Registration Approval definition
Examples of Registration Approval in a sentence
If and when a Health Registration Approval is obtained in any country of the Territory, Flexion shall inform AstraZeneca of such Health Registration Approval within thirty (30) days.
In the event that PRAECIS has any such technical or scientific concerns which cannot be satisfied, then PRAECIS may notify Synthelabo to that effect and Synthelabo shall not undertake the Clinical Trial or other technical activity contemplated, provided that no such determination shall (i) be made unreasonably by PRAECIS or (ii) prevent Synthelabo from applying for, obtaining or maintaining a Registration Approval or Reimbursement Approval in the Territory.
Throughout the term of this Agreement, promptly after Registration Approval of a Licensed Product for a particular Application has been obtained in or with respect to a Territory Country, Synthelabo shall use diligent efforts to Advertise, Promote and sell such Licensed Product for such Application throughout such Territory Country, provided such commercialization is reasonably economically viable.
Without limitation of the immediately preceding sentence, upon termination of this Agreement in its entirety by Synthelabo pursuant to Section 17.7, Synthelabo shall provide PRAECIS with such documentation, authorization, or permission as may be available to Synthelabo to enable PRAECIS to obtain access to, and to officially make reference to, the Synthelabo Registration Approval and Reimbursement Approval files, data, correspondence and records throughout the entire period of their existence.
PRAECIS further warrants that (i) neither it nor any Third Party manufacturer engaged by it shall make any change to its Licensed Product manufacturing process or place of manufacture which would adversely affect Registration Approvals in the Territory, unless consent to such change is first obtained from Synthelabo and (ii) PRAECIS will make any change to the manufacturing process or place of manufacture required by regulatory authorities to maintain Registration Approval in a Territory Country.