The National Law Forum

The Blog of the The National Law Review

Shaking Down the Thunder From the Sky: Notre Dame’s Challenge to the Contraception Mandate

For the second time in as many years, the Seventh Circuit has declined to grant Notre Dame’s request for an injunction exempting the university from the contraception requirements of the Affordable Care Act

As was true back in 2014, the court remained skeptical of the link between Notre Dame’s actions (filling out a form noting its religious objections to contraceptives and sending the form to its insurance administrator) and the resulting actions (the administrator then providing the contraceptives directly to the insured). Consequently, the court ruled that Notre Dame did not meet its burden of showing that its religious beliefs were substantially burdened by the contraceptive mandate. Judge Posner wrote the majority opinion, which Judge Hamilton joined while writing a separate concurrence.

The case was back before the Seventh Circuit following the Supreme Court’s vacating of the Seventh Circuit’s 2014 opinion with directions to review the case in light of the Court’s Hobby Lobby opinion. (Odd, then, that the Seventh Circuit’s decision does not begin discussing Hobby Lobby until page 18 and discusses the case for little more than a page in a 25-page opinion.) The court concluded in short order that Hobby Lobby had virtually no application in Notre Dame’s case: In Hobby Lobby, a private sector employer wanted to receive the accommodation afforded to religious organizations, whereas Notre Dame argued that the accommodation itself was insufficient to protect its religious beliefs.

As in the original opinion, Judge Flaum strongly dissented. He once again argued that the majority was inappropriately judging the sincerity of Notre Dame’s beliefs, something he believes was foreclosed by the Hobby Lobby decision.

Perhaps most noteworthy about this opinion is that—nearly 18 months after Notre Dame filed suit—the decision simply affirmed the denial of a preliminary injunction. As both Judge Posner’s majority opinion and Judge Hamilton’s concurrence note, the record is still barren of the kinds of facts that a trial will bring out—and that could allow Notre Dame to introduce more evidence of the religious burden the contraceptive provisions of the Affordable Care Act place on the school. Yet it seems likely that before that trial occurs, Notre Dame will again petition the Supreme Court to review the Seventh Circuit’s opinion. And given the Court’s willingness to weigh in on these issues, the thunderstorm shows no signs of letting up.

© 2015 Foley & Lardner LLP

New Chicago Affordable Housing Ordinance Means Greater Costs for Developers

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The Chicago City Council recently passed an amendment to the existing Affordable Requirements Ordinance (the 2015 ARO), which will increase the cost to develop most affordable housing projects in Chicago.  With the passage of the 2015 ARO, developers must now provide on-site or off-site affordable housing in addition to the in lieu fees which makes it impossible for developers to circumvent the purpose of the affordable housing requirements mandated by the ordinance.  In addition, the 2015 ARO significantly increases the in lieu fees that developers must pay in order to satisfy the requirements of the ordinance.

The Affordable Requirements Ordinance was enacted in 2003 and revised in 2007 to expand access to housing for low-income and moderate-income households and to preserve the long-term affordability of such housing in the Chicago.  Housing is considered “affordable” if the sales price or rent for the housing unit does not total more than a certain percentage of a family’s household income.  To qualify for affordable housing, the household must make at or below a certain percentage of an area’s median income as established by the Department of Housing and Urban Development.

Before the 2015 ARO, developers could pay an “in lieu fee” in the amount of $100,000.00 for every affordable unit they elected not to include in their projects to completely satisfy the affordable housing requirements.

You can click here for a complete summary of the 2015 ARO.  It is a quick reference guide for anyone considering the development of residential projects in Chicago.

Application

The 2015 ARO applies to residential projects that contain ten (10) or more residential units and satisfy one of the following requirements:

  • The project receives a zoning change that permits a higher floor area ratio, changes the use from non-residential to residential or permits residential uses on ground floors where that use was not previously allowed;

  • The project includes land that was purchased from the City of Chicago;

  • The project received financial assistance from the City of Chicago; or

  • The project is part of a planned development in a downtown zoning district.

