OBD Chronic Product definition

OBD Chronic Product means a Product for the management of ------------------- patients with bowel dysfunction caused by the ** administration of opioids.

Examples of OBD Chronic Product in a sentence

  • To the extent such transfer is not timely made, the time period of any delay in transfer shall toll the timeline for Development of the OBD Chronic Product as set forth in the applicable U.S. Development Plan.

  • GSK shall be solely responsible for the ----------------- performance of all Development activities, including regulatory filings, for each GI Product (other than the OBD Chronic Product covered in Section 4.1.2) that is required to obtain Marketing Authorization in the United States for such GI Products in accordance with the applicable U.S. Development Plan for such GI Products.

  • The Parties acknowledge that Adolor is in the process of conducting clinical studies on the OBD Chronic Product necessary to file the NDA and such activities **.

  • Thereafter, Marketing Expenses for the OBD Chronic Product shall be shared in accordance with the sharing of the GI Product Marketing Contribution for such OBD Chronic Product as adjusted pursuant to Section 6.3.4. Notwithstanding the foregoing, upon notice by Adolor to GSK of a Royalty Conversion Election, GSK shall be solely responsible and pay for all Marketing Expenses relating to periods after such notice for the OBD Chronic Product for which the Royalty Conversion Election was made.

  • GSK shall have the overall responsibility ------------------- for the performance of all Development activities, including regulatory filings, of the OBD Chronic Product that is required to obtain Marketing Authorization for the OBD Chronic Product in the United States and, in furtherance thereof, the Parties shall perform Development activities, all in accordance with the applicable U.S. Development Plan, for the OBD Chronic Product.

  • The Parties shall ---------------------------------- plan and implement periodic joint sales and marketing meeting, including a national launch meeting, for each Adolor Product, and the OBD Chronic Product and each other GI Product where Adolor has elected to fund Development Expenses under Section 4.6.5 and where Adolor has not made a Royalty Conversion Election, in the United States.

  • Subject to ---------------------------------------- reconciliation as provided in Section 6.7.5, Adolor shall be responsible and pay for ** percent (**%) and GSK shall be responsible and pay for ** percent (**%) of the Marketing Expenses in connection with the OBD Chronic Product for Commercialization in the United States incurred from the Effective Date through ** = Certain information on this page has been omitted and filed separately with the Commission.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.3 shall not be available for the OBD Chronic Product.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.2 shall not be available for the OBD Chronic Product.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.1 shall not be available for the OBD Chronic Product.

Related to OBD Chronic Product

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.