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”).

“Manufacture” and “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.

Supplier shall permit representatives of Buyer to visit Supplier’s facilities for the purpose of observing the manufacturing, testing, labeling, packaging and storing of the Parts. Buyer agrees to give Supper reasonable notice of any proposed visit to the facilities. Any such visits shall be during normal business hours on work days and any information gathered during such visits shall be kept confidential in accordance with the provisions of [Article 10] hereof.

Ownership of Technical Information. As between the Parties, # all Intellectual Property Rights and inventions related primarily to a Product, whether developed pursuant to this Agreement or otherwise, shall be owned solely by TRIS during and after the Term of such Product, and # all Intellectual Property Rights used in the formulation, manufacture, Labeling and/or Packaging of a Product (excluding AYTU Marks), whether developed pursuant to this Agreement or otherwise shall be solely owned by TRIS during and after the Term of such Product.

“Primary Product-Related Materials” means all advertising and promotional materials (including but not limited to flyers, brochures, pamphlets and electronic media), labeling and packaging materials, and any materials or items similar to the foregoing to the extent, in each case, pertaining exclusively to any Primary Royalty Products in the Primary Field and in the possession or control of Primary or any Affiliate thereof, and all copyright and similar rights to the contents thereof, provided that the foregoing rights shall not include any rights to any trademark, logos, or the like other than Primary Product Trademarks.

Highland Packaging Highland Packaging Solutions, LLC, a Florida limited liability company and

Indemnification by Denali. Denali shall defend, indemnify and hold harmless ​ and their respective officers, directors, shareholders, employees and agents from and against any and all Third Party liabilities, claims, suits, and expenses, including reasonable attorneys’ fees (collectively, “Losses”), arising out of or in any way attributable to # the inaccuracy or breach of any representation, warranty, or covenant made by Denali under this Agreement, # the research, development, marketing, approval, manufacture, packaging, labeling, handling, storage, transportation, use, distribution, promotion, marketing or sale of Licensed Products by or on behalf of Denali, # the negligence or willful misconduct of Denali or its respective officers, directors, employees or agents, or # Denali’s failure to comply with Applicable Law with respect to the manufacture, use, labeling, importation or marketing of Licensed Products; in each case except to the extent that such Losses are attributable to # ​’s breach of any representation, warranty, or covenant made by ​ under this Agreement, # ​’s breach of its obligations under this Agreement, and/or # the negligence or willful misconduct of ​, its Affiliates or their respective officers, directors, employees, or agents.

“Legacy Product-Related Materials” means # DAS Product-Related Materials and # all other advertising and promotional materials (including but not limited to flyers, brochures, pamphlets and electronic media), labeling and packaging materials, and any materials or items similar to the foregoing to the extent, in each case, pertaining exclusively to any Legacy Royalty Products in the Legacy Field and in (or coming into) the possession or control of Legacy or any Affiliate thereof upon or following any termination of any Downstream Agreement, and all copyright and similar rights to the contents thereof, provided that the foregoing rights shall not include any rights to any trademark, logos, or the like other than Legacy Product Trademarks.

Prior to the beginning of each calendar quarter, Buyer shall provide to Supplier a written forecast of the number of Parts expected to be ordered in the following three (3) month period. Based on the forecast, Supplier shall purchase Raw Materials for the manufacturing, labeling and packaging of the Parts, in such quantities, in Supplier's reasonable judgment, that are required to fill forecasted orders during such period. Buyer shall reimburse Supplier for any Raw Materials which remain in Supplier’s possession following the termination of this Agreement or a decision of Buyer or an agreement of the Parties which render such Raw Materials obsolete or not useable by Supplier hereunder. Reimbursement shall be made at actual cost including appropriate overheads.

UCC Financing Statement against Peninsula Packaging, LLC with the Secretary of State for the State of California, original file # ​, by Allied Packaging Corp.

is packaging and shipping materials;