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`UNITED STATES OF AMERICA
`BEFORE THE FEDERAL TRADE COMMISSION
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`COMMISSIONERS:
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`Rebecca Kelly Slaughter, Acting Chair
`Joseph J. Simons
`Noah Joshua Phillips
`Rohit Chopra
`Christine S. Wilson
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`________________________________________________
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`In the Matter of
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`PFIZER INC.,
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`a corporation;
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`UPJOHN INC.,
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`a corporation;
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`VIATRIS INC.
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`a corporation;
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`MYLAN N.V,
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`a public limited liability company;
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`and
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`UTAH ACQUISITION SUB INC.,
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`a corporation.
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`________________________________________________)
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`DECISION AND ORDER
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`Docket No. C-4727
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`DECISION
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`The Federal Trade Commission initiated an investigation of Respondent Pfizer Inc.’s
`(“Pfizer”) proposal to spin off its Upjohn division and combine it with the assets of Respondent
`Mylan N.V. Upon consummation, the combination is expected to be renamed Viatris Inc. and
`will be comprised of certain legacy Pfizer assets held by Upjohn Inc. and its subsidiaries,
`Respondent Pfizer’s Greenstone LLC business, and all of the assets of Respondent Mylan N.V.
`The Commission’s Bureau of Competition prepared and furnished to each Respondent the Draft
`Complaint, which it proposed to present to the Commission for its consideration. If issued by the
`Commission, the Draft Complaint would charge Respondents with violations of Section 7 of the
`Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act,
`as amended, 15 U.S.C. § 45.
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`Respondents and the Bureau of Competition executed an Agreement Containing Consent
`Orders (“Consent Agreement”) containing (1) an admission by Respondents of all the
`jurisdictional facts set forth in the Draft Complaint; (2) a statement that the signing of said
`agreement is for settlement purposes only and does not constitute an admission by Respondents
`that the law has been violated as alleged in the Draft Complaint, or that the facts as alleged in the
`Draft Complaint, other than jurisdictional facts, are true; (3) waivers and other provisions as
`required by the Commission’s Rules; and (4) a proposed Decision and Order and Order to
`Maintain Assets.
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`The Commission considered the matter and determined that it had reason to believe that
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`Respondents have violated the said Acts, and that a complaint should issue stating its charges in
`that respect. The Commission accepted the Consent Agreement and placed it on the public
`record for a period of 30 days for the receipt and consideration of public comments; at the same
`time, it issued and served its Complaint and Order to Maintain Assets. The Commission duly
`considered any comments received from interested persons pursuant to Commission Rule 2.34,
`16 C.F.R. § 2.34. Now, in further conformity with the procedure described in Rule 2.34, the
`Commission makes the following jurisdictional findings, and issues the following Decision and
`Order (“Order”):
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`1.
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`2.
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`3.
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`4.
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`Respondent Pfizer Inc. is a corporation organized, existing, and doing business
`under and by virtue of the laws of the State of Delaware with its executive offices
`and principal place of business located at 235 East 42nd Street, New York, New
`York 10017.
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`Respondent Upjohn Inc. is a corporation organized, existing, and doing business
`under and by virtue of the laws of the State of Delaware with its executive offices
`and principal place of business located at 235 East 42nd Street, New York, New
`York 10017. Upon completion of the combination, Upjohn Inc. is expected to be
`renamed Viatris Inc. and will become Respondent Viatris Inc. with its executive
`offices and principal place of business located at 1000 Mylan Boulevard,
`Canonsburg, Pennsylvania 15317.
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`Respondent Mylan N.V. is a public limited liability company organized, existing,
`and doing business under and by virtue of the laws of the Kingdom of the
`Netherlands with its executive offices and principal place of business located at
`Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL,
`England. Mylan N.V.’s United States address for service of process in this matter
`is as follows: 1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317.
`
`Respondent Utah Acquisition Sub Inc. is a corporation organized, existing, and
`doing business under and by virtue of the laws of the State of Delaware with its
`executive offices and principal place of business located at 235 East 42nd Street,
`New York, New York 10017. Upon completion of the combination, Utah
`Acquisition Sub Inc. will become a subsidiary of Respondent Viatris Inc. with its
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`executive offices and principal place of business located at 1000 Mylan
`Boulevard, Canonsburg, Pennsylvania 15317.