Minimum Percentages of Affordable Housing

While there are certain exemptions, the 2015 ARO creates minimum percentages for affordable units in projects as follows:

  • Rezoning – In the case of a rezoned property, the developer is required to designate 10% of the units in the project as affordable housing (or 20% if the developer receives financial assistance from the City of Chicago).  Financial assistance from the City of Chicago includes grants, direct or indirect loans or allocation of tax credits to the development.

  • City Land Sales – Where the City of Chicago sells property to a developer and such property is subsequently developed for residential purposes or is incorporated into a residential housing project site in order to satisfy City of Chicago Municipal Code requirements, the developer must designate no less than 10% of the units in the project as affordable housing (or 20% if the developer receives financial assistance from the City of Chicago).

  • Existing Buildings | Zoning Change – Where there is an existing building that contains housing units at the time of an approved zoning change or an existing building that contains a mixed-use occupancy with use being residential at the time of an approved zoning change, only the additional housing units permitted under the rezoning are subject to the affordable housing requirements of the ordinance.  However, in the event the developer has received financial assistance from the City of Chicago, then the entire building is subject to the affordable housing requirements of the ordinance.

Additional Considerations for Affordable Housing Units by Project Location

Compliance with the ordinance will depend on the area where the project is located:

1.  Low-Moderate Income Areas 

  • For low-moderate income areas (designated by the City of Chicago Department of Planning and Development), a developer must provide at least 25% of the required affordable units on-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site affordable housing units; (b) paying an in lieu fee in the amount of $50,000.00 per unit; or (c) any combination of (a) and (b).

2.  Higher Income Areas 

  • In higher income areas (those areas that are not designated as low-moderate income areas), the developer must provide at least 25% of the required affordable units on-site or off-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site or off-site affordable units; (b) paying an in lieu fee in the amount of $125,000.00 per unit; or (c) any combination of (a) and (b).

  • All off-site units must be located within a two (2) mile radius of the residential housing project at issue and in the same or a higher income area or in a district zoned “D” (downtown district) under the City of Chicago Zoning Ordinance.

3.  Rental Units in Downtown Districts

  • In downtown districts and planned developments in a downtown district (zoned “D”), a developer of rental units must provide at least 25% of the required affordable rental units on-site or off-site.

  • For the remaining 75% of the required affordable housing units, the developer has the option of satisfying the requirements of the ordinance by (a) establishing additional on-site or off-site affordable units; (b) paying an in lieu fee; or (c) any combination of (a) and (b).

  • The in lieu fee is $140,000.00 per unit through and including the first anniversary of the publication date of the ordinance in the Journal of the Proceedings of the City Council of the City of Chicago.  The in lieu fee is increased to $175,000.00 thereafter.

  • All off-site units must be located within a two (2) mile radius of the residential housing project at issue and in the same or a higher income area or in a district zoned “D” (downtown district) under the City of Chicago Zoning Ordinance.

4.  Owner-Occupied Units in Downtown Districts 

  • In downtown districts and planned developments in a downtown district (zoned “D”), a developer of owner-occupied units (i.e., condominiums) may establish affordable housing in the following ways: (a) establishing affordable owner-occupied units as part of the residential housing project; (b) establishing off-site affordable owner-occupied units; (c) paying an in lieu fee; or (d) any combination of (a), (b) and/or (c).

  • The in lieu fees are the same as rental units in downtown districts; however, in the event the developer elects not to provide a minimum of 25% of the required affordable owner-occupied units either on-site or off-site, the in lieu fee shall be increased to $160,000.00 per unit through and including the first anniversary of the publication date and $225,000.00 per unit thereafter.

  • Off-site affordable owner-occupied units may be located anywhere in the City of Chicago, subject to the Department of Planning and Development’s approval.

In summary, the 2015 ARO has significantly increased a developer’s cost to develop residential units in the City of Chicago.  It also mandates that affordable housing units be built even if it is off-site.  It remains to be seen if these new laws will in fact inhibit developers from constructing residential projects in the City of Chicago.  To learn more about 2015 ARO and its implications for your business, contact a member of the Much Shelist Real Estate practice group.

