Common use of Publication by Principal Investigator Clause in Contracts

Publication by Principal Investigator. The Sponsor agrees that the Principal Investigator or any of the Research Staff who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trial, shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Trial, subject to this clause 11 and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 11. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.8. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) period for review of a proposed publication referred to in clause 11.6above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical Trial. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.

Publication by Principal Investigator. The Sponsor agrees that the Principal Investigator or any of the Research Staff who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trial, shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Trial, subject to this clause 11 and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 11. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.8. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) period for review of a proposed publication referred to in clause 11.6above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical Trial. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.

Publication by Principal Investigator. The Sponsor agrees that the Principal Investigator or any of the Research Staff anybody who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trialresearch, shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Trial, subject to this clause 11 11. and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 11. .. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.8. .. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) period for review of a proposed publication referred to in clause 11.6above11.6.above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 11.7. shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6.) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical Trial. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.

Publication by Principal Investigator. The Sponsor agrees and Institution agree that the Principal Investigator or any of the Research Staff who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trial, shall be permitted to present the Research Data at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical TrialResearch, subject to this clause 11 8 and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial Research in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 117. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.87.7. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) days period for review of a proposed publication referred to in clause 11.6above8.4 above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; (i) make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and (ii) may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical TrialResearch. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.

Publication by Principal Investigator. The Sponsor agrees that the Principal Investigator or any of the Research Staff who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trial, shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Trial, subject to this clause 11 and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 11. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.8. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) period for review of a proposed publication referred to in clause 11.6above11.6 above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical Trial. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.

Publication by Principal Investigator. The Sponsor agrees that the Principal Investigator or any of the Research Staff who fulfills the ICMJE authorship criteria and is highly involved in the Clinical Trial, shall be permitted to present at symposia, national or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise of its own choosing, methods and results of the Clinical Trial, subject to this clause 11 and any publication policy described in the Protocol, provided any such policy does not obstruct publication unreasonably. Principal Investigator shall appropriately disclose Sponsor’s role in the Clinical Trial in any such publication or presentation. If the Clinical Trial is a multi-centre Clinical Trial, any publication based on the results obtained at the Trial Site (or a group of sites) shall not be made before the first multi-centre publication or presentation unless otherwise agreed in writing. If a publication concerns the analyses of sub-sets of data from a multi-centre Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi-centre publication is not published within twelve (12) months after completion of the Clinical Trial and lock of the Clinical Trial database at all research sites that are part of the multi-centre Clinical Trial or any earlier termination or abandonment of the Clinical Trial, or if Sponsor informs the Principal Investigator that such multi-centre publication will not take place, or if publication has been agreed otherwise, the Principal Investigator shall have the right to publish or present the methods and results of the Clinical Trial in accordance with the provisions of this clause 11. The foregoing provided however, that any such publication will take in account the rights and interests of all investigators involved in the multi-centre Clinical Trial and authorship will be determined in accordance with clause 11.8. Material for public dissemination will be submitted to the Sponsor for review at least thirty (30) days prior to submission for publication, public dissemination, or review by a publication committee. If Sponsor does not respond within this period Institution and/or the Principal Investigator is/are free to proceed with the intended publication or presentation without further delay. During the thirty (30) period for review of a proposed publication referred to in clause 11.6above11.6 above, the Sponsor shall be entitled to comment on the scientific content of the proposed publication. The Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication or presentation will be incorporated into the publication or presentation. Reasonable comments for the purposes of this clause 11.7 shall mean such comments and suggestions that, with a view to the scientific interest or the treatment of patients, will clarify or improve the proposed publication or presentation of the results of the Clinical Trial or the conclusions drawn from such results, and such other comments that aim to avoid that such publication or presentation will misrepresent the results; make a reasoned request to the Principal Investigator that publication be delayed for an additional period of sixty (60) days (following the 30 day period referred to in clause 11.6) in order to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How, and the Principal Investigator shall not unreasonably withhold its consent to such a request; and may cause the Principal Investigator to remove from the projected publication any Sponsor Confidential Information received by Principal Investigator that are not constituted results of the Clinical Trial. The Institution shall not unreasonably withhold or delay its consent to the reasoned request from the Sponsor.