Oral Form definition

Oral Form means a finished dosage form that is delivered to the gastrointestinal tract after delivery through the mouth, in any dosage strength or form. Specifically, an Oral Form includes forms that dissolve in the mouth but not forms that are delivered by injection or inhalation.
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Oral Form. If BMI develops an oral form of Licensed Product, than within thirty (30) days after receiving from BMI both the final preclinical report for a study reporting the results of oral [*] testing in an animal model of Omega Interferon and the results of one of the clinical trials pursuant to Section 5.2.3, BII shall inform BMI in writing whether it wishes to negotiate the reversion of some or all of the rights granted to BMI under this Agreement in the countries of the Territory except for countries where BMI has granted a Sublicense under Clause 5.2.
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Oral Form means a finished dosage form that is delivered to the gastrointestinal tract after delivery through the mouth, in any dosage strength or form. Specifically, an Oral Form includes forms that dissolve in the mouth but not forms that are delivered by injection or inhalation. 1.120 “Order” is defined in Section 7.1.3. 1.121 [**] 1.122 “Parent” is defined in Section 10.4.2. 1.123 “Party” and “Parties” is defined in the Introduction. 1.124 “Patent Rights” means any and all (a) U.S. or foreign patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (b) all U.S. or foreign patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, and (c) any other form of government-issued right substantially similar to any of the foregoing. 1.125 “Payments” is defined in Section 6.11.1. 1.126 “Permitted Purpose” is defined in the definition of “Territory.” 1.127 “Person” means any individual, corporation, company, limited liability company, partnership, limited liability partnership, trust, estate, proprietorship, joint venture, association, organization, or entity. 1.128 “Pharmacovigilance Agreement” is defined in Section 5.2.4. 1.129 “Phase II” in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any foreign equivalent thereto. 1.130 “Phase III” in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto. 1.131 “Phase IV” in reference to a clinical trial means a trial conducted for purposes of further characterizing and supporting a Product for marketing but not for purposes of seeking Regulatory Approval or otherwise fulfilling a requirement of a Regulatory Authority. 1.132 “Post-Amendment Period” is defined in Section 11.2(a)(iii). 1.133 “Post-Approval Research” means ongoing research and development of a Product after such Product has received Regulatory Approval in the Territory, including Phase IV clinical studies and clinical studies in support of indications within the Field or labeling changes for such Product within the Field in the Territory during the Term. 1.134 “Pre-Amendment Period” is defined in Section 11.1(a). 1.135 “Prior Agreement” is defined in the Introduc...
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More Definitions of Oral Form

Oral Form. If BMI develops an oral form of Licensed Product, than within thirty (30) days after receiving from BMI both the final preclinical report for a study reporting the results of oral [*] testing in an animal model of Omega Interferon and the results of one of the clinical trials pursuant to Section 5.2.3, BII shall inform BMI in writing whether it wishes to negotiate the reversion of some or all of the rights granted to BMI under this Agreement in the countries of the Territory except for countries where BMI has granted a Sublicense under Clause 5.2.2. If BII does so wish, then both BMI and BII agree to negotiate in good faith for no more than an additional sixty (60) days the Reversion Terms. Until the expiration of this sixty (60) day period, BMI may not conclude a Sublicense agreement with any third party except for countries in Asia pursuant to Section 3.2. Discussions shall then continue as described in paragraphs 2 and 3 of Clause 5.2.3.”
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Related to Oral Form

  • Oral Instruction has the meaning ascribed thereto in Section 2.1 hereof.

  • Oral Instructions means verbal instructions received by Custodian from an Authorized Person or from a person reasonably believed by Custodian to be an Authorized Person.

  • Oral and maxillofacial surgeon means an individual with a D.D.S. or a D.M.D. degree, who has completed additional training in oral and maxillofacial surgery.

  • Oral communication means any oral communication uttered by a person exhibiting an expectation that such communication is not subject to interception under circumstances justifying such expectation, but such term does not include any electronic communication;

  • Functional behavioral assessment means an individualized assessment of the student that results in a team hypothesis about the function of a student’s behavior and, as appropriate, recommendations for a behavior intervention plan.