© 2015 Much Shelist, P.C.
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Patent Safe Harbor Applies To Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application andCitizen’s Petition. However, the Federal Circuit remanded the case to the district court to determine whether other allegedly infringing activities, such as using the information to file a patent application, also were shielded by the statute.

The Claims At Issue

The patent at issue was Classen’s U.S. 6,584,472, directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing the new use. Claim 36 (which depends from claim 33, which was canceled during reexamination) is representative of the asserted method claims, and claim 59 is representative of the asserted kit claims:

33. A method for creating and using data associated with a commercially available product, wherein the method comprises the steps of:
accessing at least one data source, comprising together or separately, adverse event data associated with exposure to or use of the product and commercial data regarding marketing, sales, profitability or related information pertaining to the product;
analyzing the accessed data to identify (i) at least one new adverse event associated with exposure to or use of the product, (ii) at leastone new use for the product responsive to identification of the at least one new adverse event, and (iii) the potential commercial value of the at least one new use for the product; and
commercializing the newly identified product information based upon the analyzed data.

36.  The method of claim 33, wherein the commercializing step comprises formatting the data relating to at least one new adverse event associated with exposure to, or use of the product, or documenting same, such that a manufacturer or distributor of the product must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product.

59.  A proprietary kit comprising (i) product and (ii) documentation notifying a user of the product of at least one new adverse event relating to the product, wherein determination of the new adverse event is based upon the data provided by the method of claim 36.

Footnote 1 of the Federal Circuit decision states, “Because issues of validity are not before us in this appeal, we express no opinion as to whether the asserted claims cover patent ineligible subject matter in light of the Supreme Court’s decision in Alice Corp. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014).”

Procedural Background

Classen asserted U.S. Patent No. 6,584,472 against Elan, alleging that Elan infringed the patent by (i) studying the effect of food on the bioavailability of the FDA-approved muscle relaxant Skelaxin, (ii) using the clinical data to identify a new use for the drug, and (iii) commercializing the new use. In particular, after Skelaxin was approved, Elan conducted clinical studies on the effect of the drug when administered with or without food, and then submitted the results to the FDA when seeking approval of a supplemental New Drug Application (“sNDA”) to revise the labeling for Skelaxin and in a Citizen’s Petition proposing changes to the approval requirements for generic versions of Skelaxin. Additionally, Elan filed patent applications based on the new clinical data and sold kits with the revised label containing information derived from the data.

The U.S. District Court for the District of Maryland granted Elan’s motion for summary judgment of non-infringement, finding that Elan’s activities were “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act (FDCA), and were therefore protected by the safe harbor provision of 35 U.S.C. § 271(e)(1). Classen appealed to the Federal Circuit.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Lourie and joined by Chief Judge Prost and District Judge Gilstrap (of the Eastern District of Texas) sitting by designation.

On appeal, Classen argued that Elan’s activities are not exempt under the safe harbor because they involved merely “routine” post-approval reporting to the FDA, which the Federal Circuit held in its 2011 decision in Classen Immunotherapies, Inc. v. Biogen IDEC lies outside the scope of the § 271(e)(1) safe harbor.

This statute provides in relevant part:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .

In Classen v. Biogen, the court indicated that the safe harbor applies only to pre-marketing activities, and held that the safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” However, a year later in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor can shield post-approval activities from giving rise to liability for patent infringement where the information submitted to the FDA “is necessary both to the continued approval of the ANDA and to the ability to market the … drug.” Thus, it is not surprising that in this case the Federal Circuit noted that the statutory language does not “categorically exclude post-approval activities from the ambit of the safe harbor.”

Turning to the activities at issue, the Federal Circuit found that post-approval studies conducted to support an sNDA “serve similar purposes as pre-approval studies in ensuring the safety and efficacy of approved drugs.” Thus, the court reasoned, “As an integral part of the regulatory approval process, those activities are ‘reasonably related to the development and submission of information’ under the FDCA, 35 U.S.C. § 271(e)(1), and are therefore exempt from infringement liability.” The court  therefore concluded that the post-approval clinical trials, sNDA and Citizen’s Petition “clearly fall within the scope of the safe harbor.”

