Termination by Novartis. (i) Prior to submission of a registration package requesting Approval for commercial sale of the first Product(s) in the first Major Country, this Agreement and the licenses granted hereunder may be terminated by Novartis, with or without cause, at any time upon ***** prior written notice thereof to Tanox. During such period, pending the effectiveness of such termination notice, Novartis agrees to withhold public disclosure of such termination until it has provided the reasons for such termination to Tanox. Any payments according to Section 9.1 of this Agreement shall, however, not become payable by Novartis to Tanox during such ***** period. (ii) Subsequent to submission of a registration package requesting approval for commercial sales of the Product(s) in the first Major Country, if Novartis reasonably determines, in good faith, that there are unanticipated limitations on the market opportunity represented by the Product(s) because of restrictive labeling requirements, side effects, absence of medical needs, conditions which in Novartis’ reasonable judgment make it commercially unreasonable to launch the Product(s), or similar problems, then this Agreement and the licenses granted hereunder may be terminated by Novartis upon ***** prior written notice thereof to Tanox. ***** Any payments according to Section 9.1 of this Agreement shall, however, not become payable by Novartis to Tanox during such ***** notice period. (iii) Subsequent to commercial launch of Product(s) in the first Major Country, Novartis may terminate this Agreement and the licenses granted hereunder upon ***** prior written notice thereof to Tanox. During such notice period: (A) Novartis shall use Commercially Reasonable Efforts to continue Commercialization of the Product(s) in such countries as the Product(s) were being Commercialized at the time of its notice of termination and will continue to use Commercially Reasonable Efforts with respect to any Development activities with respect to the Product(s) which were ongoing at the time of its notice of termination; and (B) Tanox may, by written notice to Novartis, terminate the Agreement with respect to any particular country with effect from the date set forth in such notice (which date shall not be less than ***** after the receipt by Novartis of such notice).
Appears in 2 contracts
Samples: Development and Licensing Agreement, Development and Licensing Agreement (Tanox Inc)
Termination by Novartis. (iSubject to Section 18.3(c) Prior to submission of a registration package requesting Approval for commercial sale of the first Product(s) in the first Major Countrybelow, Novartis may terminate this Agreement with respect to itself (including, without limitation, its rights and obligations after the licenses granted hereunder may be terminated by Novartiseffective date of such termination, with or without causesubject to the provisions of Section 18.6), at any time upon after the date which is *****, by giving ***** prior written notice thereof to Tanox. During such period, pending the effectiveness of Genentech and Tanox and paying all amounts it is financially responsible for hereunder up to such termination notice, Novartis agrees to withhold public disclosure of such termination until it has provided the reasons for such termination to Tanox. Any payments according to Section 9.1 of this Agreement shalldate; provided, however, such notice shall not become payable by be deemed delivered hereunder unless and until Novartis gives written notice of termination of the JCA to Tanox during such Genentech, with a copy to Tanox, and written notice of termination of the Ancillary D&L Agreement to Tanox, with a copy to Genentech; and provided, further, that within ***** period.
(ii) Subsequent to submission of a registration package requesting approval for commercial sales receipt of the Product(s) in the first Major Countrysuch notice, if Novartis reasonably determines, in good faith, that there are unanticipated limitations on the market opportunity represented by the Product(s) because of restrictive labeling requirements, side effects, absence of medical needs, conditions which in Novartis’ reasonable judgment make it commercially unreasonable to launch the Product(s), or similar problems, then this Agreement Genentech and the licenses granted hereunder may be terminated by Novartis upon ***** prior written notice thereof to Tanox. ***** Any payments according to Section 9.1 of this Agreement shall, however, not become payable by Novartis to Tanox during such ***** notice period.
