EMA Sample Clauses
The EMA (Excess Market Adjustment) clause defines how adjustments are made to contract terms or pricing in response to significant changes in market conditions. Typically, this clause sets out specific thresholds or triggers—such as price fluctuations in raw materials or market indices—that, when met, allow for a recalculation of costs or obligations under the agreement. By providing a mechanism to address unforeseen market volatility, the EMA clause helps both parties manage risk and maintain fairness in long-term contracts.
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EMA. The term “
EMA. The Erasmus Mundus Students and Alumni Association (EMA) is a platform for all EMJMD-Students and can be found via ▇▇▇▇://▇▇▇.▇▇-▇.▇▇/. The student is encouraged to join EMA.
EMA. AMAG shall provide Takeda with all information required and requested by Takeda to transfer the European Commission marketing authorization to AMAG, including information regarding AMAG’s EU legal entity, Qualified Person for Pharmacovigilance, pharmacovigilance system, named person for scientific services, site of manufacture of Product for import and batch release in the EU and Qualified Person for batch release of Product. Takeda shall notify the EMA product team leader prior to transfer, shall prepare and file with the EMA the Letters of Transfer and shall file the Marketing Authorization Transfer Application with EMA.
EMA. “EMA” shall mean the European Medicines Agency, or any successor entity.
EMA. Procedural advice for Orphan Medicinal Product Designation: Guidance for sponsors. Eur Med Agency. 2021;EMA/420706(September):1-13.
EMA. Schedule 4.1(X) lists: (a) all of the Commitments (the "EMA Agreements") to which the Company is a party relating to EMA, and (b) all Liabilities of the Company towards EMA or its stockholders (other than the Company) which are not contained in the EMA Agreements. The Company is in compliance with all of its obligations under the EMA Agreements and the other Liabilities the existence of which are listed on Schedule 4.1(X), except where the failure to so comply could not reasonably be anticipated to result in a Material Adverse Effect on the Business. The Seller has delivered true and complete copies of all of the EMA Agreements to the Purchaser.
EMA. Prepandrix. 2008 [updated May 14, 2008; cited 2011]; Available from: ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇▇▇▇.▇▇/ema/index.jsp?curl=pages/medicines/human/medicines/000822/human_ med_000986.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125.
EMA. The Company and its Subsidiaries: (A) are and, since January 1, 2022, have been in compliance with all applicable statutes, rules, or regulations, including but not limited to those administered by the European Medicines Agency (“EMA”) and similar governmental authorities (foreign or local) regarding the testing, development, manufacture, packaging, processing, use, distribution, labeling, storage, import, export or disposal of any products being developed, manufactured or distributed by the Company or its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any warning letter or other written correspondence or notice from the EMA or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) to the Company’s knowledge, have since January 1, 2022, possessed all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (D) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such governmental authority or third party intends to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received written notice that any governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations; (F) have, since January 1, 2022, filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (G) have not, either voluntarily or involuntarily, initiated, conducted, or is...
EMA. The EU regulatory system for medicines. A consistent approach to medicines regulation across the European Union. Ema. 2016:1-6. ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇▇▇▇.▇▇/en/documents/leaflet/european- regulatory-system-medicines-european-medicines-agency-consistent-approach-medicines_en.pdf.