Although the Federal Circuit remanded to the district court to determine whether Elan’s activities related to “reanalyzing the clinical data to identify patentable information and filing patent applications are commercial activities outside the scope of the safe harbor,” and whether “selling Skelaxin with the revised label that contained the information derived from the clinical study” infringed the Classen kit claims, the court took it upon itself to “assist the district court in its analysis of infringement . . . [by] mak[ing] the following observations of the record:”

  • Filing a patent application is generally not an infringement of a patent

  • Filing a patent application is not commercialization of an invention, and so a method claim requiring commercialization is likely not infringed by Elan’s actions

  • Placing information submitted to the FDA on a product label generally cannot be an act of infringement.

Given these “observations,” it seems unlikely that the district court will find that Elan infringed the claims at issue.

The Wide Mouth of the Safe Harbor

This decision is one of many Federal Circuit decisions that broadly construe the safe harbor of § 271(e)(1). Indeed, less than one year after the court seemed to draw a bright line around the scope of the safe harbor that excluded post-approval activities, the court blurred that line in Momenta and now it has erased it further in this case.

The Commercial Value of Patent Applications

Although the Federal Circuit’s “observation” that filing a patent application generally is not an act of infringement may be correct, we question its suggestion that filing a patent application is not a commercial activity. To the contrary, filing a patent application can be an essential step of a commercialization plan, and can increase the commercial value of the invention. On the other hand, we would agree that it is unusual that a patent could be infringed by “commercializing … information,” as recited in the Classen patent.

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U.S. Supreme Court’s Wynne Decision Calls New York’s Statutory Resident Scheme into Question

On May 18, the U.S. Supreme Court issued its decision inComptroller of the Treasury of Maryland v. Wynne. In short, the Court, in a five-to-four decision written by Justice Alito, handed the taxpayer a victory by holding that the county income tax portion of Maryland’s personal income tax scheme violated the dormant U.S. Constitution’s Commerce Clause.

Specifically, the Court concluded that the county income tax imposed under Maryland law failed the internal consistency test under the dormant Commerce Clause, because it is imposed on both residents and non-residents with Maryland residents not getting a credit against that Maryland local tax for income taxes paid to other jurisdictions (residents are given a credit against the Maryland state income tax for taxes paid to other jurisdictions).

The Supreme Court emphatically held (as emphatically as the Court can be in a five-to-four decision) that the dormant Commerce Clause’s internal consistency test applies to individual income taxes. The Court’s holding does create a perilous situation for any state or local income taxes that either do not provide a credit for taxes paid to other jurisdictions or limit the scope of such a credit in some way.

The internal consistency test—one of the methods used by the Supreme Court to examine whether a state tax imposition discriminates against interstate commerce in violation of the dormant Commerce Clause—starts by assuming that every state has the same tax structure as the state with the tax at issue. If that hypothetical scenario places interstate commerce at a disadvantage compared to intrastate commerce by imposing a risk of multiple taxation, then the tax fails the internal consistency test and is unconstitutional.

Although the Wynne decision does not address the validity of other taxes beyond the Maryland county personal income tax, the decision does create significant doubt as to the validity of certain other state and local taxes such as the New York State personal income tax in the way it defines “resident.” New York State imposes its income tax on residents on all of their income and on non-residents on their income earned in the state; this is similar to the Maryland county income tax at issue in Wynne.

“Resident” is defined as either a domiciliary of New York or a person who is not a domiciliary of New York but has a permanent place of abode in New York and spends more than 183 days in New York during the tax year. N.Y. Tax Law § 605. (New York City has a comparable definition of resident.) N.Y.C. Administrative Code § 11-1705. Thus a person may be taxed as a statutory resident solely because they maintain living quarters in the state and spend more than 183 days in the state, even if those days have absolutely nothing to do with the living quarters; this category of non-domiciliary resident is commonly referred to a “statutory resident.” As such, under New York’s tax scheme, a person can be a resident of two states—where domiciled and where a statutory resident—and thus be subject to taxation on all of their income in both states.

