Packaging and Labeling. The Parties shall reasonably cooperate to change the Label of Tuzistra XR so that such Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”). Within three (3) months of the Effective Date, AYTU shall supply to TRIS, in a timely fashion, its logo and the layout required to Label the CCP-08 Product in accordance with Applicable Laws and Section 4.10(a). TRIS shall be responsible, at its sole cost and expense, for securing any approvals required by Agencies in the Territory or other applicable Regulatory Approvals for the initial Label for the CCP-08 Product, and shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to develop a bottle size smaller than ​ and larger than ​, which the Parties currently expect will be a ​ bottle size (the “Medium Bottle Size”) with the exact size determined in TRIS’ sole discretion after consultation with AYTU for the Products; provided however, that costs and expenses of Labeling design (except for the Tuzistra XR Initial Label Changes) and filings and interactions with Regulatory Authorities shall be at the sole cost and expense of AYTU for any post-NDA Approval Regulatory Approval. All changes to Labels or Packaging prior to Regulatory Approval shall be at AYTU’s sole cost and expense. Any changes or supplements to the Labeling for any Product following the transfer of the NDA for a Product to AYTU shall be at AYTU’s sole cost and expense; provided, however, that the costs and expenses of the Tuzistra XR Initial Label Changes, other than incurred with respect to filings and interactions with Regulatory Authorities, shall be at TRIS’ sole cost and expense. In the event that AYTU wishes to modify or change the Label for a Product, other than such changes to the Label as of the Effective Date on Tuzistra XR to effectuate the Tuzistra XR Initial Label Changes, AYTU shall provide at least sixty (60) days’ advance notice of such desired change to TRIS and forward such modifications or changes to TRIS for incorporation into the Packaging and Labeling of such Products. All reasonable costs relating to changes in the Labels or Packaging, other than changes with respect to the Label of Tuzistra XR existing as of the Effective Date which are necessary to effectuate the Tuzistra XR Initial Label Changes, including artwork, as well as destruction and other costs (including TRIS’ reasonable and documented out-of-pocket costs and expenses) relating to Labels or Packaging that are no longer usable, shall be paid by AYTU to TRIS within thirty (30) days of invoice to AYTU including, for example, expenses of Labels or Packaging materials that are no longer useable by TRIS in the Packaging or Labeling of the Products because of # TRIS’ reliance on the Forecasts provided pursuant to Section 5.1 hereof, or # changes requested by AYTU.

Packaging and Labeling. WuXi ATU will package and label Product for Delivery in accordance with its standard operating procedures and Graphite’s specifications. All costs and expenses of whatever nature incurred by WuXi ATU in complying with the foregoing and will be charged to Graphite in addition to the shipping fees.

Packaging and Labeling. ​ shall properly pack, mark, and ship the Product as instructed by ​ and otherwise in accordance with applicable law and industry standards and shall provide ​ with shipment documentation showing ​’s identification number for the subject Product, the quantity of pieces in shipment, shipment tracking number and/or bill of lading number, and such other information as ​ reasonably requests.

#​ shall not attempt to white label the Product or alter the Product labeling or packaging in any capacity;

“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce Product including the manufacturing, processing, packaging, labeling, quality control testing, stability testing, release, storage or supply of Product.

Electronic Nicotine Delivery Systems (“ENDS”). FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS, but excludes accessories.

“Specifications” means the specifications for the Parts, including, but not limited to, product specifications, manufacturing, testing, labeling, packaging and storing instructions, and standards of quality, which are attached under [Exhibit A] hereto.

“Specifications” or “UAV Specifications” shall mean the product characteristics, model numbers, design requirements, processing, labeling, and packaging requirements, protocols and standards pertaining to the manufacture or supply of the Supply Deliverables as specified in Exhibit A attached hereto.

Labeling/Shipping Information. With respect to any goods or other materials sold or otherwise transferred to Buyer hereunder, Seller shall provide all relevant information, including without limitation, safety data sheets in the language and the legally required format of the location lo which the goods will be shipped and mandated labeling information, required pursuant to applicable requirements such as: # the Occupational Safety and Health Act (“OSHA”) regulations codified at 29 CFR 1910,1200; # EU REACH Regulation (EC) No. 1907/2006, EU Regulation (EC) No. 1272/2008 classification, labeling and packaging of substances and mixtures (“CLP”), EU Directives 67/548/EEC and 1999/45/EC, as amended, if applicable, and # any other applicable law, rule or regulation or any similar requirements in any other jurisdictions to or through which Buyer informs Seller the goods are likely to be shipped or through which Seller otherwise has knowledge that shipment will likely occur, such as U.S. Department of Transportation regulations governing the packaging, marking, shipping and documentation of hazardous materials, including hazardous materials specified pursuant to 49 CFR, the international Maritime Organization (“IMO”) and the International Air Transport Association (“I ATA”).

“Regulatory Authority” means the FAA in the United States and the equivalent regulatory authority or entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale of UAVs in any country other than the United States.