Basilea definition
Examples of Basilea in a sentence
Once Basilea receives the National Marketing Authorisations in such countries, Basilea shall transfer them to Cardiome or, upon Cardiome’s request, to Cardiome’s approved Third Party Sublicensees (pursuant to Section 2.1).
Neither ArQule in the Excluded Territory, nor Basilea in the Territory shall, without the other Party’s prior consent (such consent not to be unreasonably withheld or delayed), carry out any activity in their own territory that has or is reasonably likely to have any material adverse effect on the Product outside their own territory, meaning a materially negative impact on the development, regulatory status or manufacturing of the Product (a “Material Adverse Effect”).
In case of a breach by Cardiome of this Section 2.6, Basilea may terminate the Agreement in accordance with Section 14.4(b).
Basilea shall provide Qualified Person Release (meaning the certification by a Qualified Person that Product is manufactured in accordance with the requirements of the relevant authorizations pursuant to Annex 16 to the EU Guide to Good Manufacturing Practice) and certificates of compliance and certificates of analysis with each batch of Product at Delivery.
Any remainder after such reimbursement is made shall be retained by Basilea; provided that, to the extent that any award or settlement (whether by judgment or otherwise) with respect to an ArQule Patent is attributable to loss of sales or profits with respect to a Product, such award shall be deemed Net Sales in the Calendar Quarter in which payment is actually received by Basilea.
If Cardiome fails to purchase the Minimum Purchase Quantities for two consecutive calendar years in a certain country, Basilea may terminate the Distribution Agreement for that country in accordance with Section 14.4(f).
The Parties shall subsequently discuss in good faith and agree a second Quality Agreement no later than the transfer date of the first Marketing Authorization to cover the period of time during which Basilea supplies Cardiome and Cardiome holds the Marketing Authorisation in any country or countries in the Territory (the “Second Quality Agreement”).
Siderar shall not and shall not cause or permit Basilea to, and Basilea shall not, allow any of its equity interests in Hylsamex to become subject to any Lien during the term of this Letter Agreement.
Cardiome shall keep Records including normal business accounts which must be complete, accurate and in conformity with generally accepted accounting procedures (US GAAP or IAS) and that include a record of the sales or other disposition of the Product, any amounts paid to Basilea, and any amounts referenced in this Agreement.
If an excursion from the storage and transport conditions specified by Basilea occurs during Cardiome’s transport or storage of the Product, then Cardiome may request from Basilea, and Basilea shall provide, such data and information as is necessary for Cardiome to evaluate such excursion.