Although New York State grants a credit to residents for taxes paid to another jurisdiction, that credit is only for taxes paid “upon income derived” from those other jurisdictions. N.Y. Tax Law § 620. As such, New York State does not grant a credit for taxes paid to another jurisdiction on income earned from intangible property, such as stocks, because income earned from intangible property is not ‘derived from’ any specific  jurisdiction.

To illustrate using an example, suppose an investment banker is unquestionably a domiciliary of New Jersey and has an apartment, i.e., permanent place of abode, in New York that he uses only occasionally. Further, suppose that the investment banker spends more than 183 days in New York during a tax year by going to his office in New York on most workdays. In such a case, the investment banker is a resident of both New Jersey and New York and subject to tax as a resident in both states on his entire worldwide income. New York does not give a credit for taxes paid to New Jersey on income derived from intangible property, and thus the investment banker pays tax on this income twice, once to New Jersey and once to New York, clearly disadvantaging interstate commerce and resulting in double taxation.

This is not some hypothetical example. This is actually the fact pattern in In the Matter of John Tamagni v. Tax Appeals Tribunal of the State of New York, 91 N.Y.2d 530 (1998). In that case, the New York Court of Appeals (New York State’s highest court) held that New York State’s taxing scheme did not violate the dormant Commerce Clause and did not fail the internal consistency test. The validity of the Court of Appeals’ decision is seriously called into question under the Wynne case.

The Court of Appeals, relying upon Goldberg v. Sweet, held that the dormant Commerce Clause did not apply to residency-based taxes because those taxes were not taxing commerce, but rather a person’s status as a resident. However, the U.S. Supreme Court’s decision in Wynne not only repudiates the very dicta from Goldberg v. Sweet cited by the New York Court of Appeals in Tamagni, but the U.S. Supreme Court also determined that even if a state has the power to impose tax on the full amount of a resident’s income, “the fact that a State has the jurisdictional power to impose a tax [under the Due Process clause of the Constitution] says nothing about whether that tax violates the Commerce Clause.” After Wynne, it is clear that the dormant Commerce Clause applies to residency-based personal income taxes.

The second reason that the vitality of the Tamagni decision is in question is its application of the internal consistency test. The Court of Appeals held that even if the dormant Commerce Clause applied, the internal consistency test was not violated because the tax at issue was imposed upon a purely local activity and thus could not violate the Complete Auto tests. However, as discussed above, New York State’s lack of a credit for taxes paid to other jurisdictions mirrors the lack of a credit under Maryland’s county income tax scheme.

New York State taxpayers should be cognizant of the Wynnedecision and should consider filing refund claims if they have paid— or will pay—tax to New York State as a statutory resident (i.e., not as a New York domiciliary). One would expect the New York State Department of Taxation and Finance to be quite resistant to granting such refunds and likely to vigorously defend the existing taxing scheme.

It may be worthwhile to note that this problem of double taxation was acknowledged and addressed in an agreement executed in October 1996 by the heads of the revenue agencies of Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont. Under that agreement, the “statutory resident” state would provide a credit for the taxes paid by the individual on his or her investment income to his/her state of domicile. Unfortunately, that agreement was never implemented through legislation— maybe now is the time for that to be done.

Finally, a word about New York City: New York City imposes a personal income tax on residents, allowing no credit for taxes paid to other jurisdictions. However, New York City does not impose a tax on non-residents, making its personal income tax different than the Maryland county income tax. Thus, the constitutionality of the New York City personal income tax is not specifically addressed by the U.S. Supreme Court’s decision. However, similar to the New York State definition of resident, a person can be a resident in two different jurisdictions under the New York City definition of resident. As such, New York City’s personal income tax could be imposed twice on a person if the person is a domiciliary of one state and a statutory resident in another. Thus, the tax potentially fails the internal consistency test.