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`The Commission has jurisdiction over the subject matter of this proceeding and
`over the Respondents, and the proceeding is in the public interest.
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`ORDER
`I. Definitions
`IT IS ORDERED that, as used in the Order, the following definitions shall
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`5.
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`apply:
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`“Pfizer” means Pfizer Inc., its directors, officers, employees, agents, representatives,
`successors, and assigns; and the joint ventures, subsidiaries, partnerships, divisions,
`groups, and affiliates controlled by Pfizer Inc., and the respective directors, officers,
`general partners, employees, agents, representatives, successors, and assigns of each.
`“Upjohn” means Upjohn Inc., its directors, officers, employees, agents, representatives,
`successors (including Viatris Inc.), and assigns; and the joint ventures, subsidiaries,
`partnerships, divisions, groups, and affiliates controlled by Upjohn Inc., and the
`respective directors, officers, general partners, employees, agents, representatives,
`successors, and assigns of each.
`“Viatris” means Viatris Inc., its directors, officers, employees, agents, representatives,
`successors, and assigns; and the joint ventures, subsidiaries, partnerships, divisions,
`groups, and affiliates controlled by Viatris Inc., and the respective directors, officers,
`general partners, employees, agents, representatives, successors, and assigns of each.
`“Mylan” means Mylan N.V., its directors, officers, employees, agents, representatives,
`successors, and assigns; and the joint ventures, subsidiaries, partnerships, divisions,
`groups, and affiliates controlled by Mylan N.V., and the respective directors, officers,
`general partners, employees, agents, representatives, successors, and assigns of each.
`“Utah Acquisition Sub” means Utah Acquisition Sub Inc., its directors, officers,
`employees, agents, representatives, successors, and assigns; and the joint ventures,
`subsidiaries, partnerships, divisions, groups, and affiliates controlled by Utah Acquisition
`Sub Inc., and the respective directors, officers, general partners, employees, agents,
`representatives, successors, and assigns of each.
`“Commission” means the Federal Trade Commission.
`“Respondents” means Pfizer, Upjohn, Viatris, Mylan, and Utah Acquisition Sub.
`“Acquirer(s)” means:
`1. A Person specified by name in this Order to acquire particular assets or rights
`pursuant to this Order; or
`2. Any other Person that the Commission approves to acquire particular assets or
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`A.
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`B.
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`C.
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`D.
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`E.
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`F.
`G.
`H.
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`rights pursuant to this Order.
`“Acquisition” means the transactions contemplated by Separation and Distribution
`Agreement by and between Pfizer Inc. and Upjohn Inc., dated as of July 29, 2019, and the
`Business Combination Agreement by and among Pfizer Inc., Upjohn Inc., Utah
`Acquisition Sub Inc., Mylan N.V., Mylan I B.V., and Mylan II B.V. dated as of July 29,
`2019, as filed with the Commission.
`“Acquisition Date” means the date the parties close on the Business Combination
`Agreement by and among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan
`N.V., Mylan I B.V., and Mylan II B.V. dated as of July 29, 2019.
`“Agency(ies)” means any government regulatory authority or authorities in the world
`responsible for granting approval(s), clearance(s), qualification(s), license(s), or permit(s)
`for any aspect of the research, Development, manufacture, marketing, distribution, or sale
`of a Product. The term “Agency” includes the FDA.
`“Authorized Generic Products” mean the authorized generic versions of each of the
`following products:
`“Medroxyprogesterone Products” mean the Products in Development or authorized
`1.
