POCKET COSTS BORNE BY GSK FOR THE [***] OF SUCH PRODUCT.
IN THE EVENT THAT GSK
ELECTS TO MANUFACTURE PRODUCT AT A MANUFACTURING FACILITY OWNED AND OPERATED BY
GSK, THEN THE COSTS SET FORTH IN CLAUSES (A), (B) AND (C) ABOVE SHALL BE
PRO-RATED BASED ON CAPACITY UTILIZED BY GSK IN THE MANUFACTURE OF SUCH PRODUCT,
AS THE CASE MAY BE, OR ANY INTERMEDIATE THEREOF AT SUCH FACILITY AS COMPARED TO
THE CAPACITY USED TO MANUFACTURE ANY OTHER PRODUCT OR INTERMEDIATE.
FOR
PURPOSES OF CLARITY (I) THE BASIS FOR ALL ALLOCATIONS UNDER THIS SECTION SHALL
BE INCLUDED IN ANY INVOICE FOR MANUFACTURING COSTS AND (II) ALL ALLOCATIONS
UNDER THIS SECTION SHALL BE BASED ON SPACE OCCUPIED OR HEAD-COUNT OR OTHER
ACTIVITY-BASED METHOD.
1.80
"MANUFACTURING DEVELOPMENT" MEANS, WITH RESPECT TO API OR PRODUCT,
ALL ACTIVITIES RELATED TO THE OPTIMIZATION OF A COMMERCIAL-GRADE MANUFACTURING
PROCESS FOR THE MANUFACTURE OF API OR PRODUCT INCLUDING, WITHOUT LIMITATION,
TEST METHOD DEVELOPMENT AND STABILITY TESTING, FORMULATION DEVELOPMENT,
VALIDATION, PRODUCTIVITY, TROUBLE SHOOTING AND NEXT GENERATION FORMULATION,
PROCESS DEVELOPMENT, MANUFACTURING SCALE-UP, DEVELOPMENT-STAGE MANUFACTURING,
AND QUALITY ASSURANCE/QUALITY CONTROL DEVELOPMENT.
1.81
"MINOR INDICATION" MEANS ANY INDICATION THAT IS NOT A MAJOR
INDICATION.
1.82
"NDA" MEANS A NEW DRUG APPLICATION, AS DEFINED IN THE FDCA AND
REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION OR PROCEDURE
REQUIRED TO SELL A PRODUCT IN THE UNITED STATES.
1.83
"NET SALES" MEANS THE GROSS AMOUNT BILLED OR INVOICED BY GSK OR ANY
OF ITS AFFILIATES OR SUBLICENSEES (EACH, A "SELLER") TO THIRD PARTIES THROUGHOUT
THE TERRITORY FOR SALES OR OTHER DISPOSITIONS OR TRANSFERS FOR VALUE OF PRODUCTS
LESS (A) ALLOWANCES FOR NORMAL AND CUSTOMARY [***] ACTUALLY ALLOWED AND TAKEN,
(B) [***] PAID BY THE SELLER, (C) [***] (REGARDLESS OF THE METHOD FOR PAYING FOR
SUCH [***]), [***] PURSUANT TO AGREEMENTS (INCLUDING, WITHOUT LIMITATION, [***]
AGREEMENTS) OR GOVERNMENT REGULATIONS, TO THE EXTENT ACTUALLY ALLOWED, (D) [***]
PAID BY THE SELLER IN RELATION TO THE PRODUCT AND ANY OTHER EQUIVALENT [***]
IMPOSED UPON THE IMPORTATION, USE OR SALE OF THE PRODUCT, (E) [***] TO CUSTOMERS
ON ACCOUNT OF RETROSPECTIVE PRICE REDUCTIONS AFFECTING THE PRODUCT, (F) THE
ACTUAL AMOUNT OF ANY [***] AND (G) ANY OTHER [***] ITEMS ACTUALLY DEDUCTED FROM
GROSS INVOICED SALES AMOUNTS AS REPORTED BY GSK IN ITS FINANCIAL STATEMENTS THAT
ARE ALLOCABLE TO THE SALE OR DISPOSITION FOR VALUE OF PRODUCTS IN ACCORDANCE
WITH THE INTERNATIONAL FINANCIAL REPORTING STANDARDS ("IFRS"), APPLIED ON A
CONSISTENT BASIS.
THIS DEFINITION OF NET SALES MAY BE UPDATED FROM TIME TO TIME
BY GSK TO REFLECT CHANGES REASONABLY REQUIRED BY (I) THE ADOPTION BY GSK OF
ACCOUNTING STANDARDS OTHER THAN IFRS, DUE TO GSK'S MERGER WITH ANOTHER ENTITY,
OR AS REQUIRED BY APPLICABLE LAWS, OR (II) IFRS TO THE EXTENT GSK IS UTILIZING
IFRS AS ITS ACCOUNTING STANDARD, FROM TIME TO TIME; PROVIDED, THAT, GSK SHALL
PROMPTLY PROVIDE SYNTA WITH WRITTEN NOTICE OF ANY SUCH UPDATES.
IN ADDITION,
NET SALES ARE SUBJECT TO THE FOLLOWING:
(A)
If the Seller or any of its Affiliates effects a sale, disposition
or