TO [***] IN THE ALNYLAM FIELD (EACH AS DEFINED IN
THE REGULUS LICENSE AGREEMENT).
THE EXCLUSIVE LICENSE GRANTED TO REGULUS BY
ISIS PURSUANT TO SECTION 2.2(A) OF THE REGULUS LICENSE AGREEMENT IS SUBJECT TO
ISIS' RETAINED RIGHT TO [***] IN THE ISIS FIELD (EACH AS DEFINED IN THE REGULUS
LICENSE AGREEMENT).
ALL RIGHTS IN AND TO REGULUS TECHNOLOGY AND REGULUS' RIGHTS
IN COLLABORATION TECHNOLOGY NOT EXPRESSLY LICENSED TO GSK HEREUNDER OR PURSUANT
TO THE OPERATION OF THE RELEVANT APPLICABLE EXPRESS PROVISIONS OF THIS
AGREEMENT, AND ANY OTHER PATENT RIGHTS OR KNOW-HOW OF REGULUS OR ITS PARENT
COMPANIES OR AFFILIATES, ARE HEREBY RETAINED BY REGULUS OR SUCH PARENT COMPANY
OR AFFILIATE.
5.3
TECHNOLOGY TRANSFER AFTER EXERCISE BY GSK OF A PROGRAM OPTION.
5.3.1
GENERALLY.
AFTER GSK EXERCISES ITS PROGRAM OPTION FOR A PROGRAM
HEREUNDER, AND DURING A PERIOD NOT TO EXCEED [***] THEREAFTER, REGULUS SHALL
PROMPTLY DELIVER TO GSK, AT NO COST TO GSK (EXCEPT AS SET FORTH IN SECTION 5.3.2
BELOW), ALL REGULUS TECHNOLOGY AND REGULUS COLLABORATION TECHNOLOGY IN REGULUS'
POSSESSION OR CONTROL RELATING TO THE OPTION COMPOUNDS DEVELOPED UNDER SUCH
PROGRAM, INCLUDING, BUT NOT LIMITED TO (A) INFORMATION REGARDING THE BULK DRUG
SUBSTANCE AND METHODS OF MANUFACTURING THE SAME, INCLUDING BULK AND FINAL
PRODUCT MANUFACTURING PROCESSES, MANUFACTURING DATA, BATCH RECORDS, VENDOR
INFORMATION
58
AND VALIDATION DOCUMENTATION, WHICH IS NECESSARY OR USEFUL FOR THE EXERCISE BY
GSK OF THE MANUFACTURING RIGHTS GRANTED UNDER SECTION 5.2.1, (B) PRE-CLINICAL
AND CLINICAL DATA AND RESULTS (INCLUDING PHARMACOLOGY, TOXICOLOGY, EMULATION AND
STABILITY STUDIES), ADVERSE EVENT DATA, PROTOCOL RESULTS, ANALYTICAL
METHODOLOGIES, (C) COPIES OF PATENT APPLICATIONS AND PATENTS INCLUDED WITHIN
REGULUS PATENTS AND REGULUS COLLABORATION PATENTS AND OTHER RELEVANT PATENT
INFORMATION, (D) REGULATORY FILINGS (INCLUDING ALL RELEVANT INDS AND REGULATORY
APPROVALS), REGULATORY DOCUMENTATION, REGULATORY CORRESPONDENCE, AND APPLICABLE
REFERENCE STANDARDS; AND (E) BULK DRUG SUBSTANCE OR OTHER MATERIALS, INCLUDING
DRUG SUBSTANCE, DRUG PRODUCT AND INTERMEDIATE STOCKS, REFERENCE STANDARDS AND
ANALYTICAL SPECIFICATION AND TESTING METHODS USED TO MANUFACTURE THE APPLICABLE
OPTION COMPOUNDS, AS FURTHER DESCRIBED IN AND SUBJECT TO SECTION 5.3.2 BELOW.
ALL INFORMATION SHOULD BE SUPPLIED TO GSK IN ELECTRONIC FORMAT TO THE EXTENT
POSSIBLE.
WITHOUT LIMITING THE FOREGOING, REGULUS SHALL USE DILIGENT EFFORTS TO
PERFORM THE TRANSFER OF SUCH INFORMATION AND MATERIALS TO GSK IN AN ORDERLY
MANNER AND WITHOUT UNDUE INTERRUPTION OF GSK'S DEVELOPMENT OF OPTION COMPOUNDS
AND RELATED LICENSED PRODUCTS HEREUNDER, AND, UPON DELIVERY OF SUCH INFORMATION
AND MATERIALS TO GSK, GSK SHALL USE DILIGENT EFFORTS TO PROMPTLY IMPLEMENT SUCH
INFORMATION AND MATERIALS INTO ITS DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES
WITH RESPECT TO SUCH OPTION COMPOUNDS AND RELATED LICENSED PRODUCTS HEREUNDER.
FOR THE AVOIDANCE OF DOUBT, THE OBLIGATION ON REGULUS TO DELIVER TO GSK ALL
REGULUS TECHNOLOGY AND OTHER KNOW-HOW AND INFORMATION IN ACCORDANCE WITH THIS
SECTION 5.3.1 SHALL INCLUDE (I) THE PROCUREMENT OF ANY REGULUS TECHNOLOGY IN THE
POSSESSION OF ANY REGULUS AFFILIATE OR PARENT COMPANY ENGAGED BY REGULUS AS A
SUBCONTRACTOR IN ACCORDANCE WITH SECTION 3.10 AND (II) THE USE OF DILIGENT
EFFORTS TO PROCURE ANY REGULUS TECHNOLOGY IN THE POSSESSION