`for marketing or sale in the United States pursuant to the following FDA
`Authorizations: NDA No. 02046 and NDA No. 012541, and any supplements,
`amendments, or revisions to these NDAs;
`“Amlodipine/Atorvastatin Products” mean the Products in Development or
`authorized for marketing or sale in the United States pursuant to the following FDA
`Authorization: NDA No. 021540, and any supplements, amendments, or revisions
`to this NDA;
`“Phenytoin Products” mean the Products in Development or authorized for
`marketing or sale in the United States pursuant to the following FDA
`Authorization: ANDA No. 084427, and any supplements, amendments, or revisions
`to this ANDA;
`“Prazosin Products” mean the Products in Development or authorized for
`marketing or sale in the United States pursuant to the following FDA
`Authorization: NDA No. 017442, and any supplements, amendments, or revisions
`to this NDA; and
`“Spironolactone Products” mean the Products in Development or authorized for
`marketing or sale in the United States pursuant to the following FDA
`Authorization: NDA No. 012616, and any supplements, amendments, or revisions
`to this NDA.
`“Authorized Generic Product License” means an exclusive, royalty-free, fully paid-up
`right to market, promote, distribute, sell, and offer for sale a non-branded version of each
`of the Authorized Generic Products in the United States under the applicable FDA
`Authorization for a term of at least 10 years.
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`2.
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`3.
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`4.
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`5.
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`I.
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`J.
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`K.
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`L.
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`M.
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`“Business” means the research, Development, manufacture, commercialization,
`distribution, marketing, advertisement, importation, and sale of a Product.
`“Business Information” means all written information, wherever located or stored,
`relating to or used in a Divestiture Product Business, including documents, graphic
`materials, and data and information in electronic format. Business Information includes
`records and information relating to research and development (including copies of
`Product Development Reports), manufacturing, process technology, engineering, product
`formulations, production, sales, marketing (including Product Marketing Materials),
`logistics, advertising, personnel, accounting, business strategy, information technology
`systems, customers, customer purchasing histories, customer preferences, delivery
`histories, delivery routing information, suppliers and all other aspects of the Divestiture
`Product Business. For clarity, Business Information includes any Respondent’s rights
`and control over information and material provided by that Respondent to any other
`Person. Business Information includes Confidential Business Information.
`“cGMP” means current Good Manufacturing Practice as set forth in the United States
`Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and
`regulations promulgated by the FDA thereunder.
`“Confidential Business Information” means all Business Information that is not in the
`public domain.
`“Customer” means any Person that is either a direct purchaser or who negotiates price on
`behalf of a direct purchaser (e.g., group purchasing organization) of any Divestiture
`Product from a Respondent or the Acquirer.
`“Development” means all new chemical entity research, and all studies of the safety or
`efficacy of a Product, including test method development and stability testing;
`toxicology; bioequivalency; bioavailability; formulation; process development;
`manufacturing scale-up; development-stage manufacturing; quality assurance/quality
`control development; statistical analysis and report writing; conducting studies of the
`safety or efficacy of a Product for the purpose of obtaining any and all approvals,
`licenses, registrations or authorizations from any Agency necessary for the manufacture,
`use, storage, import, export, transport, promotion, marketing, labeling, and sale of a
`Product (including any government price or reimbursement approvals); Product Approval
`and registration; and regulatory affairs related to the foregoing. “Develop” means to
`engage in Development.
`“Direct Cost” means a cost not to exceed the cost of labor, material, travel, and other
`expenditures to the extent the costs are directly incurred to provide the relevant assistance
`or service. “Direct Cost” to the Acquirer for its use of any of a Respondent’s employees
`shall not exceed then-current average hourly wage rate for such employee.
`“Divestiture Agreements” mean:
`1. Asset Purchase Agreement by and between Mylan Pharmaceuticals Inc. and
`Prasco, LLC dated as of September 18, 2020; Authorized Generic License,
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`N.
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`O.
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`P.
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`Q.
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`R.
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`S.
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`T.
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`U.
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`Distribution, and Supply and Product Transfer Agreement by and between Pfizer
`Inc. and Prasco, LLC, dated as of September 18, 2020; Partial Assignment and
`Assumption Agreement by and between Upjohn US 2 LLC and Prasco, LLC, dated
`as of September 18, 2020; Product Transition Agreement by and between Upjohn
`Inc. and Prasco, LLC, dated as of September 18, 2020; Technology Transfer
`Agreement by and between Pfizer Inc. and Upjohn Inc. dated as of September 18,
`2020; Amendment to the Form of Manufacturing and Supply Agreement between
`Pfizer Inc., Upjohn Inc., and Mylan N.V. dated as of September 18, 2020;
`Amendment No. 3 to the Separation and Distribution Agreement by and between
`Pfizer Inc. and Upjohn Inc. dated as of September 18, 2020; and all amendments,
`exhibits, attachments, agreements to the above referenced agreements; and
`2. Any other agreement between a Respondent(s) and the Acquirer (or between a
`Divestiture Trustee and the Acquirer, or between Respondents for the benefit of the
`Acquirer) that has been approved by the Commission to accomplish the
`requirements of this Order.