(iii) Subsequent to commercial launch of Product(s) in the first Major Country, Novartis may terminate this Agreement and the licenses granted hereunder upon ***** prior written notice thereof to Tanox. During such notice period: (A) Novartis shall use Commercially Reasonable Efforts to continue Commercialization of the Product(s) in such countries as the Product(s) were being Commercialized at the time of its notice of termination and will continue to use Commercially Reasonable Efforts with respect to any Development activities with respect to the Product(s) which were ongoing at the time of its notice of termination; and (B) Tanox may, by written giving joint notice to Novartis, terminate Novartis accelerate the Agreement with respect effective date of any such termination to any particular country with effect from the a date set forth in such notice (which date shall not be less than ***** after from the receipt date of Novartis’ notice of termination under this Section18.3(b). Subject to Sections 18.3(c) and 18.6 below, if Novartis terminates this Agreement with respect to itself (or terminates as to East Asia and ROW as described in subclause (iii) below):
(i) except as provided in subsection (ii) below and *****, Novartis’ rights under this Agreement with respect to East Asia and the ROW (including ownership of all Approvals held by Novartis and Novartis’ rights to vote and participate on Committees but excluding ownership of intellectual property), Novartis’ rights to Develop and Commercialize Anti-IgE Products in East Asia and ROW under this Agreement and the Ancillary D&L Agreement, and such other rights under this Agreement with respect to East Asia and ROW which Novartis has licensed from Genentech or Tanox shall be transferred or granted, as the case may be, to Tanox and all license rights granted by Novartis to Tanox with respect to Novartis’ Anti-IgE Patents, Company Information, Know-How and Biological Materials, covering Anti-IgE Products Approved or in active Development as of the effective date of termination shall remain in full force and effect, even with respect to future Anti-IgE Products *****. With effect from the effective date of such noticetermination, but subject to Section 18.3(d), Tanox shall assume all of Novartis’ obligations under this Agreement and the Ancillary D&L Agreement with respect to East Asia and the ROW and shall be entitled to continue the Development and Commercialization of Anti-IgE Antibodies and Anti-IgE Products in East Asia and the Rest of World without further compensation to Novartis except as required with respect to the Manufacture of Anti-IgE Products. For the avoidance of doubt, Tanox shall have and retain exclusive rights for the Development and Commercialization of Anti-IgE Antibodies and Anti-IgE Products in East Asia and the Rest of World and Novartis will have no further rights to develop or commercialize Anti-IgE Antibodies or Anti-IgE Products in East Asia or the ROW. *****
(ii) Novartis’ rights under this Agreement with respect to the US and Europe (including ownership of all Approvals held by Novartis and Novartis’ rights to vote and participate on Committees but excluding ownership of intellectual property), Novartis’ rights to Develop and Commercialize Anti-IgE Products in the United States and Europe, and such other rights under this Agreement with respect to the US and Europe which Novartis has licensed from Genentech or Tanox, shall be transferred or granted, as the case may be, to Genentech *****, and all license rights granted by Novartis under this Agreement to Genentech with respect to Novartis’ Anti-IgE Patents, Know-How and Biological Materials covering Anti-IgE Products Approved or in active Development as of the effective date of termination shall remain in full force and effect, even with respect to future Anti-IgE Products *****. With effect from the effective date of such termination, subject to Section 18.3(c), Genentech shall assume all of Novartis’ obligations under this Agreement and the JCA with respect to the US and Europe and shall be entitled to continue the Development and Commercialization of Anti-IgE Antibodies and Anti-IgE Products in the United States and Europe, subject to Tanox’s rights under this Agreement, without further compensation to Novartis except as required with respect to the Manufacture of Anti-IgE Products. For the avoidance of doubt, ***** Genentech shall have and retain exclusive rights for the Development and Commercialization of Anti-IgE Antibodies and Anti-IgE Products in the US and Europe and Novartis will have no further rights to develop or commercialize Anti-IgE Antibodies or Anti-IgE Products in the US or Europe.
(iii) In the event Novartis terminates its rights to develop, manufacture and commercialize Anti-IgE Antibodies and Anti-IgE Products in East Asia and the ROW only through termination of the Ancillary D&L Agreement under Section 16.5(a) thereof, then Subsection 18.3(b)(i) shall apply with respect to East Asia and ROW; provided, however, that all references in paragraph (x) of Part 3 of Schedule D to cooperation between Genentech and Tanox therein shall be deemed references to coordination between Genentech, Novartis and Tanox. In the event that Novartis terminates this Agreement as set forth in this Section 18.3(b), it shall provide all cooperation and assistance reasonably requested by Genentech and Tanox to enable them to assume with as little disruption as reasonably possible, the continued Manufacture, Development and Commercialization of the Anti-IgE Products then being Commercialized or Developed hereunder. Such cooperation and assistance shall be provided in a prompt and timely manner (having regard to the nature of the cooperation or assistance requested) and shall include, without limitation, the matters listed in Part 3 of Schedule D.
Appears in 2 contracts
Samples: Tripartite Cooperation Agreement, Tripartite Cooperation Agreement (Tanox Inc)