set forth in Section 5.3(a)
and 5.3(c).
1.74
"Opt-In Product" means any miRNA Therapeutic that is Developed,
Manufactured or Commercialized pursuant to a Development Project for which one
and only one Licensor has exercised an Opt-In Election and which the relevant
Opt-In Party subsequently licensed.
1.75
"Optional In-License" will have the meaning set forth in Section
2.4(c).
1.76
"Out-License Agreement" will have the meaning set forth in Section
2.4(a).
1.77
"Out-License Summary" will have the meaning set forth in Section
2.4(a).
7
1.78
"Paragraph IV Certification" will have the meaning set forth in
Section 9.3(a)(i)(A).
1.79
"Party" means Alnylam, Isis and/or Regulus; "Parties" means
Alnylam, Isis and Regulus, or any combination thereof.
1.80
"Patent Rights" means (a) patent applications (including
provisional applications and for certificates of invention); (b) any patents
issuing from such patent applications (including certificates of invention); (c)
all patents and patent applications based on, corresponding to, or claiming the
priority date(s) of any of the foregoing; and (d) any substitutions, extensions
(including supplemental protection certificates), registrations, confirmations,
reissues, divisionals, continuations, continuations-in-part, re-examinations,
renewals and foreign counterparts thereof.
1.81
"Payee Party" will have the meaning set forth in Section 8.1.
1.82
"Paying Party" will have the meaning set forth in Section 8.1.
1.83
"Permitted Disclosures". The following are Permitted Disclosures:
(A)
TO THE EXTENT THAT A RECIPIENT HAS BEEN GRANTED THE RIGHT TO SUBLICENSE
UNDER THE TERMS OF THIS AGREEMENT, SUCH PARTY WILL HAVE THE RIGHT TO PROVIDE A
DISCLOSING PARTY'S CONFIDENTIAL INFORMATION TO THE EMPLOYEES, CONSULTANTS AND
ADVISORS OF SUCH RECIPIENT'S AFFILIATE AND THIRD PARTY SUBLICENSEES AND
POTENTIAL SUBLICENSEES WHO HAVE A NEED TO KNOW THE CONFIDENTIAL INFORMATION FOR
PURPOSES OF EXERCISING SUCH SUBLICENSE AND ARE BOUND BY AN OBLIGATION TO
MAINTAIN IN CONFIDENCE THE CONFIDENTIAL INFORMATION OF THE DISCLOSING PARTY;
PROVIDED, THAT SUCH PERSONS ARE BOUND TO MAINTAIN THE CONFIDENTIALITY OF SUCH
INFORMATION TO THE SAME EXTENT AS IF THEY WERE PARTIES HERETO.
(B)
EACH RECIPIENT WILL HAVE THE RIGHT TO PROVIDE A DISCLOSING PARTY'S
CONFIDENTIAL INFORMATION:
(I)
TO GOVERNMENTAL OR OTHER REGULATORY
AGENCIES IN ORDER TO SEEK OR OBTAIN PATENTS, TO SEEK OR OBTAIN APPROVAL TO
CONDUCT CLINICAL TRIALS, OR TO GAIN REGULATORY APPROVAL, AS CONTEMPLATED BY THIS
AGREEMENT; PROVIDED THAT SUCH DISCLOSURE MAY BE MADE ONLY TO THE EXTENT
REASONABLY NECESSARY TO SEEK OR OBTAIN SUCH PATENTS OR APPROVALS; AND
(II)
AS NECESSARY, IF EMBODIED IN PRODUCTS, TO
DEVELOP AND COMMERCIALIZE SUCH PRODUCTS AS CONTEMPLATED BY THIS AGREEMENT.
1.84
"Permitted License" means a license granted by a Licensor to a
Third Party to enable such Third Party to broadly manufacture or formulate
oligonucleotides, where such Third Party is primarily engaged in [***];
provided, however, that any such license will not grant rights to research,
manufacture or formulate miRNA Compounds or miRNA Therapeutics for which the
other Licensor has obtained or later obtains a license pursuant to Section 5 or
pursuant to the Buy-Out process in the LLC Agreement.
8
1.85
"Person" means any corporation, limited or general partnership,
limited liability company, joint