2Optimization Sample Clauses

2Optimization. Following both Parties’ exercise of their respective Opt-In Right with respect to an Evaluated Bispecific Antibody, the Parties shall promptly agree upon an optimization plan (the “Joint Optimization Plan”) and associated budget for the Evaluated Bispecific Antibody (the “Joint Optimization Budget”); provided that, if the Parties are [*] after both Parties have exercised their respective Opt-In Right with respect to an Evaluated Bispecific Antibody, or such longer period as the Parties may mutually agree, either Party may, [*]. If neither Party [*] time period, then subject to the two (2) Original Unilateral Program limit ([*]) the [*], and the [*]. For clarity, [*]), and the non-Lead Party has not, the non-Lead Party shall [*]. Pursuant to the foregoing, (a) if one Party (but not the other Party) [*], ​ ​ ​ ​ then such Evaluated Bispecific Antibody shall be [*]) as set forth in Section 5.3.1(b)), or (b) if both Parties [*] such Evaluated Bispecific Antibody shall be the subject of a Declined Program and subject to the terms and conditions of Section 5.1.2(c). For clarity, if either Party [*], such Evaluated Bispecific Antibody will not be the subject of a Joint Program or count towards the two (2) Joint Program limit under Section 5.2.1(b). If the Parties agree upon an initial Joint Optimization Plan and initial Joint Optimization Budget, and continue with the Joint Program, the Parties, through the JSC, shall mutually amend and update the Joint Optimization Plan and Joint Optimization Budget from time-to-time, but no less frequently than [*]; provided, however, to the extent that the Parties are unable to agree upon such amendment, the Lead Party shall have final decision-making authority with respect to such amendment. Each Party shall use Commercially Reasonable Efforts to conduct its respective activities set forth in the Joint Optimization Plan in accordance with the Joint Optimization Budget, under the leadership of the Lead Party. The JDC will evaluate all relevant data and determine whether each Optimized Bispecific Antibody meets the Joint Clinical Candidate Criteria, and if so determined, recommend to the JSC that it approves of such Optimized Bispecific Antibody as a Joint Clinical Candidate.
Sample 1
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Related to 2Optimization

  • Screening After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

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