Pharmaceutical Product. Any Merck A/S drug/medicinal product, biological product, or medical device (irrespective of patent status and/or whether it is branded or not), whether used alone or in combination, that is intended to be used on the prescription of, or under the supervision of, a Healthcare Professional, and which is intended for use in the diagnosis, treatment, or prevention of disease in humans, or to affect the structure or any function of the human body.

Pharmaceutical Product. Print Name Manufacturing and Service Contract (BVL and BMS-MI) APPENDIX A: List of Products: Cardiolite / Sestamibi Neurolite Ligand Neurolite Buffer Definity / Luminity / DMP115-e Eluant, **** mg/mL liquid, **** mL in a **** xX xxxx Eluant, **** mg/mL liquid, **** mL in a **** xX xxxx Transition Service Agreement (BVL and Lantheus) Attachment “F” Customer Supplied Equipment PFP CART Squarewave test equipment and associated spare parts 97 Attachment “G” Representation regarding Customer’s Qualified Person CUSTOMER LETTERHEAD Customer Address BEN VENUE LABORATORIES, INC. ATTN: COMPLIANCE MANAGER A Boehringer Ingelheim Company 000 Xxxxxxxxxx Xxxx Xxxxxxx, Xxxx 00000 Dear BVL COMPLIANCE MANAGER, Please take notice that Lantheus Medical Imaging hereby confirms in writing to BVL that it has appointed one or more Qualified Person(s) in compliance with the requirements of Article 48 of Directive 2001/83/EC, with respect to the product(s) subject to the manufacturing and services contract for commercial and developmental products between Ben Venue Laboratories, Inc. and Lantheus Medical Imaging, Inc. dated . Said Qualified Person(s) shall be responsible for release of Product(s) into EU member states and shall comply with Article 51 of 2001/83/EC. Sincerely, Name Title Attachment “H” Certificate of Compliance Boehringer Ingelheim Ben Venue Laboratories Ben Venue Laboratories, Inc. 000 Xxxxxxxxxx Xxxx X.X. Xxx 00000 Xxxxxxx, Xxxx 00000-0000 CONTRACT CLIENT PRODUCT NAME: BVL LOT NUMBER: CUSTOMER: CUSTOMER LOT NUMBER: DOSAGE: CONTAINER TYPE MANUFACTURING SPECIFICATION: MPR TESTING SPECIFICATION: o REFER TO CoA o N/A DATE OF MANUFACTURE: o PREP or o EXP DATE: QUANTITY RELEASED: Regulatory statement: I hereby certify that the above information is authentic and accurate. This Product was manufactured in accordance with the Manufacturing Process approved mutually by the customer and BVL. In addition, all Product production and control records are reviewed and approved by BVL’s Quality Assurance Department to determine compliance with all established, aproved written procedures in determining that this Product could be released, in accordance with 21 C.F.R § 211.192 of cGMP regulations found in the Code of Federal Regulations of the U.S. Food and Drug Administration. Deviations were documented, reviewed, and approved prior to release. The batch/lot has been released by an authorized disposition individual. Released to Contract Client AUTHORIZED BY / DATE: Authorized Dispo...

Pharmaceutical Product. 3.25(a) PHSA...............................................................................................3.25(a) Principal executive officer.........................................................................3.6(c) Principal financial officer.........................................................................3.6(c) Receiving Party........................................................................................7.3

Pharmaceutical Product. Any Merck 2.4 Farmaceutický produkt. Akýkoľvek Serono drug/medicinal product, biological product, liek/lekársky produkt, biologický produkt alebo 2. or medical device (irrespective of patent status and/or whether it is branded or not), whether used alone or in combination, that is intended to be used on the prescription of, or under the supervision of, a Healthcare Professional, and which is intended for use in the diagnosis, treatment, or prevention of disease in humans, or to affect the structure or any function of the human body. zdravotnícka pomôcka (bez ohľadu na patentový stav a/alebo na to, či je značkový alebo nie), či už používaný samostatne alebo v kombinácii, ktorý je určený na používanie na predpis poskytovateľa zdravotnej starostlivosti alebo pod jeho dohľadom, a ktorý je určený na používanie v diagnostike, liečbe alebo prevencii choroby u ľudí, alebo na ovplyvnenie štruktúry alebo akejkoľvek funkcie ľudského tela. 3 Representation . s, Obligations Warranties,

Pharmaceutical Product. Any Merck drug/medicinal product, biological product, or medical device (irrespective of patent status and/or whether it is branded or not), whether used alone or in combination, that is intended to be used on the prescription of, or under the supervision of, a Healthcare Professional, and which is intended for use in the diagnosis, treatment, or prevention of disease in humans, or to affect the structure or any function of the human body. 2.4 Farmaceutický výrobok. Akýkoľvek liek/liečivo, biologický produkt alebo zdravotnícka pomôcka spoločnosti Merck (bez ohľadu na stav patentu, resp. bez ohľadu na to, či sú značkové alebo nie), používané samostatne alebo v kombinácii, ktoré sa majú používať na predpis alebo pod dohľadom zdravotníckeho pracovníka, a ktoré sa majú používať pri diagnostike, liečbe alebo prevencii ochorení u ľudí, či môžu ovplyvniť štruktúru alebo akúkoľvek funkciu ľudského tela.

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Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.
Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.
Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.
Products Products available under this Contract are limited to Software, including Software as a Service, products and related products as specified in Appendix C, Pricing Index. Vendor may incorporate changes to their product offering; however, any changes must be within the scope of products awarded based on the posting described in Section 1.B above. Vendor may not add a manufacturer’s product line which was not included in the Vendor’s response to the solicitation described in Section 1.B above.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.
Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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