`“Divestiture Assets” mean Respondents’ equitable and legal right, title, and interests in
`and to all tangible and intangible assets that are not Excluded Assets, wherever located,
`relating to a Divestiture Product Business, including the following:
`1. All Product Approvals and authorizations for the Divestiture Products, including all
`FDA Authorizations;
`2. All studies of the safety or efficacy of the Product;
`3. All Product Intellectual Property;
`4. At the option of the Acquirer, Product Manufacturing Equipment;
`5. All technological, scientific, chemical, biological, pharmacological, toxicological,
`regulatory materials and information, including studies of the safety, efficacy,
`stability, bioequivalency, bioavailability, and toxicology of a Product;
`6. All website(s), Domain Names, and social media sites related exclusively to the
`Divestiture Product and the content thereon related exclusively to the Divestiture
`Product, and the content related exclusively to the Divestiture Product that is
`displayed on any website that is not dedicated exclusively to the Divestiture
`Product;
`7. At the option of the Acquirer, Product Contracts;
`8. All Business Information;
`9. At the option of the Acquirer, all inventory and all ingredients, materials, or
`components used in the manufacture of the specified Divestiture Product in
`existence as of the Divestiture Date including, the active pharmaceutical
`ingredient(s), excipient(s), raw materials, packaging materials, work-in-process,
`and finished goods related to that Divestiture Product; and
`10. At the option of the Acquirer, the right to fill any or all unfilled Customer purchase
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`orders for the specified Divestiture Product as of the Divestiture Date.
`“Divestiture Date” means the date on which a Respondent (or a Divestiture Trustee)
`closes on a transaction to assign, grant, license, divest, transfer, deliver, or otherwise
`convey rights or assets related to a Divestiture Product to the Acquirer as required by
`Paragraph II of this Order.
`“Divestiture Products” means the:
`1. Authorized Generic Products;
`2. Eplerenone Products; and
`3. Gatifloxacin Products.
`“Divestiture Product Business” means the Business related to a Divestiture Product.
`“Divestiture Trustee” means the trustee appointed by the Commission pursuant to
`Paragraph X of this Order or Paragraph IX of the Order to Maintain Assets.
`“Domain Name” means the domain name(s) and the related uniform resource locator(s)
`and registration(s) thereof, issued by any Person or authority that issues and maintains the
`domain name registration.
`“Employee Information” means the following, for each Relevant Employee, as and to the
`extent permitted by law:
`1. With respect to each such employee, the following information:
`a. Name, job title or position, date of hire, and effective service date;
`Specific description of the employee’s responsibilities;
`b.
`c.
`Base salary or current wages;
`d. Most recent bonus paid, aggregate annual compensation for the relevant
`Respondent’s last fiscal year, and current target or guaranteed bonus, if any;
`Employment status (i.e., active or on leave or disability; full-time or part-
`time); and
`All other material terms and conditions of employment in regard to such
`employee that are not otherwise generally available to similarly situated
`employees; and
`2. At the option of the Acquirer, copies of all employee benefit plans and summary
`plan descriptions (if any) applicable to the Relevant Employees.
`“Eplerenone Products” mean the Products in Development or authorized for marketing or
`sale in the United States pursuant to the following FDA Authorization: ANDA 203896,
`and any supplements, amendments, or revisions to this ANDA.
`“Eplerenone Divestiture Assets” means all rights, title and interest in the Divestiture
`Product Business related to the Eplerenone Products, including all of the Divestiture
`Assets related to the Eplerenone Products.
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`e.
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`f.
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`W.
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`X.
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`Y.
`Z.
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`AA.
