Oral Form definition

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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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 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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Examples of Oral Form in a sentence

  • Annex 1 To the Amendment No. 2 to the License Agreement between Helsinn Healthcare SA and MGI Pharma Inc, dated November 14 , 2003 Oral Form Development Plan To be finalized.

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 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;

  • Oral order means an order placed orally either in person or by telephone.

  • 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.

  • Proposal Form means that certain Part C of the RFP, completed and executed by the Proponent, to which this Appendix 1 is appended.

  • official form means a form established by the International Bureau or any form having the same contents and format;

  • Dealing Day means every Business Day from Monday to Saturday of every week. Units will be available for dealing (purchase, redemption, transfer, switching etc) on Dealing Days during Cut-off Time. Provided that the Management Company may with the prior written consent of the Trustee and upon giving not less than seven days notice in two widely circulated English or Urdu newspapers in Pakistan declare any particular Business Day(s) not to be a Dealing Day(s).

  • written or verbal quotations means quotations referred to in paragraph 12(1)(b) of this Policy.

  • Leakage technique factors means the technique factors associated with the diagnostic or therapeutic source assembly which are used in measuring leakage radiation. They are defined as follows:

  • Speech or language impairment means a communication disorder, such as stuttering, impaired articulation, a language impairment, or a voice impairment, that adversely affects a child’s educational performance.

  • Positive Behavioral Theory and Practice means a proactive approach to individual behavior and behavior interventions that:

  • Ballot issue means a question that has been approved to be placed before the voters or is otherwise required by law to be placed before the voters. “Ballot issue” does not include the nomination or election of a candidate.

  • electoral officer or “election committee” means a person or group of persons appointed by the community council to oversee and take responsibility for the election pursuant to Article B4.1. As appropriate, references in this Community Council Electoral Code to an electoral officer include an election committee and vice versa;

  • Rate Fixing Day means the second TARGET Day before the first day of a Term or such other day as the Facility Agent determines is generally treated as the rate fixing day by market practice in the relevant interbank market.

  • Behavioral violation means a student’s behavior that violates the district’s discipline policies.

  • LIBOR Banking Day has the meaning set forth in Section 2.10(b)(1).

  • Voting Day means the final day on which the final vote is to be taken in an election and shall be Monday, October 24, 2022 with the close of voting to be at 8:00 pm.

  • Banking Days are days on which banks are open both in the country of the currency stipulated for the Purchase Price in Clause 1 and in the place of closing stipulated in Clause 8.

  • polling day means the day fixed for holding the poll at an election;

  • Flocculation means a process to enhance agglomeration or collection of smaller floc particles into larger, more easily settleable particles through gentle stirring by hydraulic or mechanical means.

  • Behavioral health means the promotion of mental health, resilience and wellbeing; the treatment of mental and substance use disorders; and the support of those who experience and/or are in recovery from these conditions, along with their families and communities.

  • Electronic, mechanical or other device means any device or apparatus which can be used to intercept a wire or oral communication other than:

  • Floating Day Count Fraction means, in respect of the calculation of an amount of interest for any Interest Period:

  • Operating Day means the daily 24 hour period beginning at midnight for which transactions on the PJM Interchange Energy Market are scheduled.

  • Normal Form means a monthly annuity which is one twelfth of the amount of the member’s accrued benefit which is payable for the member’s life. If the member dies before the sum of the payments he or she receives equals his or her accumulated contributions on the annuity starting date, the named beneficiary shall receive in one lump sum the difference between the accumulated contributions at the annuity starting date and the total of the retirement income payments made to the member.