Safety Reasons definition

Safety Reasons means it is a Party’s reasonable belief that there is an unacceptable risk for harm in humans based upon (a) preclinical safety data, including data from animal toxicology studies, or (b) the observation of serious adverse effects in humans after Product has been administered to humans, such as during a clinical study or after the First Commercial Sale, in each of clauses (a) and (b), which would materially impact the safety or efficacy and the commercial feasibility of Product.

Safety Reasons means it is BMS’s or any of its Affiliates’ or sublicensees’ reasonable belief that based upon information that becomes available at any time (or an analysis of such information), that the medical risk/benefit of the continued development or commercialization of such Compound or Product is sufficiently unfavorable as to be incompatible with the welfare of patients.

Safety Reasons means that, based upon all relevant scientific data, there are safety and public health issues relating to the Product such that the medical benefit/risk ratio of such Product is sufficiently unfavorable as to materially compromise the welfare of patients so that the use in patients is no longer justifiable and that such issues are unlikely to be reversed within a reasonable period of time with a commercially reasonable level of investment.

Examples of Safety Reasons in a sentence

• Regular Work Year for Teachers 1.92 Regular Work Year for Teachers; School Calendar 1.104 Year Round Schools 3.46 Reports (Teacher) on Students 1.77 Anecdotal Reports for Elementary Students, Staggered Part Day Entries 1.73 Conference Days - Parent Teacher 3.50 Closure of Schools for Health or Safety Reasons 4.

• If Ambrx does not agree with BMS’ opinion that BMS’ termination was due to Safety Reasons, such dispute shall be handled in accordance with Section 16.2. If such dispute is resolved pursuant to Section 16.2 in Ambrx’s favor, in such case such termination shall be treated as a termination by BMS under Section 13.2(a).

• Upon such termination for Safety Reasons, BMS shall be responsible, at its expense, for the wind-down of any Development of the applicable Product (including any Clinical Trials for the applicable Product being conducted by or on behalf of BMS) and any Commercialization activities for the applicable Product.

• BMS may terminate this Agreement on a Product-by-Product and/or country-by-country basis upon written notice to Ambrx based on Safety Reasons.

• BMS may terminate this Agreement on a Collaboration Target-by-Collaboration Target basis upon written notice to CytomX based on Safety Reasons.

More Definitions of Safety Reasons

Safety Reasons means it is BMS’ or any of its Affiliates’ or sublicensee’s reasonable belief, after due inquiry and in a manner consistent with BMS’ then-current decision-making policies and procedures with respect to such a determination, that there is an unacceptable risk for harm in humans based upon: (i) pre-clinical safety data, including data from animal toxicology studies; or (ii) the observation of serious adverse effects in humans after a Product * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. has been administered to or taken by humans, such as during a clinical trial or after the launch of a Product. BMS shall provide PDL with all relevant data for such terminated Product but shall not be obligated to assign to PDL any regulatory documents/filings relating to such terminated Product. If PDL does not agree with BMS’ opinion that BMS’ termination was due to Safety Reasons, such dispute shall be handled in accordance with Section 14.1.

Safety Reasons means that the medical risk/benefit of the Licensed Product is so unfavorable that it would be incompatible with the welfare of patients to develop or commercialize or to continue to develop or commercialize the Licensed Product

Safety Reasons means it is a Party’s reasonable belief, that there is an unacceptable risk for harm in humans based upon: (i) pre-clinical safety data, including data from animal toxicology studies; or (ii) the observation of serious adverse effects in humans after a Licensed Product has been administered to or taken by humans, such as during a clinical trial or after the First Commercial Sale of such Licensed Product.

Safety Reasons means it is a Party’s [***], after [***] and in a [***] with such Party’s [***] policies and procedures with respect to such a determination, that there is an [***] for harm in humans based upon: (a) pre-clinical safety data, including data from animal toxicology studies, or (b) the observation of serious adverse effects in humans after a Development Candidate or associated Product has been administered to or taken by humans, such as during a Clinical Trial or after the launch of a Product, in each case ((a) and (b)) so that there is [***] for the Development or Commercialization of such Development Candidate or Product. The determination of the existence of a Safety Reason will take into consideration the known safety profiles for other cell therapies in active development or commercialization by Third Parties.

Safety Reasons shall have the meaning given in Section 15.5, hereto.

Safety Reasons has the meaning set forth in Section 10.5.

Safety Reasons means it is BMS’ or one of its Affiliates’ or sublicensee’s reasonable belief that there is an unacceptable risk for harm in humans based upon pre-clinical data, including but not limited to data from toxicology studies, or based upon the observation of adverse effects in humans after a Licensed Compound or Licensed Product has been administered to or taken by humans, such as during a clinical trial or after the launch of a Licensed Product.