PAR OR ITS AFFILIATE TO A THIRD PARTY
AFTER THE FDA HAS APPROVED THE NDA FOR SUCH PRODUCT.
1.11
"CONFIDENTIAL INFORMATION" SHALL MEAN ALL INFORMATION AND DATA THAT
MAY BE EXCHANGED BY THE PARTIES WHICH MAY INCLUDE, BUT SHALL NOT BE LIMITED TO,
SALES AND PRODUCT INFORMATION, CUSTOMER INFORMATION, MANUFACTURING PROCESSES,
PRODUCT FORMULATIONS, INFORMATION REGARDING APPLICATIONS AND SUBMISSIONS
(RELATING TO EXISTING AND PROPOSED PRODUCTS) MADE TO THE FOOD AND DRUG
ADMINISTRATION, NEW PRODUCT PLANS, PRODUCT DEVELOPMENT EFFORTS, MARKETING
STRATEGIES, FINANCIAL INFORMATION AND PROJECTIONS AND OTHER COMMERCIAL AND
PRODUCT DATA WHICH IS PROPRIETARY AND OF COMMERCIAL VALUE.
IT IS ACKNOWLEDGED
THAT THE CONFIDENTIAL INFORMATION CONTEMPLATED HEREBY MAY BE DISCLOSED NOT ONLY
IN WRITING OR OTHER TANGIBLE FORMS BUT ALSO ORALLY THROUGH, FOR EXAMPLE,
DISCUSSIONS OR PRESENTATIONS INVOLVING OUR RESPECTIVE REPRESENTATIVES.
ALL
INFORMATION EXCHANGED BETWEEN THE PARTIES SHALL BE PRESUMED TO BE CONFIDENTIAL
INFORMATION.
1.12
"DELIVERED PRICE PER KG" SHALL MEAN THE PRICE PAYABLE BY PAR TO
BIOCON FOR VALIDATION AND COMMERCIAL VOLUMES OF API SUPPLIED BY BIOCON TO PAR.
2
1.13
"DELIVERY DATE" SHALL MEAN A DATE FOR WHICH DELIVERY OF API IS
SPECIFIED IN A PURCHASE ORDER.
1.14
"DMF" SHALL MEAN A FDA DRUG MASTER FILE.
1.15
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
1.16
"NDA" MEANS A NEW DRUG APPLICATION PURSUANT TO 21 U.S.C. §355 FOR
THE PRODUCT.
1.17
"REGULATORY AUTHORITY" SHALL MEAN ANY FOREIGN, FEDERAL, STATE OR
LOCAL REGULATORY AGENCY, DEPARTMENT, BUREAU OR OTHER GOVERNMENTAL AUTHORITY,
INCLUDING, WITHOUT LIMITATION, THE FDA AND THE U.S. DRUG ENFORCEMENT
ADMINISTRATION, WHICH IS RESPONSIBLE FOR ISSUING APPROVALS, LICENSES,
REGISTRATIONS (INCLUDING BUT NOT LIMITED TO, THE REGISTRATIONS), PERMITS OR
AUTHORIZATIONS NECESSARY FOR, OR OTHERWISE GOVERNS, THE MANUFACTURE, HANDLING,
USE, STORAGE, IMPORT, EXPORT, TRANSPORT, DISTRIBUTION OR SALE OF PRODUCTS IN THE
TERRITORY.
1.18
"PRODUCT" SHALL MEAN THE FINAL COMMERCIALLY DISTRIBUTED DOSAGE FORM
OF THE API.
1.19
"PRODUCT APPROVAL" SHALL MEAN FINAL FDA APPROVAL TO MARKET
COMMERCIALLY IN THE U.S.A. THE SPECIFIED PRODUCT FOR USE IN HUMANS.
1.20
"TERRITORY" SHALL MEAN THE UNITED STATES ITS TERRITORIES,
POSSESSIONS, THE COMMONWEALTH OF PUERTO RICO, CANADA AND THE STATE OF ISRAEL.
ARTICLE 2
SALE AND PURCHASE OF API
2.1
EXCLUSIVE SUPPLY REQUIREMENTS.
SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, DURING THE TERM OF THIS AGREEMENT, BIOCON SHALL
SUPPLY PAR (OR PAR'S DESIGNEE) WITH ITS REQUIREMENTS OF API FOR THE TERRITORY.
EXCEPT AS ALLOWED UNDER SECTION 2.1.1 BELOW, DURING THE TERM OF THIS AGREEMENT,
BIOCON SHALL ONLY SUPPLY API TO PAR, AND NOT TO ANY OTHER PARTY
2.1.1
THIRD PARTY SUPPLY.
THE ABOVE NOTWITHSTANDING, IN THE EVENT BIOCON
HAS (I) SUPPLIED PAR WITH [***] KG LOTS OF API; AND (II) DEVELOPED CAPACITY TO
PROVIDE AT LEAST [***] KG PER YEAR OF API TO PAR, BIOCON MAY SELL API TO OPTIMER
PHARMACEUTICALS OR ITS RESPECTIVE DESIGNEES FOR SALE OUTSIDE THE TERRITORY.
IN
THE EVENT BIOCON IS UNABLE TO MEET ITS SUPPLY REQUIREMENTS FOR API TO PAR AND
OPTIMER PHARMACEUTICALS OR ITS RESPECTIVE DESIGNEES BIOCON SHALL FIRST AND
PREFERENTIALLY SUPPLY PAR WITH ALL IF ITS