© 2015 McDermott Will & Emery
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As Drones Hit the Sky Lawsuits Predicted to Fly

The rise of Unmanned Aerial Vehicles (“UAV”), also known as drones, is well-documented.  In fact, the global market for non-military drones has recently been estimated as a $2.5 billion industry that is growing at approximately 15 to 20 percent annually.  See Clay Dillow, Get Ready for ‘Drone Nation,’ Fortune, Oct. 27, 2014.  Companies large and small are heavily investing in drone technology and generating business capabilities based on their potential.

While some of the most highly publicized forays into drone usage include Fortune 500 shipping companies – such as Amazon investigating the potential use of drones for their delivery service – less publicized industries are ripe for drone operation.  These industries include agriculture, construction, energy, and mining.  Id.  All of which are industries in which it is easy to imagine the benefits of aerial data.

In fact, the Association for Unmanned Vehicle Systems International predicts that eventually 80 percent of the commercial drone market will relate to agriculture.  See Christopher Doering, Growing Use of Drones Poised to Transform Agriculture, USA Today, Mar. 23, 2014.  This is because a drone’s ability to assist farmers in identifying and analyzing insect problems, watering issues, crop yield, missing cattle, and fertilizing make for a natural union with the industry.

While some farmers may purchase and operate their own drones, it is expected that specialized companies will fill this demand.  One such company is goFarm LLC (“goFarm”)[1], a Michigan-based agri-data business – one of the few companies authorized by the Federal Aviation Administration to legally operate commercial drones in this arena.  GoFarm performs field surveys by drones operating at low altitudes that collect imagery in visible and non-visible bands to determine health of crops.  By analyzing hundreds or thousands of images, goFarm performs detailed assessments of the condition of entire fields and individual plants.

Whether such data is collected by end-user farmers or by specialized third-party companies such as goFarm, all individuals and companies involved need to be cognizant that with great opportunity also comes risk.

Beyond, the obvious risks of property damage that could result from wayward drones, many jurisdictions have, or are in the process of, passing legislation aimed at addressing privacy concerns.  The most recent example of such legislation comes out of Florida.  On May 14, 2015, Florida Governor Rick Scott signed a drone privacy bill into law.  This bill establishes a private right of action for people photographed in their homes by drones without their consent.  Some speculate that this legislation will trigger a wave of litigation.  See Carolina Bolado, New Fla. Drone Privacy Law Could Trigger Litigation Wave, Law360, May 15, 2015.

Legislation similar to that passed in Florida creates substantial risk to drone based companies, even those operating in rural locations typically associated with industries such as agriculture and mining. GoFarm’s Chief Technology Officer, Eric Silberg, explains that “when conducting their assessments, in order to ensure adequate coverage, inevitably pictures are taken of the areas directly surrounding the field goFarm operators are contracted to assess.  These pictures may include property that does not belong to goFarm’s customer, even if the drone never flies over land not belonging to the customer.  This extraneous data is removed during the analysis process, and is not available in any product.”  While companies utilizing drones for photographic purposes will need to alter their operations to comply with any local rules and regulations, inadvertent photographs could result in litigation exposure.

In order to protect themselves from privacy related claims, as well as other liability exposures, companies utilizing drones need to assess their insurance portfolios to ensure adequate coverage.  In particular, companies need to analyze the breadth of their liability policies, including the language of any potentially applicable exclusion contained therein – such as exclusions associated with aviation risk.  This analysis should be conducted with the help of an experienced insurance broker and/or insurance coverage counsel.

In the event that the company’s liability policies are deemed not broad enough to cover its contemplated operations, the company should investigate purchasing UAV coverage.  Given the relative infancy of the drone market, insurance companies are developing and releasing new products associated with drone activity at a breakneck speed.  Consequently, coverages and pricing will likely vary across carriers.  Risk managers should speak with their insurance experts to ensure that an appropriate and cost-effective insurance solution is identified and implemented.


[1] http://www.gofarminc.com.

© 2015 Gilbert LLP
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