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`BB.
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`CC.
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`DD.
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`5.
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`“Excluded Assets” mean:
`1. Any real estate and the buildings and other permanent structures located on such
`real estate;
`2. Corporate names or corporate trade dress of a Respondent or the related corporate
`logos thereof; or the corporate names or corporate trade dress of any other
`corporations or companies owned or controlled by a Respondent or the related
`corporate logos thereof; or general registered images or symbols by which a
`Respondent can be identified or defined;
`3. The portion of any Business Information that contains information about any of a
`Respondent’s business other than a Divestiture Product Business, in those cases in
`which the redaction does not impair the usefulness of the information related to the
`Divestiture Product Business;
`4. Any original document that a Respondent has a legal, contractual, or fiduciary
`obligation to retain the original; provided, however, that Respondents shall provide
`copies of the document to the Acquirer and shall provide that Acquirer access to the
`original document if copies are insufficient for regulatory or evidentiary purposes;
`(i) Any tax asset relating to (a) the Divestiture Assets for pre-Divestiture Date tax
`periods or (b) any tax liability that any Respondent is responsible for arising out of
`the divestiture of the Divestiture Assets, (ii) all accounts receivable, notes
`receivable, rebates receivable and other miscellaneous receivables of any
`Respondent that are related to the Divestiture Product Business and arising out of
`the operation of the Divestiture Product Business prior to the Divestiture Date, and
`(iii) all cash, cash equivalents, credit cards and bank accounts of any Respondent;
`and
`6. Any records or documents reflecting attorney-client, work product or similar
`privilege of any Respondent or otherwise relating to the Divestiture Assets as a
`result of legal counsel representing any Respondent in connection with the
`divestiture of the Divestiture Assets pursuant to this Order or the Divestiture
`Agreements.
`“FDA” means the United States Food and Drug Administration.
`“FDA Authorization(s)” means all of the following: “New Drug Application” (“NDA”),
`“Abbreviated New Drug Application” (“ANDA”), “Supplemental New Drug
`Application” (“SNDA”), or “Marketing Authorization Application” (“MAA”), the
`applications for a Product filed or to be filed with the FDA pursuant to 21 C.F.R. Part 314
`et seq., and all supplements, amendments, and revisions thereto, any preparatory work,
`registration dossier, drafts and data necessary for the preparation thereof, and all
`correspondence between the holder and the FDA related thereto. “FDA Authorization”
`also includes an “Investigational New Drug Application” (“IND”) filed or to be filed with
`the FDA pursuant to 21 C.F.R. Part 312, and all supplements, amendments, and revisions
`thereto, any preparatory work, registration dossier, drafts and data necessary for the
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`EE.
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`FF.
`GG.
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`preparation thereof, and all correspondence between the holder and the FDA related
`thereto.
`“Gatifloxacin Product AG Assignment Agreement” means the Partial Assignment and
`Assumption Agreement by and between Upjohn US 2 LLC and Prasco, LLC, dated as of
`September 18, 2020.
`“Gatifloxacin Products” mean an authorized generic version of the Products in
`Development or authorized for marketing or sale in the United States pursuant to the
`following FDA Authorization: NDA #022548, and any supplements, amendments, or
`revisions to this NDA.
`“Levothyroxine Products” mean the Products in Development or authorized for
`marketing or sale in the United States pursuant to the following FDA Authorization:
`NDA No. 021301, and any supplements, amendments, or revisions to these NDAs
`“Licensed Intellectual Property” means; (i) all Product Manufacturing Technology that is
`used (but not exclusively, predominantly, or primarily used) in the manufacture of a
`Divestiture Product, and (ii) copyrights used (but not exclusively, predominantly, or
`primarily used), to commercialize, distribute, market, advertise, or sell any Divestiture
`Product as of the applicable Divestiture Date.
`“Manufacturing Designee” means any Person other than a Respondent that has been
`designated by the Acquirer to perform any part of the manufacturing process, including
`the finish or packaging of a Divestiture Product on behalf of that Acquirer.
`“Monitor” means any monitor appointed pursuant to Paragraph IX of this Order or
`Paragraph VIII of the Order to Maintain Assets, hereinafter, Monitor Paragraphs.
