COMMISSION
9
that is necessary or useful for making regulatory filings for, or
Commercializing, Licensed Products in the Territory.
1.72.
"PATENT" SHALL MEAN (I) UNEXPIRED LETTERS PATENT (INCLUDING INVENTOR'S
CERTIFICATES)
WHICH HAVE NOT BEEN HELD INVALID OR UNENFORCEABLE BY A COURT OF
COMPETENT JURISDICTION FROM WHICH NO APPEAL CAN BE TAKEN OR HAS BEEN TAKEN
WITHIN THE REQUIRED TIME PERIOD, INCLUDING WITHOUT LIMITATION ANY SUBSTITUTION,
EXTENSION, REGISTRATION, CONFIRMATION, REISSUE, RE-EXAMINATION, RENEWAL OR ANY
LIKE FILING THEREOF AND (II) PENDING APPLICATIONS FOR LETTERS PATENT, INCLUDING
WITHOUT LIMITATION ANY PROVISIONAL, CONVERTED PROVISIONAL, CONTINUED PROSECUTION
APPLICATION, CONTINUATION, DIVISIONAL OR CONTINUATION-IN-PART THEREOF.
1.73.
"PRICE APPROVAL" SHALL MEAN, WITH RESPECT TO ANY COUNTRY IN WHICH THE
PRICE AT WHICH CHIRON SELLS LICENSED PRODUCT MUST BE APPROVED BY A GOVERNMENTAL
AUTHORITY FOR REIMBURSEMENT OR PAYMENT PURPOSES, THE RECEIPT OF APPROVAL BY THE
APPLICABLE GOVERNMENTAL AUTHORITY WITH RESPECT TO SUCH PRICE.
1.74.
"PRIMARY ENDPOINT" SHALL MEAN, WITH RESPECT TO A CLINICAL TRIAL, THE
POINT AT WHICH THE PRIMARY EFFICACY OBJECTIVE HAS BEEN ACHIEVED WITH RESPECT TO
A CLINICAL OR MICROBIOLOGICAL OUTCOME AS SPECIFIED IN THE PROTOCOL FOR SUCH
TRIAL, UNLESS OTHERWISE AGREED BY THE PARTIES IN WRITING.
1.75.
"REASONABLE BUYER" SHALL MEAN, WITH RESPECT TO THE SALE, ASSIGNMENT,
SUBLICENSE OR OTHER TRANSFER OF THE CHIRON INTEREST IN ACCORDANCE WITH THE
PROVISIONS OF SECTION 15.6(B) HEREOF, A THIRD PARTY THAT, BOTH AT THE TIME A
DEFINITIVE AGREEMENT IS ENTERED INTO BY CHIRON AND SUCH THIRD PARTY IN
CONNECTION ANY SUCH TRANSFER AND AT THE TIME OF THE CLOSING OF SUCH TRANSFER:
(i)
[*];
(ii)
[*];
(iii)
[*]
(iv)
[*]:
(a)
[*]
[*]
(b)
[*]*;
(v)
[*];
(vi)
[*];
(vii)
[*];
(viii)
[*];
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
10
(ix)
[*]
(x)
[*.]
1.76.
"RECIPROCATING LICENSEE" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 4.4(B).
1.77.
"REGULATORY APPROVAL" SHALL MEAN ANY APPROVALS (INCLUDING SUPPLEMENTS,
VARIATIONS, AMENDMENTS, PRE- AND POST-APPROVALS AND PRICE APPROVALS), LICENSES,
REGISTRATIONS OR AUTHORIZATIONS OF ANY NATIONAL, SUPRA-NATIONAL (E.G., THE FDA,
THE EUROPEAN COMMISSION OR THE COUNCIL OF THE EUROPEAN UNION, OR OTHER SIMILAR
BODY IN ANY COUNTRY), REGIONAL, STATE OR LOCAL REGULATORY AGENCY, DEPARTMENT,
BUREAU, COMMISSION, COUNCIL OR OTHER GOVERNMENTAL ENTITY, NECESSARY FOR THE
MANUFACTURE, DISTRIBUTION, USE, SALE, IMPORT OR EXPORT OF LICENSED PRODUCTS IN A
REGULATORY JURISDICTION.
1.78.
"REGULATORY AUTHORITY" SHALL MEAN A FOREIGN COUNTERPART OF THE FDA.
1.79.
"REGULATORY PLAN" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN SECTION
5.1(B) HEREOF.
1.80.
"REPLACEMENT INDICATION" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 4.1(D) HEREOF.
1.81.
"REPLACEMENT INDICATION STUDY" SHALL HAVE THE MEANING ASSIGNED TO SUCH
TERM IN SECTION 4.1(D) HEREOF.
1.82.
"REPLACEMENT STUDY" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 4.1(C).
1.83.
"REQUIRED STUDY" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN SECTION
4.1.
1.84.
"RESTRICTED PERIOD" SHALL MEAN, WITH RESPECT TO EITHER PARTY, THE PERIOD
OF TIME COMMENCING ON THE EFFECTIVE DATE AND ENDING ON THE EARLIER OF (I) THE
EXPIRATION OR TERMINATION