CERTIFICATE OF ANALYSIS.
3.5.4
THE PARTIES AGREE THAT ANY SUPPLY OF ALICAFORSEN API UNDER THIS
SECTION 3.5 WILL BE SUBJECT TO AND IN ACCORDANCE WITH THE TERMS OF THE
MANUFACTURING AGREEMENT (AS DEFINED BELOW).
SECTION 3.6
COMMERCIAL SUPPLY AND MANUFACTURING OF ALICAFORSEN API.
3.6.1
FOLLOWING THE EFFECTIVE DATE, AT ATLANTIC'S ELECTION, ISIS AND
ATLANTIC WILL NEGOTIATE IN GOOD FAITH, AGREE AND EXECUTE A SEPARATE WRITTEN
AGREEMENT FOR THE COMMERCIAL SUPPLY AND MANUFACTURE OF ALICAFORSEN API BY ISIS
FOR ATLANTIC (THE "MANUFACTURING AGREEMENT") SUCH MANUFACTURING AGREEMENT TO BE
ENTERED INTO WITHIN [***] OF THE EFFECTIVE DATE.
SUCH ALICAFORSEN API WILL BE
MANUFACTURED IN ACCORDANCE WITH CGMP, APPLICABLE ALICAFORSEN API SPECIFICATIONS,
AND THE TERMS AND CONDITIONS OF THE MANUFACTURING AGREEMENT, WHICH WILL INCLUDE,
AMONG OTHER STANDARD COMMERCIAL TERMS, ISIS' AGREEMENT TO MAINTAIN A DRUG MASTER
FILE FOR ALICAFORSEN API ("DMF") AND ATLANTIC'S RIGHT TO REFERENCE THE DMF IN
ITS REGULATORY DOCUMENTATION.
SHOULD: (A) A REGULATORY AUTHORITY IN A
PARTICULAR JURISDICTION IN WHICH ISIS HAS NOT FILED A DMF, OR (B) A REGULATORY
AUTHORITY WHICH DOES NOT ALLOW CROSS-REFERENCING TO AN EXISTING DMF, REQUEST
INFORMATION REGARDING ALICAFORSEN API AND ITS MANUFACTURE CONTAINED IN A DMF
SOMEWHERE IN THE WORLD, ISIS UNDERTAKES TO (I) PROVIDE SUCH INFORMATION DIRECTLY
ON BEHALF OF ATLANTIC TO THE APPLICABLE REGULATORY AUTHORITY, OR IF NOT LEGALLY
POSSIBLE (II) CONSULT WITH ATLANTIC IN GOOD FAITH REGARDING THE APPROPRIATE
RESPONSE TO SUCH INQUIRY AND TO GIVE ATLANTIC (AND ITS RELEVANT SUB-LICENSEE(S))
REASONABLE ASSISTANCE WITH ANSWERING THAT REGULATORY AUTHORITY'S QUESTIONS, SAVE
THAT SHOULD A REGULATORY AUTHORITY REQUEST ISIS'S PROPRIETARY INFORMATION
RELATING TO THE ALICAFORSEN API OR ITS MANUFACTURE OUTSIDE OF THE DEFINITION OF
ISIS MANUFACTURING KNOW-HOW ISIS SHALL NOT BE OBLIGED TO SHARE SUCH INFORMATION
WITH ATLANTIC (OR ITS RELEVANT SUB-LICENSEE(S)) AND SHALL RESPOND DIRECTLY TO
THE REGULATORY AUTHORITY ON ATLANTIC'S OR THE RELEVANT SUBLICENSEE'S BEHALF.
NOTWITHSTANDING SECTION 2.1.1 AND 2.2.1 ABOVE, WHILE ISIS IS MANUFACTURING
ALICAFORSEN API FOR ATLANTIC UNDER THE MANUFACTURING AGREEMENT, ISIS WILL
TRANSFER, AT ATLANTIC'S WRITTEN REQUEST AND SUBJECT TO THE CONFIDENTIALITY
OBLIGATIONS UNDER ARTICLE 8, ANALYTICAL METHODS WITHIN EXCLUDED MANUFACTURING IP
NECESSARY TO PROPERLY CHARACTERIZE AND RELEASE THE ALICAFORSEN API.
3.6.2
ATLANTIC AGREES THAT A MINIMUM ORDER SIZE OF [***] KG AT A PRICE OF
[***] DOLLARS ($[***]) PER GRAM WILL APPLY TO ALL PURCHASES OF ALICAFORSEN API
UNDER THE MANUFACTURING AGREEMENT.
*** CONFIDENTIAL TREATMENT REQUESTED
4
3.6.3
ISIS AND ATLANTIC AGREE THAT ATLANTIC SHALL ONLY BE PERMITTED TO
EXERCISE ITS LICENSE RIGHTS UNDER SECTION 2.1.1(II) TO MANUFACTURE ALICAFORSEN
API IN THE EVENT EITHER THAT ISIS IS UNABLE TO SUPPLY ATLANTIC WITH ITS
REQUIREMENTS OF ALICAFORSEN API FOR [***] SUCCESSIVE CALENDAR QUARTERS OR THAT
ISIS FAILS TO SUPPLY ATLANTIC WITH ALICAFORSEN API THAT MEETS THE AGREED
SPECIFICATION THEREFOR FOR [***] SUCCESSIVE CALENDAR QUARTERS OR BECAUSE
ATLANTIC IS OTHERWISE ENTITLED TO TERMINATE THE MANUFACTURING AGREEMENT FOR
CAUSE AND THERE IS NOT ANOTHER AVAILABLE SUPPLIER WHO CAN PRODUCE ALICAFORSEN
API WITHOUT ACCESS TO THE EXCLUDED MANUFACTURING IP.
FOR CLARITY SUCH
PERMISSION SHALL NOT ARISE SIMPLY BY VIRTUE