Pediatric Product definition

Pediatric Product means the product for which Regulatory Approval is being sought under pediatric line extension filed in the EMA with procedure number EMA/X/0000268892.

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Pediatric Product means the pharmaceutical presentation of the Compound (a) that utilizes or incorporates PULSYS(TM), (b) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Compound, and (c) that is used or is being developed for the Pediatric Product Indications, other than formulations of Exhibit A.

Pediatric Product means a pediatric form of the Product.

Examples of Pediatric Product in a sentence

INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS ▇-▇▇, ▇▇▇▇▇▇▇▇ ▇ ▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇, ▇▇▇-▇▇▇▇ ▇▇▇▇▇ TELEPHONE:(▇▇)▇▇▇▇ ▇▇▇▇ FAX: (03)3281 • ▇▇▇▇ (▇▇)▇▇▇▇-▇▇▇▇ Agreement in respect to the Once-Daily Product and the Pediatric Product shall terminate, and in such a case Cornerstone shall assist and cooperate with Meiji Seika for continuing the Development if Meiji Seika desires to continue any of the Development even after such termination.
To the extent that Myovant is responsible for the Manufacture of the preclinical and clinical supply of Compound, the Oncology Product(s) or Pediatric Product, or the commercial supply of Compound, the Oncology Product(s) in the Oncology Field or Pediatric Product in the Pediatric Field in the Pfizer Territory for Pfizer, such supply shall be pursuant to separate supply agreement between Myovant and Pfizer (the “Supply Agreement”).
Pediatric Product Sales, Marketing and Development.......................................45 SECTION 6.14.
At the same time, Parent shall determine for the preceding twelve (12) months the Gross Profit attributable to each Pediatric Product on a per commercial unit basis (based on actual net sales) (the “Per Unit Gross Profit”).
The Development activities with respect to the Pediatric Product in the Pediatric Field in the Co-Promotion Territory are set out in the initial WH Joint Medical Affairs and Development Plan and Budget.
At December 31, 2007, Parent will obtain inventory reports for each of the Pediatric Products from the three major wholesalers (McKesson, Cardinal Health and Amerisource Bergen) which shall be aggregated (on a per product basis) to determine the total number of weeks worth of inventory of each Pediatric Product in the trade at the wholesale level (based upon the average demand of such wholesalers over the previous six (6) week period).
There have been no past recalls involving the Products, except for two Class II recalls in 1999 of the Pediatric Product for three lots failing stability testing due to vitamin assays degradation.
During the Term, GSK shall devote Diligent Efforts to Commercialize (i) the Current Product for the Licensed Indication [ * ] and (ii) the Current Pediatric Product for the Licensed Indication [ * ] pursuant to GSK's development efforts to develop the Current Pediatric Product therefor in accordance with (and beginning at the time set forth in) Section 3.3(a).
To the extent set forth in Section 5.1, GSK shall devote Diligent Efforts to Commercialize the Current Product and the Current Pediatric Product for Licensed Indications in the GSK Territory.
Cornerstone shall, with full consultation with Meiji Seika, be in charge of the project management for the Development, including but not limited to filing a submission of the Once-Daily Product and the Pediatric Product to the health authorities in the Territory for obtaining the Product Registrations.

More Definitions of Pediatric Product

Pediatric Product has the meaning set forth in Section 2.24(b).

Pediatric Product means, as the case may be, (a) a pharmaceutical presentation of the Amox-Only Compound (a)(i) that utilizes or incorporates PULSYSÔ, (b)(ii) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Amox-Only Compound, and (c)(iii) that is used or is being developed for the Pediatric Product Indications, [***]; and/or (b) the pharmaceutical presentation of the Amox-Clav Compound (i) that utilizes or incorporates PULSYSÔ, that contains no active pharmaceutical ingredient other than the Amox-Clav Compound, and (iii) that is used or is being developed for the Pediatric Product Indication [***] other than formulations of Exhibit A. 8.

Pediatric Product means, as the case may be, (a) a pharmaceutical presentation of the Amox-Only Compound (a)(i) that utilizes or incorporates PULSYSÔ, (b)(ii) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Amox-Only Compound, and (c) (iii) that is used or is being developed for the Pediatric Product Indications, [***]; and/or (b) the pharmaceutical presentation of the Amox-Clav Compound (i) that utilizes or incorporates PULSYSÔ, [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. that contains no active pharmaceutical ingredient other than the Amox-Clav Compound, and (iii) that is used or is being developed for the Pediatric Product Indication [***] other than formulations of Exhibit A.

Pediatric Product means the vitamin-related pharmaceutical product marketed and sold under the unregistered trademark "MVI-Pediatric".

Pediatric Product means any product containing the Compound for any pediatric indication, that is developed pursuant to this Agreement, and is not the WH Product in the WH Field or Oncology Product in the Oncology Field existing as of the Effective Date.

Pediatric Product means the pharmaceutical presentation of the Compound (a) that utilizes or incorporates PULSYS™, (b) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Compound, and (c) that is used or is being developed for the Pediatric Product Indications, other than formulations of Exhibit A.