Common use of PUBLICATION AND AUTHORSHIP Clause in Contracts

PUBLICATION AND AUTHORSHIP. 11.1. The Sponsor acknowledges the importance of public disclosure/publication of information collected or generated by the Principal Investigator, under the condition that public disclosure/publication takes place under the provisions of this clause 11. 11.2. Upon completion of the Clinical Trial (whether prematurely or otherwise) the Principal Investigator and Sponsor shall co-operate in producing a report of the Clinical Trial detailing the methodology, results and containing an analysis of the results and drawing appropriate conclusions. 11.3. The Sponsor agrees that the Principal Investigator 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. 11.4. Upon completion of the Clinical Trial, or when the Clinical Trial data are adequate (in Sponsor's reasonable judgement), and subject to clause 11.7 hereof, the Principal Investigator may prepare the data derived from the Clinical Trial for publication or presentation. Material for public dissemination will be submitted to the Sponsor for review at least forty-five (45) days (or the time limit specified in the Protocol if longer provided it shall not exceed the time limit given under clause 11.6 sub a) prior to submission for publication, public dissemination, or review by a publication committee. 11.5. 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. 11.6. During the period for review of a proposed publication referred to in clause 11.4 above, the Sponsor shall be entitled to a. make a reasoned request to the Principal Investigator that publication be delayed for a period of up to ninety (90) days from the date of first submission to the Sponsor 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 b. 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 Trail. 11.7. If it 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, or as provided for in clause11.7 hereof. If a publication concerns the analyses of sub-sets of data from a multi-centred 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, 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. 11.8. Publications will be in accordance with international recognized scientific and ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors. Copyrights concerning Publications of the Clinical Trial remains with the authors of the Publication, regardless of any other provisions regarding intellectual property rights. 11.9. The Principal Investigator will not issue and will cause the Research Staff not to issue any information or statement to the press or public, including but not limited to advertisements for the enrolment of Clinical Trial Subjects, without, where appropriate, its review and the delivery of a favourable opinion from the Ethics Committee and the prior written permission of the Sponsor.

PUBLICATION AND AUTHORSHIP. 11.1. The Sponsor acknowledges the importance of public disclosure/publication of information collected or generated by the Principal Investigator, under the condition that public disclosure/publication takes place under the provisions of this clause 11. 11.2. Upon completion of the Clinical Trial (whether prematurely or otherwise) the Principal Investigator and Sponsor shall co-operate in producing a report of the Clinical Trial detailing the methodology, results and containing an analysis of the results and drawing appropriate conclusions. 11.3. The Sponsor agrees that the Principal Investigator 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. 11.4. Upon completion of the Clinical Trial, or when the Clinical Trial data are adequate (in Sponsor's reasonable judgement), and subject to clause 11.7 hereof, the Principal Investigator may prepare the data derived from the Clinical Trial for publication or presentation. Material for public dissemination will be submitted to the Sponsor for review at least forty-five (45) days (or the time limit specified in the Protocol if longer provided it shall not exceed the time limit given under clause 11.6 sub a) prior to submission for publication, public dissemination, or review by a publication committee. 11.5. 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. 11.6. During the period for review of a proposed publication referred to in clause 11.4 above, the Sponsor shall be entitled to a. to make a reasoned request to the Principal Investigator that publication be delayed for a period of up to ninety (90) days from the date of first submission to the Sponsor 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 b. 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 Trail. 11.7. If it 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, or as provided for in clause11.7 hereof. If a publication concerns the analyses of sub-sets of data from a multi-centred Clinical Trial the publication shall make reference to the relevant multi-centre publication(s). Notwithstanding the foregoing, if a multi- 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, 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. 11.8. Publications will be in accordance with international recognized scientific and ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors. Copyrights concerning Publications of the Clinical Trial remains with the authors of the Publication, regardless of any other provisions regarding intellectual property rights. 11.9. The Principal Investigator will not issue and will cause the Research Staff not to issue any information or statement to the press or public, including but not limited to advertisements for the enrolment of Clinical Trial Subjects, without, where appropriate, its review and the delivery of a favourable opinion from the Ethics Committee and the prior written permission of the Sponsor.