANTIC (THE
"SECOND GENERATION DEVELOPMENT PLAN").
IF ATLANTIC FAILS TO ELECT TO DEVELOP A
SECOND GENERATION ICAM-1 PRODUCT USING THE SECOND GENERATION ICAM-1 ASO DRUG
CANDIDATES UNDER THIS ARTICLE 4 NEITHER ISIS NOR ATLANTIC WILL HAVE ANY FURTHER
OBLIGATIONS UNDER THIS AGREEMENT WITH REGARD TO THE CANDIDATE POOL, ANY SECOND
GENERATION ICAM-1 ASO DRUG CANDIDATE OR ANY SECOND GENERATION ICAM-1 PRODUCT.
IF, DESPITE ISIS' COMMERCIALLY REASONABLE EFFORTS, ISIS FAILS TO PRODUCE A
CANDIDATE
*** CONFIDENTIAL TREATMENT REQUESTED
5
Pool that is reasonably acceptable to Atlantic, neither Isis nor Atlantic will,
for a period of three years following the date of the Notice, take any steps to
research another anti-sense oligonucleotide drug candidate designed to directly
inhibit ICAM-1 without the prior consent of the other Party.
4.1.3
LICENSE GRANT. IF ATLANTIC SO INFORMS ISIS OF