Phase IV Strategy; Disclosure; Publications Sample Clauses

Phase IV Strategy; Disclosure; Publications. Neither Party will undertake, or permit its Affiliates or (sub)licensees to undertake, within the Territory or the EU, any pre-clinical or clinical marketing studies of the Product, including, without limitation, Phase IV marketing studies, but excluding any studies required for registration or imposed by regulatory authority in the Territory or the EU, without consultation with, and approval of, the Parties (which shall consult with appropriate development personnel of the Parties for this purpose). ALMIRALL will coordinate Phase IV studies performed outside both the Territory and the EU with the intent to keep those studies consistent with the mutually-agreed approach adopted for Territory and EU studies. FOREST and ALMIRALL will cooperate to oversee a worldwide publication strategy and activities related to scientific and medical conferences on a worldwide basis, including through delegation to appropriate working groups of the Parties. Without limiting the generality of Section 12.1(b), each Party shall be afforded the opportunity to review and approve any scientific paper or presentation proposed for publication, presentation or distribution by the other Party, its Affiliates or licensees, for the Territory or European Union and shall have no more than [***] (or such shorter period as may be required to comply with publication or presentation deadlines communicated to it by the Party proposing publication) to complete such review and furnish comments to such Party. The Party proposing publication or presentation shall not unreasonably reject comments furnished by the other Party. ALMIRALL will coordinate publications originating from outside both the Territory and the EU with the intent to keep consistency with mutually-agreed approach adopted for the Territory and the EU. Each Party may disclose the initiation and results of clinical studies performed by any Party to the extent required by law or best industry practices, provided all proposed disclosures and publications will be submitted for expeditious review by each Party and due regard will be given to the comments of the other Party.
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Related to Phase IV Strategy; Disclosure; Publications

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  • Disclosure Updates Promptly and in no event later than 5 Business Days after obtaining knowledge thereof, notify Agent if any written information, exhibit, or report furnished to the Lender Group contained, at the time it was furnished, any untrue statement of a material fact or omitted to state any material fact necessary to make the statements contained therein not misleading in light of the circumstances in which made. The foregoing to the contrary notwithstanding, any notification pursuant to the foregoing provision will not cure or remedy the effect of the prior untrue statement of a material fact or omission of any material fact nor shall any such notification have the effect of amending or modifying this Agreement or any of the Schedules hereto.

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