Registration Dossiers definition
Examples of Registration Dossiers in a sentence
To obtain access to the Registration Dossier(s) developed by the IP Consortium, the Non- Lead Member party must pay the Joint Registration Compensation (in effect, the cost of Letter of Access) consisting of the total of the following two amounts as defined below: the Advantage Compensation Payment, and the Dossier Costs Contribution (Pro Rata Share), This payment does NOT enable the Non-Lead Member to become a member of the IP Consortium, for which there is a separate Entry Fee.
That is, shared participation in all expenses incurred in producing, managing and submitting the Registration Dossiers, including IP Consortium administration costs, and including costs of existing and new Information obtained or developed by the IP Consortium for the Purpose.
As between the Parties, BMS shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and Licensed Products being Developed by BMS during the Combined Period and with respect to the Retained Compounds and Retained Products being Developed by BMS after the Combined Period, and BMS shall own all such regulatory filings, including all Registration Dossiers.
Upon receipt of such information, the Lead Registrant(s) shall submit the Joint Registration Dossier(s) also on behalf of such Affiliate.
With respect to each Licensed Product, DS shall allow Esperion a reasonable opportunity to review and comment on all filings, including Registration Dossiers, and other submissions to Regulatory Authorities or other Governmental Authorities in the DS Territory related to such Licensed Product and for that purpose DS shall provide English versions of filings and submissions (excluding those materials provided by Esperion) to Esperion in advance of submission of any such filing.
CIBA Vision shall thereafter update such information to MGI with any additional documentation it or any CIBA Vision Sublicensee may add to such Health Registration Dossiers, within thirty (30) days after the date on which it was submitted to the respective Competent Authority, subject to Section 2.5.
Esperion shall provide to DS, [***] basis through the JCC, an update on the progress of the Pre-Approval Clinical Studies and the preparation for the Registration Dossiers in South Korea and Taiwan.
This results in the rights, as specified in this Agreement for all Members, to refer to the Registration Dossiers for REACH Registration of the Consortium Substances for which the New Member is Directly or Indirectly Concerned..
The Lead Company shall if required and approved by the Governing Committee, appeal any adverse decisions of the Agency or the Member States relating to the joint submission or Registration Dossiers.
Alpharma hereby authorises the Licensor or its agent or representative to use any Registration Dossier supplied pursuant to Clause 10.2.3 or 10.3.3 to effect a duplicate registration in the relevant country, and, in the case of Registration Dossiers supplied pursuant to Clause 10.3.3, to effect Product Licence registrations anywhere in the world, in either case in the name of the Licensor and/or such other party as the Licensor may in its sole discretion determine.