1.50.
"TARGET LABEL" SHALL MEAN APPROVED LABELING FOR THE PRODUCT WITH:
(I) AN INDICATION FOR THE TREATMENT OF INSOMNIA; (II) [**] WHICH WOULD [**], AND
(III) [**] ATTACHED AT SCHEDULE 1.50. FOR THE AVOIDANCE OF DOUBT, THE LABEL
REQUIREMENTS AT SECTION 1.50(II), ABOVE, SHALL NOT APPLY TO [**].
1.51.
"TERM" SHALL MEAN THE PERIOD DESCRIBED IN SECTION 14.1 OF THIS
AGREEMENT.
1.52.
"THIRD PARTY" SHALL MEAN ANY PERSON OTHER THAN SEPRACOR, GSK AND
THEIR RESPECTIVE AFFILIATES.
1.53.
"THIRD PARTY TECHNOLOGY" MEANS ANY PATENTS, KNOW-HOW, INVENTIONS,
OR OTHER INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY A THIRD PARTY BUT NOT
OWNED OR CONTROLLED BY A PARTY OR ITS AFFILIATES.
1.54.
"TRANSITION PERIOD" SHALL MEAN THE PERIOD OF TIME BEGINNING ON THE
EFFECTIVE DATE OF THE AGREEMENT AND ENDING ON THE EARLIER OF (I) THE DATE OF
FINAL APPROVAL OF A MAA FILED WITH THE EMEA; OR (II) A DATE INDICATED IN A
WRITTEN AGREEMENT BY SEPRACOR AND GSK.
1.55.
"VALID CLAIM" SHALL MEAN A CLAIM OF ANY ISSUED, UNEXPIRED PATENT
THAT HAS NOT BEEN REVOKED OR HELD UNENFORCEABLE OR INVALID BY A DECISION OF A
COURT OR GOVERNMENTAL AGENCY OF COMPETENT JURISDICTION FROM WHICH NO APPEAL CAN
BE TAKEN, OR WITH RESPECT TO WHICH AN APPEAL IS NOT TAKEN WITHIN THE TIME
ALLOWED FOR APPEAL, AND THAT HAS NOT BEEN DISCLAIMED OR ADMITTED TO BE INVALID
OR UNENFORCEABLE THROUGH REISSUE, DISCLAIMER OR OTHERWISE.
1.56.
"VAT" SHALL MEAN THE TAX IMPOSED BY COUNCIL DIRECTIVE 2006/112/EC
OF THE EUROPEAN COMMUNITY AND ANY NATIONAL LEGISLATION IMPLEMENTING THAT
DIRECTIVE TOGETHER WITH LEGISLATION SUPPLEMENTAL THERETO AND IN PARTICULAR, IN
RELATION TO THE UNITED KINGDOM, THE TAX IMPOSED BY THE VALUE ADDED TAX ACT OF
1994 OR OTHER TAX OF A SIMILAR NATURE IMPOSED ELSEWHERE INSTEAD OF OR IN
ADDITION TO VALUE ADDED TAX.
1.57.
"WIND-DOWN PERIOD" SHALL MEAN ANY PERIOD AFTER THE DATE OF
TERMINATION OF THIS AGREEMENT, IN ITS ENTIRETY OR ON A COUNTRY-BY-COUNTRY BASIS,
DURING WHICH PURSUANT TO SECTIONS 15.2(A) OR 15.3(A), GSK IS REQUIRED TO
CONTINUE TO PERFORM CERTAIN ACTIVITIES.
1.58.
OTHER DEFINITIONS. EACH OF THE FOLLOWING DEFINED TERMS SHALL HAVE
THE MEANING SET FORTH IN THE INDICATED SECTION OF THIS AGREEMENT:
CONFIDENTIAL
Defined Term
Section
Acquired Competing Product
9.1(b)
Agreement
Introduction
Commercialization Plan
6.1
Confidential Information
11.1
Commercialization Option
9.1(e)
Company RA Executives
7.2(c)(i)
Development Data
11.2
Development Plan
5.6
Disclosing Party
11.1
DMF
5.10(a)
Excluded Products
1.37
Fault of GSK
17.4(b)(ii)
Fault of Sepracor
17.4(b)(i)
Generic Product
7.3(c)(ii)
GSK Indemnities
17.2
Indemnitee
17.3
Indemnitor
17.3
Independent RA Expert
7.2(c(i)
Infringing Product
12.3
Infringing Trademark
12.4
Initial Commercialization Plan
6.1
Intervening Event
19.1
Investigator Sponsored Clinical Studies
5.5
JSC
3.1
Liabilities
17.1
Other Trademarks
13.1
Pharmacovigilance Agreement
5.14(c)
Product Liability Claim
17.5(a)
Quality Agreement
10.2
Recall Costs
17.4(b)
Receiving Party
11.1
Reconciliation Report
7.3(e)(ii)
Reconciliation Review Period
7.3(e)(ii)
SEC
11.6
Selling Party
1.31
Senior Executives
3.4(b)
Sepracor Development Plan
5.8
Sepracor Indemnitees
17.1
Subcommittee
3.2
Supply Agreement
10.2
Third Party Claim
17.1
Trademark Infringing Product
12.4
CONFIDENTIAL
ARTICLE II.
GRANT OF