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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  • PUBLICATION AND PUBLICITY The CONSULTANT agrees that it shall not for any reason whatsoever communicate to any third party in any manner whatsoever concerning any of its CONTRACT work product, its conduct under the CONTRACT, the results or data gathered or processed under this CONTRACT, which includes, but is not limited to, reports, computer information and access, drawings, studies, notes, maps and other data prepared by and for the CONSULTANT under the terms of this CONTRACT, without prior written approval from the COMMISSION, unless such release or disclosure is required by judicial proceeding. The CONSULTANT agrees that it shall immediately refer any third party who requests such information to the COMMISSION and shall also report to the COMMISSION any such third party inquiry. This Article shall not apply to information in whatever form that comes into the public domain, nor shall it restrict the CONSULTANT from giving notices required by law or complying with an order to provide information or data when such order is issued by a court, administrative agency or other authority with proper jurisdiction, or if it is reasonably necessary for the CONSULTANT to defend itself from any suit or claim. All approved releases of information, findings, and recommendations shall include a disclaimer provision and all published reports shall include that disclaimer on the cover and title page in the following form: The opinions, findings, and conclusions in this publication are those of the author(s) and not necessarily those of the Mississippi Department of Transportation, Mississippi Transportation Commission, the State of Mississippi or the Federal Highway Administration.

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  • Scientific Publications During the Research Program Term, neither Party shall first publish or first present in a public forum the scientific or technical results of any activity performed pursuant to this Agreement without the opportunity for prior review and comment by the other Party. Each Party agrees to provide the other Party with the opportunity to review any proposed abstract, manuscript or scientific presentation (including any verbal presentation) that relates to its activities performed pursuant to this Agreement during the Research Program Term, at least [**] days prior to its intended submission for publication and agrees, upon request, not to submit any such abstract or manuscript for publication until the other Party is given a reasonable period of time up to [**] to secure patent protection for any material in such publication that it believes to be patentable. Both Parties understand that a reasonable commercial strategy may require delay of publication of information or filing of patent applications first with respect to activities performed or results obtained pursuant to this Agreement during the Research Program Term, or not to publish at all if necessary to preserve trade secrets. The Parties agree to review and decide whether to delay publication of such information to permit filing of patent applications. Neither Party shall have the right to publish or present any Confidential Information of the other Party, except as provided in Section 9.2. After the Research Program Term, each Party and its Affiliates may publish or present results, data or scientific findings of any of their activities without the prior review of the other Party, provided that such publication or presentation does not disclose any of the other Party’s Confidential Information. Nothing contained in this Section 9.3 shall prohibit the inclusion of information necessary for a patent application; provided that the non-filing Party is given a reasonable opportunity to review the information to be included prior to submission of such patent application in accordance with Section 8.2. Nothing contained in this Section 9.3 shall prohibit either Party from disclosing the results, data or scientific findings of any activity performed by the other Party or its Affiliates pursuant to this Agreement without prior review and prior written consent of the other Party, where required, as reasonably determined by the disclosing Party’s legal counsel, by applicable law; provided that if a Party is required by law to make any such disclosure, to the extent it may legally do so, it will give reasonable advance notice to the other Party of such disclosure and will use its reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise).

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  • Press Releases and Public Announcements No Party shall issue any press release or make any public announcement relating to the subject matter of this Agreement without the prior written approval of the other Party; provided, however, that any Party may make any public disclosure it believes in good faith is required by applicable law or any listing or trading agreement concerning its publicly-traded securities (in which case the disclosing Party will use its reasonable best efforts to advise the other Party prior to making the disclosure).

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