External Factor definition
External Factor means the occurrence of one or more of the following with respect to a Licensed Product; provided that such occurrence was not caused by any negligence, misconduct, violation of applicable laws, or failure to act by Licensee: (a) any change imposed by a regulatory agency which is new or unanticipated and requires Licensee’s compliance; (b) the primary endpoint in any clinical study is not achieved; (c) adverse changes occur in applicable laws relating to the development or marketing of the Licensed Product; or (d) an event of force majeure occurs as set forth in Section 15.12.
External Factor means []*. The relevant date(s) in this Section 4.8(b) (and any subsequent dates) shall be extended by mutual agreement of the Parties based upon the JSC’s reasonable assessment of the period of time required to reach the applicable milestone event in light of the relevant External Factors.
External Factor means that one or more of the following events or circumstances has occurred in development, manufacturing or regulatory conditions relating to a Licensed Calcitonin Product that delays the further development of such Licensed Calcitonin Product or results in delayed achievement of the applicable event; provided that (i) such events or circumstances were not caused by the negligent, intentional or fraudulent act or omission of ▇▇▇▇▇ or any of its Affiliates or Sublicensees and (ii) ▇▇▇▇▇ or its Affiliates or Sublicensees have taken all Commercially Reasonable Efforts to overcome such events or circumstances: (A) ***, if prepared and submitted in accordance with all applicable laws, rules and regulations, *** outside the United States; (B) *** a Licensed Calcitonin Product ***, or by or on behalf of ▇▇▇▇▇ or its Affiliates or Sublicensees reasonably based on ***, or by ▇▇▇▇▇’▇ reasonable *** Licensed Calcitonin Product; (C) ***, as specified in the applicable *** for the Licensed Calcitonin Product; (D) receipt of *** Licensed Calcitonin Product; (E) decisions, communications *** the Licensed Calcitonin Product that ***, including *** the Licensed Calcitonin Product ***; (F) *** the Licensed Calcitonin Product, including *** or any failure by Unigene with respect to its supply obligations hereunder; (G) any material breach by Unigene of its obligations under this Agreement; (H) changes in applicable laws relating to the development or manufacture of a Licensed Calcitonin Product which materially and adversely affect ▇▇▇▇▇’▇ or its Affiliates’ or Sublicensees’ ability to develop or manufacture the Licensed Calcitonin Product in accordance with the Development Timeline, or (I) other external factors not in the reasonable control of ▇▇▇▇▇ or its Affiliates or Sublicensees. External Factors shall be determined on a country-by-country basis. Promptly after learning of the occurrence of an External Factor, ▇▇▇▇▇ shall notify Unigene in writing of the External Factor, and shall provide Unigene with all information reasonably requested by Unigene regarding such External Factor and with ▇▇▇▇▇’▇ plan to overcome such External Factor, which plan shall provide for *** for the Licensed Calcitonin Product, *** as soon as reasonably practicable. The relevant date(s) in the Development Timeline (and any subsequent dates) shall be extended by mutual agreement of the Parties based upon ▇▇▇▇▇’▇ reasonable assessment of the period of time required to reach the applicable miles...
Examples of External Factor in a sentence
Promptly after learning of the occurrence of an External Factor, ▇▇▇▇▇ shall notify Unigene in writing of the External Factor, and shall provide Unigene with all information reasonably requested by Unigene regarding such External Factor and with ▇▇▇▇▇’▇ plan to overcome such External Factor, which plan shall provide for *** for the Licensed Calcitonin Product, *** as soon as reasonably practicable.
More Definitions of External Factor
External Factor means a cumulative impact on a local exchange telecommunications provider's intrastate revenues of more than three percent (3%), which is attributable to federal, state, or local government law, regulations or policies which change the revenue, expense or investment of the provider, but shall not include the effect of competition on the revenues, expense or investment of the company;
External Factor means the occurrence of one or more of the following with respect to a Licensed Product; provided that such occurrence was not caused by any negligence, misconduct, violation of applicable laws, or failure to act by Licensee: (a) any change imposed by a regulatory agency which is new or unanticipated and requires Licensee’s compliance; (b) the primary endpoint in any clinical study is not achieved; (c) adverse changes occur in applicable laws relating to the development or marketing of the Licensed Product; or (d) an event of force majeure occurs as set forth in S ection 15.12.
External Factor means that one or more of the following events or circumstances, which has delayed the Development of Product in the HAE Indication in CMIC Territory, has occurred in the Development, Manufacturing or regulatory conditions relating to Product; provided that such events or circumstances were not caused by the negligent act or omission of CMIC or any of its Related Parties: [******]. The relevant date(s) in this Section 4.4(b) (and any subsequent dates reflecting an extension permitted hereunder) shall be extended by the number of days to be agreed upon by the Parties reasonably based upon the JSC’s reasonable assessment of the period of time required to reach the applicable milestone event in light of the relevant External Factors.
External Factor means one or more of the following events or circumstances occurred in Development or Manufacturing or regulatory conditions relating to the Albireo Compound or a Product that delays the further Development of a Product or results in delayed achievement of the enrollment of the first human subject in Japan in any clinical trial, including, without limitation, a Phase I clinical trial, by [***], provided that such events or circumstances were not caused by the negligent act or omission of Ajinomoto, its Sublicensees or any of its Affiliates: (i) the clinical trial of the Albireo Compound or Product is [***]; (ii) [***] difficulties, with respect to [***], for which Albireo receives written notice from Ajinomoto within [***] of becoming aware of such difficulty; (iii) [***] difficulties due to (A) incomplete conduct of activities undertaken by Albireo under the Territory Development Plan, for which Albireo receives written notice from Ajinomoto within [***] of becoming aware of such incompleteness, (B) Albireo’s notice pursuant to Section 4.1.4 which delays or withholds a Territory Study for a period greater than [***], or (C) [***] by Albireo, the adverse effects of which [***], in whole or in part, uncured by Albireo [***] after Albireo’s receipt of notice from Ajinomoto alerting Albireo to such inadequacy; or (iv) Albireo’s breach of this Agreement, which breach remains uncured for [***] measured from the date written notice of such breach is given to Albireo by Ajinomoto.