`“NDC Number(s)” means the National Drug Code number, including both the labeler
`code assigned by the FDA and the additional numbers assigned by the labeler as a
`product code and package size code for a specific Product.
`“Order Date” means the date on which the final Decision and Order in this matter is
`issued by the Commission.
`“Order to Maintain Assets” means the Order to Maintain Assets incorporated into and
`made a part of the Consent Agreement.
`“Orders” means this Decision and Order and the Order to Maintain Assets.
`“Patent(s)” means all patents and patent applications, including provisional patent
`applications, invention disclosures, certificates of invention and applications for
`certificates of invention, and statutory invention registrations, in each case filed, or in
`existence, on or before the Divestiture Date (except where this Order specifies a different
`time), and includes all reissues, additions, divisions, continuations, continuations-in-part,
`supplementary protection certificates, extensions and reexaminations thereof, all
`inventions disclosed therein, and all rights therein provided by international treaties and
`conventions.
`“Person” means any individual, partnership, joint venture, firm, corporation, association,
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`HH.
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`II.
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`JJ.
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`KK.
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`LL.
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`MM.
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`NN.
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`OO.
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`PP.
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`QQ.
`RR.
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`SS.
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`

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`TT.
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`UU.
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`VV.
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`WW.
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`trust, unincorporated organization, or other business or government entity, and any
`subsidiaries, divisions, groups, or affiliates thereof.
`“Prasco” means (i) Prasco, LLC, a limited liability company organized, existing and
`doing business under the laws of the State of Ohio with its executive offices and principal
`place of business located at 6125 Commerce Court, Mason, Ohio 45040; and (ii) any
`Person controlled by or under common control of Prasco, LLC.
`“Product(s)” means any pharmaceutical, biological, or genetic composition containing
`any formulation or dosage of a compound referenced as its pharmaceutically,
`biologically, or genetically active ingredient, or that is the subject of an FDA
`Authorization.
`“Product Approval(s)” means any approvals, registrations, permits, licenses, consents,
`authorizations, and other regulatory approvals, and pending applications and requests
`therefor, required by applicable Agencies, related to the research, Development,
`manufacture, distribution, finishing, packaging, marketing, sale, storage, or transport of a
`Product, and includes, without limitation, all approvals, registrations, licenses, or
`authorizations granted in connection with any FDA Authorization related to that Product.
`“Product Contracts” means all contracts, agreements, mutual understandings,
`arrangements, or commitments related to the Divestiture Product Business, including
`those:
`1. Pursuant to which any third party, including a Customer, purchases, or has the
`option to purchase, a Product from a Respondent or negotiates the purchase price
`on behalf of another Customer;
`2. Pursuant to which a Respondent had, or has as of the Divestiture Date, the ability to
`independently purchase the active pharmaceutical ingredient(s) or other necessary
`ingredient(s) or component(s), or had planned to purchase the active
`pharmaceutical ingredient(s) or other necessary ingredient(s) or component(s),
`from any third party for use in connection with the manufacture of a Product;
`3. Relating to any study of the safety or efficacy of a Product;
`4. With universities or other research institutions for the use of a Product in scientific
`research;
`5. For the marketing of a Product or educational matters relating solely to the
`Products;
`6. Pursuant to which a third party manufactures or plans to manufacture a Product as a
`finished dosage form on behalf of a Respondent;
`7. Pursuant to which a third party provides or plans to provide any part of the
`manufacturing process, including, without limitation, the finish or packaging of a
`Product on behalf of a Respondent;
`8. Pursuant to which a third party licenses any Product Intellectual Property or
`Product Manufacturing Technology related to a Product to a Respondent;
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`XX.
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`9. Pursuant to which a third party is licensed by a Respondent to use any of the
`Product Intellectual Property or Product Manufacturing Technology;
`10. Constituting confidentiality agreements involving a Product;
`Involving any royalty, licensing, covenant not to sue, or similar arrangement
`11.
`related to a Product;
`12. Pursuant to which a third party provides any specialized services necessary to the
`research, Development, manufacture, or distribution of a Product to a Respondent
`including, consultation arrangements; and
`13. Pursuant to which any third party collaborates with a Respondent in the
`performance of research, Development, marketing, distribution, or selling of a
`Product.
`“Product Development Reports” means information related to the Development of a
`Product, including:
`1. Pharmacokinetic study reports;
`2. Bioavailability study reports;
`3. Bioequivalence study reports;
`4. All correspondence, submissions, notifications, communications, registrations, or
`other filings made to, received from, or otherwise conducted with the FDA relating
`to the FDA Authorization(s);
`5. Annual and periodic reports related to the above-described FDA Authorization(s),
`including any safety update reports;
`6. FDA approved labeling or other Agency-approved labeling;
`7. Currently used or planned product package inserts (including historical change of
`controls summaries);
`8. FDA approved patient circulars;
`9. Adverse event reports, adverse experience information, and descriptions of material
`events and matters concerning safety or lack of efficacy;
`10. Summaries of complaints from physicians or other health care providers;
`11. Summaries of complaints from ultimate users of the Product;
`12. Summaries of complaints from Customers;
`13. Product recall reports filed with the FDA or any other Agency, and all reports,
`studies, and other documents related to such recalls;
`Investigation reports and other documents related to any out of specification results
`for any impurities or defects found in any Product;
`15. Reports from any Person (e.g., any consultant or outside contractor) engaged to
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`11
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`14.
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`investigate or perform testing for the purposes of resolving any Product or process
`issues, including, without limitation, identification and sources of impurities or
`defects;
`16. Reports from vendors of the component(s), active pharmaceutical ingredient(s),
`excipient(s), packaging component(s), and detergent(s) used to produce any
`Product that relate to the specifications, degradation, chemical interactions, testing,
`and historical trends of the production of any Product;
`17. Analytical methods development records;
`18. Manufacturing batch or lot records;
`19. Stability testing records;
`20. Change in control history; and
`21. Executed validation and qualification protocols and reports.
`“Product Intellectual Property” means intellectual property of any kind (other than
`Licensed Intellectual Property), that is owned, licensed, held, or controlled by a
`Respondent as of the Divestiture Date, including Patents, patent applications, trademarks,
`service marks, copyrights, trade dress, commercial names, internet web sites, internet
`domain names, inventions, discoveries, know-how, trade secrets, and proprietary
`information.
`“Product Manufacturing Equipment” means equipment that is being used, or has been
`used to manufacture the specified Divestiture Product.
`“Product Manufacturing Technology” means all technology, trade secrets, know-how,
`formulas, and proprietary information (whether patented, patentable, or otherwise) related
`to the manufacture of a Product, including the following: all product specifications,
`processes, analytical methods, product designs, plans, ideas, concepts, manufacturing,
`engineering, and other manuals and drawings, standard operating procedures, flow
`diagrams, chemical, safety, quality assurance, quality control, research records, clinical
`data, compositions, annual product reviews, regulatory communications, control history,
`current and historical information associated with the conformance of any Product
`Approvals, conformance with any Agency requirements, and cGMP compliance, labeling
`and all other information related to the manufacturing process, and supplier lists.
`“Product Marketing Materials” means all marketing materials used specifically in the
`marketing or sale of the specified Divestiture Product in the United States as of the
`Divestiture Date that are owned or controlled by a Respondent, including, without
`limitation, all advertising materials, training materials, product data, mailing lists, sales
`materials (e.g., detailing reports, vendor lists, sales data), marketing information (e.g.,
`competitor information, research data, market intelligence reports, statistical programs (if
`any) used for marketing and sales research), Customer information (including Customer
`net purchase information to be provided on the basis of dollars and units for each month,
`quarter or year), sales forecasting models, educational materials, advertising and display
`materials, speaker lists, promotional and marketing materials, website content, artwork
`
`12
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`YY.
`
`ZZ.
`
`AAA.
`
`BBB.
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`CCC.
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`DDD.
`
`EEE.
`
`FFF.
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`for the production of packaging components, television masters, and other similar
`materials related to the specified Divestiture Product.
`“Product Releasee(s)” means any of the following Persons:
`1. The Acquirer;
`2. A